This is not necessarily an unprecedented development. As with any innovation or invention, adoption across country borders comes hand in hand with fragmentation, as each individual government and regulator develops localised systems and standards to manage the use and development of a product or service.
But while many innovative concepts fall neatly into pre-defined categories (food is food, alcohol is alcohol, and so on), DTx is one of those unique developments that spans categories and, as such, pinning down an exact agreed-upon definition for DTx across European nations remains an ongoing challenge for developers and regulators.
In short, there is a clear need for harmonisation when it comes to improving market access for DTx. To find out more, Deep Dive editor Eloise McLennan sat down with Alberta Spreafico, global head of digital health & innovation strategy, senior director, global management team for the Healthware Group, to discuss the current landscape for DTx in Europe, and the work being done to help bring vital therapeutic options to patients.
To some, the answer to this question may appear obvious. However, across Europe there is significant fragmentation when it comes to the nomenclature of DTx. But why is this? According to Spreafico, dissonance surrounding development of standard recognised definition may be a characteristic of the early stages of innovation.
“When we’re dealing with something new in any field, there’s a space where it’s hard for that common definition to come across,” she explains.
“I think that with digital therapeutics, what’s happened is that, initially, it wasn’t so clear if they sat more into the medical device sphere or if in the therapeutics drugs field. The very notion of digital therapeutics can cause that confusion between whether they are a device or a drug. When, in fact, they have something relatively new in their identity.”
There is no single methodology used in the practise of DTx. They can be employed for a variety of conditions, including psychoeducational applications designed to help alter patient behaviours, connected wearable devices that can be used to remotely monitor the patient’s condition, and mobile apps, which offer cognitive behavioural therapy via a patient’s mobile devices.
Although debate over the specifics is ongoing, there are commonalities that appear across international borders. The most prominent being that DTx fall within the broader categorisation of medical devices.
“Ultimately, digital therapeutics refer to high-quality software programs that deliver to patients’ evidence-based therapeutic interventions to treat, manage, or prevent a disease or disorder. Increasingly so, if we look at different European frameworks, they ultimately are categorised and sit within the medical – I think there’s increasing convergence that they sit within the broader categorisation of medical devices,” explains Spreafico. “Specifically, they have a digital core, and it’s increasingly being acknowledged that this should imply some fit-for-purpose requirements in the way regulators evaluate their assessment or appraisal criteria defined to then enable access and reimbursement.”
It’s no secret that it is incredibly difficult to change legislation in healthcare. Even if calls for change avoid being hampered by existing regulation, implementing uniform legislation typically spans years. Given the red-tape and cost concerns associated with adopting a new process – combined with the unique challenges introduced by a global pandemic – it is understandable why the majority of European nations have been slow to channel DTx into state-run healthcare systems.
Those few countries that have put their metaphorical heads over the DTx parapet have become “guinea pigs” for digital health regulation in Europe. Perhaps the most notable of these can be found in Germany’s DiGA (Digitale Gesundheitsanwendung or Digital Health Applications in English) system, which approved the first prescription digital health applications in September 2020.
At their base form – DiGAs are digital health apps that can be prescribed by doctors for a variety of diagnoses. Not only can patients access these apps with a prescription, but all statutory health insurers reimburse the costs in Germany, with prices negotiated in advance. Compared to previous requirements, which saw DTx companies forced to negotiate selective contracts with multiple insurance companies, this is a big shake up when it comes to gaining market access.
Since the start of the first DiGA portal in May 2020, over a 100 applications have been submitted for assessment by Germany’s Federal Institute for Drugs and Medical Devices (BfArM). 45 DiGA are now available: 18 permanently listed and reimbursed and 27 temporarily; while 6 were revoked after provisional listing mostly due to insufficient clinical evidence.
“The DiGA model offers a structured digital health care act within which there’s an ordinance decreed regulating the appraisal criteria and access and reimbursement pathway for digital health applications, some of which include digital therapeutics,” says Spreafico.
“That’s very specific for these digital healthcare solutions, but, on the other hand, a prerequisite for it is that they are certified medical devices where the digital core, let’s say, or their main medical function, should happen through the digital feature. Then, if you look at Belgium, them too, they have a framework for digital healthcare apps, requiring them to be certified medical devices.”
But, as she notes, this is just one approach to structuring DTx policies and pathways. Nations, such as France and Belgium, are also in the process of defining how they evaluate their assessment or appraisal criteria, defined to then enable access and reimbursement.
