Status Quo: A Long way to go
The reimbursement of digital therapeutics is a crucial step towards ensuring that digital health tools are able to achieve their full potential to improve patient outcomes. With that said, progress in Europe has been slow.
Germany continues to be the country that the rest of the region looks to, as it was the first to reimburse prescription digital therapeutics at a national level. While there are signs that other EU nations will soon follow in its footsteps, including Italy and Belgium, there continue to be a myriad of obstacles preventing progress. In particular: a fragmented approach on digital health regulation that varies from country to country.
Regulatory Changes Create Ease for DTx in Germany
The Digital Healthcare Act came into force in Germany in 2019 and has made it easier for patients to make virtual doctor visits and access their health data from anywhere. Furthermore, Germany has seen an increasing number of digital health applications (DiGA) backed, with the March 2021 approval of a mental health app marking the 11th app to be passed. Although there is still some uncertainty about the long-term implications of the legislation and how it will be put into practice, the rules are designed to be updated where needed.
They may have different healthcare systems and alternative approaches to pricing and reimbursement, but we would certainly expect other countries to look to the approach Germany is taking and see how they might adapt and implement it within their own markets, OPEN Health consultants Olaf Schoeman and Emanuele Arca told Deep Dive magazine.
DTx Regulation in Europe Depends on the Region
The Belgian National Institute for Health and Disability Insurance has slowly begun reimbursing mobile apps — though so far only in small numbers, and only those that include an app that supports hip or knee replacement rehabilitation. Alongside this, the government’s mHealthBelgium platform collects all apps that have received a CE mark as a medical device, and categorizes them into three levels. Those that show “social-economic evidence” can get reimbursed.
Italy is also keen to follow Germany’s lead, according to a Feb 2021 white paper entitled Digital Therapeutics, an Opportunity for Italy. Giuseppe Recchia, director of Smith Kline Foundation, Tendenze Nuove, who championed the project, emphasized the need to integrate digital therapeutics into Italy’s healthcare system. Recommendations included making information more available to the general public, training for professionals and patients, and targeted communications to health and political institutions.
At European level, EMA has an important role in facilitating the appropriate recognition of DTx and introducing a seal of recognition that indicates the DTx products has an effect recognised by EMA may be an important first step, said Recchia.