Radicava™
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.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
