MISSISSAUGA, ON, June 25, 2014 /CNW/ - Biogen Idec Canada announces today that TECFIDERA™ (dimethyl fumarate) is now available for reimbursement in British Columbia (B.C.) through B.C. PharmaCare. 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 an important new first-line oral therapy for MS to help reduce disease activity," said Dr. Virginia Devonshire, Neurologist, MS Clinic, University of British Columbia Hospital. "This addition means we now have another treatment option for people living with MS in British Columbia."
Effective June 24, 2014, TECFIDERA™ is now eligible for reimbursement as a first-line monotherapy for people diagnosed with RRMS according to the current McDonald clinical criteria2 and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist from a designated MS clinic, who meet the following criteria: is 18 years of age or older; meet the Limited Coverage criteria; has had at least two disabling attacks of MS in the previous two years; and is ambulatory with or without aid with an Expanded Disability Status Scale (EDSS) score of 6.5 or less.
TECFIDERA™ is also available as a second-line monotherapy for a change of therapy, when prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS who have experienced failure or intolerance to a previous disease-modifying therapy.
The initial approval period is for one year. Renewals are for one year, for patients who have demonstrated that the therapeutic benefits outweigh any potential risks, as shown by relapse rate, EDSS, MRI scan, or overall clinical impression.
B.C. PharmaCare coverage and actual reimbursement is subject to the rules of the patients' PharmaCare plan, including any annual deductible requirement and any other applicable PharmaCare pricing policy. For more information, please visit: http://www.health.gov.bc.ca/pharmacare/.
"We are very pleased with the news that B.C. has given residents living with MS access to another option to manage the effects of their disease," says Tania Vrionis, president, British Columbia and Yukon Division, MS Society of Canada. "With many new MS treatment options becoming available, we are happy the Ministry of Health 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
"Biogen Idec Canada is pleased that B.C. is reimbursing TECFIDERA as an initial treatment option for patients with RRMS, joining other provinces that already provide coverage including Ontario, Saskatchewan, Newfoundland and Manitoba," said Paul Petrelli, President and General Manager, Biogen Idec Canada. "TECFIDERA is helping more than 65,000 people worldwide manage their MS, and Biogen Idec Canada continues to work closely with other provincial agencies so that more Canadians living with MS 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.3 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.2,4
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.5
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.6
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 The McDonald clinical criteria for the diagnosis of MS are current as of October 26, 2010.
3 "Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/symptoms.htm.
4 Nicholas G. LaRocca, "Impact of Walking Impairment in Multiple Sclerosis." National Multiple Sclerosis Society 4, no.3 (2011): 190.
5 "About MS." Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/.
6 BG-12 (dimethyl fumarate) Fact Sheet.
SOURCE: Biogen Idec Canada
For further information: or to arrange an interview, pleaor to arrange an interview, please contact: Laine Jaremey, GCI Group (Canada), 416-486-7224, [email protected]