Biogen Idec's hot-selling multiple sclerosis drug Tecfidera has to win reimbursement in individual European countries where governments have gotten stingy about parting with healthcare dollars. A decision Thursday by U.K. price watchdog NICE is an indication of the cost hurdles to be faced.
The U.K.'s National Institute for Health and Care Excellence is known to change its mind. But this time, Britain's cost watchdog has set limitations on its recommendation for prostate cancer pill Xtandi--and maker Astellas is none too happy.
After a December flip-flop, the word from NICE on Sanofi's Aubagio is now final: The British cost watchdog has recommended the multiple sclerosis pill for use in Britain's National Health Service, tallying a victory for an MS franchise that has seen some recent ups and downs.
Thursday, Sanofi's multiple sclerosis drug Lemtrada was stymied by the U.K.'s cost-effectiveness gatekeeper, which asked for more data on the med before it could determine its worth. But just one day later, the regulatory body gave Sanofi's MS franchise a boost: It has recommended Aubagio, its oral treatment, for use in Britain's National Health Service.
Less than a month ago, Sanofi's multiple sclerosis treatment Lemtrada ran into problems with FDA staffers who were unconvinced of the drug's safety and efficacy. Now, it looks as if the U.K. may share some of those doubts. Its cost-effectiveness gatekeeper has asked the French pharma for more data, giving the company just over a month to submit the supplementary information.
U.K. officials are finally taking the wraps off their new drug-pricing plan. The pharma industry has been waiting for the update to go public--but branded drugmakers are likely to wish they could wait longer. Under the new 5-year agreement, drugmakers will suffer new spending caps beginning next year.
Plenty of drugmakers have grumbled about the U.K.'s cost-effectiveness gatekeepers. The National Institute for Health and Care Excellence does routinely reject new drugs, particularly unless--and until--their makers offer price breaks. But until now, no major drugmaker has threatened to stop investing in Britain unless NICE changes its game.
Xtandi, the prostate cancer drug from Astellas, is a pill, and that is a benefit to patients in the eyes of an independent committee for the U.K.'s price watchdog, NICE. But then, so is Johnson & Johnson's competitor Zytiga, which NICE has already approved. The difference is that Xtandi can be taken after eating, an advantage the makes it more convenient in the eyes of NICE evaluators who have favored its use in the U.K.
The U.K. drug price watchdog today gave Johnson & Johnson's Caelyx the distinction of being one of only two drugs it believes should be funded by the National Health System to treat recurring ovarian cancer.
The cancer drug fund has been an important safety valve for some drugmakers.