September 14, 2023

Digital Therapeutics: EFPIA recommendations for access to digital therapies in the EU

The Italian version of this article has been published on June 28, 2023 on, within our bi-monthly column “Digital impact in Life Sciences: Legal Corner”.

On June 2, the European Federation of Pharmaceutical Manufacturers & Associations (“EFPIA”) published a report on Improving access to digital therapeutics in Europe that contains an analysis of how widespread digital therapeutics (“DTx”) are in the European Union and the main obstacles to citizens having broad access to these new technologies, accompanied by a number of recommendations addressed to EU institutions and the Member States. The aim is to promote a structured approach to the regulation of DTx on the European market through rules that are as clear and harmonized as possible.

The use of digital therapies in the EU is still limited, despite the fact that the Covid-19 pandemic boosted the development and implementation of digital tools in the health sector and elsewhere. One of the main culprits is the lack of an adequate and uniform regulatory framework at the EU level, from the clinical and technological evaluation of digital therapies to their authorization and possible reimbursement by the health and insurance systems of the various countries. Very few Member States have regulated these aspects with regard to the DTx phenomenon, with Germany in the lead.

In any case, digital therapies do not lack a general regulatory frame of reference, as these technologies fall into the sphere of Software as Medical Devices, although their mechanism of action in some ways varies from those of more traditional SaMDs. That makes specific regulation at the EU level advisable, in particular with respect to their clinical and technological validation, and makes regulation at the national level advisable with respect to the reimbursability of these therapies.

What are DTx?

Digital therapeutics are evidence-based therapeutic interventions delivered through software designed to prevent, manage, alleviate, or treat a disorder or disease; often, their mechanisms of action are designed to modify a patient’s dysfunctional behavior and improve disease outcomes, on the assumption that there is a close relationship between thoughts, emotions, and behavior. They are used to treat issues such as anxiety and depression, insomnia, migraines, obesity, and diabetes.

Although they are part of the broader context of digital health technologies, they differ from traditional health and wellness apps (e.g., apps promoting healthy lifestyles or for monitoring and measuring vital signs) due to their therapeutic function, as demonstrated in clinical studies. From a regulatory point of view, DTx are qualifiable as medical devices under the definition in Regulation (EU) 2017/745 (the Guidance issued in October 2019 by the Medical Device Coordination Group is particularly relevant for their classification), but their mechanism of action is often assimilated—with due distinctions—to that of drugs.

Like a drug, a DTx is composed of an active ingredient, though in this case it is not a chemical but instead is an algorithm specifically designed and tested to treat a disease. Similarly, digital inactive ingredients include functions that facilitate the administration of the therapy, from reminders to patient rewarding tools to remote assistance from healthcare personnel or even chatbots and virtual assistants.

DTx can provide standalone therapy (standalone DTx), or in combination with other therapies, including pharmacological ones (companion and combination DTx).

Needless to say, the implementation of artificial intelligence technologies finds fertile ground in this context. Indeed, a significant number of new applications appearing on the global market use AI to enable algorithms to learn and adapt therapies to the behavior a user manifests during the therapy itself.

DTx in Europe

As the EFPIA report shows, Germany is in the lead in this area both in the number of applications related to digital therapeutics currently authorized and reimbursed by German health insurers (40 as of January 2023), and for having equipped itself as of 2019 with a simplified procedure for the evaluation, approval, and reimbursability of such technologies, albeit limited to stand-alone therapies only.

There is a similar situation in Belgium, where since 2021 DTx can be reimbursed by the National Institute for Health and Disability Insurance, although as of January 2023 only one application had been reimbursed. France also adopted a procedure for the reimbursement of digital therapies in 2023. The French procedure allows temporary reimbursement (for one year) for certain types of DTx that may become permanent provided that milestones concerning the proof of clinical and/or organizational benefits are reached.

In Italy, on the other hand, ad hoc rules for the use of DTx are currently lacking. Since these are medical devices, the Ministry of Health oversees the matter, starting with issuing authorization for clinical investigation for the purposes of CE marking. Questions remain as to whether the AIFA or the Ministry of Health should oversee evaluation for the purposes of reimbursability.

To date, two digital therapies are being tested in Italy that have been given the green light by the Ministry of Health.[1] The first is KidneYou, an application developed by AstraZeneca and AdvicePharma for the treatment of CKD (chronic kidney disease) that delivers therapeutic intervention for the management of patients’ eating and exercise habits by constantly monitoring their health status.  The second is DTxO, a digital therapy for outpatient obesity management, developed by AdvicePharma with Theras Lifetech. It provides customized diet plans, advice, exercise programs, assessment programs, and cognitive-behavioral support, sometimes using gamification techniques.

