HSE PRIMARY CARE
REIMBURSEMENT SERVICE
URINARY INCONTINENCE PRODUCTS
REIMBURSABLE UNDER THE GMS AND THE
COMMUNITY DRUGS SCHEMES
GUIDELINES FOR
MANUFACTURERS/DISTRIBUTORS
Primary Care Reimbursement Services
Exit 5, M50 North Road
Finglas
Dublin 11
April 2014
INTRODUCTION
These guidelines have been prepared by a HSE Expert Group, including Patient
Representatives, for the information of Manufacturers/Distributors of Urinary Incontinence
Products. Additions to the Reimbursable List will be considered in compliance with the
Health (Supply and Pricing of Medical Goods) Act, 2013.
1.
There are two types of submission for products:
Type 1-New/Innovative Products and
Type 2-Existing (Rollover/Minor Change) Products.
2.
These guidelines are applicable to both Type 1 and Type 2 products.
3.
Companies wishing to have a product listed for reimbursement under the GMS
Scheme and Community Drugs Schemes must make written application to:Ms Karen Burns
HSE Urinary & Ostomy Review Group
c/o HSE Procurement
Units 1-3 Finisklin Business Park
Sligo
Ireland.
4.
Applicants must demonstrate:(a)
(b)
(c)
(d)
Compliance with the appropriate British Standard, ISO Standard or any
other equivalent standard in force in a Member State of the European
Union.
or
Compliance with Directive 93/42/EEC, with each product carrying the CE
marking. This Directive is implemented in Ireland via the European
Communities (Medical Devices) Regulations 1994 (S.I. No.252 of 1994).
and
Compliance with the attached Criteria for Urinary Incontinence Products.
and
Consumer acceptability by the presentation of the results of User Trials to be
conducted independently of the Manufacturer. Minimum Data requirements
are set out in Appendix 1.
5.
Products used on the body, or inserted into the body, must not cause an adverse or
toxic reaction.
6.
Must be suitable for self administration use under the supervision of a general
medical practitioner or other relevant health professional and not be restricted to
hospital or medical specialist use.
7.
Must be cost effective. This may be demonstrated via published literature in peer
reviewed journals. Although this is primarily applicable to Type 1 Innovative
Products, the HSE may request same for premium price product on a case by case
basis.
1
8.
Must not be advertised or promoted to the public in everyday
magazines/newspapers/TV/radio. However marketing activity which is aimed
primarily at healthcare professionals is acceptable. Claims for patient outcome
improvement should be supported by clinical evidence. On line advertising can
present difficulties where claims for patient outcome improvement are made without
the clinical evidence to support the claim.
9.
The list of Urinary Products reimbursable under the GMS and Community Drugs
Schemes will be maintained in compliance with the Health (Pricing and Supply of
Medical Goods) Act 2013.
The HSE acknowledges that it will comply with the requirements of this Act.
However the interchangeability or substitution clause is intended for those medicinal
products deemed interchangeable by the Irish Medicines Board and will not be
applied to devices. However, the HSE reserves the right to determine a bench mark
price for products that are similar in nature and deliver the same functionality to
patients.
10.
The Categories / Classifications listed may be subject to change on an annual basis.
APPLICATION PROCESS
1. Applicants should complete the price application form and appropriate application
form for Type 1 or Type 2 products, as attached, for each product they seek to
include on the Reimbursement List for GMS and Community Drugs Schemes. One
signed copy of each form, along with appropriate backup material should be sent to
the HSE – see Appendix 3, Application Checklist.
2. In the case of products similar to products already listed, the HSE will generally aim
to ensure that the price of the new products is broadly in line with those already
listed. If applicant companies want, at the time of application, to suggest factors
supporting the price they are seeking they are free to do so.
Similar products are those that, in the opinion of the HSE Expert Group, offer an
equivalent technical solution and/or an equivalent level of clinical care for patients.
3. The original hard signed copy of the application form must be received before an
application can be accepted formally by the HSE and an acknowledgement letter
sent.
4. Product samples should be identical to the final product, though not necessarily from
a production run if this is impractical. The text of the proposed labelling should be
final although it may be presented in mock up form if the finally produced version is
not available.
5. In this first phase all applications submitted must be received complete by the closing
dates of 23rd June 2014 (Type 2) and the 11th July 2014 (Type 1). Going forward the
HSE will acknowledge each application within 10 working days of receipt and will be
considered in compliance with the Health (Pricing and Supply of Medical Goods) Act
2013. An application will not be released for assessment until all necessary
information has been received. If, after 28 working days, the full documentation
has not been received by the HSE, a reminder will be sent asking for this to be sent
within the next 28 days. Failure to send the missing paperwork / samples will prompt
the HSE to ask for collection of any paperwork / samples to be arranged within the
2
next 7 days, after which they will be destroyed. Any further applications for the
product will then have to start anew.
6. Manufacturers should inform the HSE if any changes are made to their products that
affect their entry to the Reimbursable List e.g product name change, a change in
Manufacturer / Distributor of the product, a change in packaging (including product
