Test Pricing and Reimbursement in Genomic Medicine: Towards a General Strategy

Vozikis, Athanassios; Cooper, David N.; Mitropoulou, Christina; Kambouris, Manousos E.; Brand, Angela; Dolzan, Vita; Fortina, Paolo; Innocenti, Federico; Lee, Ming Ta Michael; Leyens, Lada; Macek Jr, Milan; Al-Mulla, Fahd; Prainsack, Barbara; Squassina, Alessio; Taruscio, Domenica; van Schaik, Ron H.; Vayena, Effy; Williams, Marc S.; Patrinos, George P.

doi:10.1159/000449152

Article navigation

Review Articles| January 05 2017

Test Pricing and Reimbursement in Genomic Medicine: Towards a General Strategy

Subject Area: Genetics , Public Health

Athanassios Vozikis;

Athanassios Vozikis

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

David N. Cooper;

David N. Cooper

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Christina Mitropoulou;

Christina Mitropoulou

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Manousos E. Kambouris;

Manousos E. Kambouris

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Angela Brand;

Angela Brand

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Vita Dolzan;

Vita Dolzan

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Paolo Fortina;

Paolo Fortina

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Federico Innocenti;

Federico Innocenti

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Ming Ta Michael Lee;

Ming Ta Michael Lee

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Lada Leyens;

Lada Leyens

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Milan Macek Jr;

Milan Macek Jr

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Fahd Al-Mulla;

Fahd Al-Mulla

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Barbara Prainsack;

Barbara Prainsack

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Alessio Squassina;

Alessio Squassina

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Domenica Taruscio;

Domenica Taruscio

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Ron H. van Schaik;

Ron H. van Schaik

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Effy Vayena;

Effy Vayena

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Marc S. Williams;

Marc S. Williams

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

George P. Patrinos

aLaboratory of Health Economics and Management, Department of Economics, University of Piraeus, Piraeus, Greece; bInstitute of Medical Genetics, School of Medicine, Cardiff University, Cardiff, and cThe Golden Helix Foundation, London, UK; dDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, and eMaastricht Economic and Social Research Institute on Innovation and Technology (MERIT), Graduate School of Governance, Faculty of Humanities and Sciences, Maastricht University, Maastricht, The Netherlands; fSchool of Medicine, University of Ljubljana, Ljubljana, Slovenia; gKimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pa., hInstitute of Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, N.C., and iGenomic Medicine Institute, Geisinger Health System, Danville, Pa., USA; jInstitute of Biology and Medical Genetics, Charles University Prague 2nd Faculty of Medicine and University Hospital Motol, Prague, Czech Republic; kMolecular Pathology Unit, Health Sciences Center, Faculty of Medicine, University of Kuwait, Safat, Kuwait; lDepartment of Global Health &amp; Social Medicine London, King's College London, London, UK; mDepartment of Biomedical Sciences, School of Medicine, University of Cagliari, Cagliari, and nNational Centre for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy; oHealth Ethics and Policy Lab, Epidemiology Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland; pDepartment of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece

Search for other works by this author on:

This Site

PubMed

Google Scholar

Public Health Genomics (2017) 19 (6): 352–363.

https://doi.org/10.1159/000449152

Abstract

This paper aims to provide an overview of the rationale and basic principles guiding the governance of genomic testing services, to clarify their objectives, and allocate and define responsibilities among stakeholders in a health-care system, with a special focus on the EU countries. Particular attention is paid to issues pertaining to pricing and reimbursement policies, the availability of essential genomic tests which differs between various countries owing to differences in disease prevalence and public health relevance, the prescribing and use of genomic testing services according to existing or new guidelines, budgetary and fiscal control, the balance between price and access to innovative testing, monitoring and evaluation for cost-effectiveness and safety, and the development of research capacity. We conclude that addressing the specific items put forward in this article will help to create a robust policy in relation to pricing and reimbursement in genomic medicine. This will contribute to an effective and sustainable health-care system and will prove beneficial to the economy at large.

