%0 Journal Article
%T Factors influencing the reimbursement of cancer drugs in Europe: A scoping review.
%A Nieto-Gómez P
%A Castaño-Amores C
%J J Eval Clin Pract
%V 0
%N 0
%D 2024 Jul 3
%M 38959379
%F 2.336
%R 10.1111/jep.14080
%X <B>BACKGROUND: </B>Reimbursement process of oncology drugs in Europe occurs within a complex decision-making process that varies between Member States. Distinctions between the States trigger societal debates since it is necessary to balance access to medicines and health systems sustainability.<BR><B>OBJECTIVE: </B>We aimed to review the evidence concerning factors associated with the reimbursement decision or Health Technology Agency recommendation of oncology drugs in Europe.<BR><B>METHODS: </B>A systematic literature search was performed in two databases from inception to august 2023. Screening and data extraction were performed by pairs.<BR><B>RESULTS: </B>Thirteen articles were included and encompassed data from 11 nations. Seven articles showed that cost-effective (C-E) drugs and lower Incremental Cost-Effectiveness Ratios (ICERs) had higher likelihood of reimbursement. Disease severity might influence the reimbursement decision with financial agreements. Improvement in clinical outcomes, substantial clinical benefit (p < 0.01) or overall survival gains (p < 0.05) were positively associated. Orphan drug designation impact varies between countries but positive decisions are usually achieved under specific conditions. Clinical and C-E uncertainty frequently led to reimbursement with financial agreements or outcomes-based conditions. Sociodemographic factors as: social health insurance system, higher Gross Domestic Product and larger elderly population were positively associated with reimbursement (p < 0.01).<BR><B>CONCLUSIONS: </B>There is a need for further research into key determinants of reimbursement decisions in Europe and the development of drug access models that can effectively address and overcome costs and effectiveness uncertainties.