reference codes), a change in product specification and if the product has been
discontinued.
7. Products that the Manufacturer/Distributor wishes to have deleted/discontinued (Type
2-Existing (Rollover/Minor Change)) from the Reimbursement List must remain valid
for a period of at least 12 months to allow for client transition to an alternative
product.
8. Where an application has been rejected, either because (i) it does not satisfy the
product criteria or (ii) a price premium has been requested. An appeal can be
registered with the HSE with an opportunity to outline the patient benefits afforded by
the product which cannot be satisfied by the products already on the Reimbursement
List. In such circumstances, an appropriate cost effectiveness analysis, cost benefit
analysis or cost-consequences analysis can be submitted in support of the
application outlining the clear patient benefits for the price premium requested.
Note: Where an application has been rejected, the applicant will be furnished with
the reason why and representation will be allowed with the applicant having
discretion to provide additional information in response to the initial rejection.
3
CRITERIA FOR URINARY INCONTINENCE PRODUCTS
1.
Incontinence Sheaths/External Catheters
Incontinence Sheaths/External Catheters may be:
(a) one piece or two piece;
(b) adhesive or non adhesive
One Piece and Two Piece Systems
1.1
Sheaths must be manufactured from material that is non-abrasive to the skin, is
impermeable to water but allows air to permeate.
1.2
Each sheath must have a universal connector to allow connection to a urinary
drainage/leg bag.
1.3
Sheaths must be available in a variety of sizes: 18mm - 40mm, the minimum range
must be 25mm - 35mm.
1.4
Adhesive/adhesive strips must not cause any skin reaction and/or breakdown.
1.5
(a)
One piece system – each sheath must have adequate adhesive to ensure it
remains in place under normal circumstances for a minimum wear time of twelve
hours.
(b)
Two piece system –must have adequate adhesive to ensure it remains in
place under normal circumstances for a minimum wear time of twelve hours.
1.6
(a)
(b)
Each sheath must be easily removed, without causing skin trauma.
The adhesive must be easily removed, without causing skin trauma.
1.7
Sheaths must be individually wrapped and packed in boxes of 30 and in the case of a
two piece system must contain an adhesive strip.
1.8
A measuring guide must be available for correct fitting and must be included in each
box or made available to patients as required.
1.9
Each box of sheaths must be clearly marked to allow for easy identification.
1.10
Each box of sheaths must contain a leaflet with application directions – this must be
easily understood by the client and include illustrations for ease of comprehension.
4
2.
Leg Bags and Holders
2.1
Leg bags must be available in varying capacities, from 250ml to 1500ml.
2.2
Leg bags must be available;
(a) sterilised (for use with indwelling catheters); or
(b) unsterilised (for use with incontinence sheaths).
2.3
All sterilised bags must have a non-return valve at the top of the bag.
2.4
All sterilised bags must have a needle-free sampling port.
2.5
Leg bags must be available in packs of not greater than 10. Each pack must contain
a minimum of 1 set of leg straps. Upon request, additional leg straps must be made
available FOC.
2.6
Each box must contain a leaflet with instructions for use stating minimum wear time
i.e. one week under normal circumstances.
2.7
When in contact with the skin, leg bags must not cause skin irritation.
2.8
Leg bags must be available in a variety of tubing lengths. The minimum length must
be direct, i.e. connects directly to the sheath/catheter.
2.9
Leg bag and tubing must be sold as one unit.
2.10
Tubing must be constructed in material with anti-kink properties, yet must be
sufficiently flexible to allow easy manipulation and routeing.
2.11
Connectors on leg bag must be universal.
2.12
The tap must be easily opened and closed i.e. user-friendly and must not pose a
hazard when left in an open position i.e. when the leg bag is used in conjunction with
a night drainage bag.
2.13
Straps must be elasticated and/or adjustable. The fastening must be sufficient to
ensure that the leg bag is held in place when the bag is full. When in contact with
the skin, the strap must not cause skin irritation. Straps must be included in the leg
bag pack –1 set of straps per ten leg bags is acceptable, but additional leg straps
must be made available FOC, if requested.
2.14
A sleeve will be acceptable as an alternative to straps.
2.14.1 Sleeves should be available in a variety of sizes (small, medium, large and
extra large).
2.14.2 The sleeve should be machine washable or disposable.
2.14.3 The sleeve should ensure that the leg bag is held in place when the bag is
full.
2.14.4 The sleeve should not cause skin irritation when in contact with skin.
2.14.5 The sleeve should last for a minimum of 1 week.
2.15
A smaller bag (250mls) may be required for intermittent urinary leaks or dribbling.
5
3
Urinary Catheters
Catheters may be:(a)
(b)
(c)
(d)
indwelling catheters for short term use – minimum wear time of 7 days
under normal circumstances.
indwelling catheters for long term use suitable for urethral and suprapubic
– maximum wear time of 12 weeks under normal circumstances.
indwelling catheters for medium term use – wear time 4 weeks or as per
manufacturer’s instructions.
intermittent self-catheterisation catheters –
(i)
Nelaton – single use only.
(ii)
Hydrophilic or coated – single use only.
(iii)
Incorporating drainage bags.
(iv)
Compact/discreet.
(v)
Catheters, Dilatation without Drainage Eyes.
(vi)
Catheters with Balloon Dilators.
3.1
Catheters must be composed of silicone, non silicone, latex coated or non coated: or
