The second application for reimbursement under PECAN to date has been rejected in France.
The reasons given for the rejection are as follows:
- Proof of clinical benefit was provided solely on the basis of a literature review. Its data, however, comes mainly from the USA, and only 20 percent of the studies were conducted in the intended patient population.
- The studies included were also only able to demonstrate moderate effectiveness.
- A study running in France with the digital therapy has not yet been completed.
The HAS (Haute Autorité de Santé) did, however, expressly point the manufacturer to the option of applying directly for permanent reimbursement via inclusion in the LPPR once the study is complete.
As always, you can find a detailed account of the reimbursement of DiGA in France in our expert article at PECAN & DMD – A Guide for DiGA in France