PUBLIC SUMMARY DOCUMENT

Product:New SenSura Mio One-Piece Closed Flat

Applicant:Coloplast Pty Ltd

Date of SPAP Meeting:28 April 2014

  1. Proposed Listing on the Stoma Appliance Scheme

The applicant, Coloplast, sought listing of the New SenSura Mio One-Piece Closed Flat pouch in sub-group 1(b) of the Stoma Appliance Scheme (SAS) Schedule. The product, including 10 variants, was proposed for listing at the benchmark unit price of $2.735, with a maximum monthly quantity of 90 units.

  1. Comparator

The application was for listing at the benchmark price, based on the presence of attributes as defined for products in sub-group 1(b).

  1. Background

This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.

  1. Clinical Place for the Product

The proposed product provides an alternative for users requiring a one-piece closed pouch with flat baseplate. The product is a direct substitute for other pouches currently available in sub-group1(b).

  1. 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 1(b).

Table 1: Group 1 - One-Piece Closed - (b) Flat Baseplate

Key Feature: Closed Pouch

Related Feature / Variant
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
Headspace / Low headspace
Standard headspace

Table 2: Group 1 - One-Piece Closed - (b) Flat Baseplate

Key Feature: Flat Baseplate

Related Feature / Variant
Baseplate Material / Hydrocolloid
Hydrocolloid with Aloe Vera
Baseplate Thickness / 1.3 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 / Cut-to-fit
Pre-cut
Pre-cut mouldable
Release Tabs / Release tabs
No release tabs

The New SenSura Mio One-Piece Closed Flat pouch is an updated version of the currently listed SenSura Mio product in sub-group 1(b).

Economic Analysis

The applicant stated that the product is expected to deliver additional value to that of existing products and that a price premium may be appropriate. However, due to evidence not yet being available they sought listing at the benchmark price.SPAP noted this statement.

Without additional evidence the New SenSura Mio One-Piece Closed Flat pouch is considered to be equivalent to products currently available at the benchmark price in sub-group 1(b), 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 1(b) 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.

  1. SPAP Recommendation

The SPAP recommended that the New SenSura Mio One- Piece Closed Flat pouch, including 10 variants, be listed in sub-group1(b) of the SAS Schedule at a unit price of $2.735, with a maximum monthly quantity of 90 units.

  1. 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.

  1. Applicant’s Comment

Coloplast appreciates the recommendation made by SPAP for listing the product at benchmark price, and will pursue premium price when superiority data becomes available.

CT#14