Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p101
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 101/191)
Character Range: 10656448–10664457

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.
C8831               P8831          CN8831           Secukinumab                                                                                                                                                                Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND
                                                                                                                                                                                                                               Must be treated by a dermatologist.
C8839               P8839          CN8839           Etanercept                                                                                                                                                                 Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Subsequent continuing treatment, whole body
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; 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 per subsequent continuing treatment course authorised under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or