PUBLIC SUMMARY DOCUMENT
Product: Dansac NovaLife 1 Closed Soft Convex
Applicant: Dansac
Date of SPAP Meeting: 28 April 2014
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, Dansac, sought listing of the NovaLife 1 Closed Soft Convex pouch in subgroup 1(c) of the Stoma Appliance Scheme (SAS) Schedule. The product, including seven
variants, was proposed for listing at the unit price of $4.707, inclusive of a price premium of
$0.274 over the benchmark unit price for sub-group 1(c) ($4.433). The applicant sought
listing with a maximum monthly quantity of 60 units.
The price premium requested was for the AF300 filter.
2. Comparator
The applicant nominated the Dansac NovaLife One-Piece Closed Convex, listed in subgroup 1(c) of the SAS Schedule, as the comparator. This product is currently listed at the
unit price of $4.707, 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 proposed product provides an alternative for users requiring a one-piece closed pouch
with convex baseplate. The product is a direct substitute for other pouches currently
available in sub-group 1(c).
5.
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(c).
Table 1: Group 2 – One-Piece Closed – (c) Convex Baseplate
Key Feature: Closed Pouch
Related Feature
Pouch Filter
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
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
DA#2
Table 2: Group 2 – One-Piece Closed – (c) Convex Baseplate
Key Feature: Flat Baseplate
Related Feature
Baseplate Material
Baseplate
Thickness
Baseplate Shape
Baseplate Skin
Adhesion
Baseplate Wear
Time
Baseplate Opening
Type
Baseplate
Achieving
Convexity
Degree of
Convexity
Release Tabs
Variant
Hydrocolloid
Hydrocolloid with Aloe Vera
1.65 mm
Round
Oval
Oval with contouring spaces
Diamond
Oblong
Square
Triangle
Hexagon
Hydrocolloid self adhesive
Hydrocolloid self adhesive with tape border
Standard
Cut-to-fit
Pre-cut
Pre-cut mouldable
Rigid convex ring
Extra thick baseplate material
Firm baseplate material
Shallow
Medium
Deep
Release tabs
No release tabs
The SPAP noted that the product, which contains the AF300 filter, is similar to the
NovaLife One-Piece Closed Convex. The main differences between the two products are the
softer convex dish and the split fabric backing in the proposed product.
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. It was also noted
that no evidence was provided as to whether the performance of the product differs from
other products in sub-group 1(c).
Economic Analysis
The applicant proposed that utilisation of this product will replace that of the comparator.
As the product is equivalent to products at the same nominated price currently available in
sub-group 1(c), a cost-minimisation analysis was considered appropriate.
Financial Analysis
Listing of this product is recommended on a cost minimisation basis compared with the
nominated comparator product in sub-group 1(c) 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.
DA#2
6. SPAP Recommendation
The SPAP recommended that the NovaLife 1 Closed Soft Convex be listed in sub-group
1(c) of the SAS Schedule at a unit price of $4.707, 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
Dansac accepts the SPAP recommendation.
DA#2