Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p8
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 8/69)
Character Range: 228019–236580

PBS‑subsidised treatment with nivolumab as induction therapy for this condition.
                                                                                                                Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
                                                                                                                The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C9216               P9216          Nivolumab                                                                    Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 9216
                                                                                                                Initial treatment
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy; AND
                                                                                                                Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor for this condition.
                                                                                                                The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
                                                                                                                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.
C9252               P9252          Nivolumab                                                                    Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 9252
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must have stable or responding disease; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                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.
C9298               P9298          Nivolumab                                                                    Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 9298
                                                                                                                Continuing treatment
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must have previously been issued with an authority prescription for this drug 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.
C9299               P9299          Nivolumab                                                                    Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 9299
                                                                                                                Continuing treatment
                                                                                                                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; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                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.
C9312               P9312          Nivolumab