Abstract
When high–price drugs or new drugs with immature information about their efficacy come to market, will cause uncertainty in the health systems, especially for health–service buyers as the payers in the health systems. Managed Entry Agreement (MEA) is the tools for manage uncertainty that are widely used in many countries such as United Kingdom, two third of OECD member countries, European Union countries. MEA can be divided into two types: financial–based agreement and performance–based agreement. The financial–based agreement aims to limit budget impact through controlling drug costs. It is a simple method, effective in reduce drug prices and limit budget impact, but the details contained in the agreement are confidential, resulting in a lack of transparency. It may give some payers the benefit of such details. It can be implemented at 2 levels: population level and patient level. At the population level, consists of MEA in the model of discount / rebate, price–volume agreement, and expenditure cap. At the patient level, consists of MEA in the model of free initiation treatment and utilization cap that provides individual patient coverage. The performance–based agreement is an agreement based on the actual treatment efficacy. Sometimes referred to as health outcome–based agreement. This agreement is divided in two groups. The first group aims to optimize drug use, known as performance linked reimbursement, which consists of MEA in the model of conditional treatment continuation and pay by result. The second group aims to address uncertainty about drug efficacy with more research studies. This model of MEA is known as coverage with evidence development, or CED. It is a good solution to the problems, but it is complicated to operate, and affect stakeholders in the health systems widely, and high cost in operation. However, the decision–makers in the health system should carefully consider in the selection and implementation of MEA, as each model of MEA has different strengths and limitations, for efficient budgeting and equal access to medicines.
