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What is Gilenya?
Gilenya (fingolimod) is a new oral medication approved by Health Canada on March 10th, 2011 for treating the relapsing-remitting form of MS in adults. It is known as a disease-modifying treatment (DMT) and targets both the immune system and the central nervous system to significantly reduce relapses.
GILENYA (fingolimod) is indicated as a second-line monotherapy to reduce the frequency of clinical exacerbations and to delay the progression of physical disability in those with the relapsing-remitting form of MS who have had an inadequate response to, or are unable to tolerate, one or more first-line therapies.
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How is it different from current treatments?
Gilenya is the first oral disease modifying treatment (available as a capsule) and it is also the first in a new class of medications known as sphingosine 1- phosphate receptor (S1PR) modulators. It reduces the frequency of MS relapses (when new symptoms appear, or existing ones get worse) by preventing certain immune cells from reaching the central nervous system, where they could potentially attack myelin, the fatty substance that insulates nerves and helps them transmit impulses between the brain and the body.
Current first-line disease modifying treatments reduce relapse rates by approximately 30% in two-year studies.1 All require injections (ranging from daily to weekly). In one study (TRANSFORMS study), Gilenya was found to reduce relapses by 52% (0.5 mg) versus interferon beta-1a IM (Avonex® ,30 μg), a first-line treatment over one year and by 54% versus placebo in a two-year study(FREEDOMS study). 2,3
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Will Gilenya slow my disease?
In the same two-year study, Gilenya was able to reduce the risk of sustained disability worsening by 30% compared to those on a placebo.3 Gilenya also reduced the increase in brain tissue injury and brain atrophy as measured by MRI over the course of the study as compared to the placebo.1
In the one year study (TRANSFORMS) Gilenya also had beneficial effects on the brain MRI scans of treated patients compared to those on Avonex treatment.
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How is it taken?
Gilenya is a capsule (0.5 mg) taken once a day, with or without food.
Gilenya doses higher than 0.5 mg are associated with a higher risk of adverse reactions without additional benefit and are not approved for use.
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Who can prescribe Gilenya?
Gilenya can only be prescribed by a neurologist.
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When will it be available?
Gilenya will be available in Canadian pharmacies by April 1, 2011.
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Is Gilenya safe? How comprehensive were the studies?
Gilenya has a well-studied safety and tolerability profile. It has been studied in over 4,000 people with MS around the world, some of whom are in their seventh year of treatment. Health Canada’s approval of Gilenya includes data from the largest clinical trial program in MS ever submitted as part of a new drug submission. The long-term (>7years) safety of this drug is unknown.
While the benefit of the therapy has been demonstrated in clinical trials, there are risks to this therapy. Please see question #17 for important information on side effects associated with Gilenya use.
Other Phase III clinical trials of Gilenya, including one involving people with primary progressive MS, are still under way, as are extension studies involving those who have completed trials. The MS Society will closely monitor all information with respect to Gilenya’s safety and efficacy profile and will provide updates as required.
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Were head-to-head studies comparing treatments conducted?
Gilenya was found to reduce relapses by 52% (0.5 mg) versus interferon beta-1a IM (Avonex®), a standard of care.2
Additional head-to-head studies are required.
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Is it right for me?
People with MS should discuss their disease management plans with their physician, keeping in mind their disease history and treatment goals, to determine whether Gilenya is a suitable option for them. Importantly, the drug is approved only for those whose MS includes a relapsing-remitting course.
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How does this compare to CCSVI procedure?
It is not possible to compare treatment of Gilenya with the CCSVI procedure until additional research has been conducted in the area of CCSVI and MS. For more information about CCSVI, please visit www.ccsvi.ca
Any treatment decisions should be made in consultation with your physician, keeping in mind your treatment goals and disease history.
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How much will Gilenya cost?
Gilenya has been priced at $31,000 per year.
Novartis Pharmaceuticals Inc., the company that makes Gilenya is working with insurance plans and provincial governments to secure coverage for Canadians living with MS.
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Will it be covered by my private plan? Government plans?
The company that makes Gilenya, Novartis Pharmaceuticals Inc., will submit applications for coverage to private health plans, as well as the Common Drug Review (CDR) and Conseil du Médicament (Québec). The CDR is the first step in review for coverage on provincial health plans (with the exception of Quebec). The CDR review takes a number of months. When it is complete, they will recommend whether provincial governments should or should not pay for Gilenya. Provincial governments will then conduct their own reviews. (This process can take anywhere from 8-24 months depending on the province.) It should be noted that Quebec conducts its own review, independent of the CDR.
The MS Society of Canada is urging all provincial governments to make this oral therapy accessible to people living with MS by including Gilenya as a disease-modifying therapy that is covered by public health care.
It is expected that most private insurance plans will cover Gilenya. Some plans will have coverage almost immediately and others will take many months to review this file. It is important that people check with their providers for the details of their individual plans.
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Should I switch from my current therapy?
People with MS should discuss their disease management plans with their physician, keeping in mind their disease history and treatment goals, to determine whether Gilenya is a suitable option for them.
Gilenya is generally recommended in people who have had an inadequate response to, or are unable to tolerate, one or more first-line therapies for MS.
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What is involved in switching therapies? Is there a wash out period? Is there a period when I cannot take any MS treatment?
No wash out period is required for first line disease modifying treatments which include Avonex® (interferon beta-1a); Betaseron® (interferon beta-1b); Extavia® (interferon beta-1b); Rebif® (interferon beta-1a) and Copaxone® (glatiramer acetate).
If you are going on Gilenya, you will first need to obtain baseline (pre-treatment) blood tests, and an electrocardiogram (ECG) test. The blood tests will assess your haemoglobin and white blood cell count, liver function and whether or not you have had chicken-pox. To go on the drug you must be immune to the chicken-pox virus.
Within a few months of going on the drug you will also have to have an eye assessment of your retina as the drug can occasionally cause swelling with visual blurring (macular edema).
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Can Gilenya be used to treat progressive MS?
Gilenya is currently only approved for the relapsing-remitting form of MS in Canada; however clinical trials are underway involving individuals with primary progressive MS. The MS Society of Canada will provide updates on these studies when they become available.
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Can it be used after a CIS (clinically isolated syndrome) episode?
At this time, Gilenya is only approved for the relapsing-remitting form of MS in Canada. For information on CIS approved treatment options please speak with your physician or contact your MS Society of Canada division office at 1-800-268-7582.
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What are the most common side effects associated with Gilenya use?
The most common adverse reactions listed in Gilenya’s label are headache, flu, diarrhea, back pain, liver enzyme elevations and cough.
The label also carries warnings about other potential serious risks, including decreased heart rate and/or other heart effects after the first dose; increased risk of infections (in clinical trials, a small number of serious herpes infections occurred, including two deaths from herpes infections that occurred in people taking a dose higher than the approved dose of fingolimod); risk of macular edema (swelling of the center of the retina inside the eye); decrease in lung function; slight increase in blood pressure; increases of liver enzymes (which could indicate liver malfunction), and risk of harm to fetus (Category C, based on animal studies).
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Where do I turn if I have any additional questions about Gilenya?
For additional information about Gilenya, please refer to the following numbers:
Gilenya® Go Program: 1-855-PILL-4MS (1-855-745-5467)
Please discuss any other questions about treatment options with your physician.
