Product Details

Rebif

Interferon Beta-1A
22 mcg/0.5 mL
Solution for Subcutaneous Injection
Single-Dose 0.5-mL (22 mcg) Pre-Filled Syringe

DIN/PIN/NPN

02237319

Manufacturer

EMD Serono

Formulary Listing Date

2023-04-28

Unit Price

165.5460

Amount MOH Pays

165.5460

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

92:20:00 Biologic Response Modifiers

Therapeutic Note

NO

ATC Code

L03AB07

Interchangeable Products

NO

LU Clinical Criteria

NO

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Multiple Sclerosis Drugs	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 auto-injector For the treatment of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS) (see CIS criteria in next section). For CDMS: Avonex requests for patients with CDMS will be reviewed by external medical experts when the following information is provided: Details of the most recent neurological examination within the last ninety (90) days, including a description of any recent attacks (date and neurological findings) The patient has experienced at least two clinical attacks including one clinical attack within the past year MRI findings as applicable The patient’s EDSS is less than or equal to 6.0 Renewal requests for Avonex can be submitted through the Telephone Request Service. Avonex renewals will be considered for patients who have benefited from therapy. Patients must be stable (i.e., no relapses or attacks during the last year) and the patient’s EDSS must be less than or equal to 6.0 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
Multiple Sclerosis Drugs	Interferon beta-1a 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 For the treatment of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS) (see CIS criteria in next section). For CDMS: Rebif 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 ≤ 6. Duration of Approval: 1 year Renewal requests for Rebif 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
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-1a Brand(s): Avonex, Rebif Dosage Form/Strength: - (Avonex) 30 mcg/0.5 mL prefilled syringe, 30 mcgs prefilled autoinjector; - (Rebif) 22 mcg and 44 mcg syringe injection, 66 mcg and 132 mcg prefilled cartridge In RRMS/CDMS and CIS: EAP will renew coverage of Interferon beta-1a 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