The introduction of maximum reimbursement prices for digital health applications in Germany in 2022: Current developments

Germany serves as a pioneering example for the integration of digital health applications. Since October 2020, digital health applications that passed a benefit evaluation have been provisionally or permanently included in the benefit basket of the German statutory health insurance. However, free price setting by the manufacturers in the first year after the introduction in the benefit basket led to high prices. After several policy debates, maximum reimbursement prices were introduced. This article provides an overview of the changing reimbursement and pricing landscape after implementing maximum reimbursement prices. Processes of setting reimbursement prices are described, first results of maximum reimbursement prices are presented and critically reflected by views of stakeholders affected. Results of the first 1.5 years show that only four digital health applications were assigned a product-specific maximum price. For three of these digital health applications, the manufacturer's price is below the statutory health insurance's maximum reimbursement price. Although there is relatively minor impact on costs so far, this may change over the years with a growing number of digital health applications. Nevertheless, a systematic and transparent adjustment of the pricing mechanism after one year of inclusion in the benefit basket is necessary to strike a balance between the benefits of new digital health applications, statutory health insurance expenditures and the promotion of novel digital health applications.