PUBLIC SUMMARY DOCUMENT Product: Welland Stoma Powder Applicant: Omnigon Pty Ltd Date of SPAP Meeting: 17 &18 August 2015 1. Proposed Listing on the Stoma Appliance Scheme The applicant, Omnigon, sought listing of the Welland Stoma Powder 25g, in subgroup 9(j) of the Stoma Appliance Scheme (SAS) Schedule. The product was proposed at the unit price of $8.70, with a maximum monthly quantity of two units. 2. Comparator The applicant nominated ConvaTec Powder 28g (SAS code 3511T) which is currently listed in subgroup 9(j) as the comparator. This product is currently listed at the unit price of $8.70, with a maximum monthly quantity of two units. 3. Background This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product. 4. Clinical Place for the Product The proposed product provides an alternative for users requiring a powder to manage their stoma. The product is a direct substitute for the comparator currently available in subgroup 9(j). 5. SPAP Comment Clinical Analysis The Panel noted that the proposed product prevents peristomal skin complications by absorbing moisture from broken or weeping skin and creates a sticky surface which assists an ostomy pouch to adhere to the skin. The Panel noted that the proposed product is available as a 25g puffer pack allowing two options for application – either a puff as a cloud for hard to reach areas or targeted lines or dots for more accurate application. The Panel also noted the clinical evidence provided by the applicant did not compare the product with the comparator. The product is a direct substitute for other powder products currently available in subgroup 9(j). Economic Analysis The Panel noted the comparator is listed a unit price of $8.70 for 28g, i.e. a price per gram of $0.31. The 25g product should therefore be listed at a price of $7.77. Financial Analysis Listing of this product is recommended at a lower price than the nominated comparator in subgroup 9(j), listing the product would therefore result in a cost reduction to Government. OG#1 6. SPAP Recommendation The SPAP recommended that the Welland Stoma Powder 25g, be listed in subgroup 9(j) of the SAS Schedule at the unit price of $7.77, $0.31 per gram, with a maximum quantity of two units. However, the Panel noted that all recommendations for products to be listed in Group 9 of the SAS Schedule may be subject to change as a result of the outcomes from the Group 9 Review. The outcomes of the Group 9 Review are expected in 2015. 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 Pty Ltd agrees with SPAP’s recommendation contained in the Public Summary Document. OG#1