Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation

Research output: Contribution to journalArticleResearchpeer review

Authors

  • Jan B. Brönneke
  • Annika Herr
  • Simon Reif
  • Ariel D. Stern

Research Organisations

External Research Organisations

  • Health Innovation Hub (hih)
  • Centre for European Economic Research (ZEW)
  • Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU Erlangen-Nürnberg)
  • Massachusetts Institute of Technology
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Details

Original languageEnglish
Article numbere72
Number of pages11
JournalInternational Journal of Technology Assessment in Health Care
Volume39
Issue number1
Early online date17 Nov 2023
Publication statusE-pub ahead of print - 17 Nov 2023

Abstract

Objectives Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for prescribable health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. Methods We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. Results When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. Conclusions Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

Keywords

    biomedical technology assessment, digital health, Germany, government regulation, medical economics, reimbursement, software

ASJC Scopus subject areas

Sustainable Development Goals

Cite this

Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation. / Brönneke, Jan B.; Herr, Annika; Reif, Simon et al.
In: International Journal of Technology Assessment in Health Care, Vol. 39, No. 1, e72, 17.11.2023.

Research output: Contribution to journalArticleResearchpeer review

Brönneke JB, Herr A, Reif S, Stern AD. Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation. International Journal of Technology Assessment in Health Care. 2023 Nov 17;39(1):e72. Epub 2023 Nov 17. doi: 10.1017/S0266462323002726
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abstract = "Objectives Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for prescribable health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. Methods We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. Results When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. Conclusions Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.",
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AU - Brönneke, Jan B.

AU - Herr, Annika

AU - Reif, Simon

AU - Stern, Ariel D.

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N2 - Objectives Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for prescribable health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. Methods We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. Results When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. Conclusions Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

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KW - medical economics

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