Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p157
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 157/161)
Character Range: 14634841–14644713

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.
                                                                                   This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
C13912              P13912         CN13912          Sapropterin                    Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                   Subsequent continuing
                                                                                   Must be treated by a metabolic physician; or
                                                                                   Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                   Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications.
C13913              P13913         CN13913          Calcitonin salmon              Symptomatic Paget disease of bone                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                   The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease.
C13920              P13920         CN13920          Abacavir                       Human immunodeficiency virus (HIV) infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                   Patient must be less than 13.00 years of age;
                                                                                   Patient must be unable to take a solid dose form of this drug; AND
                                                                                   The treatment must be in combination with other antiretroviral agents.
C13921              P13921         CN13921          Lenvatinib                     Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 13921
                                                                                   Initial treatment
                                                                                   Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug and pembrolizumab of either:
                                                                                    (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records; AND
                                                                                   The condition must be untreated; AND
                                                                                   Patient must have a WHO performance status of 2 or less; AND
                                                                                   Patient must be undergoing combination therapy consisting of:
                                                                                    (i) pembrolizumab, (ii) lenvatinib.  or
                                                                                   Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records.
C13923              P13923         CN13923          Asciminib                      Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 13923
                                                                                   Continuing treatment for patients without T315I mutation
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must be undergoing first continuing treatment with this drug,