ReviewValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research2020
Use of Real-World Evidence in US Payer Coverage Decision-Making for Next-Generation Sequencing-Based Tests: Challenges, Opportunities, and Potential Solutions.
Review in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled 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.
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
22 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Availability of secondary healthcare data for conducting pharmacoepidemiology studies in Mexico: a systematic review.Journal of comparative effectiveness research · 2026Pooled it
- Real-world data: a comprehensive literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology assessment process.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2024Pooled it
- Health economic evidence for the use of molecular biomarker tests in hematological malignancies: A systematic review.European journal of haematology · 2022Pooled it
- Liquid biopsy in oncology practice: A global survey by the Young Committee of the International Society of Liquid Biopsy (ISLB).The journal of liquid biopsy · 2026Article
- Beyond Accuracy: Methodological Advances for Assessing the Clinical Impact of Infectious Disease Diagnostics.Open forum infectious diseases · 2025Article
- The use of real-world evidence among healthcare payers: a scoping review.International journal of technology assessment in health care · 2025Article
- An Assessment of Real-World Evidence and Other Sources Supporting Payer Coverage Decisions for Pharmacogenomic Testing in Psychiatry.Journal of personalized medicine · 2025Article
- Costs and Benefits of Whole-Exome, Whole-Transcriptome Sequencing in Patients With Advanced Non-Small Cell Lung Cancer.JCO precision oncology · 2025Article
- Implementation of Cancer Genomics in the United States: Views of Payers and Other Stakeholders on Challenges and the Role of Payers in Solutions.JCO precision oncology · 2025Article
- Pharmacogenomics: Driving Personalized Medicine.Pharmacological reviews · 2023Review
- External control arms: COVID-19 reveals the merits of using real world evidence in real-time for clinical and public health investigations.Frontiers in medicine · 2023Review
- Cost-effectiveness of precision molecular diagnostic tests for stage II colorectal cancer.Annals of translational medicine · 2022Article
- Global real-world data on hemodiafiltration: An opportunity to complement clinical trial evidence.Seminars in dialysis · 2022Review
- An Idealized Clinicogenomic Registry to Engage Underrepresented Populations Using Innovative Technology.Journal of personalized medicine · 2022Article
- Delivering precision oncology to patients with cancer.Nature medicine · 2022Review
- Analyzing Precision Medicine Utilization with Real-World Data: A Scoping Review.Journal of personalized medicine · 2022Article
- Factors Affecting Citizen Trust and Public Engagement Relating to the Generation and Use of Real-World Evidence in Healthcare.International journal of environmental research and public health · 2022Article
- Identifying the Steps Required to Effectively Implement Next-Generation Sequencing in Oncology at a National Level in Europe.Journal of personalized medicine · 2022Article
- Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World.Clinical pharmacology and therapeutics · 2022Review
- Correlation Between Early Endpoints and Overall Survival in Non-Small-Cell Lung Cancer: A Trial-Level Meta-Analysis.Frontiers in oncology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
objectivesGiven the potential of real-world evidence (RWE) to inform understanding of the risk-benefit profile of next-generation sequencing (NGS)-based testing, we undertook a study to describe the current landscape of whether and how payers use RWE as part of their coverage decision making and potential solutions for overcoming barriers.
methodsWe performed a scoping literature review of existing RWE evidentiary frameworks for evaluating new technologies and identified barriers to clinical integration and evidence gaps for NGS. We synthesized findings as potential solutions for improving the relevance and utility of RWE for payer decision-making.
resultsPayers require evidence of clinical utility to inform coverage decisions, yet we found a relatively small number of published RWE studies, and these are predominately focused on oncology, pharmacogenomics, and perinatal/pediatric testing. We identified 3 categories of innovation that may help address the current undersupply of RWE studies for NGS: (1) increasing use of RWE to inform outcomes-based contracting for new technologies, (2) precision medicine initiatives that integrate clinical and genomic data and enable data sharing, and (3) Food and Drug Administration reforms to encourage the use of RWE. Potential solutions include development of data and evidence review standards, payer engagement in RWE study design, use of incentives and partnerships to lower the barriers to RWE generation, education of payers and providers concerning the use of RWE and NGS, and frameworks for conducting outcomes-based contracting for NGS.
conclusionsWe provide numerous suggestions to overcome the data, methodologic, infrastructure, and policy challenges constraining greater integration of RWE in assessments of NGS.
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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.