A literature review and background analysis to
support the review of accessory products listed
under Group 9 of the Stoma Appliance Scheme
Schedule
Prepared for the Australian Government Department of Health
by the Centre for Health Services Research,
University of Tasmania
May 2014
1
ACKNOWLEDGEMENTS
This project is funded by the Australian Government Department of Health. The information and opinions contained in it do not
necessarily reflect the views or policy of the Australian Government or the Department of Health.
Disclosures: Dr Kelly Shaw and Dr Paul Woodhouse are senior consultants with KP Health.
CITATION
Roberts A, Shaw K, Woodhouse P. A literature review and background analysis to
support the review of accessory products listed under Group 9 of the Stoma
Appliance Scheme Schedule: a report prepared for the Australian Government by
the Centre for Health Services Research, University of Tasmania. May 2014.
Centre for Health Services Research
School of Medicine
University of Tasmania
Level 1, Medical Science 1
17 Liverpool Street
Hobart TAS Australia
T +61 3 6226 4757
F +61 3 6226 4816
W http://www.utas.edu.au/medicine/medicine/research/chsr
2
TABLE OF CONTENTS
Executive Summary .............................................................................................................. 5
Key findings ....................................................................................................................... 5
Conclusions ....................................................................................................................... 7
Introduction ........................................................................................................................... 8
This project ........................................................................................................................ 8
This report ....................................................................................................................... 11
The context for stoma accessory use .................................................................................. 11
Use of accessories in stoma management ...................................................................... 13
Project methods .................................................................................................................. 17
Project results ..................................................................................................................... 18
The effectiveness of Group 9 accessories ....................................................................... 18
The cost-effectiveness of Group 9 accessories ............................................................... 21
Discussion .......................................................................................................................... 36
Appendix 1 - A systematic review of the peer-reviewed and 'grey' literature........................ 45
Criteria for considering publications for inclusion ............................................................. 45
Databases searched........................................................................................................ 45
Criteria for inclusion and exclusion of studies .................................................................. 48
Critical appraisal and data extraction ............................................................................... 49
Assimilation and interpretation of the body of evidence ................................................... 50
Evidence statements for peer-reviewed studies............................................................... 50
Part A: Results from the peer-reviewed literature ................................................................ 51
Level of evidence of included references ......................................................................... 53
Systematic reviews identified in the peer-reviewed literature ........................................... 53
Other publications identified in the peer-reviewed literature ............................................. 55
1. Skin care and protection accessories .............................................................................. 56
2. Stoma support garments ................................................................................................. 62
3. Cleansers and adhesive removal accessories................................................................. 65
4. Deodorisers and gas suppressants ................................................................................. 68
5. Skin fillers and adhesive products ................................................................................... 71
Summary of the main results from the peer-reviewed literature ....................................... 75
Overall completeness and applicability of the evidence ................................................... 75
Quality of the evidence .................................................................................................... 75
Potential biases in the systematic review process ........................................................... 76
3
Conclusions ..................................................................................................................... 76
Part B - Results from the 'grey' literature ............................................................................. 77
'Grey' literature database searches ................................................................................. 77
Position papers................................................................................................................ 78
Guidelines and best practice manuals ............................................................................. 78
International stoma schemes ........................................................................................... 82
Conclusions ..................................................................................................................... 88
Attachment 1 (Appendix 1): Characteristics of excluded publications .............................. 90
Attachment 2 (Appendix 1): Included 'grey' literature ....................................................... 93
Attachment 3 (Appendix 1): References from peer-reviewed literature review ................. 96
Appendix 2 - Analysis of available financial information regarding Group 9 products ........ 102
Introduction ................................................................................................................... 102
Sub-group price comparison.......................................................................................... 103
Financial studies identified in searches of peer-reviewed literature................................ 126
4
Executive Summary
The Stoma Appliance Scheme (SAS) is an Australian Government program that assists
eligible people with stomas to better manage their condition by providing subsidised access
to a range of different stoma-related products.
The Department engaged the Centre for Health Services Research, University of Tasmania,
to perform a literature review and background analysis to support the SAS Schedule Group
9 - Accessories Review. Group 9 of the Schedule is a collection of miscellaneous products
used to support the clinical management of both paediatric and adult patients with a stoma.
Evidence about Group 9 SAS products was compiled from all identifiable information
sources in order to describe the clinical appropriateness and relevance of these products for
any described outcome in patients with a stoma. The project methods comprised:

A systematic review of the peer-reviewed literature;

A systematic review of the 'grey' literature; and

An analysis of available financial information regarding Group 9 products.
Key findings
We identified a small, methodologically limited body of evidence regarding the effectiveness
of stoma accessories. As a result, firm conclusions about the effectiveness and costeffectiveness of Group 9 products cannot be drawn from the available literature.
Our comprehensive search of the peer-reviewed literature identified 13 references.
Accessories for which outcomes information was available included skin care and protection
accessories (five studies), stoma support garments (one study), cleansers and adhesive
removal accessories (three studies), deodorisers (one study) and skin fillers and adhesive
products (five studies). Some publications provided information regarding more than one
class of accessory. The effectiveness of all sub-groups of accessories within Group 9 of the
Schedule was unable to be determined from the available studies.
The level of evidence of included studies was generally low and the quality of included
studies was poor. One study was a systematic review that included randomised controlled
trials (RCTs); however this study did not identify RCTs that were relevant to Group 9
accessories in spite of searching for relevant RCTs. In addition, we identified one RCT, one
nested diagnostic study conducted within a cohort study and one case series. All other
studies were not able to be rated against the National Health and Medical Research
Council's levels of evidence.
Our search of the 'grey' literature identified 27 materials of broad relevance to stoma
accessories. Of these, 11 publications were documentation from international stoma
schemes, nine publications related to accessory product pricing, three publications were
guidelines / best practice manuals, two publications were consensus statements and two
publications were position papers. These materials provided information regarding stoma
schemes in other countries including product costs, limits in quantities of Group 9 accessory
5
products supplied to consumers in other countries and guidelines that are in place in other
countries to inform use of Group 9 accessories.
Guideline developers internationally confirm the results of our systematic review and have
also noted a paucity of published studies of the effectiveness of stoma accessories.
Published guidelines are based largely on the opinions of clinicians in the stoma field rather
than on empirical evidence. Further, industry sponsorship of panel members involved in
developing guidelines is common and introduces a significant risk of bias in the guideline
development process.
In the absence of data regarding the effectiveness of accessories, cost-effectiveness of
these products is unable to be assessed. We therefore conducted a comparative analysis of
SAS accessory costs compared with other domestic and international product schemes. Our
analysis demonstrates that sub-groups of accessories on the SAS Schedule split neatly into
two categories in terms of the overall cost of the sub-group and the growth in costs over the
past five years. The first category are the sub-groups with a high total cost, high growth and
dynamic changes in market share of products within the sub-group (adhesive barriers (a),
adhesive removers / cleansers and adhesive removal (d), hernia belts (h), protective films (k)
and seals (l)). The second category comprises the sub-groups with lower total cost, low
annual growth and stable product mixes.
We identified that new products are more commonly introduced in the high cost, high growth
sub-groups and quickly achieve a significant share of the product market. This was in spite
of an absence of published studies in the public domain that demonstrate the effectiveness
of the new product. Further, there were no studies of comparative effectiveness that indicate
substitution of an established product with a newer product is justified by published evidence
of improved effectiveness of the newer product.
We found that the SAS price of some high cost products exceeds international comparator
product costs. There are five products from sub-group seals (l), three in adhesive barriers
(a), one in adhesive removers / cleansers and adhesive removal (d), one in hernia belts. The
international comparator cost for these products is $1.9 million less in total than the SAS
cost in 2012-13 dollars and suggest that cost savings may be achieved through achieving a
purchase price for these products that is equivalent to the product price in comparator
schemes.
Limits to the quantity of Group 9 accessories provided to consumers are specified in the
SAS Schedule. Some international stoma guideline documents also specify limits to the
quantity of stoma products that are provided to consumers. Overall, limits to product
quantities specified in the SAS Schedule are consistent with limits in international schemes.
No studies were identified that indicated product limits were inappropriate or had any
adverse impact on patient outcomes.
6
Conclusions
We formulated the following conclusions regarding the effectiveness and cost-effectiveness
of Group 9 accessories on the SAS Schedule and how these may be determined into the
future.
Conclusion 1
A requirement for level 2 evidence or higher for the listing of new accessory products on the
Group 9 SAS Schedule would enable a more detailed assessment of the effectiveness and
cost-effectiveness of Group 9 accessories to be performed into the future.
Conclusion 2
A review of current purchasing arrangements for high cost products with a comparator price
that is lower than the current SAS price would confirm that the purchasing arrangements for
these products are efficient.
Conclusion 3
Limits to product quantities specified in the SAS are consistent with limits in international
schemes.
Conclusion 4
There is an absence of evidence that Group 9 accessory products are either effective or
ineffective, and therefore insufficient information to suggest changes to the range of
accessory product types on Group 9 of the SAS based on this review alone.
7
Introduction
The Stoma Appliance Scheme (SAS) is an Australian Government program that assists
eligible people with stomas to better manage their condition by providing subsidised access
to a range of different stoma-related products.
The SAS commenced operation in 1975 and is legislated under Section 9A of the National
Health Act (1953).
The Australian Government Department of Health ('the Department') and the Department of
Human Services administer the SAS on behalf of the Australian Government. The
Department has overall policy responsibility for the Scheme and manages the SAS Schedule
and the product application and assessment process. It also provides secretariat support for
the Stoma Product Assessment Panel (SPAP), the Department’s independent technical
advice panel.
Subsidised stoma-related products are distributed via 22 regional stoma associations in
Australia.
This project
The Department engaged the Centre for Health Services Research, University of Tasmania,
to perform a literature review and background analysis to support the SAS Schedule Group
9 - Accessories Review. The objective of the SAS Group 9 Review is to examine the
accessories listed under Group 9 of the SAS Schedule to assess their clinical
appropriateness, cost effectiveness and relevance to the SAS.
Group 9 of the Schedule is a collection of miscellaneous products used to support the
clinical management of both paediatric and adult patients with a stoma. The group can be
broadly categorised into the following product types (Table 1):
8
Table 1: Products in Group 9 of the Schedule
Category
Indication
Product type
9a and 9f and 9k
Skin care and protection
Protective sheets
Elastic tape
Strips to picture frame skin barriers
Barrier creams
Conditioning cream
Protective pastes
Emollient creams
Protective barrier wipes
Protective barrier spray
Protective barrier film
9b and 9h
Stoma support garments
Stoma support belts / briefs
Hernia support garments
Stoma and hernia support garments
Abdominal support garments / belts
9c
Clamps & clips
Clamps
Clips
9d
Cleanser & adhesive removal
Wipes
Spray
Lotions
Liquids
9e
Convexity inserts
Convex seal inserts
9g
Deodorisers and gas suppressants
Deodoriser drops
Deodoriser liquids
Lubricating deodorants
Gas suppressant tablets
Gas suppressant liquids
9i
Night drainage
Taps
9
Category
Indication
Product type
Drainage outlets
Drainage bags
9j
Skin fillers and adhesive products
Stomadhesive paste
Stomadhesive powder
Skin filling paste
Moisture-absorbing powder
Protective stoma paste
9l
Seals
Stoma seals
Stoma rings
Stoma collars
Cushioning and sealing dressings
Barrier rings
Barrier seals
9m
Miscellaneous
Carbon filters
Absorbent powder
Velcro bands
Thickening agents
Adhesive aerosol spray
10
This report
Evidence about Group 9 SAS products was compiled from all identifiable information
sources in order to describe the effectiveness and cost-effectiveness of these products for
any described outcome in patients with a stoma. The evidence was identified and critically
appraised through:

A systematic review of the peer-reviewed literature;

A systematic review of the 'grey' literature; and

An analysis of available financial information regarding Group 9 products.
This is the report of the review.
The context for stoma accessory use
A stoma, also known as an ostomy, is a surgically created opening onto the abdominal wall
to allow the exit of faeces and / or urine. There are three main types of stomas1:

A colostomy is formed from the colon (large bowel/intestine). The colostomy is often
formed in the left iliac fossa. The output is often formed stool and flatus.

An ileostomy is made from the ileum (small bowel). The ileostomy is generally formed in
the right iliac fossa. The faeces will be more liquefied than a colostomy output, which is
often described as a porridge consistency—flatus will also be passed.

A urostomy (or ileal conduit) is frequently formed in the right iliac fossa. The urostomy is
usually formed from the ileum, but is used to pass urine and not faeces.
A stoma can be temporary or permanent. Stomas are required for paediatric or adult patients
due to diseases (including cancer and inflammatory bowel disease), injury, birth defects or
other causes2.
People who have a stoma require stoma appliances and accessories for the ongoing care
and maintenance of their stoma. In Australia these are largely accessed through a funded
national program: the SAS. In 2008-09 there were approximately 37,000 ostomates (people
with a stoma) in Australia who received products under the SAS3.
To be eligible for SAS products, an ostomate must become a member of a stoma
association. The volunteer stoma associations purchase stoma related products from
suppliers and distribute to their members as required. Total Australian Government
1
Burch J, Sica J. Common peristomal skin problems and potential treatment options. British Journal
of Nursing 2008;17(17):S4, S6, S8 passim. Epub 2008/10/25.
2
Burch J, Sica J. Common peristomal skin problems and potential treatment options. British Journal
of Nursing 2008;17(17):S4, S6, S8 passim. Epub 2008/10/25.
3
Deloitte Access Economics. Deloitte report on the economic impact of incontinence in Australia.
2011.
11
Australian Government expenditure on the SAS was $67 million in 2008-09 and $72. million
in 2009–104.
The stomal care needs of ostomates change over time. In the immediate post-operative
period, patients usually wear a clear bag, so that the stoma can be seen. This enables staff
and the patient to check for complications that may occur, including necrosis of the bowel
used to form the stoma. In the post-operative period the appliance used for a colostomy or
ileostomy often does not have a filter. No filter in the appliance allows the nurse and
ostomate to see when flatus is passed5.
Once discharged, the patient enters a maintenance phase in the care of their stoma. Some
ostomates continue to use a clear appliance once they are discharged home into the
community. Alternatively the ostomate may choose an opaque or patterned appliance. This
is supplemented with the use of accessories to facilitate achieving positive outcomes for
patients. Stoma accessories are used in conjunction with stomal appliances to maintain
peristomal skin integrity and promote pouch reliability, thereby increasing patients'
confidence in their stoma management. There are a multitude of stoma accessories that are
used in conjunction with stoma appliances, the types of which are described below.
The ideal outcome for patients with a stoma is that they reach the optimal level of
rehabilitation and return to their normal day-to-day activities, while being able to manage
their stoma without disruption and reliance on excessive routine.
The equipment needs of ostomates vary between patients and according to stoma type.
Indicative average use of stoma supplies by an ostomate are provided at Table 2.
Table 2: Average use of stoma supplies6
Colostomy
One piece appliance
Two piece appliance
2 bags a day
2-3 flanges a week
2 bags a day
Ileostomy
1 bag a day
Urostomy
1 bag a day
2-3 flanges a week
1 bag a day
2-3 flanges a week
1 bag a day
1 night bag a week
Night bag
1 bag a week
Accessories (if needed):
2-3 a month
Adhesive remover
Skin protector
4
2-3 a month
AIHW. Incontinence in Australia: prevalence, experience and cost. 2012.
5
Burch J. An update on available stoma appliances in the community. British Journal of Community
Nursing. 2009;14(4):146.
6
Black P. Stoma care nursing management: cost implications in community care. British Journal of
Community Nursing. 2009;14(8):350.
12
Use of accessories in stoma management
A stoma accessory is defined as 'any product used in addition to a stomal appliance'7.
Ostomates may manage independently without needing to use the wide array of accessories
available on the market. However, there are a subgroup of patients for whom accessories
enable greater independence and improved management of their stoma - an estimated one
in three patients has a problematic stoma that requires the use of one or more accessories
to keep them clean and dry for a period of 24 hours8 and between 39% and 55% of people
with a stoma will experience problems at some time that necessitate the use of stoma
accessories9.
Clinical decisions regarding the use of accessories are guided by the ability of the individual
patient to use them, and also take into account10:

the condition of peristomal skin;

the likelihood of increased skin sensitivity and with it an increased probability of further
problems;

the type of stoma/fistula and the nature of its output; and

the patient’s ability to use the products.
Indications for the use of accessories vary according to stoma care nurses and patients
(Table 3)11:
Table 3: Indications for the use of accessories, according to stoma care nurses and
patients
Stoma care nurses
Patients
Sore skin
Sore skin
Peristomal moats and dips
Damage to skin
Damage to skin
Enhancing pouch security
Leakage around the stoma
Pain on removal of appliance
Pain on removal of appliance
Odour
7
Rudoni C, Dennis H (2009) Accessories or necessities? Exploring consensus on usage of stoma
accessories. Br J Nurs 18(18): 1106–112
8
Cottam J, Richards K (2006) National audit of stoma complications within 3 weeks of surgery.
Gastrointestinal Nursing 4(8): 34–9.
9
Lyon CC, Beck MH (2001) Irritant reactions and allergy. In: Lyon CC, Smith AJ, eds. Abdominal
Stomas and their Skin Disorders. Martin Dunitz, London.
10
Borwell B, Breckman B (2005) Practical management of bowel stomas. In: Breckman B, ed. Stoma
Care and Rehabilitation. Churchill Livingstone, Edinburgh.
11
Rudoni C, Dennis H. Accessories or necessities? Exploring consensus on usage of stoma
accessories. British Journal of Nursing. 2009;18(18):1106.
13
Ideally, patients using stoma accessories are assessed intermittently with regard to their
ongoing need for accessories because of the financial constraints faced by the health
service and the resultant costs associated with the use of accessories on health system
budgets12.
Different categories of stoma accessories have different functions. Broadly, these can be
described as products for13:

leakage prevention;

adhesive removal;

skin protection;

adhesion assistance;

support and protection; and

odour elimination.
Leakage prevention and management14: Seals (also termed washers), filler paste
(available in tubes or strips) and belts may be used by providers to prevent and / or manage
a leaking appliance. Seals and filler paste may be used to ‘fill’ skin dips or creases and are
used under the flange. A seal is circular in shape and may be used directly around the stoma
or broken into pieces to fill creases. Filler paste may be used in the same way. A belt may be
used to more securely hold the appliance to the abdomen.
Adhesive removal15: Adhesive removers are available in wipes and sprays and may be
used to help remove appliances. For ostomates with fragile or damaged skin, an adhesive
remover may be used to reduce trauma or pain associated with appliance removal. Adhesive
removers may also be used to remove the adhesive left on the abdomen by the appliance.
This may collect the fluff from clothes and leave an unsightly ring on the abdomen.
Alternatively, patients may use a damp cloth to assist in appliance removal. Instead of an
adhesive remover, a small amount of soap may be used to remove residual adhesive but
this may dry the skin.
Skin protection16: Accessories may be used to protect the peristomal skin. These are
available as protective films, wipes, creams, sprays and protective powders.
12
Boyles A. Keeping up to date with stoma care accessories: Enabling informed choice.
Gastrointestinal Nursing. 2010;8(6).
13
Boyles A. Keeping up to date with stoma care accessories: Enabling informed choice.
Gastrointestinal Nursing. 2010;8(6).
14
Burch J. Resuming a normal life: holistic care of the person with an ostomy. British Journal of
Community Nursing. 2011b;16(8):366-73. Epub 2011/08/16.
15
Ibid
16
Ibid
14
Peristomal skin may be treated with a protective film if it is at risk of damage due to
appliance leakage. Broken peristomal skin may be managed using protective powder to help
to ‘dry’ and protect the skin prior to an appliance being adhered to the abdomen. Barrier
creams may be used on the peristomal skin to add protection and provide moisture to dry
skin that is potentially at risk of cracking or breaking down. Barrier creams may also be used
on perianal skin following reversal of a stoma, to protect the skin around the anus.
If the stomal output comes into contact with the skin, skin breakdown may occur. This is
particularly evident in ileostomies or urostomies because urine and loose faeces are more
corrosive on the skin than the more formed stool passed from the colostomy. To protect the
peristomal skin, barrier wipes or sprays may be used. These are applied after the peristomal
skin is cleaned and dried. Barrier sprays or wipes either protect skin that is red but intact, or
protect healthy peristomal skin that is at risk of becoming damaged (i.e. if the patient has a
known high output from his/her stoma).
Protective powder may be used to protect wet, weeping peristomal skin.
Adhesion assistance17: If an appliance is not adhering adequately to the skin this might
lead to appliance leakage or seepage of the stoma effluent under the flange. Both may result
in sore skin, discomfort and possibly embarrassment if the appliance leaks. There are a
number of stoma accessories that may be used to aid adhesion.

Stoma filler paste may be used to improve adhesion or to ‘level’ skin for the flange to
adhere more securely. The paste comes in two forms; either in a tube, which may be
‘squeezed’ into the appropriate area, or in strips that may be ‘ripped’ into the correct size
and placed in the area of leakage (i.e. a skin crease).

Seals are generally used directly around the stoma to protect the skin by giving greater
adhesive properties or to level the skin in that area to improve adhesion. Seals also allow
the stoma flange to remain in place for longer periods of time before skin damage
occurs, extending the length of time the appliance may be worn and reducing the
number of appliance changes required. Some ostomates have a ‘moat’ or ‘dip’ below the
stoma, and in this case a seal cut in half may be used in the dip to level the skin.

Specialist adhesives are also available for appliance flanges that do not adhere with
adequate strength to the abdomen. These are used directly on the back of the flange to
increase the adhesive properties.

Some stomas are large in diameter and thus the aperture in the flange also needs to be
large. Although there is always a few centimetres of flange left outside the cutting area,
for some ostomates there may be concerns about the flange securely adhering to the
abdomen. Other ostomates may have stomas near abdominal creases and the outer
edge of the flange might not adhere well. In these situations the use of a flange
extension may be used.
17
Burch J. Resuming a normal life: holistic care of the person with an ostomy. British Journal of
Community Nursing. 2011b;16(8):366-73. Epub 2011/08/16.
15

Many of the flanges, particularly the convex appliances, have two small ‘hooks’ on the
edge of the appliance. These are used, if necessary, to clip a thin elastic belt to. These
thin belts are used to secure a stoma shield to the abdomen.
Support and protection18: Support belts may be used for ostomates with a parastomal
hernia. Both small and large hernias may cause a ‘dragging’ sensation of the abdomen.
Supporting the hernia may make it less obtrusive, more comfortable and more discreet.
Support belts need to be specifically measured for the ostomate by the stoma specialist
nurse
Ostomates may use a stoma shield to prevent inadvertent damage to their stoma. The shield
is applied on top of the stoma appliance and held in position with a thin elastic belt. Some
ostomates also use a stoma shield to prevent stoma prolapse.
Odour elimination19: Ostomates may be concerned about odour from their stoma. Although
often the faeces do not smell worse than faeces passed by people anally, the smell may be
more evident due to the position of the stoma. Stoma odour-eliminating sprays are designed
to eliminate rather than mask odours.
18
Burch J. Resuming a normal life: holistic care of the person with an ostomy. British Journal of
Community Nursing. 2011b;16(8):366-73. Epub 2011/08/16.
19
Ibid
16
Project methods
We conducted a systematic literature review and background analysis to answer the
question: What is the effectiveness and cost effectiveness of accessory products on the
Group 9 SAS Schedule?
The project methods are described in detail at Appendix 1 (a systematic review of the peerreviewed and ‘grey’ literature) and Appendix 2 (analysis of financial information).
In summary, we considered for inclusion any publication that reported on the use of a Group
9 class of product for the management of any patient with a stoma regardless of publication
type. We sought publications in children and adults of any age, gender or socio-demographic
characteristics with a stoma and that reported any patient relevant outcome (including
morbidity, mortality, quality of life, patient satisfaction, cost or any economic metric related to
cost). We sought relevant literature only from countries with comparable health systems,
including Australasia, Europe and North America.
The databases that were used to obtain relevant publications were MEDLINE via Pubmed;
EMBASE; CINAHL via Ebsco and the Cochrane Library. The findings of the above search
strategy were supplemented with a systematic search of the 'grey' literature using Google;
Google Scholar; OpenSIGLE; and Bing to identify position papers; other literature reviews;
information on international stoma schemes; suppliers’ websites and domestic and
international guidelines and best practice manuals. The search terms used and findings from
these searches are reported at Appendix 1.
We also examined national and international stoma schemes and product prices of
relevance to the review and analysed financial information provided by the Department. The
findings from these searches are reported at Appendix 2 - an analysis of available financial
information regarding Group 9 products.
17
Project results
The effectiveness of Group 9 accessories
The findings from the systematic review of peer-reviewed and ‘grey’ literature are reported in
full at Appendix 1.
Findings from the peer-reviewed literature
We identified a small, methodologically limited body of evidence. Firm conclusions about the
effectiveness and cost-effectiveness of Group 9 products cannot be drawn from the studies
that were identified.
Our comprehensive search of the peer-reviewed literature regarding stoma accessories
identified 2,548 records. Of these 465 were excluded as they were duplicate records, 2,009
were excluded at the abstract stage and 61 full text articles were excluded.
Reasons for excluding abstracts were:

not a human study (11 abstracts);

participants did not have a stoma (1,649 abstracts);

publication not relevant to any patient outcome (morbidity, mortality, quality of life, patient
satisfaction, cost or any economic metric related to cost) (312 abstracts); and

publication not from a country with a comparable health system i.e. not Australasia,
Europe or North America (37 abstracts).
Reasons for exclusion of full text records were:

no patient relevant outcomes were reported (35 articles);

the article was not relevant to a Group 9 product (21 articles);

the article referred to previously published (and included) data (three articles);

participants did not have a stoma (one article); and

the article was a narrative discussion about unpublished data (one article).
This resulted in a total of 13 references that were identified by the above search strategy and
were included in the systematic review of the literature. The types of Group 9 products that
were the subject of included studies were skin care and protection accessories (five studies),
stoma support garments (one study), cleansers and adhesive removal accessories (three
studies), deodorisers (one study) and skin fillers and adhesive products (five studies).

Five studies reported information about Group 9 skin care and protection
accessories. One study reported seven proven allergic reactions to skin wipes and
skin gel in 149 patients with unexplained peristomal dermatitis. A product evaluation
in over 3,000 patients reported reduced accessory product use with the SenSura
18
ostomy appliance. Another product evaluation involving 172 patients and 49 nurses
showed high product performance with SurFit Natura mouldable skin barrier
protection. A case series of four patients reported reduced peristomal skin problems
with the Hollister brand of appliance products. A survey of nurses showed high
awareness of nurses of alcohol- and silicone-based skin products and a nurse
preference to prescribe silicone products.

One publication described relevant outcomes for stoma support garments. This
survey of 322 people with a parastomal hernia reported that 45% of people with
stoma support garments used them regularly and 27% thought that these garments
were the best way to manage their hernia.

Three publications described outcomes for cleansers and adhesive removal
accessories. One cohort study showed three of 149 patients experienced allergic
reactions to adhesive removers. A product evaluation of a silicone-based adhesive
remover in 54 patients showed silicone-based products improve ease of removal of
the stoma bag and improve skin condition. A survey of 363 nurses reported nurses
preferred prescribing silicone-based removers to patients who find it painful and / or
difficult to remove their pouch.

One publication described relevant outcomes for deodoriser. Patch testing in 149
patients with unexplained dermatitis showed three positive reactions to deodorisers.
Two of these patients were using the deodoriser product inappropriately.

