Limited Coverage Drugs - Fingolimod

Generic Name / Strength / Form

fingolimod / 0.5 mg / 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 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:

  • Patient has failed to respond2 to full and adequate courses of treatment with at least one first line MS disease modifying drug therapy OR has documented intolerance3 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 scan4 OR at least one gadolinium-enhancing lesion

    AND
     
  • Patient has had one or more disabling attack/relapses5 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 5.56

    AND
     
  • Is prescribed by a neurologist experienced in the management of RRMS and the request is received within 90 days of a recent neurological examination.
1 year
Renewal:
  • Prescribed by a neurologist experienced in the management of RRMS

    AND
     
  • Patients must be stable or have experienced no more than one disabling attack/relapse in the past year7

    AND
     
  • Must provide details from a neurological examination that has taken place within the past 90 days. Details include the exam date AND EDSS score.
2 years

Practitioner Exemptions

  • No practitioner exemptions

Special Notes

  1. The current clinical criteria for the diagnosis of MS are the McDonald criteria, as of October 26, 2010.
  2. 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).
  3. 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.
  4. MRI lesion evidence is defined as: three or more new lesions.
  5. 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.
  6. EDSS score less than or equal to 5.5 specifies that: patients must be able to ambulate at least 100 metres without assistance.
  7. 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.

Special Authority Request Form(s)