Product: Hollister New Image Ceraplus Flat Barrier

PUBLIC SUMMARY DOCUMENT

Product: Hollister New Image CeraPlus Flat 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 Flat Barrier in subgroup 4(b) of the Stoma Appliance Scheme (SAS) Schedule. The product including three variants, was proposed at the unit price of $4.742, with a maximum monthly quantity of 20 units.

2. Comparator The applicant nominated Hollister New Image Skin Barrier (SAS code 9903F) from its own range, which is currently listed in subgroup 4(b), as the comparator. This product is currently listed at a unit price of $4.742, 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 flat 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. Economic Analysis Not undertaken.

HO#5 Financial Analysis Listing of this product is recommended on a cost minimisation basis compared with the nominated comparator in subgroup 4(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 New Image CeraPlus Flat Barrier, be listed in subgroup 4(b) of the SAS Schedule at a unit price of $4.742, including three 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.