Managed Entry Agreements: An Overview
Managed Entry Agreements (MEAs) are tools used by healthcare systems to control costs associated with the introduction of new drugs. These agreements are becoming increasingly popular, especially in countries where healthcare expenditures are high. The Organisation for Economic Co-operation and Development (OECD) has played a significant role in promoting the use of MEAs as a means of improving access to new drugs and ensuring the sustainability of healthcare systems.
What are Managed Entry Agreements?
Managed entry agreements are contracts drawn up between pharmaceutical companies and healthcare authorities to determine how new drugs will be introduced into the market. MEAs can be used to manage the risk associated with the uncertainty of clinical outcomes, safety, and cost-effectiveness of new treatments. These agreements are often used for drugs that are considered high-cost or have limited clinical data.
Types of Managed Entry Agreements
There are multiple types of MEAs that can be used to define the entry of a new drug into the market. These include:
1. Discount-based Agreements: In this type of agreement, the manufacturer offers a discount on the drug’s price in exchange for guaranteed access to a specific patient population. The discount can be based on various factors such as the size of the population, the number of patients treated, or the specific indication.
2. Outcome-based Agreements: These agreements are based on the clinical outcomes of a new drug. The manufacturer will only be paid if the drug achieves predefined clinical outcomes such as improved survival rates, reduced hospitalization, or improved quality of life.
3. Risk-Sharing Agreements: These agreements are based on the idea that the risks associated with new drugs should be shared between the manufacturer and the healthcare authority. The risk can be shared through various mechanisms, such as the introduction of a cap on the manufacturer`s liability or an agreement to reimburse the authority if the drug does not perform as expected.
The Role of OECD in Promoting Managed Entry Agreements
The OECD has played a significant role in promoting the use of Managed Entry Agreements as a means of improving access to new drugs while keeping healthcare costs under control. The organization has developed guidelines on how to design and implement MEAs, highlighting the importance of transparency, fair pricing, and the use of professional judgment.
In addition, the OECD has published a report that analyses the use of MEAs in different countries. The report highlights the challenges and opportunities associated with the use of these agreements and provides recommendations on how to overcome these challenges.
Managed Entry Agreements are becoming increasingly popular as healthcare systems strive to control costs while improving access to new drugs. The use of MEAs can help healthcare authorities manage the risks associated with new drugs and ensure that they are cost-effective. The OECD has played a significant role in promoting the use of MEAs and continues to provide guidance and recommendations to support the implementation of these agreements.