ArticleJournal of personalized medicine2014
Personalized Medicine's Bottleneck: Diagnostic Test Evidence and Reimbursement.
Article in Journal of personalized medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 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
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options.Applied health economics and health policy · 2022Pooled it
- How are we evaluating the cost-effectiveness of companion biomarkers for targeted cancer therapies? A systematic review.BMC cancer · 2021Pooled it
- Operationalizing Precision Medicine in Drug Development: Predictive Biomarkers, Companion Diagnostics, and Regulatory Pathways.Clinical pharmacology and therapeutics · 2026Review
- Article
- Exploring the Interdisciplinary Nature of Precision Medicine：Network Analysis and Visualization.JMIR medical informatics · 2021Article
- Development and Implementation of In-House Pharmacogenomic Testing Program at a Major Academic Health System.Frontiers in genetics · 2021Review
- Automated Flow Synthesis of Tumor Neoantigen Peptides for Personalized Immunotherapy.Scientific reports · 2020Article
- Anilinoquinazoline inhibitors of the RET kinase domain-Elaboration of the 7-position.Bioorganic & medicinal chemistry letters · 2016Article
- Market Access Advancements and Challenges in "Drug-Companion Diagnostic Test" Co-Development in Europe.Journal of personalized medicine · 2015Review
- Can genomic medicine improve financial sustainability of health systems?Molecular diagnosis & therapy · 2015Review
- A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics.Frontiers in genetics · 2015Article
- Emerging roles for pharmacists in clinical implementation of pharmacogenomics.Pharmacotherapy · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPersonalized medicine is gradually emerging as a transformative field. Thus far, seven co-developed drug-diagnostic combinations have been approved and several dozen post-hoc drug-diagnostic combinations (diagnostic approved after the drug). However, barriers remain, particularly with respect to reimbursement. Purpose, methods: This study analyzes barriers facing uptake of drug-diagnostic combinations. We examine Medicare reimbursement in the U.S. of 10 drug-diagnostic combinations on the basis of a formulary review and a survey.
findingsWe found that payers reimburse all 10 drugs, but with variable and relatively high patient co-insurance, as well as imposition of formulary restrictions. Payer reimbursement of companion diagnostics is limited and highly variable. In addition, we found that the body of evidence on the clinical- and cost-effectiveness of therapeutics is thin and even less robust for diagnostics. Conclusions, discussion: The high cost of personalized therapeutics and dearth of evidence concerning the comparative clinical effectiveness of drug-diagnostic combinations appear to contribute to high patient cost sharing, imposition of formulary restrictions, and limited and variable reimbursement of companion diagnostics. Our findings point to the need to increase the evidence base supportive of establishing linkage between diagnostic testing and positive health outcomes.
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.