Access to digital therapies and EFPIA recommendations

Digital therapies are trailblazers in the treatment of numerous pathologies (chronic diseases, neurological diseases, behavioral disorders, and the like) and can be used alongside traditional pharmacological therapies or as support for them. Their benefits can be manifold, in terms of both treatment effectiveness and delivering therapy to the patient, since the applications tend to be designed for direct use by patients. They also offer efficiency and cost savings for the healthcare system.

In this context, the EFPIA points to the lack of specific rules and procedures for market access in Europe for these technologies as the main obstacle to the dissemination of DTx in Europe. Such rules and procedures are harmonized as far as possible at the EU level. But there are issues along the way, from the clinical and technological evaluation phase through authorization and possible reimbursement by national healthcare systems and private insurance companies. This has created uncertainty for operators in the development and marketing of DTx in the various countries and a barrier to their dissemination on the European market.

Specifically, the four main obstacles identified by the EFPIA in its report are the following:

  • The lack of harmonization between the various national systems in terms of regulatory requirements for the authorization of DTx, in part due to differences in the interpretation of existing rules.
  • Uncertainty about the clinical evidence needed to demonstrate the value and effectiveness of digital therapies, including for the purposes of their reimbursability.
  • Lack of specific reimbursement pathways for digital therapies in different European countries.
  • Lack of adequate funding and policies to encourage the spread of DTx in Member States, so that they can be prescribed by doctors routinely.

The report also offers a number of recommendations (9) for EU institutions and individual Member States to eliminate barriers to market access for DTx. For instance, it recommends that the harmonization of the rules for scientific and technological assessment of digital therapies in the various Member States should be achieved by means of a flexible approach that takes into account the specific technology (starting with its rapid and constant evolution, which means the therapeutic software/algorithm is subject to frequent updates) and overcomes the existing disparities between the various national legislations, including in terms of the treatment of the data collected. Certainly the implementation of the new Regulation (EU) 2022/2282 on Health Technology Assessment procedures, applicable as of January 2025, marks a major step toward establishing DTx assessment criteria.

Furthermore, Member States should ensure early access pathways to DTx therapies, including when their experimental evaluation is pending. In addition to fostering dissemination and awareness of DTx among patients and healthcare professionals, this would enable the collection of data on standard administration of the therapy (i.e., real world data collected outside the experimental context). That data then could support clinical investigation activities aimed at marketing. A similar procedure already exists for medical devices, including under certain conditions (urgency, necessity, and unavailability of similar devices on the market) the use of medical devices without CE markings.[2] However, this is an exceptional procedure subject to very strict requirements.

Finally, EFPIA recommendations include the suggestion that Member States define separate reimbursement paths for DTx, whether they are stand-alone or used in combination with drugs (in the latter case, one possibility is a unitary reimbursement covering the cost of the drug and the digital therapy). It also recommends creating specific criteria for the prescription of treatments by medical personnel, as differentiated from therapies that can be provided to patients without the involvement of a doctor (similar to over-the-counter medicines). This should be accompanied by joint initiatives by the various stakeholders—institutions, healthcare personnel, associations, and companies—designed to promote awareness of these new tools and provide information on their correct use and their potential for effective and efficient treatment.

What are the prospects for DTx in Italy?

Italy currently has no regulation covering market access to and reimbursability of digital therapies; therefore, the general rules on medical devices should be consulted. Italian National Health Service procedures for pricing and reimbursement cover drugs only, and the AIFA is the relevant authority, while a tax deduction mechanism is provided for medical devices.

Nevertheless, public debate on DTx is increasing in Italy. On May 8, the Chamber of Deputies hosted a meeting on DTx and the opportunity they provide to grow and strengthen the National Health Service. It was attended by representatives from the world of research, institutions (Ministry of Health, AIFA, Agenas), associations, and companies in the sector. The occasion coincided with the foundation of the Observatory on Digital Therapies. The focus of the meeting was the need to accompany technological development of DTx with adequate regulation to allow effective development and diffusion in Italy and Europe. This bodes well for the earliest possible adoption of specific regulations on DTx at the national level.

[1] As reported during the meeting held at the Chamber of Deputies on May 8 on DTx as an opportunity for growth and strengthening of the National Health System.

[2] See Art. 59 of Regulation (EU) 2017/745 and, at the national level, Art. 11 of Legislative Decree 137/2022.

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