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Drug - Radicava™ (edavarone) [Mitsubishi Tanabe]

February 2018

Therapeutic area - Amyotrophic lateral sclerosis (ALS)

Initial criteria

  • Patient must be at least 18 years old AND
  • Patient has a diagnosis of clinically definite or probable amyotrophic lateral sclerosis (ALS) based on El Escorial revised criteria or Awaji criteria AND
  • ALS disease duration is 2 years or less AND
  • Patient has a predicted forced vital capacity of ≥ 80% AND
  • Patient has retained functionality of most activities of daily living (scores ≥ 2 on each item of the ALS Functional Rating Scale – Revised [ALSFRS-R]) AND
  • Trial and failure of Rilutek (riluzole) unless contraindicated
  • Patient has no history of hypersensitivity reactions to edaravone or product components
  • Initial approval is for 6 months

Renewal criteria

  • Patient has responded to therapy compared to pretreatment baseline with disease stability or mild progression indicating a slowing of decline on the ALSFRS-R (e.g., cumulative score on ALSFRS-R remains ≥ 4) AND
  • Patient has not experienced hypersensitivity reactions (including sulfite allergy) or unacceptable toxicity (e.g., contusion, gait changes, respiratory adverse effects, dermatitis)
  • Renewal approval is for 6 months

Quantity limits

  • First month: 28 of the 30 mg/100 mL injections per 28 days
  • Subsequent months: 20 of the 30 mg/100 mL injections per 28 days

Billing for Radicava

Radicava must be billed as a medical claim.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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