Reimbursement opportunities for digital health applications and services will improve significantly over the next few years in Europe. An EU go-to-market plan for a digital health app must factor in the four different implementation stages of standardized reimbursement processes within the European countries to avoid ineffective resource allocation or just to be too early or late in a market.
Over the last years, digital health companies were able to sell their services mainly to consumers, employers, healthcare companies incl. pharma, med tech or hospitals. The reimbursement channel used to have very long and cumbersome sales cycles. Digital health companies had and still are having to sell to each and every health insurance individually. There was no standardized process in place like the one for any new drug or medical device to get into the statutory health insurance system within a country. This is about to change. European countries are leading the development, creating significant business opportunities for digital health companies in Europe.
Germany is the first country in the EU to have implemented a standardized process for digital health apps to be prescribed by a physician or a psychotherapist and reimbursed by the statutory health insurance. Undoubtedly, the introduction of Digital Healthcare Act – DVG on November 7, 2019 (DiGA) has opened a new horizon in the digital healthcare space, for digital health companies to have their apps listed in the DiGA directory enabling them to target 73 million public health insured German residents.
With Germany’s DiGA Fast Track process set in place, several EU countries have implemented or want to implement a similar assessment framework to evaluate digital health apps and to provide a direct access to the public reimbursement system. Still the majority of EU countries have not yet shown a notable interest in providing a standardized process for digital health services into their statutory health insurance system.
The EU countries can be categorized into 4 groups based on the reimbursement process status by the public health insurance system.
Leaders – Germany, Belgium and France are the DTx reimbursement process leaders where Germany and Belgium have already implemented DiGA and mHealth Validation Pyramid to assess the quality and effectiveness of digital health applications. Currently, the DiGA directory consists of 28 apps which focus on supporting several therapeutic areas like cancer, weight management, diabetes, mental health etc.
On the other hand, mHealth Validation Pyramid in Belgium has 3 levels of assessment which evaluates risk, interoperability and clinical evidence after which apps are reimbursed by the SHI. These levels are M1, M2 and M3, where 24 apps are in M1 phase, 10 apps in M2 phase and none in M3. Additionally, France has also developed an assessment framework similar to Germany’s DiGA which is expected to be launched in 2022.
Fast Followers – Italy, Netherlands, Austria, Finland, Ireland, Luxembourg, Sweden, Denmark, Switzerland and Estonia are following the footsteps of ‘Leaders’ to implement a standardized reimbursement process. Health representatives from these countries have expressed their interest at one or the other occasion to implement a DiGA – like process, using it as a template where Netherlands and Austria have already started developing recommendations based on existing frameworks.
The expected time until the first digital health app gained access to the statutory health plans differs within this group but an average of two years should be considered in any go-to-market road mapping.
Certifiers – Countries of this group including Spain (Andalucía region), Portugal, and UK are characterized by prioritizing a certification process over a process that allows direct access to the statutory reimbursement system or by having only regional implementation of standard reimbursement processes. “Certifiers” provide quality stamps but lack a standard route to get digital health apps prescribed. As a result, digital health apps certified by AppSaludable Quality Seal in Andalucia, My SNS Selection in Portugal, or the NHS in the UK may or may not be reimbursed by the SHI in the respective countries.
Laggers – The remaining EU countries including Hungary, Croatia, Greece, Latvia, Poland, Bulgaria, Slovakia, Lithuania, Malta, Czech Republic, Republic of Cyprus, Romania, Norway, Iceland show no signs to implement DiGA-like framework in the near future.
The expected number of years those countries will need to set up a standardized process for digital health app reimbursement is not predictable. Digital health companies should closely monitor the planning within these countries to be able to adopt their go-to-market plans.
The opportunity size for a reimbursed digital health service in a country measured by the addressable statutory health insured or total population size differs a lot.
Digital health companies that want to enter the European market via the reimbursement channel will have to factor in the current implementation status of a standardized reimbursement process as well as the market opportunity size. Timing is important as well. “Follower” countries might need another 1-2 years before they are able to implement the standard reimbursement process. For other countries, digital health companies should closely monitor initiatives by the regulatory bodies within the countries to identify the ones that will start the implementation process and become a “follower” country.
Please also have a look at R2G’s white paper on “DiGA in Germany: Entering the German market with a digital health solution.”
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