NICE Requests Further Information on Genzyme’s Lemtrada
The regulatory body for the NHS in England and Wales has requested additional information from Genzyme prior to making a decision on the submission of Lemtrada.
The National Institute for Health and Care Excellence (NICE) are currently unlikely to recommend the use of Genzyme’s Lemtrada (alemtuzumab) for relapsing, remitting multiple sclerosis, as a result of gaps in the clinical data which was submitted.
Lemtrada was approved by the European regulatory body in September this year, primarily from data collect in two Phase III clinical studies, which showed that Lemtrada 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 NICE’s evaluation of the cost-effectiveness of the drug, the National Institute for Health and Care Excellence found questions they need answering to determine whether Lemtrada offers value for money for the NHS.
As a result, the regulatory body have called on Genzyme to submit “a series of clarifications on the evidence submitted,” by January 9th 2014.