Cost-effectiveness of acalabrutinib monotherapy or with obinutuzumab versus chemoimmunotherapy for untreated chronic lymphocytic leukemia in China.

Background: Acalabrutinib is a highly selective, latest generation Bruton's tyrosine kinase inhibitors for the treatment of chronic lymphocytic leukemia (CLL). The ELEVATE-TN trial (NCT02475681) found significant benefits achieved by the acalabrutinib regimen compared to the chemoimmunotherapy regimen chlorambucil plus obinutuzumab in treatment-naïve CLL. The objective of this study was to explore the cost-effectiveness of acalabrutinib in the first-line treatment of CLL in the light of Chinese healthcare system.

Methods: We constructed a 4-week partitioned survival model and a 20-year lifetime horizon to estimate the cost and utility associated with CLL treatment. The survival data, direct medical costs, and utilities came from the ELEVATE-TN trial, YAOZHI database, and published literatures. The outputs of the model including total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. One-way, probabilistic sensitivity, and scenario analyses were conducted to assess the robustness of the model.

Results: Over a 20-year lifetime horizon, treatment with acalabrutinib + obinutuzumab provided an additional 2.51 QALYs versus treatment with chlorambucil and obinutuzumab, while incurring incremental costs of $940,543 and an ICER of $374,449/QALY. Acalabrutinib had an incremental cost of $683,640 and provided an additional 2.24 QALYs, resulted an ICER of $305,562/QALY. One-way sensitivity analyses suggested that the model was most sensitive to utility of progression-free survival, progression disease, and the cost of acalabrutinib. Probabilistic sensitivity analyses showed that at the willingness-to-pay (WTP) threshold, the probabilities of the acalabrutinib regimens were at an absolute disadvantage. The scenario analyses showed altering the lifetime horizon or price of acalabrutinib did not reverse results of our model.

Conclusion: Acalabrutinib with or without obinutuzumab might not be a cost-effective option in recent China, when compared with chemoimmunotherapy for first-line patients with CLL at the commonly WTP threshold. It is therefore necessary to reduce the price of acalabrutinib.