FH23: Inside the first Digital Medicine & DTx Global Policy Summit

In early November, the inaugural Digital Medicine & DTx Global Policy Summit, part of Frontiers Health 2023, brought together experts, policymakers, and industry leaders from Europe, the US, and APAC to discuss best practices in cross-country scaling, harmonisation, and mutual recognition in appraisal criteria, access, and reimbursement processes, as well as strategies for systemic integration, adoption, and value generation.

In his opening address, Roberto Ascione, Healthware Group CEO, highlighted the importance of policy innovation to support developments in the DTx space. From technology and process he held high hopes for productive outcomes from the discussions of the Summit – a collaborative effort by Healthware Group, Digital Therapeutics Alliance (DTA), and other organisations – which he dubbed an “ecosystem and community effort”.

Global challenges: Seeking harmonisation

Alberta Spreafico – global head of digital health & innovation strategy, senior director of the global management team, and managing director of digital health & innovation at Healthware Group – welcomed to the stage Professor Dr Jochen Klucken, FNR PEARL chair of digital medicine at the University of Luxembourg, and Rosanna Tarricone, chair of the advisory group for the European Taskforce for Harmonised Evaluation of Digital Medical Devices in the EU, and associate SDA dean for the government and health division at SDA Bocconi. Klucken and Tarricone have been working together on analysing the ecosystem and the different policy frameworks across Europe, looking at supporting harmonisation. They are the chairs of the taskforce.

The Summit spanned three macro-sessions: the first focused on Europe, sharing the evolving scenario and trends possible for harmonisation; the second, was focused on APAC; and third, focus shifted to the US. By sharing the different evolving scenarios, best practices, and opportunities it was hoped that attendees and speakers would be able to connect the dots needed to achieve harmonisation across countries.

The issue of reimbursement

Looking at the EU frameworks, then: they ensure the device is safe, is protective, and they enable the technologies, but none are linking to reimbursement, noted Prof Klucken. Germany’s DiGA makes the accelerator, the incubator, and the investor all worth it, due to evidence proving the benefit for the patient, which is an interesting aspect introduced to the German model. But what must be remembered, he said, is that these are low-risk devices: they are the game-changers in the healthcare system. Countries are setting out their own frameworks, and they use different functional components and not each country is supporting each of those. Therefore, the European Taskforce for Harmonised Evaluation of Digital Medical Devices (DMDs) was set up in 2022 and inclusion and exclusion criteria are assessed under this.

“We’re not talking about one single mechanism of action, swallowing a pill and letting it work,” Prof Klucken clarified, “but a lot of different levels of user interaction are needed, and different levels of research and evaluation. Perhaps it will be done next year?”

Overcoming disparities between geographies

In Europe, particularly, a framework is emerging (e.g., Germany, France, England, and Belgium, with Italy close behind). Discussing the evolution of access and reimbursement models currently being undertaken in these countries, Spreafico noted, has led to an assessment framework adapting to fit for purpose criteria; there has been a convergence on building fast tracks and managed access agreements – the condition of generating evidence.
Indeed, “tunnelling down” into fit-for-purpose evaluation and early access pre-requisites, adapting the HTA core model, Spreafico and a colleague examined the different dimensions, the series of standards, and found that countries are asking similar things: a great starting point to avoid fragmented dossiers across geographies.

However, the issue with clinical proof of value is that evidence has to be generated locally. But, as things scale, enhancing the transferability of clinical evidence across Europe can be made possible, Spreafico explained, resulting in usability and access for all.

Currently, there is inequity across countries. In Italy, for example, it’s an out-of-pocket scenario: there’s no reimbursement framework in place, and digital health technologies are only available for those who can afford it. The risk of adopting the medical device pathway that breaks up across the municipalities is also a real risk in Italy, Spreafico noted. So, how can these issues be overcome? Spreafico suggested a 10-step pathway of scaling:

A 10-STEP pathway
    • Scale recognition and common nomenclatures
    • Scale fit-for-purpose common HTA criteria
    • Scale access and reimbursement with CED-managed entry agreements
    • Scale joint clinical evaluations and voluntary cooperation
    • Scale mutual recognition agreements, evidence transferability, and RWE
    • Scale clinical guidelines and digitally enhanced protocols
    • Scale systemic integration and a seamless UX
    • Scale multi-stakeholder engagement
    • Scale innovation-driven ecosystems
    • Scale future-proof system readiness

Germany, France, and Belgium: Three jurisdictions

Germany was the first to link assessment process with reimbursement, declaring that Risk Class 1 and 2a were the major object of the assessment, although incorporation of other types of DMDs are being considered. Other countries, such as Belgium and France, are more interested in the nature of the DMD – so, whether there is a positive effect on patients and/or a positive effect on the delivery of health services.

In the case of Belgium, they recommend a prospective study design, while France’s transitory PECAN system doesn’t recommend a specific study design, Tarricone noted, but in a perhaps more illuminated way a manufacturer can put forth the most suitable study design for the DMD wanting to submit. The same type of attitude can be seen in the comparator, also. Germany’s approach was prescriptive in the beginning, while more recently the later countries to the scene were more open, not prescribing anything specific, but dependent on the manufacturer.

