Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p20
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 20/161)
Character Range: 13945156–13955702

in the Administrative Advice).
                                                                                   Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib.
C13153              P13153         CN13153          Sunitinib                      Metastatic or unresectable malignant gastrointestinal stromal tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 13153
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   The condition must not be resectable; AND
                                                                                   The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
                                                                                   Patient must have a WHO performance status of 2 or less; AND
                                                                                   Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
C13165              P13165         CN13165          Decitabine with cedazuridine   Chronic Myelomonocytic Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must not have progressive disease.
                                                                                   Up to 6 cycles will be authorised.
C13168              P13168         CN13168          Ciclosporin                    Severe psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 13168
                                                                                   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.
C13173              P13173         CN13173          Ruxolitinib                    Intermediate-1 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; AND
                                                                                   Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy.
                                                                                   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; and
                                                                                   c) A confirmation that the patient's disease related symptoms are resistant, refractory or intolerant to available therapy.
                                                                                   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).
C13175              P13175         CN13175          Sonidegib                      Metastatic or locally advanced basal cell carcinoma (BCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                    Vismodegib                     The condition must be inappropriate for