PBAC's latest decision on Nabiximols: Recommended with restriction (2020). Considered for Adjunctive treatment of moderate to severe spasticity in patients with multiple sclerosis who have not adequately responded to oral anti-spasticity agents.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
2
first 2013
Submissions
2
2013 → 2020
Eligible population
Adults with moderate to severe spasticity due to multiple sclerosis (NRS ≥4) who have not adequately responded to oral anti-spasticity agents and demonstrate clinically significant improvement during an initial trial of therapy.
Therapy area
Neurology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Percentage of patients who responded after 12 weeks of randomised treatment (NRS score improvement of 30% or more)
ICER not stated in the PSD; economic analysis based on cost-utility but specific ICER values not published in this public summary document.
ICER (historical)
$15k/QALY–$45k/QALY in an earlier submission (2013) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Jul 2013: Not recommended · Authority Required — ICER $45k/QALY
Mar 2020: Recommended with restriction · Authority Required