PUBLIC SUMMARY DOCUMENT

Product: Salts Confidence Wound and Fistula Pouch (Medium)

Applicant: Ainscorp Pty Ltd

Date of SPAP Meeting: 8 November 2013

  1. Proposed Listing on the Stoma Appliance Scheme

The applicant, Ainscorp, sought listing of the Salts Confidence Wound and Fistula Pouch (Medium) in Group 11 of the Stoma Appliance Scheme (SAS) Schedule. The product (one variant) was proposed for listing at a unit price of $17.188, with a maximum monthly quantity of 10 units.

  1. Comparator

The applicant nominated an Omnigon product listed in Group 11 of the SAS Schedule, the Eakin Wound Pouch (Medium) (SAS code 9839W), as the comparator. This product is listed at the same unit price and with the same maximum monthly quantity as that proposed by the applicant for the product under consideration.

  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 intended for independent use in application to low volume exudating wounds and fistulae, though its use in the context of the SAS would be restricted to fistulae. It could also potentially be used as a conduit for a flow collector in highly exudating situations.

  1. SPAP Comment

Clinical Analysis

Clinical advice to the Panel highlighted the product’s wafer thin baseplate as representing a substantial difference in quality compared to the Omnigon Eakin product, which the Panel considered to be a valid comparator. It was considered that the proposed product’s baseplate may not be adequately robust to withstand fistula output, which is extremely corrosive in nature. This was a critical concern in the view of the Panel due to its potential to compromise user security.

Additionally, the Panel noted that there is no apparent clinical value associated with the

no-return valve feature as the pouch is gravity drainable, and that the product’s plug-and-cap outlet could be easily (and inadvertently) detached.

Finally, it was noted that a claim of non-inferiority to the comparator product was made by the applicant, but that no supporting comparative data – only six case studies – were presented. The Panel noted that these case studiesof patients with exudating wound(s) or fistula(e) – often in association with laparotomy – were complex and in some cases extreme, involving various management challenges and comorbidities including the presence of skin creases/folds/scarring/trauma, close proximity of stomas and drain sites, extremely high volume output, high frequency dressing changes, multiple successivesurgeries and poor physical status. It was therefore the view of the Panel that they may not have been representative of the wider patient population that would constitute potential users of the proposed product. Furthermore, clinical advice to the Panel indicated that these were cases in which the use of any drainable appliance may have been of benefit. The Panel was therefore unable to assess the applicant’s claim of non-inferiority.

Economic Analysis

A cost-minimisation analysis with reference to the selected comparator was not conducted as for the reasons stated above, the Panel was unable to establish the clinical equivalence of the proposed product and its comparator.

Financial Analysis

As listing of this product is not being recommended at this stage, budgetary impact for the SAS was not considered.

  1. SPAP Recommendation

The SPAP recommended that the application to list the Salts Confidence Wound and Fistula Pouch (Medium) in Group 11 of the SAS Schedule be deferred on the basis of clinical advice to the Panel indicating that the product may be worse in operation than its comparator. The applicant is invited to provide data to address the Panel’s concerns in relation to the quality of the pouch’s hydrocolloid backing in view of the highly corrosive nature of fistula output.

  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

Ainscorp accepts the decision of the SPAP.

AI#5