PUBLIC SUMMARY DOCUMENT
Product: Salts Confidence Natural Soft Convex Closed Pouch
Applicant: Ainscorp Pty Ltd
Date of SPAP Meeting: 8 November 2013
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, Ainscorp, sought listing of the Salts Confidence Natural Soft Convex Closed
Pouch in Subgroup 1(c) of the Stoma Appliance Scheme (SAS) Schedule. The product,
including 15 variants, was proposed for listing at the benchmark unit price of $4.433, with a
maximum monthly quantity of 60 units.
2. Comparator
The applicant nominated one of its own products currently listed in Subgroup 1(c) of the
SAS Schedule, the Salts Confidence (Supersoft) Convex Closed Pouch (SAS code 9861B),
as the comparator. This product is listed at the benchmark unit price of $4.433, with the
same maximum monthly quantity as that proposed by the applicant for the product under
consideration.
The selection of the Salts Confidence (Supersoft) Convex Closed Pouch as the comparator
product was accepted by the Stoma Product Assessment Panel (SPAP).
3. Background
This was the SPAP’s first consideration of this product.
4. Clinical Place for the Product
Clinical advice to the Panel indicated that the product would provide an effective alternative
to other closed convex pouches currently available on the Scheme.
5.
SPAP Comment
Clinical Analysis
As the application was for listing at the benchmark price based on the presence of the
attributes of the notional benchmark product as defined for Subgroup 1(c) of the SAS
Schedule, the SPAP’s analysis was conducted with reference to the notional benchmark
rather than with specific reference to the nominated comparator.
The SPAP was satisfied that the product contains the attributes of the notional benchmark
product in Subgroup 1(c) of the SAS Schedule, as indicated by bold and italicised text in the
tables below:
Table 1: Group 1 - One-Piece Closed
(c) Convex Baseplate
Key
Feature
Related Feature
Pouch Filter
Closed
Pouch
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
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Extra small
Small
Medium
Large
Extra large
No belt loops
Belt loops on each side of pouch
Belt loops on each side of baseplate
Low headspace
Standard headspace
Pouch Size
Belt Loops
Headspace
Table 2: Group 1 - One-Piece Closed
(c) Convex Baseplate
Key
Feature
Related Feature
Baseplate
Material
Baseplate
Thickness
Baseplate Shape
Convex
Baseplate
Baseplate Skin
Adhesion
Baseplate Wear
Time
Baseplate
Opening Type
Baseplate
Achieving
Convexity
Degree of
Convexity
Release Tabs
Variant
Hydrocolloid
Hydrocolloid with Aloe Vera
0.7 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
Rigid convex ring
Extra thick baseplate material
Firm baseplate material
Shallow
Medium
Deep
Release tabs
No release tabs
The Panel noted that results from a patient assessment encompassing a number of
parameters for data collection were presented, albeit without details regarding patient
baseline characteristics and usual product used. However, it was noted that the data
reported were selective in that results pertaining to important patient-relevant outcomes such
as leakage and skin condition were not provided.
The Panel reaffirmed its position that selective data reporting is not acceptable and noted
that as part of the upcoming development of SPAP guidelines on evidence requirements for
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listing on the Scheme, the attribute basis for benchmark listings will be revisited and data
requirements clarified.
Economic Analysis
As the Salts Confidence Natural Soft Convex Closed Pouch is deemed to be equivalent to
products currently available at the benchmark price in Subgroup 1(c) of the SAS Schedule, a
cost-minimisation analysis was considered appropriate.
Financial Analysis
Listing of this product would be on a cost-minimisation basis compared with the notional
benchmark product in Subgroup 1(c) 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.
6. SPAP Recommendation
The SPAP recommended that the Salts Confidence Natural Soft Convex Closed Pouch,
including 15 variants, be listed in Subgroup 1(c) of the SAS Schedule at the benchmark unit
price of $4.433, with a maximum monthly quantity of 60 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.
8. Applicant’s Comment
Ainscorp accepts the decision of the SPAP.
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