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Challenges in the Assessment of Medical Devices: The MedtecHTA Project

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  • Rosanna Tarricone
  • Aleksandra Torbica
  • Michael Drummond

Abstract

Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device–operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental cost‐effectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs. This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

Suggested Citation

  • Rosanna Tarricone & Aleksandra Torbica & Michael Drummond, 2017. "Challenges in the Assessment of Medical Devices: The MedtecHTA Project," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 5-12, February.
    • Handle: RePEc:wly:hlthec:v:26:y:2017:i:s1:p:5-12
    DOI: 10.1002/hec.3469
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    References listed on IDEAS

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    1. Petra Schnell‐Inderst & Cynthia P. Iglesias & MARJAN Arvandi & ORIANA Ciani & Raffaella Matteucci Gothe & Jaime Peters & Ashley W. Blom & Rod S. Taylor & Uwe Siebert, 2017. "A bias‐adjusted evidence synthesis of RCT and observational data: the case of total hip replacement," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 46-69, February.
    2. Claire Rothery & Karl Claxton & Stephen Palmer & David Epstein & Rosanna Tarricone & Mark Sculpher, 2017. "Characterising Uncertainty in the Assessment of Medical Devices and Determining Future Research Needs," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 109-123, February.
    3. Rosanna Tarricone & Giuditta Callea & Marko Ogorevc & Valentina Prevolnik Rupel, 2017. "Improving the Methods for the Economic Evaluation of Medical Devices," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 70-92, February.
    4. Yauheniya Varabyova & Carl Rudolf Blankart & Jonas Schreyögg, 2017. "The Role of Learning in Health Technology Assessments: An Empirical Assessment of Endovascular Aneurysm Repairs in German Hospitals," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 93-108, February.
    5. Rosanna Tarricone & Giuditta Callea & Marko Ogorevc & Valentina Prevolnik Rupel, 2017. "Improving the Methods for the Economic Evaluation of Medical Devices," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 70-92, February.
    6. Claire Rothery & Karl Claxton & Stephen Palmer & David Epstein & Rosanna Tarricone & Mark Sculpher, 2017. "Characterising Uncertainty in the Assessment of Medical Devices and Determining Future Research Needs," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 109-123, February.
    7. Aleksandra Torbica & Helen Banks & Cinzia Valzania & Giuseppe Boriani & Giovanni Fattore, 2017. "Investigating Regional Variation of Cardiac Implantable Electrical Device Implant Rates in European Healthcare Systems: What Drives Differences?," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 30-45, February.
    8. Rosanna Tarricone & Aleksandra Torbica & Michael Drummond, 2017. "Key Recommendations from the MedtecHTA Project," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 145-152, February.
    9. Petra Schnell‐Inderst & Cynthia P. Iglesias & MARJAN Arvandi & ORIANA Ciani & Raffaella Matteucci Gothe & Jaime Peters & Ashley W. Blom & Rod S. Taylor & Uwe Siebert, 2017. "A bias‐adjusted evidence synthesis of RCT and observational data: the case of total hip replacement," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 46-69, February.
    10. Oriana Ciani & Britni Wilcher & Anoukh van Giessen & Rod S. Taylor, 2017. "Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 13-29, February.
    11. Schreyögg, Jonas & Bäumler, Michael & Busse, Reinhard, 2009. "Balancing adoption and affordability of medical devices in Europe," Health Policy, Elsevier, vol. 92(2-3), pages 218-224, October.
    12. Maximilian H. M. Hatz & Jonas Schreyögg & Aleksandra Torbica & Giuseppe Boriani & Carl R. B. Blankart, 2017. "Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 124-144, February.
    13. Valzania, Cinzia & Torbica, Aleksandra & Tarricone, Rosanna & Leyva, Francisco & Boriani, Giuseppe, 2016. "Implant rates of cardiac implantable electrical devices in Europe: A systematic literature review," Health Policy, Elsevier, vol. 120(1), pages 1-15.
