Managed Entry Agreement Belgium

Managed Entry Agreement Belgium

Managed Entry Agreement in Belgium: What You Need to Know

A Managed Entry Agreement (MEA) is a contract between a pharmaceutical company and the government or healthcare payers, allowing patients access to new and innovative treatments. It is also known as a risk-sharing agreement, as it involves sharing the financial risk associated with uncertain outcomes of the treatment.

In Belgium, MEAs are regulated by the National Institute for Health and Disability Insurance (INAMI/RIZIV) and are used to determine the reimbursement of the treatment costs. The MEA is designed to ensure that patients who need new treatments can access them while allowing the healthcare system to manage its budget effectively.

Types of Managed Entry Agreements in Belgium

There are several types of MEAs in Belgium, including:

1. Cost-sharing agreements: This type of agreement involves sharing the costs of the treatment between the government and the pharmaceutical company. In this agreement, the payment of the drug is linked to the outcomes of the treatment.

2. Outcome-based agreements: These agreements are based on the clinical outcomes of the treatment. The payment of the drug is linked to the achievement of specific health outcomes.

3. Performance-based agreements: These agreements are based on the performance of the drug in terms of cost and effectiveness. The payment of the drug is linked to the achievement of specific performance targets.

Benefits of MEAs in Belgium

MEAs have several benefits for patients, healthcare payers and pharmaceutical companies. These benefits include:

1. Improved patient access to treatments: MEAs allow patients to access new and innovative treatments that may not have been available otherwise.

2. Cost-effectiveness: MEAs ensure that healthcare budgets are used effectively and efficiently.

3. Reduced financial risks: MEAs help to reduce the financial risks associated with uncertain outcomes of the treatment.

4. Innovation: MEAs encourage pharmaceutical companies to develop new and innovative treatments.

Challenges of MEAs in Belgium

Despite the benefits of MEAs, their implementation in Belgium has faced some challenges, including:

1. Complex negotiations: Negotiating an MEA requires a lot of time, resources and expertise from both the pharmaceutical company and the government.

2. Data availability: The success of an MEA depends on the availability of reliable data on the treatment outcomes.

3. Transparency: Transparency is essential for the success of MEAs, but it is not always easy to achieve as some information may be confidential.

Conclusion

Managed Entry Agreements are a valuable tool for ensuring patient access to new and innovative treatments while managing healthcare budgets effectively. In Belgium, MEAs are regulated by the National Institute for Health and Disability Insurance (INAMI/RIZIV), and there are different types of MEAs available. Despite some challenges, such as the complexity of negotiations and data availability, the benefits of MEAs outweigh the challenges.