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PUBLIC SUMMARY DOCUMENT Product: Sur-Fit AutoLock Two-Piece Closed Pouch with Mechanical Coupling Applicant: ConvaTec (Australia) Pty Ltd Date of SPAP Meeting: 28 April 2014 1. Proposed Listing on the Stoma Appliance Scheme The applicant, ConvaTec, sought the maintenance of a price premium currently applied to a product listed in Subgroup 5(a) of the Stoma Appliance Scheme (SAS) Schedule, the Sur-Fit AutoLock Two-Piece Closed Pouch with Mechanical Coupling (SAS code 3780Y). The applicant proposed a unit price inclusive of a price premium over the benchmark unit price for Subgroup 5(a) ($1.564). The price premium requested was for the Sur-Fit AutoLock feature (described by the applicant as a ‘one touch security system’). 2. Comparator The applicant nominated a Coloplast product listed in Subgroup 5(a) of the SAS Schedule, the Coloplast Alterna Comfort Two-Piece Closed Pouch with Mechanical Coupling (SAS code 3813Q), as the comparator. This product is currently listed at the benchmark unit price of $1.564. 3. Background The product was originally listed prior to 2011. Following the introduction of the new SAS pricing framework on 1 July 2011, it was listed at a unit inclusive of a price premium of $0.646 over the benchmark unit price. 4. Clinical Place for the Product The product is a closed pouch with a mechanical coupling mechanism for use in conjunction with a mechanical coupling baseplate as part of a two-piece system. It is suitable for use by people with a colostomy. 5. SPAP Comment Clinical Analysis The SPAP noted that the application discussed the importance to users with limited dexterity of being able to easily and securely attach two-piece systems, and stated that security and leakage are issues relevant to the user. The SPAP considered these assertions to be reasonable. The SPAP noted that the evidence presented by the applicant to support the claim of product superiority consisted of a single cross-over study (CC-0175-97-A606) comparing the ConvaTec MK 4 (which the Panel presumed to be the Sur-Fit AutoLock marketed under another name overseas) with the Coloplast Assura (Alterna – ie. the nominated comparator product). This study involved 45 users and had a primary endpoint of patient preference. Secondary endpoints included the pouch to baseplate connection, the pressure needed to apply the pouch to the baseplate, the ease of application/removal of the pouch and the profile of the flange under normal wearing conditions. Each user was asked to evaluate two of each brand of system, meaning a total of 4 systems evaluated per user. Data from 44 users was included in the subsequent analysis. The Panel noted that the results from study CC-0175-97-A606 appeared to favour the ConvaTec system. The Panel noted the difference in the primary endpoint of user CC#12 preference, where 75% preferred ConvaTec and 23 % preferred Coloplast (with 2% claiming equivalence), and that this result was used as the basis for the applicant’s economic evaluation. However, the Panel considered that while user preference is important, as the basis of a premium request in the absence of information on the clinical manifestation of any enhanced security (in terms of, for example, the patient-relevant outcomes of a reduction in leakage and/or appliance failure, and increased wear time defined by when the system is removed on the basis of clinical need as opposed to a routine change) it is not adequately meaningful. Economic Analysis The Panel noted that the applicant based their cost-effectiveness analysis on the difference in user preference rates for the ConvaTec and Coloplast systems. The Panel considered this to be a misapplication of the ICER as the value derived was not directly linked to the concept of ‘health benefit’. An example of an appropriate measure of health benefit would be Quality Adjusted Life Years. Financial Analysis Not undertaken. 6. SPAP Recommendation The SPAP recommended that the applicant’s request for the maintenance of a $0.646 unit price premium as currently applied to the Sur-Fit AutoLock Two-Piece Closed Pouch with Mechanical Coupling (SAS code 3780Y) which is listed in Subgroup 5(a) of the SAS Schedule, be rejected due to inadequate evidence to support the claim of product superiority. 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. CC#12