According to modern international clinical guidelines, high-risk chronic lymphocytic leukemia (CLL) patients (CLL-IPI score ≥4) should receive targeted therapy with venetoclax or Bruton’s tyrosine kinase inhibitors (BTKi) like acalabrutinib or ibrutinib. However, only a third of these patients receive modern targeted therapy in real-world Russian clinical practice, while other ones undergo ineffective chemotherapy options.

OBJECTIVE

To assess the impact of a wide use of BTKi in high-risk CLL patients on mortality from malignant neoplasms in Russia over a 10-year period.

MATERIAL AND METHODS

There are no significant available literature data on overall survival in high-risk patients undergoing BTKi compared to chemotherapy. We developed a mathematical model of CLL progression considering clinical trial and real-world evidence data to estimate long-term overall survival of patients undergoing BTKi and chemotherapy. The study evaluated the effect of increasing access to BTKi on mortality, as well as additional costs associated with expanding access to each of the two BTKi drugs for target population.

RESULTS

Up to 623 newly diagnosed high-risk CLL patients could be treated with BTKi each year in Russia. However, only 278 of these ones underwent this therapy in real-world practice. Treating all eligible patients with BTKi could prevent 9 deaths during first year, 139 deaths over three years, and 1.235 deaths over ten years compared to the current practice. Treatment cost in current practice for the period 2023—2032 is estimated to be 6.4 billion RUB per year. Additional costs in case of 100% coverage of these patients with ibrutinib therapy amount to 6.8 billion rubles annually. At the same time, acalabrutinib requires 4.8 billion rubles annually with comparable clinical outcomes.

CONCLUSION

Wide use of BTKi in high-risk CLL patients reduces cancer mortality in Russia.