Limited coverage drugs – glatiramer acetate

Last updated on August 26, 2024

Special Authority requests can now be submitted online. It's simple and quick!

Generic name	glatiramer acetate (Glatect™, Mylan-Glatiramer)
Strength & form	20 mg/mL 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 the following criteria: Patient is ambulatory with or without aid (Expanded Disability Status Scale [EDSS] of 6.5 or less) AND 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

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 the following criteria:

Patient is ambulatory with or without aid (Expanded Disability Status Scale [EDSS] of 6.5 or less)

AND

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
Each CPA must be signed by the neurologist who is requesting coverage (not a delegate)

Special notes

PharmaCare coverage of glatiramer acetate is automatic for patients who meet the limited coverage criteria and whose prescription has been written by a neurologist who has entered into a CPA. Practitioners who have not signed a CPA may submit a Special Authority request if the patient meets criteria above. These prescriptions will be considered on a case-by-case basis
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

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