Cost-Effectiveness and Budget Impact of Future Developments With Whole-Genome Sequencing for Patients With Lung Cancer

Objectives: This study aimed to investigate the cost-effectiveness, budget impact (BI), and impact of uncertainty of future developments concerning whole-genome sequencing (WGS) as a clinical diagnostic test compared with standard of care (SoC) in patients with locally advanced and metastatic non-small cell lung cancer.Methods: A total of 3 likely scenarios to take place within 5 years (according to experts) were simulated using a previously developed, peer reviewed, and published decision model. The scenarios concerned WGS results used for treatment selec-tion (scenario 1), WGS-based biomarker for immunotherapy (scenario 2), and off-label drug approval for WGS results (scenario 3). Two diagnostic strategies of the original model, SoC and WGS as a diagnostic test (base model), were used to compare our scenarios with. Outcomes were reported for the base model, all scenarios separately, combined (combined unweighted), and weighted by likelihood (combined weighted). Cost-effectiveness, BI, and value of information analyses were performed for WGS compared with SoC.Results: Total costs and quality-adjusted life-years for SoC in metastatic non-small cell lung cancer were euro 149 698 and 1.235. Incremental outcomes of WGS were euro 1529/0.002(base model), - euro 222/0.020(scenario 1), - euro 2576/0.023(scenario 2), euro 388/ 0.024(scenario 3), - euro 5041/0.060(combined unweighted), and - euro 1715/0.029(combined weighted). The annual BI for adopting WGS for this population in The Netherlands ranged between euro 682 million (combined unweighted) and euro 714 million (base model). The consequences of uncertainty amounted to euro 3.4 million for all scenarios (combined weighted) and to euro 699 000 for the diagnostic yield of WGS alone (combined weighted).Conclusions: Our findings suggest that it is likely for WGS to become cost-effective within the near future if it identifies more patients with actionable targets and show the impact of uncertainty regarding its diagnostic yield. Modeling future scenarios can be useful to consider early adoption of WGS while timely anticipating on unforeseen developments before final conclusions are reached.

Automated summary

This study aimed to investigate the cost-effectiveness, budget impact, and impact of uncertainty of future developments concerning whole-genome sequencing (WGS) as a clinical diagnostic test compared with standard of care in patients with non-small cell lung cancer. The findings suggest that WGS is likely to become cost-effective in the near future if it identifies more patients with actionable targets and shows the impact of uncertainty regarding its diagnostic yield.