The U.K.'s cost-effectiveness agency is accustomed to boos and hisses. The National Institute for Health and Care Excellence often turns down new treatments it considers too expensive for their payoff in patients. So, will a campaign by patient advocates sway its opinion on two new multiple sclerosis drugs?
NICE draft guidance recently shut out Biogen Idec's ($BIIB) drug Fampyra (dalfampridine), designed to improve walking in MS patients, and GW Pharmaceuticals' ($GWPH) Sativex, a cannabis-based oral spray for spasticity. Britain's MS Society wasn't happy--and now, it's teaming up with a group of neurologists and pain-management experts to fight the decision.
In a letter to the Daily Telegraph, the group claimed that NICE wants to block these "two potentially life changing MS treatments" that are "proven to be effective at helping people walk more easily and control painful muscle spasms." If NICE doesn't backtrack, patients will either have to pay for the drugs privately--or face the "agonizing daily frustration" of suffering while drugs that may help them remain out of their reach, the letter said.
For its part, NICE says that both drugs cost more than their benefits warrant. "[T]hey do not currently represent cost-effectiveness for the [National Health Service]," a spokesman told PharmaTimes.
Sounds like a plea for a discount on the drugs, which isn't unusual when NICE reviews new treatments. The agency often shuts out a new product on first analysis, but changes its mind after the drugmaker puts forth new data or new discounts--or both. In any case, the NICE spokesman said, the agency will allow the MS Society and other groups to critique the new guidelines.
The MS Society has been a vocal proponent of new drugs for the disease in the U.K., and it has had plenty of opportunity to voice its opinions lately. NICE initially turned away Sanofi's ($SNY) new oral treatment Aubagio (teriflunomide), but changed its mind after the French drugmaker cut the cost and offered new data analyses.
More recently, NICE backed Sanofi's Lemtrada (alemtuzumab), another new MS treatment, after initial skepticism. For that about-face, NICE won kudos from the MS Society, which called it "a major step forward in MS treatment."
Meanwhile, Biogen's Fampyra (sold as Ampyra in the U.S.) isn't the company's first MS drug to be turned away by NICE this year. The agency rebuffed Biogen's fast-selling new pill Tecfidera in February, saying the $26,680-per-year cost was too high. The MS Society is pressing NICE to change its mind on that drug, too.
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