Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p130
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 130/191)
Character Range: 10866617–10875725

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.
C9160               P9160          CN9160           Ustekinumab                                                                                                                                                                Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in 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; AND
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 28 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 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 28 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restrictions.
C9162               P9162          CN9162           Etanercept                                                                                                                                                                 Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               First continuing treatment, Whole body
                                                                                                                                                                                                                               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
                                                                                                                                                                                                                               The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                                                                                                                               Patient must not receive more than 24 weeks of treatment under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older;
                                                                                                                                                                                                                               Must be treated by a dermatologist.
                                                                                                                                                                                                                               An adequate response to treatment is defined as
                                                                                                                                                                                                                               A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
                                                                                                                                                                                                                               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 completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
                                                                                                                                                                                                                               The