Integrative Review of Managed Entry Agreements: Chances and Limitations

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Health Technology Assessment

Background:

• Managed Entry Agreements (MEAs) are financial instruments to mitigate risks associated with high-priced medicines.
• Concerns exist regarding the implementation and impact of MEAs, necessitating critical appraisal.
• There is a specific need to evaluate MEAs for their planned introduction in Brazil.

Purpose of the Study:

• To identify and appraise key attributes and concerns of MEAs.
• To provide critical considerations for the implementation of MEAs in Brazil and similar economies.
• To inform payers and their advisors on the strategic use of MEAs.

Main Methods:

• An integrative review of MEAs globally was conducted.
• The review question focused on the types of health technology MEAs applied worldwide.
• Findings were supplemented with expert knowledge, including insights from South American markets and decision-makers.

Main Results:

• Twenty-five studies were reviewed, predominantly featuring medicines (96.8%), with a focus on financial arrangements (43%).
• Antineoplastic medicines were frequently included in MEAs, and data confidentiality was common.
• Advantages like improved reimbursement were noted, alongside disadvantages such as data collection challenges for outcome-based schemes.

Conclusions:

• The use of MEAs is expected to grow due to new, high-cost treatments and resource constraints.
• Outcome-based MEAs offer potential for enhancing access to innovative medicines but require careful consideration of critical issues.
• Cross-country comparisons of MEA knowledge and practices are vital for guiding future policy in middle- and high-income countries.