Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
PUBLIC SUMMARY DOCUMENT Product: Silesse Skin Barrier Spray 28 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 (28 ml) in sub-group 9(k) of the Stoma Appliance Scheme (SAS) Schedule. The product was proposed for listing at the unit price of $14.70, with a maximum monthly quantity of one unit. 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 The Panel noted that the price per ml for the comparator is the same as that of the product under consideration. Financial Analysis The applicant has requested a maximum quantity of one 28 ml unit per month (i.e. 336 ml per year), whereas the comparator is listed at six 50 ml units per year (i.e. 300 ml per year). While the requested price per ml is the same as the comparator, the maximum annual quantity is 36 ml more. There could therefore be a cost for the SAS as a consequence of listing this product under the conditions requested by the applicant. CC#5 6. SPAP Recommendation The SPAP recommended that the Silesse Skin Barrier Spray (28 ml) be listed in sub-group 9(k) of the SAS Schedule at a unit price of $14.70, with a maximum monthly quantity of one unit. 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 It is noted that based on the comparator used for this submission is 50ml, and the cost analysis is equal per ml, there are other comparator products currently listed on the SAS at a higher price for the same volume of 28ml with an allocation of 1 per month (3M No Sting cavilon no sting barrier film, pump spray 28gm bottle, allocation of 1 per month,$15.31 & Smith & Nephew No-Sting Skin Prep Spray protective skin barrier spray - 28mL bottle, allocation of 1per month $15.31). Although there is an excess of 36ml per year, this excess will not be discarded by the user instead carried over month to month, year to year. Based on this it would mean that over a longer period of time fewer products per year will be used and thus minimising cost to the scheme. CC#5