Limited coverage criteria – teriflunomide

Last updated on March 24, 2025

 

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Generic name

teriflunomide

Strength & form

14 mg film-coated tablet

Special Authority criteria

Approval period

Initial

As first-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) diagnosed according to the current clinical criteria and magnetic resonance imaging (MRI) evidence, when a Special Authority request is submitted by a neurologist from a designated MS clinic, for patients who meet ALL of the following criteria:

Patient is ambulatory with or without aid (EDSS of 6.5 or less)

AND

Patient is 18 years of age or older

 

15 months

Renewal

As first-line or second-line monotherapy, when a Special Authority request is submitted by a by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS (RRMS)

AND

Have demonstrated that the therapeutic benefits outweigh any potential risks, as shown by relapse rate, EDSS, MRI scan, or overall clinical impression

 

24 months

Change of therapy

As second-line monotherapy, when a Special Authority request is submitted by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS (RRMS) who have experienced failure or intolerance to a previous disease-modifying therapy

 

15 months

Practitioner exemptions

  • A Collaborative Prescribing Agreement (CPA) (PDF, 400KB) is available to neurologists specializing in MS whose primary place of practice is a designated MS clinic. Neurologists who have signed a CPA are not required to submit a Special Authority request for coverage.
  • PharmaCare covers teriflunomide for patients who meet the limited coverage criteria and whose prescription has been written by a neurologist who has entered into a CPA
  • Each CPA must be signed by the practitioner who is requesting coverage and not a delegate
  • Practitioners who have not signed a CPA may submit a Special Authority request if the patient meets the criteria above. These prescriptions are not covered automatically

Special notes

  • 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)

Generic Transition Support