Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p102
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 102/476)
Character Range: 1455020–1463974

under the relevant initial treatment (monotherapy) restriction.
                                                                                                                                            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.
                                                                       C13505                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial 3 ‑ changing to this drug in combination therapy (dual or triple therapy)
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
                                                                                                                                            The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
                                                                                                                                            Patient must be undergoing existing PBS‑subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND
                                                                                                                                            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.
                                                                       C13506                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
                                                                                                                                            The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
                                                                                                                                            Patient must be undergoing continuing treatment of existing PBS‑subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND
                                                                                                                                            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.
                                                                       C13510                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                                            Initial 1 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
                                                                                                                                            Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
                                                                                                                                            Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
                                                                                                                                            The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient