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Monday, June 22, 2015

Canadians with Multiple Sclerosis One Step Closer to Accessing LEMTRADA®

Common Drug Review recommends funding the only MS treatment given once a year for two years
MISSISSAUGA, ON, June 22, 2015 /CNW/ - Genzyme Canada announced today that the Canadian Drug Expert Committee (CDEC), through the Common Drug Review (CDR), recommended to all participating provincial and other public drug plans that LEMTRADA® (alemtuzumab) be listed for the management of adult patients with relapsing-remitting multiple sclerosis (RRMS). Eligible patients with active disease defined by clinical and imaging features, and who have had an inadequate response to interferon beta or other disease-modifying therapies.

This announcement follows similar decisions by the Institut national d'excellence en santé et en services sociaux (INESSS) in Québec, and international health technology assessment agencies, such as the National Institute for Health and Care Excellence (NICE) in the UK, and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia.
"We are pleased that Canadians with relapsing-remitting MS, who have had an inadequate response to other therapies, are one step closer to benefiting from an innovative new option to manage their disease," says Sylvia Leonard, National Vice President, Talent, Programs and Services, MS Society of Canada. "Access to new treatments is critical, and so we encourage provincial governments to remain responsive in their coverage based on this recommendation."
Approved in Canada in December 2013, LEMTRADA® is a recombinant humanized monoclonal antibody that requires only two annual treatment courses. It is a selective immunomodulator indicated for the management of adult patients with RRMS, defined by clinical factors and imaging results, who have had an inadequate response to interferon beta or other disease-modifying therapies.
"The approval of LEMTRADA® represents a novel and important new treatment option for Canadians living with MS," says Dr. Anthony Traboulsee, Associate Professor of Neurology and Medical Director of the UBC Hospital MS Clinic of Vancouver Coastal Health. "Our own experience in treating 35 patients through clinical trials with LEMTRADA® has been extremely positive. LEMTRADA® demonstrated impressive effectiveness after only two treatment courses, and the benefits remained for several years after completing the treatment. We have not seen this type of prolonged remission before without ongoing treatment."
"While LEMTRADA® is already covered by many private insurers and the Quebec public formulary, this decision will help the remaining provincial drug plans provide this innovative medication that has the potential to transform the course of disease," says Peter Brenders, CEO of Genzyme Canada. "Genzyme continues to work with each province and territory to ensure that eligible Canadians who rely on provincial drug plans will have swift access to LEMTRADA®."
The CDEC recommendation is based on clinical data from the Phase III study CARE MS II (Coles 2012) and is in accordance with the Health Canada indication. The CARE MS II trial demonstrated that, as a second-line treatment, LEMTRADA® is more effective than interferon beta-1a in reducing the annual relapse rate and the time to onset of sustained accumulation of disability.   



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