Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p156
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 156/161)
Character Range: 14630549–14635178

systemic steroid treatment for this condition; AND
                                                                                   Patient must be one of the following:
                                                                                    (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; 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.
                                                                                   The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).
                                                                                   Steroid-refractory disease is defined as
                                                                                   (a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or
                                                                                   (b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.
                                                                                   (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or
                                                                                   (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.
                                                                                   Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria
                                                                                   (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or
                                                                                   (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.
                                                                                   Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.
                                                                                   Details of prior steroid use should be documented in the patient's medical records.
                                                                                   A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.
                                                                                   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