Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p137
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 137/312)
Character Range: 16324036–16332041

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 first administered dose; mark any remaining repeat prescriptions with the word 'cancelled'; where (i)/(ii) has occurred.
                                                                                                                           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).
C15283              P15283         CN15283          Osimertinib                                                            Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Continuing treatment of first-line EGFR tyrosine kinase inhibitor therapy
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; 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 first-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).
C15287              P15287         CN15287          Alogliptin                                                             Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 15287
                                                    Linagliptin                                                            The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                    Saxagliptin                                                            The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND
                                                    Sitagliptin                                                            The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin.
                                                    Vildagliptin                                                           Patient must 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