Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p25
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 25/161)
Character Range: 13981312–13989528

a contraindication to docetaxel; AND
                                                                                   The treatment must not be used in combination with a novel hormonal drug; AND
                                                                                   Patient must have a WHO performance status of 2 or less; AND
                                                                                   Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.
C13208              P13208         CN13208          Brentuximab vedotin            Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must have undergone a 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         CN13209          Brentuximab vedotin            Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with 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         CN13212          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