PUBLIC SUMMARY DOCUMENT
Product:Esteem+ InvisiClose One-Piece Drainable Convex Pouch
Applicant:ConvaTec (Australia) Pty Ltd
Date of SPAP Meeting:28 April 2014
- Proposed Listing on the Stoma Appliance Scheme
The applicant, ConvaTec, sought the addition of a price premium to a product currently listed in Subgroup 2(b) of the Stoma Appliance Scheme (SAS) Schedule, the Esteem+ InvisiClose One-Piece Drainable Convex Pouch (SAS code 5699Y). The applicant proposed a unit price inclusive of a price premium over the benchmark unit price for Subgroup 2(b) ($6.373).
The price premium requested was for the product’s filter and the ‘InvisiClose with Lock-It Pocket’ feature.
- Comparator
The applicant nominated one of its own products listed in Subgroup 2(b) of the SAS Schedule, the Esteem InvisiClose One-Piece Drainable Convex Pouch (SAS code 9961G), as the comparator. This product is currently listed at the benchmark unit price of $6.373.
- Background
The product, including 14 variants, has been listed in Subgroup 2(b) of the SAS Schedule at the applicable benchmark unit priceand with a maximum monthly quantity of 30, since 1January 2012. This is the Stoma Product Assessment Panel (SPAP)’s first consideration of this product for a price premium.
- Clinical Place for the Product
The product is a one-piece drainable appliance with a convex baseplate suitable for use by people with an ileostomy.
- SPAP Comment
Clinical Analysis
The SPAP considered the applicant’s argument about the impact of filter qualities on quality of life to be sound and accepted. The SPAP noted that the applicant questioned the higher value placed on filter qualities in one-piece closed as opposed to two-piece or drainable appliances (the price premium previously granted for the AF300 filter being $0.274 in one-piece and $0.205 in two-piece and drainable appliances). However, clinical advice on the Panel indicates that there are alternative ways to reduce ballooning in two-piece and drainable appliances.
The SPAP noted that the applicant presented the results of laboratory tests indicating the superior performance of the Esteem+ over the Esteem filter. Given the partial basis of the applicant’s request for a price premium on the Esteem+ filter, the SPAP considered its performance in relation to the AF300 filter to be relevant. As per evidence previously presented to the Panel, average filter deodorisation time for the AF300 filter under a hydrogen sulphide gas challenge is 750 minutes, in comparison with 563 minutes for the Esteem+ filter.
The SPAP then considered the results of a user evaluation presented by the applicant in which previous users of Esteem products participated in a seven day trial of Esteem+ products. It was noted that the number of participants involved (six) was very small and may have been selective (i.e. ostomates experiencing problems with odour and/or leakage). It was unclear how recently these participants had used the comparator products and therefore to what degree issues of reliance on memory would have been present, and results were not reported appropriately as a proportion of sample size (as opposed to a proportion of a selection of responses).
The Panel considered the argument made by the applicant regarding the importance of secure and discreet closures on drainable appliances to be reasonable. However the Panel were unable to interpret the results of laboratory data pertaining to the security of the Esteem+ closure as the comparator product(s) was/were unknown. It was not specified whether the comparator pouches consisted of multiple different product brands with different closure mechanisms or multiple pouches of a single brand/closure type.
The SPAP noted that in relation to the Lock-It Pocket feature forming part of the Esteem+ closure mechanism, 23% of 30 user evaluation responses (rather than sample size) indicated a preference for Esteem+, 37% indicated a preference for Esteem and 40% claimed that there was no difference between the two. These results were not supportive of the applicant’s case for a price premium.
The SPAP noted that the applicant did not specify the discrete premium amounts sought for each feature, and that this is essential information in the assessment of any application for a price premium.
Economic Analysis
The Panel noted that in presenting a cost-effectiveness analysis, the applicant cited patient preference/satisfaction figures of 10/16 for Esteem+ and 6/16 for Esteem products, representing a 25% difference in patient preference/satisfaction. Whether these figures were based on one or both features for which the applicant requested a price premium was unclear.
The Panel noted that the applicant had presenteda cost per additional patient who preferred Esteem+ over Esteem products as an incremental cost-effectiveness ratio (ICER). The Panel considered this to be a misunderstanding of the concept of ‘health benefit’. An example of an appropriate measure would be Quality Adjusted Life Years.
Financial Analysis
Not undertaken.
- SPAP Recommendation
The SPAP recommended that the applicant’s request for the application of a price premium to the Esteem+ InvisiClose One-Piece Drainable Convex Pouch (SAS code 5699Y), currently listed in Subgroup 2(b) of the SAS Schedule, be rejected due to inadequate evidence to support the claim of product superiority.
- 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
ConvaTec (Australia) Pty Ltd accepts the SPAP’s decision at this time.
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