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Canadian Drug Review Reimbursement Decision


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  Gilenya
Generic Fingolimod
Company Novartis Pharmaceuticals Canada Inc.
Indication multiple sclerosis
Condition Nervous system
Submission Type
Patient Population Fingolimod has a Health Canada indication as monotherapy for the treatment of patients with the relapsing remitting form of MS, to reduce the frequency of clinical exacerbations and to delay the progression of physical disability. According to the Health Canada indication, fingolimod is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for MS. Fingolimod is a sphingosine-1 receptor modulator. It modulates trafficking of T-cells in the central nervous system, and thus has an immunosuppressive effect. It is available as a 0.5 mg oral capsule and the Health Canada recommended dose is 0.5 mg once daily.
Status Complete
Date of Recommendation 2011-11-16
Recommendation Summary List with criteria/condition
Recommendation Details The Canadian Drug Expert Committee (CDEC) recommends that fingolimod be listed for the treatment of patients with relapsing remitting multiple sclerosis (MS) who meet all of the following criteria: • Failure to respond to full and adequate courses of at least one interferon beta formulation and glatiramer acetate, or contraindications to these therapies • Two or more disabling relapses in the previous year • Significant increase in T2 lesion load compared with that from a previous magnetic resonance imaging (MRI) scan, or at least one gadolinium-enhancing lesion. The Committee further recommends that fingolimod treatment be stopped in patients with relapsing remitting MS who meet either of the following criteria: • failure to achieve at least a 50% reduction from baseline in the average annual relapse rate after two years • attainment of an Expanded Disability Status Scale (EDSS) score of greater than 5.0.
Reason for Recommendation 1. Based on one medical study (TRANSFORMS), the Committee considered the effectiveness of Gilenya and interferon beta-1a to be similar. Although study results, based on the number of relapses per year and disability scores, appeared better for patients in the Gilenya group, the differences seen between the treatments were small. In addition, no difference in quality of life was seen between Gilenya and interferon beta-1a. 2. At recommended doses, the yearly cost of Gilenya ($30,992) is more expensive than glatiramer ($15,704), interferon beta-1a ($18,928 to $23,036), and interferon beta-1b ($18,096). 3. The Committee recognized patient group input that pointed to the need for additional treatment options in MS. 4. The Committee considered continued use of a high-cost agent to be unwarranted in the absence of substantial sustained clinical benefit. Of Note: Based on a review of the clinical evidence, the Committee felt that a reduced price similar to that of interferon products would increase the likelihood of a recommendation with less restrictive criteria.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.


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