Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p14
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 14/69)
Character Range: 274522–284271

combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.
                                                                                                                Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.
C10213              P10213         Trastuzumab                                                                  Early HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 10213
                                                                                                                Continuing treatment (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.
C10215              P10215         Atezolizumab                                                                 Locally advanced or metastatic non‑small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 10215
                                                                                                                Continuing treatment ‑ 4 weekly treatment regimen
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must have stable or responding disease.
C10216              P10216         Atezolizumab                                                                 Stage IV (metastatic) non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 10216
                                                                                                                Continuing first‑line treatment of metastatic disease ‑ 3 weekly treatment regimen
                                                                                                                Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug in this line of treatment; AND
                                                                                                                Patient must have stable or responding disease.
C10257              P10257         Atezolizumab                                                                 Stage IV (metastatic) 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.
C10294              P10294         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