KEY TAKEAWAYS
- Phase 3 of the CLL14 study looked into the cost-effectiveness of treating previously untreated CLL patients with VenO treatment instead of ClbO from Dutch society’s perspective.
- The threshold chosen by the participants as the willingness to pay was €20,000 per quality-adjusted life-years.
- VenO treatment did not exceed the €20,000/QALY threshold, and the discounted ICER was -€49,928/QALY, i.e., incremental negative costs.
- The results were run through several analyses, such as VOI analysis, deterministic sensitivity, and scenario analyses, to ensure accuracy.
- The study’s results must be corroborated with real-world data and further research with a longer FU period.
The CLL14 is a randomized, open-label, interventional study conducted from the perspective of Dutch society. The phase 3 of the CLL14 study looked into the efficacy and cost-effectiveness of Venetoclax plus Obinutuzumab (VenO) treatment and compared it with the Chlorambucil plus Obinutuzumab (ClbO) treatments in patients suffering from CLL, and other coexisting medical conditions, who did not receive any prior treatments.
The cost-effectiveness of VenO was measured in Quality-Adjusted Life-Years (QALYs) gained using a 3-state partitioned survival model to compute the Incremental Cost-Effectiveness Ratio (ICER). To explore the uncertainties of the study, analyses such as scenario analyses, deterministic and probabilistic analyses, the value of information analysis (VOI), and sensitivity analyses were used.
The study’s results demonstrated positive effects and negative incremental costs, with the discounted ICER being -€49,928. The ICER determined by the deterministic sensitivity and scenario analyses did not exceed the willingness-to-pay threshold of €20,000/QALY. Nearly all the iterations (>99%) in the probabilistic sensitivity analysis proved cost-effective. The VOI analysis was used to compute the maximum expected value that the participants of the study were willing to pay to eliminate all uncertainties taken up in the model parameter. Subsequently, this amounted to €183,591.
The study proved the superiority of VenO over ClbO in treating patients with CLL with no prior treatments. The results were run through sensitivity and scenario analyses and VOI analysis to ensure accuracy.
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02242942
Do, N., & Thielen, F. W. (2022). Cost-Effectiveness of Venetoclax Plus Obinutuzumab Versus Chlorambucil Plus Obinutuzumab for the First-Line Treatment of Adult Patients With Chronic Lymphocytic Leukemia: An Extended Societal View. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, S1098-3015(22)04732-5. Advance online publication. https://doi.org/10.1016/j.jval.2022.11.002