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.

Digital-health-levels-by-Revolve-Healthcare.webp.webp

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:

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). There are already DTx available in PECAN program. One of them is Cureety – an app supporting cancer patients care.

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?

  1. 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.

  2. Your app should be innovative – which means it should resolve healthcare issues with the newest solutions.

  3. 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.

  4. The app must ensure patient data security in compliance with GDPR. What’s more, there is a need to maintain high cyber security standards.

  5. Like DiGA, it must comply with interoperability requirements.

  6. 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.

  1. It must be CE-certified according to MDR.

  2. 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.

mHealth – Belgian DTx reimbursement system

mHealth Belgium (mobile health Belgium) is an initiative of the Belgian Federal Government, which has been active since the 25th of January 2019. It allows companies which developed CE-marked medical devices to have their DTx reimbursed in Belgium.

What is the mHealth pyramid?

When you read about mHealth Belgium, you might come across the words "mHealth pyramid". Why? Let us explain.

The Belgian mHealth reimbursement scheme consists of a three-level validation process presented in a pyramid graphic form. Hence, the name. You might wonder what happens during the mHealth assessment?

  1. The first level (M1) requires a manufacturer to provide a CE-marked app which complies with GDPR. FAMHP (Federal Agency for Medicines and Health Products) will check if the app complies with the regulations during this level.

  2. The second level (M2) is when the risk assessment happens. What does it mean? Your app will be checked in terms of data security and interoperability. You can read more about this process in the criteria description provided by the Belgian government.

  3. On the third level (M3), companies should provide clinical evidence and socio-economic value. The third level is divided into two categories.

    1. Level 3 light – an app is proving its socio-economic value and being temporarily financed by NIHDI (National Institute for Health and Disability Insurance).

    2. Level 3 plus – an app has proved its socio-economic value and is fully financed by NIHDI.

From: mheathbelgium.be

What kind of DTx can be reimbursed in Belgium?

In Belgium, software apps with a medical purpose which are CE-certified as a medical device of any class (I, IIa, IIb, III) and “allow a patient to share from his/her environment health-related information with a healthcare professional” can be reimbursed.

Where will I find apps reimbursed through mHealth Belgium?

You can find apps reimbursed in Belgium and those in the assessment process on the mHealth website. You will be able to read about DTx (its purpose, target audience, financing model, and more) and check its current level of assessment. 

DTx reimbursement in the United Kingdom

The UK is changing the reimbursement of DTx law (e.g., in terms of the required certification of medical devices); however, they already have a structured system for recommending DTx to doctors and patients.

What are DTx in the UK?

In British regulations, you will find DTx under the name “digital health technologies” (DHT), which NICE (National Institute for Health and Care Excellence) has categorised into three groups:

  1. Tier A – “DHTs intended to save costs or release staff time, no direct patients, health or care outcomes” (e.g., system service for improving staff efficiency).

  2. Tier B – “DHTs for helping citizens and patients manage their health and wellness” (e.g., apps for communicating about health or promoting good health).

  3. Tier C – “DHTs for treating and diagnosing medical conditions or guiding care choices” (e.g., diagnosing or treating a condition) (source: NICE).

In the table below, you can see groups of DHT belonging to particular tiers (source: NICE). 

DTx-in-the-UK-by-Revolve-Healthcare.webp

Where can I find DTx available in the UK?

There used to be an NHS App Library, but it was closed in 2021. Nowadays, you can find information about apps recommended to doctors and patients in an NHS App.

What are the requirements for DTx reimbursement in the UK?

  1. It must be CE-certified (according to the MDR) or UKCA (UK Conformity Assessed) marked.


    What is UKCA? It’s a mark which will eventually replace CE certification in England, Scotland, and Wales. Its requirements include QMS (quality management system) and compliance with ISO 13485, IEC 62394, and IEC 62366.

  2. DHT must pass DTAC (Digital Technology Assessment Criteria for Health and Social Care) regarding:

    1. clinical safety,

    2. data protection,

    3. technical security,

    4. interoperability,

    5. accessibility, 

    6. usability.

    You can find more information on DTAC and the questionnaire for app developers on the NHS website.

  3. Ultimately, your DHT must be considered of value to the UK health and social care system by NICE. This recommendation goes paired with the Evidence standards framework (ESF), which you should read at some point when developing a DTx for the British market.

Warning!

Bear in mind that the UK will be using only UKCA marking in the future. The CE marking will be available until the end of June 2030. After that, your DTx in the UK will have to be UKCA-marked.

It’s worth remembering that not all standards must be met by the particular DHT. For example, Tier A DHT doesn’t need to show a process for creating reliable health information. On the other hand, only Tier C DHT must provide evidence of the DHT’s effectiveness to support its claimed benefits. 

Once you pass this process, NICE will recommend your DTx to general practitioners as safe to prescribe to patients. Also, it means that this DTx is possible to get reimbursement. However, reimbursement in the United Kingdom only happens in local NHS organisations.

Can DTx be reimbursed in Poland?

In Poland, the opportunity to submit applications for evaluation has been made available in March 2023. Nowadays, medical apps can be awarded the Ministry of Health Certified Application title and placed in the Health Application Portfolio (Portfel Aplikacji Zdrowotnych – PAZ).

The first call will last until 31st March 2025, but the Ministry website states that the total call will be indefinite.

