These past decades, the world has witnessed the emergence of social media platforms, smartphones, mobile applications and wearable devices. As a consequence, general well-being and health monitoring gradually moved from activities restricted to the doctor’s office to the widespread digital world through smartphone applications, by fitting together healthcare and technology.

In this context, a new category of medicine, digital therapeutics (DTx), has emerged and delivers evidence-backed treatment through software to combat various conditions, including diabetes, chronic pain, depression and anxiety.

Several European countries such as France and Belgium are in the process of evaluating the use and regulation of digital therapeutics, with Germany spearheading these advances, as it has created a pathway named DiGA for doctors to prescribe digital therapeutics to publicly-insured patients and receive reimbursement in the same way as a traditional treatment.

The purpose of this article is to shed light on what a digital therapy is and to learn more about the process in Germany that made prescription DTx so widely available to a high percentage of the population, catapulting the country to global leaders in digital therapeutics regulation.

‍

‍

A digital viagra ?

Erectile dysfunction affects about a third of men today. When drugs such as Viagra hit the market in 1998, many thought it was the long-awaited answer to their problems. However, this drug can be harmful to men with heart diseases and only fixes symptoms, without healing the underlying condition.

On this observation, German app Kranus Health took a crazy gamble : harmless viagra, available on your phone.

Thanks to a digital app, Kranus Edera offers a holistic approach for treating erectile dysfunction. Every element in the app is based on scientific evidence and is tailored to the user and his fitness level. The treatment is based on digital coaching that comprises a 12-week therapy consisting of pelvic floor training, physical therapy exercises, cardiovascular endurance training, mindfulness and body awareness exercises. In addition, patients receive daily background knowledge to improve their understanding of the underlying principles of erectile function and the influence of lifestyle factors, such as nutrition or stress.

It is currently prescribed by practitioners in Germany and used by thousands of men as a treatment against this well-known and poorly treated pathology.

Indeed, as explained by the founder and co-CEO, Thilo Kleinschmidt: “At Kranus Health, we break taboos and solve men’s health issues that no one talks about.”

Another example of DTx is 'HelloBetter Stress and Burnout', a digital health intervention for the treatment of stress, exhaustion, insomnia and depression.

The web application is the only digital therapeutic for treating burnout. It also has an optional companion app, based on Cognitive Behavioural Therapy (CBT). It offers digital burnout therapy online. Psychologists guide patients through the therapy course, providing support and feedback.

In a three-month program, patients learn how to reduce stress levels through mindfulness techniques, behavioral activation and psycho-education, which refers to the process of providing education and information on mental health issues.

These two examples show that digital therapeutics are progressively becoming essential to healthcare delivery systems, as they provide multiples advantages to care by:

• Delivering therapies using smartphones and tablets
• Increasing patient access to clinically safe and effective therapies
• Lowering stigma associated with the delivery of certain traditional therapies by offering at-home convenience and privacy
• Providing meaningful results and insights on personalized goals and outcomes to patients and their clinicians

It should be noted that both these apps have been prescribed by primary care physicians a thousand times, and reimbursed from the moment they came out, thanks to the digital healthcare act in Germany, and their classification as DIGAs.

‍

But, what are DIGAs, the german DTx ?

According to the Federal Institute for Drugs and Medical Devices (BfArM),  an independent federal higher authority within the portfolio of the Federal Ministry of Health, a DiGA (Digitale Gesundheitsanwendungen or digital health application) is a medical device that has the following characteristics:

• Medical device of risk class I or IIa  (Xavier M mentions it in his article: Comprendre la classification des dispositifs médicaux)
• Supports the recognition, monitoring, treatment or alleviation of diseases, injuries or disabilities
• Its main function is based on digital technologies
• The DiGA is used only by the patient; or by the patient and the healthcare provider together

These “apps on prescription” were introduced by The Digital Healthcare Act in Germany that came into effect on December 19th 2019. Thanks to it, around 90% of the german population is entitled to healthcare through digital health applications.

These applications can be prescribed by physicians and psychotherapists and are reimbursed by health insurers.

Some examples below allow us to differentiate between what is a DiGA and what is not:

‍

‍

How is Germany bringing DTx to the market in 3 months, when a new drug takes a few years ?

In order for an application to be considered as a DiGA and become reimbursable, it has to complete an assessment of the BfArm in order to examine product quality :

• Data protection
• Performance
• User friendliness
• Evidence of positive effects on health through trials with patients (30 to 50 patients for preliminary approval)

‍

‍

‍

The German procedure (DiGA Fast track) allows a company to have its solution assessed in just three months, during which BfArM offers consulting, guidance and support, to make the process as convenient as possible for the manufacturers and to ensure there is sufficient evidence for a successful application process. Then, the digital therapy receives preliminary approval for commercialization over the following 12 months (data with only 30 to 50 patients suffices). During this one-year period, the company must compile definitive evidence of the solution’s efficacy in order to be permanently listed in the DiGA directory. Once approved, price negotiations will be made separately between the manufacturers and the statutory health insurance.

‍

‍

This is the fastest assessment done in Europe today, compared to other europeans countries (such as France for instance) that take 6 months in average to attain CE-labelling of medical device.

‍

Market access

The DiGA legislation provides different pricing mechanisms:

• During the first year after the inclusion in the directory, manufacturers are free to determine their sales price and pricing model
• From the beginning of the 13th month, the price is replaced by a price agreed upon by the manufacturer and the GKV-SV (German National Association of Statutory Health Insurance Funds ) in joint negotiations.

The average price of permanently listed DiGA is €396 and €493 for conditionally listed DiGA per prescription period, which usually covers 90 days.

By mid-year 2022, DiGA prescriptions have risen to 62,000, compared with approximately 45,000 in all of 2021. Hence, the corresponding DiGA market size in 2022 is about 30 million € and still growing in the years to come. Hence, we can see that

‍

DiGAs today

‍

Only 4% of physicians have prescribed a DiGA as of early 2022. Indeed, the potential of a solution to be removed from the DiGA directory may be limiting physicians trust to prescribe it. Another challenge is physician awareness of digital health solutions. After months of heavy public discussions around DiGA, 53% of physicians still did not know what a DiGA was.

‍

Conclusion

The DiGA initiative in Germany allows doctors to prescribe apps to the 73 million citizens covered by public health, with costs reimbursed through health insurance. The fast track process aims to ease the path for rapid approval, testing and market access of health apps.

In October 2021, French president Emmanuel Macron has announced plans to follow in Germany’s footsteps by making digital therapeutics available on prescription through the statutory health system : “I'm very direct: we will only replicate what works in Germany.”

However, as we have seen above, DiGAs still face challenges in adoption as only a small percentage of physicians prescribes them.

Hence, the endgame question one should be asking is : What makes doctors prescribe it and patients use it?

‍