Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p8
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 8/161)
Character Range: 13865188–13871923

must not show continuing progression of disability while on treatment with this drug.
                                                                                   Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C13039              P13039         CN13039          Infliximab                     Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              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.
C13040              P13040         CN13040          Infliximab                     Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                   Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription
                                                                                   Must be treated by a rheumatologist; or
                                                                                   Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND
                                                                                   Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
                                                                                    (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or
                                                                                   Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
                                                                                    (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions;
                                                                                   Patient must be at least 18 years of age.
                                                                                   Where there is a current, approved PBS