Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p104
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 104/476)
Character Range: 1469525–1477469

the diagnosis of PAH is current.
                                                                                                                                            (5) Confirm that this authority application is not seeking subsidy for a patient 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 test results must not be more than 6 months old at the time of application.
                                                                       C13512                                                               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; AND
                                                                                                                                            Patient must have WHO Functional Class IV PAH; 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.
                                                                                                                                            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 that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
                                                                                                                                            (a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
                                                                                                                                            (b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
                                                                                                                                            (2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
                                                                                                                                            ‑ RHC composite assessment; and
                                                                                                                                            ‑ ECHO composite assessment; and
                                                                                                                                            ‑ 6 Minute Walk Test (6MWT)
                                                                                                                                            Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
                                                                                                                                            ‑ RHC plus ECHO composite assessments;
                                                                                                                                            ‑ RHC composite assessment plus 6MWT;
                                                                                                                                            ‑ RHC composite assessment only.
                                                                                                                                            In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
                                                                                                                                            ‑ ECHO composite assessment plus 6MWT;
                                                                                                                                            ‑ ECHO composite assessment only.
                                                                                                                                            (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
                                                                                                                                            (i) for why fewer than 3 tests are able to be performed on clinical grounds;
                                                                                                                                            (ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another