KCE Glossary

In Belgium, an MEA is a temporary agreement (Article 111 agreement) between the government (RIZIV/Minister of Health) and a pharmaceutical company. It allows an innovative medicine to be temporarily reimbursed, despite uncertainties about its cost-effectiveness, clinical value or budget impact.

Objectives

• Rapid access to new treatments for patients
• Bridging uncertainty about effectiveness or value for money
• Collecting data (e.g. via real-world evidence) for later reassessment

Features

1. Temporary
   An MEA is always temporary. Such agreements usually last between one and three years, with the possibility of extension. During this period, the medicine is reimbursed under agreed conditions.
    
2. Confidential price agreements
   The actual price paid by the government for the medicine under an MEA is usually confidential. Only the official list price is publicly available. The contractual agreements on discounts or reimbursements are not made public for competitive and negotiation strategy reasons.
    
3. Conditions
   The agreement contains specific conditions under which the medicine is temporarily reimbursed. These conditions may be financial in nature, such as price discounts, budget ceilings or reimbursement mechanisms. In addition, substantive conditions may also apply, such as the mandatory collection of additional clinical data or the monitoring of patient outcomes in practice (real-world data).
    
4. Reassessment based on new data
   At the end of the agreed period, the medicine is reassessed on the basis of the data collected during the term of the agreement. Depending on the outcome, a decision is made on whether the medicine will be reimbursed on a permanent basis or whether access will be discontinued.

More info:

KCE Report 288 (2017) – How to improve the Belgian process for Managed Entry Agreements? An analysis of the Belgian and international experience 
KCE Report 343 (2021) – Do innovative medicines against cancer always have a real added value?