Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p22
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 22/161)
Character Range: 13959796–13967232

Limitations due to cumulative prior radiotherapy dose; or
                                                                                   (iv) Progressive disease despite prior irradiation of locally advanced BCC.
                                                                                   Inappropriate for curative radiotherapy is defined as
                                                                                   (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
                                                                                   (ii) Limitations due to location of tumour; or
                                                                                   (iii) Limitations due to cumulative prior radiotherapy dose; or
                                                                                   (iv) Progressive disease despite prior irradiation of locally advanced BCC.
                                                                                   For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.
C13177              P13177         CN13177          Vorinostat                     Cutaneous T-cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                                                   Patient must have received systemic treatment with chemotherapy; AND
                                                                                   Patient must demonstrate relapsed or chemotherapy-refractory disease; AND
                                                                                   Patient must be ineligible for stem cell transplant; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                   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 form 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).
C13179              P13179         CN13179          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