Product: B Braun Flexima Active One-Piece Closed Flat Pouch

PUBLIC SUMMARY DOCUMENT

Product: B Braun Flexima Active One-Piece Closed Flat Pouch

Applicant: Omnigon Pty Ltd

Date of SPAP Meeting: 29-30 July 2013

1. Proposed Listing on the Stoma Appliance Scheme

The applicant, Omnigon, sought listing of the B Braun Flexima Active One-Piece Closed Flat Pouch in Subgroup 1(b) of the Stoma Appliance Scheme (SAS) Schedule. The product (ten variants) was proposed for listing at the benchmark unit price of $2.735, with a maximum monthly quantity of 90 units.

1. Comparator

The application was for listing at the benchmark price,based on the presence of attributes as defined for products in Subgroup 1(b).

1. Background

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

1. Clinical Place for the Product

The product is a one-piececlosed pouch with a flat baseplate, suitable for use by people with a colostomy who have formed output.

1. SPAP Comment

Clinical Analysis

The SPAPnoted that the product contains the attributes of the notional benchmark product in Subgroup 1(b) of the SAS Schedule.

The Panel noted the application’sopening statement that peristomal skin complications (PSCs) are a constant issue for the majority of individuals with a stoma, and reaffirmed that PSCs are known and accepted by the SPAP to have both clinical and quality of life impact. It was noted that the Flexima Active rangecontains a new baseplate material formulation, SkinTech, that is claimed to offer ‘a unique wearing sensation’ and provide a low profile ‘second skin’ sensation to adapt to body contours and provide greater comfort due to the high flexibility of its gum. The SkinTech formulation in the B Braun Flexima Active One-Piece Closed Flat Pouchcontains 100% Styrene Isopropene Styrene (SIS)instead of Polyisobutylene (PIB). The application states that the inclusion of SIS in the baseplate provides immediate adhesion with low residue risk.

Clinical data provided by the applicant confirms that 75% of the 114 patients who participated in the post-market user evaluation stated that the product allowed for greater wearing comfort, more immediate adhesion and an absence of residue on pouch changes.

The Panel noted however thata potential toxicity issue (with particular regard to skin-related safety) may exist where listing a product containing a new baseplate formulation is concerned. It was the view of the Panel that this issue was not adequately addressed by the applicant.

In addition the Panel noted that data was presented by the applicant with specific regard to the performance of the new B Braun active protected filter contained within the product under consideration. The data compared the performance of the B Braun active protected filter to a number of other filters, including the Coloplast SenSura and the Hollister AF300. The Panel concluded that the evidence before it would suggest that the B Braun active protected filter was comparable in performance to the Coloplast SenSura filter (for which no price premium has been granted) and is not equal in performance to the Hollister AF300 filter (for which a unit price premium of $0.274 has been granted).

Economic Analysis

Not undertaken.

Financial Analysis

Listing of this product would be on a cost-minimisation basis compared with the notional benchmark product in Subgroup 1(b) of the SAS Schedule. There would therefore be no budgetary impact for the SAS as a consequence of listing this product under the conditions requested by the applicant.

1. SPAP Recommendation

In view of the potential skin-related safety implications of the new baseplate material formulation contained within this product, the SPAP recommended that listing of the product be deferred pending provision by the applicant of acceptable data pertaining to safety outcomes. Any study conducted in order to obtain such data should ideally run for a period of no less than four weeks.

In addition, the SPAP requestedevidence of conformity with Australian and European safety standards, including the results of biocompatibility tests – for example compliance with ISO-10993.

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 not to recommend 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 accepts the SPAP’s decision at this time.

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