Flexima Key Two-Piece Urostomy Pouch with Adhesive Coupling ...

PUBLIC SUMMARY DOCUMENT
Product: Flexima Key Two-Piece Urostomy Pouch with Adhesive Coupling
Applicant: Omnigon Pty Ltd
Date of SPAP Meeting: 15 March 2012
1. Proposed listing on the Stoma Appliance Scheme
The applicant sought listing of its Flexima Key Two-Piece Urostomy Pouch with Adhesive
Coupling and proposed that a new subgroup, 7(b) – Two-Piece Urostomy with Adhesive
Coupling be created for the new listing. The product, including 6 variants, was proposed for
listing at a unit price of $4.410, with a maximum monthly quantity of 60 units.
It was noted that this price was based on the benchmark price for a two-piece drainable
pouch with adhesive coupling and following the full implementation of the Stoma
Appliance Scheme’s (SAS) new pricing methodology from 1 July 2012, the target price of
all two-piece drainable pouches, whether comprising a mechanical coupling or an adhesive
coupling will be $3.504.
2. Background
This was the Stoma Product Assessment Panel’s (SPAP) first consideration of this product.
3. SPAP Comment
SPAP agreed that the proposed product comprised the minimum set of features required for
a urostomy pouch, with the addition of an adhesive coupling.
Clinical Place for the Product
The proposed product provides an alternative for users requiring a urostomy pouch utilising
a two-piece system with an adhesive coupling. The product can be a direct substitute for
other two-piece urostomy pouches currently available under the SAS.
Clinical Analysis
The product’s features have been highlighted in Table 1 below.
This table demonstrates that the proposed product comprises all of the benchmark features
for Subgroup 7(a), with the addition of adhesive coupling.
Group 7 - Two-Piece Urostomy
(a) Mechanical Coupling
Key Feature Related Feature Variant
Two-Piece
Urostomy
Pouch
Valves
Pouch Construction
Material
Pouch Size
Belt Loops
Non-return valve single chamber
Non-return valve multi chamber
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
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Pouch Coupling
Pouch Closure
Type
Night Drainage
Headspace
Mechanical coupling
Mechanical coupling with lock
Mechanical coupling with tape border
Adhesive Coupling
Plug closure
Bendable tube into fixed plug closure
Tap closure with plug
Tap closure
Direct connection to drainage bag
Adapter for connection to drainage bag
Low headspace
Standard headspace
SPAP agreed that as the comparison indicated that the proposed product comprises the
requisite benchmark features for a Urostomy Pouch, a new Subgroup 7(b) – Two-Piece
Urostomy Pouch with adhesive coupling be created.
The new subgroup should include all of the related features and variants of 7(a) – Two-
Piece Urostomy Pouch with Mechanical Coupling, except for the related feature ‘pouch
coupling’. Instead the new subgroup should specify ‘adhesive coupling’ as a related feature.
SPAP also recommended that the benchmark price for the new subgroup, from 1 July 2012,
should be $3.504. This benchmark price will accord with the target price of all two-piece
drainable pouches, effective 1 July 2012.
Economic Analysis
As the Flexima Key Two-Piece Urostomy Pouch with Adhesive Coupling is equivalent to
other urostomy pouches currently available at the benchmark price, a cost-minimisation
analysis was considered appropriate.
Financial Analysis
There will be no impact on SAS expenditure as a consequence of listing this product.
4. SPAP Recommendation and Reasons
SPAP recommends that Omnigon’s Flexima Key Two-Piece Urostomy Pouch with
Adhesive Coupling, including 6 variants, be listed in Subgroup 7(b) at the benchmark price
of $3.504 per unit with a maximum monthly quantity of 60 units.
Listing is on a cost minimisation basis compared with other urostomy pouches listed on the
SAS Schedule.
5. Applicant’s Comment
Omnigon accepts the SPAP recommendation.
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