EAHP Statements:

2.1, 4.1.

Abstract

Managed entry agreements (MEAs) are mechanisms, which have been developed to limit the reimbursement of medicines, facilitate access to the market and to generate further clinical evidence of innovative, expensive drugs.

A variety of MEAs exist, and they may be categorized into "economically based agreements" (EBAs) and "performance-based agreements" (PBAs). EBAs, such as price-volume based agreements and capping agreements, are based on drug use at an aggregated level, while PBAs, such as risk sharing agreements, are based on use of the drug at patient level.

The agreements require close monitoring of the drug use to ensure correct reimbursement of the drugs. In particular, PBAs may be challenged by the level of information needed for monitoring. Predefined, objective, clinical criteria to measure effect of the drug need to be available – preferably through clinical databases – and data should to be valid and quickly accessible for reimbursement. Otherwise it may be necessary to provide clinicians or hospital pharmacies with an administration burden to ensure availability of data.

The MEAs require an agreement between the payer and the industry, which may be difficult, since the various types of MEAs may not seem to have a balanced benefit for both parties. However, some European countries have gained some experience with MEAs during previous years.

Learning objectives

After the seminar, participants should be able to:
• List available types of MEA; and,
• Understand the benefits and limitations of MEA from the perspective of hospital pharmacists, regulators and the industry.

Educational need addressed

Managed entry agreements are becoming increasingly popular when introducing new, expensive medicines into a market. Hospital pharmacists may be involved in these agreements, hence it is of importance for hospital pharmacists to understand the mechanisms behind using managed entry agreements including risks and benefits for the hospital when implementing MAEs.

Keywords: managed entry agreements, drug cost reimbursement, new expensive drugs.