“At the country level, different countries are finding their own pathway, and some of them see defining a separate, dedicated pathway works best, but other countries are working towards scaling existing policies,” explains Spreafico. “In France, they’re using the medical device pathway, but they are differentiating this definition of digital medical devices, which they further differentiate between monitoring, purpose, and therapeutic purpose. The fact that they do need to acknowledge this digital nature comes with the fact that they do have some specifics – you do need to define fit-for-purpose requirements because they are unique in their own way.”
While the German fast-track system certainly triggered interest in DTx across Europe, with countries weighing the pros and cons of implementing similar frameworks to allow for the wide adoption of digital health solutions within their national healthcare systems. On the surface, this is fantastic news for DTx companies, as greater interest and awareness of products can translate into increased demand.
However, there is a substantial challenge to be addressed before even the most promising, clinically validated DTx can be delivered to patients. Being regulated as medical devices means that these offerings are subject to strict regulations and must undergo a lengthy and expensive approval process before they can be marketed. Across Europe, this is further complicated, as the regulatory process varies between countries, making it challenging for companies to navigate the system. This can result in delays in bringing digital therapeutics to market and may even discourage companies from investing in further research and development.
This fragmentation, while an important issue to address, is not an impossible barrier to overcome. As Spreafico explains, by focusing on the commonalties found in the regulatory requirements of different European nations, we can begin to build towards harmonising national approaches in this field.
“On the one hand, what we see is a lot of fragmentation across European countries. But, on the other, we see a great interest and an evolving scenario, which is rich in its evolution,” says Spreafico. “What we’re working on, also in partnership with the Digital Therapetuics Alliance, is seeing what do they all ask that’s common, and how can that inform some convergence?”
“For example, we currently see that, generally, they all require companies to specify the target population, the condition that they are targeting, why does it matter, and what value can you generate versus a standard of care? These are prerequisites so that you’re sure that you’re using a device that is safe, secure, and that can then be interoperable with a national or European-wide infrastructure digital infrastructure. Then, on top of that, you would have the clinical evidence.”
Interoperability, Spreafico notes, is key. Digital solutions have enormous potential when it comes to scaling access in a cost-effective manner, if, of course, adequate frameworks are in place to allow for fast tracks, or early access pathways, where you can develop evidence in a real-world setting.
“I think countries are moving forwards on that,” she says. “Many of them are just figuring out whether it’s worth creating a new pathway or separate dedicated pathways or working within their medical device framework, and then the harmonisation component instead requires governance at the EU level, as well as aligned incentives across countries to do something so that it’s not each country trying to have their own framework, but even recognising possible best practices that could apply to the national specificities.”
“The value [of DTx] is there and in some cases it’s strongly validated. In other cases, it has great potential with limited side effects. Why don’t we enable pathways? Really, I would work on enabling global, national, regional in the sense of Europe, cross border access, and access pathways, which can make them accessible to patients and citizens, and the other one is, really, I would work on, I would hope in parallel, the enabling infrastructure, enabling environments, are being set up. They can be accessed by everyone because they do have the knowledge, the connectivity, and then they can be fully expressed, their potential, through the generational real-world data that actually has guidelines for us to generate value from them.”
With clinical evidence supporting the promise of DTx, and growing examples of possible market access pathways already turning heads, the argument for not pursuing these solutions is limited. DTx are here to stay, and it is now up to decision makers to ensure patients have affordable access to treatment.
As Spreafico concludes, “When there is sound clinical evidence supporting the value of DTx, why should it not be an option for patients to access it? If we have validated DTx that can enhance depression treatment and management; or digital medical devices that, if used appropriately can enhance survivorship, for example, in cancer care, why should we not make those equitably accessible? I think that, where there is that supporting clinical evidence, the question really becomes why not?”
Alberta Spreafico, Global Head of Digital Health & Innovation Strategy, Healthware Group
Alberta is a health innovator, global health expert and digital health strategist with over 10 years of experience as senior director and management consultant in the health and life sciences sector; she is also a Contract Professor of development economics and social policies at the University of Pavia (Italy).
Alberta has directed and co-founded numerous global health innovation programs worldwide, focused on effectively integrating digital health technologies across healthcare systems and care pathways to enhance quality, access, and sustainability of care.
Alberta now serves as Global Head of Digital Health & Innovation Strategy at Healthware Group, where she leads programs aimed at enabling the systemic integration and adoption of digital health innovations across healthcare systems, in partnership with diverse ecosystem stakeholders. In this role, she also leads Healthware’s commitment as knowledge partner for the Digital Therapeutics Alliance to monitor, inform and scale Digital Therapeutics (DTx) Policies in Europe.
Connect with Alberta Spreafico on Linkedin
Eloise McLennan is the editor for pharmaphorum’s Deep Dive magazine. She has been a journalist and editor in the healthcare field for more than five years and has worked at several leading publications in the UK.