Limited coverage drugs – teriflunomide

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: 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 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

• Log in to eForms
• HLTH 5351 - Disease Modifying Drugs for Multiple Sclerosis - Initial/Renewal/Switch (PDF, 567KB)

Generic Transition Support

• HLTH 5845 - Aubagio/Teriflunomide Patient List Request (PDF, 79KB)