The German Fast Track for digital health: what comes next for digital health providers?
With a landscape of thousands of solutions, the German digital health market is more attractive than ever for new companies working in digital health, with new revenue streams and business models on the horizon. Beyond the Fast Track process requirements, providers of digital health solutions need to plan for a smart distribution strategy to reach their users and should integrate a multi-channel approach.
The Digital Healthcare Act positioned Germany as a top market worldwide in 2020. (see also Why Germany becomes a top country for digital health solutions). As the year 2020 comes to its last quarter, the German digital health industry has achieved major developments in terms of market access and adoption of its services. With the Digital Healthcare Act entering into force in January 2020, local and global providers of all types of digital health applications (Digitale Gesundheitsanwendungen – DiGA) are now eligible to be reimbursed for their services by the national statutory health insurance funds when prescribed as part of healthcare treatments. By primarily adjusting the Social Security Code V (Sozialgesetzbuch V—SGB V), now digital health providers can offer their solutions to healthcare providers or health insurance, and reach a market population of over 73 million statutory healthcare members (+85% of population) in Germany.
Digital health providers must apply to the Fast-Track Process to be reimbursed and prescribed as part of treatment in Germany. Organized by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM), the Fast Track process reviews and ensures that the digital solutions meet fundamental medical device criteria and that, of course, they are verifiably fit for purpose before entering the market. Briefly summarized, the fast track process consists of four steps: First, digital health providers need to provide evidence on agreed key performance indicators during a 3-month period. Second, when and if approved by the BfArM, the solutions will be officially listed in the DiGA directory and tested during a 1-year trial period on their performance. Third, if the targets are met at the end of this first year, the BfArM will provide clearance and the providers’ solutions will be officially listed as reimbursable and assigned codes for their prices. Fourth, providers will need to submit continuous proof of evidence after launch.
A smart market strategy with clear distribution channels is also necessary. Once approved, the success of digital health providers is, however, not limited to a successful BfArM application. After completing the Fast-Track process, providers who took the time in parallel to develop acquisitions and distribution channels will be most likely to reach their target audience and consolidate a strong market presence in Germany. Digital health providers should include a clear understanding of both traditional and new distribution channels to address their user-base successfully. Among the possible channels in Germany, there are at least 10 key ones which are worth revising.
TRADITIONAL CHANNELS
- Health Insurance
- Healthcare Provider
- Hospitals
- Employers Health Programs
- Big Phrama deals
DIGITAL CHANNELS
- Online HCP marketplaces
- Commercial App Stores
- Digital Therapeutics partner
- Telehealth partner
- Online Pharmacies
Healthcare providers (HCP) are a second-most important distribution channel for digital solutions. When entering the German market, health insurance providers are a clear channel for solution distribution and customer acquisition, but providers should not limit their strategy. It is important to consider working with general practitioners, psychiatrists, psychotherapists and even gynecologists as channels to connect with customers. Together with GPs which are usually the first contact for all patients, other specialists are also key to reach out to the audience, while also prescribing reimbursable solutions. Harnessing the power of the German market will thus require working alongside healthcare providers in charge of prescribing solutions. Given that HCP are key gatekeepers in several settings, it will be critical to select and prioritize a clear value proposition to the healthcare providers to truly capture the market. A collaborative sales strategy that includes the HCP is one option to access patients through digital marketing.
Although trying to align digital services with traditional therapy seems a daunting challenge, the Digital Healthcare Act opens a new space to re-think today’s business models to support the growth of tomorrow’s healthcare system in Germany. As of September 2020, the first two healthcare apps have already been approved and are now starting to be prescribed by healthcare providers in Germany with the costs covered by statutory insurance. Kalmeda, on one side, aims to reduce the effect of tinnitus, and Velibra, on the other, is a digital therapeutics provider helping members with anxiety management. This is only the start!
If you want to learn more about DiGA, get first-hand experience and know-how from different healthcare stakeholders, please join our masterclass session “Fast track market entry for digital health apps in Germany: turning point or flash in the pan – what happens after listing?” at this years’ Frontiers Health global conference on November 12-13, 2020.
This unique hybrid event will combine online global streaming together with offline events and activities held at Local Hubs in Switzerland, Germany, Italy, Finland, Malta, Spain, USA, and more locations to be known. Check the impressive speakers’ line-up and all the inspirational, informative and controversial sessions!
Get your pass with R2G’s special 25% promo code here!
We hope to see you in person in Berlin or online as part of Frontiers Health global digital health online community!
