PUBLIC SUMMARY DOCUMENT
Product:B Braun Flexima 3S Fistulae
Applicant:Omnigon Pty Ltd
Date of SPAP Meeting:17 &18 August 2015
- Proposed Listing on the Stoma Appliance Scheme
The applicant, Omnigon Pty Ltd, sought listing of the B BraunFlexima 3S Fistulae pouch, in subgroup 11(a) of the Stoma Appliance Scheme (SAS) Schedule. The product including six variants was proposed at the unit price of $16.377, with a maximum quantity of 240 units per annum.
- Comparator
The applicant nominated OmnigonAlmarys Twin (SAS code 9973X) from its own range,which is currently listed in subgroup 11(a), as the comparator. This product is currently listed at the unit price of $16.377, with a maximum quantity of 240 units per annum.
- Background
This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.
- Clinical Place for the Product
The product is intended for independent use in application to low volume exudating wounds and fistulae. It could also potentially be used as a conduit for a flow collector in highly exudating situations.
- SPAP Comment
Clinical Analysis
The Panel noted the B BraunFlexima 3S Fistulae is a further development of the current Almarys Twin. The Panel noted that the proposed product has two types of mechanical coupling to ensure greater security, a traditional ‘Tupperware’ coupling system which provides an audible click, and ‘security points’ for additional attachment.
The product also contains the new protectedLaminar filter. While filter performance test results were provided, no price premium was sought and the Panel determined that the product appears to be ‘no worse than’ other products currently available in subgroup 11(a).
Economic Analysis
Not undertaken.
Financial Analysis
Listing of this product is recommended on a cost minimisation basis compared with the notional benchmark product in subgroup 11(a) 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.
- SPAP Recommendation
The SPAP recommended that the B BraunFlexima 3S Fistulae, be listed in subgroup 11(a) of the SAS Schedule at the unit price of $16.377, including six variants, with a maximum quantity of 240 units per annum.
- 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
Omnigon Pty Ltd agrees with SPAP’s recommendation contained in the Public Summary Document.
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