Advanced therapy medicinal products (ATMPs) are a relatively new class of medicine incorporating cell and gene therapies and tissue/genetic engineering. Their innovation and effectiveness, however, comes with a high price and minimal evidence. Health technology assessment (HTA) bodies, therefore, must be able to review both traditional and new medicines, such as the ATMPs, despite their very different profiles.
This guidance note presents examples sustainable ATMP payment models and examples of how to gain ATMP marketing authorisation, and explores innovative contracting trends in Europe, the use of real-world evidence and the impact of varying funding methods.

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