, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the National Institute for Health and Care Excellence (NICE) issued final guidance recommending that Lemtrada™ (alemtuzumab) be reimbursed on the NHS, for treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. A Final Appraisal Determination (FAD) issued earlier this year concluded Lemtrada is a cost-effective use of NHS resources for MS treatment, and formed the basis of the final guidance for reimbursement.
“The fact that NICE has followed the European Commission decision on patient eligibility for Lemtrada marks a step change in the clinical approach to treating MS,” said Dr. Alasdair Coles, Senior Lecturer, Department of Clinical Neurosciences, University of Cambridge. “With this final guidance, the responsibility for treatment decisions with Lemtrada is now handed over to UK healthcare professionals and their patients.”
The final guidance follows the European Commission’s granting of marketing authorization for Lemtrada in September 2013. Aubagio
became available on the NHS in April 2014.
“We are pleased that NICE has recommended Lemtrada as being both clinically effective and cost effective for people with relapsing remitting MS,” said David Meeker, President and CEO, Genzyme. “There are approximately 100,000 people in the UK diagnosed with the disease and Lemtrada can be a potentially transformative treatment for appropriate patients.”
Lemtrada is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
The Lemtrada clinical development program included two pivotal randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif®) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.