Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p106
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 106/162)
Character Range: 15218678–15224099

(PD-1/PD-L1) inhibitor therapy; or
                                                                                                         The condition must have progressed on/following platinum-based chemotherapy, whilst PD-1/PD-L1 inhibitor therapy resulted in an intolerance that required treatment cessation; AND
                                                                                                         Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND
                                                                                                         The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                                         Patient must be undergoing treatment with this drug for the first time.  or
                                                                                                         Patient must be undergoing continuing treatment with this drug, with each of the following being true:
                                                                                                          (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.
C14425              P14425         CN14425          Bimekizumab                                          Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                                                                                                         Initial treatment - Initial 1, Whole body (new patient)
                                                                                                         Patient must have severe chronic plaque psoriasis where lesions 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 24 weeks of treatment under this restriction;
                                                                                                         Patient must be at least 18 years of age;
                                                                                                         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 of application.
                                                                                                         Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
                                                                                                         Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an