PEC-AN in France: Meet Its New Digital Medtech Reimbursement Fast-Track
They finally did it: France introduced an accelerated market access pathway for certain digital health products, inspired by similar systems in neighboring Germany (DiGA) and Belgium (mHealth). So how does the French reimbursement program work and which solutions are eligible? Let’s figure it out together.
Where It All Began for France
We will not be right if we say that the reimbursement implementation has started in France only now. Thus, in 2022, the ETAPES (Telemedicine Experiments for the Improvement of Health Pathways) program was created for remote monitoring of five chronic diseases: heart, kidney, and respiratory failures, diabetes, and implanted heart prostheses. This program reimbursed more than fifty remote monitoring solutions, devices, and apps that were submitted for consideration.
Is PEC-AN a “Tough Nut”?
The new PEC-AN (Prise en Charge Anticipée “PEC-AN”) is a transitional one-year reimbursement pathway that provides rapid patient access to digital health solutions at a temporary one-year reimbursement rate to a more permanent listing. The pathway involves either DTx (for individual use) or a telemonitoring solution outside the five chronic diseases covered by the ETAPES program, as we mentioned above. From the start of early coverage, solutions must submit a claim for reimbursement:
within six months for digital medical devices with therapeutic goals;
during nine months of remote monitoring.
To be qualified for a new temporary pathway, solutions must have the following:
CE marking as a medical device under the MDR;
technical certification on cybersecurity, compliance, and GDPR norms;
clinical evaluation (until the end of one year term);
information about medical usefulness or improvement in care arrangements.
After obtaining approval from the CNEDiMTS (National Commission for the Evaluation of Medical Devices and Technologies) established on the first available data and from the National Digital Health Agency for compliance with interoperability and security measures, the solution will be reimbursed for one year.
The company then has several months to finish its evidence file, which would authorize it to obtain a common law reimbursement. If this information is not available, the cost of the solution will not be reimbursed for the second year (and beyond) and the provider must reapply when acceptable data is ready. Approved solutions can settle on a final cost.
Digital health solutions that follow this path must interact with three different stakeholders and satisfy their requirements to succeed: the HTA Agency (HAS), the National Digital Health Agency, and the Department of Health.
DiGA & PEC-AN: Was Inspiration Worth It?
The DiGA pathway paved the course for DTx reimbursement in the EU, so, unsurprisingly, its elements have inspired others.
A pre-listing in the DiGA registry entitles companies to register at a fixed price for a year while they gather the necessary clinical data, which resembles France’s new transitional and temporary one-year reimbursement pathway.
Both paths require devices to be CE certified and meet data protection and cybersecurity standards. However, the DiGA pathway has a more extensive list of requirements (over 100), which includes passing a penetration test (a simulated cyber attack on your computer system to test for exploitable vulnerabilities).
Perhaps the most obvious difference between DiGA and PEC-AN is that the first of the above only covers devices from class I to IIa (lower risk classes), whereas its new French “relative” is available for all device classes (I, IIa, IIb, III). It will be beneficial and give many hopes for higher-risk devices requiring reimbursement in the French market.
In Lieu of a Postscript
So, France officially joined the number of “leaders of the reimbursement race.” And what about the rest of Europe?
In 2022, the first-ever Digital Health Action Plan was launched to strengthen the ongoing digital transformation in Europe. The commitment made by 53 member states to this new action project could potentially increase investment in digital health over the next few years and accelerate the development of regulations affecting reimbursement.
In addition, France created the European Working Group on Digital Medical Devices (DMD) to harmonize clinical criteria and methodologies for DMD assessment so that these decisions can avoid duplicating medical technology estimates and be more easily adopted across EU countries.
At the very end, as a company that readily cooperates with digital health startups, we have something to note: at one time, the appearance of DiGA in Germany raised a real wave for development in the sphere. We hope that the French ecosystem will become equally fruitful and inspiring for new ideas, new names, and new companies in this complex but vital field. And, of course, we are looking forward to similar achievements in other European countries soon.
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