Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p202
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 202/381)
Character Range: 12860988–12869625

a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib 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; 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.
C12579              P12579         CN12579          Methoxsalen                                                                                                     Chronic graft versus host disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 12579
                                                                                                                                                                    Initial treatment in a treatment episode
                                                                                                                                                                    The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; or
                                                                                                                                                                    The condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; or
                                                                                                                                                                    The condition must have relapsed with each of the following conditions being met:
                                                                                                                                                                     (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed; AND
                                                                                                                                                                    Patient must be undergoing treatment with this drug that is being administered within at least one of:
                                                                                                                                                                     (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25th dose) of a 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 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.
C12585              P12585         CN12585          Siltuximab                                                                                                      Idiopathic multicentric Castleman disease (iMCD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have a diagnosis of iMCD consistent with the latest international, evidence-based consensus diagnostic criteria for this condition with the relevant diagnostic findings documented in the patient's medical records; AND
                                                                                                                                                                    The condition must not be, to the prescriber's best knowledge, any of the following diseases that can mimic iMCD:
                                                                                                                                                                     (i) human herpes virus-8 infection, (ii) an Epstein-Barr virus-lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human