Factors influencing the reimbursement of cancer drugs in Europe: A scoping review.

Abstract

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. We aimed to review the evidence concerning factors associated with the reimbursement decision or Health Technology Agency recommendation of oncology drugs in Europe. A systematic literature search was performed in two databases from inception to august 2023. Screening and data extraction were performed by pairs. 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). 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.