ABSTRACT
Previously, when a drug received marketing authorisation, the process of achieving a price for the new drug was negotiated with government bodies without any need to demonstrate the value of the new treatment. In some countries, this process was replaced by a revised paradigm (Figure 11.1) in which a payer evidence review body – that is, a group of experts – assesses whether the new treatment is cost-effective. Hence, two sets of experts, one that assesses efficacy and another that separately assesses value, review the evidence for efficacy and cost-effectiveness/reimbursement. Reimbursement authorities are essentially representatives of health systems from different countries who determine the level of compensation for the drugs that are made available for their patient populations through their respective health systems.
