MISSISSAUGA, ON, Aug. 7, 2014 /CNW/ - Biogen Idec Canada announces today that Alberta Health will now reimburse TECFIDERA™ (dimethyl fumarate) through the Alberta Drug Benefit List (DBL). 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 first-line oral treatment for MS. Clinical trials have shown significant effectiveness and a favorable safety profile," said Dr. Fabrizio Giuliani, Medical Director of the Multiple Sclerosis Clinic, Edmonton and Associate Professor of Medicine, University of Alberta. "This expansion of our available therapeutic options will directly benefit the many people in Alberta living with MS."
As of August 1, 2014, TECFIDERA™ is listed on the Alberta DBL as a special authorization benefit for first-line monotherapy for adult patients (18 years of age or older) with RRMS. Criteria for the coverage of TECFIDERA™ include:
- This drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request;
- The registered MS Neurologist must confirm a diagnosis of RRMS;
- The adult patient must have active disease which is defined as at least two relapses of MS during the previous two years or in the two years prior to starting an MS disease modifying therapy (DMT);
- The adult patient must be ambulatory with or without aid (the registered MS Neurologist must provide a current updated Expanded Disability Status Scale (EDSS) score less than or equal to 6.5).
The initial approval period is for one year and adult patients will be limited to receiving one month supply per prescription at their pharmacy for the first 12 months. Coverage of this drug may be considered in an adult patient with a sustained EDSS score of 7.0 or above in exceptional circumstances.
There are also additional criteria for renewals and for patients restarting therapy after an interruption greater than 12 months. Additional information regarding the criteria is available at: www.ab.bluecross.ca/dbl/pdfs/dbl_aug.pdf.
"We are very pleased with the news that the province has given Albertans living with MS access to another option to manage the effects of their disease," says Neil Pierce, President, Alberta and Northwest Territories Division and national Vice-president, Government Relations and Volunteer Engagement, MS Society of Canada. "With many new MS treatment options becoming available, we are happy Alberta 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
"I have been on TECFIDERA for almost a year, and the oral treatment is not only easy to take but has improved my quality of life," said Amanda Fuller, a mother of two from Calgary, who was diagnosed with MS six years ago. "I'm very happy to know that other Albertans living with MS will also have the opportunity to benefit from this 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 rates 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: Please contact: Lisa Cancian, GCI Group (Canada), 416-486-9783, [email protected]nada.com