In 2020, Germany implemented a standardized pathway for low-risk digital health solutions into the statutory health system. 33 digital health solutions have passed the approval process. Listed companies generated more than €41 million sales. New R2G white paper published.
The German Federal Parliament passed the Digital Healthcare Act (DVG) in December 2019 and launched the standard reimbursement pathway in 2020 to support healthcare innovation and digitalization. With this act, DiGAs can theoretically be prescribed to 73 million people in Germany covered by a statutory health insurance.
DiGAs must have CE mark class I or IIa for medical devices and meet two criteria: 1) general safety requirements by the Digital Health Applications Ordinance (e.g., data protection, information security, interoperability, and ease of use), and 2) proven positive patient outcomes (e.g., medical benefits, adherence, and health literacy improvement).
Apps that meet both criteria can apply for the permanent DiGA status or the provisional listing without proving patient outcomes (the Fast-Track). In this case, companies should submit the clinical evidence of the app within the next 12 months. Plus, vendors can set the provisional prices and renegotiate reimbursement amounts with the National Association of Statutory Health Insurance Funds (GKV) after the provision ends.
A new R2G whitepaper examines the value of reimbursement channels for digital health solutions in Germany and Europe. (We invite you to get your copy)
The first DiGA was authorized for use in September 2020, and currently, 13 apps have permanent listing status, while 20 apps have provisional listing status. Therapeutic areas of all listed apps include mental health (40%), diabetes and obesity (12%), musculoskeletal diseases (12%), and others. Prescription prices vary from €119 – 952 per one-time use over a 90-day period and are fully reimbursed by statutory health insurances (with no co-payment required for patients).
Since the first listing of a digital health solution in Q3 2020 a total of 150 digital health companies have applied for DiGA listing. Out of those, 33 have been approved, with 13 applications being rejected so far. The number of apps in the directory has increased over the time with fewer additions in 2022.
The average price of a DiGA-listed app was €321 in 2021 (with similar prices across all quarters of 2021). However, the average prices are expected to decline in 2022, for the majority of the apps launched in the previous year will face a negotiation with GKV resulting in decreased reimbursement prices. The price decline will overcompensate the steady increase of redeemed prescriptions. In the last quarter of 2022, approximately 25,000 DiGA app codes will be activated (redeemed prescriptions), resulting in €6 million or DiGA revenue in Q4 2022. By the end of 2022 DiGA-listed apps will have generated €41 million since the first app was listed.
The average monthly turnover per DiGA app is around €60,000. The best performing DiGA apps make 3-4 times more than the average. After two and a half years since the launch of DiGA, this is probably more than what most digital health apps make in a month. The downside, however, is that only a few apps have been able to use this channel for themselves so far. Only 1 in 5 apps has been able to make it to the list. The rest was either rejected by the BfArM or withdrawn.
The slow acceptance process by the BfArM is just one of the barriers for a broader uptake of the DiGA market in Germany. Lack of clinical evidence, self-pricing, and prescriber barriers are the other main barriers.
To find out more, please download the free R2G whitepaper “Is reimbursement the best market entry option for digital health companies in Europe? DIGA 2022: Is it worth the hype?“