Final guidance: NICE recommends Biogen Idec's Tecfidera for RRMS
- The National Institute for Health and Care Excellence (NICE) had previously rejected Tecfidera (dimethyl fumarate) in February, citing clinical and cost concerns. NICE has now reversed course, but the agency specified that Tecfidera can only be used to treat relapsing-remitting multiple sclerosis (RRMS) in patients who do not have highly active or rapidly evolving RRMS.
- Another stipulation requires that Biogen Idec put a patient access scheme in place to lower the overall cost of the drug to National Health Services (NHS).
- Tecfidera is an oral treatment option for MS, unlike most other treatments which require injections.
NICE has continually expressed concerns over Tecfidera's price. But Biogen’s commitment to implementing a patient access scheme helped convince the agency to reverse course and approve it. Recommended dosing is 120 mg twice daily for the first week, followed by 240 mg twice daily after the first week.
So how much will the treatment run you? A 14-tablet pack of 120-mg tablets costs roughly $569 and covers the first week of therapy, while a 56-tablet pack of 240-mg tablets costs roughly $2277 and covers four weeks of treatment. The goal of the patient access scheme is to bring this cost down to a more manageable level for government payers like the NHS, and in turn, make it more affordable for patients.
Clinical evidence has clearly shown that Tecfidera is more effective than similar treatments in reducing relapse rates and delaying progression of MS-related disability.
- pharmafile.com NICE final ‘yes’ for Biogen’s MS pill