Elafibranor More Cost-Effective Than Seladelpar for Second-Line PBC Treatment

New research is shedding light on the comparative health benefits and associated costs of second-line treatment with elafibranor versus seladelpar in patients with primary biliary cholangitis (PBC).1

The data were presented at the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting by Kashyap Nalakonda, MD, University of New Mexico, and suggest elafibranor provides greater health benefit at a lower cost than seladelpar and should therefore be the preferred second line pharmacologic therapy for PBC.1

“Up to 40% of patients with PBC exhibit incomplete biochemical response to UDCA,” Nalakonda and colleagues wrote.1 “Elafibranor and seladelpar, both peroxisome proliferator activated receptor agonists, are approved second line options, yet their relative economic value remains unclear.”

Prior to the US Food and Drug Administration (FDA) accelerated approvals of elafibranor and seladelpar, obeticholic acid served as the sole FDA-approved second line option for patients with an inadequate response to or intolerance of ursodeoxycholic acid (UDCA). Initially granted accelerated approval in 2016, the next second-line agent after obeticholic acid did not enter the treatment landscape until 2024, when the FDA approved elafibranor and seladelpar over the span of 2 months.2

However, on September 11, 2025, Intercept Pharmaceuticals announced its decision to voluntarily withdraw obeticholic acid from the US market for the treatment of PBC following a request from the FDA. The action followed a November 2024 Complete Response Letter to the supplemental New Drug Application for obeticholic acid for the treatment of PBC. With obeticholic acid no longer available as a second-line treatment option for UDCA non-responders, understanding the cost-effectiveness of elafibranor and seladelpar will be important for informing treatment decisions.2

In the present study, investigators employed a Markov model that followed UDCA incomplete responders for 5 years from payer and societal perspectives. Health states including response, non-response, progression, death cycled every 3 months, with transition probabilities derived from phase 3 trials. Costs in 2025 USD and utilities were discounted at 3% per year.1

The primary outcome was incremental cost effectiveness ratio (ICER) at a willingness to pay (WTP) of $100,000/quality adjusted life years (QALY).1

Upon analysis, the 5-year discounted cost was $657,342 for elafibranor compared with $720,313 for seladelpar. QALYs were 3.14 and 3.05, respectively. Investigators noted elafibranor dominated seladelpar, saving $62,971 per patient (ICER, –$250,415/QALY).1

Probabilistic sensitivity analysis at 10,000 iterations showed elafibranor was cost effective in 99.6% of simulations at the prespecified WTP. Additional budget impact analysis projected annual US savings >$40 million if elafibranor replaced seladelpar in eligible patients.1

“Elafibranor provides greater health benefit at lower cost versus seladelpar and should be the preferred second line pharmacologic therapy for PBC,” investigators concluded.1 “Substantial price reductions would be required for seladelpar to become cost effective.”

References

1. Nalakonda K, Telbany A, Perez ET. Cost Effectiveness Analysis of Elafibranor versus Seladelpar for Primary Biliary Cholangitis. Presented at the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting. Phoenix, Arizona. October 27-29, 2025.

2. Brooks A. Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market. HCPLive. September 11, 2025. Accessed October 30, 2025. https://www.hcplive.com/view/intercept-voluntarily-withdrawals-obeticholic-acid-ocaliva-for-pbc-from-us-market