Limited coverage drugs – dimethyl fumarate

Important note:

After February 5, 2022, the brand formulation of dimethyl fumarate (Tecfidera™) is only eligible for partial coverage; generic dimethyl fumarate is eligible for full coverage.

Generic name

dimethyl fumarate

Strength

120 mg, 240 mg

Form

delayed-release capsule

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 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 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 in a designated MS clinic. Neurologists who have signed a CPA are not required to submit a Special Authority request form for coverage
  • Important: PharmaCare covers dimethyl fumarate 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 is subject to the rules of a patient’s PharmaCare plan, including any annual deductible requirement and any other applicable PharmaCare pricing policy
  • Each CPA must be signed by the neurologist 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 will not be 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)