Product Details

Glatect

Glatiramer Acetate
20 mg/mL
Solution for Subcutaneous Injection
Single-Use 1-mL Prefilled Syringe

DIN/PIN/NPN

02460661

Manufacturer

Pharmascience Inc.

Formulary Listing Date

2018-09-27  

Unit Price

35.8400

Amount MOH Pays

35.8400

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L03AX13

Interchangeable Products

NO  

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
535 1 year

As monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) meeting ALL the following criteria:

-Recent neurological examination consistent with the diagnosis of RRMS; AND

-Lesions typical of multiple sclerosis on brain magnetic resonance imaging (MRI); AND

-Experienced at least 2 clinical attacks in their lifetime with one attack occurring within the prior year; AND

-EDSS score less than or equal to 6.0 prior to start of treatment; AND

-Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis.

Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy.
536 1 year

As monotherapy for the treatment of patients who have experienced a single demyelinating event/ Clinically Isolated Syndrome (CIS) meeting ALL the following criteria:

- CIS occurred within the prior 12 months; AND

- Recent neurological examination; AND

- Lesions typical of CIS confirmed on brain magnetic resonance imaging (MRI); AND

- EDSS score less than or equal to 6.0 prior to start of treatment; AND

- Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis

Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy.
537 1 year

Renewal of therapy for patients diagnosed with relapsing remitting multiple sclerosis (RRMS) or a single demyelinating event /Clinically Isolated Syndrome (CIS) who meet ALL the following criteria:

- Used as monotherapy for the treatment of RRMS or CIS; AND

- EDSS score less than or equal to 6.0; AND

- Disease activity is stabilized as determined by a neurological exam and the number of clinical relapses experienced while on treatment; AND

- Prescribed by a neurologist experienced in the treatment of Multiple Sclerosis (MS) OR a prescriber in consultation with a neurologist overseeing the patient's MS.
 

Requirements

NA

EAP Criteria

 
Therapeutic Class Reimbursement Criteria
Multiple Sclerosis Drugs

Glatiramer acetate – See Formulary listing for Glatect

  • Brand(s): Copaxone, Glatect (available as Limited Use drug on ODB formulary)
  • Dosage Form/Strength: 20 mg/mL pre-filled syringe for subcutaneous injection
 

Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx

Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions.

Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document).

It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g., manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023.
Clinically Isolated Syndrome Drugs

Glatiramer acetate (Coverage is provided for Glatect)

  • Brand(s): Glatect; Copaxone will only be funded for patients who meet a medical exemption as of December 29, 2023 (Refer to the Biosimilar policy)
  • Dosage Form/Strength: 20 mg/mL pre-filled syringe for subcutaneous injection

Interferon beta-1a

  • Brand(s): Avonex PS, Avonex Pen
  • Dosage Form/Strength: 30 mcg/0.5mL prefilled syringe for intramuscular injection, 30 mcg single-use prefilled autoinjector

  • Brand(s): Rebif
  • Dosage Form/Strength: 22 mcg and 44 mcg prefilled syringe for subcutaneous injection, 66 mcg/ml and 132 mcg/ml pre-filled cartridge

Interferon beta-1b

  • Brand(s): Betaseron
  • Dosage Form/Strength: 0.3 mg/vial subcutaneous injection

  • Brand(s): Extavia
  • Dosage Form/Strength: 0.3 mg/vial subcutaneous injection

For the treatment of Clinically Isolated Syndrome (CIS): requests for patients who have experienced a single demyelinating event will be reviewed by external medical experts when the following information is provided: 

  • Date and details of the most recent neurological examination which must have been conducted within the last ninety days of the request; 

  • The patient’s EDSS is less than or equal to 6.0 (please provide EDSS score); AND 

  • The patient’s clinically isolated syndrome occurred within the last twelve months. 

Duration of Approval: 1 year 

Renewal requests will be assessed according to the following criteria: 

  • the requesting physician provides the date and details of the patient’s most recent neurological examination and EDSS scores; 

  • the patient’s neurological examination occurred within that last ninety days; 

  • the patient is stable (i.e., no relapses or attacks during the last year) AND 

  • the patient’s EDSS is less than or equal to 6.0

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph