Presentation (CTI)

OBJECTIVES: Based on over 10 years of available data and over 100 drugs with Orphan designation that went through the AMNOG process in Germany, this research aimed to analyse the evolution of manufacturer-set list prices and negotiated rebates for newly launched ODs. Additionally, we assess whether manufacturers use US price strategies when setting list-prices in Germany, and how these strategies impact negotiated rebates.
METHODS: RADAR is a proprietary, multi-country database of ODs that received EMA Marketing Authorization between 2013-2024, including information on first indication, HTA outcome, list price, negotiated net price, rebates. Price comparison is based on annual costs using published prices and dosing regimen. ODs were analysed within two launch periods: 2013-2018 and 2019-2024, comparing mean annual cost based on manufacturer-set list prices and negotiated rebates for the ODs’ first indication. For US-Germany price comparison, ODs had to be launched first in US with identical indication and formulation.
RESULTS: Mean manufacturer-set list prices and rebates increased between time periods, without differences in benefit ratings or clinical evidence. List-price increase (60%) was substantially larger than rebate increase (15%) driven by increase of oncology OD list-prices by 190%. The mean list price in Germany was at launch consistently ~89% of €-denominated WAC (exchange rate at EMA approval date) across the observation period 2013-2024. US price developments in the period 2013-2018 vs 2019-2024 were followed with similar list prices developments in Germany. Negotiated rebates increased for oncology OD with increasing list-price levels; however, not proportionally. Non-oncology OD maintained similar price and rebate levels over time.
CONCLUSIONS: GKV is willing to reimburse significantly higher prices, especially for oncology OD, over time. Driver are new therapy approaches (e.g., Car-T) with very high list prices and lower prevalence as observed previously. Data suggests US price strategies are used when manufacturers enter rebate negotiations.