Melbourne, Australia, 15 March 2019
Third meeting of Highly Specialised Technology Committee
CLINUVEL PHARMACEUTICALS LTD announced that it had met with the Highly Specialised Technology (HST) Committee of the English National Institute of Health and Care Excellence (NICE) in Manchester on 14 March (Greenwich Mean Time) as part of the ongoing evaluation of CLINUVEL’s drug SCENESSE® (afamelanotide 16mg).1
This constituted the third Committee meeting since 2017. The discussions centred around the grounds of appeal upheld by the NICE Appeal Panel in October 2018 and around the possibility of a Managed Access Agreement for SCENESSE® for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). The next steps will be for the HST Committee to issue a new Final Evaluation Document (FED). Timelines have not been disclosed.