NICE Gives Nod to Biogen Idec’s MS Drug Tecfidera
The UK’s drug watchdog agency has recommended coverage of Biogen Idec’s oral multiple sclerosis drug Tecfidera, reversing its negative decision issued in February.
In a guidance, the National Institute for Health and Care Excellence (NICE) says Tecfidera (dimethyl fumarate) is an option for treating adults with active relapsing–remitting multiple sclerosis (i.e., normally defined as two clinically significant relapses in the previous two years) if the patients do not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis; and if the manufacturer provides the drug with a discount agreed to in its patient access scheme.
The recommended dosage of the drug is 120 mg twice daily in the first week of treatment and 240 mg twice daily thereafter. The prices of a pack of 120-mg tablets (14 tablets per pack) and 240-mg tablets (56 tablets per pack) are about $590 and $2,350, respectively.
Tecfidera is more effective in reducing relapse rates — and is as effective for disability progression — compared with disease-modifying therapies such as beta interferons and glatiramer acetate, according to the guidance.
The decision to recommend the drug comes after NICE issued draft guidance in February calling on the company to provide more information.
The NICE appraisal committee concluded there was insufficient evidence from the manufacturer to make recommendations for Tecfidera in rapidly evolving severe, and highly active, relapsing–remitting multiple sclerosis.
The FDA approved the drug for adults with relapsing-remitting MS last spring. Biogen Idec also received support last year from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for use of the drug in adults with relapsing-remitting MS. — Jonathon Shacat
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.