Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p13
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 13/381)
Character Range: 11505418–11516918

non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 10257
                                                                                                                                                                    Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen
                                                                                                                                                                    Patient must have experienced intolerance to combination treatment with bevacizumab; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND
                                                                                                                                                                    Patient must have stable or responding disease; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
C10268              P10268         CN10268          Glecaprevir with pibrentasvir                                                                                   Chronic hepatitis C infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                                                                    Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
                                                                                                                                                                    Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
                                                                                                                                                                    The treatment must be limited to a maximum duration of 16 weeks.
                                                                                                                                                                    The application must include details of the prior treatment regimen containing an NS5A inhibitor.
                                                                                                                                                                    The application must include details of the prior treatment regimen containing an NS5A inhibitor.
C10271              P10271         CN10271          Encorafenib                                                                                                     Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10271
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The condition must be positive for a BRAF V600 mutation; AND
                                                                                                                                                                    The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or
                                                                                                                                                                    Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND
                                                                                                                                                                    Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less.
C10294              P10294         CN10294          Trastuzumab                                                                                                     Early HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 10294
                                                                                                                                                                    Continuing treatment (3 weekly regimen)
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
                                                                                                                                                                    Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.  or
                                                                                                                                                                    Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.
C10297              P10297         CN10297          Atezolizumab                                                                                                    Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority