PBAC's latest decision on Riluzole: Recommended (2018). Considered for Treatment of amyotrophic lateral sclerosis (ALS) in patients diagnosed by a neurologist, with disease duration not exceeding 5 years, at least 60% predicted forced vital capacity, ambulatory or with upper limb/swallowing ability, without prior tracheostomy or respiratory failure.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2018
Submissions
1
2018 → 2018
Eligible population
Patients with amyotrophic lateral sclerosis diagnosed by a neurologist, with disease duration ≤5 years, FVC ≥60% predicted, ambulatory or with upper limb/swallowing ability, no prior tracheostomy or respiratory failure.
Therapy area
Neurology
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
Other
Pivotal trial size
30 patients
Key trials
CRO-PK-11-251
Comparator
riluzole tablets
Economic model
Not modelled
ICER note
No economic analysis was submitted; this was a minor submission for a new formulation of an existing drug.