Health Technology Assessment of Advanced Therapy Medicinal Products: Comparison Among 3 European Countries.

ABSTRACT: Even for centrally approved products, each European country is responsible for the effective national market access. This step can result in inequalities in terms of access, due to different opinions about the therapeutic value assessed by health technology assessment (HTA) bodies. Advanced therapy medicinal products (ATMPs) represent a major issue with regard to the HTA in order to make them available at a national level. These products are based on genes, tissues, or cells, commonly developed as one-shot treatment for rare or ultrarare diseases and mandatorily authorized by the EMA with a central procedure. This study aims to provide a comparative analysis of HTA recommendations issued by European countries (France, Germany, and Italy) following EMA approval of ATMPs. We found a low rate

SUBMITTER: Gozzo L 

PROVIDER: S-EPMC8531540 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature