Market access

France will allow rapid access to the digital therapeutics market

French President Emmanuel Macron has announced his intention to follow in Germany’s footsteps by making digital therapies available on prescription through the legal healthcare system.

In 2019, Germany introduced its DiGA Fast Track process for the rapid approval, testing, piloting and evaluation of healthcare applications, which is open to all companies in the European Union (EU).

Speaking at the HealthTech Innovation Days (HTID) event in Paris earlier this month, French President Emmanuel Macron announced: “We are also creating an immediate access procedure for market access for innovative products , in the same way as in Germany. I’m very direct with you – we’ll just replicate what works in Germany.

The DiGA initiative, created as part of the Digital Health Act (DVG) of 2019, allows doctors to prescribe apps to 73 million German citizens covered by public health, with costs reimbursed by health insurance .

From 2020, medical applications for patients that are CE marked as low risk class 1 and 2a medical devices were able to apply for accelerated market entry in Germany. There are currently 22 apps approved for reimbursement, nearly 50% of which focus on mental health.

WHY IS IT IMPORTANT

The “fast-track” process aims to facilitate the path from innovation to regular care. As part of this initiative, developers no longer have to conduct randomized clinical trials to provide evidence and can use other methods to demonstrate the benefits of care at the German Federal Institute for Drugs and Medical Devices ( BfArM).

In addition to providing reimbursement, the DiGA program can increase patient and provider awareness and confidence in digital therapies.

THE BROADER CONTEXT

The European Commission is creating a common regulatory framework for digital transformation in all EU member states, including regulations on data privacy – GDPR, medical devices, artificial intelligence and health technology assessment.

Meanwhile, in the South West of England, millions of people will have access to digital healthcare libraries, thanks to a partnership between the Organization for the Review of Healthcare and Care Applications (ORCHA) and Seven integrated care systems (ICS). Each library will provide hundreds of relevant health apps for different medical and lifestyle issues, with a focus on mental health support and weight management.

NHS Scotland has also launched a digital initiative to help adults with anxiety and insomnia by providing free access to Big Health’s Daylight and Sleepio digital therapy apps.

ON THE RECORD

Armin Scheuer, Vice President of International Business Development at HIMSS, said: “There is no such thing as a European healthcare system. All health care is really the responsibility of the Member States. Nevertheless, the two largest economies in the EU economy, Germany and France, have started to align some of their approaches and at the same time these countries are really the engines of EU integration. .

“We can expect that this process and many other ongoing steps can lead to the development of a more aligned European health sector – certainly when it comes to digitization.”


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