Trends in Reimbursement Agreements for Innovative Orphan and Oncological Medicines in Spain 2020-2025
Author(s)
Júlia Armengol, MSc, ELISENDA POMARES MALLOL, MSc, Cristina Espinosa, Sr., MBA, MD.
Cencora Spain, Barcelona, Spain.
Cencora Spain, Barcelona, Spain.
OBJECTIVES: To analyze trends in the reimbursement for innovative, orphan, and oncology drugs in Spain from January 2020 to June 2025.
METHODS: Data were extracted from BIFIMED, a public database on the reimbursement situation for medicines managed by the Spanish Ministry of Health. The analysis focused on the different types of reimbursement agreements, as well as prescription and dispensing conditions (e.g., hospital use or diagnosis). The drugs included were innovative (defined as non-generic and/or non-biosimilar), orphan, and oncology (defined as ATC L01) new drugs or indications.
RESULTS: Between 2020 and 2025, 43% of innovative drugs (N=582), 42% of oncology drugs (N=164) and 94% of orphan drugs (N=230) were subjected to limited reimbursement conditions through specific agreement. Seguimed was the most common agreement across all categories (51% for innovative, 43% for oncology and 36% for orphan drugs). These agreements increasingly incorporated monitoring and financial control mechanisms, such as budget caps, maximum cost per patient, and sales thresholds. In particular, budget cap and sales thresholds were more commonly applied for orphan drugs, while oncology drugs were more often subject to sales thresholds and payback mechanisms (i.e., the difference between the reimbursement ex-factory price and the foreign price used for drugs in special situations). Prescription or dispensing restrictions were observed in 49% of innovative drugs and 66% of oncology drugs. In contrast, such limitations were significantly more prevalent for orphan drugs, affecting 92% of them.
CONCLUSIONS: These findings suggest an alignment between drug categories and the characteristics of the agreements applied to them. The widespread use of Seguimed underscores the importance of monitoring systems within managed entry agreements. The frequent application of financial agreements for orphan drugs mainly reflects efforts to address high treatment costs, while the use of such agreements for oncology drugs indicates a focus on controlling overall expenditure driven by high treatment volumes.
METHODS: Data were extracted from BIFIMED, a public database on the reimbursement situation for medicines managed by the Spanish Ministry of Health. The analysis focused on the different types of reimbursement agreements, as well as prescription and dispensing conditions (e.g., hospital use or diagnosis). The drugs included were innovative (defined as non-generic and/or non-biosimilar), orphan, and oncology (defined as ATC L01) new drugs or indications.
RESULTS: Between 2020 and 2025, 43% of innovative drugs (N=582), 42% of oncology drugs (N=164) and 94% of orphan drugs (N=230) were subjected to limited reimbursement conditions through specific agreement. Seguimed was the most common agreement across all categories (51% for innovative, 43% for oncology and 36% for orphan drugs). These agreements increasingly incorporated monitoring and financial control mechanisms, such as budget caps, maximum cost per patient, and sales thresholds. In particular, budget cap and sales thresholds were more commonly applied for orphan drugs, while oncology drugs were more often subject to sales thresholds and payback mechanisms (i.e., the difference between the reimbursement ex-factory price and the foreign price used for drugs in special situations). Prescription or dispensing restrictions were observed in 49% of innovative drugs and 66% of oncology drugs. In contrast, such limitations were significantly more prevalent for orphan drugs, affecting 92% of them.
CONCLUSIONS: These findings suggest an alignment between drug categories and the characteristics of the agreements applied to them. The widespread use of Seguimed underscores the importance of monitoring systems within managed entry agreements. The frequent application of financial agreements for orphan drugs mainly reflects efforts to address high treatment costs, while the use of such agreements for oncology drugs indicates a focus on controlling overall expenditure driven by high treatment volumes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PT33
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy, Risk-sharing Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology, Rare & Orphan Diseases