Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p153
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 153/161)
Character Range: 14614851–14620723

The treatment must be for the purposes of adjuvant use following complete surgical resection that occurred within 16 weeks prior to initiating this drug; AND
                                                                                   The condition must have evidence, through resected specimen, that residual disease meets the Tumour Nodes Metastases (TNM) staging system (as published by the Union for International Cancer Control) of either:
                                                                                    (i) at least ypT1, (ii) at least ypN1; document this evidence in the patient's medical records; AND
                                                                                   Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must be undergoing treatment with a dosing regimen as set out in the drug's approved Australian Product Information; AND
                                                                                   Patient must not be undergoing PBS-subsidised treatment with this drug where this prescription extends treatment beyond whichever comes first:
                                                                                    (i) 12 months from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease recurrence despite treatment with this drug; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.
C13906              P13906         CN13906          Ruxolitinib                    Moderate to severe chronic graft versus host disease (cGVHD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 13906
                                                                                   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
                                                                                   The treatment must be the sole PBS-subsidised treatment for this condition with the exception of:
                                                                                    (i) corticosteroids, (ii) calcineurin inhibitors; 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.
                                                                                   The severity of cGVHD is defined by the National Institutes of Health (NIH) criteria (Jagasia et al., 2015)
                                                                                   (a) Moderate cGVHD at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1
                                                                                   (b) Severe cGVHD at least 1 organ with a score of 3, or lung score of 2 or 3
                                                                                   Steroid-refractory disease is defined as
                                                                                   (a) a lack of response or disease progression after administration of a minimum prednisone dose of 1 mg/kg/day for at least 1 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