Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p139
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 139/312)
Character Range: 16339590–16347105

not have achieved a clinically meaningful glycaemic response with an SGLT2 inhibitor; OR
                                                                                                                           Patient must have a contraindication/intolerance requiring treatment discontinuation of an SGLT2 inhibitor.
                                                                                                                           Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist.
C15303              P15303         CN15303          Tafamidis                                                              Transthyretin amyloid cardiomyopathy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                           Second and subsequent PBS-subsidised prescriptions for this drug
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2; AND
                                                                                                                           The treatment must be ceased where the patient's heart failure has worsened to persistent New York Heart Association (NYHA) Class III/IV heart failure; AND
                                                                                                                           The treatment must be ceased where the patient has received any of: (i) a heart transplant, (ii) a liver transplant, (iii) an implanted ventricular assist device.
                                                                                                                           Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment.
                                                                                                                           Confirm whether heart failure has worsened to NYHA Class III/IV since the last authority application (yes/no).
                                                                                                                           If 'no', continued PBS subsidy is available.
                                                                                                                           If 'yes', continued PBS subsidy is available, but the prescriber must undertake a review of the patient within 3 months to determine whether the worsening heart failure was transient or persistent.
                                                                                                                           Where this subsequent clinical review finds that the heart failure persists as NYHA Class III/IV heart failure despite active treatment with this drug, then PBS subsidy is not available.
C15310              P15310         CN15310          Osimertinib                                                            Stage IB, II or IIIA non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Adjuvant therapy
                                                                                                                           Patient must be continuing existing PBS-subsidised treatment with this drug; OR
                                                                                                                           Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with EGFR-TKI at the time this drug was initiated.
                                                                                                                           The treatment must be for the purpose of adjuvant therapy following surgical resection; AND
                                                                                                                           Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND
                                                                                                                           Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.
                                                                                                                           The treatment must be commenced within 26 weeks of surgery; AND
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.
                                                                                                                           Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 3 years in total for this condition from the