Limited Coverage Drugs - Glatiramer Acetate

 

PharmaCare is changing coverage of glatiramer products.

  • Multiple sclerosis patients currently using Copaxone® brand glatiramer must transition to Glatect™ (in consultation with their prescriber) to maintain PharmaCare coverage.

  • As of November 27, 2018, all Special Authority (SA) requests and renewals for glatiramer acetate for multiple sclerosis patients will be approved for Glatect™ brand only.

  • Patients with existing SA approval for glatiramer will have coverage for both brands during the transition period beginning November 27, 2018 until May 28, 2019, when Copaxone® coverage for MS patients ends.

  • To maintain patients’ coverage, prescribers must write a new prescription for their Copaxone patients, indicating the transition to Glatect. The patient’s existing glatiramer SA remains in effect until the next renewal date.

  • For patients who are medically unable to transition, you can submit a new SA request for exceptional coverage of Copaxone, which will be reviewed by Special Authority on a case-by-case basis. This request must be submitted before May 28, 2019 to ensure continued coverage.

 

Generic Name

glatiramer acetate                

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 2010 McDonald  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:

  • The patient has had at least 2  MS attacks in the previous 2 years, where 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.
    AND
  • The patient is ambulatory with or without aid (EDSS of 6.5 or less). 
    AND
  • The patient is 18 years of age or older.

1 Year

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.

1 Year

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

DISCONTINUATION OF THERAPY

Discontinuation of therapy may be considered for patients who are 60 years of age or older, with inactive disease or stable disease, in the absence of new inflammatory activity within the past 5 years.
 

Practitioner Exemptions

  • Neurologists who have signed a Collaborative Prescribing Agreement (PDF) are not required to submit a Special Authority request form for coverage.
    • A CPA is available for neurologists specializing in MS whose primary place of practice is in a designated MS clinic.
    • 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 criteria; these prescriptions will not be covered automatically.

Special Notes

  • None

Special Authority Request Form