Insurers critique high costs and low benefits of prescription apps

The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) has presented the current report on the use and development of digital health applications (Digitale Gesundheitsanwendungen, DiGA) for 2024 to the Bundestag. By the end of 2024, over one million DGAs had been prescribed or approved by health insurance companies, 81% of which were actually activated, according to the report. DiGAs for the treatment of mental illnesses are particularly in demand, followed by applications for "metabolic diseases" and diseases of the "musculoskeletal system" as well as "diseases of the ear". The majority of users are women and the average age is 47, as also shown in previous reports.

87 percent of prescriptions are issued "by a doctor or psychotherapist". 13% of DiGAs are approved directly by the health insurance companies. According to the GKV-Spitzenverband, "four DiGAs account for just under 50 percent of all redemptions in the reporting period (September 2020 to December 2024) and the most frequently prescribed or approved DiGA accounts for just under 30 percent of all redemptions in 2024". A total of 146,600 activation codes were redeemed for the weight loss app Oviva, 91,200 activation codes for Vivira, an app for back pain patients, and 87,900 activation codes for Zanadio, another weight loss app. A total of 33.8 million euros was spent on Oviva, 20.7 million euros on Zanadio and 18 million euros on Vivira.

Despite the strong growth, the GKV-Spitzenverband criticizes weaknesses in the evidence for the applications: Only 12 out of a total of 68 DiGA have been able to demonstrate a benefit directly with their inclusion in the DiGA directory of the Federal Institute for Drugs and Medical Devices (BfArM). Many DiGAs are rarely or not at all used by patients in everyday care. Overall, only half of all DiGAs listed in the BfArM directory to date would deliver their promised benefits.

541 euros per DiGA

The GKV-Spitzenverband sees a further problem in the pricing. In the first year after approval by the BfArM, manufacturers are free to set the price of their DiGA, regardless of whether the benefit has already been scientifically proven or not. "It is noteworthy that the six most expensive DiGAs are all those that were only approved for testing," the report states. Two of the six most expensive DiGAs also had to be removed from the list because no positive effect on care could be proven. DiGA manufacturers can set their prices for the trial period, whereby maximum amounts apply from the first day a DiGA is included in the DiGA directory if a maximum amount has already been set for the respective DiGA group. On the other hand, it is pleasing that around two thirds of the negotiated prices could be "agreed between the contracting parties" and did not have to be determined by an arbitration board.

The average manufacturer price is 541 euros per application, in individual cases even more than 2,000 euros. Only in the second year do the negotiated prices usually apply, which are significantly lower at an average of EUR 226 – unless the trial period has been extended or a maximum amount has been set for the respective DiGA group. If DiGA manufacturers extend their trial periods, the health insurance funds must pre-finance the DiGA. This has resulted in costs amounting to 55 million euros. In addition, insolvency proceedings have already meant that funds amounting to almost 20 million euros have not been repaid. Zanadio, for example, filed for insolvency around two years ago.

Considering these developments, the GKV-Spitzenverband is calling for a fundamental reform of the DiGA system. In the future, only those applications whose medical benefits are sufficiently proven should be included in the list. In addition, the negotiated prices should apply from the first day of inclusion in order to protect the solidarity-based community of insured individuals from unnecessary additional costs. The association also recommends that the benefit assessment should in future be carried out by the Federal Joint Committee (G-BA), the highest decision-making body of the joint self-administration of doctors, dentists and psychotherapists, in order to ensure quality and patient safety.

Criticism of the health insurance funds

Recently, the Spitzenverband Digitale Gesundheitsversorgung (SVDGV) criticized the statements of the GKV-Spitzenverband. It demands that the GKV-Spitzenverband "limit the report in future to the statutory mandate in accordance with Section 33a (6) SGB V or commission a neutral body to prepare the DiGA report in future". In the SVDGV's view, the report is biased and ignores the DiGA's success story. In addition, manufacturers would have to make "considerable advance payments" for their "development, studies and certifications" to bring a DiGA onto the market. The presentation of the evidence is also "distorted", as manufacturers have to present studies "that indicate a positive effect on care" even for provisional inclusion, and these are almost always "randomized controlled clinical trials".

In its own DiGA report, the SVDGV speaks of the success of the fast-track procedure, which means that new apps are quickly entering the healthcare sector. Germany is regarded as a pioneer in digital healthcare in the DiGA. Despite this success, the SVDGV criticizes, among other things, the fact that it takes an average of 14 days for patients to receive an activation code from their health insurance provider after receiving a prescription. However, this should change in future with an electronic prescription, so that patients can use DiGA more quickly, for example directly via an app, without having to rely on manual activation codes.

(mack)