Cost regulators for the NHS in England and Wales are currently minded not to recommend the use of Sanofi's Lemtrada (alemtuzumab) for relapsing, remitting multiple sclerosis, because of gaps in the data submitted.
Lemtrada was approved in Europe in September, primarily on data from two Phase III studies showing that the drug was significantly more effective than Merck KGaA’s Rebif (subcutaneous interferon beta-1a) at reducing relapse rates.
Accumulation of disability was also significantly slowed in patients taking Lemtrada, and patients were significantly more likely to experience improvement in pre-existing disabilities versus Rebif.
However, in its cost-effectiveness appraisal of the drug, the National Institute for Health and Care Excellence found questions it needs answering in order to determine whether Lemtrada offers the NHS value for money.
Consequently, it has called on Sanofi's Genzyme unit to provide "a series of clarifications on the evidence submitted", and the drugmaker has until January 9 to do so.