Study Highlights Regional Variability in PBC Prevalence, Limited Specialist Care Access

Findings from a recent study are shedding light on the population-based estimated prevalence of primary biliary cholangitis (PBC) in the US, helping to address the need for improved knowledge of its epidemiology and geographic variation to improve access to care.1

Leveraging data from Komodo's Healthcare Map, a national administrative claims database encompassing approximately 330 million patients in the US, the study found the adjusted prevalence of adult patients with PBC in 2021 was 40.9 per 100,000 persons, with the greatest absolute number of patients with PBC in heavily populated urban areas. However, the prevalence adjusted for population size was greatest in some rural areas, and notable variations were observed in specialist care.1

“This analysis provides the most comprehensive, population-based estimate of PBC prevalence in the United States to date,” Cynthia Levy, MD, a professor of medicine in the division of digestive health and liver diseases and associate director of the Schiff Center for Liver Diseases at the University of Miami, and colleagues wrote.1

Recent years have seen significant progress in understanding the natural history and overall management of PBC, as evidenced by the approval of 2 new second-line therapies in 2024 alone. Elafibranor (Iqirvo) and seladelpar (Livdelzi), both peroxisome proliferator-activated receptor agonists, were granted accelerated approval by the US Food and Drug Administration in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in those unable to tolerate UDCA.2,3

Despite these advances, knowledge on the epidemiology and geographic variation of PBC in the United States remains limited but will be necessary in order to improve access to care.1

To estimate the prevalence of PBC in the United States, its regional variability, and the type of care received by patients with PBC, investigators identified individuals ≥ 18 years of age with either ≥ 1 inpatient or ≥ 2 outpatient claims ≥ 1 day apart with a diagnosis code for PBC between January 2014 and December 2021 from Komodo's Healthcare Map. Individuals ≥ 18 years of age were identified and included as the prevalence denominator.1

Additionally, patients’ 3-digit ZIP Codes were mapped to ZCTA3s, with certain ZCTA3s combined into groups to allow for 1:1 mapping. Investigators adjusted the PBC prevalence per 100,000 adult population by age and gender at the ZCTA3 level, which was derived from the 2021 American Community Survey.1

In an exploratory analysis, patients’ PBC-related medical or pharmacy claims were used to determine health care provider specialties and affiliations.1

A total of 41,426 adults in Komodo Health met all study selection criteria. Investigators noted most patients were female (83.0%), with a mean age in 2021 of 61.9 (standard deviation, 13.2) years. Of the 31,806 (76.8% of total) patients with race/ethnicity information available, 67.6% were White.1

The adjusted prevalence of adult patients with PBC was 40.9 per 100,000 persons, for an estimated total of 105,506 adults with PBC in the US in 2021. Investigators pointed out that although the highest absolute number of patients with PBC was in heavily populated urban areas, prevalence adjusted for population size was highest in some rural areas.1

Further analysis of Komodo Health claims data revealed the vast majority (83.2%) of patients, irrespective of therapy use, received care from a specialist, including a gastroenterologist or hepatologist, at some point during the study period. However, only 53.5% of patients were seen by a specialist at their most recent visit with a PBC-related claim, suggesting barriers to specialist care may exist for some patients.1

“The prevalence estimates of PBC and regional variability, especially in some rural areas, highlight the need to further examine potential risk factors for PBC,” investigators concluded.1 “Additionally, most patients with PBC, irrespective of therapy use, were treated by a specialist at some point during the study period, but only approximately half received specialist care in their most recent claim. Greater access to specialist care once patients are diagnosed to support awareness of PBC and its management is needed.”

References

1. Levy C, Buchanan-Peart KA, MacEwan JP, et al. A nationwide study of primary biliary cholangitis prevalence, geographic distribution, and health care providers. Hepatol Commun. doi:10.1097/HC9.0000000000000677.

2. Brooks A. FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC. HCPLive. June 10, 2024. Accessed April 22, 2025. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-elafibranor-iqirvo-for-pbc

3. Brooks A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed April 22, 2025. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis