|By PR Newswire||
|August 7, 2014 10:01 AM EDT||
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
"We view the cloud not really as a specific technology but as a way of doing business and that way of doing business is transforming the way software, infrastructure and services are being delivered to business," explained Matthew Rosen, CEO and Director at Fusion, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 28, 2016 06:45 PM EDT Reads: 1,615
Redis is not only the fastest database, but it is the most popular among the new wave of databases running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 19th Cloud Expo, Dave Nielsen, Developer Advocate, Redis Labs, will share the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
Jul. 28, 2016 06:30 PM EDT Reads: 1,654
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Jul. 28, 2016 06:00 PM EDT Reads: 942
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.
Jul. 28, 2016 05:30 PM EDT Reads: 1,850
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 28, 2016 05:30 PM EDT Reads: 2,210
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Jul. 28, 2016 05:00 PM EDT Reads: 416
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA. This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...
Jul. 28, 2016 04:30 PM EDT Reads: 896
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Jul. 28, 2016 04:30 PM EDT Reads: 1,182
Security, data privacy, reliability, and regulatory compliance are critical factors when evaluating whether to move business applications from in-house, client-hosted environments to a cloud platform. Quality assurance plays a vital role in ensuring that the appropriate level of risk assessment, verification, and validation takes place to ensure business continuity during the migration to a new cloud platform.
Jul. 28, 2016 04:15 PM EDT Reads: 362
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Jul. 28, 2016 04:15 PM EDT Reads: 1,772
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus...
Jul. 28, 2016 03:45 PM EDT Reads: 1,023
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
Jul. 28, 2016 03:45 PM EDT Reads: 1,118
UpGuard has become a member of the Center for Internet Security (CIS), and will continue to help businesses expand visibility into their cyber risk by providing hardening benchmarks to all customers. By incorporating these benchmarks, UpGuard's CSTAR solution builds on its lead in providing the most complete assessment of both internal and external cyber risk. CIS benchmarks are a widely accepted set of hardening guidelines that have been publicly available for years. Numerous solutions exist t...
Jul. 28, 2016 03:30 PM EDT Reads: 714
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
Jul. 28, 2016 03:30 PM EDT Reads: 368
Verizon Communications Inc. (NYSE, Nasdaq: VZ) and Yahoo! Inc. (Nasdaq: YHOO) have entered into a definitive agreement under which Verizon will acquire Yahoo's operating business for approximately $4.83 billion in cash, subject to customary closing adjustments. Yahoo informs, connects and entertains a global audience of more than 1 billion monthly active users** -- including 600 million monthly active mobile users*** through its search, communications and digital content products. Yahoo also co...
Jul. 28, 2016 03:15 PM EDT Reads: 698