Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p71
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 71/312)
Character Range: 15874293–15884035

is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.
                                                                                                                           A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
                                                                                                                           Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.
C14764              P14764         CN14764          Obinutuzumab                                                           Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 14764
                                                                                                                           For combination use with acalabrutinib from treatment cycles 2 to 7 inclusive in first-line therapy
                                                                                                                           The condition must be untreated; AND
                                                                                                                           The treatment must be in combination with PBS-subsidised acalabrutinib (refer to Product Information for timing of obinutuzumab and acalabrutinib doses).
C14770              P14770         CN14770          Pembrolizumab                                                          Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Initial treatment - 3 weekly treatment regimen
                                                                                                                           The treatment must be in addition to complete surgical resection; AND
                                                                                                                           Patient must have a WHO performance status of 1 or less; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must not have received prior PBS-subsidised treatment for this condition; AND
                                                                                                                           The treatment must commence within 12 weeks of complete resection; AND
                                                                                                                           Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).
C14776              P14776         CN14776          Venetoclax                                                             Chronic lymphocytic leukaemia (CLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                           Dose titration for relapsed/refractory disease
                                                                                                                           The condition must have relapsed or be refractory to at least one prior therapy; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND
                                                                                                                           Patient must not be undergoing retreatment with this drug where any of:
                                                                                                                            (i) prior treatment of CLL/SLL with this same drug was unable to prevent disease progression; (ii) 24 months of PBS-subsidised treatment has been administered with this drug for this condition.
C14778              P14778         CN14778          Olaparib                                                               High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Continuation of first-line maintenance therapy (BRCA1/2 gene mutation)
                                                                                                                           The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase:
                                                                                                                            Initial first-line maintenance therapy (BRCA1/2 gene mutation); 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 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response.
C14786              P14786         CN14786          Pembrolizumab                                                          Resected Stage