High prices despite a lack of proven efficacy

Study by FAU researchers about digital health applications

Whether it’s for a smartphone, tablet or as a web-based application on a PC: Physicians in Germany have been able to prescribe something known as digital health applications (“digitale Gesundheitsanwendungen – DiGA”) for more than four years now. However, since their introduction, DiGA, which are supposed to improve healthcare provision, have often been the source of conflict between the stakeholders involved such as health insurance providers, developers and service providers. Researchers from the digiDEM Bayern Digital Dementia Register (digiDEM Bayern) at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) have now produced an overview analyzing the scientific standard of the approval trials for DiGA and their pricing. The results show that several of the studies conducted to prove the efficacy of these applications have considerable scientific shortcomings.

The range of uses for digital health apps is varied, ranging from apps to quit smoking or to alleviate the symptoms of depression, reduce back pain and those to promote cardiac health. The aim of DiGA is to treat or alleviate the symptoms of illness in the form of an app or as a browser-based web application.

Physicians in Germany have been able to prescribe them for over four years now. The costs for these medical products are paid by statutory health insurance providers. The prices for an “app on prescription” are between 260 and 570 euros for one use for three months per patient. However, since their introduction, DiGA have increasingly been the source of conflict between the health insurance providers and developers of these apps.

Quality of approval trials is unsatisfactory

“Several of the studies conducted by developers for the efficacy of their apps have serious scientific flaws,” summarizes Dr. Nikolas Dietzel, lead author of the overview and research associate at digiDEM Bayern. Among other reasons, this is because the participants knew before the approval studies whether they were going to receive the treatment or not. This lack of blinding can influence the result of research.

In addition, the people in the control group often did not receive treatment. This means that there was no “active control group” – an important criterion to scientifically prove the efficacy. Other reasons for scientific shortcomings were the high study drop-out rates, the fact that so-called before and after comparisons were carried out and a lack of transparency due to unpublished study records. The participants of some studies were also not representative, for example as there were several “digitally savvy” participants in the studies. “The results of studies could be biased, which means the results may not reflect the actual efficacy,” explains Dr. Nikolas Dietzel.

Special responsibility of developers

In light of the lack of proven efficacy of DiGA, Dr. Nikolas Dietzel emphasizes: “As is the case with medication, for example, DiGA are financed by the contributions of those with statutory health insurance. There is a particular responsibility towards them to ensure that the approval trials are conducted without bias and correspond with internationally valid standards of evidence-based medicine.” This involves both reducing the potential for bias as well as the ability to transfer the results of the study to day-to-day healthcare provision. “If study results cannot be generalized, the efficacy of DiGA measured in the study must seriously be questioned,” says Prof. Dr. Peter Kolominsky-Rabas, co-author of the overview.

Criticism of developers’ pricing

The pricing set by developers is another reason for the contention between them and health insurance providers. Developers were able to set the prices for their DiGA themselves between certain limits during the trial period and the first year of reimbursement, provided the DiGA are permanently included in the DiGA register of the Federal Institute for Drugs and Medical Products (Bundesinstitut für Arzneimittel und Medizinprodukte). “This means that applications can be reimbursed for which developers have not proven their efficacy at all,” says Dr. Nikolas Dietzel. “But even if there is proof of efficacy, the prices set by developers are, in some cases, well above the final remuneration levels paid after the negotiations with the health insurance providers,” says Prof. Peter Kolominsky-Rabas.

Studies about costs in relation to efficacy of DiGA are rare and have come to varying results. This constitutes a gap in research that needs to be closed. “This raises the fundamental question of whether a community based on solidarity of those paying statutory health insurance contributions should spend considerable sums of money on the lack of efficacy of digital health applications,” says Prof. Peter Kolominsky-Rabas.

Digitalization of healthcare

With regard to the acceleration of digital processes in healthcare, Prof. Peter Kolominsky-Rabas says: “Healthcare provision must improve for patients. If DiGA are not to serve purely as wishful thinking for the long-overdue digitalization of the German healthcare system, the developers of DiGA must do their homework.”

With the introduction of what is known as an ongoing evaluation, the legislator intends to increase the scientific requirements that developers have to meet as of January 2026. In future, the new requirements mean that scientific data will be collected even after the approval of an app, such as the amount of usage, satisfaction with an app and about the health status reported by patients. The information gathered in this way could have an effect on the reimbursed price.

Link to the study   DiGA register of BFARM

Further information:

Ilona Hörath
digiDEM Bayern
Phone: +49 163 883 884 5
ilona.hoerath@fau.de