other suitable material, in the case of:
(a)
indwelling short term
(b)
indwelling long term
(c)
indwelling medium term
(d)
intermittent self catheterisation.
3.2
Catheters must be smooth and free from surface irregularities – they must appear
clean and free from extraneous matter when examined by normal or corrected vision.
3.3
Indwelling catheters must be sterile, with the expiry date of sterility clearly marked on
both the inner and outer packaging It is recommended to come with two removable
stickers, detailing size, batch expiry date etc.
3.4
Intermittent catheters must be sterile, with the expiry date of sterility clearly marked.
3.5
A recognised mark of sterilisation must be visible on each unit of packaging.
3.6
In the case of indwelling catheters each catheter must have a universal connector, to
allow connection to a drainage system without the use of a separate connector.
3.7
Catheters must be available in female length (22cm. approximately) and standard
length (40cm. approximately).
3.8
Intermittent female catheters available in a wide range of compact/discreet lengths
(e.g. from 3.5cm to the normal size 20cm).
3.9
Intermittent male catheters should also be available in a wide range of
compact/discreet sizes (e.g. from 10Ch to 18Ch), compact or standard.
3.10
Option of collecting bag attached with intermittent catheters to be available.
3.11
State if for single use or reusable.
6
3.12
Catheters should be available in a wide range of Charriére sizes (e.g. 10Ch. to
30Ch). And intermittent catheters should also be available in a wide range of
Charriére sizes (e.g. 8Ch. to 18Ch).
3.13
Catheters for paediatric use should be available in a wide range of sizes (e.g. 6Ch. to
10Ch) – the length of paediatric catheters must be 25cm approximately.
3.14
Indwelling catheters should be available in a wide range of balloon sizes (e.g.
ranging from 3ml (paed) to 30ml). The volume required to inflate the balloon must be
clearly marked on the packaging. The standard balloon size is 10mls.
3.15
In the case of indwelling catheters Charriére size and balloon size must be detailed
on the packaging and on the universal connector of each catheter.
3.16
Indwelling and intermittent catheters may be available with varying tips, e.g. Round,
Couvelaire, Dulour, Le Guillon, Nelaton and Tiemann tip.
3.17
Intermittent catheters may be self-lubricating e.g. with Polyvinylpyrrolidone (P.V.P.)
hydrophilic coating or lubricant on the surface of the catheter. Any lubricant used
must be sterile, non-toxic and certified as such by a recognised body.
3.18
In the case of:
(a)
(b)
(c)
(d)
(e)
indwelling catheters short term – pack sizes must not exceed 10.
indwelling catheters long term – individually wrapped sterilised within pack.
indwelling catheters medium term - must not exceed 5.
indwelling catheters can come as a complete kit.
intermittent catheters (i)
Nelaton – pack sizes must not exceed 30-50
(ii)
Lubricated – pack sizes must not exceed 30.
3.19
It is preferable that intermittent catheters would have universal colour coding for size
purposes for the client and the pharmacist for order purposes.
3.20
In the case of intermittent catheters, each box should contain a leaflet with
instructions for use and care after use.
3.21
Outer packaging must be durable to avoid damage to products during transport
and/or storage with easy to identify Charrière size, type of catheter and length.
3.22
Instructions for storage must be given to pharmacist and client by the supplier, e.g.
avoid kinking of catheter, avoid direct sunlight, avoid damp conditions, store flat, etc.,
4.
Catheter Valves
4.1
The materials used in manufacturing valves must be smooth and free from surface
irregularities.
4.2
Catheter valves must have a universal inlet connector. This connector should be non
slip and secure.
4.3
Each catheter valve must have an outlet connector which is universal. This allows
for the use of a drainage system either leg or overnight drainage bag.
7
4.4
Catheter valves must have an opening mechanism which is easy to use, i.e. userfriendly and minimising the risk of hand contamination.
4.5
The tap must have the facility to be left in an open or closed position. The tap must
not pose a hazard when left in the open position, i.e. when used in conjunction with
leg or overnight drainage bag.
4.6
All catheter valves must be sterile. A recognised mark of sterilisation and expiry date
of same must be clearly marked on inner and outer packaging.
4.7
Each catheter valve must be individually wrapped sterilised.
4.8
Each box of catheter valves must contain a leaflet with directions for use, which must
be easily understood by the client and include illustration for ease of comprehension.
Instructions must state minimum wear time, i.e. 7 days under normal circumstances.
5.
Overnight Drainage Bags
Drainage bags may be:(a)
drainable; or
(b)
non-drainage.
5.1
Drainable bags must be available:(a)
sterilised (for use with indwelling catheters); or,
(b)
unsterilised (for use with incontinence sheaths).
5.2
All sterilised bags must have a non-return valve at the top of the bag.
5.3
All sterilised bags must have a needle-free sampling port.
5.4
Sterilised bags must be available singly and unsterilised bags must be available in
packs of 10 to 30.
5.5
Each box must contain a leaflet with instructions for use, stating minimum wear time
under normal circumstances in the case of(a)
drainable – one week.
drainable bags for use with catheters should be sterile when used,
and discarded when disconnected, max use for 7 days if on
continuous drainage.
(b)
non-drainable – 12-24 hours.
non-drainable bags to be discarded when ¾ full (12-24 hrs).
5.6
The length of tubing must be 1,000mm approximately.
5.7
Tubing must be constructed in material with anti-kink properties, yet must be
sufficiently flexible to allow easy manipulation and routeing.
