Background and importance R&D and market entry for orphan medicinal products (OMPs) are incentivised with a 10-year market exclusivity period as stated in Regulation (EC) No 141/2000. Notably, OMP prices often remain high after market exclusivity expiry (MEE). This has led to societal debate on OMP pricing. However, transparency on the purchase prices of OMPs is lacking due to confidentiality issues. Research on OMP prices is needed to support policymaking.

Aim and objectives Our research aimed to explore trends in both list prices and purchase prices of brand-name OMPs before and after market exclusivity expiry in Western European countries.

Material and methods Annual average list prices and purchase prices of brand-name OMPs from a number of university hospitals were collected. The selection of OMPs was in accordance with our research protocol – published EJHP. To capture confidentiality constraints, the annual average price in the year of market exclusivity expiry (MEE=0) was set as index year (p=100%) for list prices and purchase prices separately. Proportions were then created to illustrate price trends over time.

Results 14 OMPs were included. A first analysis including four hospitals demonstrated that 2 years after market exclusivity expiry (MEE+2), list prices had dropped on average by 2.01% compared to list prices in the year of market exclusivity expiry (MEE=0) and purchase prices increased on average by 0.09% compared to purchase prices at MEE=0. Three years after market exclusivity expiry (MEE+3), list prices dropped on average by 0.56% compared to list prices at MEE=0 and purchase prices increased on average by 0.09% compared to purchase prices at MEE=0.

Conclusion and relevance List prices of brand-name OMPs have dropped very modestly in the first years after market exclusivity expiry compared to the list prices at the times of market exclusivity expiry. The purchase prices of brand-name OMPs even increased slightly on average in the first years after market exclusivity in our dataset. This potentially implies a lack of incentives for pharmaceutical companies to lower prices after market exclusivity expiry. Additional data collection is required to draw more robust conclusions.

References and/or acknowledgements 1. Dane A, Klein Gebbink A, van der Kuy PHM. The importance of publishing research protocols for pharmacoeconomic studies. Eur J Hosp Pharm. https://ejhp.bmj.com/content/early/2021/09/15/ejhpharm-2021-002987.

Conflict of interest No conflict of interest