Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p61
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 61/69)
Character Range: 612342–619969

(PD‑L1) inhibitor for this condition.
C15500              P15500         Durvalumab                                                                   Unresectable Stage III non‑small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 15500
                                                                                                                Initial treatment
                                                                                                                Patient must have received platinum based chemoradiation therapy; AND
                                                                                                                The condition must not have progressed following platinum based chemoradiation therapy; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                Patient must be untreated with immunotherapy at commencement of this drug; AND
                                                                                                                The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition.
C15527              P15527         Nivolumab                                                                    Urothelial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                The treatment must be for each of: (i) adjuvant therapy that is/was initiated within 120 days of radical surgical resection, (ii) muscle invasive type disease, (iii) disease considered to be at high risk of recurrence based on pathologic staging of radical surgery tissue (ypT2‑ypT4a or ypN+), but yet to recur, (iv) use as the sole PBS‑subsidised anti‑cancer treatment for this condition; AND
                                                                                                                Patient must have received prior platinum containing neoadjuvant chemotherapy; AND
                                                                                                                Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1.
                                                                                                                Patient must be undergoing treatment with a dosing regimen as set out in the drug's Therapeutic Goods Administration (TGA) approved Product Information; AND
                                                                                                                Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.
                                                                                                                An increase in repeat prescriptions, up to a value of 11, may only be sought where the prescribed dosing is 240 mg administered fortnightly.
C15818              P15818         Trastuzumab emtansine                                                        Early HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                                                                                Initial adjuvant treatment
                                                                                                                The treatment must be prescribed within 12 weeks after surgery; AND
                                                                                                                Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND
                                                                                                                Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; 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
                                                                                                                The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.
                                                                                                                Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
                                                                                                                (a) details (date, unique identifying number/code or provider number) of the pathology report