5.8
Connectors must be universal.
8
5.9
In the case of drainage bags the tap must be easily opened and closed, i.e. userfriendly.
5.10
A smaller bag (250 mls) may be required for intermittent urinary leaks or dribbling
250 mls.
5.11
Bed/floor bag holder(s) should be provided FOC by the drainage bag supplier, as
required by the client.
6.
Retracted Penile Continence System
6.1
Plastic
6.1.1 Must be of good quality and be odour proof.
6.1.2 Must be flexible and comfortable.
6.1.3 Must be discreet and unobtrusive.
6.1.4 Must be quiet film.
6.2
Bag (with tap)
6.2.1 Bags must be available in boxes of not greater than 10.
6.2.2 Each box of bags must contain a leaflet with application directions – this must
be easily understood by the client and include illustrations for ease of
comprehension. Instructions must clearly state minimum wear time, i.e. 1-3
days under normal circumstances.
6.3
Adhesive
6.3.1 Must be easy to apply and remove.
6.3.2 Must be secure.
6.3.3 Must be comfortable.
6.3.4 Must incorporate a skin protective.
6.3.5 If the appliance incorporates an adhesive tape, the tape must be non-allergic.
6.4
Taps
6.4.1 The tap must be easily opened and closed, i.e. user-friendly and must not
pose a hazard when left in an open position.
6.5
Connectors
6.5.1 Connectors on retracted penile continence system bags must be universal to
facilitate easy attachment to night drainage and/or leg bags.
7.
Nephrostomy Drainage
7.1
Nephrostomy bags must be available in a variety of capacities, from 350ml-500ml.
7.2
Nephrostomy bags must be sterile.
7.3
Nephrostomy bags must have a non-return valve at the top of the bag.
7.4
Should be available in packs not greater than 10.
9
7.5
Each box must contain a leaflet with instructions for use stating minimum wear time
i.e. one week under normal circumstances.
7.6
When in contact with the skin, nephrostomy bags must not cause skin irritation.
7.7
Nephrostomy bags must be available in a variety of tubing lengths. The minimum
length must be direct.
7.8
Nephrostomy bag and tubing must be sold as one unit.
7.9
Tubing must be constructed in material with anti-kink properties, yet must be
sufficiently flexible to allow easy manipulation and routeing.
7.10
The tap must be easily opened and closed.
7.11
There may be a requirement for a connector to connect nephrostomy bag to a night
drainage bag.
7.12
Straps must be elasticated and/or adjustable. The fastening must be sufficient to
ensure that the nephrostomy bag is held in place when the bag is full. When in
contact with the skin, the strap must not cause skin irritation. Straps must be
included in the nephrostomy bag pack.
8.
Catheter Securement
8.1
Comfortable to wear to prevent traction / movement or pulling on the catheter.
8.2
Easy to apply and remove that doesn’t cause skin damage.
8.3
Fits any size catheter.
8.4
Each box of devices must contain application directions – this must be easily
understood by the client and include illustrations for ease of comprehension.
Instructions must clearly state minimum wear time, i.e. 3-5 days under normal
circumstances.
8.5
When in contact with the skin, they must not cause skin irritation.
8.6
May be single use or machine washable.
9.
Spigots
9.1
Spigots should be sterile.
9.2
Spigots should be of durable plastic.
10
10.
Urinary Clamps/Dribble Stops
10.1
Applies pressure to penis without skin damage.
10.2
Discreet and comfortable to wear.
10.3
Adjustable for the individual.
10.4
Available singly.
10.5
Each box of bags must contain a leaflet with application directions – this must be
easily understood by the client and include illustrations for ease of comprehension.
Instructions must clearly state minimum wear time, i.e. 24 hour bladder control under
normal circumstances.
11.
Catheter Maintenance Solutions (CMS)
11.1
The materials used in manufacturing of CMS must be compatible with the
connectors.
11.2
Catheter solutions must have a universal inlet connector, suitable to attach to all
catheters.
11.3
This connector should be non slip and secure.
11.4
CMS must have an opening mechanism which is easy to use, i.e. user-friendly and
minimising the risk of hand contamination.
11.5
CMS must have the facility to be left in an open or closed position.
11.6
All CMS must be sterile. A recognised mark of sterilisation and expiry date of same
must be clearly marked on inner and outer packaging.
11.7
Each CMS must be individually wrapped and available in boxes of 10.
11.8
Each box of CMS must contain a leaflet with directions for use, which must be easily
understood by the client and include illustration for ease of comprehension.
Instructions must state frequency of use.
11.9
Instruction on disposal of waste.
12.
Trans Anal Irrigation
12.1
Pump/control unit /water holder and rectal catheters may be separate.
12.2
Supplies of rectal catheters must be available in boxes of not greater than 10-15.
11
12.3
Rectal Catheters must be smooth and free from surface irregularities – they must
appear clean and free from extraneous matter when examined by normal or
corrected vision.
12.4.
Rectal catheters may be available in different sizes.
12.5
State if rectal catheters are for single use.
12.6
Rectal catheters may be self-lubricating or any lubricant used must be non-toxic and
certified as such by a recognised body.
12.7
Pump system should be easily filled.
12.8
Each box must contain a leaflet with directions – this must be easily understood by
the client and include illustrations for ease of comprehension. Instructions must
clearly state how often this should be used.
12.9
Information on disposable of waste in every pack (i.e.: catheters do/do not flush down
the toilet.
12
Appendix 1: Guidelines for Manufacturers/Distributors on the Design and Execution
of User Trials of Urinary Incontinence Products

