CLINICAL AND ECONOMIC VALUE OF SELADELPAR IN COMBINATION WITH URSODEOXYCHOLIC ACID FOR THE TREATMENT OF PRIMARY BILIARY CHOLANGITIS IN SPAIN
Author(s)
Santiago Grau, PhD1, Helena Cantero, MSc2, Victoria Martín-Escudero, MSc2, Rocío González Alonso del Hoyo, MSc3, María Mareque, MBA3.
1Hospital del Mar, Barcelona, Spain, 2Gilead Sciences, Madrid, Spain, 3Pharmacoeconomics & Outcomes Research IBeria, Madrid, Spain.
1Hospital del Mar, Barcelona, Spain, 2Gilead Sciences, Madrid, Spain, 3Pharmacoeconomics & Outcomes Research IBeria, Madrid, Spain.
OBJECTIVES: The objective was to evaluate the clinical and economic outcomes of seladelpar in combination with ursodeoxycholic acid (UDCA) compared with elafibranor + UDCA in terms of clinical events avoided and associated cost savings in a hypothetical cohort of patients with primary biliary cholangitis (PBC) eligible for second-line (2L) treatment from the Spanish National Health Service (NHS) perspective.
METHODS: A cohort-level Markov state transition model was adapted to reflect the natural history of PBC by simulating liver-related complications (decompensated cirrhosis, hepatocellular carcinoma, pre-transplant, liver transplant) and PBC re-emergence over a lifetime horizon. Transition probabilities were derived from a matching-adjusted indirect comparison and published literature. The analysis considered a hypothetical cohort of 3,115 adults eligible for 2L therapy, sourced from published literature. The analysis focused on downstream liver related complication management-related costs; drug acquisition costs were not included. A 3% annual discount rate was applied to both costs and outcomes, consistent with economic evaluation guidelines. All model parameters and assumptions were validated by a multidisciplinary expert panel.
RESULTS: In the hypothetical cohort of 3,115 patients with PBC, seladelpar + UDCA reduced the number of clinical events compared to elafibranor + UDCA (-4.10% decompensated cirrhosis, -4.84% hepatocellular carcinoma, -4.27% pre-transplant, -4.68% liver transplantation, and -5.75% PBC re-emergence). These reductions translated into €3,561,058 in total cost savings compared to elafibranor + UDCA, associated with managing liver-related complications, including €414,571 for decompensated cirrhosis, €80,820 for hepatocellular carcinoma, €481,490 for pre-transplant care, €2,546,992 for liver transplantation, and €37,185 for PBC re-emergence.
CONCLUSIONS: According to the model results, seladelpar + UDCA may reduce clinical events associated with PBC progression (including decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and PBC re-emergence) compared with elafibranor + UDCA. Seladelpar + UDCA reduced disease progression and associated healthcare costs, and may generate substantial cost savings for the Spanish NHS.
METHODS: A cohort-level Markov state transition model was adapted to reflect the natural history of PBC by simulating liver-related complications (decompensated cirrhosis, hepatocellular carcinoma, pre-transplant, liver transplant) and PBC re-emergence over a lifetime horizon. Transition probabilities were derived from a matching-adjusted indirect comparison and published literature. The analysis considered a hypothetical cohort of 3,115 adults eligible for 2L therapy, sourced from published literature. The analysis focused on downstream liver related complication management-related costs; drug acquisition costs were not included. A 3% annual discount rate was applied to both costs and outcomes, consistent with economic evaluation guidelines. All model parameters and assumptions were validated by a multidisciplinary expert panel.
RESULTS: In the hypothetical cohort of 3,115 patients with PBC, seladelpar + UDCA reduced the number of clinical events compared to elafibranor + UDCA (-4.10% decompensated cirrhosis, -4.84% hepatocellular carcinoma, -4.27% pre-transplant, -4.68% liver transplantation, and -5.75% PBC re-emergence). These reductions translated into €3,561,058 in total cost savings compared to elafibranor + UDCA, associated with managing liver-related complications, including €414,571 for decompensated cirrhosis, €80,820 for hepatocellular carcinoma, €481,490 for pre-transplant care, €2,546,992 for liver transplantation, and €37,185 for PBC re-emergence.
CONCLUSIONS: According to the model results, seladelpar + UDCA may reduce clinical events associated with PBC progression (including decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and PBC re-emergence) compared with elafibranor + UDCA. Seladelpar + UDCA reduced disease progression and associated healthcare costs, and may generate substantial cost savings for the Spanish NHS.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE247
Topic
Economic Evaluation
Disease
Rare & Orphan Diseases