Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p117
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 117/312)
Character Range: 16201084–16208396

date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C15193              P15193         CN15193          Ondansetron                                                            Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 15193
                                                                                                                           The condition must be associated with radiotherapy being used to treat malignancy; OR
                                                                                                                           The condition must be associated with chemotherapy (including methotrexate) being used in the treatment of malignancy and juvenile autoimmune conditions.
C15195              P15195         CN15195          Upadacitinib                                                           Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                                                                                           First Continuing treatment
                                                                                                                           Must be treated by a rheumatologist; OR
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                           Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           An adequate response to treatment is defined as:
                                                                                                                           an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
                                                                                                                           AND either of the following:
                                                                                                                           (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                                           (b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
                                                                                                                           (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                                           (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                                                                                           Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
                                                                                                                           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).
                                                                                                                           An application for the continuing treatment must be accompanied with the assessment of response conducted