Deprexis is a digital therapy that failed to be commercialized in France. More specifically, it is an online intervention software prescribed to depressed patients as a complement to usual care. Belonging to the class of products known as DTx (digitally delivered therapeutic treatments that are scientifically validated), Deprexis is marketed in the United States, Germany, and Switzerland. In the United States, it is offered by healthcare professionals working in federal healthcare facilities and public establishments. In Germany, Deprexis has been recognized, reimbursed, and adopted within national frameworks as a valuable digital therapeutic intervention to help manage depression. The application has been particularly noted for its use by patients with comorbid conditions such as epilepsy and multiple sclerosis, demonstrating its ability to improve depressive symptoms and quality of life for these patients. In the United Kingdom, Deprexis was evaluated and recommended by NICE (National Institute for Health and Care Excellence) in 2023 for the treatment of adult patients suffering from depression.

Denise Silber from Basil Strategies interviewed Aurore Gérigné, former Commercial Director of Ethypharm Digital Therapy, who had acquired the rights to Deprexis in France, so that we could better understand what happened.

Q1: Aurore, thank you for taking the time to answer our questions. When did you join the Deprexis team and what was the status of the product at that time?

I was working at the time at Ethypharm as the Strategic Marketing Director for the Group. In this capacity, we were looking for innovation levers to expand the product portfolio and became interested in digital therapies. In 2020, there was real excitement around these new therapies, and we chose Deprexis because it was the only solution that had already been clinically validated with 12 randomized clinical trials (RCTs). The product was already available in Germany, and we acquired the rights for France, the United Kingdom, Spain, and Italy.

Q2: How did Ethypharm, as the company holding the product license in France, prepare for the launch? Were you all very enthusiastic about Deprexis and the innovation it was supposed to bring?

To put it in the context of 2021, we were just coming out of COVID, and the Deprexis solution addressed major needs for mental health. Political speeches, especially during the French Mental Health Conference (Assises de la Santé mentale) of September 2021, highlighted the alarming state of access to mental health care and the urgent need for new solutions.

With our pharma industry experience, our ambition was to obtain reimbursement for Deprexis as a Class 1 Medical Device. This is what we attempted, first through a request to the French program called PECT (Temporary Coverage) and then through a common law coverage request for inclusion in the list of reimbursable products and services (LPPR) in France.

In parallel with these activities, we presented the solution to psychiatrists and developed our promotional activities to increase the product’s visibility.

Q3: What feedback did you receive from French physicians and patients who had the opportunity to try the product?

Psychiatrists were very interested in this solution, particularly for clinics and in private practice. Insufficient access to psychiatric care is a challenge that Deprexis could address by offering new care options. Some physicians did not wait for reimbursement to offer Deprexis to their patients, as it was available on a non-reimbursed basis.

The general practitioner is on the front line in mental health care; they produce 80% of depression diagnoses. Our plan was also to present the solution to them, but in a second phase, as we were limited by our human resources.

The feedback we received was very encouraging to us. Patients appreciated the personalization of the tool, and caregivers highlighted the patient empowerment capability of Deprexis, an essential characteristic in the treatment of depression. We also conducted an acceptability study with 250 French patients to understand more deeply the factors that could encourage the uptake this type of solution.

Q4: What happened along the way to commercialization? Was there an efficacy issue for the French authorities? Did they consider that the product had been launched elsewhere?

In September 2022, after a first refusal and a hearing, the French High Health Authority (HAS) issued a favorable opinion for reimbursement with a sufficient “Expected Service” (SA), recognizing a benefit for adult patients suffering from mild to major depressive episodes, as a complement to conventional care. However, they noted that an improvement of the “Expected Service” (ASA) would be important, considering that the study biases limited the scope of their conclusions.

The necessary evaluation was conducted by Cnedimts (the National Evaluation Commission for Devices and New Technologies) based on the clinical studies submitted in the application file. Ethypharm also indicated that the German DIGA (virtual medical products that are available as apps for mobile devices or as browser applications) framework reimbursed the therapy and that NICE in the UK had just published a recommendation in favor of Deprexis, after evaluating several digital solutions.

However the French institutions (HAS, DGS, and DSS) did not accept to proceed with the reimbursement of Deprexis, considering that it could not provide an economic benefit, given its level of “Expected Service” or ASA V, which signifies absence of improvement.

Q5: What was the impact of the economic aspect of the story?

Having found that a non-reimbursed offer was not economically viable, but noting that mental health costs were very high and had exploded since the health crisis, we approached private psychiatric clinics and mutual insurance companies. The discussions were rich given the need to propose innovative solutions, and we had started several partnership projects. At the same time, Deprexis was launched in England. The product was developing well, and we had already signed several contracts with local NHS entities. Unfortunately, deploying a digital therapy in several countries simultaneously requires a significant amount of time and investment, and our revenues were not sufficient. Being 100% funded by the Ethypharm group, the strategic decision was finally made at the end of 2023 to cease our digital product operations.

Q6: How could the situation have evolved differently?

It is of course a difficult question. Today, we see encouraging signs aimed at integrating digital technology into the healthcare offer. Market access issues, however, remain at the heart of the concerns of digital health actors. Even if initiatives are emerging to allow coverage, such as the PECAN program or “Early Access to Digital Therapies”, the time required remains a challenge. Proposing and implementing a regulatory and financial framework for digital therapies is a very long process, and digital companies do not usually have the financial means to wait. The financing of companies is key to the development and sustainability of the sector; yet every week, a digital health startup goes out of business.

Digital therapies, like remote monitoring, are at the heart of the transformation of healthcare management, and these digital applications can help treat, prevent, or manage a disease. They therefore have a strong economic impact on the healthcare system, and their successful deployment is a public health issue.

Q7: What lessons do you take away from this experience?

Living such an entrepreneurial adventure is both exhilarating and a source of learning. We began our efforts in a context where mental health needs and digital health were omnipresent in the media and in political speeches. So we thought we were going to be welcomed with open arms! However, we underestimated the need for education inside the public authorities and administrations, and even some of the physician societies. Presenting, explaining, reassuring, and convincing them about the expected benefits of digital solutions is paramount.

Next, the need for training healthcare professionals on digital projects has become indispensable. We must accelerate this in order to accelerate usage and prescription by healthcare professionals and the healthcare system, given that more and more digital tools will be needed to prepare the future of healthcare.

Finally, we have found that the creation of value for a DTx does not rely solely on its technology but on the data it generates. This is a very new concept compared to “classical” pharmaceuticals, and especially for the authorities in their evaluation of medical devices. Thus, the commercialization of a digital therapy must be considered in its entirety, including the use of the data, without which digital health cannot develop. It is a new paradigm for the entire healthcare ecosystem!

Thanks Aurore Gérigné for taking the time to provide this information!

Denise Silber