Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p255
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 255/476)
Character Range: 2421783–2430103

with this drug following 3 months of initial treatment:
                                                                                                                                            (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
                                                                                                                                            (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
                                                                                                                                            Further reassessments must be undertaken and documented at six‑monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.
Maraviroc                                                              C5008                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 5008
                                                                                                                                            Patient must be infected with CCR5‑tropic HIV‑1, AND
                                                                                                                                            The treatment must be in addition to optimised background therapy, AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents, AND
                                                                                                                                            Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.
                                                                                                                                            Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity.
                                                                                                                                            A tropism assay to determine CCR5 only strain status must be performed prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible.
Mepolizumab                                                            C13865                                                               Chronic rhinosinusitis with nasal polyps (CRSwNP)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must have both demonstrated and sustained an adequate response to this drug, defined as having at least one of: (i) an improvement in bilateral endoscopic nasal polyp score of at least 1.0 compared to the baseline level provided with the initial authority application, (ii) an improvement in nasal obstruction visual analogue scale (VAS) score of at least 3.0 compared to the baseline level provided with the initial authority application, (iii) an improvement in overall symptom VAS score of at least 2.5 compared to the baseline level provided with the initial authority application.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                       C13890                                                               Chronic rhinosinusitis with nasal polyps (CRSwNP)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.
                                                                                                                                            Patient must have a diagnosis of