Finally, in terms of financing schemes, another convergence and learning effect is the type of reimbursement system and pricing negotiations. Germany tends to assess, prescribe, and price technology, while other countries are more prone to considering the possibility of incorporating more innovative pricing schemes. Incorporation of the DMD might change the whole patient’s clinical pathway, after all, instead of demonstrating an isolated ‘plus’ in terms of a positive health outcome for the patient, Tarricone advised.

Overall, innovation is welcome, but it must be regulated. There is a longitudinal revolutionary aspect representing a learning effect, in her opinion. From an academic perspective, this can be seen in terms of scope, benefits, and remuneration. Additionally, the measurement of the benefits, what makes the difference between a DMD and a medical device, is the possibility to trigger patient outcomes not seen in the past with conventional medical devices. Talk of patient engagement, autonomy, and self-confidence – these benefits make these devices work more effectively than the comparator, Tarricone said.

But how can the triggers be measured? If these are missed, the whole story is missed. So, a dual approach is necessary. In some jurisdictions, there’s the approach of a multidimensional, deliverative approach.

In short, Tarricone believes the route to harmonisation is already here. There is certainly the momentum to do so. Those countries who have already begun can help other countries to catch up and not make the same mistakes. Yet, there is a strong momentum to include also other stakeholder perspectives, and this is what the Taskforce does with its external advisory board for DMDs. The Summit was a sign of positive momentum for one of Tarricone’s dreams: the dream for these types of technologies, and medical devices, to no longer have a division between pre- and post-market.

The European situation

A panel and presentations with Alberta Spreafico, Marco Marchetti, Dr Wolfgang Lauer, Lily Tang, and Vincent Vercamer followed.
Dr Wolfgang Lauer commented that in past years there had been tremendous increase in approaches to DMDs and into national healthcare systems and reimbursement and business models. The main point, he said, is sitting together, talking challenges and experiences and standardisation where possible, but importantly exchanging ideas for a European initiative.

Vercamer thinks harmonisation requires broad movement and lots of differences done separately, but that they can move forwards together step by step, collaboratively, creating a common market for the solution and resulting in the best outcomes for patients. Spreafico responded that clinical evidence transferability is what will make a difference, here.

Tang, meanwhile, mentioned reimbursement, commissioning, and funding – but that what is missing is greater health economic assessment that keeps pace with the evolution of the digital health technology market. There has to be value-adding for investment there for parity: when a patient swallows a pill or uses an Apple watch, there isn’t yet enough work done on health economics to help purchasers. So, digital health technology must be supported to be more agnostic of the means to the end for the same outcomes. Secondly, upstreaming and articulating the demand on the ground, a supplier and developer push onto markets, rather than pull, must be undertaken. This will result in adoption and access. Behavioural economics is important in this to support the awareness and empowerment of patients, too.

Marchetti noted the common interest in building something that could be very fast and effective. If it’s based on the availability of the clinical evidence, it is something that will be useful to transfer between different countries. “We are in a very enthusiastic season of the process, but there is much to be done in the next year,” he said.

Tarricone and Klucken also added final thoughts on the European situation, Tarricone commenting that harmonisation is dependent on jurisdictions and other stakeholders to work closely with the European Commission, with the EU, to make the harmonisation process within the MDR and NDHR. Otherwise, she said, there is risk of harmonising a third pole – which is not needed. It took 15 years with EUNECTA to get NDHR, she noted – a true harmonisation of assessment process – and what is not needed is another 15-year wait.

The APAC perspective

Anh Bourcet – founder of Health Access Solutions (HAS4P), strategic advisor at the Asia Pacific Medical Technology Association (APACMed), and VP of healthcare & Middle East Africa at Stratence Partners – and Roberta Sarno – director of APAC Liver Disease Alliance, advisor to APACMed, and founder of and global health advisor for D-Health Consulting – were joined virtually by Dr Chaemin Shin and Dr Izzuna Mudla Mohamed Ghazali to discuss the current landscape in the APAC region.

In APAC, there is a lack of a specific fit-for-purpose framework to assess value, and coverage is fragmented across countries and solutions. Evidence generation requirements are also unclear. In fact, in most APAC countries, reimbursement is very new, and the patient voice needs to be better incorporated into the policy development framework. Such countries as Japan, Australia, and Singapore lack this framework, so, technologies are funded through a mix of private, public, and out of pocket mechanisms. This is the environment in which APACMed is trying to create a new space.

Dr Shin presented the innovative health technology policy in Korea. In March 2023, the Korean Government officially announced private investment and tax support to foster biohealth and increased government R&D in this area. HTA assessment (nHTA) has been continuously improved as well, Dr Shin said, deciding upon reimbursement and non-reimbursement items. Looking for simultaneous decision through improvements of processes, value-based assessment for innovative technologies, is a new pathway for these to enter the clinical field. This will take 120 days, and after approval, side effects must be reported and evidence accumulated for a period of three years. In 2023, integrated assessment for AI and DTx began.

In comparison with DiGA, Korea’s framework allows three years of use, after which there is reassessment of safety and effectiveness. Patient consent will be mandatory.

