Key takeaway
Europe is split because each country decides on its own whether to pay for prescribed health apps. Germany pays through its DiGA route, Belgium has a tiered validation route and France offers temporary early access, while most other countries still have no national pathway.
Short answer: Europe is split because each country decides on its own whether to pay for prescribed health apps. Germany created a statutory route in 2020 and has listed 74 apps. Belgium has a tiered validation route, and France offers temporary early access. Most other countries still have no national pathway, so the same app can be reimbursed in Berlin and unpaid in Madrid.
At the 5th Digital Health Conference in Madrid on 23 October 2025, Craig Adkins of Takeda presented Mind the DTx Gap: Accelerating Digital Engagement. He set out why digital therapeutics matter, how Germany made them prescribable, and why the rest of Europe lags behind.
"Germany's DiGA experiment demonstrates how a supportive regulatory and reimbursement environment can catalyse a digital therapeutics revolution." Craig Adkins, Takeda, 5th Digital Health Conference
His case for DTx rests on four pressures they can relieve: shortages of healthcare professionals and long waiting lists, rising chronic and mental illness, poor treatment adherence, and the cost of in-person care. By 2035, he argued, pharma could move from "pill-centric" care to drug-plus-DTx combinations.
A pharma case study: Takeda's ADHD app. Takeda co-developed ORIKO with MiNDNET, describing it as the first digital therapeutic for adults with ADHD. It is a 12-week digital psychotherapy programme listed as a DiGA in Germany. Its pilot study for provisional listing enrolled 278 patients at 6 sites within 14 days, and met its primary quality-of-life endpoint and 6 of 8 secondary endpoints. A full randomised controlled trial has since started, because a provisional listing is lost if benefit is not proven in time.
What pharma needs to do, in his view:
His October 2025 figures already showed the pattern the 2026 reports confirm: only 12% of listed apps could show a benefit from the start, and prices fell 62% after negotiation.
A digital therapeutic is software, usually an app, that prevents, manages or treats a medical condition and is prescribed or recommended by a clinician. In Europe, most are certified as medical devices under the EU Medical Device Regulation (MDR). Certification proves the app is safe to sell. It does not decide who pays for it, and that is where national systems diverge.
Germany's Digital Healthcare Act (DVG) created the DiGA (Digitale Gesundheitsanwendungen) route, and the first apps became prescribable in September 2020. Apps listed by the Federal Institute for Drugs and Medical Devices (BfArM) can be prescribed by doctors and paid for by statutory health insurance. Apps go through a 3-month fast-track review at BfArM. They must be low-risk, CE-marked medical devices and show "positive healthcare effects". Apps with promising early evidence can be listed provisionally for 12 months, extendable to 24, while they collect proof of benefit. Statutory insurance covers about 90% of the population, and patients receive an activation code from their insurer to use the app free of charge.
The results are mixed. Of 74 apps added by the end of 2025, only 14 showed a benefit at market entry, and 16 have since been removed (BARMER). Statutory insurers have spent about €400 million on DiGA since 2020. Their national association notes that manufacturers can set any price in the first year, and says this "systematically leads to significantly inflated prices" (our translation; GKV-Spitzenverband, April 2026).
Launch prices for German apps have risen, while negotiated prices settle far lower:
Mental health and metabolic disorders are the most common indications. Family doctors write most prescriptions, and most users are women (BARMER). Use is still growing: insurers counted 63% more DiGA uses in 2025 than in 2024 (GKV-Spitzenverband).
Germany responded with three rule changes in 2026 (Covington):
France launched PECAN (prise en charge anticipée numérique) in 2023, giving digital medical devices 12 months of temporary funding while evidence is gathered. Uptake has been slow. The French health authority (HAS) issued 13 PECAN opinions between July 2023 and June 2026. All 4 favourable opinions went to telemonitoring solutions, and all 6 digital therapeutics were rejected (CEMKA, ISPOR Europe 2026).
PECAN is inspired by DiGA but stricter on timing. The French Digital Health Agency checks interoperability and data security, and the Ministry of Health decides within 90 days. As Adkins noted, developers then have 6 to 9 months to submit evidence for permanent listing, against 12 to 24 months under DiGA (G_NIUS, French Ministry of Health).
Belgium uses the mHealthBelgium validation pyramid. Apps climb from CE marking (level M1) through data-security checks (M2) to a top tier where they can be considered for reimbursement by the National Institute for Health and Disability Insurance (NIHDI) (QbD Group).
Moving up the pyramid means proving secure connection to Belgium's eHealth platform, meeting authentication and GDPR requirements, and verifying the link between patient and healthcare provider. Adkins counted 20 digital therapeutics on the platform in 2025, and described reaching reimbursement as "complex and resource intensive".
In the UK, a positive NICE assessment does not guarantee funding. Developers must then win approval from each regional Integrated Care Board (ICB), which, according to experts Adkins cited, expect £2 to £3 in savings for every £1 spent within the same year. He also flagged a paradox: an app that improves adherence can raise medicine spending, which makes the budget case harder to win.
Sources: BARMER (2026), CEMKA/ISPOR (2026), Muragundi et al./ISPOR (2026), Theorema4H/ISPOR (2025), Research2Guidance via QbD Group (2024).
Three things keep the market fragmented:
The European Health Data Space (EHDS) regulation, in force since 26 March 2025, may help in the longer run. From March 2029, patient summaries and ePrescriptions must be exchangeable in every member state, and rules for reusing health data for research start to apply (European Commission). Better shared data could feed the real-world evidence payers ask for. It does not create a common reimbursement route.
Header photo: National Cancer Institute on Unsplash.
DiGA stands for Digitale Gesundheitsanwendungen, Germany's prescribable digital health applications. Apps listed by BfArM can be prescribed by doctors and are paid for by statutory health insurance. 74 apps were added between 2020 and the end of 2025.
PECAN is France's temporary early-access scheme for digital medical devices, launched in 2023. It funds a device for 12 months while evidence is collected. By June 2026, only telemonitoring solutions had received favourable opinions.
Germany has the most established route, through the DiGA directory. Belgium allows reimbursement at the top of its mHealthBelgium pyramid, and France offers temporary early access through PECAN. Most other European countries have no national pathway yet.
Yes. From 1 January 2026, at least 20% of each app's payment depends on performance. From the third quarter of 2026, manufacturers must report usage and patient-reported outcomes every quarter.
In 2025 the average DiGA launch price was €544, with prices ranging from €119 to €2,077. Once a benefit is proven, the price is negotiated with statutory insurers. Negotiated prices for 40 apps average €227, and across the period they were 59% below launch prices on average.
No. In the UK, a positive NICE assessment does not equal reimbursement. Developers must also secure funding from each regional Integrated Care Board, which typically expects savings within the same year.
The Digital Health Conference, organised by UBIQ Events, brings together pharma, medtech and digital health leaders to discuss digital therapeutics, real-world evidence, AI and regulation.
