Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p35
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 35/38)
Character Range: 130626–136572

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 prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,
                                                       c. Biological agents and other treatments that deplete or inhibit