This is applicable to Type 1: New/Innovative Products only.

It is not a prerequisite that a User Trial must have been conducted in Ireland.

Each Company who initiated a User Trial must have appointed a person who would
have been responsible to the Manufacturer for co-ordinating each trial. The duties of
a Co-ordinator should have included:Preparing information booklets containing correct trial procedures,
Formulating a questionnaire,
Distributing the above documentation,
Collecting the questionnaires,
Collating the data,
Presenting the results.

A User Trial should ideally have been conducted independently of a
Manufacturer/Distributor by a Continence Care Nurse or any other appropriately
qualified medical or nursing person who had no direct or indirect association with any
Manufacturer/Distributor.

If there was any link between the Manufacturer/Distributor and the person who
conducted the trial, this link should be declared on Type 1 Product Application Form.

The minimum requirements of the HSE which must have been provided for in the
design and organisation of such trials are set out on Page iii of this document.

Each User Trial must have been conducted at not less than 3 centres.

A trial cannot be judged to have been satisfactory unless there was a minimum
number of at least 20 participants in total across the 3 centres.

Product Accountability – The Company was responsible for the supply of all products
used for the trial including the necessary items that allowed a product to have been
used effectively e.g. set of straps to have been used with leg bags.

Permission to carry out the trial must have been obtained by the Co-ordinator
conducting the trial from the relevant authority.

Each enrolled participant must have been fully informed of the trial procedures and
their written consent must have been obtained.

Non GMS reimbursable accessories must have been excluded in the trial of
products. Each product on trial must have been assessed on its own merit and
without the benefit of any additional product, e.g. adhesive spray when testing
incontinence sheaths.

A trial participant may have been withdrawn from the User Trial at any time at the
discretion of the person who conducted the trial.

A Company initiating a User Trial must have supplied:-
i

all technical details about its products including specifications and
recommended wear time.

adverse reaction forms to the Co-ordinator who should have
transmitted them to the person who conducted the trial.

The following were prerequisites for participation in a User Trial:o Participants must have been willing to use the product on trial.
o Participants must have provided informed consent.
o Participants must have been able to comprehend and complete the
questionnaire provided.
o Participants must have been established for the period outlined in the table
below on the type of product under trial.

