OBJECTIVES: Differences in reimbursement for medications used to treat relapsed/refractory chronic lymphocytic leukemia (R/R CLL) may exist between Central and Eastern European (CEE) countries. This study aims to explore the reimbursement landscape for novel targeted therapies across CEE countries.

METHODS: The data on reimbursement policies were meticulously collected from eight CEE countries (Bosnia and Herzegovina, Bulgaria, Croatia, Montenegro, Estonia, Poland, Romania, and Slovakia). The authors gathered the information from national databases using a comprehensive questionnaire. The survey included detailed questions about the reimbursement policy and HTA assessment for R/R CLL therapies (ibrutinib, zanubrutinib, acalabrutinib, venetoclax, idelalisib, and duvelisib). The data collection focused on understanding the general reimbursement policy, target populations, costs, availability of cost-effectiveness results, and challenges in the reimbursement process.

RESULTS: Ibrutinib, first reimbursed in Romania (December 2016) and most recently in Slovakia (July 2022), is reimbursed in all analyzed countries. Second-generation BTK inhibitors, such as acalabrutinib, are covered only in Bulgaria, Croatia, Estonia, and Poland, while zanubrutinib – only in Bulgaria and Poland. PI3K inhibitors (duvelisib, idelalisib) are not reimbursed in any country. In most countries, reimbursement indications allow treating all R/R CLL patients. However, some exceptions exist (e.g., Croatia, Estonia), where reimbursement does not cover patients without del17p/mTP53 with late relapses. In all countries, the reimbursement level is 100% for all drugs. Information about the number of treated patients is often not publicly available. In Bosnia and Herzegovina and Croatia, HTA assessment is not required to obtain reimbursement. Other countries require and conduct HTA assessments, but detailed cost-effectiveness indicators are confidential. The main challenges include unequal treatment access between regions (e.g., Bosnia and Herzegovina), issues with access to genetic diagnostics (e.g., Bulgaria, Romania), and lack of consideration of unmet medical needs in HTA evaluations.

CONCLUSIONS: Disparities in CLL therapy reimbursement and access across CEE countries highlight the need for harmonized policies.