Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p5
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 5/381)
Character Range: 11423393–11434696

Authority Required procedures - Streamlined Authority Code 10116
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised therapy for HIV infection.
C10119              P10119         CN10119          Nivolumab                                                                                                       Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The treatment must be adjuvant to complete surgical resection; AND
                                                                                                                                                                    Patient must have a WHO performance status of 1 or less; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    Patient must not have received prior PBS-subsidised treatment for this condition; AND
                                                                                                                                                                    The treatment must commence within 12 weeks of complete resection; AND
                                                                                                                                                                    Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
                                                                                                                                                                    Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
C10120              P10120         CN10120          Nivolumab                                                                                                       Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
                                                                                                                                                                    Patient must not have experienced disease recurrence; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
                                                                                                                                                                    Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
C10121              P10121         CN10121          Budesonide with formoterol                                                                                      Chronic obstructive pulmonary disease (COPD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 10121
                                                                                                                                                                    Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND
                                                    Fluticasone furoate with vilanterol                                                                             Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months.

                                                    Fluticasone propionate with salmeterol

C10125              P10125         CN10125          Atezolizumab                                                                                                    Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 10125
                                                                                                                                                                    Initial treatment 2
                                                                                                                                                                    Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND
                                                                                                                                                                    The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND
                                                                                                                                                                    Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                                                                    Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND
                                                                                                                                                                    Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND
                                                                                                                                                                    Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung