HSE PRIMARY CARE
REIMBURSEMENT SERVICE
OSTOMY 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 Ostomy 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 and
Community Drugs Schemes must make 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 Ostomy 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 be safe and of good
quality.
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 Ostomy 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
2
the HSE to ask for collection of any paperwork / samples to be arranged within the
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 OSTOMY PRODUCTS
1.
Ostomy Collection Pouches
1.1
1.1.1
1.1.2
Size (All Pouches)
All pouches except Fistula must be available in a wide range of gasket sizes.
Fistula pouches must be available as a standard "cut to fit".
1.2
1.2.1
1.2.2
1.2.3
1.2.4
Plastic (All Pouches)
The plastic must be of good quality and be odour proof.
Must be flexible and comfortable.
Must be discreet and unobtrusive.
Must be quiet film.
1.3
1.3.1
Pouch (All Pouches)
The pouch must have a soft, absorbent backing and be available in clear (including
split cover variants) and opaque presentations.
Each box of pouches must be packed in box sizes ranging 10 – 30 units.
In the case of two piece systems, shelf containers and preferably unit and inner
containers, must contain a statement as to which pouches and flanges will couple
together.
Each box of pouches must contain a leaflet with application directions. Directions
must be easily understood by the client and include illustrations for ease of
comprehension.
A measuring guide must be available for correct fitting and must be included
in each box or be available upon request. In the case of fistula pouches a template
must be included.
1.3.2
1.3.3
1.3.4
1.3.5
.
1.4
1.4.1
1.4.2
1.4.3
1.4.4
1.4.5
Adhesive (All Pouches and Flanges)
Must be easy to apply and remove.
Must be secure.
Must be comfortable.
Must incorporate a skin protective.
If the appliance incorporates an adhesive tape, the tape must be non allergenic.
1.5
1.5.1
Filters
Filters must be discreet and effective.
(i.e. Odour or faecal material should not leak from the filter, they should prevent
ballooning, designed to avoid blockage of the filter, waterproof in shower/bath or
filter covers should be included in box of products).
1.6
1.6.1
1.6.2
1.6.3
Pouch Closures (Drainable, Fistula and Post-Op. Pouches)
Pouch closures should be integrated into the pouch.
Pouch closures should be easy to clean and allow for repeated opening and closing.
If a soft wire tie is the method of closure a minimum of one tie per pouch must be
included.
If a bung type closure is the method of closure the bung should be securely
attached to the pouch.
Standard clip – 1 clip per ten pouches is acceptable.
1.6.4
1.6.5
4
1.7
1.7.1
1.7.2
Convexity
Convex products should identify the degree of convexity e.g. shallow or deep or
more preferably the depth of convexity in mm’s. This should be displayed on outer
box.
Literature included with the pouch should outline appropriate use of and precautions
required when using convexity. E.g. should be used under the supervision of a
medical heathcare professional such as a stoma clinical nurse.
1.8
1.8.1
Taps (Urostomy)
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 pouch is used in conjunction with
leg and night drainage bag.
1.9
1.9.1
Non-Return Valve (Urostomy)
Urostomy pouches must have a non-return valve.
1.10
1.10.1
Connectors (Urostomy)
Connectors on urostomy pouches must be universal to facilitate easy attachment to
leg and night drainage pouches.
One connector per pack of 10 pouches is acceptable.
1.10.2
1.11
1.11.1
Tubing (Urostomy Drain Tubing)
Tubing must be constructed in material with anti kink properties, yet must be
sufficiently flexible to allow easy manipulation and routeing.
1.12
1.12.1
Drainage Bags
Faecal ostomy pouch free drainage bags must;
1.12.1.1
Contain an instruction leaflet.
1.12.1.2
Have a capacity between 2 and 3 litres.
1.12.1.3
Be made from a good quality plastic.
1.12.1.4
Have volume measuring markings on bag.
1.12.1.5
Have a durable and secure emptying tap/device.
1.12.1.6
Have universal eyelets to attach bag to a stand.
1.12.1.7
Be available in pack sizes between 10-30 units.
