Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p154
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 154/161)
Character Range: 14620281–14625950

week (or equivalent); or
                                                                                   (b) disease persistence without improvement despite continued treatment with prednisone at greater than 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent).
                                                                                   Steroid-dependent disease is defined as an increased prednisone dose to greater than 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent).
                                                                                   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 24 weeks after initiating treatment with ruxolitinib to be eligible for continuing treatment.
                                                                                   Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib.
                                                                                   (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy.
                                                                                   (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies.
                                                                                   The assessment of response must be documented in the patient's medical records.
                                                                                   This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
C13907              P13907         CN13907          Ruxolitinib                    Grade II to IV acute graft versus host disease (aGVHD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 13907
                                                                                   Initial treatment
                                                                                   Patient must have received prior 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