Presentation (CTI)

OBJECTIVES: Historically, price erosion for new medicines in Europe was influenced by international reference pricing (IRP), tendering, and lifecycle events such as indication expansion. However, the introduction of new global pricing policies, such as the Most Favored Nation (MFN) pricing models, creates uncertainty around how European net prices may evolve in the future. This study aims to assess historical drivers of net price erosion in Europe and evaluate how new policies could reshape payer expectations, manufacturer launch strategy, and lifecycle pricing dynamics impacting European net pricing.
METHODS: A retrospective analysis was conducted using European list and net price data for new therapies receiving EMA approval in 2021, classified by therapeutic area (e.g. oncology, orphan non-oncology, etc). Additionally, markets were categorized by the different proposed MFN models reference baskets. List and net prices were evaluated in USD at the product-description and country level from 2021-2026. Additionally, several ex-payers were engaged with to gather insights on potential European price erosion dynamics and likely scenarios for manufacturers seeking to launch new therapies.
RESULTS: Average year-over-year price erosion in European markets excluded from the MFN GENEROUS reference basket was seen to have higher erosion than markets included in the MFN GENEROUS reference basket. Prior to the introduction of new global policies, price erosion was primarily driven by market-specific mechanisms such as IRP, tendering, and indication expansion. Several future scenarios are possible, with European price erosion likely to reduce over time as manufacturers consider delaying indication expansion or payers implementing new pricing & access policies to preserve patient access.
CONCLUSIONS: Given new pricing and access policies in place, manufacturers should seek to update existing European price assumptions to account for a shift in expected price erosion due to several levers. Understanding how policy shifts and payer expectations will impact European price erosion will support future launch decisions.