Five studies reported patient outcomes associated with skin filler and adhesive
products. A survey of 363 nurses showed high nurse awareness of adhesive tape
and hydrocolloid products. The majority of nurses recommended hydrocolloid instead
of adhesive tape products for patients who require extra adhesion or security. A
product evaluation in over 3,000 patients reported reduced skin filler and adhesive
use with the SenSura ostomy appliance. One case study reported a positive skin
reaction to Gantrez 425 and a second case study reported a positive skin reaction to
Dansac 1 soft paste, an ingredient of stomadhesive paste. A final study reported the
results of a RCT in 81 patients. Findings from this study demonstrated improved
peristomal skin in patients treated with hydrocolloid power versus water cleansing
before application of the ostomy appliance.
We identified no studies for clamps, convexity inserts, gas suppressants, night drainage,
seals or miscellaneous products not already addressed in the other product groupings.
The level of evidence of included studies was generally low and the quality of included
studies was generally poor. One study was a systematic review that included RCTs;
however this study did not identify RCTs that were relevant to Group 9 accessories in spite
of searching for relevant RCTs (Recalla 2013). This review therefore did not contribute
empirical evidence to our systematic review. In addition to this systematic review, we
identified one RCT (Park 2011), one nested diagnostic study conducted within a cohort study
(Al Niami 2012) and one case series (Thompson 2011). All other studies were not able to be
rated using the NHMRC’s levels of evidence.
19
Findings from the ‘grey’ literature
We identified 27 publications of broad relevance to Group 9 accessories from the 'grey'
literature. These materials provided information regarding stoma schemes in other countries,
recommended limits in quantities of Group 9 accessory products supplied to consumers in
other countries and guidelines that are in place in other countries to inform use of Group 9
accessories.

Two guidelines informing the use of Group 9 accessory products were identified. The
guidelines are based on consensus due to a paucity of published studies. Guidelines
identified are limited to the role of accessory products in moisture associated skin
disease (MASD). Guidelines by Colwell20 and Gray21 recognise the role of accessory
products in improving the seal between the stoma appliance skin barrier and the skin.
Guidelines also recognise the need for appropriate use of accessory products and that
inappropriate use can result in skin related problems and increased or variant accessory
use. However, published guidelines are based largely on the opinion of clinicians in the
stoma field rather than empirical evidence. Further, industry sponsorship of panel
members involved in developing guidelines introduces a significant risk of bias in the
guideline development process.

Three prescribing guidelines for stoma appliances were identified that included Group 9
accessories. All three prescribing guidelines were developed by committees within
English NHS Trusts. Consensus guidelines for prescribing have been developed in
response to the high and growing cost of stoma accessories with the aim of facilitating
more judicious prescribing and use of the products. The prescribing guidelines identified
were brief, generally describing products at the category level rather than the product
level. In comparing the recommended quantities with those listed on the Australian SAS,
where comparators were available, they were broadly consistent.

In comparing the Australian Stoma Appliance Scheme Schedule with schedule
information available from other international stoma schemes, similarities exist between
the SAS Scheme and NHS Scotland and NHS England and Wales schemes. The three
schemes provide an extensive list of stoma care products that are available free of
charge (or very low cost) to resident ostomates. Choice of product is supported by
Stoma Care Nurses. The Australian SAS Schedule varies from the NHS Price lists as it
includes maximum quantity and other product restriction information. Comparative price
information is provided in the cost effectiveness of group 9 accessories section of this
report.
20
Colwell, JC. MASD Part 3: Peristomal Moisture-Associated Dermatitis and Periwound MoistureAssociated Dermatitis: A consensus. Journal of Wound Ostomy and Continence Nursing.
2011;38(5):541-53.
21
Gray, M. Peristomal Moisture Associated Skin Damage in Adults with Fecal Ostomies: A
Comprehensive Review and Consensus. Journal of Wound Ostomy and Continence Nursing.
2013;40(4):389-99.
20

When comparing the stoma schemes of NHS Scotland and NHS England and Wales
with the Australian SAS, the schemes are most divergent in product order and
distribution methodology. Both NHS schemes require stoma care items to be prescribed
by a GP. NHS Scotland also allows items to be prescribed by Specialist Stoma Care
Nurses with demonstrated prescribing competency. Prescriptions are dispensed through
a Community Pharmacy Contractor, Dispensing GP or Appliance Contractor. Dispense
and delivery fees are paid for prescriptions and customisation fees are also payable for
eligible products. The NHS dispense and delivery fees are higher than the Australian
SAS handling fees paid to stoma associations. The comparison identifies that the SAS
has lower order and distribution costs for Government compared with NHS Scotland and
NHS England and Wales.

Information pertaining to the evaluation and selection process for stoma care items listed
on the NHS Scotland Stoma Appliance Price List and the NHS England and Wales Drug
Tariff was not identified in the grey literature search and as such a comparison of product
listing process cannot be considered.
The cost-effectiveness of Group 9 accessories
In order to assess cost-effectiveness, the cost of a product in monetary terms is assessed
against the expected health gain associated with the use of the product. We were unable to
establish the effectiveness of Group 9 products. As a result, the cost-effectiveness of these
products cannot be determined.
In the absence of sufficient data to assess cost-effectiveness we have compared the SAS
Scheme with other stoma appliance schemes and direct purchasing options in countries with
similar health systems.
We found that NHS Scotland and NHS England / Wales were sufficiently detailed to enable
price comparisons with the Australian Scheme to be performed. We have also reviewed
direct pricing in US, Canadian and domestic markets with available (albeit limited)
information.
The findings from the analysis of financial information are reported in full at Appendix 2.
Stoma Appliance Scheme – All group comparison
The Department of Health provided five year trend data on the cost impacts of the SAS
Group 9 products at the group level and at the cost of individual products which has
informed this analysis.
The SAS is divided into 11 product groups, with Group 9 (Accessories) being the subject of
this review. Table 4 describes the change in costs for the period 2007-08 to 2012-13.
Group 9 products represent the largest financial impost on the scheme overall and make-up
24% of the SAS’s cost in 2012-13, up from 19% in 2007-08. This change in the relative
impact of Group 9 products is reflected in the average annual growth rate of 11.7% since
2007-08, compared with the overall rate of growth of the SAS of 6.3%. With the exception of
the Group 11 (Fistula) products which contribute just over 1% of the costs of the scheme, the
21
rate of increase for Group 9 products has been more than 50% higher than any of the other
nine groups.
This is represented graphically in Figure 1, which shows the relative contributions each
Group of products makes to the overall cost of the SAS. It clearly demonstrates the
progressive increase in Group 9 costs compared with the other groups.
Table 4: Change in SAS Group costs 2007/08 to 2012/13 (AUD)
Year
2007/08
2008/09
2009/10
2010/11
2011/12
2012/13
Annual
growth
rate
Group 01
$11,401,097
$12,135,021
$12,381,181
$12,971,697
$14,842,970
$16,191,913
7.3%
Group 02
$11,087,846
$12,469,986
$13,319,188
$14,440,770
$13,891,587
$13,559,066
4.1%
Group 03
$3,544,760
$3,985,410
$4,371,743
$4,812,129
$4,564,467
$4,271,633
3.8%
Group 04
$8,832,263
$9,813,590
$10,185,492
$10,693,668
$10,997,430
$11,009,460
4.5%
Group 05
$5,127,611
$5,630,828
$5,834,220
$6,089,981
$5,909,208
$5,631,498
1.9%
Group 06
$5,156,007
$5,754,269
$5,829,166
$6,216,335
$6,302,235
$6,126,315
3.5%
Group 07
$1,867,503
$2,047,498
$1,999,969
$2,046,758
$2,268,865
$2,485,377
5.9%
Group 08
$609,235
$667,333
$696,771
$749,828
$803,547
$856,954
7.1%
Group 09
$11,272,018
$13,000,167
$14,368,322
$15,950,913
$17,499,425
$19,560,437
11.7%
Group 10
$193,471
$215,111
$215,560
$229,053
$233,061
$248,912
5.2%
Group 11
$510,394
$699,401
$735,732
$700,564
$998,516
$953,418
13.3%
Total
$59,602,206
$66,418,613
$69,937,343
$74,901,698
$78,311,311
$80,894,982
6.3%
22
Figure 1: SAS group expenditure as percentage of total SAS expenditure, 2007/082012/13
Percentage of total SAS expenditure
30%
25%
20%
15%
10%
5%
0%
2007-08
2008-09
2009-10
2011-12
2012-13
Annual growth rate
2010-11
Group 9 (Accessories) sub-group analysis
Group 9 is made up of 13 sub-groups, with costs in 2012/13 ranging from a low of $2,657 for
‘Clamps and Clips’ to more than $7.7 million for ‘Seals’ (Table 5). As there is such a
divergent impact upon overall Group 9 costs, there is value in assessing the relative effects
of each of the sub-groups.
Five of the subgroups: ‘Seals (l), Cleansers and Adhesive Removal (d), Skin Care and
Protection (k), Adhesive Barriers (a) and Stoma Support Garments (h) generate costs in
excess of $1 million each, with an average exceeding $3.5 million. By comparison the other
eight sub-groups have average costs of $252,180.
23
Table 5: Group 9 sub-group change in costs 2007/08 to 2012/13 (AUD)
Financial year
2007/08
2008/09
2009/10
2010/11
2011/12
2012/13
(a) Adhesive barrier
$987,903
$1,252,209
$1,565,969
$1,860,024
$2,066,363
$2,458,283
Year on year change
-
26.8%
25.1%
18.8%
11.1%
19.0%
$73,116
$101,878
$82,987
$90,346
$93,124
$95,632
-
39.3%
-18.5%
8.9%
3.1%
2.7%
$2,991
$3,059
$2,443
$3,194
$2,752
$2,657
-
2.3%
-20.1%
30.7%
-13.8%
-3.4%
$1,747,760
$2,022,004
$2,173,107
$2,451,586
$2,764,343
$3,135,468
Year on year change
-
15.7%
7.5%
12.8%
12.8%
13.4%
(e) Convexity inserts
$19,282
$16,187
$14,909
$12,754
$11,070
$11,598
Year on year change
-
-16.1%
-7.9%
-14.5%
-13.2%
4.8%
$152,250
$142,265
$131,787
$137,657
$130,751
$132,141
Year on year change
-
-6.6%
-7.4%
4.5%
-5.0%
1.1%
(g) Deodorisers & gas
$575,048
$472,971
$465,595
$534,081
$501,986
$498,985
-
-17.8%
-1.6%
14.7%
-6.0%
-0.6%
$800,719
$1,016,540
$1,114,367
$1,045,551
$1,120,668
$1,205,900
-
27.0%
9.6%
-6.2%
7.2%
7.6%
$203,793
$231,764
$259,652
$268,848
$297,136
$311,639
-
13.7%
12.0%
3.5%
10.5%
4.9%
$733,095
$713,937
$685,800
$697,459
$706,050
$741,751
-
-2.6%
-3.9%
1.7%
1.2%
5.1%
$1,991,598
$2,284,000
$2,419,542
$2,631,735
$2,819,304
$3,017,659
-
14.7%
5.9%
8.8%
7.1%
7.0%
$3,880,517
$4,636,817
$5,324,310
$6,033,143
$6,782,096
$7,725,689
-
19.5%
14.8%
13.3%
12.4%
13.9%
$103,946
$106,536
$127,852
$184,535
$203,782
$223,035
-
2.5%
20.0%
44.3%
10.4%
9.4%
$11,272,018
$13,000,167
$14,368,322
$15,950,913
$17,499,425
$19,560,437
-
15.3%
10.5%
11.0%
9.7%
11.8%
(b) Stoma support
garments (belts)
Year on year change
(c) Clamps & clips
Year on year change
(d) Cleanser & adhesive
removal
(f) Skin care &
protection
suppressants
Year on year change
(h) Stoma support
garments (hernia belts)
Year on year change
(i) Night drainage
Year on year change
(j) Skin fillers &
adhesive products
Year on year change
(k) Skin care &
protection (films)
Year on year change
(l) Seals
Year on year change
(m) Miscellaneous
Year on year change
SAS Group 9
Year on year change
Source: Department of Health, 2014
Table 6 sets out the effect of the change in sub-group costs over the period under review.
The five high cost sub-groups represent 90% of the total Group 9 costs. The percentage
increase in this set of sub-groups, increased by 86% over the five years, compared with just
8% for other eight sub-groups. Of the $8.3 million increase in Group 9 costs, $8.1 million, or
98% can be attributed to the high cost sub-groups.
24
Table 6: Cost impact of high- and low-cost sub-groups
Group 9 sub-groups
% of Group 9 costs
% increase 2007/08-
% of increased costs
2012/13
2007/08-2012/13
Five high cost sub-groups
90%
86%
98%
Eight lower cost sub-groups
10%
8%
2%
Figure 2 demonstrates the consistent increase year to year for the high cost sub-groups.
Figure 2: Group 9 high cost sub-group annual costs, 2007/08-2012/13
$9,000,000
Annual sub-group costs
$8,000,000
$7,000,000
$6,000,000
$5,000,000
$4,000,000
$3,000,000
$2,000,000
$1,000,000
$0
(l) Seals
2007/08
(d) Cleansers &
Solvents
2008/09
2009/10
(k) Protective
Films
2010/11
(a) Adhesive
barrier
2011/12
(h) Hernia
Support Belts
2012/13
The average annual increase for each of these sub-groups was therefore: Adhesive Barriers
– 20.0%; Seals – 14.8%; Cleaners and Adhesive Removal – 12.4%; Protective Films – 8.7%
and Hernia Belts and Garments – 8.5%.
Sub-group analysis
The analysis of each sub-group will provide information about products that have been
prescribed in 2012/13, including the SAS specified Pack Price, a comparator rate, which will
usually be the NHS England and Wales (E&W)22,23 except where that was not available, in
which case one of the following will be used:
22
NHS Electronic Drug Tariff England and Wales (Mar. 29, 2014).
23
Conversion rate1 Great British Pound = 1.84 Australian Dollar (Mar. 13, 2014).
25

an Australian private consumer rate (APri) - the price to an Australian consumer
purchasing from a national on-line wholesaler website24

an Australian online rate (AOnl) - the price displayed on the company’s Australian
website or electronic brochure.

the NHS Scotland rate (Scot)25;

a US online rate (US)26;

a Canadian online rate27 (Can)
In general terms the NHS England and Wales costs are very similar to the NHS Scotland
rates, with some slightly higher and others lower. Similarly with the US online rates, there is
no uniform finding, with some product prices higher than the NHS prices and others lower.
The price to the Australian private consumer is typically substantially higher than the SAS
Pack Price.
The conversion rate used for the United Kingdom prices was $1AUD = 0.5435 pence (i.e.
x1.84)28, for the United States $1AUD=90.1US cents (i.e. x1.11)29 and Canada $1AUD=98
Canada30 cents.
The annual SAS cost in 2012/13 for each product is presented, with a brief description of the
trend in costs since 2007/08. An estimate of the potential cost differential with the
comparator is also made, where the comparison rate is lower than the SAS price.
Further pricing detail including data references and findings from the analysis of financial
information are reported in full at Appendix 2.
Analysis of sub-group (a) – Adhesive Barrier price and costs
The Department of Health identified costs were incurred for ten products in the Adhesive
Barrier sub-group out of 13 listed.
In 2007/08 there were just six of the current products prescribed at a total cost to the SAS of
$987,903. Of those Omnigon Welland Hydroframe represented 76% of the market, with
Coloplast Protective Sheet having 13% and Convatec Skin Barrier 8% of the total, with the
other three products having a negligible impact.
24
25
CH2 Online Intouch (Feb. 28, 2014).
NHS Scotland. Stoma Appliances Price List Scotland March 2014. (Mar. 12, 2014).
26
Cos Medical Supplies Online (Apr. 7, 2014).
27
Online Ostomy Supplies (Apr.7, 2014).
28
Conversion rate1 Great British Pound = 1.84 Australian Dollar (Mar. 13, 2014).
29
Conversion rate $1US=$1.11 Australian (Mar. 21, 2014).
30
Conversion rate $1 Australian = $0.98 Canadian. (Apr. 7, 2014).
26
During 2008/09 Ainscorp Salts Secu Plast Hydro was listed as a product and quickly
secured a 12% share in that year, with a peak in costs being achieved in 2011/12 at
$759,127, which was 37% of total sub-group costs. Omnigon Welland Hydroframe also
achieved peak costs in 2011/12 of $1,015,307 and 49% of the market.
A second Ainscorp product Salts SecuPlast Hydro Aloe was introduced in 2011/12 year and
by 2012/13 had achieved a 16% share, with the other Ainscorp product achieving 25% in the
same year. In 2012/13 another new product, Coloplast Elastic Tape was listed and it too
rapidly established a market share.
Overall the costs for this sub-group are volatile, with new products on the list quickly
establishing a presence in the market, so much so that three dominant products in 2007/08
which collectively represented 97% of the costs, had been reduced to a share of 48% in
2012/13, with the three new products making up almost all the rest.
The SAS pack price for the three new products was found to be in excess of available
comparator prices, with the NHS England and Wales price for the two Ainscorp products
being 45-50% less than the SAS price.
SAS
Brand Name
Pack
Comparator
Price
(AUD)
(AUD)
Ainscorp Salts Secu Plast Hydro
$43.74
Ainscorp Salts SecuPlast Hydro Aloe
$43.74
Coloplast Brava Elastic Tape
$29.16
Coloplast Brava Protective Sheet
% of total
Estimated
2012/13
sub-group
cost using
costs
costs
lower price
(AUD)
2012/13
comparator
(AUD)
$21.96 (E&W)
$608,423
25%
$305,464
$388,577
16%
$211,346
$23.39 (E&W)
$259,611
11%
$208,241
$72.90
$96.66 (E&W)
$137,112
6%
n/a
Coloplast Protective Sheet Dispenser
$47.14
$201.70 (APri)
$13,812
1%
n/a
Convatec Skin Barrier
$14.38
$21.91 (E&W)
$52,087
2%
n/a
Hollister Flextend
$14.38
$14.38 (E&W)
$4,990
0%
n/a
Hollister Hollihesive
$14.38
$22.15 (E&W)
$3,466
0%
n/a
Omnigon Welland Hydroframe
$28.56
$42.74 (US)
$985,877
40%
n/a
Omnigon Welland Hydroframe Mini
$42.84
$18.29 (E&W)
$4,327
0%
$1,847
$44.53 (Can)
$23.79 (E&W)
$48.70 (Can)
Analysis of sub-group (b) – Stoma Support Garments prices and costs
The Department identified costs for nine products listed in sub-group B, with some products
having a number of sizes. In 2007/08 six of these products had costs attributed to them.
There has been a relatively modest 6% annual growth rate for this sub-group, with little
change in relative market share, with the notable exception of the Coloplast Brava Belt which
was introduced in 2012/13, and which appears to have substantially displaced the other
Coloplast product.
None of the identified price comparators were less than the SAS pack price.
27
SAS
Brand Name
Pack
Comparator
Price
(AUD)
(AUD)
2012/13
costs
(AUD)
% of total
Estimated
sub-group
cost using
costs
lower price
2012/13
comparator
Ainscorp Salts Adjust. Ostomy Belt
$5.98
$13.56 (Scot)
$3,654
4%
n/a
Coloplast Belt
$5.98
n/a
$3,211
3%
n/a
Coloplast Brava Belt
$5.98
$12.16 (E&W)
$22,234
23%
n/a
ConvaTec Belt
$5.98
$6.33 (E&W)
$8,593
9%
n/a
Dansac Beige Ostomy Belt
$5.98
13.41 (Scot)
$11,799
12%
n/a
Hollister Adapt
$5.98
$14.30 (E&W)
$32,872
34%
n/a
Omnigon Adjustable Belt
$5.98
n/a
$9,329
10%
n/a
Omnigon Braun Stomacare Belt
$5.98
13.89 (Scot)
$1,429
1%
n/a
Omnigon Flair Belt Pack*
$5.98
$13.41 (E&W)
$2,512
3%
n/a
*This product is listed as one belt and one ring on the SAS and listed as one belt and five rings on the E&W drug
tariff. The E&W price has been divided by five to allow for comparison. Further detail about NHS E&W pricing for
this product is provided at Appendix 2, Table 2.3.
Analysis of sub-group (c) – Clamps and Clips prices and costs
The Clamps and Clips sub-group represent just 0.01% of the total cost of the SAS, which is
reduction in absolute and relative terms compared with 2007/08 when it constituted 0.03%.
Costs have fallen by 10% over that period as well.
No new products have been introduced to the list in the five years of analysis and the share
of the costs for each product appears fairly stable from year to year.
Comparator costs were less than the SAS pack price for the Hollister Clamps and Coloplast
Alterna Slimline.
28
Brand Name
SAS Pack
Comparator
2012/13
% of total
Estimated
Price
(AUD)
costs
sub-group
cost using
(AUD)
costs
lower price
2012/13
comparator
(AUD)
(AUD)
Hollister Clamps
$46.10
$38.90 (E&W)
$1,346
51%
$1,136
ConvaTec Clips
$23.05
$44.20 (APri)
$373
14%
n/a
Coloplast Alterna Slimline
$46.10
$39.43 (E&W)
$537
20%
$459
Hollister ModermaFlex
$2.30
$2.30 (AOnl)
$243
9%
n/a
Dansac Nova Drainable Clamp
$2.30
n/a
$156
6%
n/a
Analysis of sub-group (d) – Cleansers and Adhesive Removal prices and costs
The Cleansers and Adhesive Removal sub-group represent the second largest cost of the
Group 9 sub-groups which in 2012/13 was 16% up from 15.5% of the total cost in 2007/08.
The sub-group costs increased at an annual rate of 12%.
In 2007/08 there were six products to which costs were attributed with ConvaTec Convacare
and Dansac Skin Wipes contributing almost three quarters of the sub-group costs. Five new
products have been added to the list since 2007/08 though none have established a
significant share.
The major shift has been the increase in the Omnigon Welland share from just 2% in
2007/08 to 36% in the latest year and Dansac Skin Lotion increasing from less than 1% to
14% over the same period.
In terms of comparative costs all accessed costs were higher than the SAS pack prices.
Brand Name
SAS
Comparator
2012/13 costs
% of total
Estimated
Pack
(AUD)
(AUD)
sub-group
cost using
Price
costs
lower price
(AUD)
2012/13
comparator
Ainscorp Salts Wipe Away
$14.34
$16.54 (E&W)
$77,386.10
2%
n/a
Coloplast Brava No Sting Adhesive
$11.94
$26.97 (E&W)
$37,214.96
1%
n/a
$10.23
$16.27 (E&W)
$49,144.92
2%
n/a
Coloplast Comfeel (2 products)
$8.35
$32.16 (E&W)
$135,458.58
4%
n/a
ConvaTec ConvaCare
$32.00
$33.10 (E&W)
$541,587.52
17%
n/a
Dansac Skin Lotion
$8.35
$32.22 (E&W)
$403,586.82
13%
n/a
Dansac Skin Lotion Wipes
$23.90
$27.60 (E&W)
$454,412.61
14%
n/a
Hollister Cleanser
$8.35
$8.35 (AOnl)
$8,792.55
0%
n/a
Hollister Universal
$16.00
$24.95 (E&W)
$145,500.80
5%
n/a
Omnigon Eakin Release Wipes
$11.94
n/a
$12,895.20
0%
n/a
Omnigon Welland
$23.90
$43.09 (US)
$1,122,607.39
36%
n/a
Omnigon Welland Adhesive
$10.23
n/a
$9,176.31
0%
n/a
Remover Wipes
Coloplast Brava No Sting Adhesive
Remover Spray
Remover Spray
29
Smith & Nephew Remove
$16.00
$44.00 (APri)
$137,136.00
4%
n/a
Smith & Nephew SECURA
$8.35
n/a
$567.80
0%
n/a
Analysis of sub-group (e) – Convexity Inserts prices and costs
The Convexity Inserts sub-group cost was the second smallest cost of the Group 9 subgroups. In 2012/13 it had declined from 0.17% of the total group 9 costs to 0.06%, which
represents a 9% per annum reduction in costs.
There is one brand on the SAS list, with various size options available. No comparator price
was identified.
Brand Name
SAS Pack
Comparator
Price
2012/13 costs
% of total
Estimated
(AUD)
sub-group
cost using
costs 2012/13
lower price
(AUD)
comparator
ConvaTec Sur-Fit Plus
$9.46
n/a
$11,598
100%
n/a
Analysis of sub-group (f) – Skin care and protection (creams and ointments) prices
and costs
The products in 2012/13 were unchanged from the 2007/08 list, which reflects the very
stable nature of the products, their share and cost profiles.
Overall there was a 2.8% annual decrease in the sub-group costs, which led to the subgroups proportion of total costs falling from 1.4% in 2007/08 to 0.7% in 2012/13.
Within the sub-group Coloplast Comfeel had reduced share from 22% to 8% whilst
Sudocream increased from 5% to 19%.
In terms of comparative costs all accessed costs were higher than the SAS pack prices.
Brand Name
SAS Pack
Comparator
2012/13 costs
% of total
Estimated
Price (AUD)
(AUD)
(AUD)
sub-group
cost using
costs
lower price
2012/13
comparator
3M Cavilon Durable
$5.75
$7.32 (E&W)
$2,105
2%
n/a
Calmoseptine Oint 20g
$4.71
$5.20 (APri)
$871
1%
n/a
Calmoseptine Oint 75g
$7.68
$11.30 (APri)
$8,387
6%
n/a
Coloplast Comfeel
$7.92
$8.85 (E&W)
$10,288
8%
n/a
Coloplast Conveen Critic
$7.85
$19.60 (APri)
$3,721
3%
n/a
ConvaTec Orabase
$8.74
$15.90 (APri)
$34,444
26%
n/a
Dansac Ostomy
$8.74
n/a
$15,888
12%
n/a
Hollister Skin Conditioning
$7.92
$7.92 (AOnl)
$21,859
17%
n/a
Smith & Nephew Uni Derm
$7.92
n/a
$10,058
8%
n/a
Sudocrem Healing Cream
$5.54
$8.90 (APri)
$24,520
19%
n/a
Cream
30
Analysis of sub-group (g) – Deodorisers & Gas Suppressants prices and costs
Deodorisers & Gas Suppressants is another sub-group with a very stable product and cost
profile, with an average annual reduction in costs of 2.8%. This led to the overall sub-group
costs falling as a percentage of total Group costs from 5.1% to 2.6%.
All products except for the Ainscorp product were available in 2007/08, with the three leading
brands Hollister Adapt, Dansac Windless and Dansac Nodor maintaining dominance
throughout the period.
In terms of comparative costs all accessed costs were higher than the SAS pack prices.
Brand Name
SAS Pack
Comparator (AUD)
Price
2012/13
% of total
Estimated
costs (AUD)
sub-group
cost using
costs
lower price
2012/13
comparator
(AUD)
Ainscorp Salts No-Roma
$8.13
$5.15 (E&W)
$4,740
1%
n/a
Dansac Nodor "S"
$4.05
$8.02 (E&W)
$73,698
15%
n/a
Dansac Windless
$11.31
n/a
$133,718
27%
n/a
Hollister Adapt
$9.91
$17.13 (E&W)
$209,226
42%
n/a
Hollister M9 Drop
$8.13
$8.13 (AOnl)
$13,301
3%
n/a
Hos-Toma Lube
$9.91
n/a
$10,406
2%
n/a
Hos-Toma No Smell
$4.05
n/a
$25,879
5%
n/a
Hos-Toma No-Gas
$11.31
n/a
$12,565
3%
n/a
Laza Odorgon
$4.05
n/a
$16
0%
n/a
Smith & Nephew Banish
$3.97
n/a
$7,142
1%
n/a
Wooltec Wooltec
$4.05
n/a
$8,294
2%
n/a
Analysis of sub-group (h) – Stoma support garments prices and costs
The Stoma Support Garments of sub-group (h) has the fifth highest costs of all the subgroups. Costs have increased by an annual rate of 8.5% since 2007/08, however even in
that context the sub-groups share of group costs has fallen from 7.1% to 6.2%
The product range has been quite dynamic, with just four products representing nearly all
costs in 2007/08. In 2012/13 the share for those products had declined to just 32%.
Unfortunately this sub-group proved the most difficult to establish comparative prices. Where
they were available they were generally lower than the SAS pack price.
31
Brand Name
SAS
Comparator
2012/13
% of
Estimated cost
Pack
(AUD)
costs
total
using lower
(AUD)
sub-
price comparator
group
(AUD)
Price
(AUD)
costs
2012/13
Ainscorp Salts Simplicity
$60.00
$22.93 (E&W)
$371,400
31%
$141,937
Omnigon Diamond Plus
$60.00
n/a
$256,373
21%
n/a
Omnigon Kool-Knit
$45.15
n/a
$140,146
12%
n/a
$60.00
$31.28 (E&W)
$1,380
0%
n/a
Omnigon Stoma Support Belt
$71.01
$83.57 (Scot)
$106,160
9%
n/a
Omnigon Support Briefs for Her
$60.00
$31.28 (E&W)
$42,120
3%
$21,959
Omnigon Support Pants for Him
$60.00
$31.28 (E&W)
$99,360
8%
$51,800
Omnigon Total Control
$71.01
n/a
$63,270
5%
n/a
$120.02
$155.00 (Aonl)
$125,421
10%
n/a
$45.15
n/a
$271
0%
n/a
Abdominal support
Omnigon Mens support Boxers.
Hernia support garment,
Statina Healthcare Corsinel
Abdominal support
Sutherland Medical Abdominal
Binder
Analysis of sub-group (i) – Night Drainage prices and costs
The Night Drainage sub-group costs increased by a significant 8.9% each year, with it
contributing 1.6% of total group costs in 2012/13 compared with 1.8% in 2007/08.
There has been a marked shift in the availability of products, where previously the two
Unomedical products were the only ones available, now there are eight. Again the entry of
new products has significantly shifted the cost mix between products.
These appear to be fairly standard products with the SAS pack price below the comparators.
Brand Name
SAS
Comparator
2012/13
% of total
Estimated
Pack
(AUD)
costs
sub-group
cost using
(AUD)
costs
lower price
2012/13
comparator
Price
(AUD)
Ainscorp Salts Night Drainage Bag
$2.19
n/a
$6,301
2%
n/a
Coloplast S3 extended term -urostomy
$2.19
$2.50 (APri)
$39,845
13%
n/a
$2.19
$6.40 (APri)
$73,361
25%
n/a
Hollister T-Tap Night Drainage Collector
$65.70
$65.70 (AOnl)
$28
0%
n/a
Hollister Night Drainage Collector -
$2.19
$2.19 (AOnl)
$122,672
41%
n/a
Omnigon Braun Urimed Bag 2L
$21.90
n/a
$1,229
0%
n/a
Unomedical A4 Drainage Bag
$2.19
n/a
$45,291
15%
n/a
Unomedical Night Drainage Bag
$2.19
n/a
$9,813
3%
n/a
night drainage bag
Coloplast Simpla S4 - urostomy night
drainage bag
32
Analysis of sub-group (j) – Skin Filler and Adhesive Product prices and costs
The Skin Filler and Adhesive Products subgroup has the sixth highest costs in the group. In
the five year period there was an annual average increase in sub-group costs of just 0.24%,
with its proportion of overall group costs falling from 6.5% to 3.8%.
The product range has been very stable with the introduction of just one new product since
2007/08, the Ainscorp Paste, which is responsible for just 1% of the sub-group costs.
Otherwise the shares of the dominant products have been largely maintained.
The NHS England and Wales comparator prices for some products remain significantly
lower.
Brand Name
SAS Pack
Comparator
2012/13
% of
Estimated
Price
(AUD)
costs (AUD)
total
cost using
sub-
lower price
group
comparator
costs
(AUD)
(AUD)
2012/13
Ainscorp Salts Stoma Paste
$11.28
$12.80 (E&W)
$8,448
1%
n/a
Coloplast Brava Strip Paste
$11.28
$14.35 (E&W)
$21,781
3%
n/a
Coloplast Paste Tube
$11.28
$11.59 (E&W)
$21,307
3%
n/a
ConvaTec Paste
$11.28
$13.73 (E&W)
$325,112
44%
n/a
ConvaTec Powder
$8.70
$18.10 (APri)
$201,805
27%
n/a
Dansac Soft Paste
$11.28
$6.62 (E&W)
$38,216
5%
$22,428
Hollister Adapt Paste
$11.28
$7.10 (E&W)
$72,214
10%
$45,454
Hollister Karaya Paste
$11.28
$15.51 (E&W)
$6,023
1%
n/a
Hollister Premium Powder
$8.70
$4.73 (E&W)
$46,840
6%
$25,466
Analysis of sub-group (k) – Skin Care and Protection (films) prices and costs
The Skin Care and Protection sub-group (k) has the third highest costs in the group. It has
had increases in annual costs of 8.7% over the period. In 2007/08 there were seven
products to which costs were attributed of which two shared 88% of the total. The 3M
Cavilon product was introduced in 2009/10 and has quickly achieved a 45% share. Whilst
the Omnigon WBF Barrier Film has dropped from 51% to a 37% sub-group share, given the
dynamics involved the total costs incurred for this product has still increased by 50%.
With respect to price comparison, some low volume products have SAS prices in excess of
the comparators, whereas the high volume products are typically lower.
33
Brand Name
SAS Pack
Comparator
2012/13
% of total
Estimated
Price
(AUD)
costs (AUD)
sub-group
cost using
costs
lower
2012/13
price
(AUD)
comparat
or (AUD)
3M Cavilon
$31.95
$36.97 (Scot)
$1,351,712
45%
n/a
3M No Sting
$15.31
$12.24 (E&W)
$22,812
1%
$18,238
Ainscorp Salts Peri-Prep Sensitive
$31.95
$28.47 (E&W)
$53,484
2%
$47,893
Coloplast Brava No Sting Skin
$26.25
$21.12 (E&W)
$11,970
0%
$9,631
$31.95
$40.11 (E&W)
$48,760
2%
n/a
ConvaTec ConvaCare
$29.00
$33.10 (E&W)
$323,249
11%
n/a
Hollister Skin Gel
$14.50
$25.54 (E&W)
$40,426
1%
n/a
Omnigon WBF Barrier Film
$31.95
$49.50 (AOnl)
$1,113,319
37%
n/a
Smith & Nephew SECURA No-Sting
$52.10
$41.78 (E&W)
$470
0%
$377
$14.50
n/a
$49,957
2%
n/a
Smith & Nephew Skin Prep Aerosol
$8.45
$18.64 (US)
$1,470
0%
n/a
Smith and Nephew Skin Prep Spray
$15.31
$10.25 (E&W)
$31
0%
$21
Barrier Spray
Coloplast Brava No Sting Skin
Barrier Wipes
Barrier Film
Smith & Nephew Skin Prep
Analysis of sub-group (l) – Seals prices and costs
The Seals subgroup costs represent by far the greatest cost in the overall Group 9 costs,
which in 2012/13 was 39.5%, compared with 34.4% in 2007/08. Annual growth in costs has
been 14.8% over the period.
In 2007/08 five products incurred SAS costs, with four representing almost a 100% share.
These products represented an 82% share in 2012/13, with five new products causing some
displacement of these products.
However with the near doubling in Seal sub-group costs all products incurred increased
costs.
The NHS England and Wales comparator costs are often significantly lower than the SAS
price.
34
Brand Name
SAS
Comparator
2012/13 costs
% of total
Estimated cost
Pack
(AUD)
(AUD)
sub-group
using lower
costs 2012/13
price
Price
(AUD)
comparator
(AUD)
Ainscorp Salts Dermacol
$135.96
$100.22 (E&W)
$438,471
6%
$323,210
Ainscorp Salts Secuplast
$45.31
$41.44 (E&W)
$583,595
8%
$533,749
AMSL Medicina Ace
$104.19
n/a
$37,925
0%
n/a
Coloplast Brava
$135.93
$104.24 (E&W)
$176,392
2%
$135,729
Dansac GX-TRA
$135.96
$77.94 (E&W)
$1,050,291
14%
$602,087
Dansac NovaLife
$135.96
$122.14
$166,242
2%
$149,344
Hollister Adapt barrier
$45.31
$32.27 (E&W)
$1,438,103
19%
$1,024,224
$45.31
$34.22 (E&W)
$38,649
1%
$29,189
Omnigon Cohesive Seal
$135.96
$204.66 (US)
$1,859,587
24%
n/a
Omnigon Cohesive Slims
$135.96
$171.45 (US)
$1,936,433
25%
n/a
mouldable
Mouldable Ring
seals
Hollister Oval Convex
Barrier Rings
Analysis of sub-group (m) – Miscellaneous prices and costs
There has been a rapid increase in the Miscellaneous sub-group costs of 16.9% per annum,
which can be attributed almost solely to the introduction of the Omnigon Eakin Perform
product in 2008/09. Indeed alone it contributed to 93% of the increased expenditure in the
sub-group between 2008/09 and 2012/13.
Brand Name
SAS
Comparator
2012/13
% of total
Estimated
Pack
(AUD)
costs
sub-group
cost using
(AUD)
costs
lower price
2012/13
comparator
Price
(AUD)
(AUD)
Coloplast Cathstrap
$4.78
$13.38 (APri)
$7,184
3%
n/a
Coloplast Filtrodor
$17.95
$42.03 (E&W)
$8,616
4%
n/a
Ebos Group Vernagel
$74.70
$137.20 (APri)
$22,299
10%
n/a
Hollister Silicone Adhesive Spray
$35.65
$30.73 (E&W)
$8,271
4%
$7,130
Omnigon Eakin Perform
$49.80
n/a
$176,666
76%
n/a
35
Discussion
The SAS is an Australian Government program legislated under Section 9A of the National
Health Act (1953) that assists eligible people with stomas to better manage their condition by
providing subsidised access to a range of different stoma-related products. The Stoma
Product Assessment Panel (SPAP) is an independent technical advice panel appointed by
the Department to review applications from suppliers requesting inclusion of a stoma-related
product on the SAS Schedule.
The SAS Application and Assessment Guidelines (September 2012) state that SPAP "refers
to the National Health and Medical Research Council (NHMRC)’s Hierarchy of Evidence
when assessing the quality of evidence presented in applications". The NHMRC specifies
levels of evidence for the effectiveness of interventions. Level 1 evidence (the 'gold standard'
for interventions in health care) is a systematic review of randomised controlled clinical trials
(RCTs); level 2 evidence is a single RCT of an intervention.
While reference may be made, according to the Guidelines there is no minimum level of
evidence required for the listing of new products on the SAS. However, SPAP considers the
following questions to determine the relevance and propriety of the evidence submitted:

