Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p148
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 148/312)
Character Range: 16393634–16399741

years inclusive.
                                                                                                                           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.
C15369              P15369         CN15369          Inclisiran                                                             Familial heterozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                           Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2024; AND
                                                                                                                           The treatment must be in conjunction with dietary therapy and exercise; AND
                                                                                                                           The condition must have been confirmed by genetic testing prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6 prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have had an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease at the time non-PBS-subsidised treatment with this drug for this condition was initiated; OR
                                                                                                                           Patient must have had an LDL cholesterol level in excess of 5 millimoles per litre at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND
                                                                                                                           Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must have developed a clinically important product-related adverse event necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
                                                                                                                           Patient must have been treated