MelatoninCircadin
Treatment of insomnia in children aged 2-18 years with Smith-Magenis Syndrome (SMS) where sleep hygiene measures have been insufficient.
Decisions on record
- Meeting Dec 2023 Recommended Insomnia in patients aged 2–18 with Smith-Magenis syndrome (SMS) no PSD
- Meeting Jul 2021 Deferred Insomnia in Smith-Magenis syndrome
- Meeting Mar 2021 Not recommended Insomnia in children aged 2-18 with ASD and/or SMS
Access path
- TGA registered · Circadin
TGA label narrower than the PBS population
- Nov 2021Recommended
vs extemporaneously compounded melatonin; Circadin (2 mg…
- PBS listing · Authority Required
From the public summary
5.1 The PBAC deferred making a recommendation for melatonin for the treatment of insomnia in patients with Smith-Magenis Syndrome (SMS) to allow for further consultation with the sponsor regarding a cost-effective price for melatonin.PSD · Jul 2021
5.2 The PBAC noted the resubmission presented a revised restriction for the SMS population and advised that, in addition to the changes proposed by the Secretariat in paragraph 3.1, the following amendments would be appropriate: The eligibility criteria should be consistent with that used in the clinical trials, rather than referring to the DSM-5 or ICSD-3 classifications: ‘Patient must have failed to achieve an adequate response to sleep hygiene and …PSD · Jul 2021
4.5 The PBAC previously considered prolonged release melatonin may be acceptably cost- effective for the SMS population at a price consistent with that of extemporaneously compounded melatonin.PSD · Jul 2021
4.6 The resubmission stated that prolonged release melatonin (and specifically, Slenyto) provided additional benefits over immediate release (IR) compounded melatonin: IR melatonin only addresses sleep latency in SMS. Prolonged release melatonin improves both sleep latency and total sleep time for SMS patients.PSD · Jul 2021
4.2 The PBAC noted and welcomed the input from a health care professional and the National Aboriginal Community Controlled Health Organisation (NACCHO) via the Consumer Comments facility on the PBS website. The comments supported the PBS listing of melatonin for Aboriginal or Torres Strait Islander children. 3PSD · Jul 2021
Cost-effectiveness
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.
Decision context
PopulationChildren 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).
Risk sharingPBAC 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended | extemporaneously compounded melatonin; Circadin (2 mg over-the-counter melatonin) | — | RCT · Sleep latency; total sleep time |
Consumer voice
A health care professional and the National Aboriginal Community Controlled Health Organisation (NACCHO) provided input supporting the PBS listing of melatonin for Aboriginal or Torres Strait Islander children.
The PBAC noted and welcomed the input from a health care professional and the National Aboriginal Community Controlled Health Organisation (NACCHO) via the Consumer Comments facility on the PBS website. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to Smith-Magenis Syndrome only, excluding ASD from the TGA-registered indication.