Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p360
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 360/476)
Character Range: 3173617–3181714

or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non‑response of aGVHD.
                                                                                                                                            The assessment of response must be documented in the patient's medical records.
                                                                                                                                            This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting.
Selexipag                                                              C11193                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have developed disease progression while receiving treatment with this drug for this condition; 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: (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
                                                                                                                                            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.
                                                                                                                                            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.
                                                                                                                                            For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:
                                                                                                                                            (i) Hospitalisation due to worsening PAH;
                                                                                                                                            (ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6‑Minute Walk Distance from baseline, combined with worsening of WHO functional class status;
                                                                                                                                            (iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6‑Minute Walk Distance from baseline, combined with the need for additional PAH‑specific therapy;
                                                                                                                                            (iv) Initiation of parenteral prostanoid therapy or long‑term oxygen therapy for worsening of PAH;
                                                                                                                                            (v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.
                                                                       C11195                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial treatment following dose titration
                                                                                                                                            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 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: (i) selexipag with one endothelin receptor antagonist,