DIN/NPN/PIN 02404508 TECFIDERA 120 MG ORAL DELAYED-RELEASE CAPSULE DIMETHYL FUMARATE |
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Date Listed/Coverage Update: | 01-Aug-2014 | ||||
Unit Price: | 17.7064 | ||||
LCA Price: | 4.4266 | ||||
MAC Price: |
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Unit of Issue: | Capsule | ||||
Manufacturer: | BIOGEN IDEC CANADA INC (BIO) | ||||
ATC: | N07XX09 | ||||
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Interchangeable Products: | Yes | ||||
Coverage Status: | SPECIAL AUTHORIZATION |
Applies to Clients of: | Non-Group Coverage (Group 1) Coverage for Seniors (Group 66) Palliative Coverage (Group 20514, Please note your client may have Group 1 or Group 66 coverage) Child and Family Services (Group 20403) Alberta Child Health Benefit (Group 20400) Children and Youth Services (Group 19824) Income Support (Group 19823) Alberta Human Services (AISH) (Group 19823) Alberta Adult Health Benefit (AAHB) (Group 23609) |
Special Authorization Request Form: | |
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"Special authorization may be provided for the reduction of the frequency and severity of clinical relapses and reduction of the number and volume of active brain lesions, identified on MRI scans, in ambulatory adult patients (18 years of age or older) with relapsing remitting multiple sclerosis. Coverage For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request. To register to become an MS Neurologist please complete the Registration for MS Neurologist Status Form (ABC 60002). Initial Coverage 1) The registered MS Neurologist must confirm a diagnosis of RRMS; 2) 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). *A relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 48 hours in the absence of fever, not associated with withdrawal from steroids. Onset of clinical relapses must be separated by a period of at least one month. At least one new T2 lesion or definite gadolinium-enhancing T1 MRI lesion (not questionable faint enhancement) obtained at least 90 days after initiation of the DMT and at least 90 days before or after a relapse may substitute for one clinical relapse. 3) 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). Coverage may be approved for up to 12 months. Adult patients will be limited to receiving a one-month supply of dimethyl fumarate per prescription at their pharmacy for the first 12 months of coverage. Continued Coverage For continued coverage beyond the initial coverage period, the adult patient must meet the following criteria: 1) The adult patient must be assessed by a registered MS Neurologist; 2) The registered MS Neurologist must confirm a diagnosis of RRMS; 3) The registered MS Neurologist must provide a current updated EDSS score. The adult patient must not have an EDSS score of 7.0 or above sustained for one year or more. Coverage of this drug may be considered in an adult patient with a sustained EDSS score of 7.0 or above in exceptional circumstances. For MS DMT coverage to be considered, details of the exceptional circumstance must be provided in a letter from the registered MS Neurologist and accompany the Special Authorization Request Form. Continued coverage may be approved for up to 24 months. Adult patients may receive up to 100 days' supply of dimethyl fumarate per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 24 Months In order to be eligible for coverage, after an interruption in therapy greater than 24 months, the adult patient must meet the following criteria: 1) At least two relapses* during the previous 24 month period." All requests (including renewal requests) for dimethyl fumarate must be completed using the Dimethyl Fumarate/Glatiramer Acetate/Interferon Beta-1b/Ocrelizumab/Ofatumumab/Peginterferon Beta-1a/Teriflunomide for RRMS/Interferon Beta-1a for SPMS or RRMS Special Authorization Request Form (ABC 60001). |
Review Status / Past Decisions
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