ARTICLE SUMMARY:
There is not yet a clear global consensus on what constitutes sufficient evidence to support a financially sustainable launch and long-term market access of new digital devices. France’s health technology assessment body rolled out some of its answers to this question in two detailed guidelines published last month.
Generating data robust enough to show that software and novel digital devices can operate as clinical-grade therapeutics, diagnostics, or monitoring tools is difficult enough. Constructing the evidence chain to convince payors to support the software for broadscale implementation in a healthcare system is the next-level challenge. Reimbursement and market access frameworks have traditionally been designed to help pay for clinician services and physical items like drugs, medical equipment, and implants. But there isn’t as clear-cut a path to paying for software as a primary treatment or diagnostic, or as a remote monitoring service.
The US, for instance, has struggled in the face of outdated Medicare benefit category designations and payment methodologies, although CMS andother gatekeepers are making incremental progress. Some European countries are farther ahead, starting with Germany and its Digital Health Applications (DiGA) framework, which launched in 2020 as a fast-track evidence review and payment mechanism for digital therapeutics. France, meanwhile, is a close, and sophisticated, follower.
