PUBLIC SUMMARY DOCUMENT
Product: Welland Stoma Paste
Applicant: Omnigon Pty Ltd
Date of SPAP Meeting: 8 November 2013
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, Omnigon, sought the listing of Welland Stoma Paste (100 g) in Group 9(j) of
the Stoma Appliance Scheme (SAS) Schedule. The product was proposed for listing at a
unit price of $16.92, with a maximum monthly quantity of two units.
2. Comparator
The applicant nominated a Coloplast product listed in Group 9(j) of the SAS Schedule, the
Coloplast Paste Tube (60 g) (SAS code 3534B), as the comparator. This product is listed at
a unit price of $11.28, with a maximum monthly quantity of three units.
3. Background
This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.
4. Clinical Place for the Product
The product is a hypo-allergenic, hydrocolloid based and alcohol free paste, intended to be
used to fill skin dips, smooth over scar lines and create the ideal base for safe, secure pouch
application. The product is intended to reduce the risk of leakage and faeces-induced skin
irritation.
5.
SPAP Comment
Clinical Analysis
The Panel noted clinical advice to the effect that the product offered very good tack and ease
of application. The Panel agreed that any hydrocolloid-containing paste (i.e. any of the
pastes currently listed in Subgroup 9(j) with the exception of Hollister Karaya) would
constitute an appropriate comparator. The applicant’s choice of comparator was therefore
considered to be valid.
The Panel noted the applicant’s claims that the product is superior to its comparator and that
it is the only product available containing no alcohol, meaning ‘no sting’ on application.
The Panel noted that the application did not provide evidence to support these claims in the
form of any demonstrated improvement in clinical outcomes.
Economic Analysis
As Welland Stoma Paste is deemed to be equivalent to products currently available in
Subgroup 9(j) of the SAS Schedule (including the comparator), a cost-minimisation analysis
with reference to the selected comparator was considered appropriate.
In view of the maximum monthly quantities for the comparator and equivalent products
within the subcategory as against that proposed for the product under consideration, the
requested unit price of $16.92 for the proposed product was considered by the Panel to be
equivalent. Maximum issue of the comparator and equivalent products would provide 180 g
of paste per month (3 x 60 g at $11.28 per 60 g) while that of the proposed product would
provide 200 g of paste per month (2 x 100 g at $16.92 per 100 g) – each at a monthly cost of
$33.84.
OG#1
Financial Analysis
Listing of this product would be on a cost-minimisation basis compared with the selected
comparator (and other equivalent products) in Subgroup 9(j) of the SAS Schedule. It is
therefore not expected that there would be any budgetary impact for the SAS as a
consequence of listing this product under the conditions requested by the applicant.
6. SPAP Recommendation
The SPAP recommended that Welland Stoma Paste (100 g) be listed in Group 9(j) of the
SAS Schedule at a unit price of $16.92, with a maximum monthly quantity of two units.
The SPAP also agreed that the clinical need for pastes and powders in stoma management
should be investigated further as part of the upcoming review of Group 9 (accessory)
products available under the Scheme.
7. Context for Decision
The SPAP helps decide whether stoma products should be subsidised and, if so, the
conditions of their subsidisation in Australia. It considers submissions in this context. An
SPAP decision not to recommend listing or changes to a listing does not represent a final
SPAP view about the merits of a particular stoma product. A company can resubmit to the
SPAP following a decision not to recommend listing or changes to a listing. The SPAP is
an advisory committee and as such its recommendations are non-binding on Government.
All SPAP recommendations are subject to Cabinet/Ministerial approval.
8. Applicant’s Comment
Omnigon accepts the SPAP recommendation
OG#1