OBJECTIVES: Advanced Therapy Medicinal Products (ATMPs) are innovative therapies including gene, cell therapies, and tissue-engineered products. These therapies hold promises to cure diseases with high clinical unmet needs. However, ATMPs are facing critical hurdles in accessing the market. The study objective was to review ATMP assessments by Health Technology Assessment (HTA) bodies in the 5 big European Countries (EU5) to understand main limitations for securing adoption.

METHODS: A search was conducted on 01/06/2018 in European Medicines Agency (EMA) website to identify ATMPs approved in Europe. Available ATMPs HTA reports were extracted from EU5 HTA websites and were reviewed.

RESULTS: Ten ATMPs were approved in Europe: Chondrocelect^®, Glybera^®, MACI^®, Provenge^®, Holoclar^®, Imlygic^®, Strimvelis^®, Zalmoxis^®, Spherox^® and Alofisel^®