Sanofi Genzyme announced that the Government of Ontario has added Lemtrada (alemtuzumab) to the province’s Exceptional Access Program (EAP), opening coverage to the treatment for eligible patients with relapsing-remitting multiple sclerosis (RRMS).
The program facilitates patient access to drugs not funded on the Ontario Drug Benefit (ODB) Formulary, or those for which no listed alternative is available. To receive coverage, the patient must be eligible to receive benefits under the ODB program. Ontario joins Manitoba, Quebec, Saskatchewan and other provinces in making the drug available to patients 18 years or older meeting coverage criteria.
“I am pleased to see the approval of alemtuzumab for Ontario patients. It is the only agent proven to be more effective than first-line treatment for those whose disease was not adequately controlled with prior therapy,” said Dr. Mark S. Freedman, a professor of Neurology at the University of Ottawa, in a recent news release.
Lemtrada, approved in Canada in 2013, is as a disease-modifying therapy for adults with relapsing MS. The therapy is given as intravenous infusions for five consecutive days initially, and for three consecutive days one year later. Because of its safety profile, the prescribing information indicates that Lemtrada use should generally be reserved for people who have had an inadequate response to two or more MS therapies.
“I welcome the addition of alemtuzumab to the Ontario provincial exceptional access formulary. This affords the opportunity for patients with public drug benefits and their treating physicians to, when clinically appropriate, utilize a very highly effective infrequent infusion therapy for treatment of active/aggressive multiple sclerosis,” said Dr. Dan Selchen, director, MS Clinic, St. Michael’s Hospital, Toronto.
“We are excited knowing there is another treatment option for Ontarians living with relapsing-remitting MS, especially an option that would be available when other treatment options have not worked,” added Lisa McCoy, president of the MS Society of Canada, Ontario Division. “Each person who lives with MS will experience their symptoms differently, and it’s important that they have choices in order to manage their disease in a way that’s right for them.”
Because patients taking Lemtrada need monitoring at regular intervals between treatment courses and for 48 months after final infusion, Sanofi Genzyme provides comprehensive and free patient support through its MS One to One program. This program was created to ensure prescribers and MS patients with MS (PwMS) are fully apprised of appropriate use of Sanofi Genzyme’s newly launched MS drugs.
Results from the CARE MS II, a Phase 3 clinical trial of Lemtrada in patients with RRMS, demonstrated that as a second-line therapy, Lemtrada is more effective than interferon beta-1a in decreasing the annual relapse rate and the time to onset of sustained accumulation of disability.
“We are very pleased that Ontario has joined a growing list of provinces committed to improving the lives of RRMS patients by making LEMTRADA® available to those in need of another option,” concluded Peter Brenders, general manager for Canada at Sanofi Genzyme.