Limited Coverage Drugs - Dimethyl Fumarate

Generic Name / Strength / Form

dimethyl fumarate / 120 mg, 240 mg / 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 McDonaldi 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 has had at least 2 disabling attacksii of MS in the previous 2 years, AND
  2. Patient is ambulatory with or without aid (EDSS of 6.5 or less), AND
  3. Patient is 18 years of age or older.

Note:

  1. The McDonald clinical criteria for the diagnosis of MS are current as of October 26, 2010.
  2. An attack 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 1 month.

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.

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.

1 Year
1 Year
1 Year

 

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 coverage 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

  • None

Special Authority Request Form(s)