References

1.

Personalized Medicine Coalition (PMC): The Case for Personalized Medicine, ed 4. Washington, Personalized Medicine Coalition, 2014.

2.

Crawford JM, Aspinall MG: The business value and cost-effectiveness of genomic medicine. Pers Med 2012;9:265-286.

https://doi.org/10.2217/pme.12.23

3.

Davis JC, Furstenthal L, Desai AA, Norris T, Sutaria S, Fleming E, Ma P: The microeconomics of personalized medicine: today's challenge and tomorrow's promise. Nat Rev Drug Discov 2009;8:279-286.

[PubMed]

https://doi.org/10.1038/nrd2825

4.

Mitropoulou C, Mai Y, van Schaik RH, Vozikis A, Patrinos GP: Stakeholder analysis in pharmacogenomics and genomic medicine in Greece. Public Health Genomics 2014;17:280-286.

[PubMed]

https://doi.org/10.1159/000365896

5.

Mai Y, Koromila T, Sagia A, Cooper DN, Vlachopoulos G, Lagoumintzis G, Kollia P, Poulas K, Stathakopoulos V, Patrinos GP: A critical view of the general public's awareness and physicians' opinion of the trends and potential pitfalls of genomic testing in Greece. Pers Med 2011;8:551-561.

https://doi.org/10.2217/pme.11.48

6.

Mai Y, Mitropoulou C, Papadopoulou XE, Vozikis A, Cooper DN, van Schaik RH, Patrinos GP: Critical appraisal of the views of healthcare professionals with respect to pharmacogenomics and personalized medicine in Greece. Pers Med 2014;11:15-26.

https://doi.org/10.2217/pme.13.92

7.

Mette L, Mitropoulos K, Vozikis A, Patrinos G: Pharmacogenomics and public health: implementing ‘populationalized' medicine. Pharmacogenomics 2012;13:803-813.

[PubMed]

https://doi.org/10.2217/pgs.12.52

8.

Prainsack B: Personhood and solidarity: what kind of personalized medicine do we want? Pers Med 2014;7:651-657.

https://doi.org/10.2217/pme.14.49

9.

Williams MS: The public health genomics translation gap: what we don't have and why it matters. Public Health Genomics 2012;15:132-138.

[PubMed]

https://doi.org/10.1159/000334341

10.

Williams MS: The genetic future: can genomics deliver on the promise of improved outcomes and reduced costs? Background and recommendations for health insurers. Dis Manag Health Outcomes 2003;11:277-290.

https://doi.org/10.2165/00115677-200311050-00001

11.

Williams MS: Insurance coverage for pharmacogenomic testing. Pers Med 2007;4:479-487.

https://doi.org/10.2217/17410541.4.4.479

12.

The Office of Inspector General (OIG): Memorandum Report: Coverage and Payment for Genetic Laboratory Tests, Department of Health and Human Services (DHHS). OEI-07-11-00011. Washington, The Office of Inspector General, 2012.

13.

The Office of Inspector General (OIG): Payments for Laboratory Tests: Comparing Medicare, State Medicaid, and Federal Employees Health Benefits Programs, Department of Health and Human Services (DHHS). OEI-07-11-00010. Washington, The Office of Inspector General, 2013.

14.

Merchant M: Pricing and Reimbursement Strategies for Diagnostics: Overcoming Reimbursement Issues and Navigating the Regulatory Environment. London, Business Insights, 2010.

15.

Department of Health and Human Services (DHHS): Coverage and Reimbursement of Genetic Tests and Services: Report of the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS). Washington, Department of Health and Human Services, 2006.

16.

National Institutes of Health: Reimbursement Models to Promote Evidence Generation and Innovation for Genomic Tests, Workshop Summary. Bethesda, National Institutes of Health, 2012.

17.

Britnell M: In Search of the Perfect Health System. Basingstoke, Palgrave Macmillan, 2015.

