Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p29
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 29/69)
Character Range: 391925–399621

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).
C13179              P13179         Brentuximab vedotin                                                          CD30 positive cutaneous T‑cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                Initial treatment
                                                                                                                Patient must have pathologically confirmed CD30 positive cutaneous T‑cell lymphoma; AND
                                                                                                                Patient must have CD30 positivity of at least 3% of malignant cells; AND
                                                                                                                Patient must have a diagnosis of mycosis fungoides; OR
                                                                                                                Patient must have a diagnosis of Sezary syndrome; OR
                                                                                                                Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND
                                                                                                                Patient must have received prior systemic treatment for this condition; AND
                                                                                                                The condition must be relapsed or refractory; AND
                                                                                                                The treatment must not exceed 4 cycles under this restriction in a lifetime; AND
                                                                                                                The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition.
                                                                                                                The authority application 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/code or provider number) of the histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and
                                                                                                                (b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and
                                                                                                                (c) Date of commencement and completion of the most recent prior systemic treatment.
                                                                                                                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).
C13181              P13181         Brentuximab vedotin                                                          CD30 positive cutaneous T‑cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must have achieved an objective response with this drug; AND
                                                                                                                Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must be 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