RADICAVA (edaravone)

RADICAVA (edaravone)

Office-Administered – intravenous (IV)

Indications for Prior Authorization:

• Amyotrophic lateral sclerosis (ALS): Treatment of ALS.

Coverage Criteria:

For diagnosis of amyotrophic lateral sclerosis (ALS):

• Prescribed by or in consultation with a neurologist with expertise in the diagnosis of ALS; AND
• Patient is age 18 years or older; AND
• Dose does not exceed FDA labeled maximum (see below):
  • Initial treatment cycle: 60 mg given IV daily for 14 days followed by a 14-day drug-free period for the initial treatment.
  • Subsequent treatment cycles: 60 mg given IV daily for 10 days out of a 14-day period followed by a 14-day drug-free period thereafter; AND
• Patient has had an inadequate response or intolerable side effects to riluzole, or patient will continue to take riluzole; AND
• Patient has scores of two or greater in all items of the most recent ALS Functional Rating Scale-Revised (ALSFRS-R) score at the start of treatment; AND
• Medical records (e.g., chart notes, laboratory values) confirm the patient has a percent forced vital capacity (%FVC) of 80% or greater at the start of treatment.

Reauthorization Criteria:

For diagnosis of amyotrophic lateral sclerosis (ALS):

• Documentation of positive clinical response from therapy (e.g., slowing in the decline of functional abilities); AND
• Patient is not dependent on invasive ventilation or tracheotomy; AND
• Dose does not exceed 60 mg given IV daily for 10 days out of a 14-day period followed by a 14-day drug-free period.

Coverage Duration:

• Initial: 6 months
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• The efficacy of Radicava for the treatment of ALS was established in a 6-month, randomized, placebo-controlled, double-blind study conducted in Japanese patients with ALS who were living independently and had a disease duration of 2 years or less. Over 90% of patients in each study group were being treated with riluzole.
• ALS Functional Rating Scale-Revised (ALSFRS-R) calculator: https://www.mdcalc.com/revised-amyotrophic-lateral-sclerosis-functional-rating-scale-alsfrs-r

Policy Updates:

• 10/19/2021 – policy updated: remove requirement of disease duration of 2 years or less; clarified requirement for a neurologist with expertise in ALS treatment to be consulted; added requirement for documentation of ALSDRS-R score and %FVC to establish targeted ALS population for treatment with Radicava; added reauthorization criteria that requires documentation of clinical response, independent breathing, and FDA-approved dosing.

References:

• 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 2019.
• 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.