Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p434
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 434/476)
Character Range: 3645592–3651932

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).
                                                                                                                                            The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
                                                                                                                                            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.
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.
                                                                                                                                            If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
                                                                                                                                            If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
Ustekinumab                                                            C9655                                                                Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                                            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)].
                                                                                                                                            Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                                            Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
                                                                                                                                            The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            Applications for authorisation must be made in writing and must include:
                                                                                                                                            (a) two completed authority prescription forms; and
                                                                                                                                            (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information