Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p18
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 18/69)
Character Range: 310719–320320

condition; AND
                                                                                                                Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND
                                                                                                                The treatment must be in combination with ipilimumab.
C11477              P11477         Nivolumab                                                                    Locally advanced or metastatic non‑small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 11477
                                                                                                                Continuing treatment as second‑line drug therapy
                                                                                                                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.
                                                                                                                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.
C11478              P11478         Ipilimumab                                                                   Stage IV (metastatic) non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 11478
                                                                                                                Initial combination treatment (with nivolumab) as first‑line drug therapy
                                                                                                                The condition must be squamous type non‑small cell lung cancer (NSCLC); AND
                                                                                                                Patient must not have previously been treated for this condition in the metastatic setting; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c‑ROS proto‑oncogene 1 (ROS1) gene arrangement in tumour material; AND
                                                                                                                The treatment must be in combination with platinum‑based chemotherapy for the first two cycles; AND
                                                                                                                The treatment must be in combination with nivolumab.
                                                                                                                The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C11755              P11755         Obinutuzumab                                                                 Follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                Re‑induction treatment
                                                                                                                Patient must not have previously received PBS‑subsidised obinutuzumab; AND
                                                                                                                The condition must be CD20 positive; AND
                                                                                                                The condition must be refractory to treatment with rituximab for this condition; AND
                                                                                                                The condition must be symptomatic; AND
                                                                                                                The treatment must be for re‑induction treatment purposes only; AND
                                                                                                                The treatment must be in combination with bendamustine; AND
                                                                                                                The treatment must not exceed 8 doses for re‑induction treatment with this drug for this condition.
                                                                                                                The condition is considered rituximab‑refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab‑containing regimen.
                                                                                                                A patient may only qualify for PBS‑subsidised initiation treatment once in a lifetime under:
                                                                                                                i) the previously untreated induction treatment restriction; or
                                                                                                                ii) the rituximab‑refractory re‑induction restriction.
C11785              P11785         Obinutuzumab                                                                 Follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                Maintenance therapy
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug under the rituximab refractory initial