PBAC's latest decision on Guanfacine: Recommended with restriction (2018). Considered for Treatment of attention deficit hyperactivity disorder (ADHD) as add-on therapy to stimulants in patients aged 6-18 years who have failed to achieve an adequate response to optimised stimulant therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
2
first 2017
Submissions
2
2017 → 2018
Eligible population
Children and adolescents aged 6-18 years with ADHD diagnosed according to DSM-5 criteria, receiving maximum tolerated dose of stimulant (dexamphetamine, methylphenidate or lisdexamfetamine) for at least four weeks, experiencing residual moderate to severe ADHD symptoms resulting in impaired functioning in at least one setting.
Therapy area
Neurology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Surrogate
Pivotal trial size
449 patients
Key trials
Trial 313
Comparator
placebo
Economic model
CUA
Submission history
Jul 2017: Recommended with restriction · Authority Required