Translating pharmacogenetics from research to routine clinical practice – a survey of the IGNITE Network

Abstract Background Translating pharmacogenetic research findings that have shown clinical efficacy into sustainable, routine clinical care at the institutional level requires strong evidence of improved patient outcomes bolstered by equitable reimbursement and a sound financial analysis. Although e...

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Main Authors: Kenneth D. Levy, R. Ryanne Wu, Daisuke Goto, Michelle A. Ramos, Victoria M. Pratt, J. Kevin Hicks, Ebony B. Madden, Gillian C. Bell, Kathryn V. Blake, Michelle Cohen, Benjamin Q. Duong, James P. Franciosi, Lori A. Orlando, Kunal Sanghavi, Geoffrey S. Ginsburg
Format: Article
Language:English
Published: BMC 2020-04-01
Series:Translational Medicine Communications
Subjects:
Online Access:http://link.springer.com/article/10.1186/s41231-020-00057-y
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spelling doaj-20908957b6b54961a1cda009e709ac912020-11-25T02:37:12ZengBMCTranslational Medicine Communications2396-832X2020-04-01511910.1186/s41231-020-00057-yTranslating pharmacogenetics from research to routine clinical practice – a survey of the IGNITE NetworkKenneth D. Levy0R. Ryanne Wu1Daisuke Goto2Michelle A. Ramos3Victoria M. Pratt4J. Kevin Hicks5Ebony B. Madden6Gillian C. Bell7Kathryn V. Blake8Michelle Cohen9Benjamin Q. Duong10James P. Franciosi11Lori A. Orlando12Kunal Sanghavi13Geoffrey S. Ginsburg14Indiana University School of MedicineCenter for Applied Genomics & Precision Medicine, Duke University School of MedicineUniversity of Maryland School of PharmacyIcahn School of Medicine at Mount SinaiIndiana University School of MedicineH. Lee Moffitt Cancer Center and Research InstituteNational Human Genome Research InstituteMission Health, Fullerton Genetics CenterNemours Children’s Specialty CareNational Human Genome Research InstituteNemours Children’s Hospital, University of Central Florida College of MedicineNemours Children’s Hospital, University of Central Florida College of MedicineCenter for Applied Genomics & Precision Medicine, Duke University School of MedicineThe Jackson Laboratory for Genomic MedicineCenter for Applied Genomics & Precision Medicine, Duke University School of MedicineAbstract Background Translating pharmacogenetic research findings that have shown clinical efficacy into sustainable, routine clinical care at the institutional level requires strong evidence of improved patient outcomes bolstered by equitable reimbursement and a sound financial analysis. Although extensive research on the clinical value of pharmacogenetics has been completed, adoption into clinical practice lags due to a lack of evidence of clinical effectiveness and limited reimbursement. Methods The Sustainability Working Group within the NHGRI IGNITE I Network conducted an online survey of funded and non-funded IGNITE members to determine which genes they are researching, which have been translated into clinical practice, and how tests are billed. Data from the online surveys was consolidated and analyzed with results being tabulated for key findings. Due to the limited sample size, statistical analysis was forgone and results should be considered directional in nature. Results Fifteen out of twenty (75%) online survey responses were received and analyzed from IGNITE member sites delivering clinical care. Forty different genes were identified as being used for either research or clinical care. Thirty-two different genes were reported as being used clinically, an average of 6.9 genes were reported per site. Twenty-two and twenty-one genes were reported as being billed to third party payers or patients respectively. Although the survey did not ask whether sites submitting for reimbursement received payment, Medicare and Medicaid only reimburse for 6 of the 40 (15%) genes being tested. Of the 40 genes, 18 are rated by CPIC as having A/B level of evidence with the remainder being rated as C/D or having no rating. Approximately 32% more A/B rated genes were being reported clinically than non-A/B. Conclusion Adoption of pharmacogenetic testing continues to lag even at sites where leading experts conduct research and have the capability to report tests clinically. Clinical research that supports CPIC A level of evidence is important for provider and payer support. Adoption of pharmacogentic testing must also be justified financially, reimbursement is one key factor, and more health economic studies are needed in order to capture the value created by preventing drug-gene adverse events, emergency room visits, and hospitalizations.http://link.springer.com/article/10.1186/s41231-020-00057-yGenomicsReimbursementStandard of careImplementation scienceTranslational medicineReimbursement
