PUBLIC SUMMARY DOCUMENT
Product:SenSura Magnum High Output Two Piece System
Applicant:Coloplast Pty Ltd
Date of SPAP Meeting:25 November 2014
- Proposed Listing on the Stoma Appliance Scheme
The applicant, Coloplast, sought the listing of two variants to the SenSura Magnum High Output Two-Piece System (SAS code 3734M) currently listed in Subgroup 11 on the Stoma Appliance Scheme (SAS) Schedule. The products are proposed for listing at the unit price of $16.39, with a maximum monthly quantity of 10 units.
- Comparator
Not required.
- Background
The current SenSura Magnum High Output Two-Piece System (SAS code 3734M) was listed 1 July 2013 on the SAS Schedule,Coloplastis requesting to extend the current product range.
- Clinical Place for the Product
The proposed product provides an alternative for users requiring a high output pouch. The product is a direct substitute for other pouches currently available in Subgroup11(a).
- SPAP Comment
Clinical Analysis
The Panel noted that the proposed products are an extension to the existing range, and are transparent with post-op outlets.
Economic Analysis
Not undertaken.
Financial Analysis
As the proposed products are a variation to the currently listed SenSura Magnum High Output Two-Piece System (SAS code 3734M), it is therefore unlikely that there would be any budgetary impact for the SAS as a consequence of listing these variants under the conditions requested by the applicant.
- SPAP Recommendation
The SPAP recommended that the two variants to SenSura Magnum High Output Two-Piece System (SAS code 3734M) be listed in sub-group 11(a) of the SAS Schedule at a unit price of $16.39, with a maximum monthly quantity of 10 units.
- 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
Coloplast Pty Ltd agrees with the SPAP’s recommendation contained in the Public Summary Document.
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