OBJECTIVES: This study compares and contrasts the evaluation and reimbursement pathways for digital therapeutics (DTx) in Germany, France, Belgium and England.

METHODS: Four frameworks for DTx assessment: the German DiGA fast track, the French PECAN fast track, the Belgium mHealth Pyramid, and the English Early Value Assessment (EVA) were reviewed to compare and contrast their objectives, methodology, and eligibility criteria.

RESULTS: DiGA and PECAN fast tracks aim to accelerate reimbursement for eligible DTx. Both processes offer a one-year transitional reimbursement period to collect patient data that can be used in determining product value and achieving permanent reimbursement.

The mHealth Pyramid focuses on informative function and categorizes DHAs based on functionality, compliance, and health-economic value, offering funding potential only to those meeting higher-level criteria. The English Early Value Assessment evaluates the clinical and cost-effectiveness of DTx among other medical technologies to inform local funding decisions and support the generation of meaningful real-world data.

Across frameworks, assessed DTx must be CE-marked and meet safety and interoperability criteria. Reimbursement eligibility varies: Germany includes class I and IIa DTx, while France evaluates class IIb, III, and telemonitoring devices under PECAN, with DiGA focusing on potential positive health effects and PECAN prioritizing clinical benefits or improved care organization. In the mHealth Pyramid framework, only apps that enable remote diagnosis, therapy, or monitoring by healthcare providers are eligible for funding. NICE DTx out of those have Digital Assessment Criteria (DTAC) approval for evaluation in the EVA process based on their potential to address prioritized national unmet needs.

CONCLUSIONS: As a result of the distinct differences in the objectives and methodology employed to assess the value of DHAs across countries, companies need adopt a country-specific approach, resulting in increased costs and resources, in order to facilitate patient access across the EU.