Digital Therapeutics (DTX): Market Access Challenges and Stakeholder Perspectives in Germany

Speaker(s)

Heldt D1, Arca` E2
1OPEN Health Evidence & Access, Berlin, BE, Germany, 2OPEN Health Evidence & Access, Rotterdam, ZH, Netherlands

Presentation Documents

OBJECTIVES: To assess the market access challenges, both pre- and post-launch, faced by digital therapeutics (DTx) in Germany and to map stakeholders’ positions toward DTx implementation and use.

METHODS: A narrative review of peer-reviewed and grey literature was conducted following searches on PubMed and relevant stakeholders’ websites.

RESULTS: Two types of challenges were identified, procedural and implementational. The review also assessed perceptions among developers, payers (health insurance funds), and healthcare professionals (HCPs).

Procedural challenges, specific to the pre-market launch phase, focused on assessment and price negotiations. Developers criticized BfArM’s short-notice change requests, e.g., for non-prespecified subgroup analyses, the focus on clinical endpoints for apps that aim to improve care structure and processes, the difficulty in conducting double-blind trials with DTx, the disproportionate increase in evidence requirements for the one-year preliminary admission, and the unavailability to the public of prior assessments. Payers criticized the high prices, the low requirements for preliminary admissions, the high risk of bias in the submitted evidence, and the inability of many developers to prove efficacy through additional evidence after preliminary admission. The latter two critiques were also expressed by HCPs.

Challenges related to implementation included HCPs’ lack of trust in DTx products, as well as a heavy administrative burden and inadequate reimbursement for consulting and monitoring of DTx. Finally, patients and HCPs often lack awareness of DTx products, further limiting uptake.

CONCLUSIONS: A need exists to develop more and better evidence for DTx, along with more flexible frameworks that account for the characteristics of DTx products and allow for innovative methodologies with a greater focus on acceptance and usability.

Digital literacy is key for successful implementation of DTx in medical practice; thus educational programs should be set in place to engage stakeholders and unleash the full potential of DTx to deliver personalized care.

Code

MT24

Topic

Health Policy & Regulatory, Health Technology Assessment, Medical Technologies

Topic Subcategory

Decision & Deliberative Processes, Reimbursement & Access Policy, Systems & Structure

Disease

Medical Devices, No Additional Disease & Conditions/Specialized Treatment Areas