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NICE ENGLAND UPDATE ON SCENESSE®

2 May 2017

CLINUVEL PHARMACEUTICALS LIMITED today announced that the Department of Health (DoH) has designated SCENESSE® (afamelanotide 16mg) to be evaluated as a Highly Specialised Technology (HST). The re-classification acknowledges that the National Institute for Health and Care Excellence (NICE) committed an error in its earlier assessment of SCENESSE® as only eligible for review under a Single Technology Appraisal (STA), a mainstream appraisal pathway.

The HST referral has been accepted by the UK Secretary of State for Health for the treatment of adult patients with the rare genetic disorder erythropoietic protoporphyria (EPP)1 and NICE’s timelines for the start of the drug’s formal review will be released shortly. Should NICE recommend SCENESSE® at the end of the HST appraisal it will then be made available for adult EPP patients under the National Health Service (NHS) in England.

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