Document ID: chunk:federal_register_of_legislation:F2024L01389:schedule:1:p48
Version: federal_register_of_legislation:F2024L01389
Segment Type: schedule
Provision Reference: sch 1 (pt 48/66)
Character Range: 138448–143791

Streamlined Authority Code 16009
                         Buprenorphine with naloxone  The treatment must be within a framework of medical, social and psychological treatment.
                                                      The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum 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
                         Galcanezumab                 Initial treatment
                                                      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