Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p118
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 118/162)
Character Range: 15273721–15278782

Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 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 24 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 24 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 24 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 24 weeks treatment available under the above restrictions; AND
                                                                                                         Must be treated by a dermatologist.
C14453              P14453         CN14453          Ixekizumab                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                                                                                                         Initial treatment - Initial 1, Face, hand, foot (new patient)
                                                                                                         Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
                                                                                                         Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                         Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
                                                                                                          (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND
                                                                                                         The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                         Patient must be aged 18 years or older;
                                                                                                         Must be treated by a dermatologist.
                                                                                                         Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time