Product Details

Radicava

Edaravone
105 mg/5 mL
Oral Suspension


DIN/PIN/NPN

02532611

Manufacturer

Innomar Strategies, Inc.

Formulary Listing Date

2023-07-19  

Unit Price

184.0000

Amount MOH Pays

184.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

N07XX14

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Central Nervous System Drugs

Edaravone

  • Brand(s): Radicava
  • Dosage Form/Strength: 30mg/100mL IV solution, 105 mg/5mL oral suspension
  • Effective date: May 11, 2020 (IV solution); July 19, 2023 (Oral suspension)

Initiation Criteria:

For the treatment of amyotrophic lateral sclerosis (ALS) in patients meeting ALL the following criteria:

  1. Diagnosis of definite ALS or probable ALS; AND 

  1. ALS symptom onset occurred within the past two years or less; AND 

  1. Has a score greater than or the same as two (2) points on each of the 12 items of the ALS Functional Rating Scale – Revised (ALSFRS-R); AND 

  1. Forced vital capacity (FVC) is greater than or equal to 80% of predicted; AND 

  1. Does not require permanent non-invasive or invasive ventilation; AND 

  1. Is under the care of a specialist with experience in the diagnosis and management of ALS 

Discontinuation Criteria: 

Reimbursement will be discontinued in patients who meet any one of the following criteria: 

  • patient becomes non-ambulatory (ALSFRS-R score ≤ 1 for item 8) AND is unable to cut food and feed themselves without assistance, irrespective of whether a gastrostomy is in place (ALSFRS-R score below 1 for item 5a or 5b); OR 

  • patient requires permanent non-invasive or invasive ventilation.

Renewal Criteria:
Renewals will be considered in patients who do not meet the discontinuation criteria.

Recommended dose: 

60 mg administered as an intravenous infusion according to the following schedule: 

  • An initial treatment cycle with daily doses for 14 days, followed by a 14-day drug-free period 

  • Subsequent treatment cycles with daily doses for 10 days out of 14-day periods, followed by 14-day drug-free periods. 

105 mg (5 mL) administered orally or via a feeding tube according to the following schedule: 

  • an initial treatment cycle with daily doses for 14 days, followed by a 14-day drug-free period, and 

  • subsequent treatment cycles with daily doses for 10 days out of 14-day periods, followed by 14-day drug-free periods. 

Approval duration of initials and renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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