Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p361
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 361/476)
Character Range: 3181272–3188050

combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) 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'); AND
                                                                                                                                            Patient must have completed the dose titration phase; AND
                                                                                                                                            The treatment must not be as monotherapy.
                                                                                                                                            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.
                                                                                                                                            Patient must have had at least one PBS‑subsidised PAH agent prior to this authority application.
                                                                                                                                            Select one appropriate strength (determined under the 'Initial treatment ‑ dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.
                                                                                                                                            A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
                                                                                                                                            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% of predicted.
                                                                                                                                            PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
                                                                                                                                            (i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
                                                                                                                                            (ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
                                                                       C11261                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ dose titration
                                                                                                                                            Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND
                                                                                                                                            Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
                                                                                                                                            Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
                                                                                                                                            The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND
                                                                                                                                            The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of either: