Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p189
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 189/476)
Character Range: 1988473–1994408

assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
                                                                                                                                            (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
                                                                                                                                            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:
                                                                                                                                            (a) a completed authority prescription form(s); and
                                                                                                                                            (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
                                                                                                                                            (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
                                                                                                                                            (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
                                                                                                                                            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 the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                            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 within this treatment cycle.
                                                                       C14502                                                               Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 1 (new patient)
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                                            Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                            Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a