NICE Recommends Genzyme’s Multiple Sclerosis Treatment

The UK’s National Institute for Health and Care Excellence (NICE) issued final guidance recommending Sanofi-owned Genzyme's Lemtrada (alemtuzumab) to be reimbursed by the National Health Service, for treatment of adults with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

A Final Appraisal Determination issued earlier this year determined Lemtrada is a cost-effective use of NHS resources for MS treatment, and provided the basis of the final guidance for reimbursement, the Cambridge, Mass.-based company said.

Last year NICE was inclined to not recommend Lemtrada because of gaps in data, but Genzyme's subsequent clarifications on the evidence it submitted were enough to sway its position, the company said. The European Commission granted marketing authorization for Lemtrada last September.

Current treatments for RRMS are either pills or injections given several times a week, but Lemtrada is taken intravenously once a year for two years (the first course is administered for five consecutive days and the second for three). This offers patients a more convenient treatment regimen and provides freedom from frequent dosing, the company noted.

Lemtrada is Genzyme’s second MS treatment to recently secure NHS reimbursement, following NICE’s April approval of Aubagio, a once-daily, oral therapy for treatment of adult patients with RRMS. — Kellen Owings

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