PUBLIC SUMMARY DOCUMENT

Product:Welland Aurum 2- Two Piece Urostomy with Mechanical Coupling

Applicant:Omnigon Pty Ltd

Date of SPAP Meeting:17 & 18 August 2015

  1. Proposed Listing on the Stoma Appliance Scheme

The applicant, Omnigon, sought listing of the product Welland Aurum 2urostomy pouch, in subgroup 7(a) of the Stoma Appliance Scheme (SAS) Schedule. The productincluding four variants was proposed for listing at the unit price of $3.504, with a maximum monthly quantity of 60 units.

  1. Comparator

The applicantnominated Almarys Twin Plus (SAS code 3835W) from its own range which is currently listed in subgroup 7(a) as the comparator. This product is currently listed at a unit price of $3.504, with a maximum monthly quantity of 60 units.

  1. Background

This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.

  1. Clinical Place for the Product

The proposed product provides an alternative drainable pouch for use with a mechanical coupling baseplate as part of a two-piece system. This product is a direct substitute for other pouches currently available in subgroup7(a) and is suitable for use by people with aurostomy.

  1. SPAP Comment

Clinical Analysis

The Panel noted the proposed product part of a new two piece range which is an extension to the current Aurum One Piece range. The Panel also noted the features of the proposed product, include mechanical coupling via a flexible rim and adhesive ring. Clinical advice to the Panel noted that these features added dual security for users.

The proposed product is considered to be equivalent to products currently available at the benchmark price in subgroup 7(a).

Economic Analysis

Not undertaken.

Financial Analysis

Listing of this product would be on a costminimisation basis compared with the nominated comparator product in Subgroup 7(a) of the SAS Schedule. It is therefore not expected 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 Welland Aurum 2 urostomy pouch, be listed in subgroup7(a) of the SAS Schedule at the unit price of $3.054,including four variants, with a maximum monthly quantity of 60 units.

  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

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

OG#10