Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p387
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 387/476)
Character Range: 3365938–3373547

one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
                                                                                                                                            Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
                                                                                                                                            The authority application for selexipag must be approved prior to the authority application for this agent.
                                                                                                                                            For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
                                                                                                                                            PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
                                                                                                                                            PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
                                                                                                                                            (i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
                                                                                                                                            (ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
                                                                                                                                            The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
                                                                                                                                            The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.
                                                                                                                                            A maximum of 5 repeats may be requested.
                                                                                                                                            Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.
Teduglutide                                                            C11999                                                               Type III Short bowel syndrome with intestinal failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ balance of supply
                                                                                                                                            Must be treated by a gastroenterologist; OR
                                                                                                                                            Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
                                                                                                                                            Patient must have previously received PBS‑subsidised initial treatment with this drug for this condition; AND
                                                                                                                                            Patient must have received insufficient therapy with this drug under the initial treatment restriction to complete the maximum duration of 12 months of initial treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 12 months of treatment.
                                                                       C14534                                                               Type III Short bowel syndrome with intestinal failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Must be treated by