23/06/2022 | BlogPost
Recently Germany has made strides in moving forward with their Digital Health Care Act in virtue to provide digital health applications with a reimbursement path. In May 2022, the KBV and GKV-SV agreed on updating clinicians’ fees for apps listed in provisional list for DiGAs and in June 2022 eligibly for being reimbursed by the DiPA (Digitaler Pflegeanwendungen) initiative was laid out.
One of the strategies listed by European commission titled "Europe’s Digital Decade: digital targets for 2030" enumerates the priorities of EU states and envisages their digital future. Aligning with those values, the introduction of Digital Health Care Act by Germany laid down the path for access and reimbursement of Digital Health Apps in Germany.
Currently DiGA (Digitalen Gesundheitsanwendungen) is the framework to reimburse from statutory health insurance funds (SHI) for digital health applications approved by The Federal Institute for Drugs and Medical Devices (BfArM) in Germany. The system had 31 apps in the list by May 2022, some under a provisional list and some under a permanent list. The framework is a fast-track process of evaluation of the digital applications in 3 months based on requirements of data policy, safety and added benefits. The requester can be added to a provisional list or to the directory after an evaluation, which gives access to prescribe and reimburse the applications by doctors for the patients with government insurance (GKV).
DiPA is another framework by The Federal Institute for Drugs and Medical Devices (BfArM) in Germany. This framework is used for digital health apps to be applied for nursing and care giving for patients, especially impacting long term care. This initiative is aimed to assist home care and reduced the burden on nursing and care giving. Recently a framework for including digital applications in the directory under DiPA was released and the framework looks similar to DiGA framework but with differences on a few points. The reimbursement for the solutions has a cap of 50 Euros per month and any additional cost will be paid out of pocket by patients. The solutions will be enabled to the patients directly by the long-term insurer and the solutions need not be approved as a medical device to be listed in the directory.
Though both DiGA and DiPA frameworks have different target populations, they have a lot in common as they interact with similar agencies. This brings a set challenge, as we have evidently seen from DiGAs, which have been in the market since 2019.
Catching up with Regulators: First set of reimbursements will always have some beginner’s advantage. The regulatory framework catches up with time. Now applicants for DiGAs must deal with complex issues like demonstrating added benefits over the existing apps for patients and healthcare systems or they might have to deal with classification of software as a medical device according to MDR Guidelines. The current framework also adds uncertainty on the minds of physicians regarding availability of an application, as applications could be removed from the directory after the provisional period without sufficient real-world data on added benefits.
Price and volumes: Companies look for profitable business and digital health applications are no different. As time passes, it is inevitable to have price cuts and price caps. DiPA already has a price cap of 50 Euros per month. This signifies the pressure is on prescribers and insurers to appreciate the added benefits and prescribe or suggest the app for the right audience. To make commercially viable decisions the manufacturers must think of appropriate strategy (DiPA, DiGA or B2C) to generate sufficient profits.
Expand Marketing: According to a recent report in 2022 by TK (largest insurer in Germany) on DiGA Berlin remains as the largest market for DiGA, as most of the manufacturers have their head office located there and have the possibility to interact with physicians. The initiatives need to be more pan Germany, and this requires more conventional marketing that we know from traditional pharma and medical device firms.
IT education and infrastructure: Only 4% of the Physicians are currently prescribing DiGA, so this percentage would need to grow. In order to improve the numbers, it would not only require better marketing but also a better understanding of the benefits when using digital health apps on the part of physicians and patients. For patients, this could get a bit tricker based on the target audience as many apps might target 60+ patients who might have low digital expertise and understanding.
Advancement in Tech: As an industry, the companies must push the boundaries to add more personalization, create better UX and provide diligent assistance to patients as the market matures. This ensures relevancy of the application against competitors and pushes regulators to catch up with innovations.
Target patients: Addressing unmet needs for patients remains the core of reimbursement procedures. For example, with many apps in DiGA currently addressing mental health space it would be difficult to imagine negotiating a price topping the existing price of mental health services.
Though the Digital Health Care Act from Germany is a leap towards digital acceptance in Europe with its vision of a digital world, it needs to be seen how regulators and companies handle the challenges moving forward.