PUBLIC SUMMARY DOCUMENT
Product:SenSura One-Piece Closed Flat Pouch
Applicant:Coloplast Pty Ltd
Date of SPAP Meeting:28 April 2014
- 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 One-Piece Closed Flat Pouch (SAS code 9830J). The applicant proposed a unit price inclusive of a price premium over the benchmark unit price for Subgroup 1(b) ($2.735).
- Comparator
The applicant nominated the Hollister Moderma Flex (SAS code 3934C), listed in subgroup 1(b) of the SAS Schedule, as the comparator. This product is currently listed at the unit price of $3.009.
- Background
The product was originally listed prior to 2011. From 1 July 2011 it was listed at a unit price of $3.233, inclusive of a price premium of $0.498. This premium was removed as a result of the Group 1 Price Premium Review in November 2012. A further application for a price premium was rejected by the SPAP at its July 2013 meeting.
- 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.
- SPAP Comment
Clinical Analysis
The applicant presented numerous studies in support of its application. The Panel noted there was no material difference in between the evidence submitted in November 2012 and July 2013. Study DK109OS was conducted in 2005 prior to the introduction of the AF300 filter and thus issues regarding ballooning and preference are likely to be confounded. Similarly for studies DK145OS and CP201OC.
A post hoc subgroup analysis was presentedfrom study CP219OC (a study comparing SenSura Mio with five alternative products) for patients using Moderma Flex. The data suggest that ballooning was experienced by 2% of subjects using Mio compared to 8% using Hollister Flex. However, it was noted that in Study CP201OC, presented for other applications by theapplicant, 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#3 SenSura One-Piece Closed Flat Pouch) and July 2013 (CT#2 SenSura One-Piece Closed Flat Pouch).
Economic Analysis
As was the case for clinical analysis the Panel noted that the applicant has not provided any economic information beyond that which was provided previously in November 2012 and July 2013 in support of a price premium.
Financial Analysis
Not undertaken.
- SPAP Recommendation
The SPAP recommended that the applicant’s request for the application of a unit price premium to the SenSura One-Piece Closed Flat Baseplate (SAS code 9830J), currently listed in subgroup 1(b) of the SAS Schedule, be rejected due to inadequate evidence to support of the claim of product superiority.
- 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.
- 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.
CT#2