18.

Miller I, Ashton-Chess J, Spolders H, Fert V, Ferrara J, Kroll W, Askaa J, Larcier P, Terry PF, Bruinvels A, Huriez A: Market access challenges in the EU for high medical value diagnostic tests. Pers Med 2011;8:137-14812.

https://doi.org/10.2217/pme.11.2

19.

Velasco Garrido M, Børlum Kristensen F, Palmhøj Nielsen C, Busse R: Health Technology Assessment and Health Policy-Making in Europe. Current Status, Challenges and Potential. Brussels, European Observatory on Health Systems and Policies, 2008.

20.

Institute of Medicine: Conflict of Interest in Medical Research, Education, and Practice. Washington, National Academies Press, 2009.

21.

Kwon S: Positive Listing of Pharmaceuticals. Health Policy Monitor, 2007. http://www.hpm.org/survey/kr/a9/2.

22.

European Commission: European Workshop on Genetic Testing Offer in Europe, EU Scientific and Policy Report by the Joint Research Centre of the European Commission, Report EUR 25684 EN. Luxembourg, Publications Office of the European Union, 2013.

23.

Patrinos GP, Baker DJ, Al-Mulla F, Vasiliou V, Cooper DN: Genetic tests obtainable through pharmacies: the good, the bad and the ugly. Hum Genomics 2013;7:17.

[PubMed]

https://doi.org/10.1186/1479-7364-7-17

24.

Pavlidis C, Lanara Z, Balasopoulou A, Nebel JC, Katsila T, Patrinos GP: Meta-analysis of nutrigenomic biomarkers denotes lack of association with dietary intake and nutrient-related pathologies. OMICS 2015;19:512-520.

[PubMed]

https://doi.org/10.1089/omi.2015.0109

25.

Pavlidis C, Patrinos GP, Katsila T: Nutrigenomics: a controversy. Appl Transl Genomics 2015;4:50-53.

[PubMed]

https://doi.org/10.1016/j.atg.2015.02.003

26.

European Commission: Guidelines on a Medical Device Vigilance System, E.U. DG Health and Consumers (SANCO) Directorate B-Consumer Affairs Unit B2 - Health Technology and Cosmetics, MEDDEV 2.12-1 rev 8. Luxembourg, Publications Office of the European Union, 2013.

27.

Evans JP, Watson MS: Genetic testing and FDA regulation: overregulation threatens the emergence of genomic medicine. JAMA 2015;313:669-670.

[PubMed]

https://doi.org/10.1001/jama.2014.18145

28.

Council of Europe: Recommendation CM/Rec(2010)11 of the Committee of Ministers to member states on the impact of genetics on the organisation of health care services and training of health professionals, adopted by the Committee of Ministers on 29 September 2010 at the 1094th meeting of the Ministers' Deputies. Strasbourg, Council of Europe, Committee of Ministers, 2010.

29.

Dierking A, Schmidtke J, Matthijs G, Cassiman J-J: The EuroGentest Clinical Utility Gene Cards continued. Eur J Hum Genet 2013;21:1.

[PubMed]

https://doi.org/10.1038/ejhg.2012.161

30.

European Commission: Recommendation on Cross Border Genetic Testing of Rare Diseases in the European Union. Brussels, EC Commission Expert Group on Rare Diseases, 2015.

31.

Kierkegaard P: E-prescription across Europe. Health Technol 2013;3:205-219.

https://doi.org/10.1007/s12553-012-0037-0

32.

Personalized Medicine Coalition (PMC): The Adverse Impact of the US Reimbursement System on the Development and Adoption of Personalized Medicine Diagnostics, Issue Brief. Washington, Personalized Medicine Coalition, 2010.

33.

Personalized Medicine Coalition (PMC): The Future of Coverage and Payment for Personalized Medicine Diagnostics. Washington, Personalized Medicine Coalition, 2014.

