Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p141
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 141/312)
Character Range: 16353349–16360343

of 'severe chronic plaque psoriasis'.
                                                                                                                           This assessment must be documented in the patient's medical records.
C15329              P15329         CN15329          Osimertinib                                                            Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Initial treatment as second-line EGFR tyrosine kinase inhibitor therapy
                                                                                                                           Patient must not have previously received this drug for this condition; AND
                                                                                                                           The treatment must be as monotherapy; AND
                                                                                                                           Patient must have a WHO performance status of 2 or less; AND
                                                                                                                           The condition must have progressed on or after prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition; AND
                                                                                                                           Patient must have evidence of EGFR T790M mutation in tumour material at the point of progression on or after first line EGFR TKI treatment.
                                                                                                                           PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).
C15333              P15333         CN15333          Melatonin                                                              Insomnia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Initial
                                                                                                                           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).
                                                                                                                           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.
                                                                                                                           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,