In March 2024, France introduced a fast-track market access pathway for digital health applications and—what’s new—telemonitoring systems. Based on the German DiGA blueprint, this regulation aspires to provide access to digital therapeutics for 60 million French citizens covered by mandatory health insurance. However, getting listed in PECAN is not that easy.
Apps like pills
The PECAN (La prise en charge anticipée numérique) reimbursement scheme aims to reimburse digital health applications (DTx) and remote monitoring systems in a fast-track model. This means developers of applicable DTx do not need to prove their effectiveness through clinical trials. Their solution can become prescribable for a limited time if they demonstrate potential benefits for patients, along with meeting other requirements such as obtaining a CE mark and complying with safety standards.
Like the pioneering German DiGA approach, the fast-track scheme is designed to help med-tech startups scale into the health market. Unlike pharmaceutical companies, young companies often lack the resources and funding to conduct expensive, lengthy clinical trials. Even if they manage to do so, the French healthcare system has, until now, largely ignored digital therapeutics, forcing these startups to target only patients who can pay out of pocket or to seek other business models outside of statutory health insurance.
This is a challenge in most European countries, with reimbursement systems focusing on classical medicines and medical devices and ignoring new digital health solutions like mobile health apps. Many studies show that digital therapeutics (DTx) can be a powerful complement to drug therapies, particularly in the treatment of chronic diseases such as diabetes, insomnia, and depression, without side effects. They can play a crucial role in prevention and in supporting patients with the lifestyle changes necessary to recover or better manage their diseases.
According to the latest report by the World Health Organization, “Going Digital for Non-Communicable Diseases," investing today just an additional US $0.24 per patient per year in telemedicine, mobile messaging, and chatbots could have a significant impact over the next ten years, including saving 2 million lives, averting 7 million acute events and hospitalizations, gaining 5 million life years, generating an additional US $199 billion in economic benefits, and achieving a return on investment of US $19 for every US $1 invested.
DiGA-inspired but different
The PECAN program covers two categories of solutions: digital health applications (Digital Therapeutics, DTx) and remote health monitoring systems. To be reimbursed under the fast-track scheme, digital solutions must meet the following conditions:
- Have the European CE mark, regardless of the system's risk class;
- Demonstrate innovativeness, measured as potential clinical benefits;
- Show the prospect of providing clinical evidence during the transition period;
- Meet interoperability and data security requirements set by the French Digital Health Agency (Agence du Numérique en Santé).
Early access to reimbursement for digital devices covers up to 12 months. The Digital Health Agency validates the solution, and the French Ministry of Health makes the final decision. The entire process takes no longer than 90 days. After a favorable decision, the accepted solution can be added to the list of reimbursed medical products and services. After the initial 12-month period, the provider must deliver evidence of clinical benefit for the solution to enter the reimbursement scheme permanently.
There are a few differences between DiGA and PECAN. For example, DiGA covers only digital health applications, while PECAN also covers telemonitoring solutions. In PECAN, eligible medical devices include those with class I, IIa, IIb, and III. In DiGA, only class I and II devices are eligible. The French approach is also stricter regarding timing—the developers have 6 to 9 months to submit evidence for permanent listing, while in DiGA, it is 12 to 24 months.
Fast-track, not so fast
PECAN sets very high requirements for digital health solutions because, like medicines, they affect patients' physical and mental health. Ensuring a high level of medical data security and GDPR compliance is essential.
The second rationale is the need for high-quality data generated following best practices and standards. For example, if the solution involves a health monitoring device, it must be able to export data in a format that allows integration with other systems. Equally important is the innovativeness of the solution and the benefits to the patient. These criteria ensure that only high-quality solutions qualify for the reimbursement trial period. PECAN is not intended to be a testbed for every application.
In practice, the process works as follows:
- A startup checks the eligibility criteria and, if it meets them, submits an application on an online platform;
- The Digital Health Agency verifies that the application meets all requirements;
- The startup provides evidence that it meets the interoperability and data security requirements;
- The application is reviewed by the Digital Health Agency (up to 60 days) and then reviewed by the National Committee for the Evaluation of Medical Devices and Health Technologies;
- If the review is positive, the Ministry of Health issues a decision (up to 30 days);
- Once the e-health solution is approved, the startup is added to the list of reimbursed products (LPPR or LATM) for several years.
The initial feedback from the market suggests that qualifying for the PECAN program will not be easy. The provider of six DiGAs in Germany, HelloBetter, announced in early August that it received a negative opinion from the Haute Autorité de Santé (HAS) regarding the reimbursement coverage of the prescription digital therapeutic (PDTx) "HelloBetter Insomnie" in France (a digital therapeutic for patients with insomnia). According to a statement by CEO Hannes Klöpper, HelloBetter “remains the first and only DTx company to submit a dossier for reimbursement under the innovative ‘Prise en charge Anticipée Numérique’ (PECAN) pathway, designed to accelerate market access for digital medical devices and telemonitoring solutions.”
Klöpper highlights that the PECAN process currently does not allow for appeals or the submission of additional information. In contrast, the process in Germany includes "deficiency letters," ample time for evaluation, and comprehensive guidelines for manufacturers, which facilitate such exchanges. This approach has significantly contributed to the successful reimbursement of many digital therapeutics (DTx) solutions over the years, with 52 solutions currently listed in the DiGA directory.
