S2750 Cost Effectiveness Analysis of Elafibranor Versus Seladelpar for Primary Biliary Cholangitis

Introduction: Up to 40% of patients with primary biliary cholangitis (PBC) exhibit incomplete biochemical response to ursodeoxycholic acid (UDCA). Elafibranor and Seladelpar, both peroxisome proliferator activated receptor agonists are approved second line options, yet their relative economic value remains unclear. Methods: A Markov model followed UDCA incomplete responders for 5 years from payer and societal perspectives. Health states (response, non-response, progression, death) cycled every 3 months. Transition probabilities derived from phase III trials. Costs (2025 USD) and utilities were discounted at 3% per year. Primary outcome: incremental cost effectiveness ratio (ICER) at a willingness to pay (WTP) of $100,000/QALY. Probabilistic sensitivity analysis (PSA, 10,000 iterations) explored uncertainty. Results: Five-year discounted cost was $657,342 for elafibranor vs $720,313 for seladelpar. Quality adjusted life years (QALYs) were 3.14 and 3.05, respectively. Elafibranor dominated seladelpar, saving $62,971 per patient (ICER: –$250,415/QALY). PSA showed Elafibranor was cost effective in 99.6% of simulations at the prespecified WTP. Budget impact analysis projected annual U.S. savings >$40 million if elafibranor replaced seladelpar in eligible patients. Conclusion: Elafibranor provides greater health benefit at lower cost versus seladelpar and should be the preferred second line pharmacologic therapy for PBC. Substantial price reductions would be required for seladelpar to become cost effective.