Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p7
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 7/161)
Character Range: 13859758–13865601

a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
                                                                                   5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).
                                                                                   Blast crisis is defined as either
                                                                                   1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
                                                                                   2. Extramedullary involvement other than spleen and liver.
                                                                                   The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include
                                                                                   (i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or
                                                                                   (ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and
                                                                                   (iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and
                                                                                   (iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.
                                                                                   All reports must be documented in the patient's medical records.
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (i) A completed authority prescription form; and
                                                                                   (ii) 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).
                                                                                   Up to a maximum of 18 months of treatment may be authorised under this initial restriction.
C13034              P13034         CN13034          Diroximel fumarate             Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 13034
                                                                                   Continuing 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 previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient 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