PUBLIC SUMMARY DOCUMENT
Product: Medicina Grip-Lok ACE Stopper Dressing
Applicant: Australasian Medical & Scientific Ltd
Date of SPAP Meeting: 29 – 30 July 2013
- 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.
- Comparator
The applicant nominated its own product Medicina ACE Stopper Dressing (SAS code 9846F), as the comparator.
- Background
This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.
- 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 and 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 3-4 days compared to the daily use of the current product.
- 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.
The Panel noted that a clinical need for the proposed product may be argued, but without clinical evidence the Panelwas unable to determine whether or not the claim of the product lasting three to four days is supported.
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-four days clinical evidence is required. In the absence of evidence the Panel was unable to determine if the product could be listed on a cost minimisation basis.
Financial Analysis
Based on the lack of clinical evidence provided the Panel was unable to determine a cost saving.
- SPAP Recommendation
The Panel recommended thatlisting of the AMSLMedicina 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.
- 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.
- Applicant’s Comment
Australasian Medical & Scientific Ltd acknowledges the findings of the Panel. We do however disagree with these findings. We will be meeting with the Chair of the Panel, Professor Sansom, to further discuss the decision that was made.
AM#1