Exclusions:-

o
Participants who were found to have had a skin assessment rating of 2, 3, or
4 must have be cleared by medical advice if they were included in the User
Trial:0 = Normal intact skin,
1 = Patchy redness,
2 = Extensive redness,
3 = Reddened blistered but not broken,
4 = reddened with open areas of skin.
o
Participants who were undergoing Radiotherapy or Chemotherapy treatment
must also have been excluded from the trial.
The following must have been compiled with when conducting a User Trial:o
Length of Trial – The minimum length of trial period must have been set for
each specific product as indicated hereunderClassification
Incontinence Sheath/External Catheters
Leg Bags & Overnight Drainage Bags
Straps/Sleeves
Urinary Catheters
(a) Indwelling Long Term
(b) Intermittent Self Catheterisation
(c) Indwelling Short/Medium Term
Catheter Valves
Retracted Penile Continence System
Nephrostomy Drainage
Catheter Securement
Spigots
Urinary Clamps/Dribble Stops
Catheter maintenance solutions
Trans Anal Irrigation.
ii
Period
7 Days
7 Days
28 Days
3 Months
7 Days
1 Month
14 Days
14 Days
7 days
7 days
7 days
7 days
7 days
14 days
Minimum Dataset
Questionnaire for each appliance on trial must have been provided by the Coordinator to the person who conducted the trial and this must have been completed
by the trial participant.
1.
Incontinence Sheath
1.1
1.2
1.3
1.4
1.5
1.6
1.7
Security.
Comfort.
Ease of application.
Ease of removal.
Adhesive residue.
Frequency of change – durability.
Wear time/Reasons for change.
2.
Leg Bags & Overnight Drainage Bags
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10
2.11
Sterilised.
Unsterilised.
Effectiveness of non-return valve.
Effectiveness of needle-free sampling port.
Ease of use of needle-free sampling port.
Effectiveness of tap.
Ease of opening of tap.
Tubing anti-kink properties.
Flexibility of tubing.
Ease of attachment to Night Drainage/Leg Bag.
Ease of removal from Night Drainage/Leg Bag.
3.
Straps/Sleeves
3.1
3.2
3.3
3.4
3.5
Clear instructions.
Ease of application.
Comfort.
Effectiveness.
Skin health.
4.
Urinary Catheters
4.1
4.2
4.3
4.4
Sterility mark.
Universal connector.
Balloon size.
Non-toxic.
iii
5.
Catheter Valves
5.1
5.2
5.3
5.4
5.5
Connectors – Ease of attachment.
Connectors – Ease of removal.
Ease of opening of tap.
Ease of closing of tap.
Clear instructions.
6.
Retracted Penile Continence System
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.11
6.12
6.13
6.14
Security.
Comfort.
Odour proof material.
Discreet.
Unobtrusive.
Noise/rustle factor.
Ease of application.
Ease of removal.
Adhesive effectiveness.
Skin health.
Effectiveness of tap.
Ease of opening of tap.
Ease of closing of tap.
Connectors – ease of attachment.
7.
Nephrostomy Drainage
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
Sterilised.
Unsterilised.
Effectiveness of non-return valve.
Effectiveness of needle-free sampling port.
Effectiveness of tap.
Ease of opening of tap.
Tubing anti-kink properties.
Flexibility of tubing.
8.
Catheter Securement
8.1
8.2
8.3
8.4
8.5
Clear instructions.
Ease of application.
Comfort.
Effectiveness.
Skin health.
9.
Spigots
9.1
9.2
Sterilised.
Durability.
iv
10.
Urinary Clamps/Dribble Stops
10.1
10.2
10.3
10.4
10.5
10.6
10.7
10.8
Comfortable safe to wear.
Discrete.
Effectively control bladder leakage.
Easy to use.
Easy to clean.
Skin health.
Clear instructions.
Frequency of change durability.
11
Catheter Maintenance Solutions
11.1
11.2
11.3
11.4
11.5
11.6
Clear instructions.
Ease of use.
Frequency of use.
Non-toxic solution.
Sterile.
Effectiveness.
12
Trans Anal Irrigation
12.1
12.2
12.3
12.4
12.5
12.6
Clear instructions.
Easy of assembly.
Ease of use.
Easy to clean.
Effectiveness.
Frequency of change / durability.
v
Appendix 2 - Pricing Rules HSE will apply to all Urinary Product Applications
1)
a. UK equivalent (at 12 month average exchange rate).
OR
b. Average of the lowest three European countries.
OR
c. Price proposed to the HSE.
Note: whichever is the lowest.
2)
UK equivalent based on either:
a. C&D (the most current edition available at the time of pricing)
b. BNF (the most current edition available), if C&D unavailable
c. Submitted UK Price, if C&D and BNF not available
3)
Benchmarked Pricing
The HSE reserves the right to offer a reimbursement price which will be
benchmarked against the prices(s) available to the HSE, for products that, in the
opinion of the HSE Expert Group, offer an equivalent technical solution and/or an
equivalent level of clinical care for patients.
Appendix 3 – Application Checklist
Type 1 - New/Innovative Products:
No.
Included
Yes/No
Requirement
1
Complete all sections of Type 1 Product Application Form.
2
Complete all sections of the Price Application Form
3
Provide 3 samples, including patient information leaflet and outer packaging
4
Provide CE Certificate
5
Provide evidence – published literature
6
Provide User Trial Evidence
Note: The above must be completed for each Type 1 product for which an application is
