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

35.0000

Amount MOH Pays

35.0000

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

92:20:00 Biologic Response Modifiers

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 Glatect 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 Glatect 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.

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 Effective September 27, 2018, Glatiramer as Copaxone for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS)/ Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS) will only be considered for funding for existing EAP renewals. All EAP requests for patients treatment-naïve to Copaxone should consider Glatiramer as Glatect upon meeting Limited Use Criteria on the Ontario Drug Benefit Formulary effective on September 27, 2018. Effective March 31, 2018, all patients on glatiramer as Copaxone through the ODB program should transition to Glatiramer as Glatect upon meeting Limited Use Criteria on the Ontario Drug Benefit Formulary. Glatiramer as Copaxone for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS)/ Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS) will not be funded by the Ministry for any patient unless the patient is approved for an exemption from the biologic switch policy through the Exceptional Access Program on a case-by-case basis to approve ongoing access to originator Copaxone. For the treatment of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS) (see criteria in next section). Also, note that patients who are treatment naïve to Copaxone should refer to the formulary for consideration of Glatect. For CDMS: Copaxone requests for patients with CDMS will be reviewed by external medical experts when the following information is provided: Date and details of the most recent neurological examination (within the last 90 days); AND Dates and details (e.g., neurological findings) of at least two clinical attacks, including one clinical attack within the past year; AND EDSS score ≤ 5. Duration of Approval: 1 year Renewal requests for Copaxone can be submitted through the Telephone Request Service and will be considered for patients who have benefited from therapy and have an EDSS score ≤ 6. The physician must provide the following information: Description of the patient’s clinical course in the last year, including details of all attacks; Date and details of the most recent neurological examination (within the last 90 days); AND The patient’s most recent EDSS score. As applicable, include information regarding the requesting physician’s specialty (e.g., is the physician a neurologist or a physician with specialized experience with multiple sclerosis (MS), the name of the MS clinic where the neurologist is based, or an MS consult note supporting the diagnosis as this information may reduce the turnaround times for assessment. Duration of Approval: - First Renewal: 2 years - Second and subsequent renewals: 5 years EAP Drug Request Form: Standard Form for EAP Drug Requests
Clinically Isolated Syndrome Drugs	Glatiramer acetate Brand(s): Copaxone 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
Renewals of Multiple Sclerosis Drugs – Telephone Request Service (TRS) Drugs	Glatiramer Acetate Brand(s): Copaxone, Glatect Dosage Form/Strength: 20 mg/mL Injection All treatment naïve patients will be required to access Glatiramer biosimilar Glatect through the ODB formulary upon meeting Limited Use Criteria. In RRMS/CDMS: EAP will renew coverage of Glatiramer for patients who have benefited from therapy and have an EDSS score ≤ 6. The physician must provide the following information: Description of the patient’s clinical course in the last year, including details of all attacks; Date and details of the most recent neurological examination (within the last 90 days); AND EDSS score Standard Approval Duration: 2 years In CIS: EAP will renew coverage of Glatiramer only for patients who have benefited from therapy and have an EDSS score ≤ 6. The physician must provide the following information: Description of the patient’s clinical course in the last year, including details of all attacks; Date and details of the most recent neurological examination (within the last 90 days); AND EDSS score Standard Approval Duration: 2 years for first renewal, 5 years for 2nd and subsequent renewals Renewal requests where patients have experienced more than 1 attack in the past year will be externally reviewed.

Product Monograph