PUBLIC SUMMARY DOCUMENT

Product: Salts Harmony Duo Convex Baseplate

Applicant: Ainscorp Pty Ltd

Date of SPAP Meeting: 29 – 30 July 2013

1.  Proposed Listing on the Stoma Appliance Scheme

The applicant, Ainscorp, sought listing of the Salts Harmony Duo Convex Baseplate in subgroup 4 (f) of the Stoma Appliance Scheme (SAS) Schedule. The product (nine variants) was proposed for listing at the benchmark unit price of $6.930, with a maximum monthly quantity of 20 units.

2.  Comparator

The Applicant did not nominate a comparator but stated that Salt Harmony Duo Convex Baseplate would be used as an alternative to any of the other convex baseplates currently listed on the SAS.

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 two-piece convex baseplate. The product is a direct substitute for other two piece convex baseplates currently available in subgroup 4(f).

5.  SPAP Comment

Clinical Analysis

The product’s features are highlighted in Table 1 below.

Table 1: Group 4 - Two-Piece Baseplate
(f) Adhesive Coupling – Convex
Key Feature / Related Feature / Variant
Convex Baseplate / Baseplate Material / Hydrocolloid
Hydrocolloid with Aloe Vera
Baseplate Thickness / 4 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 AND cut-to-fit variants
Pre-cut mouldable
Baseplate Achieving Convexity / Rigid convex ring
Extra thick baseplate material
Firm baseplate material
Degree of Convexity / Shallow
Medium
Deep
Baseplate Coupling / Adhesive coupling
Baseplate Flange / Rigid flange
Floating flange
Semi-floating flange
Belt Loops / No belt loops
Belt loops on each side of baseplate
Release Tabs / Release tabs
No release tabs

The SPAP was satisfied that the product contains the attributes of the notional benchmark product in subgroup 4(f) of the SAS Schedule. For this reason SPAP accepted that the proposed product’s function is equivalent to comparable products in subgroup 4(f) of the SAS Schedule.

Economic Analysis

As the Salts Harmony Duo Convex Baseplate is equivalent to products currently available at the benchmark price in subgroup 4(f), a cost-minimisation analysis was considered appropriate.

Financial Analysis

The applicant stated that listing the product at the benchmark price of $6.930 would provide a saving for the Government. This however, is not the case as the $8.82 price of all other products in subgroup 4(f) noted by the applicant is no longer the case as price premiums were removed in April 2013.

Listing of this product would be on a cost minimisation basis compared with the notional benchmark product in subgroup 4(f) of the SAS Schedule. There would therefore be no 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 Ainscorp Salts Harmony Duo Convex Baseplate (nine variants) be listed in subgroup 4(f) at the price of $6.930 per unit with a maximum monthly quantity of 20 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 not to recommend 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 SPAP’s recommendation.

AI#1