Presentation (CTI)

OBJECTIVES: Global pharmaceutical spending is expected to increase due to rising medicine use and the high cost of innovative treatments, posing affordability challenges for healthcare systems—particularly for rare disease and cancer therapies. To manage uncertainty around the real-world effectiveness of new drugs, managed entry agreements (MEAs) have been widely adopted in Europe, Australia, and parts of Asia. These agreements allow for price reductions and performance-linked reimbursements. On behalf of the ISPOR Nordic Chapter, this study aims to describe the processes used to establish MEAs in the Nordic countries—known for their strong health technology assessment (HTA) systems—and to categorize the types of agreements implemented.
METHODS: Processes and MEA characteristics are described based on publicly available information for 2023 to 2025, sourced from relevant authority websites.
RESULTS: Descriptive findings show that Sweden, Denmark, and Finland apply MEAs more frequently than Norway, indicating a more active use of such agreements. There are also notable differences in how MEAs are applied to outpatient versus inpatient drugs. Across the region, cost-sharing agreements—including confidential discounts, rebates, and refunds—are the most common. In contrast, performance-based agreements, where reimbursement is tied to clinical outcomes, remain rare, suggesting a cautious approach to outcome-based models.
CONCLUSIONS: Country-specific differences are evident: Denmark predominantly uses straight rebates, while Sweden favors cost-sharing but has yet to implement performance-based MEAs. In Sweden, companies often propose confidential agreements, but regional authorities are less inclined to pursue them, partly due to the perceived administrative burden. This misalignment has led to reported delays in access to new treatments. Outcome-based agreements, when aligned with specific risks, tend to require less strict confidentiality and may yield higher refunds for payers. Moreover, if relevant endpoints are available through national registries, the administrative burden is reduced, improving feasibility and making such models more attractive in resource-constrained settings.