Toluwase Akinsoji, Nick Dragojlovic, Cécile Darviot, Michel Meunier, Mark Harrison, Larry D Lynd
{"title":"Innovation Headroom for a Highly Accurate PD-L1 Companion Diagnostic in Non-small Cell Lung Cancer.","authors":"Toluwase Akinsoji, Nick Dragojlovic, Cécile Darviot, Michel Meunier, Mark Harrison, Larry D Lynd","doi":"10.1007/s40273-025-01512-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>Companion diagnostics (CDx) are critical to precision medicine. Developing and commercializing new CDx faces regulatory and economic challenges. This study aims to illustrate the utility of an early health technology assessment in quantifying the unmet clinical need and commercial opportunity created by the limited accuracy of existing programmed cell death ligand 1 CDx.</p><p><strong>Methods: </strong>The study uses an early health technology assessment and market sizing to assess the potential value of a novel programmed cell death ligand 1 CDx for non-small cell lung cancer (NSCLC). Decision tree-based cost-effectiveness models were used to evaluate clinical and economic outcomes for improved programmed cell death ligand 1 testing in atezolizumab-treated patients with stage II-IIIA and metastatic NSCLC from a US payer perspective in 2023 US Dollars. Three strategies were examined: standard care, new CDx for cytology specimens only, and new CDx for all patients. Commercial opportunities from the perspectives of diagnostics and pharmaceutical manufacturers were assessed using headroom and threshold analyses.</p><p><strong>Results: </strong>Headroom analyses indicated that a new CDx is not cost effective for metastatic NSCLC but holds significant value for stage II-IIIA NSCLC. Assuming perfect sensitivity and specificity, the incremental cost-effectiveness ratio for the new CDx in stage II-IIIA NSCLC was $57,650/quality-adjusted life-year and $54,950/quality-adjusted life-year for cytology specimens only and all patients, respectively. A threshold analysis showed that at a $500 price point, the new CDx is cost effective at sensitivity levels of 0.9 for all patients and 0.8 for cytology only. The total addressable US market for the CDx manufacturer was estimated at $2.6 million per year with a $500/test kit price.</p><p><strong>Conclusions: </strong>A novel, highly accurate CDx for stage II-IIIA NSCLC could provide significant value to patients, payers, and manufacturers.</p>","PeriodicalId":19807,"journal":{"name":"PharmacoEconomics","volume":" ","pages":""},"PeriodicalIF":4.4000,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"PharmacoEconomics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40273-025-01512-0","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ECONOMICS","Score":null,"Total":0}
引用次数: 0
Abstract
Background and objective: Companion diagnostics (CDx) are critical to precision medicine. Developing and commercializing new CDx faces regulatory and economic challenges. This study aims to illustrate the utility of an early health technology assessment in quantifying the unmet clinical need and commercial opportunity created by the limited accuracy of existing programmed cell death ligand 1 CDx.
Methods: The study uses an early health technology assessment and market sizing to assess the potential value of a novel programmed cell death ligand 1 CDx for non-small cell lung cancer (NSCLC). Decision tree-based cost-effectiveness models were used to evaluate clinical and economic outcomes for improved programmed cell death ligand 1 testing in atezolizumab-treated patients with stage II-IIIA and metastatic NSCLC from a US payer perspective in 2023 US Dollars. Three strategies were examined: standard care, new CDx for cytology specimens only, and new CDx for all patients. Commercial opportunities from the perspectives of diagnostics and pharmaceutical manufacturers were assessed using headroom and threshold analyses.
Results: Headroom analyses indicated that a new CDx is not cost effective for metastatic NSCLC but holds significant value for stage II-IIIA NSCLC. Assuming perfect sensitivity and specificity, the incremental cost-effectiveness ratio for the new CDx in stage II-IIIA NSCLC was $57,650/quality-adjusted life-year and $54,950/quality-adjusted life-year for cytology specimens only and all patients, respectively. A threshold analysis showed that at a $500 price point, the new CDx is cost effective at sensitivity levels of 0.9 for all patients and 0.8 for cytology only. The total addressable US market for the CDx manufacturer was estimated at $2.6 million per year with a $500/test kit price.
Conclusions: A novel, highly accurate CDx for stage II-IIIA NSCLC could provide significant value to patients, payers, and manufacturers.
期刊介绍：
PharmacoEconomics is the benchmark journal for peer-reviewed, authoritative and practical articles on the application of pharmacoeconomics and quality-of-life assessment to optimum drug therapy and health outcomes. An invaluable source of applied pharmacoeconomic original research and educational material for the healthcare decision maker.
PharmacoEconomics is dedicated to the clear communication of complex pharmacoeconomic issues related to patient care and drug utilization.
PharmacoEconomics offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
