PBAC's latest decision on Edaravone: Recommended with restriction (2024). Considered for Adjunct treatment to current standard of care with or without riluzole in patients with amyotrophic lateral sclerosis (ALS) who are independent in activities of daily living with normal respiratory function and disease onset within two years.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$115k/QALY
Range: $95k/QALY–$115k/QALY
Submissions
2
first 2023
Submissions
2
2023 → 2024
Eligible population
Adults with amyotrophic lateral sclerosis diagnosed within 2 years of symptom onset, independent in activities of daily living, with normal respiratory function (≥80% predicted FVC/SVC), not requiring assistance for eating or ambulation, with ALSFRS-R score of at least 2 on each item, without tracheostomy or prior respiratory failure.
Therapy area
Neurology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
ALSFRS-R
Key trials
Study 19, Study 16
Comparator
current standard of care with or without riluzole
Economic model
CUA
Submission history
Nov 2023: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required — ICER $115k/QALY