Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p373
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 373/476)
Character Range: 3262430–3269960

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 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 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.
Siltuximab                                                             C12585                                                               Idiopathic multicentric Castleman disease (iMCD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must have a diagnosis of iMCD consistent with the latest international, evidence‑based consensus diagnostic criteria for this condition with the relevant diagnostic findings documented in the patient's medical records; AND
                                                                                                                                            The condition must not be, to the prescriber's best knowledge, any of the following diseases that can mimic iMCD: (i) human herpes virus‑8 infection, (ii) an Epstein‑Barr virus‑lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human immunodeficiency virus, tuberculosis) leading to inflammation with adenopathy, (iv) an autoimmune/autoinflammatory disease, (v) a malignant/lymphoproliferative disorder.
                                                                                                                                            Must be treated by a haematologist; OR
                                                                                                                                            Must be treated by a medical physician working under the supervision of a haematologist; AND
                                                                                                                                            Patient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed;