Biogen Idec Canada makes TECFIDERA available for reimbursement in Ontario

TECFIDERA is a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). TECFIDERA is indicated as monotherapy for the treatment of RRMS to reduce the frequency of clinical exacerbations and to delay the progression of disability.

"TECFIDERA is a first-line treatment that offers patients the convenience of an oral administration coupled with clinically proven effectiveness and favorable safety profile," said Dr. Marcelo Kremenchutzky, Director of the Multiple Sclerosis Clinic, London, Ontario.

"The decision to list TECFIDERA through the Ontario Public Drugs Program’s Exceptional Access Program means more people in Ontario may have greater access to another valuable treatment option."

TECFIDERA is now eligible for EAP reimbursement, retroactively effective from April 29, 2014, for people living with RRMS who meet the following criteria: requires TECFIDERA for the proper treatment of RRMS; has had one or more clinical relapses in the year preceding the request; has a recent Expanded Disability Status Scale (EDSS) score = 5; and requested and followed by a neurologist experienced in the management of RRMS.

The request includes documentation setting out the details of the patient’s most recent neurological examination, which must have been conducted within 90 days of the EAP request, including a description of any recent attacks, the dates, and neurological findings.

The initial approval period is for one year. Renewals are for two years, and will be considered for patients who have benefited from therapy in the preceding year (stable or no more than one clinical relapse) and have an EDSS score = 5.

"We are very pleased with the news that the province has given Ontarians living with MS access to another option to manage the effects of their disease," said Sylvia Leonard, president, Ontario and Nunavut Division and national vice president, client services, MS Society of Canada.

"With many new MS treatment options becoming available, we are happy the Ministry of Health and Long-Term Care continues to be responsive in their public listing of these new therapies. For those living with MS interested in exploring treatment options, we encourage them to consult with their healthcare team to find the course that is most appropriate for them."

The Health Canada approval of TECFIDERA was based on findings from two global Phase III two-year studies, DEFINE and CONFIRM.

In DEFINE, TECFIDERA, administered twice-daily, significantly reduced the proportion of patients who relapsed by 49 per cent (p1

"Now through the Ontario Exceptional Access Program, more people living with MS will have access to TECFIDERA, a first-line treatment that is helping more than 65,000 people world-wide manage their disease," said Paul Petrelli, President and General Manager, Biogen Idec Canada.

"Biogen Idec Canada will continue to work closely with other provincial agencies so that more Canadians may have access to this important treatment option.