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 amyotrophic lateral sclerosis (ALS)
    • AND
  • Prescribed by or in consultation with a neurologist
    • 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-711731

  • Formulary
    Premium

  • Effective date
    Nov 1, 2026

  • P&T approval date
    Jul 26, 2017

P & T Revisions

2026-09-17, 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/Radicava ORS Prescribing Information. Shionogi Inc. Florham Park, NJ. May 2026.
  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. Edaravone Injection Prescribing Information. XGen Pharmaceuticals DJB, Inc. Big Flats, NY. March 2025.
  1. Authorization period is based on the pivotal study duration of 24 weeks. [1-3]
  • 2026-09-17: 2026 annual review: revised diagnosis check and prescriber requirement. Background updates.
  • 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.