Limited Coverage Drugs - Natalizumab
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 (MS), diagnosed according to clinical criteria1 and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist from a designated MS clinic, for patients who meet ALL of the following criteria:
AND
AND
|
1 Year |
RENEWAL
AND
|
1 Year |
Special Notes
- For the purposes of assessing PharmaCare Special Authority, the clinical criteria for the diagnosis of MS are the 2010 McDonald criteria.
- 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 AND 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.
- An attack is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 24 hours in the absence of fever, and preceded by stability for at least one month.
Practitioner Exemptions
- None