TY - JOUR
T1 - Barriers to clinical adoption of next generation sequencing
T2 - Perspectives of a policy Delphi panel
AU - Messner, Donna A.
AU - Al Naber, Jennifer
AU - Koay, Pei
AU - Cook-Deegan, Robert
AU - Majumder, Mary
AU - Javitt, Gail
AU - Deverka, Patricia
AU - Dvoskin, Rachel
AU - Bollinger, Juli
AU - Curnutte, Margaret
AU - Chandrasekharan, Subhashini
AU - McGuire, Amy
N1 - Funding Information:
This work was supported by a grant ( R01HG006460 ) from the National Human Genome Research Institute (NHGRI) . The content solely represents the views of the authors and not necessarily the views of the NHGRI. The authors would like to thank the NHGRI's David Kaufmann for his vision and leadership in the conceptualization and implementation of this project.
Publisher Copyright:
© 2016 The Authors
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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.
AB - 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.
KW - Clinical genomics
KW - Coverage and reimbursement
KW - FDA regulation
KW - Intellectual property
KW - Next generation sequencing
KW - Personalized medicine
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U2 - 10.1016/j.atg.2016.05.004
DO - 10.1016/j.atg.2016.05.004
M3 - Article
AN - SCOPUS:84973535622
SN - 2212-0661
VL - 10
SP - 19
EP - 24
JO - Applied and Translational Genomics
JF - Applied and Translational Genomics
ER -