BMJ Clinical pointers: Managing chronic oedema/lymphoedema in primary care
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. Most of the agreements require close monitoring of the drug use to ensure correct reimbursement of the drugs, and especially 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, 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. On the other hand, MEAs may give hospitals the opportunity to offer patients new, expensive drugs at a lower cost for a period of time. The lecture will give an overview of existing MEAs and provide advice on when the individual MEAs are feasible for use in practice.
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