Health Technology Assessment Throughout the Drug Lifecycle

Abstract

This thesis investigated whether medicines could be used more quickly by patients through better cooperation between authorities that deal with the approval and reimbursement of medicines. The approval of medicines is largely done by the European Medicines Agency (EMA), while the reimbursement of medicines is regulated separately by each European country. Usually a national agency is responsible for decisions regarding reimbursement. This research project has shown that the assessments regarding drug approval (by a regulatory authority) and reimbursement (by a reimbursement authority) have certain similarities, which opens up options for better alignment of the two evaluations and thus a speedier overall evaluation process. If reimbursement authorities are involved earlier in the drug development process, they can help promote the generation of relevant evidence that will help them make better reimbursement decisions faster.