Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p17
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 17/161)
Character Range: 13922554–13930509

18 years of age.
                                                                                   Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'.
C13097              P13097         CN13097          Infliximab                     Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                   Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made
                                                                                   Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND
                                                                                   Patient must be undergoing treatment with this benefit where:
                                                                                    (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved;
                                                                                   Patient must be at least 18 years of age.
                                                                                   The authority application must be made in writing and must include
                                                                                   (1) a completed authority prescription form; and
                                                                                   (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                   The PBS administrator will confirm that
                                                                                   (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;
                                                                                   (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.
C13104              P13104         CN13104          Infliximab                     Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                   Balance of supply for Initial treatment, Continuing treatment - subcutaneous form
                                                                                   Must be treated by a rheumatologist; or
                                                                                   Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                   Patient must have received insufficient therapy with this drug for this condition under the Initial treatment with subcutaneous form restriction to complete 22 weeks initial treatment (intravenous and subcutaneous inclusive); or
                                                                                   Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; AND
                                                                                   The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND
                                                                                   The treatment must provide no more than the balance of up to 22 weeks treatment available under the Initial treatment - subcutaneous form; or
                                                                                   The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form;
                                                                                   Patient must be at least 18 years of age.
C13122              P13122         CN13122          Ciclosporin                    Severe psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 13122
                                                                                   Management (initiation, stabilisation and review of therapy)
                                                                                   The condition must be ineffective to other systemic therapies; or
                                                                                   The condition must be inappropriate for other systemic therapies; AND