Has an appropriate approach been used to select studies for presentation in the
application (i.e. is there any risk that there is selection bias in the presentation of
studies)?

What is the quality of the studies (i.e. what is the likelihood that the results of the
studies have been affected by bias during their conduct)?

Are the results of the studies presented consistent and are they consistent with the
results of studies that may have been excluded from presentation in the application?

Is there any reason why results of the studies may not be generalised to the
Australian setting?
We sought evidence for the effectiveness and cost-effectiveness of the thirteen product subgroups in the Group 9 accessories. We found that these sub-groups split neatly into two
categories in terms of the overall cost of the sub-group and the growth in costs over the past
five years. The first category are the sub-groups with a high total cost, high growth and
dynamic changes in market share of products within the sub-group (adhesive barriers (a),
adhesive removers / cleansers and adhesive removal (d), hernia belts (h), protective films (k)
and seals (l)). The second category comprises the sub-groups with lower total cost, low
annual growth and stable product mixes.
We found insufficient evidence for the effectiveness of any product type within any subgroup of the Group 9 accessories schedule. We identified that new products are more
commonly introduced in the high cost, high growth sub-groups and quickly achieve a
significant share of the product market. There were no studies of comparative effectiveness
that indicate substitution of an established product with a newer product is justified by
published evidence of improved effectiveness of the newer product.
36
It is possible that robust studies have been conducted but have not been published in the
public domain due to commercial in-confidence reasons. We approached manufacturers to
request unpublished studies but did not receive any information in addition to materials
identified in the public domain. Our conclusions are therefore based on the information
described in this report and accompanying appendices.
Our systematic review of the peer-reviewed literature identified the potential for adverse
events associated with some accessories, as demonstrated in case reports and case series,
and low patient compliance with some Group 9 garments. Intervention studies are required
to establish with greater certainty the comparative safety, adverse event profile, patient
satisfaction and quality of life impacts of different product types within Group 9 sub-groups.
Guideline developers internationally confirm the results of our systematic review and have
also noted a paucity of published studies of the effectiveness of stoma accessories. The
NHMRC Guidelines for Guideline Developers31 determine the appropriate level of evidence
for an intervention is level 2 evidence or higher. Well-conducted RCTs that compare
products listed on the Group 9 SAS schedule with either no intervention or an active
comparison intervention are feasible. RCTs would provide much-needed evidence to inform
development of clinical practice guidelines and protocols for the effective and cost-effective
use of Group 9 accessories.
Conclusion 1
A requirement for level 2 evidence or higher for the listing of new accessory products on the
Group 9 SAS Schedule would enable a more detailed assessment of the effectiveness and
cost-effectiveness of Group 9 accessories to be performed into the future.
Where comparison prices could be identified, 19 of 48 (40%) products in high cost, high
growth sub-groups had SAS prices exceeding international comparators, compared with just
4 of 40 (10%) for the low cost, low growth sub-groups
Table 7 provides an overview of the individual Group 9 accessory products which incurred
the highest cost in 2012/13. Of the top 29 highest cost products, 25 were in the high cost
sub-groups.
31
NHMRC (2009). NHMRC Levels of Evidence and Grades for Recommendations for Developers of
Guidelines. Canberra: National Health and Medical Research Council.
37
Table 7: Analysis of highest cost products, 2012/13
Brand Name
Sub-group
2012/13 (AUD)
Annual growth rate
Data range
SAS Pack Price (AUD)
Comparator (AUD)
Omnigon Cohesive
9l seals
$1,936,433
24%
07/08-12/13
$135.96
$171.45 (US)
9l seals
$1,859,587
3%
07/08-12/13
$135.96
Slims
Omnigon Cohesive
$248.95 (AOnl)
Seal
Hollister Adapt barrier
$204.46 (US)
$213.30 (AOnl)
9l seals
$1,438,103
16%
07/08-12/13
$45.31
seals
$31.10 (Scot)
$32.27 (E&W)
$45.31 (AOnl)
$76.19 (US)
3M Cavilon
9k films, skin care
$1,351,712
14%
09/10-12/13
$31.95
$36.97 (Scot)
$42.87 (E&W)
Omnigon Welland
9d adhesive removal
$1,122,607
99%
07/08-12/13
$23.90
$43.09 (US)
Omnigon WBF Barrier
9k films, skin care
$1,113,319
18%
07/08-12/13
$31.95
$49.50 (AOnl)
Dansac GX-TRA
9l seals
$1,050,291
2%
07/08-12/13
$135.96
$77.94 (E&W)
Omnigon Welland
9a adhesive barrier
$985,877
6%
07/08-12/13
$28.56
$42.74 (US)
9a adhesive barrier
$608,423
41%
08/09-12/13
$43.74
$21.16 (Scot)
Film
Hydroframe
Ainscorp Salts Secu
Plast Hydro
Ainscorp Salts
$21.96 (E&W)
9l seals
$583,595
247%
08/09-12/13
$45.31
Secuplast seal
ConvaTec ConvaCare
$39.56 (Scot)
$41.44 (E&W)
9d adhesive removal
$541,588
-5%
07/08-12/13
$32.00
$31.61 (Scot)
$33.10 (E&W)
$59.70 (APri)
Dansac Skin Lotion
9d adhesive removal
$454,413
-4%
07/08-12/13
$23.90
$27.60 (E&W)
Wipes
38
Brand Name
Sub-group
2012/13 (AUD)
Annual growth rate
Data range
SAS Pack Price (AUD)
Comparator (AUD)
Ainscorp Salts
9l seals
$438,471
31%
09/10-12/13
$135.96
$99.36 (Scot)
Dermacol
$100.22 (E&W)
Dansac Skin Lotion
9d adhesive removal
$403,587
165%
07/08-12/13
$8.35
$32.22 (E&W)
Ainscorp Salts
9a adhesive barrier
$388,577
117%
11/12-12/13
$43.74
$22.72 (Scot)
SecuPlast Hydro Aloe
Ainscorp Salts
$23.79 (E&W)
9h support garments belts
$371,400
341%
07/08-12/13
$60.00
Simplicity underwear
ConvaTec Paste
$22.28 (Scot)
$22.93 (E&W)
9j skin filler and adhesive
$325,112
-4%
07/08-12/13
$11.28
$13.73 (E&W)
$15.93 (US)
$21.20 (APri)
ConvaTec ConvaCare
9k skin care
$323,249
-2%
07/08-12/13
$29.00
$31.61 (Scot)
$60.20 (APri)
Coloplast Brava
9a adhesive barrier
$259,611
n/a
12/13 only
$29.16
$23.09 (Scot)
9 hernia support
$256,373
33%
10/11-12/13
$60.00
n/a
9g deodorisers
$209,226
0%
07/08-12/13
$9.91
$9.91 (AOnl)
Elastic Tape
Omnigon Diamond
Plus
Hollister Adapt
$16.50 (Scot)
ConvaTec Powder
9j skin filler, paste and powder
$201,805
5%
07/08-12/13
$8.70
$13.25 (US)
$18.10 (APri)
Omnigon Eakin
9m miscellaneous
$176,666
137%
08/09-12/13
$49.80
n/a
9l seals
$176,392
n/a
12/13 only
$135.93
$99.25 (Scot)
Perform
Coloplast Brava
Mouldable Ring
Dansac NovaLife
$104.24 (E&W)
9l seals
$166,242
363%
11/12-12/13
$135.96
$122.14 (Scot)
39
Brand Name
Sub-group
2012/13 (AUD)
Annual growth rate
Data range
SAS Pack Price (AUD)
Comparator (AUD)
Hollister Universal
9d adhesive removal
$145,501
2%
07/08-12/13
$16.00
$16.00 (AOnl)
$24.03 (Scot)
Omnigon Kool-Knit
9 hernia support
$140,146
77%
08/09-12/13
$45.15
n/a
Smith & Nephew
9d adhesive removal
$137,136
4%
07/08-12/13
$16.00
$40.00 (APri)
9a adhesive barrier
$137,112
1%
07/08-12/13
$72.90
$93.10 (Scot)
Remove
Coloplast Brava
Protective Sheet
$96.66 (E&W)
40
Table 8, identifies the high cost products where the SAS price exceeds international
comparators. There are five products from sub-group seals (l), three in adhesive barriers (a),
one in adhesive removers / cleansers and adhesive removal (d), one hernia belt in stoma
support garments (h).
Table 8: Highest cost products with comparator prices lower than SAS price
Brand
Sub-group
Name
2012/13
Annual
Data
SAS Pack
Comparator
Low
(AUD)
growth
range
Price (AUD)
(AUD)
comp
07/0812/13
$45.31
$31.10 (Scot)
$32.27 (E&W)
$45.31 (AOnl)
$76.19 (US)
$77.94 (E&W)
Hollister
Adapt
barrier seals
9l seals
$1,438,103
rate
16%
/SAS
69%
Dansac GXTRA
9l seals
$1,050,291
2%
07/0812/13
$135.96
Ainscorp
Salts Secu
Plast Hydro
Ainscorp
Salts
Secuplast
seal
ConvaTec
ConvaCare
9a adhesive
barrier
$608,423
41%
08/0912/13
$43.74
$21.16 (Scot)
$21.96 (E&W)
48%
9l seals
$583,595
247%
08/0912/13
$45.31
$39.56 (Scot)
$41.44 (E&W)
87%
9d adhesive
removal
$541,588
-5%
07/0812/13
$32.00
$31.61 (Scot)
$33.10 (E&W)
$59.70 (APri)
99%
Ainscorp
9l seals
Salts
Dermacol
Ainscorp
9a adhesive
Salts
barrier
SecuPlast
Hydro Aloe
Ainscorp
9h support
Salts
garments
Simplicity
belts
underwear
Coloplast
9a adhesive
Brava
barrier
Elastic Tape
Coloplast
9l seals
Brava
Mouldable
Ring
Total 2012/13 costs for
these products
$438,471
31%
09/1012/13
$135.96
$99.36 (Scot)
$100.22 (E&W)
73%
$388,577
117%
11/1212/13
$43.74
$22.72 (Scot)
$23.79 (E&W)
52%
$371,400
341%
07/0812/13
$60.00
$22.28 (Scot)
$22.93 (E&W)
37%
$259,611
n/a
12/13
only
$29.16
$23.09 (Scot)
79%
$176,392
n/a
12/13
only
$135.93
$99.25 (Scot)
$104.24 (E&W)
73%
$5,856,451
Estimated cost at
low comparator
$3,920,320
Estimated saving:
$1,936,130
57%
The international comparator cost for these products is $1.9 million less in total than the SAS
cost. These data suggest that cost savings may be achieved through achieving a purchase
price for products in Table 8 that is equivalent to the product price in comparator schemes.
Conclusion 2
A review of current purchasing arrangements for high cost products with a comparator price
that is lower than the current SAS price would confirm that the purchasing arrangements for
these products are efficient.
41
Limits to the quantity of Group 9 accessories provided to consumers are specified in the
Schedule. Some international stoma guideline documents also specify limits to the quantity
of stoma products that are provided to consumers. We found one publication that described
the equipment needs of ostomates in the UK but no publications that described accessory
use in detail (Table 9). According to Black (2009), night bag, adhesive remover and skin
protector use varies according to the type of appliance the ostomate uses32.
Table 9: Estimated accessory product use
One piece appliance
Urostomy
Two piece appliance
1 night bag a week
Night bag
1 bag a week
Adhesive remover
2-3 a month
Skin protector
2-3 a month
We identified consensus based prescribing guidelines for stoma appliances and accessories
published by NHS Trusts in England. The SAS specifies limits at the product level whereas
the NHS Trust guidelines generally specify these limits at the category level.
In comparing the recommended quantities with those listed on the Australian SAS where
comparators were available they were broadly consistent (Table 10).
Overall, limits to product quantities specified in the SAS are consistent with limits in
international schemes. No studies were identified that indicated product limits had an
adverse impact on patient outcomes.
32
Black P. Stoma care nursing management: cost implications in community care. British Journal of
Community Nursing. 2009;14(8):350.
42
Table 10: Summary of recommended product quantities from published guidelines
Item type
SAS Max
Qty33
Coventry and
Warwickshire
Av. Qty /
month34
Northamptonshire
Qty / month35
Leicestershire
Qty / Month36
Ostomy Belts
Night Drainage
Bags
Adhesive
Remover Spray
Deodorants
4 / year
5 bags
3 / year
4 bags
3 / year
4 bags
2-3 / year
4 bags
2 / month
1-3 cans
1-3 cans
2-3 bottles
1-2 / month
(depending on
bottle size)
1 bottle
n/a
n/a
Lubricating
deodorant gel
Powder
Barrier Wipes
1 bottle /
month
2 / month
30 / month
2 bottles
n/a
n/a
n/a
n/a
n/a
n/a
Barrier Spray
1 / month
n/a
n/a
Protective Rings
30 / month
n/a
n/a
Adhesive
remover wipes
Pastes
100 / month
n/a
n/a
n/a
n/a
n/a
n/a
3-6 / year
Retention strips
3 tubes /
month
3 belts / year,
6 garments /
year (restricted
access)
60 / month
1 container
10-15 wipes (one
wipe / flange)
1-9 bottles (1
bottle / 10
pouches)
10-15 (one /
flange)
15-90 wipes (one /
pouch change)
1 tube
n/a
n/a
Clips
10 / year
n/a
n/a
30-90 (1-3 /
pouch)
10 every 6 months
Hernia Belts,
Girdles and
Garments
*n/a = not available
Conclusion 3
33
Department of Health, Stoma Appliance Scheme Schedule (Mar. 30, 2014).
34
Coventry and Warwickshire Area Prescribing Committee, Arden Cluster Prescribing Guidelines for
Stoma Appliances, (Mar. 4, 2014).
35
National Health Service Northamptonshire, Prescribing Guidelines for Stoma Appliances, (Mar. 3,
2014).
36
Leicestershire Medicines Strategy Group, A Guideline to Prescribing Stoma Care Appliances and
Stoma Nurse Referral November 2011, (Mar. 4, 2014).
43
Limits to product quantities specified in the SAS are consistent with limits in international
schemes.
Consumers are able to request additional quantities of products from the Department if
required. An important limitation to this analysis is that we did not review data regarding
applications for additional quantities. The Department may wish to review this additional
information to establish the extent to which consumer demand for additional product
quantities.
The accessory product range available on Group 9 of the SAS Schedule is comprehensive
and is of similar range to the NHS Scotland and NHS England / Wales. We found no
empirical evidence to suggest that any accessory product on the Schedule is ineffective per
se. Further, we found no statements within consensus guidelines that explicitly discourage
the use of any accessory product type in the Schedule.
In the absence of evidence to the contrary we could find no justification for removal of any
product type from the SAS.
Conclusion 4
There is an absence of evidence that Group 9 accessory products are either effective or
ineffective, and therefore insufficient information to suggest changes to the range of
accessory product types on Group 9 of the SAS based on this review alone.
Finally, evidence-based guidelines identified in the peer-reviewed literature demonstrate that
increased accessory use is associated with poor support of patients, a lack of access to
specialist stomal therapist nurses and inappropriate use of accessory products. Although
outside the direct scope of this project, it is important to ensure other elements of the quality
of the stomal service system is maximised in order to ensure judicious use of accessories on
Group 9 of the SAS Schedule.
44
Appendix 1 - A systematic review of the peer-reviewed and 'grey'
literature
We conducted a systematic literature review to answer the question:
What is the effectiveness and cost effectiveness of accessory products on the Group 9 SAS
Schedule?
Criteria for considering publications for inclusion
In this systematic review we considered for inclusion any publication that reported on the use
of a Group 9 class of product for the management of any patient with a stoma. The following
PICO criteria informed the methods of the literature review:

Population: children and adults of any age, gender or socio-demographic characteristics
with a stoma;

Intervention: any Group 9 product listed in the Group 9 SAS;

Comparison: no intervention, inactive (i.e. 'sham') intervention or active intervention
comparison; and

Outcome: any patient relevant outcome as reported in each information source
[(including morbidity, mortality, quality of life), patient satisfaction, cost (any cost or
economic metric related to cost)]. These outcomes included but were not limited to the
following stoma-relevant patient outcomes: security, support, amount of leakage, skin
integrity, smell, wound healing rates, erosion, tissue overgrowth and infection.
Databases searched
The following databases were used to obtain relevant peer-reviewed publications:
Electronic searches

MEDLINE via Pubmed;

EMBASE;

CINAHL via Ebsco;

