PBAC's latest decision on Lisdexamfetamine: Recommended with restriction (2020). Considered for Treatment of attention deficit hyperactivity disorder (ADHD) in patients diagnosed after the age of 18 years, with retrospective confirmation of symptoms present before age 12.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2013
Submissions
3
2013 → 2020
Eligible population
Adults diagnosed with ADHD after age 18 years with retrospective confirmation of symptoms of ADHD present before age 12 years, requiring continuous coverage over 12 hours, with maximum daily dose not exceeding 70 mg.
Therapy area
Neurology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
ADHD-RS (ADHD-Rating Scale total score); CGI-I (Clinical Global Impressions-ADHD Improvement)
Key trials
NRP 104-303, SPD489-403, SPD489-316, SPD489-401
Comparator
immediate release dexamfetamine (IR DEX)
Economic model
Cost-minimisation
ICER note
cost-minimisation analysis; no numeric ICER calculated. PBAC based recommendation on cost-effectiveness being acceptable if LDX was no more costly on a per day basis (at ex-manufacturer price) than IR DEX.
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.