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Tytuł pozycji:

Use of Real-World Evidence in US Payer Coverage Decision-Making for Next-Generation Sequencing-Based Tests: Challenges, Opportunities, and Potential Solutions.

Tytuł :
Use of Real-World Evidence in US Payer Coverage Decision-Making for Next-Generation Sequencing-Based Tests: Challenges, Opportunities, and Potential Solutions.
Autorzy :
Deverka PA; Deverka Consulting, LLC, Apex, NC, USA. Electronic address: .
Douglas MP; Center for Translational and Policy Research on Personalized Medicine, Department of Clinical Pharmacy, University of California at San Francisco, San Francisco, CA, USA.
Phillips KA; Center for Translational and Policy Research on Personalized Medicine, Department of Clinical Pharmacy, University of California at San Francisco, San Francisco, CA, USA; Philip R. Lee Institute for Health Policy, University of California, San Francisco, San Francisco, CA, USA; Helen Diller Family Comprehensive Cancer, University of California at San Francisco, San Francisco, CA, USA.
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Źródło :
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research [Value Health] 2020 May; Vol. 23 (5), pp. 540-550. Date of Electronic Publication: 2020 Mar 26.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Review
Język :
English
Imprint Name(s) :
Publication: Jan./Feb. 2011- : New York : Elsevier
Original Publication: Malden, MA : Blackwell Science, c1998-
MeSH Terms :
Decision Making*
High-Throughput Nucleotide Sequencing*/economics
High-Throughput Nucleotide Sequencing*/trends
Technology Assessment, Biomedical*
Evidence-Based Medicine/*economics
Insurance, Health, Reimbursement/*economics
Economics, Pharmaceutical ; Humans ; Medical Oncology/economics ; Medical Oncology/trends ; Stakeholder Participation ; United States
Grant Information :
R01 CA221870 United States CA NCI NIH HHS; U01 HG009599 United States HG NHGRI NIH HHS
Contributed Indexing :
Keywords: coverage policies*; decision making*; next-generation sequencing*; payers*; real-world data*; real-world evidence*; reimbursement*
Entry Date(s) :
Date Created: 20200512 Date Completed: 20200828 Latest Revision: 20200828
Update Code :
20201023
PubMed Central ID :
PMC7219085
DOI :
10.1016/j.jval.2020.02.001
PMID :
32389218
Czasopismo naukowe
Objectives: Given 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.
Methods: We 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.
Results: Payers 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.
Conclusions: We provide numerous suggestions to overcome the data, methodologic, infrastructure, and policy challenges constraining greater integration of RWE in assessments of NGS.
(Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

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