Sanofi ($SNY) felt the sting of lost sales potential when the FDA nixed its multiple sclerosis treatment Lemtrada in December. But the EU sees things a bit differently, and now a new nod from Britain's cost watchdog has unlocked some new top-line potential.
In final guidance, the National Institute for Health and Care Excellence (NICE) has recommended Lemtrada as a treatment option on Britain's National Health Service, PharmaTimes reports, opening the drug up to a significant market. The drug will run £7,045 ($11,800) per 12-mg vial, or £56,360 ($94,430) for the full course of treatment, NICE said in a statement, though prices may vary because of negotiated discounts.
And it's not just the U.K. that follows NICE's decisions; many other countries look to the cost-effectiveness gatekeeper as they decide how to proceed with their own coverage and pricing.
It's especially welcome news for the French drugmaker, considering NICE's previous review at the end of last year. Uncertainty over Lemtrada's value led it to call in more information from Sanofi, PT notes.
But NICE isn't the only body that has had its doubts. The risk of side effects, including cancer and autoimmune diseases, led the FDA to stiff-arm the drug last winter, throwing $400 million of Lemtrada's $700 million peak sales estimate into question and setting it back behind oral competitors already on the U.S. market, such as Biogen Idec's ($BIIB) soaring Tecfidera.
Sanofi hasn't taken the FDA's verdict lying down, however; last month it offered a new analysis of its Phase III studies to try to sway FDA to change its mind. In the meantime, though, it will celebrate a NICE approval that Nick Rijke, director for policy and research at the MS Society in the U.K., called "a major step forward in MS treatment."
"This drug has taken decades to develop, and while it's not without risk, it's proven to be a highly effective medicine for people with relapsing remitting MS," he told PT.
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