Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p192
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 192/381)
Character Range: 12792872–12801617

Must be treated by a haematologist; or
                                                                                                                                                                    Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or
                                                                                                                                                                    Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND
                                                                                                                                                                    Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND
                                                                                                                                                                    Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition.
C12549              P12549         CN12549          Nilotinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 12549
                                                                                                                                                                    Grandfather treatment for patients initiated with nilotinib 200 mg prior to 1 April 2012 as first-line therapy
                                                                                                                                                                    The condition must be in the chronic phase; AND
                                                                                                                                                                    Patient must have received PBS-subsidised treatment with nilotinib 200mg as a first-line therapy for this condition prior to 1 April 2012; AND
                                                                                                                                                                    Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or
                                                                                                                                                                    Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    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.
C12557              P12557         CN12557          Nilotinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - first-line therapy
                                                                                                                                                                    Patient must have a primary diagnosis of chronic myeloid leukaemia; AND
                                                                                                                                                                    The condition must be in the chronic phase; AND
                                                                                                                                                                    The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or
                                                                                                                                                                    The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND
                                                                                                                                                                    Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; AND
                                                                                                                                                                    The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment