Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p62
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 62/381)
Character Range: 11908237–11920730

previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND
                                                                                                                                                                    The treatment must be in combination with nivolumab.
C11445              P11445         CN11445          Apomorphine                                                                                                     Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 11445
                                                                                                                                                                    Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
                                                                                                                                                                    The treatment must be commenced in a specialist unit in a hospital setting.
C11468              P11468         CN11468          Nivolumab                                                                                                       Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 11468
                                                                                                                                                                    Continuing combination treatment (with ipilimumab) of first-line drug therapy
                                                                                                                                                                    The condition must be squamous type non-small cell lung cancer (NSCLC); 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 PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND
                                                                                                                                                                    The treatment must be in combination with ipilimumab.
C11473              P11473         CN11473          Fulvestrant                                                                                                     Locally advanced or metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 11473
                                                                                                                                                                    The condition must be hormone receptor positive; AND
                                                                                                                                                                    The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
                                                                                                                                                                    The condition must be inoperable;
                                                                                                                                                                    Patient must not be premenopausal.
                                                                                                                                                                    A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
C11477              P11477         CN11477          Nivolumab                                                                                                       Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 11477
                                                                                                                                                                    Continuing treatment as second-line drug therapy
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
                                                                                                                                                                    Patient must have stable or responding disease.
                                                                                                                                                                    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.
C11478              P11478         CN11478          Ipilimumab                                                                                                      Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 11478
                                                                                                                                                                    Initial combination treatment (with nivolumab) as first-line drug therapy
                                                                                                                                                                    The condition must be squamous type non-small cell lung cancer (NSCLC); AND
                                                                                                                                                                    Patient must not have previously been treated for this condition in the metastatic setting; AND
                                                                                                                                                                    Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                                                                    The condition must not