Download CC#12 ConvaTec Sur-Fit Autolock Two

PUBLIC SUMMARY DOCUMENT
Product: Sur-Fit AutoLock Two-Piece Closed Pouch with Mechanical Coupling
Applicant: ConvaTec (Australia) Pty Ltd
Date of SPAP Meeting: 28 April 2014
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, ConvaTec, sought the maintenance of a price premium currently applied to a
product listed in Subgroup 5(a) of the Stoma Appliance Scheme (SAS) Schedule, the Sur-Fit
AutoLock Two-Piece Closed Pouch with Mechanical Coupling (SAS code 3780Y). The
applicant proposed a unit price inclusive of a price premium over the benchmark unit price
for Subgroup 5(a) ($1.564).
The price premium requested was for the Sur-Fit AutoLock feature (described by the
applicant as a ‘one touch security system’).
2. Comparator
The applicant nominated a Coloplast product listed in Subgroup 5(a) of the SAS Schedule,
the Coloplast Alterna Comfort Two-Piece Closed Pouch with Mechanical Coupling (SAS
code 3813Q), as the comparator. This product is currently listed at the benchmark unit price
of $1.564.
3. Background
The product was originally listed prior to 2011. Following the introduction of the new SAS
pricing framework on 1 July 2011, it was listed at a unit inclusive of a price premium of
$0.646 over the benchmark unit price.
4. Clinical Place for the Product
The product is a closed pouch with a mechanical coupling mechanism for use in conjunction
with a mechanical coupling baseplate as part of a two-piece system. It is suitable for use by
people with a colostomy.
5.
SPAP Comment
Clinical Analysis
The SPAP noted that the application discussed the importance to users with limited
dexterity of being able to easily and securely attach two-piece systems, and stated that
security and leakage are issues relevant to the user. The SPAP considered these assertions
to be reasonable.
The SPAP noted that the evidence presented by the applicant to support the claim of product
superiority consisted of a single cross-over study (CC-0175-97-A606) comparing the
ConvaTec MK 4 (which the Panel presumed to be the Sur-Fit AutoLock marketed under
another name overseas) with the Coloplast Assura (Alterna – ie. the nominated comparator
product). This study involved 45 users and had a primary endpoint of patient preference.
Secondary endpoints included the pouch to baseplate connection, the pressure needed to
apply the pouch to the baseplate, the ease of application/removal of the pouch and the
profile of the flange under normal wearing conditions. Each user was asked to evaluate two
of each brand of system, meaning a total of 4 systems evaluated per user. Data from 44
users was included in the subsequent analysis.
The Panel noted that the results from study CC-0175-97-A606 appeared to favour the
ConvaTec system. The Panel noted the difference in the primary endpoint of user
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preference, where 75% preferred ConvaTec and 23 % preferred Coloplast (with 2%
claiming equivalence), and that this result was used as the basis for the applicant’s economic
evaluation. However, the Panel considered that while user preference is important, as the
basis of a premium request in the absence of information on the clinical manifestation of
any enhanced security (in terms of, for example, the patient-relevant outcomes of a
reduction in leakage and/or appliance failure, and increased wear time defined by when the
system is removed on the basis of clinical need as opposed to a routine change) it is not
adequately meaningful.
Economic Analysis
The Panel noted that the applicant based their cost-effectiveness analysis on the difference
in user preference rates for the ConvaTec and Coloplast systems. The Panel considered this
to be a misapplication of the ICER as the value derived was not directly linked to the
concept of ‘health benefit’. An example of an appropriate measure of health benefit would
be Quality Adjusted Life Years.
Financial Analysis
Not undertaken.
6. SPAP Recommendation
The SPAP recommended that the applicant’s request for the maintenance of a $0.646 unit
price premium as currently applied to the Sur-Fit AutoLock Two-Piece Closed Pouch with
Mechanical Coupling (SAS code 3780Y) which is listed in Subgroup 5(a) of the SAS
Schedule, be rejected due to inadequate evidence to support the claim of product superiority.
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
ConvaTec (Australia) Pty Ltd accepts the SPAP’s decision at this time.
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