Early access programs for medicines: comparative analysis among France, Italy, Spain, and UK and focus on the Italian case.

ABSTRACT: Early access programs (EAPs) generally refer to patient access to medicines/indications before marketing authorization, possibly extended to price and reimbursement approval. These programs include compassionate use, which is usually covered by pharmaceutical companies, and EAPs reimbursed by third-party payers. This paper aims at comparing EAPs in four European countries (France, Italy, Spain, UK) and providing empirical evidence on EAPs in Italy. The comparative analysis was conducted through a literature review (including scientific and grey literature), complemented by 30-min semi-structured interviews with local experts. The Italian empirical analysis employed data available on the National Medicines Agency website. Although EAPs are very different across countries, they exhibit some

SUBMITTER: Tarantola A 

PROVIDER: S-EPMC10193685 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature