Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p265
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 265/476)
Character Range: 2483829–2491551

continuing beyond 6 months of treatment for the first time; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; OR
                                                                                                                                            The treatment must be in combination with peginterferon alfa‑2a only if used in combination with another drug; AND
                                                                                                                                            Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.
                                                                                                                                            Must be treated by a haematologist; OR
                                                                                                                                            Must be treated by a medical physician working under the supervision of a haematologist.
                                                                                                                                            A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS‑subsidy. Response only needs to be demonstrated after the first six months of treatment
                                                                       C12531              P12531                                           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.
                                                                                                                                            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.
                                                                       C12546              P12546                                           Chronic graft versus host disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 12546
                                                                                                                                            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