Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p117
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 117/476)
Character Range: 1573878–1582218

drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
                                                                                                                                            The treatment must be limited to a maximum duration of 12 weeks.
                                                                       C10268              P10268                                           Chronic hepatitis C infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                            Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
                                                                                                                                            Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
                                                                                                                                            The treatment must be limited to a maximum duration of 16 weeks.
                                                                                                                                            The application must include details of the prior treatment regimen containing an NS5A inhibitor.
Iloprost                                                               C13491                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial 2 (change)
                                                                                                                                            Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
                                                                                                                                            Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised PAH agent for this condition.
                                                                                                                                            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.
                                                                                                                                            A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
                                                                                                                                            PAH agents are not PBS‑subsidised for 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.
                                                                                                                                            Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
                                                                                                                                            Applications to swap between the 8 PAH agents must be made 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