[PHP26] Market Access of ATPMs: Overview and Expected Challenges
2015 Value in Health
Hanna, E. | Tavella, F. | Rémuzat, C. | Auquier, P. | Toumi, M. |
Advanced therapy medicinal products (ATMPs) are a class of innovative and regenerative therapies. As of May 2015, only 5 ATMPs were granted a marketing authorisation (MA) in European Union (EU): three cell therapies, Provenge® (for advanced prostate cancer), Chondrocelect® and MACI® (for cartilage defects); one tissue engineering product, Holoclar® (for damaged cornea); and one gene therapy, Glybera®(for lipoprotein lipase deficiency). The aim of this study was to review the ATMPs assessments by EU HTA bodies.