Italy-based healthcare agency, consultancy and digital health group, Healthware, and the Digital Therapeutics Alliance, a nonprofit organization based in Virginia that provides thought leadership and education to advance digital therapeutic adoption, today announced the release of a report outlining policy pathways for digital health adoption in Europe.

Alberta Spreafico, managing director of digital health and innovation at Healthware, sat down for an exclusive interview with MobiHealthNews to discuss the report and how it can help companies navigate the European digital health landscape.

MobiHealthNews: Can you provide an overview of the report and its contents?

Alberta Spreafico: In June 2022, Healthware joined efforts with the Digital Therapeutics Alliance as knowledge partner for DTx [digital therapeutics] policies in Europe. And within this scope, we also launched a DTx policy coalition, which aimed at really engaging different stakeholders to share perspectives on the evolving scenarios and needs, provide clarity on the evolving scenarios and identify areas of potential opportunities to respond to needs, inform scalability of policies and really support equitable access to digital therapeutics.  

We're happy that a year after that now, in June 2023, during the DTA Summit, we're launching a dedicated website dtxpolicylandscape.org that is going to be a resource to provide information and clarity around the evolving landscape and evolving topic of digital therapeutics and particularly evolving policies, fit-for-purpose appraisal criteria, policies and access, and reimbursement pathways.  

Now, within this website, the first significant contribution in terms of content that we're putting out there is this report. The report is a landscape analysis of the evolving scenario in terms of DTx policy pathways in Europe and an analysis of converging trends. 

So basically what we've done in the report, we've analyzed and mapped out the European scenario in terms of countries that have already defined appraisal criteria and access and reimbursement pathways for digital therapeutics, recognizing the specific digital nature of these medical devices.

We also include insights on the evolving scenarios, because I always like to say that if we take it in this context, if you take a snapshot today, it's probably going to be different in a few months' time. So something we did was engage with stakeholders throughout this year and policymakers and leaders from different countries gathering insights on how the scenario was also evolving.

So then what we tried to do is give a picture of things as is, as well as how they're evolving and emerging. And then in our analysis of converging trends, we analyze how, even if things are evolving in a fragmented and often national specific way, if we dig deep enough, we actually can find interesting common patterns that can inform scalable approaches to DTx policies.

MHN: What countries does the report focus on?

Spreafico: So, Europe is the focus of this first report, and within that we were able to dig deeper into the EU4 plus England, so Germany, France, England, Italy, and Catalonia as a region of Spain. We then looked at Benelux–Belgium and the Netherlands. Within the Nordics, we deep dive into Denmark and Finland. And within the Baltics, we touched upon Estonia.  

In this scenario, what we then were able to look at is, identify there's clearly two broader categories: one is those that have formal frameworks in place–and by frameworks, I mean that they've defined health technology assessment, fit-for-purpose appraisal criteria for the digital nature of medical devices like DTx–and access and reimbursement policy pathways and criteria.

MHN: What were some main differences between the countries regarding their digital health landscape? 

Spreafico: Okay, well, interesting because we did find differences, but we also found a lot of commonalities. So in terms of differences, I would say that most of the countries at present are adopting national specific approaches ... and either have defined or are trying to define policies that work in their context. So the difference is this patchwork of national initiatives. 

However, when we dig deeper, we do find commonalities, which I think are important to share. First of all, that, at least in Europe, policymakers are defining policies for the broader category of what we call digital medical devices. So certified medical devices that are digital in nature and have been clinically validated. And digital therapeutics would be a subset of those. 

Second, they're all defining, acknowledging the digital nature of the device. They then acknowledge the need to define dedicated fit-for-purpose health technology assessment criteria. And then in the way that policies are structured, there is this converging trend amongst these countries that have formal frameworks in place, of defining early access pathways or fast tracks that allow access to the digital therapeutic or the digital medical device, conditionally on then generating access and reimbursement, conditional then on generating evidence within a set period of time. 

And then the other interesting thing, kind of digging a little bit deeper into those fit-for-purpose appraisal criteria and commonalities, is that we definitely see that there is convergence, similarities in defining prerequisites in terms of CE mark or certification of the medical device. So being certified medical devices and GDPR compliance, so data. Basically, there's convergence in terms of prerequisites that apply to technical characteristics and safety characteristics. 

In terms of differences, there's one I think that's important to point out. So some countries are defining dedicated policies like, you know, German DiGA for digital health apps. So digital medical devices they call them.

Others, like France, they're recognizing this category as a subgroup within the broader medical device category for policy pathways and then they're defining dedicated HTA [health technology assessment] criteria and access pathways.

Another interesting and unique approach that France has applied is that of differentiating within the digital medical device between those that have therapeutic intended purposes and those that have telemonitoring intended purposes, and then defining slightly different evaluation criteria and access pathways for the two.

MHN: How will the report help U.S. digital health companies understand what they need to do to enter the European market?

Spreafico: The report I think would be a very useful resource, because it basically will show them how each of these main European countries are structuring, whether they have or are working towards structuring, dedicated appraisal criteria access and reimbursement pathways. 

It also provides details on where [their offering] would fit in, in which category, what is the agency of reference or the institution of reference. It provides details on the kind of pricing and reimbursement mechanisms. It also provides examples of digital medical devices and digital therapeutics that have been approved and again, in terms of which therapeutic areas are covered, pricing.

So it actually provides up-to-date data and examples and then again, it provides insights on how the policies are looking to be evolved. And I think that's important because if you set out to launch, for example, a digital therapeutic in Europe today, you want to know what's going to happen in a few months time or in a year's time. So I think the report can help really inform launch and go-to-market strategies for digital therapeutic companies that are looking at Europe as an interesting market.