Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p49
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 49/476)
Character Range: 1028497–1034544

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 PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
                                                                                                                                            (4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that 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.
                                                                                                                                            If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA‑approved Product Information and no repeats.
                                                                                                                                            Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA‑approved Product Information, and a maximum of 4 repeats.
                                                                                                                                            If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA‑approved Product Information.
Buprenorphine                                                          C16009                                                               Opioid