Drainage bags for use with urostomy pouches - see "Criteria for Urinary
Incontinence Products".
1.12.2
1.13
1.13.1
1.13.2
1.13.3
Flanges
Two Piece pouches must be easy to attach to flanges.
In the case of two piece systems, shelf containers and preferably unit and inner
containers, must contain a statement as to which pouches and flanges will couple
together within a range.
However there may be instances whereby a client may not achieve the minimum
wear time. Consequently, users should be advised that the minimum wear time is
conditional e.g. on there being no leakage from under the flange or an adverse skin
reaction occurring.
5
2.
Adhesive Removers
2.1
2.2
2.3
2.4
2.5
2.6
Must include clear Client instructions i.e.- wash skin following use.
Must not damage skin.
Must not cause pain on application.
Contents must be clearly marked.
Must be easy to use.
Must not compromise the adhesion of the new pouch being applied.
3.
Belts
3.1
3.2
3.3
3.4
3.5
Must include clear Client instructions.
Must be comfortable next to skin i.e. plastic tabs.
Must be of washable fabric.
Must be compatible with pouches.
Must be easy to adjust.
4.
Deodorants/Air Freshener
4.1
4.2
Must include clear Client instructions i.e. if applicable not to be sprayed on or near
stoma.
Must be ozone friendly.
5.
Irrigation/Plug Devices
5.1
5.1.1
5.1.2
5.1.3
5.1.4
Irrigation/Plug Appliances
Appliances must contain clear instructions with illustrations for client use.
Appliances must clearly state approximate length of time for which it can be used
i.e. Pouch, Tubing, Cone - not less than 1 year.
Sleeves must be packed in boxes of 10-50 units.
Cones must be packed singly.
5.2
5.2.1
5.2.2
5.2.3
5.2.4
Irrigation Pouch
Plastic must be of good quality.
Capacity must be 1000mls. to 2000mls.
Volume capacity must be clearly labelled and easily read.
Pouch must incorporate a good quality holder/handle.
5.3
5.3.1
5.3.2
5.3.3
5.3.4
Irrigation Tubing
Must be of good quality plastic.
Must have anti-kink properties.
Must be flexible and easy to use.
Must incorporate a water controlling device which is easy to use.
6
5.4
5.4.1
5.4.2
5.4.3
5.4.4
5.5
5.5.1
5.5.2
5.5.3
5.5.4
5.6
5.6.1
5.6.2
5.6.3
5.6.4
5.6.5
Cone/Catheter
Material must be of good quality.
Must be soft.
Tip must be rounded for comfortable insertion and removal, without causing damage
to the stoma or rectum.
Must be easy to remove from the tubing for easy cleaning.
Sleeves (One Piece)
Plastic material must be of good quality.
Adhesive must be easy to apply and remove from skin.
Sleeves must contain security clip i.e. for when the client wishes to walk around
during the procedure.
Instructions must state length of time each sleeve can be used for i.e. single use.
Sleeves (Two Piece)
Plastic material must be of good quality.
Sleeve must be easy to apply to and remove from belt flange.
Sleeves must contain security clip i.e. for when the client wishes to walk around
during the procedure.
Instructions must state length of time each sleeve can be used for i.e. single use.
Must state approximate length of time each belt can be used for i.e. minimum
of 6 months.
5.7
5.7.1
5.7.2
5.7.3
5.7.4
Plugs (One Piece)
Material must be of good quality.
Material must be soft and comfortable.
Must be discreet and unobtrusive.
Must be easy to insert and remove without traumatising the stoma or peristomal
skin.
5.7.5 Must incorporate an effective filter.
5.7.6 Must be available in a selection of sizes.
5.7.7 Must contain clear instructions and illustrations for use and disposal.
5.7.8 Must be packed in boxes of 10-30 units.
5.7.9 Adhesive must be secure, easy to apply and remove from skin.
5.7.10 Adhesive must incorporate a skin protective.
5.8
5.8.1
5.8.2
5.8.3
5.8.4
5.8.5
5.8.6
5.8.7
5.8.8
5.8.9
5.8.10
Plugs (Two Piece)
Base plate must be soft and comfortable.
