Evidence map›Paper›PMID 40540171›Full record

ArticlePharmacoEconomics2025

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

Toluwase Akinsoji, Nick Dragojlovic, Cécile Darviot, Michel Meunier, Mark Harrison, Larry D Lynd

Abstract read
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In one paragraph

Article in PharmacoEconomics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Toluwase AkinsojiFaculty of Pharmaceutical Sciences, University of British Columbia, 2405 Wesbrook Mall, Vancouver, BC, V6 T 1Z3, Canada.ORCID 0009-0008-9310-5843
Nick DragojlovicFaculty of Pharmaceutical Sciences, University of British Columbia, 2405 Wesbrook Mall, Vancouver, BC, V6 T 1Z3, Canada.
Cécile DarviotDepartment of Engineering Physics, Polytechnique Montréal, Montreal, QC, Canada.
Michel MeunierDepartment of Engineering Physics, Polytechnique Montréal, Montreal, QC, Canada.
Mark HarrisonFaculty of Pharmaceutical Sciences, University of British Columbia, 2405 Wesbrook Mall, Vancouver, BC, V6 T 1Z3, Canada.
Larry D LyndFaculty of Pharmaceutical Sciences, University of British Columbia, 2405 Wesbrook Mall, Vancouver, BC, V6 T 1Z3, Canada. larry.lynd@ubc.ca.

Funding

NanoMedicines Innovation Network 2023-SI-Comm-02
6 · The paper itself

Abstract

BACKGROUND AND

objectiveCompanion 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.

methodsThe 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.

resultsHeadroom 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.

conclusionsA novel, highly accurate CDx for stage II-IIIA NSCLC could provide significant value to patients, payers, and manufacturers.

Indexed as

B7-H1 AntigenCarcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, Monoclonal, HumanizedCost-Benefit AnalysisDecision TreesHumansNeoplasm StagingPrecision MedicineTechnology Assessment, BiomedicalAntibodies, Monoclonal, HumanizedatezolizumabB7-H1 AntigenCD274 protein, human

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.