Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p369
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 369/476)
Character Range: 3233235–3241263

may be requested.
                                                                       C13482                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial 2 (change)
                                                                                                                                            Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH; AND
                                                                                                                                            Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; 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.
                                                                                                                                            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.
                                                                       C13484                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                                            Initial 1 (new patients)
                                                                                                                                            Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent.
                                                                                                                                            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 WHO Functional Class II PAH, or WHO Functional Class III PAH; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised PAH agent for this condition.
                                                                                                                                            A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
                                                                                                                                            Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
                                                                                                                                            If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                                            (a) a completed authority prescription form; and
                                                                                                                                            (b) 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).
                                                                                                                                            (1) Confirm