Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p131
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 131/312)
Character Range: 16284110–16291007

demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
C15233              P15233         CN15233          Ribociclib                                                             Locally advanced or metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                           The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND
                                                                                                                           Patient must require dosage reduction requiring a pack of 21 tablets; AND
                                                                                                                           The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
                                                                                                                           Patient must not be premenopausal.
                                                                                                                           PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).
C15236              P15236         CN15236          Risankizumab                                                           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 28 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