TY - JOUR

T1 - Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation

AU - Brönneke, Jan B.

AU - Herr, Annika

AU - Reif, Simon

AU - Stern, Ariel D.

PY - 2023/11/17

Y1 - 2023/11/17

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.

AB - 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.

KW - biomedical technology assessment

KW - digital health

KW - Germany

KW - government regulation

KW - medical economics

KW - reimbursement

KW - software

UR - http://www.scopus.com/inward/record.url?scp=85178656928&partnerID=8YFLogxK

U2 - 10.1017/S0266462323002726

DO - 10.1017/S0266462323002726

M3 - Article

C2 - 37973549

AN - SCOPUS:85178656928

VL - 39

JO - International Journal of Technology Assessment in Health Care

JF - International Journal of Technology Assessment in Health Care

SN - 0266-4623

IS - 1

M1 - e72

ER -