Cost-effectiveness of acalabrutinib regimens in treatment-naïve chronic lymphocytic leukemia in the United States

ABSTRACT Background Clinical outcomes in chronic lymphocytic leukemia (CLL) have improved with targeted therapy, including Bruton tyrosine kinase inhibitors such as acalabrutinib. Methods A semi-Markov model with three health states (progression-free, progressed disease, and death) estimated cost per quality-adjusted life-year (QALY) gained for acalabrutinib ± obinutuzumab vs chlorambucil + obinutuzumab in treatment-naive CLL (based on ELEVATE-TN). The model used direct costs and resource utilization from the US Medicare perspective and utility values sourced from literature. Sensitivity analyses tested the robustness of the model. Results Over a 30-year lifetime horizon, the model base case analysis suggested that acalabrutinib monotherapy had an incremental cost of $206,329 and 2.52 QALYs gained versus chlorambucil + obinutuzumab, resulting in an incremental cost-effectiveness ratio (ICER) of $81,960/QALY. Acalabrutinib + obinutuzumab had an incremental cost of $423,747 and 2.79 QALYs gained (ICER: $152,153/QALY). Probabilistic sensitivity analysis showed the probability of acalabrutinib monotherapy being cost-effective as 59% to 73% at a $100,000-to-150,000/QALY willingness-to-pay threshold; the probability of acalabrutinib + obinutuzumab being cost-effective ranged from 34% to 51%. Conclusions Although the analysis is limited by uncertainty in postprogression survival outcomes, acalabrutinib monotherapy is likely cost-effective vs chlorambucil + obinutuzumab in treatment-naive CLL in the US Medicare setting.

[1]  I. Flinn,et al.  Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia , 2022, Leukemia.

[2]  J. H. Lee,et al.  Three-Year Follow-up of the Ascend Trial: Acalabrutinib Vs Rituximab Plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia , 2021, Blood.

[3]  M. Davids,et al.  Matching-Adjusted Indirect Treatment Comparison (MAIC) of Acalabrutinib Alone or in Combination with Obinutuzumab Versus Ibrutinib or Venetoclax Plus Obinutuzumab in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia , 2021, Blood.

[4]  K. Davis,et al.  Overall survival, adverse events, and economic burden in patients with chronic lymphocytic leukemia receiving systemic therapy: Real‐world evidence from the medicare population , 2021, Cancer medicine.

[5]  T. Munir,et al.  Cost-Effectiveness of Acalabrutinib Monotherapy Compared with Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia , 2020 .

[6]  E. Arias,et al.  United States Life Tables, 2018. , 2020, National vital statistics reports : from the Centers for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System.

[7]  Claudio Conversano,et al.  On the Use of Markov Models in Pharmacoeconomics: Pros and Cons and Implications for Policy Makers , 2020, Frontiers in Public Health.

[8]  Á. Illés,et al.  ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. , 2020, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[9]  J. Byrd,et al.  Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment-naive chronic lymphocytic leukaemia (ELEVATE-TN): a randomised, controlled, phase 3 trial , 2020, The Lancet.

[10]  Jennifer E. Moore,et al.  Agency for Healthcare Research and Quality , 2020, Definitions.

[11]  Sukhvinder Johal,et al.  Evaluating Partitioned Survival and Markov Decision-Analytic Modeling Approaches for Use in Cost-Effectiveness Analysis: Estimating and Comparing Survival Outcomes , 2019, PharmacoEconomics.

[12]  S. Malek,et al.  Chronic Lymphocytic Leukemia , 2019, Methods in Molecular Biology.

[13]  Scott E. Smith,et al.  Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL , 2018, The New England journal of medicine.

[14]  N. Team Chronic obstructive pulmonary disease in over 16s: diagnosis and management , 2018 .

[15]  Joseph A Hill United States Life Tables , 2013 .

[16]  Nicholas R Latimer,et al.  Survival Analysis for Economic Evaluations Alongside Clinical Trials—Extrapolation with Patient-Level Data , 2013, Medical decision making : an international journal of the Society for Medical Decision Making.