How to get your digital
therapeutic (DTx) reimbursed
in Europe?
Contents
Have you developed a digital therapeutic and wonder how to reimburse it in European countries? You may have already heard about the German DiGA, but many other countries are also taking steps to introduce similar systems. Which countries are these? What requirements do they have? That's what today's text is about.
TL;DR
Digital therapeutics are increasingly common technologies that support many people's lives. However, they require legal solutions to become introduced into national markets. In our article, we discuss what countries like Germany, France, Belgium, Switzerland, the UK, and Poland are doing to introduce DTx-related reimbursement solutions.
From the text, you will learn about the differences between countries’ laws and the general challenges (such as the lack of clear regulations across Europe or the lack of any regulation in some countries) that you will have to face if you want to get your DTx reimbursed.
What are digital therapeutics (DTx)?
Before discussing the digital therapeutics (DTx) definition, we need to talk about the differences between digital health and digital medicine.
Digital health covers a wide range of healthcare-related technologies. These include software, hardware, telemedicine, wearable devices, and more. Think about it as an “umbrella term” for new technologies in healthcare.
Digital medicine is related to medical care technologies used “for measurement and intervention in the service of human health” (Digital Medicine Society). They are mainly used for diagnostics and monitoring (EFPIA).
Digital therapeutics (DTx) are “health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health” (DTxAlliance). They are designed to the highest quality standards and must be CE-certified (comply with MDR).
Some examples of DTx are:
Helpilepsy – an app to support patients with epilepsy through educational material and exercises.
ABAStroke – a digital health mobile app for neurological treatment of post-stroke cognitive deficits.
So, how to memorise the difference between digital health, digital medicine, and digital therapeutics? Think about them as presented below.
What are the benefits of digital therapeutics?
DTxs are attracting the interest of more and more healthcare professionals, patients, governments and developers for a good reason. These technologies bring numerous benefits to patient health and improve doctors' work.
Among the benefits of DTx are:
reduction of barriers to disease support (e.g., the possibility of helping people in remote places of residence)
freedom to use DTx from home equipment (smartphone, tablet)
ease of regular monitoring of the patient's health
individualisation of the patient's treatment (exercises, techniques)
Of course, there are many more benefits of DTx, but it's a topic for another article.
DTx and need for regulations
With the COVID-19 pandemic, there has been an expansion of digital health – both in terms of communication with doctors and support in the treatment of patients. Some statistics? The DTx market is forecast to be worth 56 billion dollars by 2025.
Due to the emergence of newer technologies and their widespread use, regulations are necessary to force DTx developers to offer the highest quality of services.
In addition, many countries around the world offer reimbursement for medicine. With the development of digital health, countries’ authorities decided to include DTx among the reimbursable medicines. It allows more people to access the latest solutions for healthcare assistance. As a result, the concept of DTx on prescription emerged.
How are digital therapeutics reimbursed in Europe?
So, what is the reimbursement situation for digital therapeutics in Europe? Below you will find information on countries such as Germany, France, Switzerland, Belgium, the UK, Poland and Austria.
DiGA – a precursor for DTx reimbursement
The first-ever solution for DTx reimbursement is the German DiGA (Digitale Gesundheitsanwendungen). By going through an assessment process, a medical application that meets several requirements can be included in the DiGA Directory and be prescribed to patients.
The requirements for DTx reimbursement in Germany are extensive. Among them are:
positive care effect for patients proven through clinical trials
certification according to MDR or MDD
data security following GDPR (General Data Protection Regulation)
and others, which we describe in detail in the article about DiGA.
What’s more, in Germany, reimbursement for digital nursing applications (DiPA), which doesn’t have to be a medical device and undergo the MDR process, is possible.
PECAN – digital health reimbursement in France
PECAN (Prise en Charge Anticipée Numérique) is a French equivalent to the German DiGA Fast Track, approved on 31st of March 2023 through a decree. It is a fast-track pathway that allows companies to get their DTx reimbursed for a year. After that, applying for a regular pathway of getting DTx is necessary – but we will return to that later.
