Limited Coverage Drugs - Fingolimod
Generic Name / Strength / Form
fingolimod / 0.5 mg / capsule
Special Authority Criteria
As second-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) which is diagnosed according to the current clinical criteria1 and magnetic resonance imaging (MRI) evidence. Combination therapy is not covered.
This drug is for the treatment of patients 18 years of age and older who meet ALL of the following criteria:
- No practitioner exemptions
- The current clinical criteria for the diagnosis of MS are the McDonald criteria, as of October 26, 2010.
- Failure to respond to full and adequate courses is defined as: a trial of at least six months with a first line MS disease modifying drug therapy AND experienced at least one disabling attack/relapse while on 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: needle phobia, patient preference for oral therapy over injections or skin reactions at injection site.
- MRI lesion evidence is defined as: three or more new lesions.
- A disabling attack/relapse 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.
- EDSS score less than or equal to 5.5 specifies that: patients must be able to ambulate at least 100 metres without assistance.
- Renewal requests for patients who have experienced more than one disabling attack/relapse in the past year will be reviewed on a case-by-case basis.