Quebec Government to Cover TECFIDERA™ as a First-Line Oral Treatment for Multiple Sclerosis

Important Step for those Living with MS in Quebec

MISSISSAUGA, ON, June 3, 2015 /CNW/ - Biogen Canada announces today that Quebec's Institut national d'excellence en santé et services sociaux (INESSS) has updated its recommendation for TECFIDERA™ (dimethyl fumarate) 120 mg and 240 mg to be included on the provincial drug formulary under "Médicament d'exception" as 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, which offers oral convenience coupled with a favourable efficacy and safety profile," says Dr. Donald Rivest, neurologue à l'Hôtel-Dieu de Lévis. "The expansion of available therapeutic options in Quebec will have a positive impact on the lives of MS patients."

As of June 1, 2015, TECFIDERA™ is listed on the Quebec drug formulary under "Médicament d'exception" as a benefit for first-line monotherapy for adult patients (18 years of age or older) with RRMS. Criteria for the coverage of TECFIDERA™ include²:

• Diagnosed according to the McDonald criteria (2010);
• Presentation in the adult patient of one relapse of MS during the last year;
• An Expanded Disability Status Scale (EDSS) score less than seven.

The initial approval period is for a maximum of one year, with the same criteria for further processing. Exceptional coverage of this drug may be considered in an adult patient if the physician provides evidence of beneficial effect by the absence of deterioration with a sustained EDSS score still below 7.0.² 

"We are very pleased with the news that the province has given Quebecers living with multiple sclerosis access to another option to manage the effects of their disease," says Louis Adam, Executive Director, Quebec Division of the MS Society of Canada. "With many new MS treatment options becoming available, we are happy that Quebec's Institut national d'excellence en santé et services sociaux (INESSS) continues to be responsive in their public listing of these new therapies. For those living with MS who are 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 updated INESSS recommendation of TECFIDERA™ was based on findings from two global Phase III two-year studies, DEFINE and CONFIRM, and a cost impact analysis. 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

About Biogen ONE™ Patient Services Program
Biogen 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 Canada MS products, which is intended to enhance the quality and continuity of care that Biogen ONE™ can provide to patients. Biogen ONE™ will also assist physicians and patients with documentation associated with the Exceptional Access Program application for TECFIDERA™ in Ontario. For more information about the Biogen 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 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.⁵ 

About TECFIDERA™
TECFIDERA™ is an oral therapy for relapsing forms of MS, including relapsing-remitting MS, the most common form of MS.¹ TECFIDERA™ is currently approved in the United States, the European Union, Canada, Australia and Switzerland.

TECFIDERA™ has been proven to reduce rate of MS relapses, slow the progression of disability, and the number of MS brain lesions, while demonstrating a favorable safety and tolerability profile in a broad range of patients with relapsing forms of MS.¹  In clinical trials, the most common adverse events associated with TECFIDERA™ were flushing and gastrointestinal (GI) events.¹ Other side effects included a decrease in mean lymphocyte counts during the first year of treatment, which then plateaued. TECFIDERA™ is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. ¹

The efficacy and safety of TECFIDERA™ have been studied in a large, global clinical program, which includes an ongoing long-term extension study. It is believed that TECFIDERA™ provides a new approach to treating MS by activating the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS. ¹

About Biogen Canada
Biogen Canada is the Canadian affiliate of Biogen. Through cutting-edge science and medicine, Biogen 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.biogen.ca.

References:

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¹ TECFIDERA™ Product Monograph. http://www.biogenidec.ca/product_portfolio.aspx?ID=14979.

² Québec's Institut national d'excellence en santé et services sociaux (INESSS). TECFIDERAMC – Sclérose en plaques (SEP) de forme rémittente. June 2015.

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/.

SOURCE Biogen Canada

or to arrange an interview, please contact: Quebec, Yann Langlais Plante, TACT Intelligence-conseil, 514 667-0196, poste 421, [email protected]; Amanda Federchuk, GCI Group (Canada), 416-486-7231, [email protected]