Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p11
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 11/381)
Character Range: 11484524–11496216

be given concomitantly with levetiracetam, except for cross titration.
C10212              P10212         CN10212          Trastuzumab                                                                                                     Early HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 10212
                                                                                                                                                                    3 weekly treatment regimen
                                                                                                                                                                    Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); 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.
                                                                                                                                                                    Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.
C10213              P10213         CN10213          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         CN10215          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         CN10216          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; 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.
C10248              P10248         CN10248          Sofosbuvir with velpatasvir and voxilaprevir                                                                    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