Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p43
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 43/476)
Character Range: 985924–994324

thereafter (refer to the TGA-approved Product Information).
                                                                                                                                            A multidisciplinary severe asthma clinic team comprises of:
                                                                                                                                            (i) A respiratory physician; and
                                                                                                                                            (ii) A pharmacist, nurse or asthma educator.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) details of the proposed prescription; and
                                                                                                                                            (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                            The following must be provided at the time of application and documented in the patient's medical records:
                                                                                                                                            (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and
                                                                                                                                            (b) details (date and duration of treatment) of prior biological medicine treatment; and
                                                                                                                                            (c) eosinophil count and date; and
                                                                                                                                            (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and
                                                                                                                                            (e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).
Bictegravir with emtricitabine with tenofovir alafenamide              C4470                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4470
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection.
C4522                                                                                      HIV infection                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 4522
                                                                                           Initial
                                                                                           Patient must be antiretroviral treatment naive.
Bosentan                                                               C11229                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Triple therapy ‑ Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
                                                                                                                                            The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) PBS‑subsidised selexipag (referred to as 'triple therapy'); OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of either: (i) PBS‑subsidised selexipag with one endothelin receptor antagonist, (ii) PBS‑subsidised selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
                                                                                                                                            Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
                                                                                                                                            The authority application for selexipag must be approved prior to the authority application for this agent.
                                                                                                                                            For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
                                                                                                                                            PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70%