Digital health apps (German: DiGa for short) are currently used by twelve percent of the German population. The apps on health insurance benefits, which have been approved in this way since October 6, 2020, are unique in the world. No other country has such digital helpers paid for by health insurers. According to the survey, a total of 40 percent of all people in this country would use such medical achievements, and 66 percent consider them useful. However, it is crucial that the German Federal Institute for Drugs and Medical Devices (BfArM) sets high quality standards before they can be covered by health insurance. These quality standards are mandatory for manufacturers so that the BfArM approves the apps in the first place and includes them in a so-called DiGA directory. Nine DiGa have been included so far, and others are undergoing a strict review process with very specific requirements and proof of positive supply effects, because otherwise there is only a temporary inclusion, which regulates the so-called Digital Health Applications Ordinance (DiGAV).
The prices of some of the products currently on the market are relatively high. Depending on the app, they cost up to 500 euros. Examples include the tinnitus app at 117 euros per quarter and patient, the application for anxiety disorders at 476 euros, and the obesity DiGa, which currently costs 499 euros for the GKV. The framework agreement negotiations for the DiGA have already been underway since June 29, 2020, and are based on the German Medicines Market Reorganization Act (AMNOG), which came into force in 2011. In the first year, DiGA manufacturers can decide how much their product costs. From month 13, a negotiated reimbursement price then takes effect, with differential compensation payments having to take place if the manufacturer’s price and subsequently negotiated reimbursement price differ. Pricing between health insurers and manufacturers repeatedly ends in disputes due to disagreement during price negotiations, so that an arbitration board has to be called in to settle the dispute. The arbitration board then sets the price.
Thirteen top DiGA manufacturers‘ associations participate in the negotiations. In the negotiation of the framework agreement on the AMNOG, there are only five manufacturers‘ associations.
The health insurance funds have long been calling for maximum amounts to be set, similar to the fixed amounts for pharmaceuticals. However, manufacturers reject standardized schemes because health insurers want to use an algorithm to determine prices. For DiGa manufacturers, the daily therapy price is the determining factor.
Apps that are in the DiGa directory for testing must also still be price-negotiated. However, there is again disagreement on the timing of the start of negotiations. Here, too, the Arbitration Board will have the final say.
Source: pharmazeutische-zeitung.de