Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p13
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 13/69)
Character Range: 266117–274937

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         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.
C10125              P10125         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.
                                                                                                                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 cancer.
C10206              P10206         Atezolizumab                                                                 Extensive‑stage small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 10206
                                   Durvalumab                                                                   Initial treatment
                                                                                                                The condition must be previously untreated; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The treatment must be in combination with etoposide and a platinum‑based antineoplastic drug.
C10212              P10212         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