Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p375
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 375/476)
Character Range: 3279906–3290824

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.
                                                                                                                                            The application must include details of the prior treatment regimen containing an NS5A inhibitor.
Sucroferric oxyhydroxide                                               C5530                                                                Hyperphosphataemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 5530
                                                                                                                                            Initiation and stabilisation
                                                                                                                                            The condition must not be adequately controlled by calcium; AND
                                                                                                                                            Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
                                                                                                                                            The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
                                                                                                                                            The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
                                                                                                                                            Patient must be undergoing dialysis for chronic kidney disease.
                                                                       C9762                                                                Hyperphosphataemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9762
                                                                                                                                            Initiation and stabilisation
                                                                                                                                            The condition must not be adequately controlled by calcium; AND
                                                                                                                                            Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
                                                                                                                                            The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
                                                                                                                                            The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
                                                                                                                                            Patient must be undergoing dialysis for chronic kidney disease.
Tacrolimus                                                             C5569                                                                Management of rejection in patients following organ or tissue transplantation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 5569
                                                                                                                                            The treatment must be under the supervision and direction of a transplant unit, AND
                                                                                                                                            The treatment must include initiation, stabilisation, and review of therapy as required.
                                                                       C9697                                                                Management of rejection in patients following organ or tissue transplantation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 9697
                                                                                                                                            The treatment must be under the supervision and direction of a transplant unit; AND
                                                                                                                                            The treatment must include initiation, stabilisation, and review of therapy as required.
Tadalafil                                                              C11229                                                               Pulmonary arterial hypertension (PAH)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Triple therapy ‑ Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
                                                                                                                                            The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) PBS‑subsidised selexipag (referred to as 'triple therapy'); OR
                                                                                                                                            The treatment must form part of dual combination therapy consisting of either: (i) PBS‑subsidised selexipag with 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