Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation

Germany’s 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the health care 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 the 10th of October 2023, 49 DiGA were listed in the official Directory of the Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and thus 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 evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. We describe the core issues that distinguish HTA in this setting: (1) explicit allowance for more flexible research designs, (2) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (3) the dynamic nature of both product development and product evaluation, whereby it is anticipated that a DiGA will be updated and assessed using real world data (RWD) and real world evidence (RWE). We present case studies and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis.