Performance-Based vs Finance-Based Managed Entry Agreements (MEAs): Global Trends and Challenges

Author(s)

Pushkarna D, Fazeli MS, del Aguila M, Pourrahmat MM
Evidinno Outcomes Research Inc., Vancouver, BC, Canada

OBJECTIVES: MEAs aim to avoid delayed access to drugs due to budget constraints, and are categorized into performance-based agreements (PBAs) and finance-based agreements (FBAs). However, there is limited literature published on effectiveness of MEAs associated with new drugs. This study aimed to investigate emerging trends, effectiveness and challenges associated with MEAs focusing on FBAs and PBAs.

METHODS: A literature review of peer-reviewed journal articles and policy reports (2018-2024) sourced using Pubmed and Google was conducted. The review focused on identifying trends of MEAs across regions and therapeutic area. Additionally, a descriptive analysis evaluated the effectiveness and challenges associated with MEAs.

RESULTS: Overall, 12 records were identified. This study highlighted that FBAs are more prevalent across Europe and North America than PBAs. According to Global Data’s risk-sharing database, over 1,000 RSAs were made across 28 countries from 2012 to 2022, of which 79% were FBAs. However, a slight shift has been observed towards implementation of PBAs in England and Italy. A 2019 OECD review noted that 44% of all assessed MEAs in England and 59% in Italy were PBAs. In terms of therapeutic area, more than 50% of MEAs have been applied to anticancer therapies, followed by endocrinology at 9.5% and neurology at 6.8%. A European study observed that individual negotiations with MEAs could achieve price reductions ranging from 0% to 50%. However, countries face several challenges in implementing MEAs, including1) complexity of administration and negotiation, 2) need for advanced data structure, 3) privacy and confidentiality issues, and 4) need for alignment with regulatory framework of the manufacturers.

CONCLUSIONS: FBAs are increasingly used in the pharmaceutical landscape in Europe and North America. Future research should assess the overall impact on access, cost-effectiveness and outcomes that could lead to broader adoption globally.

Conference/Value in Health Info

2024-11, ISPOR Europe 2024, Barcelona, Spain

Value in Health, Volume 27, Issue 12, S2 (December 2024)

Code

HPR185

Topic

Health Policy & Regulatory

Topic Subcategory

Risk-sharing Approaches

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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