Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2025 Apr;14(4):e240174.
doi: 10.57264/cer-2024-0174. Epub 2025 Mar 6.

Burden of illness for patients with primary biliary cholangitis: an observational study of clinical characteristics and healthcare resource utilization

Robert G Gish  1 , Joanna P MacEwan  2 , Alina Levine  2 , Dannielle Lebovitch  2 , Leona Bessonova  3 , Darren Wheeler  3 , Radhika Nair  3 , Alan Bonder  4
Affiliations
Observational Study

Burden of illness for patients with primary biliary cholangitis: an observational study of clinical characteristics and healthcare resource utilization

Robert G Gish et al. J Comp Eff Res. 2025 Apr.

Abstract

Aim: To evaluate the clinical characteristics and healthcare resource utilization for acute care and its costs for patients with primary biliary cholangitis (PBC) with or without cirrhosis. Materials & methods: This retrospective observational cohort study was conducted using two datasets (Komodo's Healthcare Map™ [Komodo Health] and Optum Clinformatics® Data Mart [CDM] database) between 2015 and 2023. Patients (≥18 years) with PBC were identified based on ≥1 inpatient or ≥2 outpatient claims. Healthcare resource utilization for acute care (hospitalizations and emergency department [ED] visits [not leading to hospitalization]) were assessed in both datasets, and associated medical costs were evaluated in Optum CDM. Results: In Komodo Health, of the 29,758 patients with PBC (mean age: 59.2 years), 21.6% had cirrhosis and 50.4% of patients with cirrhosis had Medicaid or Medicare coverage. Of the total 8143 patients in Optum CDM (mean age: 67.0 years), 20.7% had cirrhosis, and most were enrolled in Medicare (69.7%). There was a larger proportion of men in the cirrhosis group compared with the no-cirrhosis group in Komodo Health (31.7 vs 16.3%) and Optum CDM (29.7 vs 16.5%). Annually, among patients with cirrhosis who had a hospitalization, 69.3% had additional hospitalizations, and among patients who had an ED visit, 52.9% had additional ED visits in Komodo Health; similar results were observed in Optum CDM. Among patients with at least one acute-care event, the mean annual acute-care costs with and without cirrhosis were $113,568 and $47,436, respectively. Conclusion: Data from two large healthcare claims databases showed that the majority of patients who had at least one acute-care event experienced additional acute-care events, particularly among those with cirrhosis. Timely treatment to avoid hospitalization and disease progression may help mitigate the clinical and economic burden for patients with PBC.

Keywords: acute care; healthcare resource utilization; liver cirrhosis; primary biliary cholangitis.

PubMed Disclaimer

Conflict of interest statement

Competing interests disclosure

RG Gish is a consultant for Abacus, Abbott, AbbVie, Albireo, Aligos, Altimmune, Antios, Arrowhead, AstraZeneca, Audentes Therapeutics, Corcept, Dynavax, Effectus, Eiger, Eisai, Enyo, Fibronostics, Fujifilm/Wako, Genentech, Genlantis, Gerson Lehrman Group, Gilead Sciences, GSK, Helios, HepaTx, HepQuant, Intercept, Janssen, JBS Science, Kinnate Biopharma, Merck, Perspectum, Pfizer, Precision BioSciences, Quest, Seres Therapeutics, Sonic Incytes, Topography Health, Tune Therapeutics, Venatorx, and Virion. He is on the advisory board for AbbVie, Dynavax, Enyo, Genentech, Genlantis, Gilead, Helios, HepaTx, HepQuant, Intercept, Janssen, Merck, Pfizer, and Prodigy. He receives grants/research support from Gilead. He is a data safety monitoring board member for Arrowhead, CymaBay Therapeutics, Durect, Kezar Life Sciences, Sagimet and Takeda. JP MacEwan, A Levine and D Lebovitch are employees of Genesis Research Group. R Nair and L Bessonova are employees of Intercept. D Wheeler is a former employee of Intercept. A Bonder is a consultant for Intercept and GSK. He receives clinical trial funding from Chemomab, CymaBay, Gilead, Intercept and Mirum. He is the Editor for Clinical Liver Disease and DynaMed. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Figures

Figure 1.
Figure 1.. Timeline of the retrospective observational cohort study using two datasets.
The two administrative claims data source include (A) Komodo’s Healthcare Map™ administrative claims database and (B) Optum Clinformatics® Data Mart database. CDM: Clinformatics Data Mart; PBC: Primary biliary cholangitis.
Figure 2.
Figure 2.. Main patient selection criteria used in the study.
The two databases included similar selection criteria from (A) Komodo’s Healthcare Map™ administrative claims database and (B) Optum Clinformatics® Data Mart database. CDM: Clinformatics Data Mart; ICD: International Classification of Diseases; PBC: Primary biliary cholangitis.
See this image and copyright information in PMC

References

    1. Trivella J, John BV, Levy C. Primary biliary cholangitis: epidemiology, prognosis, and treatment. Hepatol. Commun. 7(6), e0179 (2023). - PMC - PubMed

    2. • The current data on the epidemiology, prognosis and treatment of primary biliary cholangitis (PBC) including repurposed and emerging novel drugs are discussed. The timely identification of the disease, access to care and early initiation of treatment were emphasized for an effective, comprehensive management for patients with PBC.

    1. Bowlus CL, Kenney JT, Rice G, Navarro R. Primary biliary cholangitis: medical and specialty pharmacy management update. J. Manag. Care Spec. Pharm. 22(10-a-s Suppl.), S3–S15 (2016). - PMC - PubMed
    1. Lu M, Zhou Y, Haller IV et al. Increasing prevalence of primary biliary cholangitis and reduced mortality with treatment. Clin. Gastroenterol. Hepatol. 16(8), 1342–1350; e1341 (2018). - PubMed
    1. Buchanan-Peart K-A, MacEwan J, Levine Aet al.. et al. (Eds). United States prevalence of diagnosed primary biliary cholangitis: 41 per 100,000 adults with wide regional variability. Poster presented at: AASLD The Liver Meeting 2023. Boston, MA, USA: (10–14 November 2023).
    1. Younossi ZM, Bernstein D, Shiffman ML et al. Diagnosis and management of primary biliary cholangitis. Am. J. Gastroenterol. 114(1), 48–63 (2019). - PubMed

Publication types

MeSH terms

LinkOut - more resources