Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p243
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 243/476)
Character Range: 2332112–2344938

Code 7843
                                                                                                                                            Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                            Patient must have had a prior episode of febrile neutropenia; OR
                                                                                                                                            Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.
                                                                       C9224                                                                Chemotherapy‑induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 9224
                                                                                                                                            Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                            Patient must be at greater than 20% risk of developing febrile neutropenia; OR
                                                                                                                                            Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.
                                                                       C9322                                                                Chemotherapy‑induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 9322
                                                                                                                                            Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                            Patient must have had a prior episode of febrile neutropenia; OR
                                                                                                                                            Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.
Lopinavir with ritonavir                                               C4454                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
                                                                       C4512                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512
                                                                                                                                            Initial
                                                                                                                                            Patient must be antiretroviral treatment naïve; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
Lumacaftor with ivacaftor                                              C14757                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
                                                                                                                                            Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
                                                                                                                                            The treatment must be given concomitantly with standard therapy for this condition.
                                                                                                                                            Patient must be 1 year of age or older.
                                                                                                                                            This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
                                                                                                                                            The authority application must be in writing and must include:
                                                                                                                                            (1) a completed authority prescription; and
                                                                                                                                            (2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
                                                                                                                                            (3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.
                                                                       C14765                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures