Cirrhotic PBC Linked to High Comorbidity Burden, Healthcare Resource Utilization

New research is shedding light on the importance of timely treatment to avoid hospitalization and disease progression for mitigating the clinical and economic burden of primary biliary cholangitis (PBC).1

Leveraging data from Komodo’s Healthcare Map™ and Optum Clinformatics® Data Mart healthcare claims databases, the study found the majority of patients who had ≥ 1 acute-care event experienced additional acute-care events, particularly among those with cirrhosis, who were also more likely to have more concomitant medical conditions.1

In 2024, the PBC treatment landscape saw the addition of 2 new therapeutic options with the accelerated approvals of seladelpar and elafibranor, helping to address unmet needs for patients who do not respond to or cannot tolerate first-line ursodeoxycholic acid.2,3 Even with these new therapies, patients continue to face numerous difficulties related to their disease.

“Patients with PBC tend to have a high comorbidity burden, healthcare resource utilization and cost burden,” Robert Gish, MD, principal of Robert G Gish Consulting LLC and medical director of the Hepatitis B Foundation, and colleagues wrote.1 “Due to the chronic, progressive nature of PBC, the development of cirrhosis has been linked to further negative clinical outcomes."

To evaluate the clinical characteristics and healthcare resource utilization for acute care and its costs for patients with PBC with or without cirrhosis, investigators conducted a retrospective observational cohort study using deidentified inpatient, outpatient, and pharmacy claims from 2 datasets, Komodo Health and Optum CDM, between 2015 and 2023.1

Investigators identified patients with a diagnosis of PBC based on PBC diagnosis codes in any position in ≥1 inpatient claim or ≥2 outpatient claims on different days. For inclusion, patients were required to be ≥18 years of age at the index date and enrolled in a health plan for ≥12 months pre-index and ≥1 day post-index.1

Patients were assessed for the presence of cirrhosis during the 12 months prior to entry into the cohort and were flagged and assigned to the cirrhosis group based on the presence of ICD-9 or ICD-10 diagnosis codes and a claim for an imaging procedure within 6 months prior to the cirrhosis diagnosis based on AASLD guidelines for follow-up imaging.1

Measures of healthcare resource utilization included outpatient visits and acute-care events consisting of hospitalizations and emergency department visits that did not lead to hospitalization.1

In Komodo Health, 29,758 patients with a mean age of 59.2 (Standard deviation [SD], 13.2) years had PBC. Of those patients, 21.6% had cirrhosis. In Optum CDM, 8143 patients with a mean age of 67.0 (SD, 12.7) years had PBC. Of those patients, 20.7% had cirrhosis.1

Investigators noted there was a larger proportion of men in the cirrhosis group compared with the non-cirrhosis group in both the Komodo Health (31.7 vs 16.3%) and the Optum CDM (29.7 vs 16.5%) datasets.1

In Komodo Health, annually, 20.8% of patients had ≥ 1 hospitalization. Among these patients, 60.2% had ≥ 1 additional hospitalization. Of note, a greater proportion of patients with cirrhosis had ≥ 1 hospitalization compared with patients without cirrhosis, and the mean length of hospital stay was longer in the cirrhosis cohort than the non-cirrhosis cohort.1

In Optum CDM, annually, 19.8% of patients had ≥ 1 hospitalization. Among these patients, 62.4% had ≥ 1 additional hospitalization. Similar to Komodo Health, a greater proportion of patients with cirrhosis had ≥ 1 hospitalization compared with patients without cirrhosis. However, investigators noted the mean length of hospitalization stay was similar in the cirrhosis cohort versus the non-cirrhosis cohort.1

Annually, among patients with cirrhosis who had a hospitalization, 69.3% had additional hospitalizations, and among patients who had an emergency department visit, 52.9% had additional emergency department visits, with similar results observed in both Komodo Health and Optum CDM.1

Further analysis revealed the mean annual total overall medical cost per patient was $62,149.47 (SD, $173,669.94). Investigators pointed out the overall liver-related and pancreatobiliary-related costs were substantially higher for patients with cirrhosis compared with those without cirrhosis. For patients with acute-care events, the overall mean annual acute-care cost was $66,598.49 (SD, $182,447.54).1

“The findings support the importance of timely treatment to prevent hospitalization and disease progression to mitigate the healthcare burden in patients with PBC,” investigators concluded.1

References

1. Gish RG, MacEwan JP, Levine A, et al. Burden of illness for patients with primary biliary cholangitis: an observational study of clinical characteristics and healthcare resource utilization. J Comp Eff Res. doi:10.57264/cer-2024-0174.

2. Brooks A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed March 11, 2025. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis

3. Brooks A. FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC. HCPLive. June 10, 2024. Accessed March 11, 2025. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-elafibranor-iqirvo-for-pbc