Prices of new medicines: International analysis and policy options.

Equitable and sustainable access to medicines is a global challenge, including for high-income countries. Over the last two decades, launch prices of new medicines have considerably increased, making some medicines unaffordable for many countries. This article is based on a presentation held by the author at the IQWiG Autumn Symposium in November 2021. The medicine price situation in European countries and beyond is presented informed by international evidence. Medicine prices vary across countries, and for some therapeutic groups (e.g., cancer drugs) medicines are largely unaffordable and/or unsustainable for most countries. Selected policy options to improve affordability, which are commonly applied and considered as potential solutions, are discussed. The article stresses the importance of price regulation, and of transparency of prices and further components across the pharmaceutical value chain. Many governments opted for concluding managed-entry agreements (e.g., pay-for-performance) with confidential discounts to make new medicines with high price tags affordable and/or to manage uncertainty about their performance. However, this policy is linked to limitations, particularly due to its secrecy of discounts. Patent expiry of biological medicines can contribute to affordable access; however, it is important to strategically exploit the biosimilar potential by implementing a mix of appropriate policies to foster competition and enhance the uptake of biosimilar medicines.