Contrasting Evidence Requirements for Early Access Schemes for Digital Health Technologies in the UK and Germany: A Challenge for Multi-Market Evidence Generation Planning

OBJECTIVES: Schemes allowing early access to digital health technologies (DHTs) provisional upon further evidence generation operate in both Germany (DiGA Fast Track Process) and the UK (NICE Early Value Assessment, EVA). We sought to understand and compare the requirements of each scheme, evidenced by recent experience.

METHODS: Public documentation on decisions, evaluated evidence, and recommended/required evidence generation was reviewed for current provisional DiGA entries and published EVAs for DHTs, and key data extracted.

RESULTS: Among 20 provisional DiGA entries, approved planned data collection for reassessment was a randomized controlled trial (RCT) in all cases, 19/20 conducted only in Germany, with trial durations 3–6 months. Twelve already had RCT evidence informing the provisional decision. Study outcomes were predominantly efficacy and health-related quality of life (HRQL), sometimes health literacy or self-management (8/20), and medication or healthcare use (5/20). In contrast, recommended evidence generation in all 8 EVAs was non-randomized studies (prospective cohort, historical control, or before-and-after designs, sometimes supplemented with qualitative research), to follow DHT use for 6–12 months. Recommendations included planning to adjust for confounding in observational data and considering local variation in NHS services. Outcomes in response to identified evidence gaps included long-term and/or subgroup effectiveness (8/8), HRQL (7/8), user characteristics (8/8), DHT uptake/accessibility/engagement (8/8), and impact on resource use (7/8) within the UK NHS context.

CONCLUSIONS: Patient and/or system benefits of DHTs may differ by health system, driving the need for country-specific data; the remits of payer assessments also differ. However, the identified differences in evidence requirements pose challenges for developers considering multi-market evidence generation planning, potentially exacerbated by future policy changes, e.g., greater emphasis on cost-effectiveness in the UK. Developer and policy-maker alignment on evidence expectations will be needed if the benefits of DHTs are to be realized in an effective, timely way across markets.