AcalabrutinibCalquence

7.1 The PBAC deferred making its decision on whether to recommend the Authority Required listing of acalabrutinib for use in combination with venetoclax (AV) in a fixed duration (FD) regimen for the treatment of previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), noting that a TGA Delegate’s Overview was not available at the time of the PBAC meeting.PSD · Nov 2025

7.2 The PBAC noted that, while multiple treatment options are available, there was a moderate clinical need for a second all oral, FD treatment option which would increase access for rural and regional patients and reduce the burden of treatment, compared to VO, which involves intravenous infusion.PSD · Nov 2025

6.30 The submission presented a cost-minimisation approach (CMA) comparing treatment costs with AV versus VO for patients with previously untreated CLL/SLL. The CMA assumed equivalent total treatment costs for AV and VO, incorporating cost offsets related to the administration of obinutuzumab and a lower incidence of TLS.PSD · Nov 2025

6.31 Table 7 summarises the key components and assumptions of the CMA. 17 OFFICIALPSD · Nov 2025

6.24 The submission described AV as non-inferior in terms of effectiveness compared with IV and VO, superior in terms of safety compared to IV and more favourable in terms of safety compared to VO.PSD · Nov 2025

6.25 On balance, the evaluation considered the clinical claim of non-inferior effectiveness was adequately supported by the evidence presented in the submission. The anchored (Bucher) ITC found no statistically significant difference between AV and VO in terms of PFS and OS in ‘fit’ patients. This finding was supported by the unanchored ITC that found no difference between AV and VO or IV, assuming use in unfit patients.PSD · Nov 2025

6.2 The PBAC noted and welcomed the input from health care professionals (1) and organisations (3) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with acalabrutinib including that it prolongs response to first line therapy, and is a tolerable, oral therapy for transplant ineligible patients, including those in rural and regional locations.PSD · Jul 2025

6.3 The PBAC noted that some of the comments outlined potential uses for acalabrutinib which were outside the submission’s proposed restriction including as initial monotherapy in elderly patients, and as part of induction in transplant eligible patients. The PBAC noted that such uses were not supported by the trial data.PSD · Jul 2025