Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p30
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 30/69)
Character Range: 399133–407590

the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND
                                                                                                                The treatment must not exceed 12 cycles under this restriction in a lifetime.
                                                                                                                An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positron‑emission tomography (PET) and/or computed tomography (CT) standard criteria.
C13182              P13182         Brentuximab vedotin                                                          CD30 positive systemic anaplastic large cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                                                Initial treatment
                                                                                                                The treatment must be for curative intent; AND
                                                                                                                Patient must have undergone appropriate prior front‑line curative intent chemotherapy; AND
                                                                                                                Patient must demonstrate relapsed or chemotherapy‑refractory disease; AND
                                                                                                                Patient must have responded to PBS‑subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T‑cell lymphoma, non‑cutaneous type; AND
                                                                                                                The treatment must not exceed 4 cycles 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 and must include:
                                                                                                                (a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour's CD30 positivity; and
                                                                                                                (b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and
                                                                                                                (c) Dates of commencement and completion of front‑line curative intent chemotherapy; and
                                                                                                                (d) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.
                                                                                                                All reports must be documented in the patient's medical records.
                                                                                                                If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                (i) A completed authority prescription form; and
                                                                                                                (ii) 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).
C13207                             Cabazitaxel                                                                  Castration resistant metastatic carcinoma of the prostate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 13207
                                                                                                                The treatment must be in combination with prednisone or prednisolone; AND
                                                                                                                The condition must be resistant to treatment with docetaxel; OR
                                                                                                                Patient must have a documented intolerance necessitating permanent treatment withdrawal or 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         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