Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p189
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 189/381)
Character Range: 12768753–12778656

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.
C12531              P12531         CN12531          Methoxsalen                                                                                                     Chronic graft versus host disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 12531
                                                                                                                                                                    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.
C12536              P12536         CN12536          Imatinib                                                                                                        Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 12536
                                                                                                                                                                    Continuing treatment - first-line therapy
                                                                                                                                                                    The condition must be in the chronic phase; AND
                                                                                                                                                                    Patient must have received initial continuing PBS-subsidised treatment with this drug as a first-line therapy for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with dasatinib for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with nilotinib for this condition; 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.
C12541              P12541         CN12541          Imatinib                                                                                                        Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - first-line therapy
                                                                                                                                                                    The condition must be 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;