Limited coverage drugs – glatiramer acetate

Generic name

glatiramer acetate (Glatect™)

Strength

20 mg/mL

Form

pre-filled syringe

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 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 glatiramer acetate 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