News Feed Item

TECFIDERA™, a First-Line Oral Treatment for Multiple Sclerosis, Reimbursed in Alberta

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

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
So you think you are a DevOps warrior, huh? Put your money (not really, it’s free) where your metrics are and prove it by taking The Ultimate DevOps Geek Quiz Challenge, sponsored by DevOps Summit. Battle through the set of tough questions created by industry thought leaders to earn your bragging rights and win some cool prizes.
Today every business relies on software to drive the innovation necessary for a competitive edge in the Application Economy. This is why collaboration between development and operations, or DevOps, has become IT’s number one priority. Whether you are in Dev or Ops, understanding how to implement a DevOps strategy can deliver faster development cycles, improved software quality, reduced deployment times and overall better experiences for your customers.
The security needs of IoT environments require a strong, proven approach to maintain security, trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vic...
Cloud based infrastructure deployment is becoming more and more appealing to customers, from Fortune 500 companies to SMEs due to its pay-as-you-go model. Enterprise storage vendors are able to reach out to these customers by integrating in cloud based deployments; this needs adaptability and interoperability of the products confirming to cloud standards such as OpenStack, CloudStack, or Azure. As compared to off the shelf commodity storage, enterprise storages by its reliability, high-availabil...
In the next forty months – just over three years – businesses will undergo extraordinary changes. The exponential growth of digitization and machine learning will see a step function change in how businesses create value, satisfy customers, and outperform their competition. In the next forty months companies will take the actions that will see them get to the next level of the game called Capitalism. Or they won’t – game over. The winners of today and tomorrow think differently, follow different...
The IoT industry is now at a crossroads, between the fast-paced innovation of technologies and the pending mass adoption by global enterprises. The complexity of combining rapidly evolving technologies and the need to establish practices for market acceleration pose a strong challenge to global enterprises as well as IoT vendors. In his session at @ThingsExpo, Clark Smith, senior product manager for Numerex, will discuss how Numerex, as an experienced, established IoT provider, has embraced a ...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in Embedded and IoT solutions, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 7-9, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and ...
The Internet of Things (IoT), in all its myriad manifestations, has great potential. Much of that potential comes from the evolving data management and analytic (DMA) technologies and processes that allow us to gain insight from all of the IoT data that can be generated and gathered. This potential may never be met as those data sets are tied to specific industry verticals and single markets, with no clear way to use IoT data and sensor analytics to fulfill the hype being given the IoT today.
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Donna Yasay, President of HomeGrid Forum, today discussed with a panel of technology peers how certification programs are at the forefront of interoperability, and the answer for vendors looking to keep up with today's growing industry for smart home innovation. "To ensure multi-vendor interoperability, accredited industry certification programs should be used for every product to provide credibility and quality assurance for retail and carrier based customers looking to add ever increasing num...
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
The Open Connectivity Foundation (OCF), sponsor of the IoTivity open source project, and AllSeen Alliance, which provides the AllJoyn® open source IoT framework, today announced that the two organizations’ boards have approved a merger under the OCF name and bylaws. This merger will advance interoperability between connected devices from both groups, enabling the full operating potential of IoT and representing a significant step towards a connected ecosystem.
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, discussed how leveraging the Industrial Internet a...
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...