WHA
 

Radicava (edaravone)

Indications for Prior Authorization

Radicava (edaravone) injection, Radicava ORS (edaravone) oral suspension
  • For diagnosis of Amyotrophic Lateral Sclerosis (ALS)
    Indicated for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Criteria

Brand Radicava IV, generic edaravone IV, Radicava ORS

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Amyotrophic Lateral Sclerosis (ALS)

  • Diagnosis of “definite” or “probable” amyotrophic lateral sclerosis (ALS) per the revised EL Escorial and Airlie House diagnostic criteria
    • AND
  • Prescribed by or in consultation with a neurologist with expertise in the diagnosis of ALS
    • AND
  • Patient has scores greater than or equal to 2 in all items of the ALS Functional Rating Scale-Revised (ALSFRS-R) criteria at the start of treatment
    • AND
  • Patient has a percent (%) forced vital capacity (%FVC) greater than or equal to 80% at the start of treatment
    • AND
  • Patient is not dependent on invasive ventilation or tracheostomy

  • Guideline ID
    GL-533239

  • Formulary
    Premium

  • Effective date
    May 1, 2026

  • P&T approval date
    Jul 26, 2017

P & T Revisions

2026-03-03, 2025-09-03, 2024-12-23, 2024-09-05, 2024-07-31, 2023-10-26, 2023-10-16, 2022-08-04, 2022-07-05, 2022-06-08, 2021-08-03, 2020-07-20

  1. Abe K, Itoyama Y, Sobue G, et al. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014; 15(7-8):610-7.
  2. Radicava Prescribing Information. Mitsubishi Tanabe Pharma. December 2024.
  3. The Writing Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomized, double-blind, placebo-controlled trial. Lancet Neurol 2017; 16(7):505-512.
  4. Radicava ORS Prescribing Information. Mitsubishi Tanabe Pharma. Jersey City, NJ. December 2024.
  5. Edaravone Injection Prescribing Information. Piramal Crtical Care, Inc. Bethlehem, PA. May 2024.
  1. Authorization period is based on the pivotal study duration of 24 weeks. [1-3]
  • 2026-03-03: Removing reauthorization requirement as part of extended reauthorization program
  • 2025-09-03: 2025 Annual Review - updated references
  • 2024-12-23: Addition of new Edaravone GPI
  • 2024-09-05: 2024 Annual Review - no changes
  • 2024-07-31: Addition of generic edaravone injection
  • 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-10-16: Annual review. Added ventilation criterion to initial auth.
  • 2022-08-04: 2022 Annual Review - no criteria changes
  • 2022-07-05: Addition of new oral formulation, Radicava ORS
  • 2022-06-08: Removed submission of medical records requirement from prior authorization criteria
  • 2021-08-03: 2021 Annual Review, no changes to criteria.
  • 2020-07-20: 2020 Annual Review, no changes to criteria, background updates only.