Mississauga, ON – August 7,
2014 – 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.[i]
2014 – 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.[i]
“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.”
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:
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;
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 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
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 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.
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.
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.”
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
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.”
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.
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.[ii] 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,[iii]
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.[ii] 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,[iii]
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.[iv]
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.[iv]
About TECFIDERA™
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.[v]
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.[v]
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.
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.
-30-
For more information or to arrange
an interview, please contact:
an interview, please contact:
Lisa Cancian
GCI Group (Canada)
416-486-9783
[ii] “Managing MS
Symptoms.” Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/symptoms.htm.
Symptoms.” Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/symptoms.htm.
[iii] Nicholas G.
LaRocca, “Impact of Walking Impairment in Multiple Sclerosis.” National
Multiple Sclerosis Society 4, no.3 (2011): 190.
LaRocca, “Impact of Walking Impairment in Multiple Sclerosis.” National
Multiple Sclerosis Society 4, no.3 (2011): 190.
[iv] “About MS.”
Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/.
Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/.
GCI GROUP : changeRULES
lisacancian | consultant | gcigroup | phone: 416.486.5906 | mobile: 416.433.2332 | fax: 416.486.9783 |
lisacancian | consultant | gcigroup | phone: 416.486.5906 | mobile: 416.433.2332 | fax: 416.486.9783 |
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