Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p109
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 109/381)
Character Range: 12224854–12232163

will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the 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.
                                                                                                                                                                    A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
C11917              P11917         CN11917          Guselkumab                                                                                                      Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Must be treated by a rheumatologist; or
                                                                                                                                                                    Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND
                                                                                                                                                                    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 aged 18 years or older.
                                                                                                                                                                    An adequate response to treatment is defined as
                                                                                                                                                                    an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
                                                                                                                                                                    The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
                                                                                                                                                                    The authority application must be made in writing and must include
                                                                                                                                                                    (a) a completed authority prescription form(s); and
                                                                                                                                                                    (b) 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).
                                                                                                                                                                    Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy.
                                                                                                                                                                    Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to