Barriers to clinical adoption of nextgeneration sequencing: A policy Delphi panel's solutions

Donna A. Messner; Pei Koay; Jennifer Al Naber; Robert Cook-Deegan; Mary Majumder; Gail Javitt; Rachel Dvoskin; Juli Bollinger; Margaret Curnutte; Amy L. McGuire

doi:10.2217/pme-2016-0104

Barriers to clinical adoption of nextgeneration sequencing: A policy Delphi panel's solutions

Donna A. Messner, Pei Koay, Jennifer Al Naber, Robert Cook-Deegan, Mary Majumder, Gail Javitt, Rachel Dvoskin, Juli Bollinger, Margaret Curnutte, Amy L. McGuire

Research output: Contribution to journal › Article › peer-review

8 Scopus citations

Abstract

Aim: Identify solutions to the most important policy barriers to the clinical adoption of next-generation sequencing. Materials & methods: Four-round modified policy Delphi with a multistakeholder panel of 48 experts. The panel deliberated policy solutions to (previously reported) challenges deemed most important to address. Results: The group advocated using consensus panels to promote consistency in payer policies and to standardize test reporting, and favored making genomic data-sharing a condition of regulatory clearance, certification, or accreditation processes. They were split on the role of US FDA. Conclusion: Panelists found common ground on solutions for health plan coverage policy consistency, data-sharing, and standardizing reporting, but were sharply divided on the role of the FDA in mitigating risks to patients.

Original language	English (US)
Pages (from-to)	339-354
Number of pages	16
Journal	Personalized Medicine
Volume	14
Issue number	4
DOIs	https://doi.org/10.2217/pme-2016-0104
State	Published - Jul 2017

Keywords

Clinical data reporting
Clinical genomics
Coverage and reimbursement
Intellectual property
Next-generation sequencing
Personalized medicine
Policy
Regulation

ASJC Scopus subject areas

Molecular Medicine
Pharmacology

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title = "Barriers to clinical adoption of nextgeneration sequencing: A policy Delphi panel's solutions",

abstract = "Aim: Identify solutions to the most important policy barriers to the clinical adoption of next-generation sequencing. Materials & methods: Four-round modified policy Delphi with a multistakeholder panel of 48 experts. The panel deliberated policy solutions to (previously reported) challenges deemed most important to address. Results: The group advocated using consensus panels to promote consistency in payer policies and to standardize test reporting, and favored making genomic data-sharing a condition of regulatory clearance, certification, or accreditation processes. They were split on the role of US FDA. Conclusion: Panelists found common ground on solutions for health plan coverage policy consistency, data-sharing, and standardizing reporting, but were sharply divided on the role of the FDA in mitigating risks to patients.",

keywords = "Clinical data reporting, Clinical genomics, Coverage and reimbursement, Intellectual property, Next-generation sequencing, Personalized medicine, Policy, Regulation",

author = "Messner, {Donna A.} and Pei Koay and {Al Naber}, Jennifer and Robert Cook-Deegan and Mary Majumder and Gail Javitt and Rachel Dvoskin and Juli Bollinger and Margaret Curnutte and McGuire, {Amy L.}",

note = "Funding Information: This project was supported by grant R01HG006460 from the US National Human Genome Research Institute (National Institutes of Health). D Messner is employed by the nonprofit Center for Medical Technology Policy (CMTP) and runs the Green Park Collaborative (GPC) program noted in the Discussion, but receives no direct remuneration from the GPC program. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: {\textcopyright} 2017 Future Medicine Ltd.",

year = "2017",

month = jul,

doi = "10.2217/pme-2016-0104",

language = "English (US)",

volume = "14",

pages = "339--354",

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T1 - Barriers to clinical adoption of nextgeneration sequencing

T2 - A policy Delphi panel's solutions

AU - Messner, Donna A.

AU - Koay, Pei

AU - Al Naber, Jennifer

AU - Cook-Deegan, Robert

AU - Majumder, Mary

AU - Javitt, Gail

AU - Dvoskin, Rachel

AU - Bollinger, Juli

AU - Curnutte, Margaret

AU - McGuire, Amy L.

N1 - Funding Information: This project was supported by grant R01HG006460 from the US National Human Genome Research Institute (National Institutes of Health). D Messner is employed by the nonprofit Center for Medical Technology Policy (CMTP) and runs the Green Park Collaborative (GPC) program noted in the Discussion, but receives no direct remuneration from the GPC program. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: © 2017 Future Medicine Ltd.

PY - 2017/7

Y1 - 2017/7

N2 - Aim: Identify solutions to the most important policy barriers to the clinical adoption of next-generation sequencing. Materials & methods: Four-round modified policy Delphi with a multistakeholder panel of 48 experts. The panel deliberated policy solutions to (previously reported) challenges deemed most important to address. Results: The group advocated using consensus panels to promote consistency in payer policies and to standardize test reporting, and favored making genomic data-sharing a condition of regulatory clearance, certification, or accreditation processes. They were split on the role of US FDA. Conclusion: Panelists found common ground on solutions for health plan coverage policy consistency, data-sharing, and standardizing reporting, but were sharply divided on the role of the FDA in mitigating risks to patients.

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Barriers to clinical adoption of nextgeneration sequencing: A policy Delphi panel's solutions

Abstract

Keywords

ASJC Scopus subject areas

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