PUBLIC SUMMARY DOCUMENT Product: Dansac NovaLife 1 Closed Soft Convex Applicant: Dansac Date of SPAP Meeting: 28 April 2014 1. Proposed Listing on the Stoma Appliance Scheme The applicant, Dansac, sought listing of the NovaLife 1 Closed Soft Convex pouch in subgroup 1(c) of the Stoma Appliance Scheme (SAS) Schedule. The product, including seven variants, was proposed for listing at the unit price of $4.707, inclusive of a price premium of $0.274 over the benchmark unit price for sub-group 1(c) ($4.433). The applicant sought listing with a maximum monthly quantity of 60 units. The price premium requested was for the AF300 filter. 2. Comparator The applicant nominated the Dansac NovaLife One-Piece Closed Convex, listed in subgroup 1(c) of the SAS Schedule, as the comparator. This product is currently listed at the unit price of $4.707, inclusive of a $0.274 price premium. 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 one-piece closed pouch with convex baseplate. The product is a direct substitute for other pouches currently available in sub-group 1(c). 5. SPAP Comment Clinical Analysis The product’s features are highlighted in the table below. This table demonstrates that the proposed product comprises the benchmark features for sub-group 1(c). Table 1: Group 2 – One-Piece Closed – (c) Convex Baseplate Key Feature: Closed Pouch Related Feature Pouch Filter Pouch Construction Material Variant Protected dual carbon filter Protected single carbon filter Transparent with fabric backing Transparent with fabric cover on both sides including viewing window Opaque with fabric backing Opaque with fabric cover on both sides Pouch Size Extra small Small Medium Large Extra large Belt Loops No belt loops Belt loops on each side of pouch Belt loops on each side of baseplate Headspace Low headspace Standard headspace DA#2 Table 2: Group 2 – One-Piece Closed – (c) Convex Baseplate Key Feature: Flat Baseplate Related Feature Baseplate Material Baseplate Thickness Baseplate Shape Baseplate Skin Adhesion Baseplate Wear Time Baseplate Opening Type Baseplate Achieving Convexity Degree of Convexity Release Tabs Variant Hydrocolloid Hydrocolloid with Aloe Vera 1.65 mm Round Oval Oval with contouring spaces Diamond Oblong Square Triangle Hexagon Hydrocolloid self adhesive Hydrocolloid self adhesive with tape border Standard Cut-to-fit Pre-cut Pre-cut mouldable Rigid convex ring Extra thick baseplate material Firm baseplate material Shallow Medium Deep Release tabs No release tabs The SPAP noted that the product, which contains the AF300 filter, is similar to the NovaLife One-Piece Closed Convex. The main differences between the two products are the softer convex dish and the split fabric backing in the proposed product. The SPAP has previously granted a price premium of $0.274 for the AF300 filter in closed bags, therefore no evidence was provided on the performance of the filter. It was also noted that no evidence was provided as to whether the performance of the product differs from other products in sub-group 1(c). Economic Analysis The applicant proposed that utilisation of this product will replace that of the comparator. As the product is equivalent to products at the same nominated price currently available in sub-group 1(c), 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 1(c) 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. DA#2 6. SPAP Recommendation The SPAP recommended that the NovaLife 1 Closed Soft Convex be listed in sub-group 1(c) of the SAS Schedule at a unit price of $4.707, with a maximum monthly quantity of 60 units. 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 Dansac accepts the SPAP recommendation. DA#2