Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p138
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 138/312)
Character Range: 16330706–16340138

not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.

C15288              P15288         CN15288          Alogliptin with metformin                                              Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 15288
                                                    Linagliptin with metformin                                             The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                    Saxagliptin with metformin                                             The condition must be inadequately responsive to metformin.
                                                    Sitagliptin with metformin                                             Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.
                                                    Vildagliptin with metformin

C15289              P15289         CN15289          Dapagliflozin with metformin                                           Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 15289
                                                    Empagliflozin with metformin                                           The condition must be inadequately responsive to metformin.
                                                                                                                           Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.
C15290              P15290         CN15290          Pioglitazone                                                           Diabetes mellitus type 2
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
C15299              P15299         CN15299          Osimertinib                                                            Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Initial treatment as first-line epidermal growth factor receptor tyrosine kinase inhibitor therapy
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must have a WHO performance status of 2 or less; AND
                                                                                                                           Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); OR
                                                                                                                           Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.
                                                                                                                           Patient must have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors.
                                                                                                                           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).
C15301              P15301         CN15301          Dulaglutide                                                            Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                    Semaglutide                                                            First PBS-prescription for this drug
                                                                                                                           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; AND
                                                                                                                           Patient must 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