PUBLIC SUMMARY DOCUMENT
Product: Esteem+ Mouldable Drainable Flat Pouch
Applicant: ConvaTec (Australia) Pty Ltd
Date of SPAP Meeting: 28 April 2014
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, ConvaTec (Australia) Pty Ltd, sought listing of the Esteem+ Mouldable
Drainable Flat Pouch in sub-group 2(a) of the Stoma Appliance Scheme (SAS) Schedule.
The product, including six variants, was proposed for listing at the benchmark unit price of
$4.674, with a maximum monthly quantity of 30 units.
2. Comparator
The application was for listing at the benchmark price, based on the presence of attributes as
defined for products in sub-group 2(a).
3. Background
This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.
4. Clinical Place for the Product
The proposed product provides an alternative for users requiring a one-piece drainable
pouch with flat baseplate. The product is a direct substitute for other pouches currently
available in sub-group 2(a).
5.
SPAP Comment
Clinical Analysis
The product’s features are highlighted in the table below. This table demonstrates that the
proposed product comprises the benchmark features for sub-group 2(a).
Table 1: Group 2 One-Piece Drainable – (a) Flat Baseplate
Key Feature: Drainable Pouch
Related Feature
Pouch Filter
Pouch Construction
Material
Variant
Protected dual carbon filter
Protected single carbon filter
Transparent with fabric backing
Transparent with fabric cover on both sides including viewing
window
Opaque with fabric backing
Opaque with fabric cover on both sides
Pouch Size
Extra small
Small
Medium
Large
Extra large
Belt Loops
No belt loops
Belt loops on each side of pouch
Belt loops on each side of baseplate
Pouch Closure Type
Integrated closure
Tap closure with plug
Headspace
Low headspace
Standard headspace
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Table 2: Group 2 One-Piece Drainable – (a) Flat Baseplate
Key Feature: Flat Baseplate
Related Feature
Baseplate Material
Baseplate Thickness
Baseplate Shape
Baseplate Skin Adhesion
Baseplate Wear Time
Baseplate Opening Type
Release Tabs
Variant
Hydrocolloid
Hydrocolloid with Aloe Vera
1.8 mm
Round
Oval
Oval with contouring spaces
Diamond
Oblong
Square
Triangle
Hexagon
Hydrocolloid self adhesive
Hydrocolloid self adhesive with tape border
Standard
Pre-cut
Cut-to-fit
Pre-cut mouldable
Release tabs
No release tabs
The Panel noted that the product includes a separate removable seal and a mouldable skin
barrier with reboundable memory technology, features which are unlikely to make the
product less effective than existing products in the sub-category.
It was noted that clinical advice may be required in the application of the removable seal.
Economic Analysis
As the Esteem+ Mouldable Drainable Flat Pouch is equivalent to products currently
available at the benchmark price in sub-group 2(a), a cost-minimisation analysis was
considered appropriate.
Financial Analysis
Listing of this product is recommended on a cost minimisation basis compared with the
notional benchmark product in sub-group 2(a) of the SAS Schedule. It is therefore unlikely
that there would be any budgetary impact for the SAS as a consequence of listing this
product under the conditions requested by the applicant.
6. SPAP Recommendation
The SPAP recommended that the Esteem+ Mouldable Drainable Flat Pouch, including six
variants, be listed in sub-group 2(a) of the SAS Schedule at a unit price of $4.674, with a
maximum monthly quantity of 30 units.
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.
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8. Applicant’s Comment
ConvaTec (Australia) Pty Ltd accepts the SPAP’s decision at this time.
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