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Biogen Idec's ($BIIB) multiple sclerosis pill Tecfidera has been steamrolling since it hit the U.S. market last April. And now, it's poised to pad global sales with a victory in the U.K., whose cost watchdog has given it the OK in final guidance after flip-flopping on a February decision not to endorse the drug.
The National Institute for Health and Care Excellence (NICE) has recommended that Tecfidera be an option for adults with relapsing-remitting MS, but only for those whose disease is not highly active or rapidly evolving, PharmaTimes reports. Patients in that latter group already have access to other treatments, including rival pill Gilenya from Novartis ($NVS).
Biogen is "proud that we are able to bring this first-line cost-effective oral treatment to market with proven efficacy demonstrated through a robust clinical trials program," the company's managing director for the U.K. and Ireland, Terry O'Regan, said (as quoted by PT).
The decision represents a change of heart for NICE, which back in February said Tecfidera's cost--£16,000, or $26,680--didn't justify its benefits. But now, Biogen will be offering the drug under a so-called patient access scheme--a price break drugmakers often need to offer up to get past the cost-effectiveness gatekeeper.
The new guidance will boost the already-soaring newcomer, which snagged an EU nod in February after Biogen shored up patent protection on the continent. With approval and reimbursement on both sides of the pond, Tecfidera is set to keep its lead on oral rivals Gilenya and Sanofi's ($SNY) Aubagio, both of which beat it to market.
It's also set to ride its blistering sales streak to blockbuster land; after posting $876 million in 2013 sales, the drug will rake in $3.71 billion by 2020, EvaluatePharma predicts.
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