being made.
Type 2 - Existing Products (Rollover/Minor Change)
No.
Requirement
1
Complete appropriate Type 2 Application Form for each GMS Code.
(Continuation, Minor Change or Discontinuation)
2
Complete all sections of the Price Application Form.
3
Provide artwork or packaging (Minor Change).
Sample is required if artwork not available.
4
Provide Patient information leaflet (Minor Change).
5
Provide CE Certificate.
Included
Yes/No
Note: The above must be completed for each Type 2 existing GMS Code for which an
application is being made.
An application will not be released for assessment until all necessary information has
been received.
Appendix 4 – Forms
1.
Price Application Form – Type 1 and Type 2 Products
2.
Product Application Form – Type 1
New/Innovative Products to be added to the HSE List of Reimbursable Items
3.
Product Application Form – Type 2
Declaration Form for Continued Listing of Product/s
4.
Product Application Form - Type 2
Minor Change of Product on the HSE List of Reimbursable Items
5.
Product Application Form – Type 2
Notice of Intention to Discontinue Product from the HSE List of Reimbursable
Items
=====================
HEALTH SERVICE EXECUTIVE
PRICE APPLICATION FORM:
Reimbursement of Urinary Products
Product Name & Description
GMS Code*:
Pack Size
Type of
Application
(Type 1/Type 2)
Reimbursement
Price Proposed to
HSE(€)
Product Reference Code:
European Pricing
 United Kingdom price should be quoted in Pound Sterling.
 State the European Country and Reimbursement Price in Euro where this product is marketed
and reimbursed under the country’s Schemes/Insurance System.
 HSE will require independent validation of the European prices submitted which must
accompany this form. Where this information is not available, please provide explanatory
footnote/s in the table provided below.
 If this product is not available, specify N.A.
United Kingdom
Country
Country
Country
£
€
€
€
Country
Country
Country
Country
€
Country
€
Country
€
Country
€
Country
€
Country
€
Country
€
Country
€
Country
€
€
€
€
Country
Average of the three lowest European Countries
Country
Country
Average
€
€
European Pricing Footnotes:
*GMS Code where applicable
€
€
United Kingdom Equivalent
C&D
£
(the most current edition available at time of application)
BNF (if C&D price is not available)
(the most current edition available at time of application)
£
Name and Address of Key Contact
Name:
Position:
Address:
I confirm that the information provided in this application is correct.
Signature:
__________________________
Telephone No: ____________________________
Date: _______________
E-mail Address: ________________
The completed form along with application information should be returned to;
Ms Karen Burns
HSE Urinary & Ostomy Review Group
c/o HSE Procurement
Units 1-3 Finisklin Business Park
Sligo
Ireland.
HEALTH SERVICE EXECUTIVE
TYPE 1 Product Application Form:
New/Innovative Urinary Products
to be added to the HSE List of Reimbursable Items
Product Name:
Product Description:
Product Pack Size:
Product Reference Code:
Product Specification:
Manufacturer/Distributor:
Proposed launch date for product:
Please confirm that the product will be
made readily available to a dispensing
contractor through the normal wholesale
network.
I confirm that the product will be made readily available to a
dispensing contractor □
Are comparable products already listed
including those from other
manufacturers/suppliers Y/N, If Y please
detail here:
User Trial
A User Trial should ideally have been conducted independently of a Manufacturer/Distributor
by a Continence Care Nurse or any other appropriately qualified medical or nursing person
who had no direct or indirect association with any Manufacturer/Distributor.
If there was any link between the Manufacturer/Distributor and the person who conducted the
trial, please declare and give details of the link here:
Application Checklist
All sections of Type 1 Product Application Form complete
□
Price Application Form submitted
□
The correct/relevant documents submitted
□
CE Certification submitted
□
Sample of the final packaging submitted
□
Three samples of the product submitted (including Patient Information Leaflet)
□
This application will not be released for assessment until all necessary information has been
received.
Name and Address of Key Contact
Name:
Position:
Address:
I confirm that the information provided in this application is correct.
Signature:
__________________________
Telephone No: ____________________________
Date: _______________
E-mail Address: ________________
The completed form along with application information should be returned to;
Ms Karen Burns
HSE Urinary & Ostomy Review Group
c/o HSE Procurement
Units 1-3 Finisklin Business Park
Sligo
Ireland.
HEALTH SERVICE EXECUTIVE
TYPE 2 Product Application Form:
Declaration Form for Continued Listing of
Urinary Product/s
I declare that
Product Name & Description



