The national budget impact of managed entry agreement strategies match with high-cost drugs to maximise drug cost saving: a study protocol.

Background: Drug expenditure is an important part of health expenditure. Managed Entry Agreement (MEA) is a common strategy implemented in many countries, such as the United States, the United Kingdom, and the European countries to control drug expenditures, especially for new and high-cost drugs. This study aims to explore the appropriate MEA technique for reaching the lowest cost of drug procurement under specified uncertainty of the high-cost drug. Methods: The cost of drug procurement varied by the MEA techniques will be investigated in the quantitative analysis based on MEA taxonomies and uncertainty in terms of price, use, and effectiveness. Then, the content analysis will be employed to the qualitative analytical part to summarise the matching of appropriate MEA technique with the characteristics of high-cost drug to lower the cost of drug procurement and increase access to high-cost drugs. Discussion: The rationales for each MEA technique selection are similar across their objectives. MEA can help reduce drug expenditures. Therefore, the budget in health care system could be sustainable and the patient access to high-cost drug could be increased. However, it might not be suitable for some circumstances and should not be implemented to determine drug price or used as regular reimbursement.