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. 2025 Sep;43(9):1135-1145.
doi: 10.1007/s40273-025-01512-0. Epub 2025 Jun 20.

Innovation Headroom for a Highly Accurate PD-L1 Companion Diagnostic in Non-small Cell Lung Cancer

Toluwase Akinsoji  1 , Nick Dragojlovic  1 , Cécile Darviot  2 , Michel Meunier  2 , Mark Harrison  1 , Larry D Lynd  3   4
Affiliations

Innovation Headroom for a Highly Accurate PD-L1 Companion Diagnostic in Non-small Cell Lung Cancer

Toluwase Akinsoji et al. Pharmacoeconomics. 2025 Sep.

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.

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Conflict of interest statement

Declarations. Funding: This work was supported by grants from the Nanomedicines Innovation Network (NMIN), which also funded the development of a range of novel diagnostic technologies. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication. Conflicts of Interest/Competing Interests: Toluwase Akinsoji, Nick Dragojlovic, Cécile Darviot, Michel Meunier, Mark Harrison, and Larry D. Lynd have no conflicts of interest that are directly relevant to the content of this article. Ethics Approval: No ethics approval was necessary as the research did not involve humans and/or animals. Consent to Participate: Not applicable. Consent for Publication: Not applicable. Availability of Data and Material: Not applicable. Code Availability: Not applicable. Authors’ Contributions: All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by TA and ND. The first draft of the manuscript was written by TA and ND and all authors commented on subsequent versions of the manuscript. All authors read and approved the final manuscript. All data for this research were obtained from the existing published literature and are fully described in the supplementary materials.

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