Europe’s Fragmented DTx Reimbursement is Undermining Its Own Digital Health Strategy

Europe’s ambitions for scaling digital therapeutics are being undermined not by clinical doubt or technological barriers, but by inconsistent national reimbursement. While interest in evidence-based digital health is strong, the lack of a unified coverage pathway across the European Union has created a fractured market. Developers face an uneven policy environment, physicians lack prescribing clarity, and patients are offered radically different access depending on where they live.

Germany and France have taken early leadership. Germany’s DiGA program provides a fast-track to reimbursement for low-risk digital applications that demonstrate clinical benefit. More than 50 applications have cleared the approval process since 2020, ranging from mental health interventions to digital diabetes management. However, uptake remains modest. Many physicians are reluctant to prescribe DiGA-approved tools due to workflow friction and lack of system integration. Products may be reimbursed, but they are not yet embedded.

France launched its PECAN framework in 2023 to support temporary reimbursement for digital therapeutics while additional real-world evidence is gathered. The pathway is structured and rigorous, requiring CE-marking, clinical evaluation, and a clear pricing rationale. Yet fewer than a dozen companies have progressed through PECAN successfully, reflecting the operational difficulty of navigating the French process, especially for small or early-stage firms.

Beyond these two markets, the rest of the EU remains fragmented. Some countries rely on pilot projects without national coverage authority. Others force digital therapeutics into legacy reimbursement categories meant for pharmaceuticals or durable medical equipment, creating misalignment and underpayment. In many markets, there is simply no defined route to reimbursement at all.

This policy gap undercuts the EU’s stated goals around cross-border data integration and digital health acceleration. The European Health Data Space initiative is designed to facilitate interoperable access to health data across all member states. But without common reimbursement standards, it cannot fully support the commercialization or scale-up of digital therapeutics. Products that rely on continuous remote monitoring, real-time patient engagement, or machine learning cannot deliver on their promise if health systems are unable or unwilling to pay for them.

The European Commission and national health authorities have a clear opportunity to set coordinated expectations. A harmonized framework for DTx reimbursement could define clinical evidence requirements, outline health economic benchmarks, and establish shared pathways for real-world evidence development. Regulatory bodies such as the European Medicines Agency and the EUnetHTA consortium could support evaluation consistency while leaving pricing and budget impact decisions to national payers.

Without this shift, Europe risks losing its early advantage. While the United States moves forward with CMS pilot programs for software-based therapeutics, and countries in Asia-Pacific experiment with bundled digital care packages, the EU is stalled in procedural ambiguity. The result is that market entry for digital therapeutics remains slow, physician adoption remains limited, and innovation funding is migrating elsewhere.

For the EU to retain global competitiveness in digital health, reimbursement policy must catch up to regulatory ambition. That means recognizing digital therapeutics not as peripheral technologies, but as core clinical tools—and building the financial structures that treat them as such. Germany and France have laid the groundwork. Now Brussels must lead the alignment.