Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p133
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 133/476)
Character Range: 1675628–1684076

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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            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.
                                                                       C9068                                                                Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment ‑ balance of supply
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
                                                                       C9111                                                                Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                            Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 22 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions.
                                                                       C9188                                                                Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 9188
                                                                                                                                            Subsequent continuing treatment
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for