The reimbursement channel for digital health apps in Europe has traditionally been long and complex. 

But new analysis from Research2Guidance (R2G) predicts reimbursement opportunities will improve significantly over the next few years.

An R2G report has categorised European countries into groups of leaders, fast followers, certifiers and laggards, based on their public health insurance system’s reimbursement process status.

Leading the way are Germany, Belgium and France which have standardised reimbursement processes in place or soon to be launched. 

Fast followers are Italy, Netherlands, Austria, Finland, Ireland, Luxembourg, Sweden, Denmark, and Switzerland, which have expressed interest in implementing standardised reimbursement processes in the future.

Certifiers include Spain (Andalucía region), Portugal, and the UK, which prioritise certification over allowing direct access to the statutory reimbursement system.

The remaining EU countries are categorised as laggers, which show no signs of implementing a reimbursement framework soon. These include Estonia, Hungary, Croatia, Greece, Latvia, Poland, Bulgaria, Slovakia, Lithuania, Malta, Czech Republic, Republic of Cyprus, Romania, Norway and Iceland.

WHY IT MATTERS

In the past there was no standardised process in place for digital health vendors to get their apps prescribed by healthcare providers in Europe, as there is for new drugs or medical devices. However, this is now changing.

According to R2G, an EU go-to-market plan for a digital health app must factor in the country’s stage of standardised reimbursement processes to avoid ineffective resource allocation.

THE LARGER CONTEXT 

Germany’s Digital Health Applications (DiGA) Fast-Track process, created under the 2019 Digital Healthcare Act, allows apps to be prescribed by doctors and the costs reimbursed through German health insurance. 

App providers must prove to the federal Institute for Drugs and Medical Devices (BfArM) that their solutions can improve patient care. There are more than 28 approved apps to date, with the Cara Care app for gastroenterological issues most recently added to the directory.

Belgium also announced in January 2021 that it would launch a digital health app reimbursement scheme. Apps that are CE-marked as a medical device are listed on the mHealthBelgium platform, which centralises relevant and required information for patients, healthcare professionals and healthcare institutions.

In October 2021, French president Emmanuel Macron announced plans to follow in Germany’s footsteps by making digital therapeutics available on prescription through the statutory health system. A standardised, DiGA replica is expected to be launched in 2022.

ON THE RECORD

Vibhindika Chawla, digital health analyst and consultant, R2G, said: "In Europe, getting your digital health solution reimbursed is still the gold standard for monetisation. It is good to see that EU countries are following the example of Germany and building standardised reimbursement processes for digital health apps. Belgium and France are the most advanced. It will take a while until digital health companies can rely on significant revenue sources from the reimbursement channel. Other channels are still relevant."