What digital medicine can be reimbursed in PECAN?
Among digital medicines which can be reimbursed in France are therapeutic applications (DTx) and remote medical monitoring activities (such as telemonitoring solutions). Interestingly, they can be classified as MDR Class I, Class IIa, Class IIb, or Class III.
In Germany, those apps are named "DiGA"; however, in France, they are referred to as "DMD" (Digital Medical Device).
Where can you find apps reimbursed through PECAN?
You can check out the list of DMDs the French Health Insurance Fund covers on the List of Products and Services (LPP).
As we read on the French Ministry of Health and Prevention website, on LPP you can find out about "medical devices intended for the diagnosis and treatment of diseases and injuries, assistive devices for daily living, dietary foods, external prostheses, implantable medical devices, digital medical devices".
What are the requirements for PECAN?
As already mentioned, the app must be CE-certified and therefore, according to the MDR, belong to Class I, Class IIa, Class IIb, or Class III.
Your app should be innovative – which means it should resolve healthcare issues with the newest solutions.
You must indicate a clinical benefit and/or organisational benefits of your app. However, when going through fast-track assessment, you have a year to show evidence of clinical trials.
The app must ensure patient data security in compliance with GDPR. What’s more, there is a need to maintain high cyber security standards.
Like DiGA, it must comply with interoperability requirements.
If you want to apply for fast-track, your app must be reimbursed in France for the first time.
Remember
It is worth remembering that personal health data can only be hosted by a cloud service with the French Health Data Hosting (HDS) certificate.
You will find a checklist if you are eligible for the reimbursement here.
PECAN – Fast Track and Standard Path
If you decide to go through fast-track (PECAN) in France, you can get a temporary (one- year) reimbursement for your DTx, which cannot be renewed. So why is it even worth the interest? PECAN allows you to place your app on the LPP reasonably quickly. In addition, you can apply for DTx reimbursement while you are in clinical trials.
After one year, you will have to go through a process called 'Standard Path' where you can permanently apply for reimbursement of your DTx.
How to get DTx reimbursed in Switzerland?
In Switzerland, DTx reimbursement is regulated by compulsory health insurance (OKP). It’s important to remember that when you look for information on DTx reimbursement, you will most likely find information only on “medical devices”. As in their law, they don’t use “DTx” wording.
What regulates medical devices in Switzerland?
Medical devices in Switzerland are regulated by:
the Therapeutic Products Act
the Medical Devices Ordinance
the Ordinance on In Vitro Diagnostic Medical Devices
the Human Research Act
the Ordinance on Clinical Trials with Medical Devices
If you plan on selling your DTx in Switzerland, we highly recommend reading the above acts and ordinances.
What are the Swiss requirements for getting DTx reimbursed in Switzerland?
There are two main requirements that DTx must meet to be reimbursed in Switzerland.
It must be CE-certified according to MDR.
It must meet criteria (so-called WZW) of:
a) Effectiveness (Wirksamkeit) – medical effect and medical benefits of the DTx.
b) Appropriateness (Zweckmässigkeit) – ability to fulfil its purpose.
c) Cost-effectiveness (Wirtschaftlichkeit) – economic aspect; price and funding DTx by the health system.
However, in the Therapeutic Products Act (TPA), you can read that a medical device will also be checked in terms of safety and quality management, and there will be a need for clinical trials which should be conducted in compliance with the Ordinance on Clinical Trials with Medical Devices.
After this process, FOPH (Federal Office of Public Health) decides to accept (or not) your DTx. Then, your app can become reimbursable in Switzerland. However, you should be aware that it usually takes about 650 days to make your app available to Swiss patients.
What is Swiss MiGeL?
Once your DTx is up to become reimbursable, it will be listed in MiGeL. MiGeL (Mittel und Gegenständeliste) – The List of Remedies and Equipment – is a document in which you can find information on devices covered by the OKP in Switzerland. In MiGeL, you can check out particular medical devices, including their reimbursement prices.
