Innovation in regulating digital therapeutics: a European challenge to benefit patients

The BioRegion has seen a significant growth in digital health in the last ten years, as well as in the investment raised, as shown by the Report of the BioRegion of Catalonia 2021, presented last month. Within this subsector we find the category of digital therapeutic products (DTx), clinically evaluated digital technology solutions (software), which offer therapeutic interventions that directly impact patients, that have scientific evidence, and that prevent, manage or improve the disease treatment.

In 2019, Germany blazed the trail for reimbursement of these digital therapeutics with a clear strategy (‘Digitale Versorgung Gesetz’ or DVG), establishing its own regulatory seal (‘DiGAs’ [Digitale Gesundheitsanwendungen]) that, once granted, means health apps can be prescribed to any person covered by the German public healthcare system. This technology adoption innovation is serving as a benchmark for other countries like France, Belgium and the UK, which are developing their own models. 

Catalonia isn’t resting on its laurels. Work is underway here as well, in line with Catalan competences within the national framework, moving towards setting up a notifying authority to guide and advise DTx firms in the BioRegion through the process of being integrated into the system. “A neutral body within the system, like Biocat, could guide digital startups in complying with care and regulatory requirements, helping speed up and optimize the final evaluation process by AQuAS, as the competent agency,” notes Biocat CEO Robert Fabregat. 

Evaluation and funding: main challenges facing DTx in Europe

Venture capital for the global DTx industry went from $130 million in 2015 to $1.2 billion in 2019. The DTx industry is growing quickly, above all in the United States, where the FDA is proactively encouraging these therapies through its Digital Health Center of Excellence. According to Yolanda Puiggròs, a lawyer specializing in health and society at Roca Junyent, Europe runs the risk of being left behind by not acting as a single market and not having mutual recognition of certification or, in many cases, even standardized clinical evidence: “We don’t have specific regulations or a funding model that ensures access and efficacy of these digital applications,” she explained in a session organized by EIT Health Spain on this topic. What we have is a series of rules that, to some extent, cover the three phases in the lifecycle of this type of technology: authorization, assessment and funding.”

The first phase (authorization) is resolved with CE marking, which shows the product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. The second, regarding scientific evidence, however, poses a challenge: the lack of Europe-wide regulation for these therapies means they are still evaluated like any other medical device. In Spain, the situation is even more complex because assessment falls to the individual autonomous communities. 

And finally, we need to resolve who funds digital therapeutics and how. Meaning: who is in charge of reimbursing the companies that own these digital solutions when they are prescribed to patients? On this point, there are also two options on the table: first, for the State or insurers to be responsible for funding the use of this technology and second, for the solutions to be integrated into the system through public procurement of innovation. Either way, Yolanda Puiggròs believes it must be an “agile” mechanism to ensure the technology doesn’t fall into disuse before receiving compensation.

German procedure, pioneer in regulation

Germany is the only country in the EU with a large-scale model that allows companies to gain approval and set up sustainable businesses. The German procedure  -DiGA Fast Track- allows a company to have its solution assessed in just three months. Then, the digital therapy receives preliminary approval for commercialization over the following 12 months. During this one-year period, the company must compile definitive evidence of the solution’s efficacy in order to be permanently listed in the DiGA directory.

“The patient receives a code when a doctor prescribes a digital therapy, which gives them access to the solution through their insurance company or the public system. Once the patient has requested to use it, it is the insurer that directly pays the company that has developed the solution,” explains Anne Sophie Geier, managing director of Spitzenverband Digitale Gesundheitsversorgung, the organization in charge of managing DiGA. 

Source: Digital Care Act: Is Germany now ready for #DigitalHealth?

According to Pablo Prieto, Chief Revenue Officer at Fosanis GmbH –the company that owns MIKA, the first DiGA for cancer patients– this model is still in the early stages, and it is yet to be seen if it is profitable and brings value added. In fact, certain limitations have been found, like the scheme designed for distribution, which isn’t ideal for a public that is still used to paper prescriptions. There is also room for improvement in managing payment once the application has been approved: “With preliminary listing, you move into a free-pricing model that requires negotiations with each of the insurers,” he explains. 

In Germany today, there are 2,780 mobile apps related to health, but only 30 are registered as DiGA. By the middle of this year, they hope to have 50 prescription apps listed in the directory.

One country that has drawn inspiration from the German approach is France. President Macron announced in late 2021 that he wants a fast track to make digital therapies accessible to patients and reimbursable by the public health system. According to Nina Bufi, eHealth projects director for the Ministry of Health, this would be a true “turning point” for the French healthcare sector, a real “weapon” for diversifying the care offered. She explained this in the panel discussion ‘Hi I’m a SME, where is my fast track?’, organized by Biocat, where she also announced that the strategy will receive €650 million in funding and be divided into five focal points. They hope that DTx can start reaching the French population in late 2023.

For its part, Belgium has also taken a step forward in bringing digital therapies to patients. The Federal Agency for Medicines and Health Products (FAMHP) is in charge of reviewing CE certified applications based on a validation pyramid with three levels, assessing the risk, interoperability and clinical evidence. There are currently 34 health apps at levels M1 and M2 of the Belgian validation pyramid. The apps that manage to reach the third level will receive reimbursement through the National Institute for Health and Disability Insurance (NIHDI). The following graph shows the three DTx reimbursement processes that currently coexist in Europe. 

Source: How to get your digital health app reimbursed in Europe? Start with Germany, Belgium and France

An authority to guide Catalan DTx through integration into the system 

“It would be great if we were working in the line Germany has designed, which France is now following,” assured Biocat CEO Robert Fabregat, who also noted: “It’s a good starting point, although there are work lines that could be improved, for instance adapting assessment to the type of technology. The assessment processes could be segmented by the risk the solution poses: establishing more agile, less stringent mechanisms for the ones that are less complex.” However, Fabregat believes that the BioRegion’s plan must include a notifying authority that guides and advises Catalan DTx on their path towards integration into the system, and Biocat could play a significant role throughout the process.

For now, public procurement of innovation is one of the instruments facilitating adoption of innovations and the development of innovation and technology policies, and it is the path the Catalan Ministry of Health has chosen to integrate technology into the system. This is how digital solutions end up becoming part of the toolbox available to healthcare providers through a traditional licensing scheme. Ramon Maspons, Chief Innovation Officer at AQuAS, reveals that the system focuses on technology that has the following characteristics: servitization (turning a product into a service), personalization, prevention and sustainability. But he warns: “The new mechanisms for collaboration between the public and private sectors are a useful tool, but it is important to have a clear idea of what we mean by value and which strategy we are using to achieve it.” 

Source: 2021 BioRegion Report

In the 2021 BioRegion Report, Biocat identified 30 companies in the DTx category, classified according to whether they offer a solution for self-management and monitoring, prevention, treatment or genomics. The selection criteria were: proven clinical evidence (whether through European [EMA] or US [FDA] certification, or a pilot study) with a real, direct impact on treating patients. 

Now some of these companies are taking part in 4 Years From Now (4YFN), the benchmark event that brings together the most innovative startups in Barcelona. Over 60 healthtech startups from the BioRegion have already confirmed they will attend the event, giving us the opportunity to get a first-hand look at their proposals from the entrepreneurs leading the companies. We’ll share what we learn in our next post. Don’t miss it!