Must be discreet and unobtrusive.
Adhesive must be secure, easy to apply and remove from skin.
Adhesive must incorporate a skin protective.
Must incorporate an effective filter.
Plug must be easy to attach and remove from base plate.
Must be packed in boxes of 10-30 units.
Must contain clear instructions and illustrations for use and disposal.
Must be available in a selection of sizes.
Plug must be easy to insert and remove without traumatising the stoma or
peristomal skin.
7
6.
Skin Fillers and Protectives (Sprays, Powders, Pastes and Wipes)
6.1
6.2
6.3
6.4
6.5
Contents must be clearly labelled.
Instructions must be clearly stated.
Must be easy to apply to and remove from skin.
Must not cause pain on application.
Must not cause damage to skin.
7.
Skin Protectors (Seals/Rings)
7.1
7.2
7.3
7.4
7.5
7.6
Must adhere to moist skin.
Must be comfortable on skin.
Must be flexible on skin.
Must be available in a variety of sizes i.e. rings.
Must be easy to apply to and remove from skin.
Must contain Instructions.
8.
High Output Pouches
8.1
8.2
8.3
8.4
Must have a bung type closure to allow for connection to free drainage if required.
Must have an adhesive resistant to corrosive effluent.
Convex high output pouches must have an option of attaching a belt.
Must have a larger than average pouch capacity.
9.
Anal Plugs
9.1
9.2
9.3
9.4
9.5
Contents must be clearly labelled.
Instructions must be clearly stated.
Must be available in a variety of sizes.
Must be easy to apply to and remove from skin.
Must be individually wrapped.
8
Appendix 1: Guidelines for Manufacturers/Distributors on the Design and Execution
of User Trials of Ostomy 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:o Preparing information booklets containing correct trial procedures;
o Formulating a questionnaire;
o Distributing the above documentation;
o Collecting the questionnaires;
o Collating the data;
o Presenting the results.

A User Trial should ideally have been conducted independently of a
Manufacturer/Distributor by a Stoma Care Nurse or any other appropriately qualified
medical or nursing person who has no direct or indirect association with any
Manufacturer/Distributor.

If there was any link between the Manufacturer/Distributor and the person who
conduced 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 in 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. flanges to have been used with two piece system pouches.

Permission to carry out the trial must have been obtained by the Co-ordinator who
conducted 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 pouch adhesion.

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 o all technical details about their products including
recommended wear time.
i
specifications
and
o

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
o
o
o
Participants must have been willing to use the product on trial.
Participants must have provided informed consent.
Participants must have been able to comprehend and complete the
questionnaire provided.
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 been excluded from 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.
o Products excluded from User Trials are Post-Op. and Fistula pouches.

The following must have been complied 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
One/Two Piece Closed Pouches
One/Two Piece Open Pouches
Urostomy Pouches
Adhesive Remover
Pouch Closures ·.
Belts
Deodorant/ Air Freshener
Filters
Irrigation /Plug
Appliances(Pouch/Tubing/Cone/Sleeve)
Skin Fillers & Protectives
Skin Protectors
Anal Plugs
o
Period
10-12 Days
18-20 Days
18-20 Days
To be determined by the type of pouch being worn
18-20 Days
To be determined by the type of pouch being worn
To be determined by the type of pouch being worn
10-12 Days
28 Days
To be determined by the type of pouch being worn
To be determined by the type of pouch being worn
28 days
The minimum wear time for Pouches/Flanges under trial will have been the
participants normal wear time for this type of product.
ii
Minimum Dataset
Questionnaire for each product on trial must have been provided by the Co-ordinator
to the person who conducted the trial and this must have been completed by the trial
participant.
1.
Pouches: One Piece Closed/Open
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.10
1.11
1.12
1.13
1.14
1.15
Security.
Comfort.
Odour proof material.
Noise/Rustle factor.
Aesthetic appearance.
Filter performance.
