Advanced Therapy Medicinal Products: Availability, Access and Expenditure in Italy.

ABSTRACT:

Background

Advanced therapy medicinal products (ATMPs) are an innovative output of biomedical research, characterized by a high level of uncertainty on long-term efficacy and safety, elevated price tags and often complex administration. All these elements compounded make their European authorization, national price negotiation for reimbursement and subsequent dispensation and administration to the patient less straightforward and often less successful than for less innovative drugs. To assess if these hurdles have affected patient access and how are ATMPs used in Italy, we have analysed availability, access and expenditure of ATMPs in the period spanning from 2016 to 2023.

Methods

We have analysed real world data on the duration of ATMP regulatory evaluations for authorisati

SUBMITTER: Rivetti di Val Cervo P 

PROVIDER: S-EPMC11530470 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature