Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p32
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 32/69)
Character Range: 413953–421755

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 (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR
                                                                                                                (b) Computed tomography‑based response: lymph nodes and extralymphatic sites ‑ greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non‑measured lesions ‑ absent/normal, regressed but no increase; new lesions ‑ none; bone marrow ‑ not applicable.
C13231              P13231         Brentuximab vedotin                                                          Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Continuing 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 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.
C13259              P13259         Brentuximab vedotin                                                          Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                Initial treatment
                                                                                                                Patient must have undergone a primary autologous stem cell transplant (ASCT); AND
                                                                                                                Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; OR
                                                                                                                Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; 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).
C13261              P13261         Brentuximab vedotin                                                          CD30 positive systemic anaplastic large cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                Continuing treatment
                                                                                                                Patient must not have developed disease progression while 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; AND
                                                                                                                The treatment