Agora Health and its partners are conducting a major study on the deployment of digital therapeutic devices (DTx) in France.

What is a DTx?

It refers to treatments delivered in digital format, which clinical efficacy has been scientifically validated (mobile applications, connected objects...).

What is not a DTx?

Well-being applications, remote monitoring applications, medical decision support software, or patient stratification software...

How is a DTx validated?

The same rigor is required in the design and development of these therapies as for any other type of medical device, including traceability in all stages of development, compliance with ISO standards, and conducting clinical trials to validate the results.

In summary, a DTx is a digital therapeutic intervention:

• that aims to prevent, manage or treat a medical disorder

• approved by notified bodies certifying the product's safety, efficacy, and intended use claims

• having demonstrated clinical evidence through RCT and/or real-world data

• that can be reimbursed by private insurers or health systems

In which diseases can a DTx be used?

DTx can address a wide range of diseases, including:

• Mental Disorders such as depression, anxiety, post-traumatic stress disorder (PTSD), and sleep disorders;

• Chronic Diseases such as diabetes, hypertension, asthma, and chronic obstructive pulmonary disease (COPD);

• Eating Disorders such as anorexia, bulimia, and binge eating disorder;

• Addictive Disorders such as alcohol consumption, smoking, and illicit substance use;

• Psychosomatic Disorders

What is the known clinical evidence of the effectiveness of DTx?

Several clinical studies have demonstrated the effectiveness of DTx in various diseases. Here are a few examples of existing publications:

• Mental health: Deprexis or HelloBetter apps have shown significant reduction of depressive and anxious symptoms in users.

• Hypertension: CureApp application showed clinical effectiveness on systolic blood pressure with a specific 12-week program.

• Type 2 diabetes: The One Drop mobile application was found effective in improving blood glucose, blood pressure, and body weight. Similarly, the BlueStar application showed significant improvements in glycemic control in users.

• Sleep disorders: The Sleepio application has demonstrated its effectiveness in improving sleep quality and reducing symptoms of insomnia in users.

Who reimburses DTx?

Germany was one of the first countries to launch a reimbursement modality exclusively for digital therapies, called DiGA. These applications are reimbursed if they meet certain criteria (CE marking, no intervention by a doctor, evidence of clinical efficacy, information security requirements) following a prescription by a doctor. About fifty DTx are reimbursed in this context.

The United States has also reimbursed digital applications under relatively similar constraints.

Belgium also offers reimbursement with a three-level pyramid (m-health).

France is now launching their own pathway for digital therapies reimbursement through the PECAN program.

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