In France, a digital therapy has been approved for reimbursement for the first time. The health authority HAS has given the “Joe” (Ludocare) app a positive evaluation, thereby paving the way for its inclusion in the standard reimbursement program under the LPPR.
The app is designed for children with severe asthma and combines a physical device with an app. An additional benefit over standard therapy was demonstrated, though only for the 7- to 11-year-old age group. The added benefit was accordingly classified as minor, and the agency required the manufacturer to collect real-world data over 12 months on disease exacerbations, medication, and treatment adherence.
What is particularly noteworthy is the reimbursement pathway chosen: Reimbursement is processed through the established LPPR system for medical devices. Thus, the first successful digital therapy in France does not utilize a new or specific DTx pathway, but rather the traditional route, which was essentially already available before PECAN:
The LPPR registry was established by the French Social Security Financing Act of December 29, 1999, and replaced the former TIPS registry.
Thus, no therapeutic application has yet been approved for reimbursement through the specially created PECAN procedure, which is intended to provide simplified access for digital therapies. “Joe” also initially failed to gain approval through PECAN and was only able to convince the authorities after submitting additional clinical data through the regular procedure. The decision thus highlights not so much a breakthrough in new procedures as the central role of traditional evidence requirements within the existing system.
To date, only pure telemonitoring solutions have been able to take advantage of the PECAN method.
Here you can find the original decision: Haute Autorité de Santé – First favorable opinion on the reimbursement of a digital therapy