Insomnia

Treatment Phase: Initial

Clinical criteria:

• Patient must have Smith-Magenis Syndrome confirmed by genetic testing,

AND

• The condition must be inadequately responsive to sleep hygiene measures, resulting in the patient experiencing a period of at least 12 consecutive weeks of impaired sleep (see definition of impaired sleep below).

Treatment criteria:

• Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types.

Population criteria:

• Patient must be at least 2 years of age, but yet to turn 18 years of age, at treatment initiation with this drug.

Definition:

For the purposes of administering this restriction, Smith-Magenis Syndrome is confirmed by the deletion or variation of the retinoic acid induced 1 (RAI1) gene on chromosome 17p11.2

Definition:For the purposes of administering this restriction, impaired sleep is at least one of:(i) less than 6 hours of continuous sleep on at least 3 occasions over a given 5-day interval; (ii) taking at least half an hour to fall asleep on at least 3 occasions over a given 5-day interval.

Prior to seeking authorisation for this pharmaceutical benefit, document the amount of continuous sleep/sleep latency in the patient's medical records for a period of 2 consecutive weeks, but ensure the impairment has been observed for at least 12 consecutive weeks. The documented values (averages) will form baseline measurements upon which the extent of response to treatment is to be considered under the Continuing treatment listing.

The observations of continuous sleep/sleep latency may be based on any of the following, including a mix of: patient self-reporting, parental observation, documented medical history, sleep studies conducted by health professionals.

Insomnia

Treatment Phase: Continuing

Clinical criteria:

• Patient must have previously received PBS-subsidised treatment with this drug for this condition,

AND

• Patient must have experienced/maintained a clinically meaningful response (as defined below) to the preceding supply of this drug - document the response improvement in the patient's medical records,

AND

• The treatment must have commenced between the ages of 2 to 17 years inclusive.

Treatment criteria:

• Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types; OR

• Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

Treatment must cease if a patient is unable to achieve a clinically meaningful response on the maximum dose of melatonin specified in the Product Information.

Definition:

A clinically meaningful response to this drug is defined as at least one of:

(i) an increase in total sleep time of at least 45 minutes per night on average from baseline;

(ii) a decrease in the time it takes to fall asleep by at least 15 minutes per night on average from baseline.