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

• Published in: Value in health Vol. 26; no. 1; pp. 71 - 80
• Main Authors: Simons, Martijn J.H.G., Uyl-de Groot, Carin A., Retèl, Valesca P., Mankor, Joanne M., Ramaekers, Bram L.T., Joore, Manuela A., van Harten, Wim H.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2023
• Subjects: budget impact; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - genetics; Cost-Benefit Analysis; cost-effectiveness; decision analytic model; future scenarios; Humans; implementation; Lung Neoplasms - drug therapy; Lung Neoplasms - genetics; molecular diagnostics; Netherlands; Off-Label Use; Quality-Adjusted Life Years; value of information; whole-genome sequencing; Netherlands; cost-effectiveness; molecular diagnostics; future scenarios; decision analytic model; whole-genome sequencing; implementation; value of information; budget impact
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2022.07.006

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. 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 selection” (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. Total costs and quality-adjusted life-years for SoC in metastatic non–small cell lung cancer were €149 698 and 1.235. Incremental outcomes of WGS were €1529/0.002(base model), −€222/0.020(scenario 1), −€2576/0.023(scenario 2), €388/0.024(scenario 3), −€5041/0.060(combined unweighted), and −€1715/0.029(combined weighted). The annual BI for adopting WGS for this population in The Netherlands ranged between €682 million (combined unweighted) and €714 million (base model). The consequences of uncertainty amounted to €3.4 million for all scenarios (combined weighted) and to €699 000 for the diagnostic yield of WGS alone (combined weighted). 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. •Modeling quantified scenarios using a probabilistic economic decision model can be useful to timely anticipate on unforeseen future developments relevant to the implementation of a new technology. A recent example of such technology is the use of whole-genome sequencing (WGS) as a diagnostic test compared with standard of care in patients with locally advanced and metastatic non–small cell lung cancer.•Scenarios about the use of WGS results for treatment selection, a WGS-based biomarker for immunotherapy, and off-label drug approval for WGS results were found cost-effective compared with standard of care, with the incremental net monetary benefits ranging from €1525 to €9815 (willingness to pay threshold: €80 000/quality-adjusted life-year). The annual budget impact for adopting WGS ranged between €682 million and €714 million. The consequences of uncertainty amounted to €699 000 for the diagnostic yield of WGS alone.•Current findings suggest that the field of clinical oncology could move into a direction where WGS will become cost-effective as a molecular diagnostic test in non–small cell lung cancer if it detects more patients with actionable targets and costs decrease. Policy makers and researchers should timely anticipate on this and consider the adoption of WGS as long as it is accompanied with further research focused on the diagnostic yield of WGS to reach final conclusions.