Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p340
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 340/476)
Character Range: 3033440–3041510

tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be documented in the patient's medical records.
                                                                                                                                            The test results conducted for continuing treatment must be no more than 2 months old at the time of application.
                                                                                                                                            The assessment of the patient's response to the continuing 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
                                                                                                                                            The maximum quantity per prescription must be based on the dosage recommendations in the TGA-approved Product Information and be limited to provide sufficient supply for 1 month of treatment.
                                                                                                                                            A maximum of 5 repeats will be authorised.
                                                                                                                                            Patients who fail to demonstrate disease stability or improvement to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
                                                                       C15272                                                               Chronic thromboembolic pulmonary hypertension (CTEPH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Balance of supply
                                                                                                                                            Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete a maximum of 20 weeks of treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete a maximum of 24 weeks of treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 20 or 24 weeks of treatment available under the above respective restriction; AND
                                                                                                                                            The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                            Must be treated in a centre with expertise in the management of CTEPH.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                       C15274                                                               Chronic thromboembolic pulmonary hypertension (CTEPH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must have WHO Functional Class II, III or IV CTEPH; AND
                                                                                                                                            The condition must be inoperable by pulmonary endarterectomy; OR
                                                                                                                                            The condition must be recurrent or persistent following pulmonary endarterectomy; AND
                                                                                                                                            The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                            Must be treated in a centre with expertise in the management of CTEPH.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            CTEPH that is inoperable by pulmonary endarterectomy is defined as follows:
                                                                                                                                            (a) Right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dyn*sec*cm-5measured 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