Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p13
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 13/161)
Character Range: 13897214–13905123

this authority application.
C13072              P13072         CN13072          Diroximel fumarate             Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 13072
                                                                                   Initial treatment
                                                                                   The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or
                                                                                   The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                                                   The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                   Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
                                                                                   Patient must be ambulatory (without assistance or support).
                                                                                   Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C13077              P13077         CN13077          Infliximab                     Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    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.
C13078              P13078         CN13078          Infliximab                     Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           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;