    14. Yauheniya Varabyova & Carl Rudolf Blankart & Jonas Schreyögg, 2017. "The Role of Learning in Health Technology Assessments: An Empirical Assessment of Endovascular Aneurysm Repairs in German Hospitals," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 93-108, February.
    15. Maximilian H. M. Hatz & Jonas Schreyögg & Aleksandra Torbica & Giuseppe Boriani & Carl R. B. Blankart, 2017. "Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 124-144, February.
    16. Aleksandra Torbica & Helen Banks & Cinzia Valzania & Giuseppe Boriani & Giovanni Fattore, 2017. "Investigating Regional Variation of Cardiac Implantable Electrical Device Implant Rates in European Healthcare Systems: What Drives Differences?," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 30-45, February.
    17. Rosanna Tarricone & Aleksandra Torbica & Michael Drummond & for the MedtecHTA Project Group, 2017. "Key Recommendations from the MedtecHTA Project," Health Economics, John Wiley & Sons, Ltd., vol. 26(S1), pages 145-152, February.
    18. Oriana Ciani & Britni Wilcher & Anoukh Giessen & Rod S. Taylor, 2017. "Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 13-29, February.
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    1. Tarricone, Rosanna & Amatucci, Fabio & Armeni, Patrizio & Banks, Helen & Borsoi, Ludovica & Callea, Giuditta & Ciani, Oriana & Costa, Francesco & Federici, Carlo & Torbica, Aleksandra & Marletta, Marc, 2021. "Establishing a national HTA program for medical devices in Italy: Overhauling a fragmented system to ensure value and equal access to new medical technologies," Health Policy, Elsevier, vol. 125(5), pages 602-608.
    2. Mónica D. Oliveira & Inês Mataloto & Panos Kanavos, 2019. "Multi-criteria decision analysis for health technology assessment: addressing methodological challenges to improve the state of the art," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 20(6), pages 891-918, August.
    3. Martina F. Baumann & Daniel Frank & Lena-Charlotte Kulla & Thomas Stieglitz, 2020. "Obstacles to Prosthetic Care—Legal and Ethical Aspects of Access to Upper and Lower Limb Prosthetics in Germany and the Improvement of Prosthetic Care from a Social Perspective," Societies, MDPI, vol. 10(1), pages 1-20, January.
    4. Michael Drummond & Carlo Federici & Vivian Reckers‐Droog & Aleksandra Torbica & Carl Rudolf Blankart & Oriana Ciani & Zoltán Kaló & Sándor Kovács & Werner Brouwer, 2022. "Coverage with evidence development for medical devices in Europe: Can practice meet theory?," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 179-194, September.
    5. Carla Rognoni & Alessandro Furnari & Marzia Lugli & Oscar Maleti & Alessandro Greco & Rosanna Tarricone, 2023. "Time-Driven Activity-Based Costing for Capturing the Complexity of Healthcare Processes: The Case of Deep Vein Thrombosis and Leg Ulcers," IJERPH, MDPI, vol. 20(10), pages 1-16, May.
    6. Philip Klein & Hedwig Blommestein & Maiwenn Al & Benedetta Pongiglione & Aleksandra Torbica & Saskia de Groot, 2022. "Real‐world evidence in health technology assessment of high‐risk medical devices: Fit for purpose?," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 10-24, September.
    7. Benedetta Pongiglione & Aleksandra Torbica, 2022. "How real can we get in generating real world evidence? Exploring the opportunities of routinely collected administrative data for evaluation of medical devices," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 25-43, September.
    8. Pedro Parreira & Liliana B. Sousa & Inês A. Marques & Paulo Santos-Costa & Sara Cortez & Filipa Carneiro & Arménio Cruz & Anabela Salgueiro-Oliveira, 2020. "Usability Assessment of an Innovative Device in Infusion Therapy: A Mix-Method Approach Study," IJERPH, MDPI, vol. 17(22), pages 1-13, November.
    9. Michael Drummond & Rosanna Tarricone & Aleksandra Torbica, 2022. "European union regulation of health technology assessment: what is required for it to succeed?," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 23(6), pages 913-915, August.

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