Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p18
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 18/161)
Character Range: 13929014–13939037

Ciclosporin                    Severe psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 13122
                                                                                   Management (initiation, stabilisation and review of therapy)
                                                                                   The condition must be ineffective to other systemic therapies; or
                                                                                   The condition must be inappropriate for other systemic therapies; AND
                                                                                   The condition must have caused significant interference with quality of life; AND
                                                                                   Must be treated by a medical practitioner who is either:
                                                                                    (i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist.
C13127              P13127         CN13127          Ruxolitinib                    High risk and intermediate-2 risk myelofibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   The condition must be either:
                                                                                    (i) primary myelofibrosis, (ii) post-polycythemia vera myelofibrosis, (iii) post-essential thrombocythemia myelofibrosis, confirmed through a bone marrow biopsy report.
                                                                                   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 bone marrow biopsy report confirming diagnosis of myelofibrosis; and
                                                                                   (b) A classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.
                                                                                   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).
C13128              P13128         CN13128          Ruxolitinib                    High risk and intermediate-2 risk myelofibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition.
C13130              P13130         CN13130          Ruxolitinib                    Intermediate-1 risk myelofibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition.
C13132              P13132         CN13132          Imatinib                       Malignant gastrointestinal stromal tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 13132
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   The treatment must be given at a dose not exceeding 600 mg per day.
                                                                                   Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib
                                                                                   Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.
                                                                                   A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of