PUBLIC SUMMARY DOCUMENT

Product: Corsinel Ostomy and Hernia Support Belt

Applicant:Statina Healthcare Australia Pty Ltd

Date of SPAP Meeting:16 October 2017

1.Proposed Listing on the Stoma Appliance Scheme

The applicant, Statina Healthcare Australia Pty Ltd, sought listing of the Corsinel Ostomy and Hernia Support Beltin subgroup 9(h) of the Stoma Appliance Scheme (SAS) Schedule. The product, including 42 variants, was proposed for listing at the unit price of $85.00with a maximum annual quantity of three units.

2.Comparator

The applicant nominatedOmnigon Stoma Support Belt (SAS code 3858C)as the comparator. This product is currently listed in subgroup 9(h) of the SAS Schedule at the unit price of $71.01 with a maximum annual quantity of three units. This product is listed with an R2 restriction – No authority for an increase in the yearly allocation can be granted.

3.Background

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

4.Clinical Place for the Product

The proposed product provides an alternative for users requiring an ostomy and hernia support belt.

5.SPAP Comment

Clinical Analysis

The Panel noted this product is a high support (compression) belt suitable to assist with hernias, available in varying sizes and offers a four way stretch to assist with adapting to the contours of the body.

Clinical advice to the Panel noted the applicant had not chosen the appropriate comparator for their application. The Panel agreed a more appropriate comparator would be the Omnigon Kool Knit (SAS Code 9753H), currently listed in subgroup 9(h) of the SAS Schedule at the unit price of $45.15.

The Panel also noted the applicant presented material supporting the use of belts in assisting hernias.However, no data was presented to compare the product with the nominated comparator therefore providing no justification for a higher price.

The Panel agreed, the Corsinel Ostomy and Hernia Support Belt should be listed with an
R2 restriction – No authority for an increase in the yearly allocation can be granted.

Economic Analysis

Not undertaken.

Financial Analysis

Listing of this product would be on a cost-minimisation basis compared to products currently listed in subgroup 9(h) 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.

6.SPAP Recommendation

The SPAP recommended that the Corsinel Ostomy and Hernia Support Belt, including
42 variants, be listed in subgroup 9(h) of the SAS Schedule at the unit price $45.15, with a maximumannualquantity of three units and an R2 restriction – No authority for an increase in the yearly allocation can be granted.

7.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.

8.Applicant’s Comment

Statina Healthcare Australia Pty Ltd does not agree with the SPAP recommendation and will resubmit with further evidence.

2017OCTST-01