Limited coverage drugs – natalizumab
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Generic name |
natalizumab |
|
---|---|---|
Strength |
300 mg/15 mL |
|
Form |
concentrate for solution for IV infusion |
Special Authority criteria |
Approval period |
---|---|
Initial: As second-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) which is diagnosed according to the current clinical criteria and magnetic resonance imaging (MRI) evidence. This drug is for the treatment of patients 18 years of age and older who meet ALL of the following criteria:
AND
AND
|
15 months |
Renewal:
AND
|
24 months |
Practitioner exemptions
- None
Special notes
- Failure to respond to a full and adequate course is defined as a trial of at least six months with one or more first-line MS disease modifying drug therapies at least one attack/relapse occurring during that therapy (MRI report does not need to be submitted with the request).
- Intolerance is defined as documented serious adverse effects or contraindications that are incompatible with further use of that class of drug. Intolerance does not include skin reactions at the injection site.
- MRI lesion evidence is defined as three or more new lesions.
- Discontinuation of therapy should be discussed with patients with stable or inactive disease who are 60 years of age or older.
Special Authority request form(s)