PUBLIC SUMMARY DOCUMENT
Product: Dansac NovaLife One Piece Closed Flat with EasiView
Applicant: Dansac Pty Ltd
Date of SPAP Meeting: 25 November 2014
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, Dansac Pty Ltd, sought listing of the Dansac NovaLife One Piece Closed Flat
with EasiView in Subgroup 1(b) of the Stoma Appliance Scheme (SAS) Schedule. The
product, including 11 variants, was proposed for listing at the unit price of $3.009, inclusive
of a price premium of $0.274 over the benchmark unit price for Subgroup 1(b) ($2.735).
The applicant sought listing with a maximum monthly quantity of 90 units.
The price premium requested was for the AF300 filter.
2. Comparator
The applicant nominated one of its own products currently listed in Subgroup 1(b) of the
SAS Schedule, the Dansac NovaLife 1 Piece Closed Flat (SAS code 5672M), as the
comparator. This product is currently listed at the unit price of $3.009, inclusive of a $0.274
price premium.
3. Background
This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.
4. Clinical Place for the Product
The SPAP agreed that the proposed product provides an alternative for users requiring a
one-piece closed pouch with flat baseplate. The product is a direct substitute for the
comparator currently available in Subgroup 1(b).
5.
SPAP Comment
Clinical Analysis
The Panel noted that the proposed product contains the AF300 filter and is similar to the
Dansac Novalife 1 Piece Closed Flat. The main difference between the two products is the
additional viewing window ‘EasiView’ in the proposed product. The additional feature
provides ostomates the benefit of viewing their stoma or ensuring that their pouch is
correctly placed.
The SPAP has previously granted a price premium of $0.274 for the AF300 filter in closed
bags, therefore no evidence was provided on the performance of the filter.
DA#4
The SPAP was satisfied that the product contains the attributes of the notional benchmark
product in Subgroup 1(b) of the SAS Schedule, as indicated by bold and italicised text in the
table below:
Table 1: Group 1 – One Piece Closed (b) Flat Baseplate
Key Feature: Closed Pouch
Related Feature
Pouch Filter
Pouch Construction
Material
Pouch Size
Belt Loops
Headspace
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
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
Table 2: Group 1 – One Piece Closed (b) Flat Baseplate
Key Feature: Closed Pouch
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
1.1mm
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
Economic Analysis
The applicant proposed that utilisation of this product will be an alternative to that of the
comparator.
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Financial Analysis
Listing of this product is recommended on a cost minimisation basis against the comparator
product in Subgroup 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.
6. SPAP Recommendation
The SPAP recommended that the Dansac NovaLife One Piece Closed Flat with EasiView,
including 11 variants be listed in Subgroup 1(b) of the SAS Schedule at a unit price of
$3.009, inclusive of a price premium of $0.274 over the benchmark unit price for Subgroup
1(b) ($2.735), with a maximum monthly quantity of 90 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
Dansac accepts SPAP’s recommendation.
DA#4