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 22/162)
Character Range: 14773094–14779464

16 weeks treatment; or
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
                                                                                                         The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
C14008              P14008         CN14008          Asciminib                                            Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                         Continuing Treatment for patients with T315I mutation
                                                                                                         Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                         Patient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.  or
                                                                                                         Patient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.
                                                                                                         A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.
                                                                                                         The continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include
                                                                                                         (i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or
                                                                                                         (ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].
                                                                                                         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).
                                                                                                         Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy
C14011              P14011         CN14011          Upadacitinib                                         Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Continuing treatment
                                                                                                         Must be treated by a gastroenterologist (code 87);