34.

Berwouts S, Fanning K, Morris MA, Barton DE, Dequeker E: Quality assurance practices in Europe: a survey of molecular genetic testing laboratories. Eur J Hum Genet 2012;20:1118-1126.

[PubMed]

https://doi.org/10.1038/ejhg.2012.125

35.

Berwouts S, Morris MA, Dequeker E: Approaches to quality management and accreditation in a genetic testing laboratory. Eur J Hum Genet 2010;18(suppl 1):S1-S19.

[PubMed]

https://doi.org/10.1038/ejhg.2010.104

36.

The European Personalized Medicine Association: Personalised Medicine in Europe - Enhancing Patient Access to Pharmaceutical Drug-Diagnostic Companion Products, Patient Access Study. Berlin, Brüggenjürgen Institute for Social Medicine, Epidemiology, and Health Economics, Charité - Universitätsmedizin, 2014.

37.

Kampourakis K, Vayena E, Mitropoulou C, Borg J, van Schaik RH, Cooper DN, Patrinos GP: Key challenges for next generation pharmacogenomics. EMBO Rep 2014;15:472-476.

[PubMed]

https://doi.org/10.1002/embr.201438641

38.

Reydon TA, Kampourakis K, Patrinos GP: Genetics, genomics and society: the responsibilities of scientists for science communication and education. Pers Med 2012;9:633-643.

https://doi.org/10.2217/pme.12.69

39.

Snyder SR, Mitropoulou C, Patrinos GP, Williams MS: Economic evaluation of pharmacogenomics: a value-based approach to pragmatic decision making in the face of complexity. Public Health Genomics 2014;17:256-264.

[PubMed]

https://doi.org/10.1159/000366177

40.

Coulter A, Jenkinson C: European patients' views on the responsiveness of health systems and healthcare providers. Eur J Public Health 2005;15:355-360.

[PubMed]

https://doi.org/10.1093/eurpub/cki004

41.

Crews KR, Hicks JK, Pui C-H, Relling MV, Evans WE: Pharmacogenomics and individualized medicine: translating science into practice. Clin Pharmacol Ther 2012;92:467-475.

[PubMed]

https://doi.org/10.1038/clpt.2012.120

42.

Mai Y, Mitropoulou C, Papadopoulou XE, Vozikis A, Cooper DN, van Schaik RH, Patrinos GP: Critical appraisal of the views of healthcare professionals with respect to pharmacogenomics and personalized medicine in Greece. Pers Med 2014;11:15-26.

https://doi.org/10.2217/pme.13.92

43.

National Academies of Sciences, Engineering, and Medicine: Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, National Academies Press, 2016.

[PubMed]

https://doi.org/10.2217/pme.13.92

Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.

Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.

Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

2016

You do not currently have access to this content.

Don't already have an account? Register

Test Pricing and Reimbursement in Genomic Medicine: Towards a General Strategy

Abstract

References

Digital Version

Email alerts

Citing articles via

Related Articles

INFORMATION

ABOUT US

SERVICES FOR

Karger International

Related Articles

Evaluating the Applied Knowledge of BRCA Testing Among Spanish-Preferring Latino Americans: The Influence of Acculturation and Literacy

Progress and Criteria in Public Health Applications of Gene Therapy and Gene Editing: Beyond the White Paper

Towards Patient Involvement and Representation in the Governance of Genomic Data Archives: Deliberative forums with patients in Germany

Workplace Genomic Testing: What Do Company Websites Say about Federal Privacy and Anti-Discrimination Laws?

From Genes to Public Health: The Journey Continues!

Test Pricing and Reimbursement in Genomic Medicine: Towards a General Strategy Available to Purchase

Abstract

References

Sign in

Individual Login

Institutional Login

Digital Version

Email alerts

Citing articles via

Related Articles

This Feature Is Available To Subscribers Only

Test Pricing and Reimbursement in Genomic Medicine: Towards a General Strategy