High-impact medicines, system sustainability and the role of access management: evidence from Catalonia
Year: 2026
Type: article
Study design: Observational Study
Abstract: Background The reimbursement of high-impact medicines (HIMs) poses growing clinical and budgetary challenges for publicly funded health systems. In Catalonia, pharmaceutical spending has increased considerably in recent years, driven by the uptake of high-cost therapies and expanded indications under clinical and economic uncertainty. To mitigate these risks, payers have increasingly used managed access mechanisms in reimbursement strategies. Objective To assess the economic impact of newly reimbursed high-impact medicines in Catalonia and describe the role and economic implications of managed access mechanisms applied to address clinical and financial uncertainty. Methods We conducted a retrospective study using real-world data from Catalonia's health service registries and billing systems. Expenditure trends for HIMs between 2019 and 2024 were analysed. Newly reimbursed indications from 2022 to 2024 were evaluated by therapeutic class, volume of patients, and aggregated expenditure per patient, taking into account the managed access mechanisms applied. Results From 2019 to 2024, HIM expenditure rose by 53% in nominal terms, from €1.10 billion to €1.69 billion; after adjustment for inflation, 2019 expenditure corresponded to approximately €1.30 billion in 2024 euros, indicating a real increase of approximately 30%. In 2024, HIM expenditure represented about 11% of the total healthcare expenditure managed by the Catalan Health Service. The top 10 medicines accounted for 43% of expenditure. Newly reimbursed indications in 2024 represented €23.6 million. Managed access mechanisms were applied to nearly three-quarters of these indications, including indication-based restrictions and formal agreements. Formal managed access agreements included confidential discounts, spending caps, patient-level spending caps, free-dose schemes, price–volume agreements, outcome-based payment models, and staggered payments. Conclusions Newly reimbursed HIMs exert concentrated expenditure pressure. These findings illustrate how the broad use of managed access mechanisms can support balancing access to innovation with health system sustainability. Future research is needed to identify the most effective managed access strategies to facilitate access to new HIMs at costs sustainable for health systems. Research in context What is already known about the topic? High-impact medicines are a major driver of pharmaceutical expenditure in many countries. Their rapid introduction often occurs with limited long-term evidence and substantial uncertainty regarding clinical outcomes and economic impact. To address these challenges, health systems have increasingly implemented managed access policies, including indication-based access restrictions and managed access agreements, although evidence on their scope and economic impact remains limited. What does this study add to the literature? This study provides a comprehensive real-world analysis of newly reimbursed high-impact medicines in Catalonia, quantifying their expenditure and describing the managed access mechanisms applied. It estimates the economic implications of managed access agreements and shows that newly reimbursed high-impact medicines have consistently higher aggregated expenditure per patient than overall high-impact medicine use, with expenditure concentrated in a small number of drugs and indications. What are the policy implications? These findings underscore the importance of managed access mechanisms as a key policy tool to mitigate the clinical and economic uncertainty associated with high-cost medicines. The Catalan experience offers a transferable example of how access governance and managed access agreements can support timely access to innovation while preserving health system sustainability.
Source: Health Policy OPEN
Institutions: Generalitat de Catalunya, Universitat Autònoma de Barcelona
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $2,740
OpenAlex ID: W7222804182