Digital therapeutics face a fragmented reimbursement map

Prescription digital therapeutics occupy an awkward position. They are regulated as medical devices, evaluated as clinical interventions, and reimbursed, where at all, through schemes designed for pharmaceuticals or for hospital services. The result is a patchwork in which a product can be funded in one member state and sold out of pocket in the next, with no portability of the evidence dossier between assessment bodies.

Assessment bodies apply different evidentiary standards. Some accept a randomised trial against standard care with a patient-reported primary endpoint; others require a health economic model with a defined cost-effectiveness threshold. A dossier built for one process rarely transfers without rework, and the rework is usually substantial enough to delay a launch by a full budget cycle or to make a smaller market uneconomic.

Engagement is the persistent weakness. Trials show effects under protocol conditions, but real-world completion rates for app-based programmes are lower, and payers have started asking for retention data at six and twelve months rather than at the end of a short study period. Vendors that cannot show sustained use are finding that a positive trial result is no longer sufficient to secure coverage.

The commercial response has been to narrow the target. Vendors increasingly launch in one or two markets with a specific clinical indication, build real-world evidence there, and use that base to approach the next payer. Broad multi-country launches have proved expensive and difficult to support clinically, and the resulting fragmentation of the user base makes it harder to demonstrate outcomes at the scale payers expect.