NICE final ‘yes’ for Biogen’s MS pill
pharmafile | August 27, 2014 | News story | Sales and Marketing | Aubagio, Biogen, RMS, RRMS, gilenya
In final guidance published today NICE has recommended NHS funding of Biogen Idec’s new multiple sclerosis pill in patients with certain forms of the condition.
Tecfidera (dimethyl fumarate) is now recommended by the watchdog as a treatment option for patients with relapsing–remitting multiple sclerosis (RRMS).
But there are some limitations – the drug can only be used in RRMS patients if they do not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis.
And it can only be used if Biogen follows through on the agreed patient access scheme, which discounts the overall cost of the drug to the NHS. The price cut has not been made public.
The drug was initially spurned by NICE with its chief executive Sir Andrew Dillon saying in February that there were “still questions to be answered about the clinical and cost effectiveness of the drug”. The patient access scheme seems to have ended any of NICE’s doubts.
RRMS is a chronic, disabling, neurological condition that, as it progresses, can be life altering and have a substantial negative impact on quality of life and activities of daily living.
Professor Carole Longson, NICE’s health technology evaluation centre director, says: “We are very pleased to be able to recommend [Tecfidera] as an option for adults with relapsing-remitting multiple sclerosis.
“Evidence has shown that this drug is more effective in reducing relapse rates and just as effective in delaying disability progression compared with current similar treatments.
“Another advantage of [the drug] is that it is an oral treatment. It will be more convenient for patients to take than other currently available treatments, which must all be injected. It will help more people with multiple sclerosis to live a normal life.”
The prices of a pack of 120mg tablets (14 tablets per pack) and 240mg tablets (56 tablets per pack) are £343 and £1,373 respectively, although this may be cheaper given the patient access scheme.
The recommended dosage is 120mg twice daily in the first week of treatment and 240mg twice daily thereafter, and treatment continues as long as patients benefit clinically, or until they experience unacceptable adverse reactions.
Biogen is shoring up its status as the leading MS speciality company as just this month it also received FDA approval for its new fast-acting MS drug Plegridy (peginterferon beta-1a), which can be used with relapsing forms of multiple sclerosis (RMS).
Tecfidera was first approved in the US in March 2013 and quickly became the country’s number one prescribed oral therapy for relapsing forms of multiple sclerosis, despite being the third oral MS drug to reach the market behind Novartis’ Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide).
NICE currently recommends Aubagio and Gilenya and also recommends Biogen’s older injectable treatment Tysabri (natalizumab) for RRMS, although it will hope its latest medicines will eventually replace this treatment.
Ben Adams
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