APAC in comparison with the US

Dr Ghazali provided the Malaysian perspective. With a multimedia ‘super corridor’ introduced in 1996, there was a digitalisation national policy of science, technology, and innovation, and a national integrated offsetting roadmap – yet, there were hiccups along the way, she said. The first paperless hospital was introduced in 2000, and a Malaysian health data warehouse in 2017. It is a matter of health and digital literacy though. Therefore, in 2021, the government introduced a national digital economy and 4IR policy/council.

Internet within even rural areas is, of course, crucial. The prioritisation of this has been clear: empower, integrate, and include sustainable and secure digital services. Again, as in other countries, evidence gathering and demonstration have been a challenge – and evidence is important for commercialisation and adoption.

Compared with the US, Bourcet stated that Asia Pacific is still behind because it consists of 60+ countries with very diverse health systems and reimbursement and funding pathways. The Philippines, for example, only started talking about universal healthcare in 2010. In terms of prioritisation and budget allocation, it is quite disparate. In terms of reimbursement, it can be categorised in three ways: fully reimbursed (Japan, Taiwan, Korea, and Australia); then, high out-of-pocket like the Philippines, with limited coverage, and restricted coverage as seen in Singapore; in the middle is the mixed market – China, with a culture of high out-of-pocket, yet, there is reimbursement. In terms of infrastructure and value recognition of digital technologies, APAC is still in its infancy.

Nonetheless, Bourcet said, there are opportunities, despite challenges. It is an attractive region to consider, due in part to the unmet need, ameliorating standard of and access to care. Encouraging policies and building ecosystems to accelerate the implementation is crucial, though. Up to 2019, telemedicine was a taboo topic in Korea, however – there is, in other words, hope enough yet.

The test case of the United States

Andy Molnar, CEO of the DTA, and Marty Culjat, SVP global head of digital medicine & regulatory innovation at EVERSANA, provided the US example. To begin with, there was a recorded interview between Molnar and Aubrey Shick, senior digital advisor for the FDA at CDRH’s Digital Health Center of Excellence.

Centring the conversation around regulatory challenges, Shick said one such issue is terminology – many want to know if their software product is a medical device, but the terminology doesn’t necessarily align. This impacts guidance and supporting materials for submission, she said. A great first step, therefore, is the Digital Health Policy Navigator, which helps with the understanding of a device. There’s also a digital health FAQs page, to know the unknowns; then, there’s the Q-submission and pre-submissions, she said.

The FDA takes a risk-based approach in general. Hip implants and pacemakers go through pre-market approval, and there is comprehensive review of safety and effectiveness. Two main ways to do this include, firstly, the first-of-its-kind product de novo pathway, or with a predicate the 5-10K pathway, talked about the most with traditional non-specifically digital health devices, for which there are the same mechanisms. Since 2017, on digital health and DTx products, Shick said the FDA has recognised at least six new categories of device software functions.

An international conference, Molnar asked about cooperations with other countries regarding assessment and Shick replied that collaborations with other countries are a priority and commitment, aligning to the questions asked and information sought, with many ongoing work groups operating in these topics. Additionally, Shick noted that understanding of the use of AI and ML is increasing within the remit of lifecycle considerations and pre-market condition recommendations.

Meanwhile, Culjat said that the FDA has been innovating in digital health for the past decade, adapting to rapidly changing times, and with new guidance documents in 2023 on handling change control and much activity around pharma’s working with digital tools. The number one challenge is trying to understand the kind of clinical evidence needed to go to the FDA, he said, and it is the same for DTx, the same for digital diagnostics – it’s not more, but what kind.

It is hard to have one guidance document to provide all the answers, and then there remain many questions about prognostics and diagnostics, what kind of pathway to choose, etc. There are challenges with change control plans that are more AI-focused, too. DTx are relatively simple from a tech standpoint, but Culjat’s take on all this is the defining of evidence requirements, and the importance of real-world data for supporting submissions. There are some suggestions for expanding label from real-world evidence, but not for approval.

There’s been a lot of interest from pharma for the companion app framework, he continued, essentially creating an option for including software on the drug label, instead of it being considered a combination product and Culjat mentioned that the DTA does an amazing job, the outlines of which are on their website, and for different markets at that. Indeed, he was buoyed by the efforts for harmonisation across Europe. On data portability, in general, the FDA likes to see data with demographics that match the US population, but more clarity is needed there, he said.

Molnar added that regulatory is step one, whereas reimbursement is fragmented in the US. Trying to change policy on a state level is a challenge because – for myriad reasons – it just isn’t streamlined.

In conclusion

Spreafico closed the Summit, saying that it had been the first time all these high-level institutions had come together to share country-level insights on how the scenario is unfolding and evolving, but doing so collaboratively. This is just the start of the journey, though, and one that must continue to be built together.

The Summit will return for Frontiers Health 2024.

About the author

Nicole Raleigh

Nicole Raleigh, Web Editor

Nicole Raleigh is pharmaphorum’s web editor. Transitioning to the healthcare sector in the last few years, she is an experienced media and communications professional who has worked in print and digital for over 18 years.

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