In further draft guidance published today (December 1), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) says it has not been able to recommend Swiss drug major Novartis’ (NOVN: VX) Gilenya (fingolimod) that could reduce relapses in some people who have a particular type of multiple sclerosis. The guidance is open to consultation until January 5, 2012.
Based on the evidence submitted by Novartis, offering the drug would not be cost effective for the National Health Service, compared with the treatments that are already available for the condition, the agency said, noting that it has not yet issued guidance for the NHS.
The second appraisal consultation document provisionally does not recommend fingolimod for highly active relapsing-remitting multiple sclerosis (RRMS), a type of the condition characterized by periods when symptoms worsen and then improve. The second draft has been published following a proposed discount from Novartis (a Patient Access Scheme) to the price of fingolimod. The NICE’s independent appraisal committee has not been convinced that offering fingolimod would be a cost effective option for the NHS, even with this discount (which Novartis has asked to be kept confidential) when compared with treatments currently offered to people with highly active RRMS, such as beta interferons.
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