PUBLIC SUMMARY DOCUMENT
Product: Silesse Skin Barrier Spray 50 ml
Applicant: ConvaTec (Australia) Pty Ltd
Date of SPAP Meeting: 28 April 2014
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, ConvaTec (Australia) Pty Ltd, sought listing of the Silesse Skin Barrier
Spray (50 ml) in sub-group 9(k) of the Stoma Appliance Scheme (SAS) Schedule. The
product was proposed for listing with a maximum quantity of six per year.
2. Comparator
The applicant nominated Coloplast Brava No Sting Adhesive Barrier Spray, a product
currently listed in SAS sub-group 9(k) with SAS Code 3925N, as the comparator. The
comparator is listed at the unit price of $26.25 for a 50 ml bottle, with a maximum quantity
of six units per year.
3. Background
This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.
4. Clinical Place for the Product
SPAP agreed that the proposed product provides an alternative for users requiring a barrier
spray for application to the peristomal skin before an ostomy appliance. However, it was
noted that a broader review of clinical and cost effectiveness is currently being undertaken
for products in Group 9.
5. SPAP Comment
SPAP noted there is no notional benchmark product and associated benchmark price
specified for sub-group 9(k).
Clinical Analysis
The applicant cited that the proposed product is 100 per cent silicone based and alcohol free.
SPAP noted that the nominated comparator has the same features and is therefore
acceptable.
The product is a direct substitute for other barrier spray products currently available in subgroup 9(k).
Economic Analysis
As the product is equivalent to products at the same nominated price currently available in
sub-group 9(k), a cost-minimisation analysis was considered appropriate.
Financial Analysis
Listing of this product is recommended on a cost minimisation basis compared with the
nominated comparator product in sub-group 9(k) of the SAS Schedule. It is therefore
unlikely 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 the Silesse Skin Barrier Spray (50 ml) be listed in sub-group
9(k) of the SAS Schedule at a unit price of $26.25, with a maximum quantity of six per year.
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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
ConvaTec (Australia) Pty Ltd accepts the SPAP’s decision at this time.
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