Cochrane Library.
The following search strategies were used to identify peer-reviewed publications.
Cochrane library
#1
MeSH descriptor: [Surgical Stomas] explode all trees
#2
stoma:ti,ab,kw OR ostomy:ti,ab,kw OR urostomy:ti,ab,kw
#3
#1 OR #2
45
MEDLINE via Pubmed
#1
"Surgical Stomas"[Mesh] OR stoma[TIAB] OR stoma[all fields] OR ostomy[all fields] OR
urostomy[all fields]
#2
Accessor*[all fields] OR product*[all fields] OR equip*[all fields] OR care[all fields] OR skin[all
fields] OR paste*[all fields] OR cream*[all fields] OR adhesive*[all fields] OR wipe*[all fields]
OR cleans*[all fields] OR spray*[all fields] OR powder*[all fields] OR remov*[all fields] OR
filler*[all fields] OR collar*[all fields] OR protective[all fields] OR garment[all fields] OR belt*[all
fields] OR underwear[all fields] OR support*[all fields] OR clamp*[all fields] OR clip*[all fields]
OR tape*[all fields] OR deodoris*[all fields] OR gas[all fields] OR seal*[all fields] OR hernia[all
fields] OR ‘peristomal hernia’[all fields]
#3
#1 AND #2
#4
#3 AND ("2004/01/01"[PDAT] : "current"[PDAT])
EMBASE
#1
‘Surgical stoma'/exp OR stoma:ab,ti OR stoma* OR ostom* OR urostom*
#2
Accessor* OR product* OR equip* OR care OR skin OR paste* OR cream* OR adhesive* OR
wipe* OR cleans* OR spray* OR powder* OR remov* OR filler* OR collar* OR protective OR
garment OR belt* OR underwear OR support* OR clamp* OR clip* OR tape* OR deodoris* OR
gas OR seal* OR hernia* OR ‘peristomal hernia’
#3
#1AND #2
#4
#3 AND (2004:py OR 2005:py OR 2006:py OR 2007:py OR 2008:py OR 2009:py OR 2010:py
OR 2011:py OR 2012:py OR 2013:py OR 2014:py)
CINAHL via Ebsco
#1
exp stoma/
#2
stoma.ti,ab.
#3
Stoma* OR ostom* OR urostom*
#4
1 or 2 or 3
#5
Accessor* OR product* OR equip* OR care OR skin OR paste* OR cream* OR adhesive* OR
wipe* OR cleans* OR spray* OR powder* OR remov* OR filler* OR collar* OR protective OR
garment OR belt* OR underwear OR support* OR clamp* OR clip* OR tape* OR deodoris* OR
gas OR seal* OR hernia* OR ‘peristomal hernia’
#6
#4 AND #5
#7
limit 6 to yr="2004 -Current"
46
The findings of the above search strategy were supplemented with a systematic search of
the 'grey' literature (Google; Google Scholar; OpenSIGLE; and Bing) to identify:

position papers;

other literature reviews;

information on international stoma schemes;

suppliers’ websites; and

domestic and international guidelines and best practice manuals.
The following search strategies were used to identify 'grey' literature publications.
Google Scholar
#1
(stoma OR surgical stoma) AND (Accessor* OR product* OR equip* OR care OR skin OR
paste* OR cream* OR adhesive* OR wipe* OR cleans* OR spray* OR powder* OR remov*
OR filler* OR collar* OR protective OR garment OR belt* OR underwear OR support* OR
clamp*)
#2
01/01/2004 to 28/02/2014
#1
"stoma guidelines" OR "stoma manual" OR "stoma scheme" OR "stoma literature review"
#2
01/01/2004 to 04/03/2014
Google (chrome)
#1
"stoma guidelines" OR "stoma manual" OR "stoma scheme" OR "stoma literature review"
#2
01/01/2004 to 28/02/2014
Open SIGLE
#1
‘stoma'
#2
01/01/2004 to 28/02/2014
Bing
#1
"stoma guidelines" OR "stoma manual" OR "stoma scheme" OR "stoma literature review"
#2
01/01/2004 to 04/03/2014
In addition to the systematic searches above, direct Google searches were performed of
publicly available information from companies that supply products on the SAS Schedule
and from national supply warehouses:

Hollister;

Statina Healthcare Australia;
47

Smith and Nephew;

Convatec;

Coloplast;

Ainscorp;

Dansac;

Future Environmental Services;

Omnigon;

3M;

Clifford Hallam Health Care; and

Ebos.
We also examined national and international stoma schemes and product prices of
relevance to the review. The findings from these searches are reported at Appendix 2 - an
analysis of available financial information regarding Group 9 products. Searches were
performed using combinations of the search terms specified above in order to identify
international schemes and schedule pricing.
Criteria for inclusion and exclusion of studies
We appraised all materials identified using the following criteria in order to identify materials
of broad relevance to the review (Table 1).
Table 1: Criteria for inclusion and exclusion of studies
1. Is the publication relevant to children and adults of any age, gender or
Yes
socio-demographic characteristics with a stoma?
No - exclude
2. Is the publication relevant to any Group 9 product listed in the Group 9
Yes
SAS?
No - exclude
3. Does the publication report results on any patient relevant outcome
Yes
(including morbidity, mortality, quality of life), patient satisfaction, cost (any
cost or economic metric related to cost), a specific stoma-relevant patient
No - exclude
outcome: security, support, amount of leakage, skin integrity, smell, wound
healing rates, erosion, tissue overgrowth or infection.
Types of studies
Publications relating to the use of Group 9 products in humans with stomas for any clinical
indication were considered for inclusion. Only materials published since 2004 were
considered for inclusion. We included studies with any empirical study design.
48
Types of participants
We included human studies with participants of any age or gender. We considered studies of
Group 9 products for any clinical indication or health problem as long as the participants had
a stoma. We included studies of Group 9 products with participants in any setting (hospital,
other healthcare, non-healthcare).
We sought relevant literature from the following countries / geographical areas:

Australasia;

Europe;

North America; and

other countries with comparable health systems.
Types of interventions
We considered studies of Group 9 products as a:

single intervention for a single condition and / or setting;

single intervention for multiple conditions and / or settings; or

component of a multiple intervention (i.e. in conjunction with one or more other
therapies) for a single condition and / or setting (e.g. stoma paste plus insert plus
urostomy bag versus urostomy bag alone).
We did not exclude any studies on the basis of being combination therapies.
Types of comparators
We considered studies comparing Group 9 products with a placebo/no treatment
comparison or with active therapeutic comparison.
Types of outcome measures
We considered the impact of Group 9 products on patient relevant outcomes, both beneficial
and harmful, as reported by the authors of the individual study. We also considered
materials describing costs of Group 9 products.
In reporting outcomes we described the highest level of evidence identified and associated
with any relevant outcomes.
Critical appraisal and data extraction
Two reviewers independently screened and reviewed full articles to determine if they met the
inclusion criteria. Any disagreement between reviewers regarding study inclusion was
resolved by achieving consensus between the reviewers.
We extracted all relevant information from included studies. Evidence was grouped into
appropriate categories according to the effectiveness, safety, quality and cost categories to
which the evidence related.
49
Assimilation and interpretation of the body of evidence
We developed a narrative account of the literature based on the findings from included
studies.
We summarised the benefits of products in each product sub-group of Group 9 for their
clinical effectiveness and cost.
Evidence statements for peer-reviewed studies
We have prepared an evidence statement for each product type from available evidence.
The evidence statements consist of three components, i) the clinical question addressed, ii)
a summary of the effects of the intervention and an assessment of the quality of the
evidence, and iii) a conclusion.
Conclusions were formed by considering the quality of available evidence about that product
type. We considered four factors that may lead to rating down the quality of the evidence,
namely, applicability of the evidence to all products listed in the relevant section of the Group
9 schedule, level of evidence of the studies that were identified and consistency of the
findings of included studies (the proportion of studies that found positive outcomes
associated with the product’s use). Based on the quality of the evidence, the following
conclusions were drawn (Table 2):
Table 2: Conclusions based on quality of the evidence
Quality of the
Conclusion (evidence statement)
evidence
Very low
The effects of the product type on outcomes are uncertain
Low
There is weak evidence for the product type on outcomes
Moderate
There is moderate evidence for the product type on outcomes
High
There is strong evidence for the product type on outcomes

In order to achieve a high quality rating, the available evidence had to be applicable
to all products listed in the relevant section of the Group 9 schedule, have level 1
evidence for relevant outcomes and have consistent findings across all studies that
were identified.

In order to achieve a moderate quality rating, the available evidence had to be
applicable to the majority of products listed in the relevant section of the Group 9
schedule, have level 2 evidence or higher for relevant outcomes and have the
majority of effect estimates from included studies in favour of the relevant products.

In order to achieve a low quality rating, the available evidence had to be applicable to
at least some products listed in the relevant section of the Group 9 schedule, have
level 3 evidence or higher for relevant outcomes and have the majority of effect
estimates from included studies in favour of the relevant products.
50
The quality of the evidence was rated by one reviewer and checked by a second reviewer.
Any disagreements in quality ratings were addressed through discussion in order to achieve
consensus.
Part A: Results from the peer-reviewed literature
The initial electronic search identified a large number of potential articles (over 25,000
results in Medline via PubMed alone). To restrict this to the most relevant references, the
following additional inclusion and exclusion filters were applied:

the filter ‘research’ was applied in EMBASE and CINAHL; and

the filter ‘human’ was specifically applied in MEDLINE via Pubmed, EMBASE and
CINAHL.
Figure A.1 shows the PRISMA chart outlining the selection process and number of
references at each stage (Moher et al., 2009).
51
Of 2,548 records identified through database searches, 465 were excluded as they were
duplicate records, 2,009 were excluded at the abstract stage and 61 full text articles were
excluded (described at Attachment 1). In summary, the reasons for exclusion of full text
articles were as follows:

1 was not related to participants with a stoma;

21 were not relevant to a Group 9 class of product;

35 did not report patient relevant outcomes from empirical data;

3 were publications that referred to previously published (and included) data; and

1 was a narrative discussion about unpublished data.
This resulted in a total of 13 references that were identified by the above search strategy and
were included in the systematic review of the literature.
We have set out the results of the publications according to the type of Group 9 product
used by the included participants and have presented these in the following sections (Table
A.1).
Table A.1: References containing information relevant to Group 9 product types
Product type
References
Skin care and protection accessories
Al Niami 2012
Berry 2007
Erwin 2012
Hoeflok 2009
Thompson 2011
Stoma support garments
Cowin 2012
Clamps & clips
No references
Cleansers and adhesive removal
accessories
Al Niami 2012
Berry 2007
Rudoni 2008
Convexity inserts
No references
Deodorisers and gas suppressants
Al Niami 2012
Night drainage
No references
Skin fillers and adhesive products
Berry 2007
Erwin 2012
Field 2010
Martin 2005
Park 2011
52
Product type
References
Seals
No references
Miscellaneous
No references
Level of evidence of included references
The level of evidence of included references was generally low.

One systematic review reported results from included studies, including a single RCT
(Recalla 2013 (level 1 evidence);

One RCT compared peristomal skin care techniques in ostomy patients (Park 2011)
(level 2 evidence);

One nested diagnostic study conducted within a cohort study of ostomates assessed
patch testing in peristomal dermatitis (Al Niami 2012) (level 3 evidence); and

