Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p154
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 154/312)
Character Range: 16427395–16434389

have caused significant interference with quality of life; AND
                                                                                                                           Patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) apremilast.
                                                                                                                           Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; OR
                                                                                                                           Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar; OR
                                                                                                                           Must be treated by a general practitioner where there is agreement to continue treatment (not initiate treatment) with one of the above practitioner types.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           For patients who do not demonstrate an adequate response to deucravacitinib, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to 'biological medicines' for the treatment of 'severe chronic plaque psoriasis'.
                                                                                                                           This assessment must be documented in the patient's medical records.
C15407              P15407         CN15407          Niraparib                                                              High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets
                                                                                                                           Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                           The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.
C15408              P15408         CN15408          Niraparib                                                              High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets
                                                                                                                           The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND
                                                                                                                           The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND
                                                                                                                           Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; OR
                                                                                                                           The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND
                                                                                                                           Patient must not have