OBJECTIVES: In CLL fixed-duration treatment are available with reimbursement from 2020 (mono, venetoclax-rituximab 2^nd L) and from 2022 (venetoclax- obinutuzumab– 1^st L) in Hungary. The aim of this research is to clarify the saving potential of novel fixed-duration targeted 1^st line therapies in CLL based on claims data in Hungary.

METHODS: This research consisted of a non-interventional, retrospective analysis of the anonymized health insurance claims database from the Hungarian National Health Insurance Fund (NHIFA). The research period was from 01.2016, through 12.2023 with one year observation period at the beginning. CLL patients were identified by defined drug therapies with relevant ICD-10 codes (C9110-C9120). The research defined patient cohorts with mono- and combination therapies of ibrutinib and venetoclax.

RESULTS: A total of 2108 eligible patients were identified. During the research period the treatment patterns showed an enormous change. From 2017 till 2019 chemotherapies and non-fixed-duration therapies were the standard. During 2020-2023 fixed-duration therapy has dominated the treatment landscape. In claims data, the average treatment duration of ibrutinib monotherapy in 1^st line was avg 89,4 (median 73,3) weeks for the whole research period, which is longer than 64 weeks threshold point to cost savings, which is the break-even point in the comparison.

The saving potential from payer perspective was found on published price level 28 265 € average per patient (10 341 € median) regarding to the full research period. The total budget saving is 7,46 million € based on average and 2,73 million € based on median therapy length calculation, if the patients treated by venetoclax-obinutuzumab combination instead of ibrutinib monotherapy in 1L.

CONCLUSIONS: This research has shown that, in real-world Hungarian practice, 1^st L fixed-duration CLL therapy of venetoclax- obinutuzumab provides substantial savings for the Payer, which can ensure access for further patients to new innovative therapies.