ArticleJournal of managed care & specialty pharmacy2026
Key considerations when assessing clinical utility for biomarker testing: A checklist.
Article in Journal of managed care & specialty pharmacy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
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.
Who cites it
2 citing papers in PubMed.
- Payer coverage principles for precision medicine biomarker testing in oncology.Journal of managed care & specialty pharmacy · 2026Article
- Advancing precision medicine access in oncology: Foundational considerations for managed care stakeholders.Journal of managed care & specialty pharmacy · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Establishing the clinical utility of biomarker tests is a critical component of benefit design. However, payers and laboratory benefit manager organizations may differ in how they evaluate clinical utility for a given test, including how they determine whether evaluated outcomes are clinically meaningful. These differences can create challenges for providers and manufacturers when navigating coverage policies across organizations. Based on expert insights from a partnership forum hosted by AMCP on June 24-25, 2025, in Alexandria, VA, on the topic of precision medicine in oncology, we developed a checklist of considerations to align payers and laboratory benefit managers around a shared, actionable approach to evaluating the clinical utility of biomarker tests and the types of evidence used to demonstrate it. The checklist begins with confirmation that analytical and clinical validity have been established before assessing clinical utility. Tests should then be categorized based on their intended use and whether they provide actionable information that informs clinical decision-making and improves patient health outcomes. Assessment of clinical utility includes consideration of the relevance, strength, and consistency of the supporting evidence base. After clinical utility is established, economic and operational considerations may also be evaluated. This checklist is intended to support a more transparent and structured approach to evaluating clinical utility in coverage decision-making.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.