Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p23
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 23/161)
Character Range: 13966907–13974177

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         CN13181          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 response by positron-emission tomography (PET) and/or computed tomography (CT) standard criteria.
C13182              P13182         CN13182          Brentuximab vedotin            CD30 positive systemic anaplastic large cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with 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