Product: Medicina Grip-Lok ACE Stopper Dressing

PUBLIC SUMMARY DOCUMENT

Product: Medicina Grip-Lok ACE Stopper Dressing Applicant: Australasian Medical & Scientific Ltd Date of SPAP Meeting: 8 November 2013

1. Proposed Listing on the Stoma Appliance Scheme The applicant, Australasian Medical & Scientific Ltd, sought listing of the Medicina Grip- Lok ACE Stopper Dressing in Subgroup 9(l) on the Stoma Appliance Scheme (SAS) Schedule. The product was proposed for listing at a unit price of $10.41 with a maximum monthly quantity of ten units.

2. Comparator The applicant nominated its own product Medicina ACE Stopper Dressing (SAS code 9846F), as the comparator.

3. Background The Stoma Product Assessment Panel (SPAP) first considered this product at its July 2013 meeting. The Panel deferred this application pending receipt of additional evidence.

4. Clinical Place for the Product The proposed product is a latex-free, reusable Grip-Lok Ace Stopper Dressing, for use with the Medicina ACE Stopper. This allows users to open the velcro-type seal, remove the Ace Stopper , perform a washout and allow drainage. The skin around the Ace Stopper remains dry, the reduced number of applications of Ace Dressings helps to protect the skin and reduces redness and pain. The applicant claims that this product can remain in place for up to three to four days compared to the daily use of the current product.

5. SPAP Comment

Clinical Analysis The Panel noted that the application stated that patients using the current Ace Stopper and Ace Dressing may need to remove the dressing up to eight times a day to perform a washout or to drain. It is stated that each removal of the current product listed on the SAS, may lose its stickiness. The Grip-Lok Ace Stopper Dressing will enable patients to reseal the dressing rather than remove the dressing and each reusable dressing lasts for three to four days. It is also noted in the application that no clinical studies have been done on this product.

As in its previous assessment, the Panel noted that there may be a clinical need for this product. However, the supplementary evidence provided to the Panel was not sufficient to support the claim of the product lasting three to four days. The supplementary material provided consisted of a testimonial rather than utilisation data as requested.

Economic Analysis The applicant claims that the price for one months supply of the proposed product (10 units at $10.419 per unit) is the same as the price for one months supply of the current AMSL Medicina Ace Dressing (30 units at $3.473 per unit). In order to substantiate this evidence of the proposed product lasting three to four days clinical evidence is required. In the absence of appropriate evidence the Panel was unable to determine if the product could be listed on a cost minimisation basis.

AM#1 Financial Analysis Based on the lack of clinical evidence provided the Panel was unable to determine a cost saving.

6. SPAP Recommendation The Panel recommended that listing of the AMSL Medicina Grip-Lok ACE Stopper Dressing in Subgroup 9(l) on the SAS Schedule, be deferred pending receipt of sufficient clinical evidence that the product will last for three to four days as stated in the application.

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 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.

8. Applicant’s Comment AMSL notes the SPAP recommendation.