PUBLIC SUMMARY DOCUMENT
Product: Salts Confidence Natural Soft Convex Drainable 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 Drainable Pouch in Subgroup 2(b) of the Stoma Appliance Scheme (SAS) Schedule. The product, including 15 variants, was proposed for listing at the benchmark unit price of $6.373, with a maximum monthly quantity of 30 units.
2. Comparator
The applicant nominated one of its own products currently listed in Subgroup 2(b) of the SAS Schedule, the Salts Confidence (Supersoft) Convex Drainable Pouch (SAS code 9885G), as the comparator. This product is listed at the benchmark unit price of $6.373, 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 Drainable 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 drainable 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 2(b) 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 2(b) of the SAS Schedule, as indicated by bold and italicised text in the tables below:
Table 1: Group 2 - One-Piece Drainable(b) Convex Baseplate
Key Feature / Related Feature / Variant
Drainable Pouch / Pouch Filter / Protected dual carbon filter
Protected single carbon filter
Pouch Construction Material / 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
Table 2: Group 2 - One-Piece Drainable
(b) Convex Baseplate
Key Feature / Related Feature / Variant
Convex Baseplate / Baseplate Material / Hydrocolloid
Hydrocolloid with Aloe Vera
Baseplate Thickness / 0.7 mm
Baseplate Shape / Round
Oval
Oval with contouring spaces
Diamond
Oblong
Square
Triangle
Hexagon
Baseplate Skin Adhesion / Hydrocolloid self-adhesive
Hydrocolloid self-adhesive with tape border
Baseplate Wear Time / Standard
Baseplate Opening Type / Pre-cut
Cut-to-fit
Pre-cut mouldable
Baseplate Achieving Convexity / Rigid convex ring
Extra thick baseplate material
Firm baseplate material
Degree of Convexity / Shallow
Medium
Deep
Release Tabs / 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, skin condition and filter performance 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 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 Drainable Pouch is deemed to be equivalent to products currently available at the benchmark price in Subgroup 2(b) 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 2(b) 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 Drainable Pouch, including 15 variants, be listed in Subgroup 2(b) of the SAS Schedule at the benchmark unit price of $6.373, 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.
8. Applicant’s Comment
Ainscorp accepts the decision of the SPAP.
AI#2