Applications submitted to the PAZ should:

  • be qualified as a medical device,

  • support the patient in the "home environment", e.g., by monitoring the state of health or supporting the implementation of medical recommendations (it is worth remembering that the application is supposed to support the patient, not the doctor),

  • have a Polish language version of the application (although an English version is also acceptable).

Submitted applications will be assessed in terms of their content and data security. As in the case of other similar regulations – it is necessary to ensure the highest quality of the app.

Will DTx be reimbursed in Poland? 

Unfortunately, we don’t have an unequivocal answer at this point. The Polish Ministry of Health is considering this possibility but makes this dependent on the reception of the PAZ pilot.

TIP

You can check out apps available in PAZ here.

What does the future of reimbursed DTx look like in Austria, Portugal, Finland, and Denmark?

DTx reimbursement in Austria

On 1st June 2023, the Digital Austria Act (DAA) was introduced in Austria, which contains 36 digitisation principles to improve Austria on numerous levels. One of them is digital health.

Regarding digital health, the act's primary focus is ensuring the highest level of security for patient data. The act also mentions that "digital health applications should be made possible in collaboration with social insurance and complement telemedical care".

How will the Austrian case develop? We have little information, but it is a country worth watching. The introduction of DTx reimbursement may be followed up shortly.

DTx reimbursement in Portugal 

Portugal does not currently have a reimbursement model for DTx. However, a white paper prepared by LabToMarket states that a DiGA-like model will be needed in the future as a part of the digitalisation of the healthcare system.

We encourage you to read this white paper as the authors list the challenges that Portuguese law-makers will face when developing a reimbursement model for DTx and propose solutions to them, such as fostering collaboration among healthcare stakeholders.

DTx reimbursement in Finland

By many experts (R2G, Binariks) on DTx reimbursement, Finland is described as a country which will soon follow Germany, France, and others in developing digital health regulations. Some researchers from Finland propose what such law might look like; however, at this point, there is no specific information on this topic.

DTx reimbursement in Denmark

Similarly to Finland, there is not much information on DTx regulation in Denmark. Some researchers (Fürstenau et al.) claim that Denmark plans on developing such law. Yet, we can't say much about their goals.

DTx reimbursement in other European countries

In addition to the European countries we described in the article, others are also taking steps to regulate digital therapeutics. These are not concrete, so for the moment, we can only say that the Netherlands or Italy are also taking steps towards DTx regulations. However, we can safely assume that more countries will follow Germany in the coming years.

Comparison-of-DiGAs-by-Revolve-Healthcare

What do we do in the area of DTx?

If you want to create a DTx which will comply with regulatory requirements in one of the European countries, you might need some support. At Revolve Healthcare, we have several specialists in the Regulatory Affairs Team who can help you through all the necessary procedures. If you would like to learn more about what we do, we encourage you to read the case study of ABAStroke, a company whose product has been recognised as a DiGA in Germany.

DTx reimbursement common requirements

As you can see, there are some commonalities in the requirements of each country. Below, you will find a list of numerous similarities.

  1. CE certification according to MDR

    One of the most common requirements for DTx is CE certification in compliance with MDR. Moreover, you should follow medical standards according to IEC 62304 and IEC 62366, which will help ensure the highest quality of DTx.

    IEC 62304 specifies the lifecycle requirements for medical software and software in medical devices. IEC 62366, on the other hand, helps to reduce the risks associated with operating errors. Both can be used as a “rule book” when developing DTx.

  2. Data protection

    One of the essential requirements for obtaining reimbursement in the various European countries is to ensure the highest quality of data protection. You will have to put much effort into protecting the personal data of patients who use DTx. Compliance with GDPR (in the case of the European Union) is needed.

    However, some countries will require compliance with additional regulations, such as ISO 27001 or their inside data protection law (e.g., French HDS certificate).

  3. Clinical evidence

    At some stage in introducing your product to particular markets, it will be necessary to present clinical evidence in the form of clinical trials or clinical studies. Therefore, please do not wait to carry out such research!

  4. Highest quality and innovativeness

    A DTx, to be reimbursed in a European country, should be innovative and of the highest quality. This “highest quality” should manifest itself in every area of your activities – the use of the application, the results it delivers or the security of patient data. Thus, it would help if you thought about the Quality Management System in your company.

Challenges in getting DTx to be reimbursed in the European countries

There are many challenges which you might face when trying to get your DTx to be reimbursed in one of the European countries. What are some of them?

  1. Lack of a single, consistent regulation for the entire EU

    The biggest issue is a lack of one directive for all EU countries. Of course, there are some common regulations (such as MDR), but there is a lack of a single, clear law for the reimbursement of DTx in Europe. 

    Many countries are now creating regulations; however, their requirements vary. Therefore, companies developing DTx must adapt to the multitude of requirements.

  2. Lack of regulation in some countries

    Unfortunately, although many governments are attempting to create appropriate regulations, it’s still in the plans in some countries. It means that you have to wait patiently for the possibility of introducing your DTx in some countries. For how long? It’s hard to assume.

  3. Need of education doctors and patients

    Some doctors and patients may be sceptical about the use of digital therapeutics. It is a barrier your company will face regardless of the country in which it tries to undertake sales. Thus, it would help if you put some effort into educating the community about using DTx.

  4. Promotion and sales challenges

    And, speaking of sales, you must consider appropriate sales tactics and promotions, e.g., door-to-door sales work best in Germany. However, in other countries, you might have to use different sales methods.

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