Prevalence of Claims-Reported Pruritus in Patients With Primary Biliary Cholangitis Overall and Among Those Treated With Obeticholic Acid
Author(s)
Aparna Goel, MD1, Joanna P. MacEwan, PhD2, Jennifer Hernandez, MS2, Alina Levine, MS2, Quynh Doan, PhD, MS3, Christopher White, MD, MSPH3, Jasmine Sham, PharmD3, Radhika Nair, PhD3.
1Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University, Stanford, CA, USA, 2Genesis Research Group, Hoboken, NJ, USA, 3Intercept Pharmaceuticals, Morristown, NJ, USA.
1Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University, Stanford, CA, USA, 2Genesis Research Group, Hoboken, NJ, USA, 3Intercept Pharmaceuticals, Morristown, NJ, USA.
Presentation Documents
OBJECTIVES: Pruritus is a common symptom of primary biliary cholangitis (PBC; ~80% of patients) that impacts health-related quality of life. We assessed the prevalence of claims-reported pruritus in patients with PBC, including a subset who initiated obeticholic acid (OCA) treatment.
METHODS: This analysis identified adults with PBC (≥2 outpatient claims or ≥1 inpatient claim) between October 1, 2016, and January 31, 2024, using Komodo’s Healthcare Map. The date of first claim with a PBC diagnosis was set as the index date. Among these patients, we identified a subset who initiated OCA, including a separate cohort generally aligned to OCA 2021 US prescribing information (USPI) criteria. For OCA-treated patients, the date of first OCA prescription claim on or after the PBC diagnosis date was set as the index date. Patients were enrolled for ≥12 months pre-index and ≥1 day (all PBC) or ≥12 months (OCA treated) post-index. Descriptive analyses were used for patient characteristics and pruritus prevalence. Pruritus was defined using ICD-10-CM code L29.X.
RESULTS: We identified 29,584 patients with PBC (mean [SD] age, 58.5 [13.1] years). Claims-reported pruritus was observed in 21.0% of patients with PBC. Since 2016, 1561 patients initiated OCA; 404 patients met USPI-aligned criteria. Mean age was 55 years in both OCA cohorts. Before initiating OCA, claims-reported pruritus was observed in 17.6% (overall OCA) and 16.6% (USPI aligned) of patients. Claims-reported pruritus before and after OCA initiation was observed in 9.8% (overall OCA) and 10.4% (USPI aligned). Incident claims-reported pruritus after OCA initiation was observed in 9.4% (overall OCA) and 8.9% (USPI aligned).
CONCLUSIONS: Although pruritus is underreported in claims, these data potentially reflect relevant pruritus-related medical visits and may be important to payers and health systems. Prevalence estimates of claims-reported pruritus in the overall PBC and OCA cohorts were similar.
©2024 Komodo Health, Inc. All rights reserved. Used with permission.
METHODS: This analysis identified adults with PBC (≥2 outpatient claims or ≥1 inpatient claim) between October 1, 2016, and January 31, 2024, using Komodo’s Healthcare Map. The date of first claim with a PBC diagnosis was set as the index date. Among these patients, we identified a subset who initiated OCA, including a separate cohort generally aligned to OCA 2021 US prescribing information (USPI) criteria. For OCA-treated patients, the date of first OCA prescription claim on or after the PBC diagnosis date was set as the index date. Patients were enrolled for ≥12 months pre-index and ≥1 day (all PBC) or ≥12 months (OCA treated) post-index. Descriptive analyses were used for patient characteristics and pruritus prevalence. Pruritus was defined using ICD-10-CM code L29.X.
RESULTS: We identified 29,584 patients with PBC (mean [SD] age, 58.5 [13.1] years). Claims-reported pruritus was observed in 21.0% of patients with PBC. Since 2016, 1561 patients initiated OCA; 404 patients met USPI-aligned criteria. Mean age was 55 years in both OCA cohorts. Before initiating OCA, claims-reported pruritus was observed in 17.6% (overall OCA) and 16.6% (USPI aligned) of patients. Claims-reported pruritus before and after OCA initiation was observed in 9.8% (overall OCA) and 10.4% (USPI aligned). Incident claims-reported pruritus after OCA initiation was observed in 9.4% (overall OCA) and 8.9% (USPI aligned).
CONCLUSIONS: Although pruritus is underreported in claims, these data potentially reflect relevant pruritus-related medical visits and may be important to payers and health systems. Prevalence estimates of claims-reported pruritus in the overall PBC and OCA cohorts were similar.
©2024 Komodo Health, Inc. All rights reserved. Used with permission.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EPH29
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
SDC: Gastrointestinal Disorders, SDC: Rare & Orphan Diseases