PUBLIC SUMMARY DOCUMENT
Product: Welland Aurum 2 Two Piece Convex Baseplate with Mechanical Coupling
Applicant: Omnigon Pty Ltd
Date of SPAP Meeting: 17 & 18 August 2015
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, Omnigon Pty Ltd, sought listing of the Welland Aurum 2 Two Piece Convex
Baseplate with Mechanical Coupling in subgroup 4(c) of the Stoma Appliance Scheme
(SAS) Schedule. The product, including seven variants, was proposed for listing at the
benchmark unit price of $5.839, with a maximum monthly quantity of 20 units.
2. Comparator
The application was for listing at the benchmark price, based on the presence of attributes as
defined for products in subgroup 4(c).
3. Background
The proposed product provides an alternative for users requiring a two-piece baseplate with
mechanical coupling.
4. Clinical Place for the Product
The application is for listing at the benchmark price, based on the presence of attributes as
defined for products in subgroup 4(c).
5. SPAP Comment
Clinical Analysis
The Panel noted a post market surveillance study provided by the applicant that showed no
adverse changes to peristomal skin conditions as a result of using a hydrocolloid flange
infused with Manuka honey.
While this was not the product being proposed for listing it had the same composition and
was therefore considered relevant. However the Panel noted that the study was of only
thirteen subjects, and was therefore too small for the results to show any significance.
The applicant also provided a certificate of conformity showing that the product had been
tested and conformed to appropriate standards. This along with no reports of adverse effects
from use of Welland products containing Manuka honey was noted by the Panel.
The Panel requested that an update on adverse effects reported be provided in 12 months
and that a medical warning be included in the product packaging due to the risk of a
potential allergic reaction to honey.
Economic Analysis
Not undertaken.
Financial Analysis
Listing of this product is recommended on a cost minimisation basis compared with the
notional benchmark product in subgroup 4(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.
OG#19
6. SPAP Recommendation
The SPAP recommended that the Welland Aurum 2 Two Piece Convex Baseplate with
Mechanical Coupling, be listed in subgroup 4(c) of the SAS Schedule, at the unit price of
$5.839, including seven variants, 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 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
Omnigon Pty Ltd notes the comments in the SPAP’s recommendations, it does not agree
with the requirement for inclusion of a ‘medical warning’ in the packaging. This is based
on the data provided in the application demonstrating how well tolerated the product is on
ostomates skin.
OG#19