Cost of Adverse Events With the Bruton Tyrosine Kinase Inhibitors Ibrutinib and Acalabrutinib in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia in Brazil
Author(s)
Ian Keary, PhD1, Marília Hernani, MSc2, Carolina Meyn Teixeira, Specialized postgraduate degree2, Ricardo Paranhos Moreira, Sr., MD3, Barry Rodgers-Gray, BSc, MSc, PhD4, John Fullarton, PhD1, MELDA DINC, MSc5, Sarah Palazuelos-Munoz, MSc, PharmD6, Fady Fam, MSc7, Doreen Tay, MSc8.
1Violicom Medical Limited, Aldermaston, United Kingdom, 2AstraZeneca, São Paulo, Brazil, 3AstraZeneca, SÃO PAULO, Brazil, 4Dr, Violicom Medical Limited, EASTLEIGH, United Kingdom, 5AstraZeneca, ISTANBUL, Turkey, 6AstraZeneca, Gaithersburg, MD, USA, 7AstraZeneca, Cambridge, United Kingdom, 8AstraZeneca, Singapore, Singapore.
1Violicom Medical Limited, Aldermaston, United Kingdom, 2AstraZeneca, São Paulo, Brazil, 3AstraZeneca, SÃO PAULO, Brazil, 4Dr, Violicom Medical Limited, EASTLEIGH, United Kingdom, 5AstraZeneca, ISTANBUL, Turkey, 6AstraZeneca, Gaithersburg, MD, USA, 7AstraZeneca, Cambridge, United Kingdom, 8AstraZeneca, Singapore, Singapore.
OBJECTIVES: Chronic lymphocytic leukaemia (CLL) is an incurable malignancy that can require long-term treatment. Bruton tyrosine kinase inhibitors (BTKis) are widely used as first-line therapy and for the treatment of relapsed/refractory (R/R) CLL. The second-generation BTKis, such as acalabrutinib, have reduced off-target effects compared with the first-generation BTKi, ibrutinib. To establish the financial implications of these clinical differences, this study assessed the cost of managing adverse events (AEs) with acalabrutinib versus ibrutinib in R/R-CLL in the Brazilian private healthcare context.
METHODS: AE rates were reported from a head-to-head comparison of acalabrutinib and ibrutinib (ELEVATE-RR trial) which included data on AEs occurring in ≥10% (any grade) or ≥5% (grade 3 or higher) of patients in either treatment arm. This analysis focused on AEs that showed statistically significant differences between the two arms (median treatment exposure 38.3 months with acalabrutinib and 35.5 months with ibrutinib). To reflect escalating intervention requirements with increasing AE severity, included AEs were stratified into grade ≤2 and grade ≥3 AEs and costs ascribed accordingly. All costs were derived from available Brazilian data.
RESULTS: Assuming a cohort of 100 patients, the base case analysis showed that the cost of managing adverse events with acalabrutinib was R$100,317 (€16,051) versus R$141,047 (€22,568) with ibrutinib, a reduction of 28.9% (R$40,730 [€6,517]) in favour of acalabrutinib. These savings were primarily driven by the costs of managing diarrhoea, atrial fibrillation, hypertension and urinary tract infections. The cost advantage in favour of acalabrutinib was maintained for both grade ≤2 and grade ≥3 AEs when considered separately (cost difference R$27,143 [€4,343] and R$13,587 [€2,174], respectively).
CONCLUSIONS: Observed differences in the AE profile of first- and second-generation BTKis can translate into meaningful differences in healthcare expenditure. These costs should be considered in decisions regarding reimbursement/funding of treatments for CLL.
METHODS: AE rates were reported from a head-to-head comparison of acalabrutinib and ibrutinib (ELEVATE-RR trial) which included data on AEs occurring in ≥10% (any grade) or ≥5% (grade 3 or higher) of patients in either treatment arm. This analysis focused on AEs that showed statistically significant differences between the two arms (median treatment exposure 38.3 months with acalabrutinib and 35.5 months with ibrutinib). To reflect escalating intervention requirements with increasing AE severity, included AEs were stratified into grade ≤2 and grade ≥3 AEs and costs ascribed accordingly. All costs were derived from available Brazilian data.
RESULTS: Assuming a cohort of 100 patients, the base case analysis showed that the cost of managing adverse events with acalabrutinib was R$100,317 (€16,051) versus R$141,047 (€22,568) with ibrutinib, a reduction of 28.9% (R$40,730 [€6,517]) in favour of acalabrutinib. These savings were primarily driven by the costs of managing diarrhoea, atrial fibrillation, hypertension and urinary tract infections. The cost advantage in favour of acalabrutinib was maintained for both grade ≤2 and grade ≥3 AEs when considered separately (cost difference R$27,143 [€4,343] and R$13,587 [€2,174], respectively).
CONCLUSIONS: Observed differences in the AE profile of first- and second-generation BTKis can translate into meaningful differences in healthcare expenditure. These costs should be considered in decisions regarding reimbursement/funding of treatments for CLL.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE178
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Budget Impact Analysis, Cost/Cost of Illness/Resource Use Studies
Disease
Oncology