A key component to ensuring the adoption of digital health products is market access and reimbursement. The European reimbursement for digital therapeutics (DTx) remains quite fragmented and is often defined at a national level. Germany was the first European country to pioneer the way for DTx reimbursement through its DiGA pathway. Shortly after, Belgium launched its mHealth reimbursement pathway and now France is following suit with the launch of their new fast-track reimbursement pathway for digital health solutions.
In this week’s blog, we explore France's new fast-track reimbursement pathway for digital health and how it compares to Germany's DiGA pathway.
France Experimented with Several Digital Health Pathways
France has experimented with different fast-track pathways for digital health solutions which proved fruitful for understanding evidence requirements and creating guidelines. The most successful program from this was their ETAPES (Telemedicine Experiments for the Improvement of Health Pathways) program for remote monitoring of five chronic conditions: heart failure, renal failure, respiratory failure, diabetes and implantable heart prostheses. This program allowed more than 55 telemonitoring devices in any of these five disease areas to be reimbursed. For example Moovcare, a web and mobile app for remote monitoring of lung cancer patients achieved reimbursement in France.
The New PEC-AN Pathway will allow Temporary Rapid Access to Digital Health Solutions for Patients
The new fast track pathway (Prise en Charge Anticipée “PEC-AN”) is a transitional one-year reimbursement access pathway to enable rapid access for patients to digital health solutions at a temporary reimbursement rate for one year before a more permanent listing. The pathway will be for either a DTx (for individual use) or a telemonitoring solution outside the five chronic diseases covered by the ETAPES program. From the start of early coverage, solutions must file a request for reimbursement:
- Within six months for digital medical devices for therapeutic purposes
- Within nine months of remote monitoring activities
To be eligible for the new temporary pathway, solutions will need to have the following:
- CE marking as a medical device under MDR
- Technical certification for cyber security, interoperability and GDPR standards
- Clinical evaluation (before the end of the 1 year period)
- Data on healthcare benefits or progress in the organisation of care
Once approval is received from the CNEDiMTS (National Commision for the Evaluation of Medical Devices and Technologies) based on the first available data and from the National Digital Health Agency on compliance with interoperability and security standards, the solution is reimbursed for a one-year period.
The company then has a few months to complete its evidence file, enabling it to obtain reimbursement under common law. If data is not available, the solutions will not be reimbursed for a second year (and beyond) and the manufacturer must reapply when they have sufficient data. Solutions which get approved can negotiate a final pricing.
Digital health solutions going through this pathway must engage with three different stakeholders and comply with their individual requirements to succeed: the HTA Agency (HAS), the National Digital Health Agency and the Ministry of Health.
The French Pathway Has Been Inspired by DiGA But Can It Do Better?
The DiGA pathway paved the way for DTX reimbursement within the E.U. and it’s no surprise that elements of this pathway have served as inspiration for other reimbursement pathways.
The preliminary listing on the DiGA registry allows companies to be listed at a fixed price for a year while they gather the necessary clinical data, which is reminiscent of this new transitional and temporary one year reimbursement access pathway in France.
Both pathways require devices to be CE- certified and compliant with data protection and cybersecurity standards. Yet the DiGA pathway has a more extensive list of requirements (more than 100) which includes completion of a penetration test (a simulated cyber attack against your computer system to check for exploitable vulnerabilities).
Both pathways take into account the overall healthcare benefit of the solution, for example, DiGA includes both the medical benefit of the solution to the patient and positive healthcare effects such as coordination of treatment procedures, while the French pathway considers improvements in the organization of care in addition to the clinical efficacy of the solution.
One of the major differences between the DiGA pathway and the French pathway is that DiGA only covers devices from class I to IIa (lower risk classes), while the new French pathway is open to all classes of devices (I, IIa, IIb, III). This will pave the way for higher-risk devices seeking reimbursement within the French market.
Tessy Huss, Head of Market Research at HealthXL says, “It will be interesting to see if France is going to overtake Germany to become the most favorable country to launch new digital products into Europe. France is a key EU market from a population standpoint, and the expanded coverage of the pathway may facilitate a speedier and multi-pronged integration of digital technologies across the health system.”
Germany, France and Belgium Lead the Pack, While the Rest of the European Market Lags Behind
While France, Germany, and Belgium have forged ahead, each introducing their own standardized reimbursement processes for digital health, the rest of the European landscape is lagging behind in comparison to the U.S.. Late last year, Europe’s first-ever Digital Health Action Plan was launched for the WHO European Region which intends to leverage ongoing digital transformation in Europe. The commitment made by 53 member states to this new action plan may potentially increase investment in digital health over the next few years and accelerate the development of policies and regulations which impact reimbursement.
In addition, France launched a European Digital Medical Device (DMD) Taskforce to harmonise clinical criteria and methodologies for evaluating DMDs so these solutions can avoid duplication of health technology assessments and be more readily accepted across different EU countries. Similarly in the U.K. NICE has developed an evidence standards framework which allows stakeholders to evaluate digital health technologies (DHTs) against a set of pre-defined criteria which will allow stakeholders to easily identify DHTs that are likely to offer benefits to users and to the health care system.
Efforts so far highlight the increased appetite within the European landscape for digital health solutions, which will hopefully increase adoption as the landscape becomes less fragmented.
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