Pack Size
Product
Reference Code
GMS Code
Current HSE
Reimbursement
Price €
Is still available under the terms agreed when it was first listed and there have been no
changes to these.
All certification is up to date.
In the event of any changes to the above, the HSE will be notified immediately in
writing.
Name and Address of Key Contact
Name:
Position:
Address:
I confirm that the information provided in this application is correct.
Signature:
__________________________
Telephone No: ____________________________
Date: _______________
E-mail Address: ________________
The completed form should be returned to;
Ms Karen Burns
HSE Urinary & Ostomy Review Group
c/o HSE Procurement
Units 1-3 Finisklin Business Park
Sligo
Ireland.
N.B. If the information provided is found to be incorrect by the HSE, your product will
be immediately deleted from the HSE List of Reimbursable Items.
HEALTH SERVICE EXECUTIVE
TYPE 2 Product Application Form:
Minor Change of Urinary Product on the HSE List
of Reimbursable Items
This form has been prepared to enable manufacturers to inform the HSE of a proposed change of Urinary
product(s) on the HSE List of Reimbursable Items. Changes to a product can include, for example;
● Packaging of product (including pack size) ● Product Specification
●Name of the product
● Manufacturer/Distributor of the product
● Product Reference Code
GMS Code:
Current Listing
Proposed Changes
Product Name:
Product Description:
Product Pack Size:
Product Reference Code:
Product Specification:
Product Packaging:
Manufacturer/Distributor:
Other:
Proposed date for minor change:
Date (month and year) when it is estimated that
stocks of currently listed product will be
depleted:
A copy of any letter(s) sent or proposed to be
sent to Health Care Professionals in relation to
the minor change of the product:
NOTE: For ALL Minor Change Applications, the HSE will require copy of the outer packaging artwork, CE
cert/license and patient information leaflet for currently listed product AND proposed minor change
product.
Name and Address of Key Contact
Name:
Position:
Address:
I confirm that the information provided in this application is correct.
Signature:
__________________________
Telephone No: ____________________________
Date: _______________
E-mail Address: ________________
The completed form should be returned to;
Ms Karen Burns
HSE Urinary & Ostomy Review Group
c/o HSE Procurement
Units 1-3 Finisklin Business Park
Sligo, Ireland.
N.B. If the information provided is found to be incorrect by the HSE, your product will be
immediately deleted from the HSE List of Reimbursable Items.
HEALTH SERVICE EXECUTIVE
TYPE 2 Product Application Form:
Notice of Intention to Discontinue Urinary Product from the HSE
List of Reimbursable Items
This form has been prepared to enable manufacturers, importers or their agents to notify the HSE of
the withdrawal of a urinary product.


At least 3 months is required where there is a reimbursed alternative for the approved
indication available on the market.
At least 12 months is required where there is no reimbursed alternative for the approved
indication available on the market.
This is in the interest of maintaining an uninterrupted supply of urinary products to patients.
Product Name & Description:
Product Reference Code:
GMS Code:
Pack Size:
HSE Reimbursement Price:
Expiry date of last manufactured batch:
Proposed date for product discontinuation:
Date (month and year) when it is estimated that
stocks of product will be depleted:
Where the product discontinuation is of a
particular pack size within a range of products
provide details of those products that will
continue to remain available:
Give reasons for the proposed product
discontinuation of the product (s) with
appropriate substantiating information:
If there is a reimbursed alternative to the
product being discontinued please provide
details:
Provide an evaluation of likely impact that the
proposed discontinuation will have on the
quality of patient care, including
an estimate of the number of patients it will
affect:
Provide details of the current status and
availability of the product in the various Member
States of the European Union:
A copy of any letter(s) sent or proposed to be
sent to Health Care Professionals in relation to
the discontinuation of the product.
€
Name and Address of Key Contact
Name:
Position:
Address:
I confirm that the information provided in this application is correct.
Signature:
__________________________
Telephone No: ____________________________
The completed form should be returned to;
Ms Karen Burns
HSE Urinary & Ostomy Review Group
c/o HSE Procurement
Units 1-3 Finisklin Business Park
Sligo
Ireland.
Date: _______________
E-mail Address: ________________