Limited coverage drugs – teriflunomide

Last updated on September 27, 2024

Generic name

teriflunomide (Aubagio®)

Strength

14 mg

Form

film-coated tablet

Special Authority criteria

Approval period

Initial

As first-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (MS) diagnosed according to the current clinical criteria 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:

  1. Patient is ambulatory with or without aid (EDSS of 6.5 or less) AND
  2. Patient is 18 years of age or older

 

15 months

Renewal

As first-line or second-line monotherapy, when prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS, AND who 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 prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS 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.
  • Important: 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.
  • PharmaCare coverage and actual reimbursement are subject to the rules of a patient’s PharmaCare plan, including any annual deductible and any other applicable PharmaCare pricing policy.
  • 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 requests

Generic Transition Support