Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p19
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 19/31)
Character Range: 61214–65277

Authority Required procedures
                      Treatment of relapsed/refractory disease
                      The condition must have relapsed or be refractory to at least one prior therapy; 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
                      The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.
                      Patient must not be undergoing retreatment with this drug where prior, active treatment of CLL/SLL with this same drug was unable to prevent disease progression; AND
                      Patient must be undergoing treatment through this treatment phase listing for the first time; OR
                      Patient must be undergoing treatment through this treatment phase listing on a subsequent occasion, with disease progression being absent.

         (b)           insert in numerical order after existing text:
   C14788  P14788     Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                 Compliance with Authority Required procedures
                      Treatment of relapsed/refractory disease
                      The condition must have relapsed or be refractory to at least one prior therapy; 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
                      The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.
                      Patient must not be undergoing retreatment (second/subsequent treatment course) with this drug where prior treatment of CLL/SLL with this same drug was unable to prevent disease progression; AND
                      Patient must be undergoing treatment through this treatment phase listing for the first time (initial treatment); OR
                      Patient must be undergoing continuing treatment through this treatment phase listing, with disease progression being absent.

     [108]           Schedule 4, Part 1, entry for Obinutuzumab
     insert in numerical order after existing text:
   C14764        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).

     [109]           Schedule 4, Part 1, entry for Olaparib
         (a)           omit:
   C10913  P10913     High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                 Compliance with Authority Required procedures
                      Continuing treatment - first line treatment
                      Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND
                      The treatment must be the sole PBS-subsidised 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