Apps on Prescription: DTx Regulation in Europe

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July 29, 2021

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The Sidebar evaluates the current and future state of Europe’s rules and regulations for digital therapeutics.

Status Quo: A Long way to go

The reimbursement of digital therapeutics is a crucial step towards ensuring that digital health tools are able to achieve their full potential to improve patient outcomes. With that said, progress in Europe has been slow.

Germany continues to be the country that the rest of the region looks to, as it was the first to reimburse prescription digital therapeutics at a national level. While there are signs that other EU nations will soon follow in its footsteps, including Italy and Belgium, there continue to be a myriad of obstacles preventing progress. In particular: a fragmented approach on digital health regulation that varies from country to country.

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Regulatory Changes Create Ease for DTx in Germany

The Digital Healthcare Act came into force in Germany in 2019 and has made it easier for patients to make virtual doctor visits and access their health data from anywhere. Furthermore, Germany has seen an increasing number of digital health applications (DiGA) backed, with the March 2021 approval of a mental health app marking the 11th app to be passed. Although there is still some uncertainty about the long-term implications of the legislation and how it will be put into practice, the rules are designed to be updated where needed.

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They may have different healthcare systems and alternative approaches to pricing and reimbursement, but we would certainly expect other countries to look to the approach Germany is taking and see how they might adapt and implement it within their own markets, OPEN Health consultants Olaf Schoeman and Emanuele Arca told Deep Dive magazine.

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DTx Regulation in Europe Depends on the Region

The Belgian National Institute for Health and Disability Insurance has slowly begun reimbursing mobile apps — though so far only in small numbers, and only those that include an app that supports hip or knee replacement rehabilitation. Alongside this, the government’s mHealthBelgium platform collects all apps that have received a CE mark as a medical device, and categorizes them into three levels. Those that show “social-economic evidence” can get reimbursed.

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Italy is also keen to follow Germany’s lead, according to a Feb 2021 white paper entitled Digital Therapeutics, an Opportunity for Italy. Giuseppe Recchia, director of Smith Kline Foundation, Tendenze Nuove, who championed the project, emphasized the need to integrate digital therapeutics into Italy’s healthcare system. Recommendations included making information more available to the general public, training for professionals and patients, and targeted communications to health and political institutions.

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At European level, EMA has an important role in facilitating the appropriate recognition of DTx and introducing a seal of recognition that indicates the DTx products has an effect recognised by EMA may be an important first step, said Recchia.

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The UK Faces Particularly Challenging Barriers

In the UK, NHS Digital and NHSX have been pushing for regulatory change, but the NHS has not been unified in its approach. The primary barrier: a disparity in funding sources across the NHS, specifically that England’s Innovation and Technology Tariff (ITT) and the Innovation and Technology Payment (ITP) funding is made available at the national level but clinical commissioning funding is provided at a regional level.

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NICE’s Medtech Innovation Briefings, which are designed to support NHS and social care commissioners and staff considering using new medical technologies, include digital health technologies (DHTs) and a review of published evidence and the likely associated cost. However, the aim of these briefings is not to make recommendations but instead support local decision-making by providing a factual overview.

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Like many other countries, digital therapeutics in the UK are also falling under existing pathways for medical devices:

The problem is, these pathways are usually more applicable to traditional medical devices where software is either a side aspect or is not present at all, whereas many DHTs today are fully software-based, said Dr Lorenzo D’Angelo, principal in CRA’s Life Sciences Practice.

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Encouragingly, NICE is making proposals to provide faster access to new medical treatments and innovations. In April 2021, the cost-effectiveness body outlined a new five-year plan to improve the speed and efficiency of technology evaluations based on lessons learned during the COVID-19 pandemic.

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The Takeaway: EMA Guidance is Key

The digital transformation of healthcare prompted by COVID-19 has paved the way for increased use of digital therapeutics, according to Urte Jakimaviciute, Senior Director of Market Research at Consultants GlobalData. “Lockdowns, movement restrictions and social distancing norms have rapidly pushed healthcare services and patient monitoring toward remote options,” she noted.

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As European health begins to rely more and more on digital tools, central guidance from the EMA is a vital next step for the future of digital therapeutics.

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