Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p211
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 211/476)
Character Range: 2104679–2111074

time of application and documented in the patient's medical records:
                                                                                                                                            (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
                                                                                                                                            (ii) a baseline BASDAI score; and
                                                                                                                                            (iii) a baseline ESR and/or CRP level.
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
                                                                                                                                            A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
                                                                                                                                            Up to a maximum of 3 repeats will be authorised.
                                                                                                                                            To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                                            Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                                            If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                       C14683                                                               Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 14683
                                                                                                                                            First continuing treatment
                                                                                                                                            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.
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
                                                                                                                                            An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
                                                                                                                                            (a) an ESR measurement no greater than 25 mm per hour; or
                                                                                                                                            (b) a