Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p336
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 336/476)
Character Range: 3000268–3013851

treatment, if applicable;
                                                                                                                                            (7) A history of kidney transplant if applicable (especially if required due to aHUS);
                                                                                                                                            (8) An inclusion of the individual consequences of recurrent disease, if applicable;
                                                                                                                                            (9) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;
                                                                                                                                            (10) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;
                                                                                                                                            (11) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
                                                                                                                                            This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab
Rifabutin                                                              C6350                                                                Mycobacterium avium complex infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 6350
                                                                                                                                            Patient must be human immunodeficiency virus (HIV) positive.
                                                                       C6356                                                                Mycobacterium avium complex infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 6356
                                                                                                                                            The treatment must be for prophylaxis; AND
                                                                                                                                            Patient must be human immunodeficiency virus (HIV) positive; AND
                                                                                                                                            Patient must have CD4 cell counts of less than 75 per cubic millimetre.
                                                                       C9560                                                                Mycobacterium avium complex infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 9560
                                                                                                                                            Patient must be human immunodeficiency virus (HIV) positive.
                                                                       C9622                                                                Mycobacterium avium complex infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 9622
                                                                                                                                            The treatment must be for prophylaxis; AND
                                                                                                                                            Patient must be human immunodeficiency virus (HIV) positive; AND
                                                                                                                                            Patient must have CD4 cell counts of less than 75 per cubic millimetre.
Rilpivirine                                                            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
Riociguat                                                              C13502                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have received their most recent course of PBS‑subsidised treatment with this PAH agent for this condition; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised PAH agent for this condition.
                                                                                                                                            A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
                                                                                                                                            PAH agents are