AI-ENABLED BUDGET IMPACT AND RISK-SHARING SIMULATION FOR A GREEK INNOVATION FUND: COMPARING TRADITIONAL REBATE POLICY WITH OUTCOME-BASED REIMBURSEMENT FOR EU JCA MEDICINES, 2026-2029
Author(s)
Thanasis Chalikias, M.Sc.1, Athanassios Vozikis, Professor2, Platon Peristeris, Ph.D.3.
1Economics Dept.,, Laboratory of Health Economics and Management (LabHEM), University of Piraeus, Piraeus, Greece, 2Laboratory of Health Economics and Management (LabHEM), University of Piraeus, Economics Dept., Piraeus, Greece, 3Laboratory of Health Economics and Management (LabHEM), University of Piraeus, Piraeus, Greece.
1Economics Dept.,, Laboratory of Health Economics and Management (LabHEM), University of Piraeus, Piraeus, Greece, 2Laboratory of Health Economics and Management (LabHEM), University of Piraeus, Economics Dept., Piraeus, Greece, 3Laboratory of Health Economics and Management (LabHEM), University of Piraeus, Piraeus, Greece.
OBJECTIVES: To estimate the four-year budget impact of EU JCA-relevant oncology, rare disease, and advanced therapy medicines in Greece, comparing a traditional rebate-based cost method with an outcome-based Innovation Fund reimbursement approach under a €50 million annual budget cap.
METHODS: A dynamic budget impact model was developed for 2026-2029, incorporating phased entry of 15 high-value medicines. Two reimbursement scenarios were compared. The Traditional Cost Method applied sequential deductions to manufacturer price: an 8.74% statutory deduction, a 70% rebate, and a 5% invoice discount, resulting in an effective cost of 26.01% of manufacturer price. The Innovation Fund Method applied a 15% flat reduction and 5% invoice discount, followed by a 100% rebate for non-responders. The model estimated annual budget impact, affordable patient access, product-level budget drivers, and probabilistic uncertainty using Monte Carlo simulation.
RESULTS: Under the Traditional Cost Method, expected budget impact increased from €3.29 million in 2026 to €14.77 million in 2027, €29.99 million in 2028, and €32.51 million in 2029. Under the Innovation Fund Method, budget impact increased from €3.84 million to €20.62 million, €45.23 million, and €49.44 million, respectively. Cumulative four-year budget impact was €80.56 million under the traditional method and €119.14 million under the Innovation Fund Method. Monte Carlo analysis showed higher budget uncertainty under the Innovation Fund Method, particularly in 2028-2029.
CONCLUSIONS: The Traditional Cost Method was more budget-conservative, while the Innovation Fund Method created a more value-aligned reimbursement structure by linking payer exposure to treatment response. However, the Innovation Fund Method increased expected budget impact and generated higher uncertainty in mature portfolio years. These findings suggest that an outcome-based Greek Innovation Fund could preserve patient access to high-cost JCA medicines, but sustainable implementation would require patient-volume controls, risk corridors, response tracking, and real-world evidence infrastructure.
METHODS: A dynamic budget impact model was developed for 2026-2029, incorporating phased entry of 15 high-value medicines. Two reimbursement scenarios were compared. The Traditional Cost Method applied sequential deductions to manufacturer price: an 8.74% statutory deduction, a 70% rebate, and a 5% invoice discount, resulting in an effective cost of 26.01% of manufacturer price. The Innovation Fund Method applied a 15% flat reduction and 5% invoice discount, followed by a 100% rebate for non-responders. The model estimated annual budget impact, affordable patient access, product-level budget drivers, and probabilistic uncertainty using Monte Carlo simulation.
RESULTS: Under the Traditional Cost Method, expected budget impact increased from €3.29 million in 2026 to €14.77 million in 2027, €29.99 million in 2028, and €32.51 million in 2029. Under the Innovation Fund Method, budget impact increased from €3.84 million to €20.62 million, €45.23 million, and €49.44 million, respectively. Cumulative four-year budget impact was €80.56 million under the traditional method and €119.14 million under the Innovation Fund Method. Monte Carlo analysis showed higher budget uncertainty under the Innovation Fund Method, particularly in 2028-2029.
CONCLUSIONS: The Traditional Cost Method was more budget-conservative, while the Innovation Fund Method created a more value-aligned reimbursement structure by linking payer exposure to treatment response. However, the Innovation Fund Method increased expected budget impact and generated higher uncertainty in mature portfolio years. These findings suggest that an outcome-based Greek Innovation Fund could preserve patient access to high-cost JCA medicines, but sustainable implementation would require patient-volume controls, risk corridors, response tracking, and real-world evidence infrastructure.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA38
Topic
Health Policy & Regulatory, Health Technology Assessment, Real World Data & Information Systems
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology, Personalized & Precision Medicine, Rare & Orphan Diseases