Innovative Drug Access in Portugal: An Analysis of Managed Entry Agreements Supporting Public Coverage 2014-2024
Author(s)
Paula Costa, BS1, Ana Margarida Advinha2, Sofia Oliveira Martins3.
1Universidade de Lisboa, Lisboa, Portugal, 2Evora, Portugal, 3Lisbon, Portugal.
1Universidade de Lisboa, Lisboa, Portugal, 2Evora, Portugal, 3Lisbon, Portugal.
OBJECTIVES: Managed Entry Agreements (MEAs) are tools designed to reduce clinical uncertainty and mitigate budget impact of often high-cost, innovative medicines. While finance-based MEAs have been widely used, the increasing complexity of therapies has driven the adoption of more sophisticated and tailored agreements, including risk-sharing models. This study aims to characterize the MEAs established to support public coverage decisions for innovative medicines—defined as those containing new active substances—that received marketing authorization between 2014 and 2024 and obtained positive reimbursement decisions in Portugal
METHODS: A structured survey was conducted between September 2024-March 2025, targeting Market Access Directors of Marketing Authorization Holders (MAHs) of the innovative medicines. The survey, administered via an Excel-based questionnaire, was qualitative in nature and consisted of closed-ended questions aiming to identify and characterize existing MEAs. The medicine cohort comprised a wide range of therapeutic areas and includes synthesized, biologics, and ATMPs.
RESULTS: Responses were obtained for 54% (120) of the new medicines reimbursed. MEAs were reported in 94% of cases. Finance-based agreements accounted for the majority, across all type of molecules and therapeutic areas, while outcome-based risk-sharing agreements represented 4%. This more complex MEAs were applied to therapies with high upfront costs and long-term benefits, particularly in areas such as oncology. Further analysis will be published.
CONCLUSIONS: MEAs have played a crucial role in enabling access to innovative therapies within Portugal’s NHS. Despite the emergence of new types of medicines, with high impact (financial and clinical), traditional finance-based agreements remain the preferred approach. Performance-based agreements are still the exception. Their limited adoption highlights the need for greater maturity, trust, and operational readiness in implementing outcome-based models. Continued evaluation and stronger collaboration among stakeholders are essential to optimize MEA use and ensure sustainable value for patients and healthcare system.
METHODS: A structured survey was conducted between September 2024-March 2025, targeting Market Access Directors of Marketing Authorization Holders (MAHs) of the innovative medicines. The survey, administered via an Excel-based questionnaire, was qualitative in nature and consisted of closed-ended questions aiming to identify and characterize existing MEAs. The medicine cohort comprised a wide range of therapeutic areas and includes synthesized, biologics, and ATMPs.
RESULTS: Responses were obtained for 54% (120) of the new medicines reimbursed. MEAs were reported in 94% of cases. Finance-based agreements accounted for the majority, across all type of molecules and therapeutic areas, while outcome-based risk-sharing agreements represented 4%. This more complex MEAs were applied to therapies with high upfront costs and long-term benefits, particularly in areas such as oncology. Further analysis will be published.
CONCLUSIONS: MEAs have played a crucial role in enabling access to innovative therapies within Portugal’s NHS. Despite the emergence of new types of medicines, with high impact (financial and clinical), traditional finance-based agreements remain the preferred approach. Performance-based agreements are still the exception. Their limited adoption highlights the need for greater maturity, trust, and operational readiness in implementing outcome-based models. Continued evaluation and stronger collaboration among stakeholders are essential to optimize MEA use and ensure sustainable value for patients and healthcare system.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR125
Topic
Economic Evaluation, Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas