Product Details

Extavia

Interferon Beta-1B
0.3 mg (9.6 MIU)/Vial
Powder for Solution for Subcutaneous Injection
Single-Use 0.3-mg Vial Pack (Preservative-Free)

DIN/PIN/NPN

02337819

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2021-04-30

Unit Price

104.6920

Amount MOH Pays

104.6920

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

92:20:00 Biologic Response Modifiers

Therapeutic Note

NO

ATC Code

L03AB08

Interchangeable Products

NO

LU Clinical Criteria

NO

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Multiple Sclerosis Drugs	Interferon beta-1b Brand(s): Betaseron Dosage Form/Strength: 0.3 mg/vial subcutaneous injection For the treatment of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS) (see criteria in next section) For CDMS: Betaseron requests for patients 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 ≤ 6. Duration of Approval: 1 year Renewal requests for Betaseron 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; AND 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
Multiple Sclerosis Drugs	Interferon beta-1b Brand(s): Extavia Dosage Form/Strength: 0.3 mg/vial subcutaneous injection For the treatment of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS) (see criteria in next section). For CDMS: Extavia requests for patients 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 ≤ 6. Duration of Approval: 1 year Renewal requests for Extavia 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	Interferon beta-1b Brand(s): Betaseron, Extavia Dosage Form/Strength: - Betaseron 9.6 MIU = 0.3mg inj - Extavia 0.3 mg vial injection In RRMS/CDMS and CIS: EAP will renew coverage of Interferon beta-1b only for patients who have benefited from therapy and have an EDSS score ≤ 6. The prescriber 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