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.

 

Last review date: November 1, 2021

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