One case series described skin barriers for different skin types (Thompson 2011)
(level 4 evidence).
In addition to the above there were also two open-label studies (Erwin 2012, Hoeflok 2009),
two case reports (Field 2010, Martin 2005) and three surveys of providers and / or patients
(Berry 2007, Cowin 2012, Rudoni 2008).
Finally, two studies reported the results of financial analyses relating to the cost of stomal
accessory products (Martins 2012, Meisner 2012). These publications are described in Part
C of the report and are not considered further in this section of the report.
Systematic reviews identified in the peer-reviewed literature
A single systematic review was identified in the peer reviewed literature that was of broad
relevance to this project. However, the review authors did not identify and report the results
of any studies that are relevant to Group 9 accessories.
Recalla 2013 conducted a systematic review of the literature to inform the development of a
best practice guideline in Canada (Registered Nurses’ Association of Ontario) for the
assessment and management of persons with colostomies, ileostomies and urostomies.
The questions that guided the systematic review were:
1. What physical and psychosocial needs require nurse-led interventions to prepare the
neonate, paediatric, or adult populations for ostomy surgery?
2. What nurse-led interventions are effective in improving ostomy care and peristomal skin
care (e.g. reducing degree / frequency of complications, shortening healing time) in
neonatal, paediatric, or adult populations?
3. What nurse-led interventions are effective in promoting patient self-care of ostomy and
peristomal skin in paediatric or adult populations?
53
4. What nurse-led interventions are effective in managing complications in ostomies and
peristomal skin in neonatal, paediatric, or adult populations?
5. What are the special considerations in caring for individuals with ostomies who have
special needs, including blindness?
6. What are the educational needs of nurses looking after individuals with ostomies?
7. What patient-focused educational interventions are effective in improving physical and
psychosocial status of individuals with ostomies?
8. What resources used by nurses in ostomy care are most effective in managing ostomies
(e.g. promoting healing, reducing complications)?
9. What resources used by patients in self-managed ostomy and peristomal care are most
effective in managing ostomies (e.g. promoting healing, reducing complications)?
A literature search was conducted in February 2008 in MEDLINE, CINAHL, PsycINFO, and
EMBASE and was updated in 2011. Broad search terms included stoma, ostomy,
enterostomy, cecostomy, colostomy, continent ileostomy, duodenostomy, ileostomy,
jejunostomy, ureterostomy, urinary diversion, fecal diversion, ostomy care, peristomal skin
care, complications, education, quality of life, enterostomal therapy and nursing. Englishlanguage systematic reviews and primary studies were included if they were within the
scope of the clinical questions and published between 1998 and 2011. There was no
preference on the basis of research design; both qualitative and quantitative primary studies
of various designs were included.
The initial search identified 929 abstracts. An additional 193 abstracts were added in the
2011 update. These were independently screened by two reviewers and 95 articles were
included in the final review. Of these, 69 were quantitative, 11 were qualitative and eight
were systematic reviews. The nature of the remaining seven studies was not reported.
Questions 2, 3, 4, 8 and 9 are of direct relevance to this project. For each of these questions
the authors searched for but did not identify studies about stoma accessory products.
2. What nurse-led interventions are effective in improving ostomy care and peristomal skin
care (e.g. reducing degree / frequency of complications, shortening healing time) in
neonatal, paediatric, or adult populations?
Fourteen descriptive quantitative studies provided information about the common types of
complications and three studies that described tools to assist nurses with diagnosing and
choosing treatment of ostomy complications. One systematic review discussed the role that
stoma irrigation played in managing complications of the ostomy. This review reported that
the literature was not extensive but what had been published identified irrigation as a safe
means of caring for one's ostomy and decreasing complications. No studies of Group 9
accessories were reported.
3. What nurse-led interventions are effective in promoting patient self-care of ostomy and
peristomal skin in paediatric or adult populations?
54
Three studies described and evaluated different appliances and interventions that promoted
patient self-care of ostomy and peristomal skin in the adult population. Two evaluated types
of ostomy appliances, including impacts on appliance changes, stool seepage, overfilling,
patient mobility, odour management, pouch flexibility, adhesiveness and erosion. One study
evaluated nurse-led interventions such as the practice of colostomy irrigation. No studies of
Group 9 accessories were reported.
4. What nurse-led interventions are effective in managing complications in ostomies and
peristomal skin in neonatal, paediatric, or adult populations?
Twelve studies provided information to address this question. Five studies describe factors
that contribute to ostomy-related complications (gender, obesity, siting of the stoma,
involvement of a stomal therapist in ongoing care). Three studies reported that pre-operative
marking reduces ostomy complications and peristomal skin complications. One study
reported the importance of patient education in reducing complications. The topic of the
remaining three studies was not described in detail. No studies of Group 9 accessories were
reported.
8. What resources used by nurses in ostomy care are most effective in managing ostomies
(e.g. promoting healing, reducing complications)?
A single study (a randomized controlled trial) was reported that addressed this question. The
study compared the costs and effectiveness of enterostomal education using a multimedia
learning education program (MLEP) and a conventional education service program (CESP).
No studies of Group 9 accessories were reported.
9. What resources used by patients in self-managed ostomy and peristomal care are most
effective in managing ostomies (e.g. promoting healing, reducing complications)?
No studies were found that addressed this research question.
Methodological quality of the systematic review
The methodological quality of this systematic review was assessed using AMSTAR criteria.
This systematic review met 4 of 11 AMSTAR criteria (there was an a priori design, duplicate
study selection and data extraction, a comprehensive literature search and status of
publication did not influence inclusion), suggesting this is a poor quality systematic review37.
Other publications identified in the peer-reviewed literature
We have set out below the results of the other publications identified in the peer-reviewed
literature according to the type of Group 9 products described in Table A.1.
37
Shea B, Grimshaw JM, Wells GA, Boers M, Andersson N, Hamel C, et al. Development of
AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC
Medical Research Methodology 2007;7(10):1-7.
55
1. Skin care and protection accessories
We identified five publications that described relevant outcomes for skin care and protection
(Al Niami 2012, Berry 2007, Erwin 2012, Hoeflok 2009, Thompson 2011).
Al Niami 2012 reported the results of patch testing for peristomal dermatitis in 149 (18%)
patients with unexplained dermatitis identified from a cohort study of 850 participants with a
stoma. Of the 149 patients there were 53 (36%) who had positive reactions on patch testing.
Of these, seven (13%) had reactions of proven relevance to their stoma products (five
patients to skin wipes, three to deodoriser and two to skin gel – some patients reacted to
more than one product), 26 (49%) had reactions of some relevance to their stoma treatment
(three to epoxy resins, two to ‘tackifiers’, one to adhesive, one to foam applicator and all
others to acrylates) and 20 (38%) were considered not relevant as they were not related to
any stoma product used by the patient. In all cases the dermatitis resolved once use of the
allergen was ceased.
Berry 2007 conducted an industry-funded survey of 648 stoma care nurses (363 responses
received; 56% response rate). The study authors reported high levels of awareness of
stomal care nurses of skin products used to manage peristomal skin problems. Nurses
mainly used silicone-based skin preparations to treat excoriated peristomal skin, wounds,
fistulae or skin at risk of excoriation (96% of respondents).
Erwin 2012 conducted an industry-funded non-controlled multicentre intervention study with
3,017 patients across 18 countries to assess patient outcomes associated with the SenSura
ostomy appliance. There were 52.5% of patients with a colostomy and 47.1% with an
ileostomy. Participants reported that the accessories they most commonly used were ‘pastes
or similar’ and ‘protective film’. At baseline 87% of participants used accessories. At 6 to 8
weeks follow-up (after commencement of use of the SenSura product and regular visits with
the wound and ostomy clinic nurse) 66% of participants used accessories (baseline to
follow-up test for statistical significance p<0.0001).
Hoeflok 2009 conducted a multicentre product evaluation study with a convenience sample
of 49 enterostomal therapy nurses from acute care facilities and 172 patients with a stoma in
Canada. The study evaluated patient outcomes with the SUR-FIT Natura Moldable Skin
Barrier (ConvaTec). At baseline 36% of patients had a colostomy and 59% had an
ileostomy; 51% had intact skin without redness. Skin barrier performance was rated as
‘excellent’ or ‘very good’ by 84% with colostomies, 85% with ileostomies and 93% with
urostomies. Average skin protection effectiveness (rated out of 5 by participant) was greatest
for patients with a colostomy and did not vary substantially between patients with intact skin,
minor redness or extensive redness. The most common problems reported by participants
were adhesion or attachment problems, issues with the flange, seal or filter, or with wear
time or skin condition. Reasons for discontinuation of the product were participants preferred
another product, (9%), difficulty with attachment or adhesive (6%) and leakage (6%).
Thompson 2011 reported narratively a case series of four patients with peristomal skin
problems whose skin conditions were subsequently managed with the Hollister range of
products. The cases demonstrated the specialist nursing approach to patient assessment,
including identification of the patient’s skin type, patient’s expectation in relation to wear time
and stoma output. The case reports showed an association between reduced skin irritation
and a well-fitting skin barrier where leakages do not occur on a regular basis.
56
Costs
No financial data were reported in these publications.
Levels of evidence of primary references
The publication by Al Niami 2012 was the highest level of evidence (level 3) identified.
57
Table A.2 References with outcomes relating to skin care and protection for people with a stoma
Reference ID
Al Niami
2012
Study
description
Cohort study
Level III
evidence
Methods
Study of 149 patients with peristomal dermatitis
conducted within a cohort study of 850 ostomates.
Outcome
description
Skin reaction to
patch testing
Participants were assessed with a general medical history
and examination, testing for infection, observation of
changing their appliance then patch testing using an
extended Manchester standard battery, the patient’s own
products and the researcher’s stoma series.
Effects for selected outcomes
Study quality issues
53 out of 149 patients had positive
reactions on patch testing.
Details of cohort study not
provided. Cohort appears to be
patients of a stomal therapy clinic.
As a result, risk of selection bias
unable to be assessed.
Seven had reactions of proven relevance
to their stoma products (including five
patients to skin wipes and two to skin gel
– some patients reacted to more than one
product)
26 had reactions of some relevance to
their stoma treatment (three to epoxy
resins, two to tackifiers, one to adhesive,
one to foam applicator and all others to
acrylates)
Berry 2007
Postal survey
Level of
evidence not
applicable
Erwin 2012
Level of
evidence not
applicable
Multicentre
product
evaluation
A survey was conducted of 648 stomal care nurses in the
United Kingdom. A structured questionnaire was
distributed by post with space for qualitative comments.
Four weeks was given for return of the survey.
Questions assessed nurses’ views on:
 Skin preparations, adhesive removers and flange
security products
 The types of products recommended in specific clinical
situations
 The benefits of certain types of products to stoma
patients with particular medical needs
 Whether the outcomes of the survey should be brought
to the attention of the DH by stomal care nurses.
Open label non-comparative multicentre study. This paper
reported the results of analysis of a sub-group of
participants of the Dialogue study. The Dialogue study is
a non-controlled clinical study that collected information
about patient experience relating to Coloplast’s SenSura
ostomy appliance. Dialogue collected data on 3,017
participants with an ostomy and included 500 wound and
ostomy care nurses across 18 countries worldwide. There
were 36 participants from Australia.
This paper reports results of assessment of peristomal
Nurses attitudes
and practices in
using skin products
20 were considered not relevant as they
were not related to any stoma product
used by the patient.
363 of 648 surveys were returned
(response rate of 56%).
Three-hundred and sixty three (100%)
were aware of alcohol-based skin
products and 362 (99.9%) were aware of
silicone-based products. Skin
preparations used on excoriated
peristomal skin, wounds, fistulae or skin
at risk of excoriation were silicone (348 of
363 respondents).
Skin condition
Quality of life
Frequency of output under the adhesive
and leakage decreased between baseline
and study follow-up with the SenSura
product.
52.5% had a colostomy and 47.1% had
an ileostomy.
Survey commissioned by four
companies in the United Kingdom
who manufacture silicone and
hydrocolloid products used in
stoma care to inform
reimbursement decisions of the
Department of Health.
Uncontrolled clinical trial. No
comparison group for assessing
outcomes.
Study funded by Coloplast, a
manufacturer of stomal products.
This study reports decreased accessory
use, improved skin condition and
significant improvement in quality of life
58
Reference ID
Study
description
Methods
Outcome
description
skin and health-related quality of life by WOC nurses at
baseline and after 6 to 8 weeks following the use of the
SenSura double-layer adhesive ostomy pouching system
the 743 patients in North America.
Hoeflok
2009
Level of
evidence not
applicable
Multicentre
product
evaluation
Convenience sample of 60 enterostomal therapy nurses
from acute care facilities and 172 patients with a stoma in
Canada. Purpose of study was to evaluate patient
outcomes with use of SUR-FIT Natura Moldable Skin
Barrier (ConvaTec).
Evaluation sponsor provided nurses with training on
product use, product samples and written information on
product use. Nurses identified a convenience sample of
their patients to participate in the study.
The patient or the nurse decided how long to trial the
product and when to complete the evaluation forms – no
minimum or maximum time frames for use were
established.
Effects for selected outcomes
Study quality issues
with the SenSura product and regular
contact with a Wound and Ostomy Clinic
nurse.
Skin barrier
performance and
protection
effectiveness
Problems with
product
Discontinuation of
product
The most widely used accessories were
‘pastes or similar’ and ‘protective film’. At
baseline 87% of participants used
accessories. At 6 to 8 weeks follow-up
66% of participants used accessories
(baseline to follow-up test for statistical
significance p<0.0001).
49 of 60 invited nurses participated in the
study and completed 195 evaluation
forms for 172 people with a stoma. The
172 patients completed 367 evaluation
forms. At baseline 36% of patients had a
colostomy and 59% had an ileostomy;
51% had intact skin without redness.
Skin barrier performance was rated as
‘excellent’ or ‘very good’ by 84% with
colostomies, 85% with ileostomies and
93% with urostomies.
Uncontrolled clinical trial. No
comparison group for assessing
outcomes.
Study conducted by ConvaTec, a
manufacturer of stomal products.
Study authors received financial
benefits from company.
Average skin protection effectiveness
(rated out of 5 by participant) varied
depending on skin condition:
- For patients with intact skin was 3.5 for
colostomy, 3.3 for ileostomy and 3 for
urostomy.
- For people with some redness ratings
were 2.9 and 3.1 for colostomy and
ileostomy respectively (no patients with
urostomy in this skin category).
- For extensive redness, scores were 2.5
and 3.5 for ileostomy and urostomy (no
patients with colostomy in this skin
category).
Problems reported by > 5% of
participants included adhesion or
attachment problems, issues with the
flange, seal or filter, or with wear time or
skin condition.
Reasons for discontinuation reported by
59
Reference ID
Study
description
Methods
Outcome
description
Effects for selected outcomes
Study quality issues
> 5% of patients were participant
preferred another product, (9%), difficulty
with attachment or adhesive (6%) and
leakage (6%).
Thompson
2011
Level IV
evidence
Case series
Narrative description of case series (four patients) with
peristomal skin problems whose skin conditions are
subsequently managed with the Hollister range of
products.
Patient satisfaction
Leakage
Maintenance of
seal
This article describes the specialist
nursing assessment and management of
four stoma patients, highlighting matching
of patient skin type with a Hollister skin
barrier product.
Different skin barrier products were
chosen for patients depending on skin
type (oily, normal, sensitive / fragile or
dry), stoma appearance (retracted,
normal, herniated), patient build
(underweight, normal, excess body
weight) and patient preferences.
One co-author is staff member of
Hollister, a manufacturer of stomal
therapy products.
Another co-author is a ‘Dansac
Senior Lecturer in Gastrointestinal
Nursing’ at an academic
institution. It is assumed that the
company that produces Dansac
sponsors this position.
Article only refers to the use of the
Hollister product range in
managing peristomal skin
problems.
60
Evidence statements
Are Group 9 skin care and protection accessories effective for improving outcomes in people
with a stoma?
Body of evidence
Outcome domain
Results
Quality of
evidence
Patient health
- Allergy
- Skin condition
Two studies reported on patient health outcomes.
One cohort study (n=149 patients) reported 7 allergic reactions of proven
relevance to a patient’s stoma product (5 to skin wipes, 2 to skin gel) and
26 reactions of some relevance (3 to epoxy resins, 2 to tackifiers, 1 to
adhesive, 1 to foam applicator and all others to acrylates).
One product evaluation study (n=3,017 patients) reported a 21% decrease
in accessory use (87% used at baseline) and improved skin condition
(quantitative outcomes not reported) associated with SenSura ostomy
appliance.
Very low
Quality of life
One product evaluation study (n=3,017 patients) reported a 21% decrease
in accessory use and improved quality of life (quantitative outcomes not
reported) associated with SenSura ostomy appliance.
Very low
Patient satisfaction
One case series (n=4 patients with peristomal skin problems) who were
managed with the Hollister range of products reported high patient
satisfaction associated with the product. Quantitative outcome measures
were not reported.
Very low
Product performance
- Leakage
- Maintenance of
seal
- Skin barrier
performance and
protection
effectiveness
- Problems with
product
- Product
discontinuation
Two studies reported product performance outcomes.
One product evaluation study (n=172 patients and 49 nurses) of SUR-FIT
Natura Moldable Skin Barrier Skin found skin protection effectiveness was
greatest for patients with intact skin and lowest for patients with extensive
redness. The most common problems reported was adhesion or
attachment problems and the most common reason for discontinuation
was participant preferred another product.
One case series (n=4 patients with peristomal skin problems) who were
managed with the Hollister range of products reported reduced leakage
associated with the product. Quantitative outcome measures were not
reported. Products used at baseline were not reported.
Very low
Nursing attitudes and
practices
One survey (n=363 stoma care nurses) reported 100% of nurses were
aware of alcohol-based skin products and 99.9% were aware of siliconebased products.
The preferred skin preparations used on excoriated peristomal skin,
wounds, fistulae or skin at risk of excoriation was silicone-based (96% of
respondents).
Very low
Evidence
statement
The effectiveness of Group 9 skin care and protection accessories for
improving outcomes in people with a stoma are uncertain.
61
2. Stoma support garments
We identified one publication that described relevant outcomes for stoma support garments
(Cowin 2012).
Cowin 2012 analysed results of a survey completed by 322 people with a parastomal hernia
who were clients of a home-delivery stoma care products service in the UK. The survey
response rate was 28% and the publication was authored by employees of the homedelivery company.
Among respondents, 55% had a colostomy, 33% an ileostomy and 10% a urostomy. Stoma
problems reported by participants included leakage under the adhesive onto the skin (66%),
‘sensations’ (56%), discomfort (40%) and odour (30%). Leakage was most severe for
patients with an ileostomy (60%) compared with urostomy (52%) or colostomy (41%).
Although all participants were registered on the home-delivery company’s database as
having received a stoma support garment, 45% of participants reported that they used their
stoma belts or girdles regularly and 27% thought that wearing a support belt or pants was
the best way to manage their hernia.
Costs
No financial data were reported in this publication.
Levels of evidence of primary references
Not applicable as no studies were identified where level of evidence could be rated.
62
Table A.3 References with outcomes relating to stoma support garments for people with a stoma
Reference ID
Cowin 2012
Level of
evidence not
applicable
Study
description
Survey
Methods
Study of experiences of patients with
parastomal hernias.
The survey was mailed to 1,876 people
who had placed an order for a support
garment on a UK home-delivery service
providing stoma care products (Salts
Medilink).
Outcome
description
Use of stoma support
garments to manage
parastomal hernia
Effects for selected outcomes
Study quality issues
The response rate was 28%. A total of 322 people stated
they had been diagnosed with a parastomal hernia; 55%
had a colostomy, 33% an ileostomy and 10% a urostomy.
Paper authors employed by
Salts Healthcare, a UK
home-delivery stoma care
product service
40% reported discomfort, 30% reported odour, 56%
reported ‘sensations’, 66% reported leakage under the
adhesive onto the skin. Leakage was described as very or
fairly bad by 60% with ileostomy, 52% with urostomy and
41% with colostomy.
59% never or rarely sought help with their hernia
management; 45% of patients regularly used their support
belt or girdle; 27% stated wearing a support belt or pants
was the best way to manage a parastomal hernia.
63
Evidence statements
Are Group 9 stoma support garments effective for improving outcomes in people with a
stoma?
Body of evidence
Outcome domain
Results
Quality of evidence
Patient health
- Use of stoma support garments to
manage parastomal hernia
One survey (n=322 patients with a parastomal
hernia) reported 45% of participants used their
stoma belts or girdles regularly and 27% thought
that wearing a support belt or pants was the best
way to manage their hernia.
Very low
Evidence statement
The effectiveness of Group 9 stoma support garments for
improving outcomes in people with a stoma are uncertain.
64
3. Cleansers and adhesive removal accessories
We identified three publications that described relevant outcomes for cleansers and
adhesive removal accessories (Al Niami 2012, Berry 2007, Rudoni 2008).
Al Niami 2012 reported the results of patch testing for peristomal dermatitis in 149 (18%)
patients with unexplained dermatitis identified from a cohort study of 850 participants with a
stoma. Of the 149 patients there were 53 (36%) who had positive reactions on patch testing.
Of these, three patients (6%) had reactions to adhesive removal products. Three patients
had positive reactions to components of cleansing wipes that are intended to remove the
adhesive debris that is left when removing a bag. These included propylene glycol (two
cases) and isopropyl alcohol (propan-2-ol; one case). All three patients reported a definite
improvement in the peristomal dermatitis following discontinuation and substitution of the
wipes with ones which did not contain either allergen.
Berry 2007 conducted an industry-funded survey of 648 stoma care nurses (363 responses
received; 56% response rate). The study authors reported high levels of awareness of
stomal care nurses of alcohol-based adhesive removers (99.4%) and silicone-based
removers (99.9%). The type of adhesive remover that nurses recommended to patients who
find it painful and/or difficult to remove their pouches was silicone-based removers (354 of
363 respondents).
Rudoni 2008 evaluated a silicone-based adhesive remover with a convenience sample of
people with a stoma who attended a stoma care open day at a single UK hospital. Of the 60
volunteers who were provided with samples of the adhesive remover 54 returned a
questionnaire reporting their experience of using the product. According to the self-reported
results, the use of the product was associated with greater ease of removal of the stoma bag
(91% of participants) and a difference with their skin (81%; the nature of the difference in the
participant’s skin was not described).
Costs
No financial data were reported in these publications.
Levels of evidence of primary references
The publication by Al Niami 2012 was the highest level of evidence (level 3) identified.
65
Table A.4 References with outcomes relating to cleansers and adhesive removal accessories for people with a stoma
Reference ID
Al Niami
2012
Study
description
Cohort study
Level III
evidence
Berry 2007
Postal survey
Level of
evidence not
applicable
Rudoni 2008
Level of
evidence not
applicable
Product
evaluation using
a questionnaire
Methods
Study of 149 patients with peristomal
dermatitis conducted within a cohort study of
850 ostomates.
Outcome
description
Skin reaction to
patch testing
Effects for selected outcomes
Study quality issues
53 out of 149 patients had positive reactions on
patch testing.
Details of cohort study not provided.
Cohort appears to be patients of a
stomal therapy clinic. As a result, risk
of selection bias unable to be
assessed.
Three patients (6%) had reactions to adhesive
removal products - propylene glycol (two
cases) and isopropyl alcohol (propan-2-ol; one
case).
Participants were assessed with a general
medical history and examination, testing for
infection, observation of changing their
appliance then patch testing using an
extended Manchester standard battery, the
patient’s own products and the researcher’s
stoma series.
A survey was conducted of 648 stomal care
nurses in the United Kingdom. A structured
questionnaire was distributed by post with
space for qualitative comments. Four weeks
was given for return of the survey.
Nurses attitudes
and practices in
using adhesive
removal
accessories
363 of 648 surveys were returned (response
rate of 56%).
Questions assessed nurses’ views on:
 Skin preparations, adhesive removers and
flange security products
 The types of products recommended in
specific clinical situations
 The benefits of certain types of products to
stoma patients with particular medical
needs
 Whether the outcomes of the survey
should be brought to the attention of the
DH by stomal care nurses.
A convenience sample of 60 participants was
provided with samples of a silicone-based
adhesive remover (Lift Plus).
Effectiveness of
silicone-based
adhesive remover
54 of 60 patients returned the survey (response
rate of 90%); 46% had ileostomies, 39% had
colostomies and 15% had urostomies.
Participants were volunteers who attended a
stoma care open day at a single UK hospital.
Participants were provided with a
questionnaire to return after using the
product.
Peristomal dermatitis improved following
discontinuation of the product.
Three-hundred and sixty-one (99.4%) were
aware of alcohol-based adhesive removers and
362 (99.9%) were aware of silicone-based
removers. The type recommended to patients
who find it painful and/or difficult to remove
their pouches was silicone (354 of 363
respondents).
91% reported the stoma bag was easier to
remove, 93% found the spray easy to use, 81%
noticed a difference with their skin when the
spray was used, 96% indicated they would
continue to use the adhesive remover and 93%
felt adhesive remover should be offered to all
patients.
Survey commissioned by four
companies in the United Kingdom
who manufacture silicone and
hydrocolloid products used in stoma
care to inform reimbursement
decisions of the Department of
Health.
Selection bias of participants – those
who attended an open day at a single
hospital and volunteered to
participate.
Non-controlled study of the product;
no comparison group to compare
results with.
66
Evidence statements
Are Group 9 cleansers and adhesive removal accessories effective for improving outcomes
in people with a stoma?
Body of evidence
Outcome domain
Results
Quality of evidence
Patient health
- Allergy
- Skin condition
Two studies reported on patient health
outcomes.
One cohort study (n=149 patients) reported 3
allergic reactions to adhesive removal
products.
One product evaluation study (n=54 patients)
reported 81% of patients found ‘a difference
with their skin’ with silicone-based removers
Very low
Product performance
- Ease of stoma bag removal
One product evaluation study (n=54 patients)
reported 91% of patients found greater ease of
removal of the stoma bag with silicone-based
removers.
Very low
Nursing attitudes and practices
One survey (n=363 stoma care nurses)
reported 99.4% of nurses were aware of
alcohol-based adhesive removers and 99.9%
were aware of silicone-based removers.
97.5% of nurses recommended silicone-based
removers to patients who found it painful /
difficult to remove their pouches.
Evidence statement
The effectiveness of Group 9 cleansers and adhesive
removal accessories for improving outcomes in people with
a stoma are uncertain.
67
4. Deodorisers and gas suppressants
We identified one publication that described relevant outcomes for deodorisers and gas
suppressants (Al Niami 2012).
Al Niami 2012 reported the results of patch testing for peristomal dermatitis in 149 (18%)
patients with unexplained dermatitis identified from a cohort study of 850 participants with a
stoma. Of the 149 patients there were 53 (36%) who had positive reactions on patch testing.
Of these, three (6%) had reactions to deodorisers of proven relevance to their stoma
products.
One patient was sensitive to oak moss absolute (Evernia prunastri) and the deodorising
product he was using that contained it. The other patient who was sensitive to a fragranced
deodorizer specifically reacted to cinnamal. Both patients were using their deodorising
preparation inappropriately, allowing significant skin contact instead of placing a few drops in
the bag itself as per the package instructions. A third patient was sensitive to formaldehyde
and the formaldehyde-releasing biocide bronopol (2-bromo-2-nitropropane-1,3-diol) which
was a declared ingredient of a deodorising spray she used intermittently. In all cases the
dermatitis resolved once use of the allergen was ceased.
Costs
No financial data were reported in this publication.
Levels of evidence of primary references
The sole publication by Al Niami 2012 was the highest level of evidence (level 3) identified.
68
Table A.5 References with outcomes relating to deodorisers and gas suppressants for people with a stoma
Reference
ID
Al Niami
2012
Level III
evidence
Study
description
Cohort study
Methods
Study of 149 patients with peristomal dermatitis
conducted within a cohort study of 850 ostomates.
Participants were assessed with a general medical
history and examination, testing for infection,
observation of changing their appliance then patch
testing using an extended Manchester standard
battery, the patient’s own products and the
researcher’s stoma series.
Outcome
description
Skin reaction
to patch
testing
Effects for selected outcomes
Study quality issues
53 out of 149 patients had positive reactions on
patch testing.
Details of cohort study not
provided. Cohort appears to be
patients of a stomal therapy
clinic. As a result, risk of
selection bias unable to be
assessed.
Three patients (6%) had allergic reaction to
deodorisers - oak moss (Evernia prunastri) (1
patient), cinnamal (1 patient) and formaldehyde and
the formaldehyde-releasing biocide bronopol (2bromo-2-nitropropane-1,3-diol) (1 patient).
The patients allergic to oak moss and cinnamal
were using their deodorising preparation
inappropriately.
In all cases the dermatitis resolved once use of the
allergen was ceased.
69
Evidence statements
Are Group 9 deodorisers and gas suppressants effective for improving outcomes in people
with a stoma?
Body of evidence
Outcome domain
Results
Quality of evidence
Patient health
- Allergy
One cohort study (n=149 patients) reported 3
allergic reactions to deodorisers that were of
proven relevance to their stoma product.
Very low
Evidence statement
The effectiveness of Group 9 deodorisers and gas
suppressants for improving outcomes in people with a stoma
are uncertain.
70
5. Skin fillers and adhesive products
We identified five publications that described relevant outcomes associated with the use of
skin fillers and adhesive products (Berry 2007, Erwin 2012, Field 2010, Martin 2005, Park
2011).
Berry 2007 conducted an industry-funded survey of 648 stoma care nurses (363 responses
received; 56% response rate). Three hundred and fifty-nine (98.9%) were aware of adhesive
tape for picture framing and 363 (100%) were aware of hydrocolloid flange extenders. Of
these, 360 of 363 recommended hydrocolloid and 25 recommended adhesive tape for
patients who require extra adhesion or security.
Erwin 2012 conducted an industry-funded non-controlled multicentre intervention study with
3,017 patients across 18 countries to assess patient outcomes associated with the SenSura
ostomy appliance. There were 52.5% of patients with a colostomy and 47.1% with an
ileostomy. Participants reported that the accessories they most commonly used were ‘pastes
or similar’ and ‘protective film’. At baseline 87% of participants used accessories. At 6 to 8
weeks follow-up (after commencement of use of the SenSura product and regular visits with
the wound and ostomy clinic nurse) 66% of participants used accessories (baseline to
follow-up test for statistical significance p<0.0001).
Field 2010 reports a case of allergic contact dermatitis due to Gantrez 425 in a patient with
an ileostomy with peristomal erythema, pruritus and scale around the stoma. The patient
was patch tested and had a positive reaction to Gantrez 425 but not Gantrez 335. The case
demonstrates a lack of cross reactivity between different Gantrez entities despite similar
chemical structure.
Martin 2005 reports a case of allergic contact dermatitis due to Dansac1 soft paste in a
patient with a colostomy who experienced a severe disabling blistering peristomal dermatitis.
Patch testing to the patient’s own products gave a positive reaction to Dansac1 soft paste
and Stomahesive1 paste. Further patch testing to the components of Dansac1 soft paste
showed a positive reaction at D2 and D4 to ester of polymethyl vinyl/maleic acid copolymer.
Park 2011 conducted a randomised controlled trial to compare the effects of standardised
peristomal skin care (SPSC) and crusting technique (CT) on the peristomal skin of
ostomates. SPSC consisted of water cleansing and direct application of ostomy appliances.
CT involved crusting hydrocolloid powder and patting with water sponge or protective barrier
liquid film. A total of 81 ostomates recruited from a tertiary hospital completed the baseline,
1-month, 2-month, and 3-month follow-up (SPSC group, n=45; CT group, n=36). Significant
between-group differences in favour of SPSC were observed for erosion and tissue
overgrowth but not discolouration.
Costs
No financial data were reported in these publications.
Levels of evidence of primary references
The publication by Park 2011 was the highest level of evidence (level 2) identified.
71
Table A.6 References with outcomes relating to skin fillers and adhesive products for people with a stoma
Reference
ID
Berry 2007
Study
description
Postal survey
Level of
evidence
not
applicable
Erwin 2012
Level of
evidence
not
applicable
Multicentre
product
evaluation
Methods
A survey was conducted of 648 stomal care nurses
in the United Kingdom. A structured questionnaire
was distributed by post with space for qualitative
comments. Four weeks was given for return of the
survey.
Questions assessed nurses’ views on:
 Skin preparations, adhesive removers and flange
security products
 The types of products recommended in specific
clinical situations
 The benefits of certain types of products to stoma
patients with particular medical needs
 Whether the outcomes of the survey should be
brought to the attention of the DH by stomal care
nurses.
Open label non-comparative multicentre study. This
paper reported the results of analysis of a sub-group
of participants of the Dialogue study. The Dialogue
study is a non-controlled clinical study that collected
information about patient experience relating to
Coloplast’s SenSura ostomy appliance. Dialogue
collected data on 3,017 participants with an ostomy
and included 500 wound and ostomy care nurses
across 18 countries worldwide. There were 36
participants from Australia.
Outcome
description
Nurses attitudes
and practices in
using skin
products
Effects for selected outcomes
Study quality issues
363 of 648 surveys were returned (response rate of
56%).
Three hundred and fifty-nine (98.9%) were aware of
adhesive tape for picture framing and 363 (100%)
were aware of hydrocolloid flange extenders. 360 of
363 recommended hydrocolloid and 25
recommended adhesive tape.
Survey commissioned by four
companies in the United
Kingdom who manufacture
silicone and hydrocolloid
products used in stoma care to
inform reimbursement
decisions of the Department of
Health.
Skin condition
Frequency of output under the adhesive and
leakage decreased between baseline and study
follow-up with the SenSura product.
Uncontrolled clinical trial. No
comparison group for
assessing outcomes.
52.5% had a colostomy and 47.1% had an
ileostomy.
Study funded by Coloplast, a
manufacturer of stomal
products.
Quality of life
This study reports decreased accessory use,
improved skin condition and significant
improvement in quality of life with the SenSura
product and regular contact with a Wound and
Ostomy Clinic nurse.
This paper reports results of assessment of
peristomal skin and health-related quality of life by
WOC nurses at baseline and after 6 to 8 weeks
following the use of the SenSura double-layer
adhesive ostomy pouching system the 743 patients
in North America.
Field 2010
Level of
evidence
not
applicable
Case report
Report of the case of a 71-year old patient with an
ileostomy who developed peristomal erytherma,
pruritus and scale around the stoma.
Peristomal
dermatitis
The most widely used accessories were ‘pastes or
similar’ and ‘protective film’. At baseline 87% of
participants used accessories. At 6 to 8 weeks
follow-up 66% of participants used accessories
(baseline to follow-up test for statistical significance
p<0.0001).
While awaiting patch testing, the patient changed
his stoma adhesive. His rash relapsed when using
Stomahesive (ConvaTec Ltd.), Adapt (Hollister
Ltd.), Dansac soft paste (Dansac Ltd.) but did not
relapse when using Karaya paste (Hollister
Ltd.).
Conflicts of interest not
reported
Patch testing was performed using a Finn
72
Reference
ID
Martin 2005
Study
description
Methods
Outcome
description
Case report
Report of the case of a colostomy patient with a
severe disabling blistering peristomal dermatitis.
Peristomal
dermatitis
Randomised
controlled trial
A randomized controlled pilot trial with 2 parallel
arms was conducted to compare the effects of
standardised peristomal skin care (SPSC) and
crusting technique (CT) on the peristomal skin of
ostomates.
Skin
discolouration,
erosion and
tissue
enlargement
Level of
evidence
not
applicable
Park 2011
Level II
evidence
81 ostomates recruited from a tertiary hospital
completed the baseline, 1-month, 2-month, and 3month follow-up (SPSC group, n=45; CT group,
n=36). SPSC consisted of water cleansing and direct
application of ostomy appliances. CT involved
crusting hydrocolloid powder and patting with water
sponge or protective barrier liquid film.
Effects for selected outcomes
chambers and Scanpor series. Reactions were
graded using International Contact Dermatitis
Research group criteria. There was a 2+ reaction to
Gantrez 425 at 100% concentration only and
negative to all concentrations of Gantrez 335 at D4.
Ten controls were negative to both Gantrez 425
and Gantrez® 335.
Patch testing to a British Contact Dermatitis Society
standard series, medicaments and plastics and
glues series was negative. Patch testing to the
patient’s own products gave a positive reaction (+)
at D2 and D4 to Dansac1 soft paste and
Stomahesive1 paste. Further patch testing to the
components of Dansac1 soft paste showed a
positive (+) reaction at D2 and D4 to ester of
polymethyl vinyl/maleic acid copolymer (Gantrez1ES) only.
In both SPSC and CT groups, the likelihood of
occurrence of discolouration (OR, 1.99; 95% CI,
1.61-2.46), erosion (OR, 1.87; 95% CI, 1.55-2.25)
and tissue enlargement (OR, 1.94; 95% CI, 1.362.77) increased with time.
There was no significant difference in
discolouration between the groups, whereas the
probability of erosion (OR, 0.38; 95% CI, 0.16-0.89)
and tissue overgrowth (OR, 0.09; 95% CI, 0.020.55) was lower in the SPSC group than in CT
group.
Study quality issues
Conflicts of interest not
reported
Rating of risk of bias using
Cochrane Risk of Bias Tool.
Met 3/7 risk of bias criteria
(random sequence generation,
reporting of outcome data, free
from selective reporting).
Trial at high risk of bias.
73
Evidence statements
Are Group 9 skin fillers and adhesive products effective for improving outcomes in people
with a stoma?
Body of evidence
Outcome domain
Results
Quality of evidence
Patient health
- Peristomal dermatitis
- Skin condition
- Skin problems (discolouration,
erosion and tissue enlargement)
Four studies reported patient health
outcomes.
One RCT (n=81 patients) reported reduced
erosion and tissue overgrowth but not
discolouration of the skin with crusting
hydrocolloid powder +/- protective barrier
liquid film compared with water alone.
Two case studies (n=2) reported peristomal
dermatitis associated with the use of
products containing Gantrez 425 and
Dansac1 soft paste / stomadhesive paste
respectively.
One product evaluation study (n=3,017
patients) reported a 21% decrease in
accessory use (including ‘pastes or similar’)
associated with SenSura ostomy appliance.
Very low
Quality of life
One product evaluation study (n=3,017
patients) reported a 21% decrease in
accessory use (including ‘pastes or similar’)
and improved quality of life (quantitative
outcomes not reported) associated with
SenSura ostomy appliance.
Very low
Nursing attitudes and practices
One survey (n=363 stoma care nurses)
reported 98.9% were aware of adhesive tape
for picture framing and 100% were aware of
hydrocolloid flange extenders. 99%
recommended hydrocolloid and 7%
recommended adhesive tape.
Very low
Evidence statement
The effectiveness of Group 9 skin fillers and adhesive
products for improving outcomes in people with a stoma
are uncertain.
74
Summary of the main results from the peer-reviewed literature
We conducted a systematic review of peer-reviewed studies investigating outcomes
associated with the use of Group 9 accessory products. Thirteen studies were identified.
One study was a systematic review that included RCTs (Recalla 2013), one was a RCT
(Park 2011), one was a nested diagnostic study conducted within a cohort study (Al Niami
2012) and one was a case series (Thompson 2011). All other studies were not able to be
rated using the NHMRC’s levels of evidence. Although we identified one relevant systematic
review, this study searched for but did not identify RCTs of Group 9 accessory products.
This review therefore did not contribute empirical evidence to our systematic review.
The types of Group 9 products that were the subject of included studies were skin care and
protection accessories (5 studies), stoma support garments (1 study), cleansers and
adhesive removal accessories (3 studies), deodorisers (1 study) and skin fillers and
adhesive products (5 studies). We identified no studies for clamps & clips, convexity inserts,
gas suppressants, night drainage, seals or miscellaneous products not already addressed in
the other product groupings.
We were unable to draw firm conclusions about the association between outcomes and any
type of Group 9 product due to a lack of high quality primary studies.
Overall completeness and applicability of the evidence
We sought publications of any Group 9 product listed in the Group 9 SAS that was used in
children and adults of any age, gender or socio-demographic characteristics with a stoma.
We included any publication regardless of patient-relevant outcomes that were reported in
each information source [(including morbidity, mortality, quality of life), patient satisfaction,
cost (any cost or economic metric related to cost)].
We found important gaps in the research evidence regarding Group 9 accessory products
and the evidence presented in Part A has important limitations. The systematic review
included 13 studies in total. This is a relatively small body of research from which
conclusions can be drawn. Further, conclusions about the impact of Group 9 accessories on
patient outcomes are limited largely to adult patients.
Quality of the evidence
The overall quality of the evidence was poor. The majority of studies were unable to be rated
using the NHMRC’s levels of evidence. The single RCT that was identified included a small
patient sample, relatively short follow-up of patients and a lack of quantitative reporting of
outcomes.
Primary outcomes were self-reported or reported by nursing proxy across included
publications, making them susceptible to reporting bias.
Significant conflicts of interest were identified for the majority of included studies. Industry
funding of the studies themselves, and / or the authors reporting the results of studies
increases the risk of bias of included studies.
75
Potential biases in the systematic review process
We are aware that there are risks of introducing bias at all stages of a systematic review. We
took steps to reduce bias by specifying an ‘a priori design and performing a comprehensive
search of the literature. Duplicate study selection and data extraction was performed. We
searched for publications regardless of publication type and provided a list of included and
excluded studies. The characteristics of included studies were provided and their scientific
quality were assessed and documented. We used the scientific quality of included studies in
formulating our conclusions. We were unable to assess for the likelihood of publication bias
due to a lack of availability of primary studies from which graphical and statistical tests of
publication bias could be performed.
We modified our search strategy after conducting our initial searches as the initial number of
abstracts that were identified was too large to enable a systematic review to be conducted.
To identify the most relevant references, the following additional inclusion and exclusion
filters were applied: the filter ‘research’ was applied in EMBASE and CINAHL; and the filter
‘human’ was specifically applied in MEDLINE via Pubmed, EMBASE and CINAHL.
We developed quality criteria to assist in the preparation of an evidence statement for each
product type. These criteria were specified after the original review protocol was developed
and after the included studies were identified.
Based on the findings of the systematic review by Recalla 2013, that searched for but did not
identify RCTs of Group 9 accessory products, we do not believe these amendments to the
review methods substantially affect the conclusions we have drawn from the available
evidence.
Conclusions
There is little evidence available in the literature on the use and efficacy of Group 9
accessories, and decisions on accessories and how to use them are often based on shared
experience and information among clinical nurse specialists rather than empirical studies
demonstrating impacts on outcomes.
There is a need for high quality randomised controlled trials to evaluate the association
between Group 9 accessories and patient outcomes. Well-designed studies with adequate
power and length of follow-up are required to allow definite conclusions to be drawn.
76
Part B - Results from the 'grey' literature
'Grey' literature database searches
The combined systematic searches of the 'grey' literature yielded 1,360 potential
publications. Of these, 1,304 publications were excluded and 56 publications were retained
for full text review (Table B.1).
Table B.1 Results of ‘grey’ literature review
Database
Google
Scholar #1
Results
963 results, review
ceased at 80 items due to
lack of relevance, 45
publications identified
Publications identified for review
40 peer reviewed journal articles and 1 systematic review–
for inclusion in the systematic literature review
3 practice manuals
1 conference presentation.
Google
Scholar #2
9 results, 1 publication
identified
1 practice manual
Google
(chrome)
302 results, ceased
search at item 100 due to
lack of relevance.
1 guideline selected
1 guideline
Open
SIGLE
Bing
7 results
Nil
79 results, 9 publications
selected
1 summary document
4 guidelines
1 stoma appliance scheme outline
1 consultation document
1 summary document for consultation responses
1 practice manual
Following review of the retained publications:

40 peer review journal articles and one systematic literature review were included in the
literature review at abstract review stage;

two duplicate practice manuals were removed;

two duplicate guidelines were removed;

two practice manuals were excluded as they do not include data about any patient
relevant outcomes and provide a nursing opinion;

one practice manual was, on review, a consensus guideline and included in the grey
literature review as a guideline;
77

one conference presentation was excluded as it did not include data about group 9
products; and

one consensus guideline was included from the systematic review search of peer
reviewed publications.
In addition to the structured ‘grey’ literature review a targeted search relating to stoma
appliance accessory manufacturers, distributors and stoma schemes was performed.
Further information is provided at attachment 2.
Overall, the following 27 materials of broad relevance were identified:

Position Papers (two publications);

Documentation from international stoma schemes (11 publications);

Guidelines and best practice manuals (three publications);

Consensus Guidelines (two publications);

