Evidence required by health technology assessment and reimbursement bodies evaluating diagnostic or prognostic algorithms that include omics data

A Barna, T Cruz-Sanchez, K Brigham, C-T Thuong, Finn Børlum Kristensen, I Durand-Zaleski

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Objectives:
Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes.

Methods:
This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017.

Results:
Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders.

Conclusions:
Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.
OriginalsprogEngelsk
TidsskriftInternational Journal of Technology Assessment in Health Care
Vol/bind34
Udgave nummer4
Sider (fra-til)368-377
ISSN0266-4623
DOI
StatusUdgivet - jan. 2018

Fingeraftryk

Insurance Carriers
Jurisprudence
Research

Citer dette

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title = "Evidence required by health technology assessment and reimbursement bodies evaluating diagnostic or prognostic algorithms that include omics data",
abstract = "Objectives:Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes.Methods:This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017.Results:Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders.Conclusions:Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.",
keywords = "Assessment and regulation, Biomarkers, Personalized medicine, Reimbursement policy, Reproducibility of Results, Prognosis, Humans, Medical Oncology/methods, Genomics/methods, Technology Assessment, Biomedical/methods, Algorithms, Cost-Benefit Analysis, Proteomics/methods, Diagnostic Techniques and Procedures/standards, Metabolomics/methods, Efficiency, Organizational",
author = "A Barna and T Cruz-Sanchez and K Brigham and C-T Thuong and Kristensen, {Finn B{\o}rlum} and I Durand-Zaleski",
year = "2018",
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doi = "10.1017/S026646231800048X",
language = "English",
volume = "34",
pages = "368--377",
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Evidence required by health technology assessment and reimbursement bodies evaluating diagnostic or prognostic algorithms that include omics data. / Barna, A; Cruz-Sanchez, T; Brigham, K; Thuong, C-T; Kristensen, Finn Børlum; Durand-Zaleski, I.

I: International Journal of Technology Assessment in Health Care, Bind 34, Nr. 4, 01.2018, s. 368-377.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Evidence required by health technology assessment and reimbursement bodies evaluating diagnostic or prognostic algorithms that include omics data

AU - Barna, A

AU - Cruz-Sanchez, T

AU - Brigham, K

AU - Thuong, C-T

AU - Kristensen, Finn Børlum

AU - Durand-Zaleski, I

PY - 2018/1

Y1 - 2018/1

N2 - Objectives:Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes.Methods:This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017.Results:Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders.Conclusions:Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.

AB - Objectives:Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes.Methods:This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017.Results:Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders.Conclusions:Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.

KW - Assessment and regulation

KW - Biomarkers

KW - Personalized medicine

KW - Reimbursement policy

KW - Reproducibility of Results

KW - Prognosis

KW - Humans

KW - Medical Oncology/methods

KW - Genomics/methods

KW - Technology Assessment, Biomedical/methods

KW - Algorithms

KW - Cost-Benefit Analysis

KW - Proteomics/methods

KW - Diagnostic Techniques and Procedures/standards

KW - Metabolomics/methods

KW - Efficiency, Organizational

U2 - 10.1017/S026646231800048X

DO - 10.1017/S026646231800048X

M3 - Journal article

VL - 34

SP - 368

EP - 377

JO - International Journal of Technology Assessment in Health Care

JF - International Journal of Technology Assessment in Health Care

SN - 0266-4623

IS - 4

ER -