The day after its Lemtrada snub, NICE blesses Sanofi's Aubagio
Thursday, Sanofi's ($SNY) 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.
The decision from the National Institute for Health and Care Excellence (NICE) follows September draft guidance that raised questions about Aubagio's effectiveness as a first-line treatment in combination with beta interferons. The cost watchdog requested comparisons among drug combinations, like the cocktail of Aubagio, Merck Serono's Rebif and Teva's Copaxone versus Rebif and Copaxone alone.
It was apparently pleased with the results--and by the undisclosed price break Sanofi offered on the £13,529-per-year tag (about $22,100). As NICE noted in its guidance, the patient-access scheme is a simple discount applied to invoices or at the point of purchase, lacking the volume discounts or performance guarantees some drugmakers settle on to get their meds past NICE for reimbursement.
The recommendation provides a lift for Sanofi, which has been banking on its MS lineup to provide sales growth. Aubagio has already won blessings from FDA and EU regulators; it hit the U.S. market in September 2012, where it competes with oral rivals Gilenya from Novartis ($NVS) and the soaring Tecfidera from Biogen Idec ($BIIB).
Lemtrada, however, has so far not been as lucky. EU approval for the drug followed closely after Aubagio's, and Sanofi is now prepping for European launches of both. But less than a month before running up against NICE's request for more data, FDA staffers delivered a blow as they questioned whether Sanofi's trials of the drug proved a clinical benefit substantial enough to overlook "serious and potentially fatal safety issues."
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