Product: Sensura Mio One-Piece Closed Flat Pouch

PUBLIC SUMMARY DOCUMENT

Product: SenSura Mio One-Piece Closed Flat Pouch Applicant: Coloplast Pty Ltd Date of SPAP Meeting: 28 April 2014

1. Proposed Listing on the Stoma Appliance Scheme The applicant, Coloplast, sought the addition of a price premium to a product currently listed in Subgroup 1(b) of the Stoma Appliance Scheme (SAS) Schedule, the SenSura Mio One-Piece Closed Flat Pouch (SAS code 5697W). The applicant proposed a unit price inclusive of a price premium over the benchmark unit price for Subgroup 1(b) ($2.735).

The price premium requested was for the SenSura Mio baseplate with BodyFit technology and the ‘new’ (2010) SenSura filter.

2. Comparator The applicant nominated a Hollister product listed in Subgroup 1(b) of the SAS Schedule, the Moderma Flex One-Piece Closed Flat Pouch (SAS code 3934C), as the comparator. This product is currently listed at a unit price of $3.009, inclusive of a price premium of $0.274 for the AF300 filter.

3. Background An application requesting a price premium was considered by the Stoma Product Assessment Panel (SPAP) in November 2012 as part of the Group 1 Price Premium Review (SAS 2012-13 Budget measure). At that time the SPAP recommended that the applicant’s request for a price premium be rejected due to an inadequate evidence base. A further application for a price premium was rejected by the SPAP at its July 2013 meeting.

4. Clinical Place for the Product The product is a one-piece closed appliance with a flat baseplate suitable for use by people with a colostomy.

5. SPAP Comment

Clinical Analysis The applicant presented three studies and a lab test of elasticity to support its claim for the superiority of the baseplate and filter. The Panel noted there was no material difference between the evidence submitted in this application and that submitted in November 2012 and July 2013.

A post hoc subgroup analysis was presented from Study CP219OC (a study comparing SenSura Mio with five alternative products) for patients using Moderma Flex. The data suggests that ballooning was experienced by 2% of subjects using Mio compared to 8% using Hollister Flex. However, it was noted that in Study CP2010C, presented for other applications by the applicant, a frequency of 23% ballooning was reported with the SenSura product in patients with a history of at least one ballooning episode per week. Such a large difference between the trials is difficult to rationalise and creates uncertainty in regard to the results of the sub group analysis. It was also noted that the applicant did not present any data on the deodorising capacity of the filter.

For further information on the Panel’s position on this evidence refer to relevant public summary documents from November 2012 (CT#1 Coloplast SenSura MIO One-Piece CT#1 Closed Flat Pouch) and July 2013 (CT#1 Coloplast SenSura MIO One-Piece Closed Flat Pouch).

Economic Analysis As was the case for clinical analysis the Panel noted that the applicant had not provided any economic information beyond that which was provided previously in November 2012 and July 2013 in support of a price premium. For the ‘superiority’ premium the applicant has simply deducted the premium price claimed for the filter from the premium the product held before the Review.

Financial Analysis Not undertaken.

6. SPAP Recommendation The SPAP recommended that the applicant’s request for the application of a price premium to the SenSura Mio One-Piece Closed Pouch (SAS code 5697W), currently listed in subgroup 1(b) of the SAS Schedule, be rejected due to inadequate evidence to support of 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 Whilst Coloplast respects the response from SPAP at this point in time, we note that there are some misunderstandings that we shall attempt to clarify as well as presenting some new evidence which shall further strengthen our subsequent submissions.