Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p377
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 377/476)
Character Range: 3296594–3304018

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.
                                                                                                                                            Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
                                                                                                                                            Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
                                                                                                                                            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.
                                                                       C13569                                                               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 must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
                                                                                                                                            Patient must be undergoing existing PBS‑subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; 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.
                                                                       C13570                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
                                                                                                                                            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.
                                                                                                                                            Patient must be undergoing continuing treatment of existing PBS‑subsidised combination therapy (dual/triple therapy, excluding selexipag), where this 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