NICE still developing Orphan drug methodology

David Haslam, new chairman of the National Institute for Health and Care Excellence, told BioCentury on Tuesday that the agency recognizes that its existing methodology for the cost utility analysis of drugs doesn't fit the Orphan drug model. On Monday, NICE officially took over responsibility for assessing Orphan drugs for use on the NHS from the Advisory Group for National Specialised Services. Haslam told BioCentury NICE is still developing a methodology for assessing Orphan drugs, and that NICE would seek public consultation on the draft methodology once it was available. He did not disclose a timeline for when the methodology might be published for consultation.

Additionally, Haslam told BioCentury that the U.K. Department of Health has not communicated with NICE regarding the framework for the U.K.'s proposed value-based pricing (VBP) scheme. He said NICE has asked the department for details, but so far "knows as much as is publicly available." Last month, the department said NICE would be responsible for conducting drug value assessments under value-based pricing (see BioCentury Extra, March 21). ...