Association Between Elevations in Alkaline Phosphatase and Healthcare Utilization and Costs Among Individuals With Primary Biliary Cholangitis In The United States
Author(s)
Robert G. Gish, MD1, Michel Mendler, MD2, Edward Mena, MD2, Chong H Kim, MPH, MS, PhD3, Fiorella Murillo Perez, PhD3, Yi Pan, PhD3, Mihail Samnaliev, PhD4, Diane Ito, MA5, Maria Agapova, PhD3.
1Robert G. Gish Consultants, San Diego, CA, USA, 2California Liver Research Institute, San Diego, CA, USA, 3Gilead, San Francisco, CA, USA, 4Director, Stratevi, Needham, MA, USA, 5Stratevi, Santa Monica, CA, USA.
1Robert G. Gish Consultants, San Diego, CA, USA, 2California Liver Research Institute, San Diego, CA, USA, 3Gilead, San Francisco, CA, USA, 4Director, Stratevi, Needham, MA, USA, 5Stratevi, Santa Monica, CA, USA.
Presentation Documents
OBJECTIVES: Primary biliary cholangitis (PBC) is a chronic, progressive liver disease. Alkaline phosphatase (ALP) is a key biomarker in the management of PBC, however evidence of the economic benefits of having normal ALP is limited. We evaluated the relationship between ALP levels and healthcare resource utilization (HRU) and costs among US individuals with PBC.
METHODS: A retrospective analysis was conducted using Komodo’s Healthcare Map insurance claims linked with laboratory data of individuals aged ≥18 years diagnosed with PBC between 09/01/2017 and 09/30/2024. At least two ALP tests conducted ≥30 days apart were required, with the second designated as the index. Continuous enrollment during the 12-month pre- and 12-month post-index was required. One-year regression-adjusted HRU and healthcare costs (2024 USD) among individuals with persistently mildly elevated (ALP>1 x upper limit of normal [ULN] ≤1.67 x ULN), elevated (ALP>1.67 x ULN but ≤3 x ULN) and highly elevated (ALP>3 x ULN) were compared to those with persistently normal ALP (ALP ≤1 x ULN).
RESULTS: 10,933 individuals with PBC were identified, including 9,544, 904, 297, 248 with persistently normal, mildly elevated, elevated, and highly elevated ALP, respectively. Median age was 66 years, most were female (86.0%), White (58.2%), Medicare-insured (59.1%), and with ≥2 Charlson comorbidities (59.8%). Only 50.6% received PBC-specific treatment during the 1-year baseline period. Average 1-year healthcare costs for the entire sample were $18,747 (SD=$48,621). Compared to the normal ALP cohort, incremental regression-adjusted 1-year healthcare costs were $2,128 [-1,140-5,397] p=0.202) greater among for those with mildly elevated ALP, $10,289 [4,730-15,848] p<0.001) greater among individuals with elevated ALP, and $12,229 [95% CI 5,934-18,524] p<0.001) greater among individuals with highly elevated ALP.
CONCLUSIONS: This claims-based analysis of patients with PBC indicates that HRU and costs are associated with elevated and highly elevated ALP. Treating PBC and lowering ALP may significantly decrease these costs.
METHODS: A retrospective analysis was conducted using Komodo’s Healthcare Map insurance claims linked with laboratory data of individuals aged ≥18 years diagnosed with PBC between 09/01/2017 and 09/30/2024. At least two ALP tests conducted ≥30 days apart were required, with the second designated as the index. Continuous enrollment during the 12-month pre- and 12-month post-index was required. One-year regression-adjusted HRU and healthcare costs (2024 USD) among individuals with persistently mildly elevated (ALP>1 x upper limit of normal [ULN] ≤1.67 x ULN), elevated (ALP>1.67 x ULN but ≤3 x ULN) and highly elevated (ALP>3 x ULN) were compared to those with persistently normal ALP (ALP ≤1 x ULN).
RESULTS: 10,933 individuals with PBC were identified, including 9,544, 904, 297, 248 with persistently normal, mildly elevated, elevated, and highly elevated ALP, respectively. Median age was 66 years, most were female (86.0%), White (58.2%), Medicare-insured (59.1%), and with ≥2 Charlson comorbidities (59.8%). Only 50.6% received PBC-specific treatment during the 1-year baseline period. Average 1-year healthcare costs for the entire sample were $18,747 (SD=$48,621). Compared to the normal ALP cohort, incremental regression-adjusted 1-year healthcare costs were $2,128 [-1,140-5,397] p=0.202) greater among for those with mildly elevated ALP, $10,289 [4,730-15,848] p<0.001) greater among individuals with elevated ALP, and $12,229 [95% CI 5,934-18,524] p<0.001) greater among individuals with highly elevated ALP.
CONCLUSIONS: This claims-based analysis of patients with PBC indicates that HRU and costs are associated with elevated and highly elevated ALP. Treating PBC and lowering ALP may significantly decrease these costs.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EE492
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Rare & Orphan Diseases, SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)