Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p135
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 135/312)
Character Range: 16305401–16314780

one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; OR
                                                                                                                           The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND
                                                                                                                           The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND
                                                                                                                           Patient must require dosage reduction requiring a pack of 21 tablets.
                                                                                                                           Patient must not be premenopausal.
                                                                                                                           PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).
C15257              P15257         CN15257          Osimertinib                                                            Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Continuing treatment of second-line EGFR tyrosine kinase inhibitor therapy
                                                                                                                           The treatment must be as monotherapy; AND
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition.
                                                                                                                           Patient must be undergoing continuing treatment with this drug as second-line therapy (i.e. there are 2 Continuing treatment listings for this drug - ensure the correct Continuing treatment restriction is being accessed).
                                                                                                                           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).
C15261              P15261         CN15261          Alogliptin                                                             Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 15261
                                                    Linagliptin                                                            The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND
                                                    Saxagliptin                                                            The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin.
                                                    Sitagliptin                                                            Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.
                                                    Vildagliptin
C15263              P15263         CN15263          Dulaglutide                                                            Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 15263
                                                    Semaglutide                                                            Subsequent PBS-prescriptions for any GLP-1 receptor agonist
                                                                                                                           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.
C15265              P15265         CN15265          Dapagliflozin                                                          Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 15265
                                                    Empagliflozin                                                          The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND
                                                                                                                           The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin.
                                                                                                                           Patient must not be undergoing concomitant PBS-subsidised treatment