| Summary: | Edaravone (Radicava) is indicated for the treatment of adult patients with amyotrophic lateral sclerosis (ALS). Edaravone is available as a 30 mg/100 mL solution for infusion. It is administered intravenously as 60 mg infusions over 60 minutes daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. In the first month of treatment, edaravone is administered for 14 days (rather than 10). The submitted price is $1,424 per 60 mg, or $1,424 per patient daily and $185,182 per patient annually ($190,880 in the first year of treatment). The manufacturer submitted a cost-effectiveness analysis based on a Markov state-transition model comparing current standard of care (interdisciplinary supportive care plus riluzole) with edaravone plus current standard of care. In standard of care, 85% of patients were concurrently taking riluzole, the only disease-modifying treatment currently available for ALS. The manufacturer assumed that all patients, at any stage of the disease, were eligible for edaravone therapy and that edaravone slowed disease progression at all stages of the disease. The model did not assume a direct treatment effect on disease-specific mortality. The analysis was run over a 20-year time horizon using a three-month cycle length. The analysis adopted a Canadian public health care system perspective. The manufacturer's analysis indicated that edaravone is not cost-effective compared with standard of care, with an incremental cost-effectiveness ratio of $1,957,200 per quality-adjusted life-year (QALY) gained
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