Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p12
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 12/161)
Character Range: 13890717–13898664

to 16 weeks therapy available under 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.
C13068              P13068         CN13068          Infliximab                     Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                   Balance of supply for Initial treatment, Continuing treatment - subcutaneous form
                                                                                   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 have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 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 provide no more than the balance of doses up to 14 to 16 weeks therapy available under 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.
C13069              P13069         CN13069          Infliximab                     Severe active rheumatoid 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.
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