Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p15
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 15/69)
Character Range: 283785–293261

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         Atezolizumab                                                                 Locally advanced or metastatic non‑small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 10297
                                                                                                                Continuing treatment ‑ 3 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 systemic anti‑cancer therapy for this condition; AND
                                                                                                                Patient must have stable or responding disease.
C10414              P10414         Pertuzumab                                                                   Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously been issued with an authority prescription for this drug for this condition; AND
                                                                                                                Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug; AND
                                                                                                                The treatment must be in combination with trastuzumab; 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.
                                                                                                                A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug.
                                                                                                                The treatment must not exceed a lifetime total of one course. However, treatment breaks are permitted. A patient who has a treatment break in PBS‑subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS‑subsidised treatment with this drug.
                                                                                                                Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.
C10509              P10509         Atezolizumab                                                                 Extensive‑stage small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 10509
                                   Durvalumab                                                                   Continuing treatment ‑ 4 weekly treatment regimen
                                                                                                                The treatment must be as monotherapy; AND
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not have developed disease progression while being treated with this drug for this condition.
C10521              P10521         Atezolizumab                                                                 Extensive‑stage small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 10521
                                                                                                                Continuing treatment ‑ 3 weekly treatment regimen
                                                                                                                The treatment must be as monotherapy; AND
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not have developed disease progression while being treated with this drug for this condition.
C10676              P10676         Pembrolizumab                                                                Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                Continuing treatment ‑ 6