Pharmacy Prior Authorization Criteria

Radicava (edaravone)

For diagnosis of Amyotrophic Lateral Sclerosis (ALS)
Indicated for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A]
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

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)
For diagnosis of Amyotrophic Lateral Sclerosis (ALS)

Patient demonstrates positive clinical response to therapy.(e.g., slowing in the decline of functional abilities)

AND

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

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.
Radicava Prescribing Information. Mitsubishi Tanabe Pharma. December 2022.
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.
Radicava ORS Prescribing Information. Mitsubishi Tanabe Pharma. Jersey City, NJ. May 2022.
Edaravone Injection Prescribing Information. Piramal Crtical Care, Inc. Bethlehem, PA. May 2024.

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.