Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p356
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 356/476)
Character Range: 3148855–3156483

(idiopathic) thrombocytopenic purpura (ITP); AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re‑initiation of interrupted continuing treatment restriction; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
                                                                                                                                            Patient must be changing therapy from eltrombopag or avatrombopag to this drug for this condition; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
                                                                                                                                            Patients receiving treatment with eltrombopag or avatrombopag may change to romiplostim under this restriction.
Ruxolitinib                                                            C13876              P13876                                           Grade II to IV acute graft versus host disease (aGVHD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 13876
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.
                                                                                                                                            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.
                                                                                                                                            Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
                                                                                                                                            (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non‑response of aGVHD.
                                                                                                                                            (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non‑response of aGVHD.
                                                                                                                                            The assessment of response must be documented in the patient's medical records.
                                                                                                                                            Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.
                                                                                                                                            This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting.
                                                                       C13892              P13892                                           Grade II to IV acute graft versus host disease (aGVHD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures