Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p272
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 272/312)
Character Range: 17170736–17179132

listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.

C16015              P16015         CN16015          Buprenorphine                                                          Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16015
                                                                                                                           Must be treated by a health care professional; AND
                                                                                                                           The treatment must be within a framework of medical, social and psychological treatment; AND
                                                                                                                           Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone.
                                                                                                                           The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.
C16018              P16018         CN16018          Eptinezumab                                                            Chronic migraine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 16018
                                                                                                                           Initial treatment
                                                    Galcanezumab                                                           Must be treated by a neurologist; or
                                                                                                                           Must be treated by a general practitioner in consultation with a neurologist; AND
                                                                                                                           Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND
                                                                                                                           Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND
                                                                                                                           Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND
                                                                                                                           Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug;
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.
                                                                                                                           Patient must have the number of migraine days per month documented in their medical records.
C16021              P16021         CN16021          Romosozumab                                                            Severe established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       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 PBS indication prior to 1 November 2024; AND
                                                                                                                           Patient must not have received PBS-subsidised treatment with any of the following prior to initiating non-PBS-subsidised treatment with this drug for this condition: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab; AND
                                                                                                                           Patient must be at very high risk of fracture; AND
                                                                                                                           Patient must have had a Bone Mineral Density (BMD) T-score of -2.5 or less prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have had a symptomatic fracture due to minimal trauma prior to starting non-PBS-subsidised treatment with this drug for this