Product pricing (nine publications).
A list of excluded publications with reasons for exclusion is provided at Attachment 1.
Publications identified from industry sources are provided at Attachment 2.
Key findings from included 'grey' literature are now described.
Position papers
Two position papers were identified. The position papers provide information to consumers
regarding stoma schemes and are discussed in the international stoma scheme section of
this report.
Guidelines and best practice manuals
Prescribing guidelines for stoma appliances and accessories
Three prescribing guidelines for stoma appliances were identified that included Group 9
accessories. All three prescribing guidelines were developed by committees within English
NHS Trusts.
The aim of the prescribing guidelines is to provide prescribers with information regarding
appropriate quantities and use of appliances and accessories. As the NHS England and
Wales Drug Tariff does not include maximum or recommended quantity information for
products listed, Trusts have developed this information independently.
A summary of recommended quantities for each guideline together with the actual or
averaged Australian SAS maximum quantity is provided at Table B.2.
78
Table B.2: Summary of recommended product quantities from published guidelines
Item type
SAS Max
Qty38
Coventry and
Warwickshire
Av. Qty / month39
Northamptonshire
Qty / month40
Leicestershire Qty
/ Month41
Ostomy Belts
Night Drainage
Bags
Adhesive
Remover Spray
Deodorants
4 / year
5 bags
3 / year
4 bags
3 / year
4 bags
2-3 / year
4 bags
2 / month
1-3 cans
1-3 cans
2-3 bottles
1-2 / month
(depending on
bottle size)
1 bottle
N/A
N/A
Lubricating
deodorant gel
Powder
Barrier Wipes
1 bottle /
month
2 / month
30 / month
2 bottles
N/A
N/A
N/A
N/A
N/A
N/A
Barrier Spray
1 / month
N/A
N/A
Protective Rings
30 / month
N/A
N/A
1 container
10-15 wipes (one
wipe / flange)
1-9 bottles (1 bottle /
10 pouches)
10-15 (one / flange)
Adhesive
remover wipes
Pastes
100 / month
N/A
N/A
3 tubes /
month
3 belts / year,
6 garments /
year (restricted
access)
60 / month
10 / year
N/A
N/A
15-90 wipes (one /
pouch change)
1 tube
N/A
N/A
3-6 / year
N/A
N/A
N/A
N/A
30-90 (1-3 / pouch)
10 every 6 months
Hernia Belts,
Girdles and
Garments
Retention strips
Clips
*N/A = not applicable
Of the three identified NHS guidelines, the Leicestershire guideline provides guidance for the
greatest range of product types by category. In general the small number of product
categories with recommended quantities in the NHS guidelines is similar to maximum
quantities set in the Australian SAS Schedule. The Australian SAS Schedule provides a
comprehensive list of maximum quantities for each product listed. SAS maximum quantities
listed by category in the table immediately above may include the average or most regularly
applied quantity across a category type where quantities vary within a category.
Consensus Guidelines
38
Department of Health, Stoma Appliance Scheme Schedule (Mar. 30, 2014)
39
Coventry and Warwickshire Area Prescribing Committee, Arden Cluster Prescribing Guidelines for
Stoma Appliances (Mar. 4, 2014)
40
National Health Service Northamptonshire, Prescribing Guidelines for Stoma Appliances, (Mar. 3,
2014)
41
Leicestershire Medicines Strategy Group, A Guideline to Prescribing Stoma Care Appliances and
Stoma Nurse Referral November 2011, (Mar. 4, 2014)
79
Two consensus guidelines containing information pertaining to stoma accessories were
identified.
Peristomal Moisture Associated Skin Damage in Adults with Faecal Ostomies (Gray 2013)
The publication by Gray42 provides a summary of the outcomes a systematic literature
review to identify studies that evaluated assessment, treatment or prevention of peristomal
moisture associated skin damage (MASD). Peristomal MASD is defined in the publication as
‘inflammation and denudation of the skin adjacent to a stoma associated with exposure to
effluent such as urine or stool’.
In addition to the results of the systematic literature review the publication also includes 10
consensus statements developed by a panel of expert Wound Ostomy Continence Nurses
and Enterostomal Therapy Nurses from the United States of America and Canada.
The literature for the systematic review was searched using MEDLINE and CINAHL, key
terms used included “ostomy,” “stoma” “peristomal,” “peristomal skin,” “complications,”
dermatitis” and “moisture associated skin damage”.
Publication type criteria for inclusion were; original research reports, integrative and
systematic reviews, best practice guidelines, individual case studies and multiple case
studies. Publications in languages other than English were excluded as were those
published before 1990. Boolean functions were used to narrow the search.
The search identified 331 articles, 96 were eliminated as they were either duplicates or
written in a language other than English. Of the 239 remaining articles 35 were original
research reports, 204 were integrative and systematic reviews, best practice guidelines,
individual case studies or multiple case studies.
The systematic review did not identify any studies that specifically evaluated treatment or
prevention of MASD. Given the paucity of evidence the expert panel drafted statements
outlining current best practice for the assessment, treatment and prevention of MASD.
Statements required agreement by more than 80% of panel members to be included.
Of the 10 consensus statements developed by the panel, four statements included
information pertaining to accessory products. The four statements identified are provided
below:

Statement Two – Conduct a focused history relating to pouching method and
management.
o
The panellists agreed that determining pouching method and management
including use of accessory products used to cleanse and protect peristomal skin
is essential when assessing an individual with MASD. Changes in the use of
42
Gray, M. Peristomal Moisture Associated Skin Damage in Adults with Fecal Ostomies: A
Comprehensive Review and Consensus. Journal of Wound Ostomy and Continence Nursing.
2013;40(4):389-99.
80
accessory products may indicate impaired efficiency of the seal of the pouching
system and its solid skin barrier.

Statement Seven - Teach the patient about the correct use of accessory products on
peristomal skin.

Statement eight - Teach the patient to limit or avoid behaviours that may interfere with
the seal between the pouch and peristomal skin.
o

Panellists agreed that misuse of accessory products or use of untested products
may interfere with the seal between skin and the pouching system. Examples
provided included emollient and oil based products reducing adhesion and
inappropriate product use resulting in drying of the peristomal skin.
Statement Ten - Treatment is directed at alleviating skin damage while maintaining an
effective seal between solid skin and peristomal skin
o
o
Identified methods for prolonging an effective seal included:

Correct sizing of the skin barrier aperture;

Appropriate skin barrier characteristics based on stoma and abdominal
contours (i.e. flat vs convex, extended wear vs standard);

Appropriate use of accessory products;

Maintenance of an optimal pouch wear time; and

Appropriate pouch changing technique.
The panel did not reach a consensus regarding the frequency of use of
accessory products.
Panel activities were supported by an unrestricted grant from Hollister Inc.
Peristomal Associated Moisture Associated Dermatitis and Periwound Moisture Associated
Dermatitis (Colwell 2011)
The publication by Colwell43 is the third of a series providing opinion from a panel of nursing
experts on various forms of MASD. In this publication peristomal MASD and periwound
MASD is discussed. Only peristomal MASD is considered in this review as only peristomal
MASD is specifically relevant to individuals with a stoma. Peristomal MASD is defined as
inflammation and erosion of the skin related to moisture that begins at the stoma/skin
junction and can extend outwards in a four inch radius.
The expert panel make the following consensus statements regarding stoma accessory
products and peristomal MASD:
43
Colwell, JC. MASD Part 3: Peristomal Moisture-Associated Dermatitis and Periwound MoistureAssociated Dermatitis: A consensus. Journal of Wound Ostomy and Continence Nursing.
2011;38(5):541-53.
81

It is a priority when managing peristomal MASD to determine the source of the irritant
and modification of the pouching system or the use of accessory products in order to
prevent further damage.

Patients should be queried about activities including product use.

In some cases accessory products can be considered to enhance the seal: skin barrier
paste, skin barrier strips or rings, skin barrier powder, liquid skin protectants and belts.
Custom made convex barriers are also an option for difficult cases.

Healing irritated skin can be done using several techniques, topical therapies are limited
to products that will allow the adhesive seal to be secured. Skin barrier powder can be
dusted over the moist skin to facilitate a seal of the solid skin barrier to the skin. Some
experts suggest the use of polymer acrylate liquid skin protectant over the powder as a
sealant. An astringent may be applied prior to pouch placement to dry the peristomal
skin.
International stoma schemes
Information was identified for stoma schemes in England and Wales, Scotland, Canada,
New Zealand and Australia.
Schemes were found to be managed at the national level (England and Wales, Scotland and
Australia) or managed at the provincial or district level (Canada and New Zealand).
Nationally managed stoma schemes
NHS Scotland
Stoma care items can be prescribed by General Practitioners and Specialist Stoma Care
Nurses with prescribing training. Prescriptions are dispensed by community pharmacy
contractors and appliance contractors (collectively known as stoma services contractors).
Specialist stoma care nurses are employed directly by NHS Boards44.
National reimbursement prices for a wide range of stoma care items are listed on the NHS
Scotland Stoma Appliances Price List45. The list includes products that may be ordered by
authorised prescribers, as listed on Health Board authorised prescriber lists. The list outlines
product specifications and reimbursement prices that apply to stoma services contractors. It
is updated monthly. Applications for addition, amendment or deletion of items on the list
must be made in writing and forwarded to National Procurement. All Scottish residents are
eligible to receive free NHS Scotland prescriptions.
44
Scottish Government Primary Care Division, Provision of appliances for Stoma Care, Scottish
Government Conclusions Following Meetings of Stoma National Review Group 2006-2009, (Mar. 4,
2014).
45
NHS Scotland, Stoma Appliances Price List March 2014, (Mar. 14, 2014).
82
Stoma services contractors are paid service fees according to the Stoma Supply Fee
schedule issued quarterly46. The fee rate for 1 January 2014 to 31 March 2014 is;

Dispensing fee £7.18 ($13.21 AUD)47

Customisation fee £5.77 ($10.62 AUD)

Delivery fee £4.49 ($8.26 AUD)
Fees are paid annually by global sum and adjusted as required to ensure no significant
under spend or overspend compared with the fee per occasion rate. Service fees have been
gradually reducing over the past three price revisions (Table B.3).
Table B.3: NHS Scotland Service fee changes with price revisions, 2012 to 2014
Jan-Mar 2014
Oct-Dec
Oct-Sep
Jul-Sep
Apr-Jun
Fee Type
(£)
2013 (£)
2012 (£)
2012 (£)
2012 (£)
Dispensing Fee
7.18
7.39
7.7
8.27
8.24
Customisation Fee
5.77
5.94
6.19
6.65
6.62
Delivery Fee
4.49
4.63
4.82
5.18
5.15
Stoma services contractors are required to adhere to the NHS Service Standards Relating to
the Supply and Provision of Stoma Care Appliances to Patients in the Community48 (the
Standards). The Standards aim to ensure a high quality and cost effective service which
meets patients’ needs and equity of provision of care.
The Standards set the following minimum requirements:

suppliers work within the nationally established contract terms;

supplier to liaise with the prescriber if clarification required on prescription or if supply
difficulties are anticipated;

requests should be dealt with by personnel trained in the use of stoma products, who
can provide advice and support in a confidential and private atmosphere; ensure
confidentiality of patient information; respond to a request to dispense a prescription,
immediately on receipt by notifying patients of expected delivery date and informing the
patient if any delay is anticipated in filling the order;

delivery should be within two working days if so requested by the patient;
46
NHS Scotland, Stoma Supply Fees, (Apr. 4, 2014).
47
Conversion rate1 Scottish Pound = 1.84 Australian Dollar, (Mar. 13, 2014).
48
NHS Scotland, Service Standards Relating to the Supply and Provision of Stoma Care Appliances
to Patients in the Community 2005, (Mar. 4, 2014).
83

supplier to provide provision for supply tailored to suit the needs of the individual patient,
ensuring flexibility of options;

provide a customer modification service of stoma appliance as required, e.g. flange
cutting and customisation on request;

supply of disposal bags and wipes are to be automatic with each delivery;

manufacturers are to make available on prescription or purchase order sample packs of
appropriate products to allow patient/stoma nurse to select the most appropriate solution
to the individual’s needs;

supply and delivery of product to patient in accordance with patient’s needs e.g. delivery
times volumes, discretion of carrier;

home delivery within two working days if requested by the patient;

procedures in place for referral to the appropriate healthcare professionals to address
patient concerns, queries and problems;

monitor supply of stoma products to patients and notify prescriber in the event of any
unusual requests or change in ordering patterns;

supplier to provide data to allow audit of service provision; and

Provide a confidential and private patient support service e.g. via phone help line or faceto-face.
The Standards also outline the level of training staff providing stoma services should attain
and maintain. It is the responsibility of each NHS Board to audit compliance with the
Standards.
The NHS Scotland stoma care scheme was significantly restructured in 2006. The
restructure was in response to concerns by the Scottish Executive Health Department that
prior arrangements were:

not of uniform quality;

were unduly influenced by industry through industry sponsorship of Specialist Stoma
Care Nurses; and

did not represent value for money.
Value for money concerns were primarily due to an inequitable two-tiered funding
arrangement that created perverse incentives for contractors to establish agency
arrangements and cross boarder arrangements to increase reimbursement49.
49
Scottish Executive Health Department, Appliance Contractors Consultation Document 18 June
2003, (Mar. 4, 2014).
84
After a period of stakeholder consultation documented in 200450 and a trial of new
arrangements in 2005, the reforms were introduced on 1 April 2006. Reforms included:

Introduction of service standards for all contractors.

A single tier funding regime for all contractors

A formal procurement process to establish specific Scottish reimbursement prices to
replace the direct link with English Tariff prices.

Establishment of specific Scottish procedure before new items are added to the list of the
products which may be prescribed.

Abolition of practice of company employment or company sponsoring of specialist stoma
nurses operating within NHS Scotland and their transfer into direct NHS employment.

Discontinued ad hoc provision of samples and replaced this with the introduction of
formal procurement arrangements for purchasing samples in the secondary sector.

Patient choice of appliance as selection of prescribed item to remain at the clinical
discretion of the Clinical Nurse Specialist (CNS).
It was the expectation of the Scottish Executive Health Department that the reforms would
be cost neutral as increased employment costs of Specialist Stoma Care Nurses (due to the
abolition of industry sponsorship of these positions) would be offset by improved product
purchasing terms established through national tendering.
The Scottish Government Primary Care Division released the findings of a review of the new
arrangements in 200951. The review found that the new arrangements had been
implemented and did not require further review with the exception of; development of local
and national audit arrangements against the National Service Standard and further
investigation of the value for money aspects of the arrangements.
The reduced prices for products gained through national tendering had not been sufficient to
cover the increased costs associated with transferring sponsored Specialist Stoma Care
Nurses to direct NHS employment and stoma product prescription growth occurring at a
greater rate than forecasted52. The review recommended that further steps be taken to
secure best value for money contract pricing.
NHS England and Wales
50
Scottish Executive Health Department, Appliance Contractors Consultation Summary Report May
2004. (Mar. 4, 2014).
51
Provision of Appliances for Stoma Care:Scottish Government Conclusions Following Meetings of
Stoma National Review Group 2006-2009
52
Ibid
85
Stoma care items are prescribed by General Practitioners. Prescriptions can be dispensed
by community pharmacy contractors, dispensing appliance contractors (DAC’s) and
Dispensing General Practices.
Community Pharmacy Contractors and Dispensing General Practices may supply two types
of service;

Essential service; includes provision of complimentary wipes, disposal bags, delivery
service and advice. All pharmacies and dispensing general practices provide at least this
level of service53.

Advanced Services; also includes customisation and appliance use review services54.
DAC’s are often integrated with stoma product manufacturers and supply companies.
Specialist stoma care nurses are employed by NHS Boards, nursing positions may be
sponsored by private companies, some reports estimate up to 75% of stoma nurse positions
are sponsored55.
National reimbursement prices for a wide range of stoma care items are listed in part IXC of
the Drug Tariff56. The list includes products that may be ordered by prescribers. The list
outlines product specifications and reimbursement prices that apply. It is updated monthly. In
addition to the listed price a delivery fee of £3.40 is payable for each item listed.
Contractors providing advanced services are also eligible for additional service fees as
outlined in parts VIC and VID of the Drug Tariff.
Advanced service fees include:

Customisation Fee of £4.32 ($7.95AUD)57 per customised item (for those items flagged
as able to be customised on the Drug Tariff)

Appliance Review Fee of £28 ($51.52 AUD) per review conducted at premises managed
by the pharmacy or appliance contractor and £54 ($99.36 AUD) per review conducted at
the user's home. Limit of one review per qualifying item per annum.
All Welsh residents are eligible to receive free prescriptions. In England ostomates with a
permanent stoma are eligible to receive free prescriptions via a medical exemption
certificate. Ostomates with a temporary stoma do not receive free prescriptions although
53
Colostomy Association, Obtaining Prescription Supplies March 2013, (Apr. 4, 2014).
54
NHS England and Wales, Electronic Drug Tariff Part VIC Advanced Services, (Apr. 4, 2014).
55
Basil, N. Stoma Care: The Market in Products Lets Patients Down. British Medical Journal.
2013;347:f6129. Epub17/10/13.
56
NHS England and Wales, Electronic Drug Tariff, (Apr. 4, 2014).
57
Converting Great British pound to Australian dollar
86
prescription costs can be capped at £2 per week through purchase of prescription
prepayment certificates58.
Australia
The Stoma Appliance Scheme, established and subsidised by the Australian Government, is
accessible free of charge (following payment of an Association membership fee) to all
Australian residents and eligible overseas residents with a permanent or temporary
ostomy59.
The wide range of products available is listed on the Stoma Appliance Scheme (SAS)
Schedule (the Schedule). Products on the Schedule have been recommended for listing by
the Stoma Product Assessment Panel (SAP), as being appropriate for use by a person with
a stoma. The SPAP is an independent technical advice panel appointed by the Department
of Health60. The Schedule lists products by group, SAS code, company code, product brand
name, description, pack size, maximum quantity, pack price and where applicable pack price
premiums and restrictions61.
Choice of products is guided by Stomal Therapy Nurses. Products are ordered and
distributed through 22 regional stoma associations across Australia. Stoma associations are
paid a 2.75% handling fee on all eligible orders. In addition stoma associations charge
ostomates a mandatory service fee or membership fee inclusive of a service fee
component62.
Ostomates apply to access the Stoma Appliance Scheme using an SAS Application Form.
The form must be signed by a Stomal Therapy Nurse or Medical Practitioner and supplied to
the local stoma association. All participating stoma associations must be members of the
Australian Council of Stoma Associations.
Stoma association membership is paid by the Ostomate to their local association; the current
annual fee is $45 per annum for full members and $35 per annum for concessional
members. Once approved, ostomates can order SAS Schedule products through the stoma
association. Ostomates are charged postage and handling costs associated with their
orders63.
Additional quantities of product above the listed maximum quantities may be obtained by
application for additional stoma supplies through the Department of Human Services, or the
58
NHS England, Help With NHS Costs, (Apr. 4, 2014).
59
Department of Health, Stoma Appliance Scheme, (Apr. 5, 2014).
60
Ibid
61
Dept. of Health Stoma Scheme Schedule
62
Department of Health, Information for Stoma Associations, (Apr. 5, 2014)
63
Ostomy New South Wales Limited, Ostomy NSW, (Apr. 5, 2014).
87
Department of Health if the request is for more than 4 times the maximum listed amount.
The application must be authorised by a Stomal Therapy Nurse or Medical Practitioner64.
Locally managed stoma schemes
Canada
Canada has a publically funded health insurance scheme called PharmaCare. The public
reimbursement of stoma care products is dependent on the PharmaCare plan type of each
individual and the product eligibility determined by the Ministry of Health for each Province.
Information published by The Ministry of Health for the Province of British Columbia (BC)
provides a list of PharmaCare Ostomy Benefits for the BC Province65. The one page list
includes product categories by product identification number, category title i.e. ‘adhesive
removers’ and then one or more example products. The list is indicative rather than
exhaustive.
Ostomates need to contact Pharmacare to confirm product eligibility and level of subsidy
with their specific insurance plan. Unlike the other international stoma schemes discussed
earlier, the BC list of ostomy supplies does not include ostomy support belts, pouch
deodorants, lubricants, support garments, cleansers and most tapes.
New Zealand
New Zealand Ostomy Services are provided through a contractual service specification, via
local District Health Boards (DHB)66. Ostomy Clinical Nurse Specialists are employed by the
DHB to provide education support and product supplies to Ostomates in the Community.
Ostomy supplies as assessed by the Clinical Nurse Specialist are provided free of charge to
Ostomates. Supplies are delivered from the DHB nominated Supply Company by courier67.
Conclusions
We identified 27 publications of broad relevance to Group 9 accessories from the 'grey'
literature. These materials provided information regarding stoma schemes in other countries,
limits in quantities of Group 9 accessory products supplied to consumers in other countries
and guidelines that are in place in other countries to inform use of Group 9 accessories.
Consensus guidelines by Colwell and Gray recognise the role of accessory products in
improving the seal between the stoma appliance skin barrier and the skin. Guidelines also
recognise the need for appropriate use of accessory products and that inappropriate use can
result in skin related problems and increased accessory use. However, published guidelines
are based largely on the opinion of clinicians in the stoma field rather than empirical
64
Dept. of Health Stoma Operational Guidelines
65
Ministry of Health, PharmaCare Ostomy Benefits October 2012, (Mar. 30, 2013).
66
NZ Continence Association, Continence Services in New Zealand, (Mar. 30, 2014).
67
Waitemata District Health Board, Ostomy Service, (Apr. 5, 2014).
88
evidence. Further, industry sponsorship of panel members involved in developing guidelines
introduces a significant risk of bias in the guideline development process.
In comparing the Australian Stoma Appliance Scheme with information available from other
international stoma schemes, similarities exist between the SAS Scheme and NHS Scotland
and NHS England and Wales schemes. The three schemes provide an extensive list of
stoma care products that are available free of charge (or very low cost) to resident
ostomates. Choice of product is supported by Stoma Care Nurses. The Australian SAS
Schedule varies from the NHS Price lists as it includes maximum quantity and other product
restriction information.
The schemes vary most in product order and distribution methods. Both NHS schemes
require stoma care items to be prescribed by a GP. NHS Scotland also allows items to be
prescribed by Specialist Stoma Care Nurses with demonstrated prescribing competency.
Prescriptions are dispensed through a Community Pharmacy Contractor, Dispensing GP or
Appliance Contractor. Dispense and delivery fees are paid for prescriptions and
customisation fees are also payable for eligible products.
The NHS Scotland dispense and delivery fee for one item is equivalent to $21.47 AUD. In
comparison the SAS scheme requires orders for eligible SAS members to be made by
Stoma Associations on behalf of ostomates. Stoma associations receive a 2.75% handling
fee (i.e. $2.75 per order value of $100). Ostomates are responsible for stoma association
membership and postage and handling fees. The SAS has lower order and distribution costs
for Government compared with NHS Scotland (and NHS England and Wales).
Information pertaining to the evaluation and selection process for stoma care items listed on
the NHS Scotland Stoma Appliance Price List and the NHS England and Wales Drug Tariff
was not identified in the grey literature search and as such a comparison of product listing
process cannot be considered.
89
Attachment 1 (Appendix 1): Characteristics of excluded publications
Excluded peer-reviewed references
Study
Reason for Exclusion
Bafford 2012
Does not report data for any patient relevant outcomes. Narrative review. Not
systematic review.
Basil 2013
Does not report data for any patient relevant outcomes. Editorial comment.
Black 2007
Does not report data for any patient relevant outcomes. Narrative review.
Black 2009
Does not report data for any patient relevant outcomes. Clinical review article. Not
systematic review.
Black 2011
Does not report data for any patient relevant outcomes. Editorial comment.
Black 2013
Does not report data for any patient relevant outcomes. Editorial comment.
Bolton 2008
Publication not relevant to participants with a stoma. Participants had wounds not
stomas.
Boyd 2004
Does not report data for any patient relevant outcomes. Opinion regarding
treatment of convexity.
Boyles 2010
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2004
Does not report data for any patient relevant outcomes. Publication is a product
update.
Burch 2004b
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2005
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2005b
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2008
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2009
Does not include information about Group 9 products.
Burch 2010
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2011
Does not report data for any patient relevant outcomes. Editorial comment.
Burch 2011b
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2011c
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2011d
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2012
Does not report data for any patient relevant outcomes. Clinical update. Not
90
Study
Reason for Exclusion
systematic review.
Burch 2013
Does not report data for any patient relevant outcomes. Expert opinion.
Burch 2013b
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Burch 2013c
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Colwell 2011
Does not report data for any patient relevant outcomes. Expert opinion based on
consensus.
Cronin 2008
Does not report data for any patient relevant outcomes. Provides an expert opinion
on the use of convex products for patients.
Cronin 2010
Does not report data for any patient relevant outcomes. Expert opinion.
Davis 2012
Duplicate publication of Erwin-Toth 2012
Dorothy 2013
Duplicate publication of Gray 2013b
Gray 2013
Does not report data for any patient relevant outcomes. Expert opinion based on
consensus.
Haughan 2005
Does not include information about Group 9 products.
Herlufson 2006
Does not include information about Group 9 products.
Johnson 2012
Does not include information about Group 9 products.
Mangnall 2013
Does not report data for any patient relevant outcomes. Expert opinion.
Martins 2011
Does not include information about Group 9 products.
Maxwell 2010
Does not include information about Group 9 products.
Meisner 2008
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Nazarali 2013
Duplicate citation of Recalla 2013
Nichols 2012
Does not include information about Group 9 products.
Nybaek 2004
Does not include information about Group 9 products. Silicone dressings mentioned
but unclear if stoma-specific product.
Nybaek 2010
Systematic review of causes of skin problems in patients with stoma (not
systematic review of interventions or therapeutic outcomes from Group 9 products).
Pontieri-Lewis
2006
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Porrett 2011
Study about appliances rather than accessories. Although authors report reduced
use of accessories with double-layer adhesive appliances, the type of accessory
was not described in sufficient detail to enable Group 9 comparisons to be made.
Redmond 2009
Narrative summary of unpublished data.
91
Study
Reason for Exclusion
Ross 2010
Does not report data for any patient relevant outcomes. Editorial comment.
Rudoni 2009
Does not report data for any patient relevant outcomes. Workforce survey.
Rudoni 2011
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Salvadalena
2008
Does not include information about Group 9 products.
Subramaniam
2009
Does not include information about Group 9 products.
Taylor 2012
Does not include information about Group 9 products.
Teniere 2007
Does not include information about Group 9 products.
Voergaard
2007
Does not include information about Group 9 products.
Vunjovich 2006
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Watson 2013
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Welser 2009
Does not include information about Group 9 products.
White 2005
Does not include information about Group 9 products.
Williams 2006
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Williams 2008
Does not report data for any patient relevant outcomes. Editorial comment.
Williams 2011
Does not report data for any patient relevant outcomes. Clinical update. Not
systematic review.
Williams 2013
Does not include information about Group 9 products.
Youngberry
2011
Does not include information about Group 9 products.
Excluded 'grey' literature
Publication
Reason for exclusion
Practice Manuals
Stoma Care (Burch 2008)
Stoma Care – Essential Clinical Skills for Nurses (Porrett 2005)
Does not report data for
any patient relevant
outcomes
Conference Presentation
Regular assessment of patients needs using up to date accessories and
equipment (Ross 2010) Wound Ostomy and Continence Conference
Does not report data for
any patient relevant
outcomes
92
Attachment 2 (Appendix 1): Included 'grey' literature
Publication type
Publication title
Peer reviewed
literature for
inclusion in the
systematic literature
review
Position Papers

46 peer reviewed journal articles. All articles were included in the
systematic review (part A of this report) at the abstract review stage.


