Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p301
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 301/312)
Character Range: 17386722–17396529

WHO performance status no higher than 1; OR
                                                                                                                           The condition must be VHL-associated brainstem tumour(s), or brain herniation, which temporarily affected the patient's WHO performance status to be higher than 1; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours.
                                                                                                                           Must be treated by a physician with expertise in the management of VHL disease associated tumours.
                                                                                                                           Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase.
                                                                                                                           For the purpose of administering this restriction, the highly characteristic manifestations of VHL disease include but not limited to:
                                                                                                                           (i) retinal, spinal, or cerebellar haemangioblastoma;
                                                                                                                           (ii) adrenal or extra-adrenal phaeochromocytoma;
                                                                                                                           (iii) renal cell carcinoma;
                                                                                                                           (iv) multiple renal and pancreatic cysts;
                                                                                                                           (v) endolymphatic sac tumours, papillary cystadenomas of the epididymis or broad ligament, or pancreatic neuroendocrine tumours.
C16220              P16220         CN16220          Dapagliflozin                                                          Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 16220
                                                                                                                           The treatment must be in combination with metformin; unless contraindicated/intolerant; AND
                                                                                                                           Patient must have cardiovascular disease; OR
                                                                                                                           Patient must be at high risk of a cardiovascular event; OR
                                                                                                                           Patient must identify as Aboriginal or Torres Strait Islander.
                                                                                                                           Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.
C16222              P16222         CN16222          Dienogest                                                              Endometriosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 16222

C16223              P16223         CN16223          Nirmatrelvir and ritonavir                                             SARS-CoV-2 infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16223
                                                                                                                           Patient must have received a positive nucleic acid test result; OR
                                                                                                                           Patient must have received a positive rapid antigen test (RAT) result; AND
                                                                                                                           Patient must have at least one sign or symptom attributable to COVID-19; AND
                                                                                                                           Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
                                                                                                                           Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND
                                                                                                                           The treatment must be initiated within 5 days of symptom onset.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with:
                                                                                                                           1. Any primary or acquired immunodeficiency including:
                                                                                                                           a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,
                                                                                                                           b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),
                                                                                                                           c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR
                                                                                                                           2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:
                                                                                                                           a. Chemotherapy or whole body radiotherapy,
                                                                                                                           b. High-dose corticosteroids (at least 20 mg of