Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p19
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 19/69)
Character Range: 318846–329599

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 restriction; AND
                                                                                                                The condition must be CD20 positive; AND
                                                                                                                The condition must have been refractory to treatment with rituximab; AND
                                                                                                                Patient must have demonstrated a partial or complete response to PBS‑subsidised re‑induction treatment with this drug for this condition; AND
                                                                                                                The treatment must be maintenance therapy; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
                                                                                                                Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition.
C11787              P11787         Obinutuzumab                                                                 Stage II bulky or Stage III/IV follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                Maintenance therapy
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug under the previously untreated initial restriction; AND
                                                                                                                The condition must be CD20 positive; AND
                                                                                                                Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND
                                                                                                                The treatment must be maintenance therapy; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
                                                                                                                Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition.
C11815              P11815         Obinutuzumab                                                                 Stage II bulky or Stage III/IV follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                Induction treatment
                                                                                                                The condition must be CD20 positive; AND
                                                                                                                The condition must be previously untreated; AND
                                                                                                                The condition must be symptomatic; AND
                                                                                                                The treatment must be for induction treatment purposes only; AND
                                                                                                                The treatment must be in combination with chemotherapy; AND
                                                                                                                The treatment must not exceed 10 doses for induction treatment with this drug for this condition.
                                                                                                                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.
C11930              P11930         Ipilimumab                                                                   Unresectable malignant mesothelioma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 11930
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The treatment must be in combination with PBS‑subsidised nivolumab for this condition; AND
                                                                                                                Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.
C11985              P11985         Nivolumab                                                                    Unresectable malignant mesothelioma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 11985
                                                                                                                Patient must have a