Colostomy Association UK. Obtaining Prescription Supplies
Ostomy New South Wales
Other literature
reviews

1 systematic review. Included in part A of this report at the abstract
review stage.
Documentation for
International Stoma
Schemes


NHS Scotland Stoma Supply Fees
Provision of Appliances for Stoma Care, Scottish Government
Conclusions Following Meetings of Stoma National Review Group
2006-2009
NHS Scotland Service Standards Relating to the Supply and
Provision of Stoma Care Appliances to Patients in the Community
2005
Scottish Executive Health Department Appliance Contractors
Consultation Document 2003
Scottish Executive Health Department Appliance Contractor
Consultation Summary Report 2004
NHS England Help With NHS Costs
Australian Department of Health Stoma Appliance Scheme
Australian Department of Health Information for Stoma Associations
British Columbia PharmaCare Ostomy Benefits 2012
Continence Services in New Zealand
Waitemata District Health Board Ostomy Service









Guidelines and best
practice manuals





Product pricing









Arden Cluster Prescribing Guidelines for Stoma Appliances
NHS Northamptonshire Prescribing Guidelines for Stoma
Appliances
Leicestershire Medicines Strategy Group Guidelines to Prescribing
Stoma Care Appliances and Stoma Nurse Referral
Gray 2013 Peristomal Moisture Associated Skin Damage in Adults
with Fecal Ostomies
Colwell 2011 Peristomal Moisture Associated Dermatitis and
Periwound Moisture Associated Dermatitis
Australian Department of Health Stoma Appliance Scheme
Schedule
NHS Scotland Stoma Appliances Price List March 2014
NHS England and Wales Electronic Drug Tariff March 2014
Hollister Ostomy Product Catalogue (Australian and New Zeland)
Statina Healthcare Australia (website)
CH2 Direct Intouch (electronic ordering website)
My Ostomy (electronic ordering website)
Total Home Care Supplies (electronic ordering website)
STL Medical (electronic ordering website)
93
Peer reviewed publications
Grey literature searches identified 46 potentially relevant peer reviewed publications.
Publications were included in the systematic review of peer reviewed publications
immediately prior to the abstract review stage.
Other literature reviews
One potentially relevant systematic literature review document was identified and included in
the systematic review of peer reviewed publications immediately prior to the abstract review
stage.
Companies and Distributors
Search key word
Results
Publications identified for review
Coloplast
6 peer
reviewed
journal articles
Martins (2008, 2010, 2011), Porrett (2011), Erwin Toth
(2012) Meisner (2012). Included in the systematic review
at abstract review stage.
Hollister
1 pricing
catalogue
Ostomy catalogue
Statina Healthcare
Australia
Garment
pricing
information
Nil
Corsinel
Product pricing
direct to
consumer
Intouch Direct
Ainscorp, Coloplast,
Convatec, Dansac,
Future Environmental
Services, 3M, Smith
and Nephew,
Omnigon, Ebos
Clifford Hallam
Healthcare
Nil
94
International Schemes and Pricing
Search key word
Results
Publications identified for review
Scotland
1 pricing
schedule
NHS Scotland. Stoma Appliances Price List Scotland
March 2014.
ISD Scotland Stoma Supplies
1 fees schedule
England and Wales
Australia
1 pricing
schedule
NHS Scotland Stoma Supply Fees
National Health Service England and Wales Electronic
Drug Tariff Section IXC – Stoma appliances
1 stoma scheme
document
Colostomy Association. Obtaining Prescription Supplies
March 2013 www.colostomyassociation.org.uk
1 position
statement
1 pricing
schedule
NHS England. Help with NHS costs
2 stoma scheme
documents
Stoma Appliance Scheme Schedule
Stoma Appliance Scheme
Information for Stoma Associations
1 position
statement
United States of
America
Canada
2 wholesaler
direct to
consumer
pricing websites
1 product
schedule
Ostomy NSW
Total Homecare Supplies
Coloplast Ostomy Accessories
PharmaCare Ostomy Benefits October 2012
1 pricing
website
New Zealand
2 scheme
documents
Continence Services in New Zealand
Waitemata District Health Board Ostomy Service
95
Attachment 3 (Appendix 1): References from peer-reviewed literature review
Included references
1. Al-Niaimi F, Beck M, Almaani N, Samarasinghe V, Williams J, Lyon C. The relevance of
patch testing in peristomal dermatitis. The British journal of dermatology.
2012;167(1):103-9. Epub 2012/03/06.
2. Berry J, Black P, Smith R, Stuchfield B. Assessing the value of silicone and hydrocolloid
products in stoma care. British Journal of Nursing (Mark Allen Publishing).
2007;16(13):778, 80, 82 passim. Epub 2007/09/14.
3. Cowin C, Redmond C. Living with a parastomal hernia. Gastrointestinal Nursing.
2012;10(1):16-24.
4. Erwin-Toth P, Thompson SJ, Davis JS. Factors impacting the quality of life of people
with an ostomy in north america: results from the dialogue study. Journal of Wound,
Ostomy & Continence Nursing. 2012;39(4):417-4.
5. Field S, O'Sullivan C, Murphy M, Bourke JF. Peristomal allergic contact dermatitis to
stoma-adhesive paste containing Monobutyl ester/maleic acid of Polymethylvinylether
(Gantrez(registered trademark) 425) but not to Isopropyl ester/maleic anhydride of
Polymethylvinylether (Gantrez(registered trademark) 335). Contact dermatitis.
2010;62(2):120-1.
6. Hoeflok J, Guy D, Allen S, St-Cyr D. A prospective multicenter evaluation of a moldable
stoma skin barrier. Ostomy Wound Management. 2009;55(5):62-9.
7. Martin JA, Hughes TM, Stone NM. Peristomal allergic contact dermatitis--case report
and review of the literature. Contact dermatitis. 2005;52(5):273-5. Epub 2005/05/19.
8. Martins L, Tavernelli K, Sansom W, Dahl K, Claessens I, Porrett T, et al. Strategies to
reduce treatment costs of peristomal skin complications. Gastrointestinal Nursing.
2012;10(10):24-32.
9. Meisner S, Lehur PA, Moran B, Martins L, Jemec GBE. Peristomal skin complications
are common, expensive, and difficult to manage: A population based cost modeling
study. PloS one. 2012;7(5).
10. Park S, Lee YJ, Oh DN, Kim J. Comparison of standardized peristomal skin care and
crusting technique in prevention of peristomal skin problems in ostomy patients. Journal
of Korean Academy of Nursing [Internet]. 2011; (6):[814-20 pp.]. Available from:.
11. Recalla S, English K, Nazarali R, Mayo S, Miller D, Gray M. Ostomy Care and
Management: A Systematic Review. Journal of Wound Ostomy & Continence Nursing.
2013;40(5):489-500.
12. Rudoni C. A service evaluation of the use of silicone-based adhesive remover. British
Journal of Nursing. 2008;17(2):S4.
96
13. Thompson H, North J, Davenport R, Williams J. Matching the skin barrier to the skin
type. British Journal of Nursing (Mark Allen Publishing). 2011;20(16):S27-30. Epub
2011/11/22.
Excluded references
1. Bafford AC, Irani JL. Management and complications of stomas. The Surgical Clinics of
North America. 2013;93(1):145-66. Epub 2012/11/28.
2. Basil N. Stoma care: the market in products lets patients down. BMJ (Clinical research
ed). 2013;347:f6129. Epub 2013/10/19.
3. Black P. Peristomal skin care: an overview of available products. British Journal of
Nursing (Mark Allen Publishing). 2007;16(17):1048, 50, 52-4 passim. Epub 2007/11/21.
4. Black P. Stoma care nursing management: cost implications in community care. British
Journal of Community Nursing. 2009;14(8):350.
5. Black P. The role of accessory product in patients with a stoma. British Journal of
Nursing (Mark Allen Publishing). 2013;22(5):S24. Epub 2013/05/17.
6. Black P, Chalmers F. Caring for stoma patients: Best practice guidelines and gaining
RCN accreditation of this resource. World Council of Enterostomal Therapists Journal.
2011;31(1):9-13.
7. Bolton L. DO Products Affect Wound Outcomes When Using Standardized Algorithms?:
2304. Journal of Wound Ostomy & Continence Nursing. 2008;35(3):S31.
8. Boyd K, Thompson MJ, Boyd-Carson W, Trainor B. Use of convex appliances. Nursing
standard. 2004;18(20):37-8.
9. Boyles A. Keeping up to date with stoma care accessories: Enabling informed choice.
Gastrointestinal Nursing. 2010;8(6).
10. Burch J. The management and care of people with stoma complications. British Journal
of Nursing. 2004;13(6):307-18.
11. Burch J, Sica J. Urostomy products: an update of recent developments. British Journal of
Community Nursing. 2004b;9(11):482-6. Epub 2004/12/08.
12. Burch J, Sica J. Stoma care accessories: an overview of a crowded market. British
Journal of Community Nursing. 2005;10(1):24-31. Epub 2005/03/08.
13. Burch J. Stoma complications encountered in the community, A-Z. British Journal of
Community Nursing. 2005b;10(7):324, 6, 8-9. Epub 2005/07/13.
14. Burch J, Sica J. Common peristomal skin problems and potential treatment options.
British Journal of Nursing 2008;17(17):S4, S6, S8 passim. Epub 2008/10/25.
97
15. Burch J. An update on available stoma appliances in the community. British Journal of
Community Nursing. 2009;14(4):146.
16. Burch J. Caring for peristomal skin: what every nurse should know. British Journal of
Nursing. 2010;19(3):166.
17. Burch J. Stoma care-related skin problems and solutions. British Journal of Nursing
(Mark Allen Publishing). 2011;20(21):1358. Epub 2012/01/14.
18. Burch J. Resuming a normal life: holistic care of the person with an ostomy. British
Journal of Community Nursing. 2011b;16(8):366-73. Epub 2011/08/16.
19. Burch J. Peristomal skin care and the use of accessories to promote skin health. British
Journal of Nursing (Mark Allen Publishing). 2011c;20(7):S4.
20. Burch J. Choosing the correct accessory for each stoma type. Gastrointestinal Nursing.
2011d;9(3).
21. Burch J. Spoilt for choice: stoma accessories and appliances. Nursing and Residential
Care. 2012;14(10):510.
22. Burch J. When to use a barrier cream in patients with a stoma. British Journal of Nursing
(Mark Allen Publishing). 2013;22(5):S12. Epub 2013/05/17.
23. Burch J. Stoma complications: an overview. British Journal of Community Nursing
2013b; 18 (8): 375-378.
24. Burch J. Choosing the correct accessory for each stoma type: an update. British Journal
of Nursing. 2013c;22(16 Supplement):S10-S3.
25. Colwell JC, Ratliff CR, Goldberg M, Baharestani MM, Bliss DZ, Gray M, et al. MASD part
3: peristomal moisture- associated dermatitis and periwound moisture-associated
dermatitis: a consensus. Journal of wound, ostomy, and continence nursing : official
publication of The Wound, Ostomy and Continence Nurses Society / WOCN.
2011;38(5):541-53; quiz 54-5. Epub 2011/08/30.
26. Cronin E. A guide to the appropriate use of convex stoma care products. Gastrointestinal
Nursing. 2008;6(2).
27. Cronin E. An overview of stoma bridges and a case study on their management. British
Journal of Nursing (Mark Allen Publishing). 2010;19(17):S16-S20. Epub 2010/09/28.
28. Davis JS, Erwin-Toth P, Thompson SJ. Factors Impacting the Quality of Life of People
With an Ostomy in North America Results From the Dialogue Study. Diabetes. 2012.
29. Dorothy MGJCC, Hoeflok DMGJ, Rao AMLMS. Peristomal Moisture–Associated Skin
Damage in Adults With Fecal Ostomies. 2013.
98
30. Gray M, Colwell JC, Doughty D, Goldberg M, Hoeflok J, Manson A, et al. Peristomal
Moisture–Associated Skin Damage in Adults With Fecal Ostomies: A Comprehensive
Review and Consensus. Journal of Wound Ostomy & Continence Nursing.
2013;40(4):389-99.
31. Haughan M, O’Neill A. The National Neonatal Surgical Benchmarking Group:
Development of a benchmark for stoma management. Infant. 2005;1(3):84-6.
32. Herlufsen P, Olsen A, Carlsen B, Nybaek H, Karlsmark T, Laursen T, et al. Study of
peristomal skin disorders in patients with permanent stomas. British Journal of Nursing.
2006;15(16):854-62.
33. Johnson T. Follow-up care of stoma patients: a systematic literature review.
Gastrointestinal Nursing. 2012;10(9):30-6.
34. Mangnall J, Lakin S, Burke D, Midgley K. An alternative model of prescribing stoma
appliances. British Journal of Community Nursing. 2013;18(10):485-6, 8-91. Epub
2014/01/30.
35. Maxwell TR, Taylor D, Durnal AM, Wills R, Kommala D, Wade S. Safety and efficacy of a
novel continence device in colostomy patients. Diseases of the colon and rectum.
2010;53(10):1422-31. Epub 2010/09/18.
36. Martins L, Samai O, Fernández A, Urquhart M, Hansen AS. Maintaining healthy skin
around an ostomy: peristomal skin disorders and self-assessment. Gastrointestinal
Nursing. 2011:9-13.
37. Meisner S, Balleby L. Peristomal Skin Complications. Seminars in Colon and Rectal
Surgery. 2008;19(3):146-50.
38. Nazarali SRKER, Gray SMDMM. Ostomy Care and Management. Journal of wound,
ostomy, and continence nursing : official publication of The Wound, Ostomy and
Continence Nurses Society / WOCN. 2013;40(5):1-12.
39. Nichols T, McPhail J. Ostomy appliance with an integral adhesive border: luxury or
necessity? Gastrointestinal Nursing. 2012;10(6).
40. Nybaek H, Jemec GB. Skin problems in stoma patients. Journal of the European
Academy of Dermatology and Venereology : JEADV. 2010;24(3):249-57. Epub
2010/05/15.
41. Nybaek H, Olsen AG, Karlsmark T, Jemec GB. Topical therapy for peristomal pyoderma
gangrenosum. Journal of cutaneous medicine and surgery. 2004;8(4):220-3. Epub
2005/08/11.
42. Pontieri-Lewis V. Basics of ostomy care. Medsurg Nursing 2006; 15(4): 199-202.
99
43. Porrett T, Nováková S, Schmitz K, Klimekova E, Aaes H. Leakage and ostomy
appliances: results from a large-scale, open-label study in clinical practice.
Gastrointestinal Nursing. 2011:19-23.
44. Redmond C. Dermacol®: A unique stoma collar to protect the skin from leakages.
Gastrointestinal Nursing. 2009;7(7).
45. Ross J, editor. Regular assessment of patients’ needs by using up to date stoma
accessories and equipment continues to enhance the ostomates quality of life. Journal of
Wound, Ostomy and Continence Nursing 2010; Lippincott Williams & Wilkins.
46. Rudoni C. Peristomal skin irritation and the use of a silicone-based barrier film. British
Journal of Nursing (Mark Allen Publishing). 2011;20(16):S12, S4, S6 passim. Epub
2011/11/22.
47. Rudoni C, Dennis H. Accessories or necessities? Exploring consensus on usage of
stoma accessories. British Journal of Nursing. 2009;18(18):1106.
48. Salvadalena G. Incidence of complications of the stoma and peristomal skin among
individuals with colostomy, ileostomy, and urostomy: a systematic review. Journal of
Wound, Ostomy & Continence Nursing. 2008;35(6):596-609.
49. Subramaniam R, Taylor C. The use of an antegrade continence enema stopper in
catheterizable channels virtually eliminates the incidence of stomal stenosis: preliminary
experience. The Journal of urology. 2009;181(1):299-301. Epub 2008/11/18.
50. Taylor L. Peristomal sore skin: assessing the effect of an alginate wafer. British Journal
of Nursing (Mark Allen Publishing). 2012;21(16):S41-2, S4-6. Epub 2012/11/06.
51. Tenière P, Welser M, Martinet C. Ostomy pouch management: two comparative studies
of one-piece pouches. World Council of Enterostomal Therapists Journal. 2007;27(2):106.
52. Voergaard LL, Vendelbo G, Carlsen B, Jacobsen L, Nissen B, Mortensen J, et al.
Product focus. Ostomy bag management: comparative study of a new one-piece closed
bag. British Journal of Nursing. 2007;16(2):95.
53. Vujnovich A. The management of stoma-related skin complications. Wounds UK.
2006;2(3):36-47.
54. Watson AJ, Nicol L, Donaldson S, Fraser C, Silversides A. Complications of stomas:
their aetiology and management. British Journal of Community Nursing. 2013;18(3):1112, 4, 6. Epub 2013/05/10.
55. Welser M, Riedlinger I, Prause U. A comparative study of two-piece ostomy appliances.
British Journal of Nursing. 2009;18(9):530-8.
56. White M, Berg K. A new flangeless adhesive coupling system for colostomy and
ileostomy. British Journal of Nursing. 2005;14(6):325-8.
100
57. Williams I. Cost-efficiency in prescription reviews: pilot study of stoma patients in one
health board in Wales. Gastrointestinal Nursing. 2013;11(7):36-44.
58. Williams J. Stoma care part 2: choosing appliance accessories. Gastrointestinal Nursing.
2006;4(7):16-9.
59. Williams J. Choosing devices for stoma patients. Practice Nursing. 2011;22(12):646.
60. Williams J, Rudoni C, Thompson MJ, Fulham J. Provision of products: should we be
concerned? Nursing and Residential Care. 2006;9(11):528-30.
61. Youngberg DRM. Individuals with a permanent ostomy: quality of life, preoperative
stoma site marking by an ostomy nurse, six peristomal complications, and out-ofpocket
financial costs for ostomy management. Journal of Wound, Ostomy & Continence
Nursing. 2011;38(3S):S5-6.
101
Appendix 2 - Analysis of available financial information regarding
Group 9 products
Introduction
Appendix 2 provides comparative pricing of products for each sub-group within Group 9 of
the Stoma Appliance Schedule. Two categories of information are provided for each subgroup. These include:

direct domestic comparators; and

direct international comparators.
In summary, product pricing information was identified by systematically reviewing the 'grey'
literature (described in Appendix 1). The domestic comparator data set includes
comparisons from private consumer and company direct information sources. International
comparators include US consumer, NHS Scotland, England and Wales prices.
Domestic pricing
Publically available pricing for SAS Group 9 products in Australia, outside of the price paid
by Government as listed in the SAS Scheme, was identified in the following publications:

Pricing direct to the consumers through online purchase from a national medicines and
medical supplies wholesaler; and

Pricing direct from the supply companies Hollister and Statina Healthcare Australia to the
public.
Pricing direct to consumers was publicly available for one company (CH2 Australia). The
company does not stock the full range of Group 9 accessories. A selection of products from
the sub groups within Group 9 of the SAS are held by the wholesaler with the exception of
stoma support wear which is not available. Product prices for companies without national
supply capability were excluded.
Pricing direct from supply companies is generally not publically available. Searches of supply
company websites did not include pricing information. The only exceptions being Statina
HeathCare Australia and Hollister; Hollister’s product catalogue includes pricing for items
equal to the SAS Scheme price to government.
International product pricing
International stoma product pricing was identified for three countries:

United States of America;

England and Wales; and

Scotland
Identified product pricing in the USA include prices direct to consumers via national
medicines and medical supplies warehouses. Many USA warehouse websites do not include
102
the price per item of products but rather require consumers to select items and enter health
insurance plan details so that a computerised algorithm can calculate the gap price between
the insurance payment and item price. Only those websites identified with direct price per
product were included.
Product prices for stoma appliance items available through the NHS England and Wales are
publically available through the Electronic Drug Tariff (EDT)68. Stoma products are listed in
part IXC. There are a number of products listed on the EDT that are also listed in SAS
Schedule Group 9.
Product reimbursement prices for stoma appliance items available in Scotland are publically
available through the Stoma Appliances Price List69. There are a number of products listed
on the Stoma Appliances Price List that are also listed on Group 9 of the Australian SAS
Schedule and listed on the NHS England and Wales EDT. This commonality allows for direct
and indirect price comparison.
Sub-group price comparison
In summary, we describe the following domestic comparators:

Private consumer - this is the price to an Australian consumer purchasing from a
national on-line wholesaler website70

Company Direct – this is the price displayed on the company’s Australian website
or electronic brochure.
International comparators include the following:

US Consumer (AUD) – this is the equivalent price expressed in Australian
dollars71,72 for an American consumer purchasing from an on-line wholesaler.

NHS Scotland (AUD) Price and Variance – this is the equivalent price expressed in
Australian dollars73 to that listed on the NHS Scotland Stoma Appliance Scheme74
followed by the variance between the NHS Scotland Stoma Appliance Scheme
price and the Australian SAS price, expressed as a percentage.

NHS England and Wales (AUD) Price and Variance – this is the equivalent price
expressed in Australian dollars to that listed on the NHS England and Wales
Electronic Drug Tariff75 followed by the variance between the NHS England and
68
NHS Electronic Drug Tarriff
69
ISD Scotland Stoma Supplies
70
http://direct.ch2.net.au/index.php?mode=intouch
71
Conversion rate $1US=$1.11AUD (Mar. 21, 2014).
72
http://continentostomymystore.com
73
Conversion rate1 Scottish Pound = 1.84 Australian Dollar (Mar. 13, 2014)
74
NHS Scotland. Stoma Appliances Price List Scotland March 2014. (Mar. 12, 2014).
75NHS
Electronic Drug Tarriff (Mar. 29, 2014).
103
Wales price expressed in equivalent Australian dollars and the Australian SAS
price, expressed as a percentage.
Products are listed as direct comparators in the event of direct match of manufacturer code
or when the product name and descriptor match with certainty. For the purpose of providing
additional information, sub-groups 9b and 9h include data that provide an indirect
comparison. This includes comparison of the same product brand and type with a different
pack size inclusion (9b) or differing brands with the same dimensions, use and general
presentation (9h).
104
1. SAS Group 9a – Skin care and protection
Of the 13 items listed in 9a direct domestic comparators were available for five items. All
comparator item prices were equivalent or greater than SAS prices (Table 1.1).
In comparison with SAS prices:

Hollister company direct prices were equivalent.

Private prices were 92% to 328% higher.
Table 1.1: Direct Domestic Comparators
SAS
Code
3509Q
3530T
3558G
3580K
3944N
Brand Name
Coloplast
Protective
Sheet
Dispenser
Hollister
Hollihesive
Hollister
Flextend
ConvaTec Skin
Barrier
Coloplast
Brava
Protective
Sheet
Pack
Size
Max
Qty
Pack
Price
(AUD)
Private
Consumer
(AUD)
Company
Direct76
(AUD)
1
1m
47.14
201.70
n/a
5
30m
14.38
n/a
14.38
5
30m
14.38
n/a
14.38
3
30m
43.74
83.80
n/a
10
30m
28.77
62.70
n/a
*n/a pricing not available
Of the 13 items listed in 9a direct international comparators were available for 11 items
(Table 1.2). Seven items had comparator prices greater than SAS prices. Four items had
comparator prices less than SAS prices.
In comparison with SAS prices:

US web-based wholesale prices to consumers were 216% to 282% higher.

Six NHS item prices were 23% to 270% higher.

Four NHS item prices were 20% to 57% lower.
76http://www.hollister.com/anz/files/pdfs/Ostomy-Catalogue_2014-15.pdf
105
Table 1.2: Direct International Comparators
SAS
Code
3508P
3530T
3532X
3558G
3580K
3581L
3897D
3944N
3599E
5691M
9853N
Brand Name
Coloplast
Brava
Protective
Sheet
Hollister
Hollihesive
Convatec Skin
Barrier
Hollister
Flextend
Convatec Skin
Barrier
Coloplast
Brava
Protective
Sheet
Coloplast
Brava Elastic
Tape
Coloplast
Brava
Protective
Sheet
Omnigon
Welland
Hydroframe
Mini
Ainscorp Salts
SecuPlast
Hydro Aloe
Ainscorp Salts
Secu Plast
Hydro
Pack
Size
Pack
Price
(AUD)
US
Consumer
(AUD)77
NHS Scotland
Price (AUD) &
Variance
NHS England
& Wales Price
(AUD) &
Variance
5
14.38
n/a
51.17
(256%)
53.10
(270%)
5
14.38
31.19
21.34
(48%)
5
14.38
n/a
n/a
22.15
(54%)
21.91
(52%)
5
14.38
40.56
n/a
n/a
3
43.74
n/a
n/a
53.69
(23%)
5
72.90
n/a
93.10
(28%)
96.66
(33%)
20
29.16
n/a
23.09
(-21%)
23.39
(-20%)
10
28.77
n/a
43.22
(50%)
44.36
(54%)
30
42.84
n/a
n/a
18.29
(-57%)
30
43.74
n/a
22.72
(-48%)
23.79
(-46%)
30
43.74
n/a
21.16
(-52%)
21.96
(-50%)
Ainscorp is an Australian company that imports and distributes Salts products in Australia. It
is worth noting that the SAS Ainscorp Salts prices are often greater than NHS Salts prices.
This probably reflects the additional cost of indirect supply from a manufacturer through a
third party.
77http://www.totalhomecaresupplies.com/CategoryDetail.aspx?CategoryName=_z%20Brand%20Holli
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106
2. SAS Group 9b – Stoma support garments
Of the 23 items listed in 9b, direct domestic comparators were available for one item. The
direct purchase from company price was equal to the SAS listed price (Table 2.1).
Table 2.1: Direct Domestic Comparators
SAS
Code
Brand Name
Pack
Size
Max Qty
Pack
Price
(AUD)
Company
Direct
(AUD)78
3887N
Hollister Adapt
1
4
annually
5.98
5.98
Of the 23 items listed in 9b, direct international comparators were available for 10 items
(Table 2.2). For three items with the same brand name there were different pack sizes but
the same comparator price per item across pack sizes. Duplicates for these products are
therefore omitted in Table 2.2.
For all 10 products the comparator price was greater than the SAS price. In general the
comparator price was more than twice that of the SAS price.
Table 2.2: Direct International Comparators
SAS
Code
Brand Name
Pack
Size
Pack
Price
(AUD)
US
Consumer
(AUD)79,80
NHS Scotland
Price (AUD) &
variance
NHS England &
Wales Price
(AUD) &
variance
3816W
Omnigon Braun
Stomacare Belt
1
5.98
n/a
13.89
(132%)
n/a
3887N
Hollister Adapt
1
5.98
11.98
13.89
(132%)
14.30
(139%)
3890R
Dansac Beige
Ostomy Belt
1
5.98
n/a
13.41
(124%)
n/a
1
5.98
12.70
11.9
(99%)
12.36
(107%)
1
5.98
12.70
12.02
(101%)
12.16
(104%)
1
5.98
n/a
13.56
(127%)
n/a
1
5.98
n/a
13.25
(122%)
13.41
(124%)
3898E
3898E
9760Q
9834N
78
Coloplast Brava
Belt Standard
100cm
Coloplast Brava
Belt Extra Large
135cm
Ainscorp Salts
Adjustable
Ostomy Belt
Omnigon Flair
Belt Pack
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79http://www.totalhomecaresupplies.com/CategoryDetail.aspx?CategoryName=_z%20Brand%20Holli
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80http://www.stlmedical.com/store/coloplast-ostomy-accessories.html
107
There are 10 items listed within 9b with SAS Code 9834N for which indirect international
comparators have been found. The listed items consist of a belt with a single belt ring of
varying sizes. The SAS reimbursement price for a pack of one belt and one ring is $5.98.
The NHS schemes reimburse for a pack of one belt with five rings*; whilst a direct
comparison of price cannot be made it is clear the SAS price is better value for money at
$5.98 for one belt and ring compared with the NHS price for one belt and five rings at $64.16
or more (Table 2.3).
Table 2.3: Indirect International Comparators
Company
Code
XBLT073
XBLT077
XBLT082
XBLT092
XBLT098
XBLT173
XBLT177
XBLT182
XBLT192
XBLT198
Brand Name
Omnigon Flair Belt
Pack
Omnigon Flair Belt
Pack
Omnigon Flair Belt
Pack
Omnigon Flair Belt
Pack
Omnigon Flair Belt
Pack
Omnigon Flair Belt
Pack
Omnigon Flair Belt
Pack
Omnigon Flair Belt
Pack
Omnigon Flair Belt
Pack
Omnigon Flair Belt
Pack
Pack
Size
1
1
1
1
1
1
1
1
1
1
Max Qty
4
annually
4
annually
4
annually
4
annually
4
annually
4
annually
4
annually
4
annually
4
annually
4
annually
NHS
England &
Wales
(AUD)
Pack
Price
(AUD)
NHS
Scotland
(AUD)
5.98
64.16*
66.06*
5.98
64.16*
67.18*
5.98
64.16*
67.18*
5.98
64.16*
67.18*
5.98
64.16*
66.06*
5.98
64.16*
66.06*
5.98
64.16*
67.18*
5.98
64.16*
67.18*
5.98
64.16*
67.18*
5.98
64.16*
66.06*
108
3. SAS Group 9c – Clamps & clips
Of the five items listed in 9c, direct domestic comparator prices were available for four items
(Table 3.1).
In comparison with SAS prices:

Hollister company direct prices were equivalent

Private prices were 91% to 121% higher
Table 3.1: Direct Domestic Comparators
SAS
Code
Brand Name
Pack
Size
Max
Qty
Pack
Price
(AUD)
Private
Consumer
(AUD)
Company
Direct
(AUD)81
3651E
Hollister Clamps
20
10
annually
46.10
n/a
46.10
3760X
ConvaTec Clips
10
10
annually
23.05
44.20
n/a
3810M
Coloplast Alterna
Slimline
20
10
annually
46.10
102.00
n/a
9915W
Hollister ModermaFlex
1
10
annually
2.30
n/a
2.30
Of the five items listed in 9c, direct international comparator prices were available for two
items. In comparison with SAS prices NHS reimbursement prices are 15% to 19% lower
(Table 3.2).
Table 3.2: Direct International Comparators
SAS
Code
Brand Name
Pack
Size
Pack
Price
(AUD)
NHS Scotland
Price (AUD) &
variance
NHS England &
Wales Price
(AUD) & variance
3651E
Hollister Clamps
20
46.10
37.46
(-19%)
38.90
(-16%)
3810M
Coloplast Alterna Slimline
20
46.10
37.46
(-19%)
39.43
(-15%)
81
http://www.hollister.com/anz/files/pdfs/Ostomy-Catalogue_2014-15.pdf
109
4. SAS Group 9d – Cleansers and adhesive removal
Of the 17 items listed in 9d, direct domestic comparators are available for six items (Table
4.1). For all six products the comparator price was equivalent or greater than the SAS price.

