Comparison of “Coverage With Evidence Development” Approaches for Digital Health Technologies and Pharmaceuticals

OBJECTIVES: Evaluation approaches for digital health technologies (DHTs) have emerged in markets including France, Germany, and the UK, characterized by “coverage with evidence development.” Similar approaches, including time-limited decisions, are used for pharmaceuticals in these markets. We aimed to understand the parallels and disparities between these approaches to determine if experience from pharmaceuticals can transfer to DHT evidence generation planning.

METHODS: We conducted a targeted literature search for public documents describing the aims, motivation, evidence requirements, operationalization, and recent use of these approaches, and made comparisons within and across markets.

RESULTS: The search highlighted that the needs of two differing situations have converged upon this approach: for pharmaceuticals, this is prompted by high unmet medical need and unwillingness to delay access until sufficient evidence for final decisions; for DHTs, instead in recognition of potential health system benefits and the impact of the technological and commercial environment of DHTs on evidence generation. Pharmaceutical schemes across markets are oriented in practice around clinical trial read-outs, while DHT schemes differ in time to reassessment (from 6–9 months in France to 3–4 years in the UK), whether reassessment evidence is stipulated, and whether evidence generation is facilitated. The role of real-world evidence (RWE) is acknowledged, with varying emphasis between markets, in evidence recommendations for DHTs, while in practice this is usually supplementary for pharmaceutical reassessment.

CONCLUSIONS: Contrasting with pharmaceuticals, evidence generation for DHTs must account for generation of RWE to show relevant benefit and plan to meet the shorter, less flexible timelines in some markets. Given its integral role of current national approaches, the inclusion and implications of “coverage with evidence development” in future European-wide HTA for DHTs will need to be monitored.