OBJECTIVES: This study aimed to assess the budget impact (BI) of introducing 12-month fixed-duration venetoclax+obinutuzumab (VEN+O) as first-line (1L) treatment in CLL for patients with or without a del17p/TP53mut and ineligible to full-dose fludarabine treatment from the French payer perspective.

METHODS: A BI model with a 5-year time horizon was developed to estimate the economic impact of the introduction of VEN+O in the therapeutic strategy from the French payer perspective. The 5-year budget impact included VEN+O, bendamustine+rituximab, obinutuzumab+chlorambucil, ibrutinib (I), acalabrutinib (A), and acalabrutinib+obinutuzumab (A+O). Total costs included first line treatment costs (acquisition, administration, and adverse events), monitoring, tumor lysis syndrome prevention, and initiation of a second line treatment. Clinical data were obtained from pivotal clinical trials (for duration of treatment, progression-free survival and adverse events) and validation by clinical expert’s opinions. Outcomes included net and cumulative costs and budget impact.

RESULTS: In 1,500 naïve CLL patients eligible for treatment each year, introducing VEN+O resulted in total cost savings of €176,632,387 over the 5-year time horizon, with savings starting year 2. Savings on first line drug acquisition costs contributed to 98.7% of the total cost savings, driven by the fixed-duration of VEN+O compared to other continuous-treatment regimens (I, A and A+O). The introduction of VEN+O resulted in a decrease in 1L drug acquisition costs (-19.5%) and second-line drug acquisition/administration costs (-5.4%). Sensitivity analyses confirmed the base-case findings.

CONCLUSIONS: Introducing VEN+O, a fixed treatment duration regimen, as treatment of 1L CLL patients offers a lower total economic cost option compared to other available treatments in France. Over the next 5 years, VEN+O is expected to generate substantial cost savings, therefore reducing the economic burden in 1L CLL treatment of patients with or without a del17p/TP53mut and ineligible to full-dose fludarabine treatment.