Melatonin

PBAC's latest decision on Melatonin: Recommended (2021). Considered for Treatment of insomnia in children aged 2-18 years with Smith-Magenis Syndrome (SMS) where sleep hygiene measures have been insufficient.

Eligible population

Children and adolescents aged 2-18 years with Smith-Magenis Syndrome (SMS) who have failed to achieve adequate response to sleep hygiene measures, with insomnia defined as minimum 3 months of impaired sleep (≤6 hours continuous sleep and/or ≥0.5 hour sleep latency in 3 of 5 nights per week for 2 weeks).

Therapy area

Neurology

Line of therapy

First-line

Evidence base

RCT

Primary endpoint

Sleep latency; total sleep time

Comparator

extemporaneously compounded melatonin; Circadin (2 mg over-the-counter melatonin)

Economic model

Cost-minimisation

ICER note

Cost-minimisation analysis; no formal ICER calculated. PBAC considered melatonin would be acceptably cost-effective at a price per mg of $0.60 at dispensed level, consistent with compounded melatonin and Circadin pricing.

Risk sharing

Risk-sharing arrangement in place — PBAC noted risk of usage in patients without SMS and considered a Risk Sharing Arrangement (RSA) would be appropriate to manage this risk. Sponsor was amenable to RSA and/or Special Pricing Arrangement.

Similar precedents

• Melatonin prolonged release
  similarity 0.88
• Midazolam
  similarity 0.57
• Modafinil
  similarity 0.56
• Somatrogon
  similarity 0.57
• Somatropin
  similarity 0.56
• Siponimod
  similarity 0.56