Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p152
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 152/161)
Character Range: 14607672–14615197

protocol and PKU diet prior to conducting initial responsiveness testing.
C13886              P13886         CN13886          Calcitonin salmon              Hypercalcaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                   The treatment must be initiated in a hospital; AND
                                                                                   The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease.
C13892              P13892         CN13892          Ruxolitinib                    Grade II to IV acute graft versus host disease (aGVHD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 13892
                                                                                   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; 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.
                                                                                   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.
C13900              P13900         CN13900          Nivolumab                      Adjuvant treatment of stage II or III oesophageal cancer or gastro-oesophageal junction cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                   The condition must have histological evidence confirming a diagnosis of a least one of:
                                                                                    (i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient's medical records; AND
                                                                                   The condition must have been treated with neoadjuvant platinum-based chemoradiotherapy; AND
                                                                                   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