Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p378
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 378/476)
Character Range: 3303554–3312463

drug in the combination remains unchanged from the previous authority application; AND
                                                                                                                                            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.
                                                                       C13572                                                               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.
                                                                                                                                            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.
                                                                                                                                            A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
                                                                                                                                            PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
                                                                                                                                            The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
                                                                                                                                            A maximum of 5 repeats may be requested.
                                                                       C13573                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial 2 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
                                                                                                                                            Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
                                                                                                                                            Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS‑subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase‑5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
                                                                                                                                            The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
                                                                                                                                            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.
                                                                       C15463                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial 3 - changing to this drug in combination therapy (dual or triple therapy)
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR
                                                                                                                                            The treatment