PUBLIC SUMMARY DOCUMENT
Product:Welland Hyperseal Washer with Manuka Honey
Applicant:Omnigon Pty Ltd
Date of SPAP Meeting:17 & 18 August 2015
- Proposed Listing on the Stoma Appliance Scheme
The applicant, Omnigon, sought listing of the product Welland Hyperseal Washer with Manuka Honey, in subgroup 9(l) of the Stoma Appliance Scheme (SAS) Schedule. The product,including six variants, was proposed for listing at the unit price of $4.532with a maximum monthly quantity of 30 units.
- Comparator
The applicantnominated Cohesive Seal(SAS code 3672G) from its own range which is currently listed in subgroup 9(l) as the comparator. This product is currently listed at a unit price of $4.532, with a maximum monthly quantity of 30 units.
- Background
This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.
- Clinical Place for the Product
Clinical advice to the Panel indicated that the product would represent a valuable addition to the range of seals currently available on the Scheme, which are useful in the context of oval and odd-shaped stomas.
- SPAP Comment
Clinical Analysis
The Panel noted that the proposed product is the same as the comparator, apart from the addition of Manuka honey. The Panel noted a post market surveillance study provided by the applicant that showed no adverse changes to peristomal skin conditions as a result of using a hydrocolloid flange infused with Manuka honey.
While this was not the product being proposed for listing it had the same composition and was therefore considered relevant. However the Panel noted that the study was of only thirteen subjects, and was therefore too small for the results to show any significance.
The applicant also provided a certificate of conformity showing that the product had been tested and conformed to appropriate standards. This along with no reports of adverse effects from use of Welland products containing Manuka honey was noted by the Panel.
The Panel requested that an update on adverse effects reported be provided in 12 months and that a medical warning be included in the product packaging due to the risk of a potential allergic reaction to honey.
Economic Analysis
Not undertaken.
Financial Analysis
Listing of this product would be on a costminimisation basis compared with the nominated comparator product in Subgroup 9(l) of the SAS Schedule. It is therefore not expected that there would be any budgetary impact for the SAS as a consequence of listing this product under the conditions requested by the applicant.
- SPAP Recommendation
The SPAP recommended that the WellandHyperseal Washer with Manuka Honey, be listed in subgroup 9(l) of the SAS Schedule at the unit price of $4.532,including six variants, with a maximum monthly quantity of 30 units.
However, the Panel noted that all recommendations for products to be listed in Group 9 of the SAS Schedule, may be subject to change as a result of the outcomes from the Group 9 Review. The outcomes of the Group 9 Review are expected in 2015.
- 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.
- Applicant’s Comment
Whilst OmnigonPtyLtd notes the comments in the SPAP’s recommendations, it does not agree with the requirement for inclusion of a ‘medical warning in the packaging’. This is based on the data provided in the application demonstrating how well tolerated the product is on ostomates skin.
OG#23