23 May 2018
CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that the English National Institute of Health and Care Excellence (NICE) maintained its position not to recommend CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) for reimbursement in England (see ASX announcement 21 December 2017). In its evaluation of novel medicinal therapies NICE advises the English National Health Service (NHS) whether a proposed therapy meets its economic criteria for reimbursement or not. CLINUVEL will now proceed to appeal the decision taken by NICE.
NICE published its draft Final Evaluation Document (FED) overnight, Australian time, and the Highly Specialised Technologies (HST) Committee of NICE maintained that SCENESSE® did not meet its health-economic criteria for reimbursement under the English NHS for the treatment of adult patients diagnosed with the ultra-rare genetic disorder erythropoietic protoporphyria (EPP).1 In December 2017 CLINUVEL announced that the HST Committee, in its preliminary assessment, did not recommend SCENESSE®. Pharmaceutical therapies recommended by NICE must be made available to patients under the NHS.
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