PUBLIC SUMMARY DOCUMENT
Product: New Image CeraPlus Convex Barrier
Applicant: Hollister
Date of SPAP Meeting: 17 & 18 August 2015
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, Hollister, sought listing of the New Image CeraPlus Convex Barrier in
subgroup 4(c) of the Stoma Appliance Scheme (SAS) Schedule. The product including
seven variants, was proposed at the unit price of $5.839, with a maximum monthly quantity
of 20 units.
2. Comparator
The applicant nominated New Image Skin Barrier (SAS code 9941F) from its own range
which is currently listed in subgroup 4(c) as the comparator. This product is currently listed
at a unit price of $5.839, with a maximum monthly quantity of 20 units.
3. Background
This was the Stoma Product Assessment Panel (SPAP)’s first consideration of this product.
4. Clinical Place for the Product
The product is a convex baseplate with a mechanical coupling mechanism suitable for use as
part of a two-piece ostomy appliance system.
5.
SPAP Comment
Clinical Analysis
The Panel noted the proposed product barrier is infused with ceramide-2, a naturally
occurring lipid in the skin. It is designed to help protect the skin’s natural moisture barrier
and may decrease transepidermal water loss from damaged or eroded skin.
The Panel noted the clinical reports provided included; a case study of four patients, a
survey of patients and clinicians and information on the impact of peristomal skin
complications. The Panel agreed that these reports did not contain comparative data to
justify a claim for superiority.
The Panel also noted that the difference between this new range and the existing Hollister
New Image range is the inclusion of Ceramide in the baseplate. The Panel agreed that a
potential toxicity issue (with particular regard to skin related safety) may exist where
considering listing of a product containing a new baseplate formulation. The applicant
provided evidence that states a Danish study offered further support for the discrepancy
between nurse and client identification of a peristomal skin complication (PSC), in the
report 80% of people diagnosed with peristomal skin disorders did not seek professional
care.
Another study of 43 adults provides additional evidence for early complications by showing
that PSCs most frequently occurred in the 21 to 40 day post-operative time period. Effluent
leakage is a common cause of PSCs, the evidence stated numerous studies again done in
Denmark and the United Kingdom, it stated that a study of 202 Danish people with a
perminant stoma, 77% of peristomal disorders were related to contact with the stoma
effluent. In a study of 325 individuals with an ostomy in the UK, eight had skin problems
caused by bacterial, viral, or fungal infections. It was the view of the Panel that this issue
was not adequately addressed by the applicant.
The Panel noted the supplementary information provided by the applicant adequately
addressed the Panel’s concerns pertaining to safety outcomes.
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Economic Analysis
Not undertaken.
Financial Analysis
Listing of this product is recommended on a cost minimisation basis compared with the
nominated comparator 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.
6. SPAP Recommendation
The SPAP recommended that the New Image CeraPlus Convex Barrier, be listed in
subgroup 4(c) of the SAS Schedule at a 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
Hollister agrees with SPAP’s recommendation contained in the Public Summary Document.
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