Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p24
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 24/161)
Character Range: 13973582–13981811

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).
C13186              P13186         CN13186          Crizotinib                     Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                    Entrectinib                    The treatment must be the sole PBS-subsidised systemic anti-cancer therapy 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.
C13205              P13205         CN13205          Decitabine with cedazuridine   Chronic Myelomonocytic Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND
                                                                                   The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.
                                                                                   No more than 3 cycles will be authorised under this restriction in a patient's lifetime.
                                                                                   The first 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 bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and
                                                                                   (b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority
                                                                                   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).
                                                                                   The following reports must be documented in the patient's medical records
                                                                                   (a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and
                                                                                   (b) full blood examination report
C13207              P13207         CN13207          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