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Limited coverage drugs – fingolimod

Last updated on August 26, 2024

Generic name

fingolimod

Strength

0.5 mg

Form

capsule

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. 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:

  • Patient has failed to respond1 to full and adequate courses of treatment with at least one first line MS disease modifying drug therapy OR has documented intolerance2 to at least two of these therapies
    AND
  • Evidence that patient has had a significant increase in T2 lesion load compared to a previous MRI scan3 OR at least one gadolinium-enhancing lesion
    AND
  • Patient has had one or more disabling attack/relapses4 in the previous year
    AND
  • Patient has not experienced a heart attack or stroke in the last six months and does not have a history of sick sinus syndrome, atrioventricular block, significant QT prolongation, bradycardia, ischemic heart disease, or congestive heart failures
    AND
  • Patient has a recent Expanded Disability Status Scale (EDSS) score less than or equal to 5.5
    AND
  • Prescribed by a neurologist from a designated multiple sclerosis clinic and the request is received within 90 days of a recent neurological examination

15 months

Renewal:

  • Prescribed by a neurologist from a designated multiple sclerosis clinic
    AND
  • Patients must be stable or have experienced no more than one disabling attack/relapse4 in the past year
    AND
  • Must provide details from a neurological examination that has taken place within the past 90 days. Details include the exam date AND EDSS score5

24 months

Practitioner exemptions

  • None

Special notes

  1. 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).
  2. 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.
  3. MRI lesion evidence is defined as: three or more new lesions.
  4. 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.
  5. EDSS score less than or equal to 5.5 specifies that: patients must be able to ambulate at least 100 metres without assistance.
  6. 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.
  7. 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)