PBAC's latest decision on Lisdexamfetamine dimesilate: Recommended with restriction (2014). Considered for Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients diagnosed between the ages of 6 and 18 years (inclusive) who have demonstrated a response to immediate release dexamphetamine sulphate with no emergence of serious adverse events and who require continuous coverage over 12 hours.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
Children and adolescents aged 6-18 years with ADHD (diagnosed per DSM-IV with baseline ADHD-RS-IV total score ≥28) who have demonstrated a response to immediate release dexamphetamine sulphate with no emergence of serious adverse events and require continuous 12-hour coverage.
Therapy area
Mental health
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
ADHD-RS-IV total score (change from baseline)
Pivotal trial size
332 patients
Key trials
SPD489-325, SPD489-301, SPD489-305
Comparator
MPH-OROS (methylphenidate osmotic release oral system) for first-line use; placebo for patients who have not demonstrated adequate response to MPH-OROS
Economic model
CUA
ICER note
Economic evaluations presented (cost-minimisation analysis in children 6-12 years; cost-utility analyses in adolescents 13-17 years and in patients who failed MPH-OROS), but ICER values are redacted in the public summary document.