Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p29
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 29/31)
Character Range: 98581–102577

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.
                 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.

         (b)           insert in numerical order after existing text:
   C14776        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.
                 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.

     [113]           Schedule 4, Part 1, entry for Zanubrutinib
         (a)           omit:
   C14344        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 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        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