Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p172
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 172/476)
Character Range: 1898839–1903448

(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).
                                                                                                                                            All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
                                                                                                                                            If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
                                                                                                                                            Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will 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 demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
                                                                                                                                            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.
                                                                                                                                            Up to a maximum of 3 repeats will be authorised.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) a completed authority prescription form(s); and
                                                                                                                                            (2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
                                                                                                                                            An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
                                                                                                                                            Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
                                                                                                                                            An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
                                                                                                                                            Where the response assessment is not submitted within this timeframe, 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