Hollister company direct prices were equivalent.

Private prices were 87% to 150% higher.
Table 4.1: Direct Domestic Comparators
SAS
Code
Brand Name
Pack
Size
3520G
Coloplast Comfeel
Wipes
30
3522J
ConvaTec ConvaCare
Wipes
100
3542K
Smith & Nephew
Remove Wipes
50
3554C
Hollister Universal
Wipes
50
3555D
Hollister Cleanser Spray
1
3775Q
Coloplast Comfeel Spray
1
Pack
Price
(AUD)
Private
Consumer
(AUD)
Company
Direct
(AUD)82
14.34
34.90
n/a
32.00
59.70
n/a
16.00
40.00
n/a
16.00
29.90
16.00
1 per
month
8.35
16.90
8.35
1 per
month
8.35
16.63
n/a
Max
Qty
100
per
month
100
per
month
100
per
month
100
per
month
Of the 17 items listed in 9d, direct international comparator prices were available for seven
products (Table 4.2). In comparison with SAS prices:

The US comparator product price was 10% higher.

One NHS Scotland product was priced 1% lower.

All other NHS product prices were 3% to 286% higher.
82
http://www.hollister.com/anz/files/pdfs/Ostomy-Catalogue_2014-15.pdf
110
Table 4.2: Direct International Comparators
US
Consumer83
(AUD)
NHS
Scotland
Price (AUD)
& variance
NHS
England &
Wales Price
(AUD) &
variance
SAS
Code
Brand Name
Pack
Size
Pack
Price
(AUD)
3522J
ConvaTec
ConvaCare Wipes
100
32.00
n/a
31.61
(-1%)
33.10
(3%)
3554C
Hollister Universal
Wipes
50
16.00
17.64
24.03
(50%)
24.95
(56%)
3716N
Dansac Skin Lotion
(bottle)
1
8.35
n/a
n/a
32.22
(286%)
3775Q
Coloplast Comfeel
Cleanser (bottle)
1
8.35
n/a
n/a
32.16
(285%)
1
10.23
n/a
15.49
(51%)
16.27
(59%)
30
11.94
n/a
25.69
(115%)
26.97
(126%)
30
14.34
n/a
15.93
(11%)
16.54
(15%)
3902J
3903K
9854P
Coloplast Brava No
Sting Adhesive
Remover Spray
Coloplast Brava No
Sting Adhesive
Remover Wipes
Ainscorp Salts Wipe
Away Wipes
5. SAS Group 9e – Convexity inserts
Direct Domestic Comparators
Direct domestic comparator prices were unavailable for the eight items listed in 9e.
Direct International Comparators
Direct international comparator prices were unavailable for the eight items listed in 9e.
83http://www.totalhomecaresupplies.com/CategoryDetail.aspx?CategoryName=_z%20Brand%20Holli
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111
6. SAS Group 9f – Skin care and protection
Of the 10 items listed in 9f, direct domestic comparators are available for seven items (Table
6.1). For all seven items the comparator price was equivalent or greater than the SAS price.

The Hollister company direct price was equivalent.

Private prices were 10% to 150% higher.
Table 6.1: Direct Domestic Comparators
SAS
Code
Brand Name
Pack
Size
Max
Qty
Pack
Price
(AUD)
Private
Consumer
(AUD)
Company
Direct
(AUD)84
3528Q
Coloplast Comfeel
1
2 per
month
7.92
19.30
n/a
3557F
Hollister Skin
Conditioning Cream
1
2 per
month
7.92
16.10
7.92
3787H
ConvaTec Orabase
1
2 per
month
8.74
15.90
n/a
9821X
Sudocrem Healing
Cream
1
1 per
month
5.54
8.90
n/a
9907K
Calmoseptine
Ointment 20g
1
2 per
month
4.71
5.20
n/a
9933T
Calmoseptine
Ointment 75g
1
1 per
month
7.68
11.30
n/a
9934W
Coloplast Conveen
Critic
1
1 per
month
7.85
19.60
n/a
Of the 10 items listed in 9f, direct international comparators are available for two items. For
both items the comparator price was greater than the SAS price (Table 6.2).
Table 6.2: Direct International Comparators
SAS
Code
Brand Name
Pack
Size
Pack
Price
(AUD)
NHS Scotland
Price (AUD) &
variance
NHS England &
Wales Price (AUD)
& variance
3528Q
Coloplast Comfeel
1
7.92
8.52
(8%)
8.85
(12%)
9858W
3M Cavilon Durable
1
5.75
6.37
(11%)
7.32
(27%)
84
http://www.hollister.com/anz/files/pdfs/Ostomy-Catalogue_2014-15.pdf
112
7. SAS Group 9g – Deodorisers & gas suppressants
Of the 13 items listed in 9g, direct domestic comparators are available for three products
(Table 7.1). In all cases the comparator price was equivalent to the SAS price.
Table 7.1: Direct Domestic Comparators
SAS
Code
Brand Name
Pack
Size
Max Qty
Pack
Price
(AUD)
Company
Direct
(AUD)85
3872T
Hollister M9 Drop
1
1 per
month
8.13
8.13
9954X
Hollister Adapt 236 ml
bottle
1
1 per
month
9.91
9.91
9988Q
Hollister Adapt sachets
50
100
annually
20.70
20.7
Of the 13 items listed in 9g, direct international comparator prices were available for four
products (Table 7.2).
In comparison with SAS prices:

The US comparator prices were 90% to 189% higher.

One NHS product price was 37% to 39% lower.

Three NHS product prices were 13% to 98% higher.
Table 7.2: Direct International Comparators
US
Consumer
(AUD)86
NHS
Scotland
Price
(AUD) &
variance
NHS England
& Wales
Price (AUD) &
variance
SAS
Code
Brand Name
Pack
Size
Pack
Price
(AUD)
3798X
Dansac Nodor "S"
1
4.05
n/a
7.73
(91%)
8.02
(98%)
9855Q
Ainscorp Salts NoRoma
1
8.13
n/a
4.95
(-39%)
5.15
(-37%)
9954X
Hollister Adapt 236
ml bottle
1
9.91
28.64
16.5
(67%)
17.13
(73%)
9988Q
Hollister Adapt
sachets
50
20.70
39.32
23.44
(13%)
24.34
(18%)
85http://www.hollister.com/anz/files/pdfs/Ostomy-Catalogue_2014-15.pdf
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113
8. SAS Group 9h – Stoma support garments
There are 164 items listed in 9h. These items can be summarised into nine groups:

Omnigon stoma support belts (10 items).

Omnigon stoma support briefs (20 items).

Omnigon ‘kool-knit’ hernia support belts (27 items).

Omnigon mens hernia support boxers (10 items).

Omnigon Diamond Plus support pants for males and females (27 items).

Ainscorp Salts Simplicity support underwear (30 items).

Omnigon Total Control stoma and hernia support belt (15 items).

Statina Healthcare Corsinel abdominal support garments (16 items).

Sutherland Medical Abdominal Binder abdominal support belt (9 items).
Products are compared at the group level (rather than the individual item level) in this
section where products are the same price across a range of product sizes or colours.
The SAS price for Statina Healthcare Corsinel abdominal support garments is 29% lower
than the company direct price (Table 8.1).
Table 8.1: Direct Domestic Comparators
SAS
Code
Brand Name
Descriptor
9958D
Statina Healthcare
Corsinel (16 product
variants)
Abdominal support hernia
garment, various sizes, for males
and females
Qty
1
Pack
Price
(AUD)
Company
Direct
(AUD)87
120.02
155.00
NHS Scotland reimbursement price for Salts Simplicity underwear varies slightly with size as
summarised in the range provided in Table 8.2.
NHS reimbursement price for Salts Simplicity abdominal support underwear (boxers and
briefs) are 62% to 63% lower than SAS prices.
87
http://www.statina.com.au/brands/corsinel.html
114
Table 8.2: Direct International Comparators
SAS
Code
Brand Name
9856R
Ainscorp Salts
Simplicity (15
product variants)
9856R
Ainscorp Salts
Simplicity (15
product variants)
Descriptor
Abdominal support (boxer)
underwear for ostomates
with hernias, two way
stretch breathable fabric,
various sizes,
Abdominal support
underwear (brief), for
ostomates with hernias,
two way stretch breathable
fabric, Brief, Neutral,
Medium/Large,
NHS
Scotland
(AUD) &
variance
NHS
England
& Wales
(AUD) &
variance
Qty
Pack
Price
1
60.00
22.08 to
22.28
(-63%)
22.93
(-62%)
1
60.00
22.08 to
22.28
(-63%)
22.93
(-62%)
Indirect International Comparators
Indirect comparisons have been made where item of differing brands have the same
dimensions, use and general presentation. In the absence of a clear indirect comparator,
comparisons have not been made.
Stoma Support Belts
There are no direct comparators to the Omnigon Stoma Support Belt. The Omnigon belts
can be indirectly compared to a similar belt type from AMI Medical, on the NHS Scotland
Stoma Appliance Price List.
Compared with SAS prices the NHS Scotland belt prices are 18% to 41% higher (Table
8.3.1). NHS England and Wales prices were 3% higher than NHS Scotland prices on all four
Supportx product types.
115
Table 8.3.1: Stoma Support Belts
SAS
Code
3858C
NHS
Scotland
NHS
Scotland
NHS
Scotland
NHS
Scotland
Brand Name
Descriptor
Qty
Pack
Price
(AUD)
Omnigon
Stoma Support
Belt (10 product
variants)
Supportx
Ostomy/Hernia
Easy Peel
Support Belt
AMI Medical
Supportx
Ostomy/Hernia
Easy Peel
Support Belt
AMI Medical
Supportx
Ostomy/Hernia
Easy Peel
Support Belt
AMI Medical
Supportx
Ostomy/Hernia
Easy Peel
Support Belt
Stoma support belt, specially knitted Isoflex
breathable fabric, no latex allergy, adjustable 15cm
velcro closure width, depth 20cm or 26cm width
variable waist sizing.
1
71.01
20cm depth various waist sizes
1
83.57
20cm depth, with hole cutting, various waist sizes
1
100.10
26cm depth, various waist sizes
1
91.89
26cm depth, with hole cutting, various waist sizes
1
108.93
Stoma Support Briefs
There are no direct comparators to the Omnigon Stoma Support Briefs. The Omnigon briefs
can be indirectly compared to a similar product type from Comfizz, on the NHS Scotland
Stoma Appliance Price List.
Compared with SAS prices the NHS Scotland brief prices are 48% lower (Table 8.3.2).
Table 8.3.2: Stoma Support Briefs
SAS Code
9752G/9853P
NHS
Scotland
Brand Name
Omnigon
Support Briefs
for (12 product
variants)
Comfizz
Stoma Support
Briefs
Descriptor
Qty
Price
(AUD)
hernia support garment, breathable fabric with
15cm wide Isoflex waistband, brief style pant,
various waist size ,
1
60.00
Various colours and sizes , level 2 support rating
1
31.28
Omnigon Kool-Knit Hot Weather Hernia Support Belts
There are no clear indirect comparators available for this product.
116
Support Boxers
There are no direct comparators to the Omnigon Stoma Support Boxers. The Omnigon
boxers may be indirectly compared to a similar product type from Comfizz, on the NHS
Scotland Stoma Appliance Price List.
Compared with SAS prices the NHS Scotland boxers prices are 48% lower (Table 8.3.3).
Table 8.3.3: Support Boxers
SAS
Code
Brand Name
Descriptor
Qty
Price
(AUD)
9785B
Omnigon Mens
Support Boxers
Hernia support garment, breathable fabric with 20cm
wide Isoflex waistband, opening for crotch, mens brief
style pant, various waist size,
1
60.00
NHS
Scotland
Comfizz unisex
boxers
Stoma support boxers, unisex, various sizes, level 2
support rating
1
31.28
Omnigon Diamond Plus Support Pants
There is insufficient detail on the NHS Scotland Stoma Appliance Price List to identify a clear
indirect comparison between Omnigon Diamond Plus support pants and other possibly
similar items available on the NHS Scotland Stoma Appliance List.
Omnigon Total Control stoma and hernia support belt
There is insufficient detail on the NHS Scotland Stoma Appliance Price List to identify a clear
indirect comparison between the Omnigon Total Control stoma and hernia support belt and
other possibly similar items available on the NHS Scotland Stoma Appliance List.
Sutherland Medical Abdominal Binder abdominal support belt
There are no clear indirect comparators available for this product.
117
9. SAS Group 9i – Night drainage
Of the 10 items listed in 9i, direct domestic comparator prices are available for four items
(Table 9.1). In comparison with SAS prices:

Hollister company direct prices were equivalent.

Private prices were 14% to 192% higher.
Table 9.1: Direct Domestic Comparator
SAS
Code
Brand
Name
3674J
Coloplast
S3
Extended
Term
3863H
Coloplast
Simpla
S4
3888P
Hollister
T-Tap
Night
Drainage
Collector
Hollister
Night
Drainage
Collector
9878X
Pack
Size
Max
Qty
Pack
Price
Private
Consumer
Company
Direct88
1
5m
2.19
2.50
n/a
1
5m
2.19
6.40
n/a
Non-sterile T-Tap
Drainage Bag,
30
5m
65.70
n/a
65.70
2ltr non-sterile
night drainage
bag, connect to
urostomy pouch
tap, punch holes
for stang, 120cm
wide bore tube
1
5m
2.19
n/a
2.19
Descriptor
urostomy night
drainage bag, 2
litre, drainage
tube, wide bore
100cm tubing,
sterile,
urostomy night
drainage bag, 2
litre, drainage
tube, wide bore
120cm tubing,
sterile,
Direct International Comparators
Direct (and indirect) international comparators are not available for the items in 9i.
88
http://www.hollister.com/anz/files/pdfs/Ostomy-Catalogue_2014-15.pdf
118
10. SAS Group 9j – Skin filler and adhesive products
Of the nine items listed in 9j, direct domestic comparators are available for five items (Table
10.1). In all cases the comparator price was equivalent or greater than the SAS price.

Hollister company direct prices were equivalent.

Private prices were 92% to 108% higher.
Table 10.1: Direct Domestic Comparators
SAS
Code
Brand Name
Pack
Size
Max
Qty
Pack
Price
Private
Consumer
Company
Direct89
3503J
ConvaTec Paste
1
3m
11.28
21.70
n/a
3511T
ConvaTec Powder
1
2 per
month
8.70
18.10
n/a
3535C
Hollister Karaya
Paste
1
3m
11.28
n/a
11.28
3556E
Hollister Premium
Powder
1
2 per
month
8.70
17.40
8.70
9906J
Hollister Adapt Paste
1
3m
11.28
n/a
11.28
Of the nine items listed in 9j, direct international comparator prices were available for all nine
products (Table 10.2).
In comparison with SAS prices:

The US comparator product prices were 4% to 85% higher.

Four NHS Scotland product prices were 2% to 48% lower.

Three NHS England and Wales product prices were 37% to 46% lower.

Remaining NHS products were 3% to 38% higher.
89http://www.hollister.com/anz/files/pdfs/Ostomy-Catalogue_2014-15.pdf
119
Table 10.2: Direct International Comparators
NHS
Scotland
(AUD) &
variance
Brand Name
Pack
Size
Pack
Price
US
Consumer
(AUD)90,91
3503J
ConvaTec Paste
1
11.28
15.93
13.72
(22%)
13.73
(22%)
3511T
ConvaTec
Powder
1
8.70
13.25
n/a
n/a
3534B
Coloplast Paste
Tube
1
11.28
11.72
11.04
(-2%)
11.59
(3%)
3535C
Hollister Karaya
Paste
1
11.28
20.9
14.94
(32%)
15.51
(38%)
3552Y
Dansac Soft
Paste
1
11.28
N/A
6.38
(-43%)
6.62
(-41%)
3556E
Hollister
Premium
Powder
1
8.70
N/A
4.56
(-48%)
4.73
(-46%)
3571Y
Coloplast Brava
Strip Paste
10
11.28
N/A
13.6
(21%)
14.35
(27%)
9762T
Ainscorp Salts
Stoma Paste
1
11.28
N/A
12.77
(13%)
12.80
(14%)
9906J
Hollister Adapt
Paste
1
11.28
17.27
6.57
(-42%)
7.10
(-37%)
SAS
Code
NHS England
& Wales (AUD)
& variance
11. SAS Group 9k – Skin care and protection
90Coloplast
91
Ostomy Accessories
Hollister
120
Of the 12 items listed in 9k, direct domestic comparators are available for three items. In all
cases the comparator price was equivalent or greater than the SAS price (Table 11.1).

The Hollister company direct price was equivalent.

Private prices were 88% to 128% higher.
Table 11.1: Direct Domestic Comparators
SAS
Code
Brand Name
Pack
Size
Max
Qty
Pack
Price
Private
Consumer
Company
website92
3502H
ConvaTec ConvaCare
Wipes
100
100
per
month
29.00
60.20
n/a
3544M
3M No Sting Spray
1
1 per
month
15.31
28.70
n/a
3553B
Hollister Skin Gel
50
100
per
month
14.50
33.10
14.5
Of the 12 items listed in 9k, direct international comparator prices were available for ten
products (Table 11.2).
In comparison with SAS prices:

The US comparator product prices were 5% to 121% higher.

Five NHS product prices were 11% to 41% lower.

Four NHS products were 9% to 76% higher.
92
http://www.hollister.com/anz/files/pdfs/Ostomy-Catalogue_2014-15.pdf
121
Table 11.2: Direct International Comparators
NHS
Scotland
(AUD) &
variance
NHS
England &
Wales
(AUD) &
variance
SAS
Code
Brand Name
Pack
Size
Pack
Price
US
Consumer
(AUD)93
3502H
ConvaTec ConvaCare
100
29.00
n/a
31.61
(9%)
33.10
(14%)
3504K
Smith & Nephew Skin
Prep Aerosol
1
8.45
18.64
n/a
n/a
3544M
3M No Sting
1
15.31
n/a
10.62
(-31%)
12.24
(-20%)
3553B
Hollister Skin Gel
50
14.50
15.20
24.60
(70%)
25.54
(76%)
30
31.95
n/a
38.2
(20%)
40.11
(26%)
1
26.25
n/a
20.11
(-23%)
21.12
(-20%)
3908Q
3925N
Coloplast Brava No
Sting Skin Barrier
Wipes
Coloplast Brava No
Sting Skin Barrier
Spray
9775L
3M Cavilon
30
31.95
n/a
36.97
(16%)
42.87
(34%)
9798Q
Smith & Nephew
SECURA No-Sting
Barrier Film
50
52.10
n/a
30.80
(-41%)
41.78
(-20%)
9799R
Smith and Nephew
Skin Prep Spray
1
15.31
n/a
n/a
10.25
(-33%)
9859X
Ainscorp Salts PeriPrep Sensitive
30
31.95
n/a
27.42
(-14%)
28.47
(-11%)
93
Hollister
122
SAS Group 9l – Seals
Of the 37 items listed in 9l, direct domestic comparators are available for eight items. For all
products the comparator price was equivalent to the SAS price (Table 12.1).
Table 12.1: Direct Domestic Comparators
SAS
Code
Descriptor
Pack
Size
3882H
Hollister Oval Convex Barrier Rings sizes
22x38mm, 30x48mm, 38x56mm (3 items)
10
9904G
Hollister Adapt convex barrier ring 20mm,
30mm, 40mm (3 items)
10
9979F
Hollister Adapt barrier seals 48mm and 98
mm
10
Max
Qty
30
per
month
30
per
month
30
per
month
Pack
Price
Company
Direct94
45.31
45.31
45.31
45.31
45.31
45.31
Of the 37 items listed in 9l, direct international comparator prices were available for 30
products (Table 12.2).
In comparison with SAS prices:

Two US comparator product prices were 44% lower.

Eight US comparator product prices were 68% higher.

All 30 NHS product prices were between 9% and 70% lower.
94
Ostomy catalogue
123
Table 12.2: Direct International Comparators
SAS
Code
3539G/35
67R
3879E
3882H
Descriptor
Dansac GX-TRA seals,
sizes 20mm,30mm, 40mm,
50mm (4 items)
Dansac Novalife Seals
20mm, 30mm, 40mm,
50mm (4 items)
Hollister Oval Convex
Barrier Rings sizes
22x38mm, 30x48mm,
38x56mm (3 items)
Pack
Price
US
Consumer95,96
(AUD)
NHS
Scotland
(AUD) &
variance
135.96
n/a
75.09
(-45%)
77.94
(-43%)
135.93
n/a
n/a
122.14
(-10%)
45.31
76.19
33.20
(-27%)
34.22
(-25%)
NHS England &
Wales (AUD) &
variance
3905M
Coloplast Brava Mouldable
Ring 2.0mm thickness
135.93
76.37
99.25
(-27%)
104.24
(-23%)
3905M
Coloplast Brava Mouldable
Ring 4.2mm thickness
135.93
76.37
101.18
(-26%)
106.28
(-22%)
9763W
Ainscorp Salts Secuplast
mouldable seal sizes large
45.31
n/a
39.56
(-13%)
41.44
(-9%)
9764X
Ainscorp Salts Secuplast
mouldable seal size
standard
135.96
n/a
88.32
(-35%)
92.50
(-32%)
9765Y
Ainscorp Salts Secuplast
mouldable seal size thin
135.96
n/a
86.94
(-36%)
91.04
(-33%)
135.96
n/a
99.36
(-27%)
100.22 to 103.15
(-26% to -24%)
45.31
76.19
31.28
(-31%)
32.48
(-28%)
9782W
9904G
Ainscorp Salts Dermacol
sizes 17.5-22mm, 20.523mm, 23.5-26mm, 26.529mm, 29.5-32mm, 32.535, 35.5-38mm, 38.5-41mm
(8 items)
Hollister Adapt convex
barrier ring 20mm, 30mm,
40mm (3 items)
9905H
Hollister Adapt convex
barrier strips
45.31
n/a
13.67
(-70%)
14.19
(-69%)
9979F
Hollister Adapt barrier seals
48mm
45.31
76.19
31.1
(-31%)
32.27
(-29%)
9979F
Hollister Adapt barrier seals
98mm
45.31
76.19
39.19
(-14%)
40.68
(-10%)
95Hollister
96
Coloplast Accessories
124
12. SAS Group 9m – Miscellaneous
Of the five items listed in 9m, direct domestic comparators are available for three items
(Table 13.1). For all products the comparator price was equivalent or greater than the SAS
price.

The Hollister company direct price was equivalent.

Private prices were 84% to 180% higher.
Table 13.1: Direct Domestic Comparators
SAS
Code
Brand
Pack
Size
Max
Qty
Pack
Price
Private
Consumer
Company
Direct97
3670E
Coloplast Cathstrap
1
2 per
month
4.78
13.38
n/a
3927Q
Ebos Group
Vernagel
100
50 per
month
74.70
137.20
n/a
9880B
Hollister Silicone
Adhesive Spray
1
1 per
month
35.65
n/a
35.65
Of the five items listed in 9m, direct international comparator prices were available for two
products (Table 13.2). In comparison with SAS prices:

One US comparator product price was 36% higher.

One NHS comparator product price was 126% to 134% higher.

One NHS comparator product price was 14% to 17% lower.
Table 13.2: Direct International Comparators
Brand
Pack
Size
Pack
Price
US Consumer98
(AUD)
NHS
Scotland
(AUD) &
variance
NHS
England &
Wales (AUD)
& variance
3570X
Coloplast
Filtrodor
50
17.95
n/a
40.48
(126%)
42.03
(134%)
9880B
Hollister Silicone
Adhesive Spray
1
35.65
48.62
29.61
(-17%)
30.73
(-14%)
SAS
Code
97
Ostomy catalogue
98Hollister
125
Financial studies identified in searches of peer-reviewed literature
Two studies were identified in Part A (a systematic review of the peer-reviewed literature)
that reported the results of financial analyses relating to the cost of stomal accessory
products (Martins 2012, Meisner 2012).
Martins 2012
Martins 2012 reported the results of a cost estimation study, the purpose of which was to
assess the impacts of early detection and treatment of peristomal skin conditions and the
use of a correctly fitted and appropriate pouching system on treatment costs.
The cost estimation was based on peristomal skin conditions among Dialogue study
participants. The Dialogue study is a non-controlled clinical study that collected information
about patient experience relating to Coloplast’s SenSura ostomy appliance. Dialogue
collected data on 3,017 participants with an ostomy and included 500 wound and ostomy
care nurses across 18 countries worldwide. There were 36 participants from Australia.
Peristomal skin conditions were assessed using an Ostomy Skin Tool – a validated skin
assessment tool. Data from skin assessments performed on study participants who regularly
or periodically visited a stoma care nurse or doctor was used for the cost modelling (2,560
participants in total). Of these, 67% of participants had a colostomy, 31% had an ileostomy
and 2% had a urostomy. All used the SenSura ostomy appliance.
The estimated cost of a seven week treatment of an average case of a peristomal skin
condition varied according to the cause of the skin condition and the condition’s severity.
Sever disease-related peristomal skin conditions are the most expensive conditions to treat
(Table 14).
Table 14: Cost of managing peristomal skin conditions (in UK £ and based on unit
costs in 2012)
Mild
Moderate
Severe
Irritant contact dermatitis
113.38
132.88
290.45
Allergic dermatitis
196.81
267.36
371.84
Mechanical trauma
106.29
118.38
219.60
Disease related
142.73
336.36
618.69
Infection
151.84
184.41
385.87
The component of these costs that is attributable to Group 9 accessories was not reported
by the study authors.
Frequency of appliance leakage is associated with the severity of a peristomal skin
condition. Appliances that leak “often” are approximately £30 more expensive to treat over a
seven week period than those that leak “rarely”.
Results of this study suggest that significant cost savings can be made in the treatment of
peristomal skin conditions if peristomal skin conditions are prevented or minimised in people
with a stoma and peristomal skin conditions are detected at an early stage.
126
Meisner 2012
Meissner 2012 reported the application of a model to estimate treatment costs of peristomal
skin conditions using the standardised assessment Ostomy Skin Tool as a reference. The
costing model was applied to peristomal skin conditions among 2,914 Dialogue study
participants (study described above) to estimate treatment costs for managing an average
case of peristomal skin condition for all levels of severity over a seven week period.
The estimated total average cost for a seven week treatment period (including appliances
and accessories) was 263€ for those with a peristomal skin condition (n = 1,742 participants)
versus 215€ for those without peristomal skin conditions (n = 1,172 participants). The
breakdown in costs for the Group 9 accessories component of the treatment was not
provided.
The mean cost of treatment increased with the severity of the skin condition, from an
additional treatment cost over seven weeks of 23.1€ and 31.5€ in patients with mild and
moderate peristomal skin conditions (compared with those with no skin complaint) to an
additional 141.2€ in patients with severe peristomal skin conditions.
127