Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p7
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 7/69)
Character Range: 217769–228476

progressive disease whilst receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition.
C7558               P7558          Pralatrexate                                                                 Relapsed or chemotherapy refractory Peripheral T‑cell Lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                Initial treatment
                                                                                                                The condition must be relapsed or chemotherapy refractory; AND
                                                                                                                Patient must have undergone appropriate prior front‑line curative intent chemotherapy.
C7943                              Bendamustine                                                                 Previously untreated stage II bulky or stage III or IV indolent non‑Hodgkin's lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 7943
                                                                                                                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 rituximab or obinutuzumab; AND
                                                                                                                The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.
C7944                              Bendamustine                                                                 Follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 7944
                                                                                                                Re‑induction treatment
                                                                                                                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 obinutuzumab; AND
                                                                                                                The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.
                                                                                                                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.
C7972                              Bendamustine                                                                 Previously untreated stage III or IV mantle cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 7972
                                                                                                                Induction treatment
                                                                                                                The condition must be CD20 positive; AND
                                                                                                                The treatment must be in combination with rituximab; AND
                                                                                                                The condition must be previously untreated; AND
                                                                                                                The condition must be symptomatic; AND
                                                                                                                The treatment must be for induction treatment purposes only; AND
                                                                                                                Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction; AND
                                                                                                                Patient must not be eligible for stem cell transplantation.
C8555               P8555          Ipilimumab                                                                   Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 8555
                                                                                                                Induction treatment
                                                                                                                The condition must not have previously been treated; AND
                                                                                                                The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
                                                                                                                Patient must have a WHO performance status of 2 or less; AND
                                                                                                                The treatment must be in combination with 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