NHS cost regulators have asked for more information on Sanofi's Genzyme unit's multiple sclerosis drug Aubagio in order to better determine whether it is a cost-effective option for the condition.
In draft guidelines, the National Institute for Health and Care Excellence said it is minded not to recommend its use on the NHS, because there are "still questions to be answered about the effectiveness of the drug for adults with relapsing-remitting multiple sclerosis," said its chief executive Andrew Dillon.
Gaps in the information provided have made is difficult to pin down a cost-effectiveness estimate for Aubagio (teriflunomide), leaving NICE's independent Appraisal Committee to conclude that, based on the data available, it is likely to fall somewhere between 6,000 and £107,000 per QALY gained compared with Teva's injectable MS drug Copaxone (glatiramer).
Consequently, the Institute has requested a series of clarifications on the evidence provided, "to ensure that we have as much information as possible to make an informed final recommendation," Dillon explained.
Genzyme now has until October 8 to submit this information for review. Final guidance on the once-daily pill is expected in January next year.
Aubagio was given the green light in Europe earlier this month, having persuaded regulators of its potential to significantly reduce the annualised relapse rate and the time to disability progression.