PCN95 - How Does G-BA Decision Impact Oncology Drug Prices in Germany?

Abstract

In Germany, drugs are freely priced between the date of launch until the final decision of the federal joint committee (G-BA). After the decision, drugs prices are re-evaluated. This study aimed to identify the potential relationship between the ranges of extent of added benefit and the price discount applied to the oncology products after price re-evaluation. Oncology drugs approved in Europe between 01/01/2015 and 02/02/2018 were identified from the European Medicines Agency website. G-BA decisions available for these drugs were downloaded from G-BA website. The ex-factory prices of oncology products available in Germany were extracted from IHS POLI database. Based on the prices history, the discounts between prices before-after GBA decision were calculated for each drug and ANOVA analysis was conducted to assess the impact of G-BA decision on the price. Twenty-five out of 42 approved oncology drugs were assessed and 18 out of the 25 products had a price available before and after G-BA final decision. Our results showed that the G-BA decision had a significant impact on the discount level of the first ex-factory price in Germany (p=0.003). The price of an oncology drug with no added benefit was discounted by almost 53%, whereas a drug with a considerable added benefit had a price discounted by 18% after negotiations with the manufacturer. When the G-BA could not decide on the extent of added benefit based on the submitted clinical data and issued a “non-quantifiable” added benefit, the prices were discounted by 27%. The added benefit set by GBA is a strong driver of price discount. However, negotiation tactics, the political climate, and other factors seem to play an increasingly influential role for the pricing of oncology drugs. Further research is needed to evaluate through multivariate analysis additional factors.