PUBLIC SUMMARY DOCUMENT

Product:Brava Elastic Tape (Straight and Belt)

Applicant:Coloplast Pty Ltd

Date of SPAP Meeting:25 November 2014

  1. Proposed Listing on the Stoma Appliance Scheme

The applicant, Coloplast, sought the listing of two variants to Brava Elastic Tape (SAS code 3897D) currently listed on the Stoma Appliance Scheme (SAS) Schedule. The variants proposed were Brava Tape Straight and Brava Tape Belt, at the unit price of $29.16, with a maximum monthly quantity of 60 units.

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  1. Comparator

No comparator was required as the Brava Elastic Tape (SAS code 3897D) is currently listed on the SAS Schedule. The applicant proposes to list two variants, the Brava Tape Straight and Brave Tape Belt, with a maximum monthly quantity of 60 units.

  1. Background

The current Brava Elastic Tape (SAS code 3897D)was first listed on 1 July 2012 on the SAS Schedule,Coloplastis requesting to extend the current product range.

  1. Clinical Place for the Product

The proposed productswill provide an alternative for users requiring the useof elastic tape for their stomas.

  1. SPAP Comment

Clinical Analysis

The Panel noted the two variants to the product Brave Elastic Tape. Brava Tape Straight is designed to ensure the edges of square baseplates do not lift, and Brava Tape Belt is also an elastic tape which will provide added protection to patients with outward areas such as hernias.

The Panel also noted the applicant’s claims that these products will follow natural body movements while keeping the baseplate in place. The applicant also advises that there will be no additional cost to the SAS Schedule as ostomates will either continue with the current listed Brava Elastic Tape or change to one of the different shapes.

Economic Analysis

Not undertaken.

Financial Analysis

As the proposed products are a variation to the currently listed Brava Elastic Tape (SAS code 3897D), 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.

  1. SPAP Recommendation

The SPAP recommended that the two variants Brava Tape Straight and Brave Tape Belt to the currently listed Brava Elastic Tape (SAS code 3897D), be listed on the Stoma Appliance Scheme (SAS) Schedule at unit price of $29.16, with a maximum monthly quantity of 60 units.

However, the Panel noted that all recommendations for products to be listed in Group 9 of the SAS Schedule may be subject to change as a result of the outcomes from the Group 9 Review. The outcomes of the Group 9 Review are expected in 2015.

  1. 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.

  1. Applicant’s Comment

Coloplast Pty Ltd agrees with the SPAP’s recommendation contained in the Public Summary Document.

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