DIN/NPN/PIN 02418320 LEMTRADA 12 MG / VIAL INJECTION ALEMTUZUMAB |
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Date Listed/Coverage Update: | 01-Sep-2016 | ||
Unit Price: | 13,031.1100 | ||
LCA Price: | N/A | ||
MAC Price: |
N/A |
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Unit of Issue: | Vial | ||
Manufacturer: | GENZYME, A DIVISION OF SANOFI-AVENTIS CA (GZM) | ||
ATC: | L01XC04 | ||
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Interchangeable Products: | No | ||
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: |
Registration For MS Neurologist Status Form (ABC 60002) Alemtuzumab for Multiple Sclerosis Special Authorization Request Form (ABC 60079) |
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"Special authorization coverage may be provided for the treatment of highly active relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses, to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans and to delay the progression of physical disability, in adult patients (18 years of age or older) who are refractory or intolerant to at least TWO of the following disease modifying therapies (DMTs): - cladribine - dimethyl fumarate - fingolimod - glatiramer acetate - interferon beta - natalizumab - ocrelizumab - ofatumumab - peginterferon beta - teriflunomide Definition of 'intolerant' Demonstrating serious adverse effects or contraindications to treatments as defined in the product monograph, or a persisting adverse event that is unresponsive to recommended management techniques and which is incompatible with further use of that class of MS disease modifying therapy (DMT). Definition of 'refractory' -Development of neutralizing antibodies to interferon beta. -When the above MS DMTs are taken at the recommended doses for a full and adequate course of treatment, within a consecutive 12-month period while the patient was on the MS DMT, the patient has: 1) Been adherent to the MS DMT (greater than 80% of approved doses have been administered); 2) Experienced at least two relapses* of MS confirmed by the presence of neurologic deficits on examination. i. The first qualifying clinical relapse must have begun at least one month after treatment initiation. ii. Both qualifying relapses must be classified with a relapse severity of moderate, severe or very severe**. *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. **Relapse severity: with moderate relapses modification or more time is required to carry out activities of daily living; with severe relapses there is inability to carry out some activities of daily living; with very severe relapses activities of daily living must be completed by others. For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist. To register to become an MS Neurologist, please complete the Registration for MS Neurologist Status Form (ABC 60002). Coverage may be considered only if the following criteria are met: 1) The registered MS Neurologist must confirm a diagnosis of RRMS; 2) The 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 DMT. In most cases this will be satisfied by the 'refractory' to treatment criterion but if a patient failed an MS DMT more than one year earlier, ongoing active disease must be confirmed. 3) The 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 5). Coverage will not be approved when any MS DMT or other immunosuppressive therapy is to be used in combination with alemtuzumab. Coverage of alemtuzumab will not be approved if the patient was deemed to be refractory to alemtuzumab in the past. Following assessment of the request, alemtuzumab may be approved for coverage at a dose of 12 mg/day administered by intravenous (IV) infusion for 2 treatment courses: - Initial Treatment Course: 12 mg/day for 5 consecutive days (60 mg total dose) - Second Treatment Course: 12 mg/day for 3 consecutive days (36 mg total dose) administered 12 months after the initial treatment course. Patients will be limited to receiving one treatment course (60 mg or 36 mg) of alemtuzumab per prescription at their pharmacy. Coverage is limited to two treatment courses (i.e., eight doses)." All requests for alemtuzumab must be completed using the Alemtuzumab For Multiple Sclerosis Special Authorization Request Form (ABC 60079). |
Review Status / Past Decisions
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