Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p266
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 266/476)
Character Range: 2491130–2498884

(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.
                                                                                                                                            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 25thdose) 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.
                                                                       C12567              P12567                                           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.
                                                                                                                                            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.
                                                                       C12579              P12579                                           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.
                                                                                                                                            Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a