Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p18
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 18/31)
Character Range: 57592–61553

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.
   C14795  P14795     Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                      Compliance with Authority Required procedures
                      First line drug treatment of this indication - as monotherapy
                      The condition must be untreated with acalabrutinib at the time of the first dose of this drug; OR
                      Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; 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 be undergoing initial treatment with this drug - this is the first prescription for this drug; OR
                      Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug.
   C14800  P14800     Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                      Compliance with Authority Required procedures
                      First line drug treatment of this indication - in combination with obinutuzumab
                      The condition must be untreated with acalabrutinib at the time of the first dose of this drug; OR
                      Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; 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 initiated as a monotherapy for 1 Cycle with treatment in combination with obinutuzumab from Cycle 2 to 7 (refer to Product Information for timing of obinutuzumab and acalabrutinib doses) after which treatment must be monotherapy.
                      Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; OR
                      Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug.

     [107]           Schedule 4, Part 1, entry for Ibrutinib
         (a)           omit:
   C14344  P14344     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