OBJECTIVES: Advanced therapy drugs offer new and potentially curative treatments for complex diseases, but their market access can be challenging. This study aims to analyze and compare market access strategies for advanced therapy drugs in the European and American markets.

METHODS: This study utilized a literature review of recent publications, government reports, and policy briefs to analyze the different market access strategies employed in these markets.

RESULTS: Results of the comparative analysis showed that there are significant differences between the European and American markets' market access strategies and outcomes. Both markets have a centralized process for approving advanced therapy drugs, while the pricing and reimbursement context is fragmented, with decisions taken by multiple payers and States. Recent policy changes and reimbursement difficulties have led to drug withdrawals for some advanced therapy drugs in Europe (7 withdrawals for 25 authorizations), which is impacting its attractiveness to drug manufacturers. The arrival on the European market of products with conditional authorizations promotes uncertainty of long-term effectiveness for payers and their reluctance concerning high ATMP prices, lengthening economic evaluation times and sometimes resulting in decisions negative refunds or disagreements in price (only 70% approved products are reimbursed [median]). In contrast, the American market is facing challenges related to high drug prices (3 ATMPS with price tags above 3M$) and limited patient access. Trends in advanced therapy drugs market access include new payment models, and increased collaboration between payers, regulators, and drug manufacturers.

CONCLUSIONS: The findings of this study suggest that the disparities between the European and American markets are beginning to mark a trend where Europe is losing attractiveness compared to the United States in its ability to absorb these innovations. Policymakers, payers, and drug manufacturers must collaborate to develop innovative market access strategies that balance patient access and affordability while promoting innovation and high-quality care.