Ease of application.
Ease of removal.
Adhesive residue.
Backing paper - ease of removal.
Flexibility.
Capacity adequacy.
Frequency of change - durability.
Visibility/Profile.
Assessment of backing material
1.16
1.17
1.18
Wear time/Reasons for change.
Daily activities - Showering/bathing - Ease of drying,
-Filter performance,
-Adhesive performance.
Status of peristomal skin at final assessment.
2.
Pouches: Two Piece System
-Comfort,
-Ability to absorb perspiration.
In addition to points referred to under 1 above, the following must have been included in the
Questionnaire2.1
2.2
2.3
2.4
Ease of attachment of flange to pouch.
Ease of removal of flange from pouch.
Incidence of "pop-off' occurrence.
Flanges
- Flexible,
- Inflexible.
3.
Urostomy Pouches
In addition to points referred to under 1 above, the following must have been included in the
Questionnaire3.1
3.2
3.3
3.4
3.5
3.6
3.7
Effectiveness of non-reflux valve.
Effectiveness or tap, security.
Ease of opening.
Ease of closing.
Ease of attachment to Night Drainage Bag/Leg Bag.
Ease of removal from Night Drainage Bag/Leg Bag.
Connectors - Ease of attachment,
- Ease of removal,
iii
- Security.
4.
Adhesive Removers
4.1
4.2
4.3
4.4
4.5
Clear instructions.
Damage to skin.
Pain on application.
Ease of application.
Compromising pouch adhesion.
5.
Pouch Closures
5.1
5.2
5.3
5.4
5.5
5.6
5.7
Ease of application.
Ease of opening.
Ease of removal.
Security.
Ease of cleaning.
Comfort.
Discreet.
6.
Belts
6.1
6.2
6.3
6.4
6.5
6.6
6.7
Clear instructions.
Ease of application.
Ease of removal.
Ease of belt adjustment.
Discreet.
Comfort.
Washable.
7.
Deodorants/Air Fresheners
7.1
7.2
7.3
7.4
Clear instructions.
Effectiveness.
Ease of Usage.
Acceptability of perfume.
8.
Filters
8.1
8.2
8.3
8.4
Visibility profile.
Effectiveness.
Acceptable wear time.
Leakage through filter.
9.
Irrigation/Plug Appliances
9.1
9.2
Clear instructions.
Ease of storage/carriage.
iv
10.
Irrigation Bag
10.1
10.2
10.3
10.4
Plastic - Durability.
Capacity.
Labelling.
Holder - quality,
- effectiveness.
11.
Irrigation Tubing
11.1
11.2
11.3
11.4
Anti-kinking.
Ease of handling.
Flexibility.
Water controlling device
11.5
Ease of removal from cone.
12.
Cone/Catheter
12.1
12.2
12.3
12.4
Ease of insertion/removal.
Comfortable.
Ease of removal from tubing.
Ease of cleaning.
13.
Sleeves
13.1
13.2
13.3
13.4
13.5
13.6
13.7
13.8
Ease of application.
Ease of removal.
Comfortable.
Ease of usage.
Effectiveness.
Ease of application of flange to belt.
Ease of removal of flange from belt.
Comfortable.
- ease of usage,
- effectiveness.
(1-Piece)
(1-Piece)
(1-Piece)
(Security clip)
(Security clip)
(2-Piece)
(2-Piece)
(2-Piece)
v
Appendix 2 - Pricing Rules HSE will apply to all Ostomy 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:
Included
Yes/No
1
Complete Type 1 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)
Included
Yes/No
1
2
3
Complete appropriate Type 2 Application Form for each GMS Code.
(Continuation, Minor Change or Discontinuation)
Complete all sections of the Price Application Form.
4
Provide artwork or packaging (Minor Change).
Sample is required if artwork not available.
Provide Patient information leaflet (Minor Change).
5
Provide CE Certificate.
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 Ostomy 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 Ostomy 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
Ostomy 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 Ostomy 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 Ostomy
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 Ostomy 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 an ostomy 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 ostomy 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: ________________