Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p198
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 198/381)
Character Range: 12834564–12843968

drug is no longer eligible for PBS-subsidised treatment with this drug.
                                                                                                                                                                    Complete remission following induction is defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count of more than 1.0 x 109 cells/L with a platelet count of 100 x 109/L or more in the peripheral blood in the absence of transfusion.
                                                                                                                                                                    Progressive disease is defined as the presence of any of the following
                                                                                                                                                                    a) Leukaemic cells in the CSF;
                                                                                                                                                                    b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
                                                                                                                                                                    c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
                                                                                                                                                                    d) Extramedullary leukaemia.
C12567              P12567         CN12567          Methoxsalen                                                                                                     Chronic graft versus host disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 12567
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both:
                                                                                                                                                                     (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis-MBS benefit for initial treatment; AND
                                                                                                                                                                    Patient must have demonstrated a response to initial treatment with this drug (administered as part of MBS-subsidised extracorporeal photopheresis treatment) obtained through this drug's 'Initial treatment' PBS-listing for the same treatment episode; AND
                                                                                                                                                                    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 concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; AND
                                                                                                                                                                    Patient must not be undergoing re-treatment through this treatment phase immediately following a relapse - see 'Initial treatment' for resuming treatment following relapse.
C12569              P12569         CN12569          Nilotinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - third-line therapy
                                                                                                                                                                    The condition must be in the chronic phase; or
                                                                                                                                                                    The condition must be in the accelerated phase; AND
                                                                                                                                                                    Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; or
                                                                                                                                                                    Patient must not have failed PBS-subsidised treatment with this drug for this condition in the second-line setting; AND
                                                                                                                                                                    Patient must have documented failure with an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; AND
                                                                                                                                                                    Patient must have failed an adequate trial of PBS-subsidised second-line treatment with dasatinib 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.
                                                                                                                                                                    Failure of an adequate trial of dasatinib is defined as:
                                                                                                                                                                    (i) Lack of response to