Reimann: Exchanging biological drugs is safe and enables significant savings

23.05.2022 17:55

The regulation on the substitution of biologicals in pharmacies set by the legislature in 2019 will take effect from August 2022 after a long lead time. The demand from several pharmaceutical associations for a stop to the “automatic” exchange of these medications is given by the CEO of the AOK Federal Association, Dr. Carola Reimann, a rejection, because in her opinion the “consistent substitution of biological medicines offers the opportunity to reduce the expenditure burden for the contributors while providing equivalent quality of care”.

Furthermore, it is not an “automatic” exchange, but rather a process carried out by qualified pharmaceutical staff and supported by advice. Reimann: “It is additionally secured by the G-BA specifications. Clinical investigations are mandatory in the approval process of biosimilars so that effectiveness and safety are guaranteed. In addition, the safety of switching between medications has been tested in numerous studies. The approval authorities also consider the exchange to be safe.”

Contrary to the representation of the pharmaceutical associations, the new regulation on the substitution of biologicals has considerable economic potential: “According to an analysis by the AOK Scientific Institute (WIdO), savings of 758 million euros would have been possible for the statutory health insurance in 2019 alone if the The cheapest, comparable biosimilar would always have been used for therapy. In addition, in many cases there is no need to change the therapy at all: according to the WIdO analysis, 55 percent of those treated were new and would have received a biosimilar from the start,” explains Reimann.