MISSISSAUGA, ON, May 27, 2014 /CNW/ - Biogen Idec Canada announces today that TECFIDERA™ (dimethyl fumarate) is now available for reimbursement in Ontario through the Ontario Public Drug Programs' (OPDP) Exceptional Access Program (EAP), as indicated in the upcoming May 29, 2014, Edition No. 42, Ontario Drug Benefit Formulary/Comparative Index. 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.1
"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 Drug Programs' 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.
For more information, please consult the EAP formulary: http://www.health.gov.on.ca/en/pro/programs/drugs/pdf/frequently_requested_drugs.pdf.
"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 (p<0.0001), the annualized relapse rate (ARR) by 53 per cent (p<0.0001), and 12-week confirmed disability progression, as measured by the EDSS by 38 per cent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA™ significantly reduced ARR by 44 per cent (p<0.0001) and the proportion of patients who relapsed by 34 per cent (p=0.002) compared to placebo at two years. Both studies also showed TECFIDERA™ significantly reduced MS lesions compared to placebo, as measured by magnetic resonance imaging (MRI). In DEFINE, TECFIDERA™ significantly reduced the odds of having Gd+ lesions by 90 per cent and T2-hyperintense lesions by 85 per cent.1
"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."
About Biogen Idec ONE™ Patient Services Program
Biogen Idec Canada is committed to delivering best-in-class services to care for MS patients. All TECFIDERA™ patients have access to a Regional Support Nurse in their region that provides personalized support for patients and healthcare providers in all aspects of patient care, from treatment to reimbursement. This provides healthcare professionals and patients the opportunity to work directly with one nurse per region across all Biogen Idec Canada MS products, which is intended to enhance the quality and continuity of care that Biogen Idec ONE™ can provide to patients. Biogen ONE™ will also assist physicians and patients with the paperwork associated with the Exceptional Access Program application for TECFIDERA™ in Ontario. For more information about the Biogen Idec ONE™ program, call 1-855-MSONE-00 or 1-855-676-6300.
About MS in Canada
MS is an unpredictable, often debilitating disease of the central nervous system (CNS) that attacks the protective covering, or myelin, of the brain and spinal cord, causing inflammation and damage.2 When this occurs, the normal flow of nerve impulses along nerve fibres, or axons, becomes disrupted.2 The result of damaged myelin may be a wide variety of symptoms including fatigue, weakness, muscle spasms, pain, tremors, double vision, bladder and bowel dysfunction, cognitive deficits and loss of mobility, among other problems.2,3
Canada is known for having one of the highest prevalence of MS in the world. Currently, more than two million people are estimated to suffer from MS worldwide, including an estimated 100,000 Canadians.4
TECFIDERA™ provides a new approach to treating MS and is the only known compound to activate the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend against inflammation and oxidative stress caused by conditions like MS. In vivo and in vitro research suggests that TECFIDERA™ can reduce the impact of inflammatory cells on the CNS and may provide protection against harmful agents accumulating in CNS cells. These effects may enhance the CNS cells' ability to resist oxidative stress that plays a role in the pathophysiological processes associated with MS.5
About Biogen Idec Canada
Biogen Idec Canada is the Canadian affiliate of Biogen Idec. Through cutting-edge science and medicine, Biogen Idec discovers, develops, manufactures and markets therapies for diseases with a focus on neurology, immunology and hemophilia. Founded in 1978, with a presence in Canada since 1998, it is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies. For press releases and additional information about the company, please visit www.biogenidec.ca.
1 TECFIDERA™ Product Monograph. http://www.biogenidec.ca/product_portfolio.aspx?ID=14979.
2 "Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/symptoms.htm.
3 Nicholas G. LaRocca, "Impact of Walking Impairment in Multiple Sclerosis." National Multiple Sclerosis Society 4, no.3 (2011): 190.
4 "About MS." Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/
5 BG-12 (dimethyl fumarate) Fact Sheet.
SOURCE: Biogen Idec Canada
For further information: or to arrange an interview, please contact: Rick Maddalena, GCI Group (Canada), 416-486-7225, [email protected]