Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p15
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 15/161)
Character Range: 13910307–13918052

compared to the baseline values. Indicate the rating (0=none, 1=slight) for each of these 3 observations in the authority application for each affected area; or
                                                                                   (ii) A reduction by at least 75% in the skin area affected, or, sustained at this level, as compared to the baseline value for this treatment cycle. State the qualifying numerical percentage figure in the authority application for each affected area.
                                                                                   All assessment findings must be no more than 1 month old at the time of application. Response assessments must be performed on the same affected area assessed at baseline.
C13080              P13080         CN13080          Infliximab                     Severe 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.
C13082              P13082         CN13082          Paliperidone                   Schizophrenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 13082
                                                                                   Patient must have previously received and be stabilised on PBS-subsidised paliperidone three-monthly injection for at least one cycle.  or
                                                                                   Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months.
C13094              P13094         CN13094          Infliximab                     Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              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 gastroenterologist (code 87); or
                                                                                   Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                   Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; 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