COMPARING THE IMPLEMENTATION OF OUTCOMES-BASED AGREEMENTS IN SPAIN AND DENMARK: IMPLICATIONS FOR MANAGING UNCERTAINTY IN EUROPEAN MARKETS
Author(s)
Olof Mogard, MSc1, Justyna Tomassy, MSc2.
1Parexel International, Zürich, Switzerland, 2Parexel International, Krakow, Poland.
1Parexel International, Zürich, Switzerland, 2Parexel International, Krakow, Poland.
OBJECTIVES: Outcomes-based agreements (OBAs) address uncertainty in high-cost therapies by aligning clinical value and financial risk. Spain and Denmark represent divergent healthcare models - budget-impact and cost-effectiveness driven, respectively. Spain developed a structured OBA approach tracked in VALTERMED since 2019, while Denmark operationalised alternative agreement models in 2023 via the Danish Medicines Council and Amgros. This study aimed to compare the maturity and implications of these approaches in countries representing two different decision-making archetypes.
METHODS: A targeted review of publicly available information on OBAs was conducted using Pubmed, ISPOR databases, and official sources, including BIFIMED, VALTERMED and Danish Medicines Council/Amgros frameworks.[1,2] A qualitative framework was used to assess implementation of OBAs across governance, data infrastructure, outcome tracking, and operational feasibility.
RESULTS: Spain demonstrated broad, systematized adoption through VALTERMED-based data collection. While ≥25 OBAs were implemented (2017-2022), uptake declined from 2023, with simpler financial agreements replacing OBAs despite existing infrastructure.[3,4] Denmark has expressed a growing interest in expanding the use of OBAs, however, only two OBAs have been implemented to date, reflecting their selective application and a strong focus on feasibility to optimize follow-up of outcomes.[5,6] Recent DMC/Amgros guidance emphasizes early alternative agreement proposals within the first six weeks of HTA review.[7]
CONCLUSIONS: Spain's experience shows that data infrastructure alone is insufficient for sustained OBAs; operational complexity limits scalability. Denmark integrates OBAs within alternative agreements, prioritizing feasibility and system compatibility. Spain's primary OBA goal is controlling expenditures and accelerating access, while Denmark addresses clinical uncertainty to maximize health gains relative to money spent. For Marketing Authorisation Holders (MAHs), early economic modelling is essential to identify and quantify uncertainty at launch, enabling alignment with country requirements. OBA proposals must be feasible (Denmark) and supported by appropriate outcomes tracking (Spain) while meeting early HTA timelines, ensuring targeted and implementable access strategies.
METHODS: A targeted review of publicly available information on OBAs was conducted using Pubmed, ISPOR databases, and official sources, including BIFIMED, VALTERMED and Danish Medicines Council/Amgros frameworks.[1,2] A qualitative framework was used to assess implementation of OBAs across governance, data infrastructure, outcome tracking, and operational feasibility.
RESULTS: Spain demonstrated broad, systematized adoption through VALTERMED-based data collection. While ≥25 OBAs were implemented (2017-2022), uptake declined from 2023, with simpler financial agreements replacing OBAs despite existing infrastructure.[3,4] Denmark has expressed a growing interest in expanding the use of OBAs, however, only two OBAs have been implemented to date, reflecting their selective application and a strong focus on feasibility to optimize follow-up of outcomes.[5,6] Recent DMC/Amgros guidance emphasizes early alternative agreement proposals within the first six weeks of HTA review.[7]
CONCLUSIONS: Spain's experience shows that data infrastructure alone is insufficient for sustained OBAs; operational complexity limits scalability. Denmark integrates OBAs within alternative agreements, prioritizing feasibility and system compatibility. Spain's primary OBA goal is controlling expenditures and accelerating access, while Denmark addresses clinical uncertainty to maximize health gains relative to money spent. For Marketing Authorisation Holders (MAHs), early economic modelling is essential to identify and quantify uncertainty at launch, enabling alignment with country requirements. OBA proposals must be feasible (Denmark) and supported by appropriate outcomes tracking (Spain) while meeting early HTA timelines, ensuring targeted and implementable access strategies.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA150
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas