PBAC's latest decision on Melatonin prolonged release: Noted (2021). Considered for Treatment of insomnia in children aged 2-18 years with Autism Spectrum Disorder (ASD) and/or Smith-Magenis Syndrome (SMS), where sleep hygiene measures have been insufficient.
PBAC outcome
Noted
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2021
Submissions
1
2021 → 2021
Eligible population
Children aged 2 to 18 years with Autism Spectrum Disorder (ASD) and/or Smith-Magenis Syndrome (SMS) with insomnia who have failed to achieve adequate response to sleep hygiene measures.
Therapy area
Neurology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Total sleep time; sleep latency
Pivotal trial size
125 patients
Key trials
NEU_CH_7911
Comparator
placebo (representing standard supportive care including behavioural therapy, sleep hygiene, environmental, dietary, and psychological measures)
Economic model
CEA
ICER note
Economic analysis based on cost per responder and cost per responder year; ICER value not stated in public text