Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p31
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 31/69)
Character Range: 407077–414212

primary autologous stem cell transplant (ASCT) for this condition; AND
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not receive more than 12 cycles of treatment under this restriction.
                                                                                                                The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime.
C13209              P13209         Brentuximab vedotin                                                          Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                Initial treatment
                                                                                                                Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND
                                                                                                                Patient must not be suitable for ASCT for this condition; OR
                                                                                                                Patient must not be suitable for treatment with multi‑agent chemotherapy for this condition; AND
                                                                                                                Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; OR
                                                                                                                Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND
                                                                                                                Patient must not receive more than 4 cycles of treatment under this restriction.
                                                                                                                Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
                                                                                                                If the application is submitted through HPOS upload or mail, it must include:
                                                                                                                (a) a completed authority prescription form; and
                                                                                                                (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
C13212              P13212         Brentuximab vedotin                                                          CD30 positive peripheral T‑cell lymphoma, non‑cutaneous type                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                Continuing treatment
                                                                                                                The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
                                                                                                                Patient must have completed 6 initial cycles of PBS‑subsidised treatment with this drug for this indication; AND
                                                                                                                Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND
                                                                                                                Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
                                                                                                                Partial response is defined using Lugano Response Criteria for Non‑Hodgkin Lymphoma as:
                                                                                                                (a) Positron emission tomography‑based response: lymph nodes and extralymphatic sites ‑ a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions ‑ not applicable; organ enlargement ‑ not applicable; new lesions ‑ none; bone marrow ‑ residual uptake higher than uptake in normal marrow but reduced compared with baseline