Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p341
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 341/476)
Character Range: 3040986–3047734

at least 90 days after start of full anticoagulation; and
                                                                                                                                            (b) A mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after start of full anticoagulation.
                                                                                                                                            CTEPH that is recurrent or persistent subsequent to pulmonary endarterectomy is defined as follows:
                                                                                                                                            RHC demonstrating a PVR of greater than 300 dyn*sec*cm-5measured at least 180 days following pulmonary endarterectomy.
                                                                                                                                            Where a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be documented in the patient's medical records.
                                                                                                                                            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).
                                                                                                                                            The following must be provided at the time of application and documented in the patient's medical records:
                                                                                                                                            (a) the results from the 3 tests below, to establish baseline measurements, where available:
                                                                                                                                            (i) RHC composite assessment, and
                                                                                                                                            (ii) ECHO composite assessment, and
                                                                                                                                            (iii) 6 Minute Walk Test (6MWT); and
                                                                                                                                            (b) confirmation of evidence of inoperable CTEPH including the pulmonary vascular resistance (PVR) value, a mean pulmonary artery pressure (PAPmean) and the starting date of full anticoagulation; or
                                                                                                                                            (c) confirmation of evidence of recurrent or persistent CTEPH including the PVR value and the date that pulmonary endarterectomy was performed; or
                                                                                                                                            (d) confirmation of an echocardiogram demonstrating right ventricular dysfunction.
                                                                                                                                            Where it is not possible to perform all 3 tests above on clinical grounds, the expected test combination, in descending order of preference is:
                                                                                                                                            (1) RHC plus ECHO composite assessments;
                                                                                                                                            (2) RHC composite assessment plus 6MWT;
                                                                                                                                            (3) RHC composite assessment only.
                                                                                                                                            In circumstance where a RHC cannot be performed on clinical grounds, the expected test combinations, in descending order of preference is:
                                                                                                                                            (1) ECHO composite assessment plus 6MWT;
                                                                                                                                            (2) ECHO composite assessment only.
                                                                                                                                            Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be documented in the patient's medical records.
                                                                                                                                            The test results provided must not be more than 2 months old at the time of application.
                                                                                                                                            Prescriptions for dose titration must provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.
                                                                                                                                            Approvals for subsequent authority prescription will be limited