European HTA recommendations for ATMPs available as of June 2019.

Advanced Therapy Medicinal Products (ATMPs) include cell therapies, gene therapies, and tissue engineered products.

As of June 2019, 14 ATMPs have been granted marketing authorization in Europe (2): seven gene therapies, three cell therapies, and four tissue engineered products. Marketing authorizations for the first four approved ATMPs have been withdrawn by their sponsors for commercial reasons.

To date, Germany is the country with the highest number of ATMPs that are or were reimbursed, with a total of six, four of which are still on the market. NICE England recommended the reimbursement of five, all of them currently available to patients. Four ATMPs were recommended for reimbursement by HTA bodies in France, while in Italy three are reimbursed and currently available to patients. Only one product was reimbursed in Spain before its withdrawal and no ATMPs have been reimbursed in Sweden.

A Review of ATMP HTA Reports