Barriers to clinical adoption of next generation sequencing: Perspectives of a policy Delphi panel.
This research aims to inform policymakers by engaging expert stakeholders to identify, prioritize, and deliberate the most important and tractable policy barriers to the clinical adoption of next generation sequencing (NGS). A 4-round Delphi policy study was done with a multi-stakeholder panel of 48 experts. The first 2 rounds of online questionnaires (reported here) assessed the importance and tractability of 28 potential barriers to clinical adoption of NGS across 3 major policy domains: intellectual property, coverage and reimbursement, and FDA regulation. We found that: 1) proprietary variant databases are seen as a key challenge, and a potentially intractable one; 2) payer policies were seen as a frequent barrier, especially a perceived inconsistency in standards for coverage; 3) relative to other challenges considered, FDA regulation was not strongly perceived as a barrier to clinical use of NGS. Overall the results indicate a perceived need for policies to promote data-sharing, and a desire for consistent payer coverage policies that maintain reasonably high standards of evidence for clinical utility, limit testing to that needed for clinical care decisions, and yet also flexibly allow for clinician discretion to use genomic testing in uncertain circumstances of high medical need.
Center for Medical Technology Policy, 401 East Pratt Street, Suite 631, Baltimore, MD 21207, USA.
Donna A
DA
Messner
Center for Medical Technology Policy, 401 East Pratt Street, Suite 631, Baltimore, MD 21207, USA.
Jennifer
J
Al Naber
Center for Medical Technology Policy, 401 East Pratt Street, Suite 631, Baltimore, MD 21207, USA.
Pei
P
Koay
Duke University, Box 90239, Durham, NC 27708, USA.
Robert
R
Cook-Deegan
Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA.
Mary
M
Majumder
Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Avenue, Baltimore, MD 21205, USA.
Gail
G
Javitt
American Institutes for Research, 1000 Thomas Jefferson Street NW, Washington, DC 20007, USA.
Patricia
P
Deverka
Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Avenue, Baltimore, MD 21205, USA.
Rachel
R
Dvoskin
Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Avenue, Baltimore, MD 21205, USA.
Juli
J
Bollinger
Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA.
Margaret
M
Curnutte
Duke Global Health Institute, Durham, NC 27710, United States.
Subhashini
S
Chandrasekharan
Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA.
Amy
A
McGuire
Clinical genomics; Coverage and reimbursement; FDA regulation; Intellectual property; Next generation sequencing; Personalized medicine
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