Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p339
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 339/476)
Character Range: 3026535–3033696

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.
                                                                                                                                            Approvals for prescriptions for dose titration will 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 to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA‑approved Product Information, and a maximum of 4 repeats.
                                                                       C15271                                                               Chronic thromboembolic pulmonary hypertension (CTEPH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must demonstrate stable or responding disease; 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.
                                                                                                                                            Response to this drug is defined as follows:
                                                                                                                                            For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease.
                                                                                                                                            For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease.
                                                                                                                                            For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease.
                                                                                                                                            Test requirements to establish response to treatment for continuation of treatment are as follows:
                                                                                                                                            The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:
                                                                                                                                            (1) RHC plus ECHO composite assessments plus 6MWT;
                                                                                                                                            (2) RHC plus ECHO composite assessments;
                                                                                                                                            (3) RHC composite assessment plus 6MWT;
                                                                                                                                            (4) ECHO composite assessment plus 6MWT;
                                                                                                                                            (5) RHC composite assessment only;
                                                                                                                                            (6) ECHO composite assessment only.
                                                                                                                                            The results of the same tests as conducted at baseline should be documented in the patient's medical record with each continuing treatment application (i.e., every 6 months), except for patients who were able to undergo all 3 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