collection DOAJ
language English
format Article
sources DOAJ
author Kenneth D. Levy
R. Ryanne Wu
Daisuke Goto
Michelle A. Ramos
Victoria M. Pratt
J. Kevin Hicks
Ebony B. Madden
Gillian C. Bell
Kathryn V. Blake
Michelle Cohen
Benjamin Q. Duong
James P. Franciosi
Lori A. Orlando
Kunal Sanghavi
Geoffrey S. Ginsburg
spellingShingle Kenneth D. Levy
R. Ryanne Wu
Daisuke Goto
Michelle A. Ramos
Victoria M. Pratt
J. Kevin Hicks
Ebony B. Madden
Gillian C. Bell
Kathryn V. Blake
Michelle Cohen
Benjamin Q. Duong
James P. Franciosi
Lori A. Orlando
Kunal Sanghavi
Geoffrey S. Ginsburg
Translating pharmacogenetics from research to routine clinical practice – a survey of the IGNITE Network
Translational Medicine Communications
Genomics
Reimbursement
Standard of care
Implementation science
Translational medicine
Reimbursement
author_facet Kenneth D. Levy
R. Ryanne Wu
Daisuke Goto
Michelle A. Ramos
Victoria M. Pratt
J. Kevin Hicks
Ebony B. Madden
Gillian C. Bell
Kathryn V. Blake
Michelle Cohen
Benjamin Q. Duong
James P. Franciosi
Lori A. Orlando
Kunal Sanghavi
Geoffrey S. Ginsburg
author_sort Kenneth D. Levy
title Translating pharmacogenetics from research to routine clinical practice – a survey of the IGNITE Network
title_short Translating pharmacogenetics from research to routine clinical practice – a survey of the IGNITE Network
title_full Translating pharmacogenetics from research to routine clinical practice – a survey of the IGNITE Network
title_fullStr Translating pharmacogenetics from research to routine clinical practice – a survey of the IGNITE Network
title_full_unstemmed Translating pharmacogenetics from research to routine clinical practice – a survey of the IGNITE Network
title_sort translating pharmacogenetics from research to routine clinical practice – a survey of the ignite network
publisher BMC
series Translational Medicine Communications
issn 2396-832X
publishDate 2020-04-01
description Abstract Background Translating pharmacogenetic research findings that have shown clinical efficacy into sustainable, routine clinical care at the institutional level requires strong evidence of improved patient outcomes bolstered by equitable reimbursement and a sound financial analysis. Although extensive research on the clinical value of pharmacogenetics has been completed, adoption into clinical practice lags due to a lack of evidence of clinical effectiveness and limited reimbursement. Methods The Sustainability Working Group within the NHGRI IGNITE I Network conducted an online survey of funded and non-funded IGNITE members to determine which genes they are researching, which have been translated into clinical practice, and how tests are billed. Data from the online surveys was consolidated and analyzed with results being tabulated for key findings. Due to the limited sample size, statistical analysis was forgone and results should be considered directional in nature. Results Fifteen out of twenty (75%) online survey responses were received and analyzed from IGNITE member sites delivering clinical care. Forty different genes were identified as being used for either research or clinical care. Thirty-two different genes were reported as being used clinically, an average of 6.9 genes were reported per site. Twenty-two and twenty-one genes were reported as being billed to third party payers or patients respectively. Although the survey did not ask whether sites submitting for reimbursement received payment, Medicare and Medicaid only reimburse for 6 of the 40 (15%) genes being tested. Of the 40 genes, 18 are rated by CPIC as having A/B level of evidence with the remainder being rated as C/D or having no rating. Approximately 32% more A/B rated genes were being reported clinically than non-A/B. Conclusion Adoption of pharmacogenetic testing continues to lag even at sites where leading experts conduct research and have the capability to report tests clinically. Clinical research that supports CPIC A level of evidence is important for provider and payer support. Adoption of pharmacogentic testing must also be justified financially, reimbursement is one key factor, and more health economic studies are needed in order to capture the value created by preventing drug-gene adverse events, emergency room visits, and hospitalizations.
topic Genomics
Reimbursement
Standard of care
Implementation science
Translational medicine
Reimbursement
url http://link.springer.com/article/10.1186/s41231-020-00057-y
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