A COST CALCULATOR FOR ESTIMATING DIRECT MEDICAL COST AVOIDANCE FROM SECOND-LINE SELADELPAR USE IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS
Author(s)
Maria Agapova, MSc, PhD1, Kaylee Lukasek, BS2, Connor Davies, BA2, Chong H Kim, MPH, MS, PhD1;
1Gilead Sciences, Foster City, CA, USA, 2Costello Medical, Boston, MA, USA
1Gilead Sciences, Foster City, CA, USA, 2Costello Medical, Boston, MA, USA
OBJECTIVES: To estimate the healthcare costs avoided associated with achievement of alkaline phosphatase (ALP) normalization or reduced pruritus with second-line seladelpar treatment for primary biliary cholangitis (PBC).
METHODS: A decision tree cost calculator was developed from a healthcare payer perspective with a one-year time horizon. Outputs were cohort-level (1,000-patient) and per-patient direct medical costs avoided with seladelpar vs no treatment.
Two analyses were conducted: analysis 1 (ALP normalization) and analysis 2 (pruritus reduction). Each considered second-line-eligible PBC patients. In analysis 2, all patients were assumed to have a pruritus diagnosis. ALP normalization and pruritus resolution/near-resolution rates were from RESPONSE (NCT04620733). In the base case, the RESPONSE average ALP normalization rate or pruritus resolution/near-resolution rate was applied. Further ALP normalization analyses considered a population with ALP above normal but below 1.67 × upper limit of normal (ULN).
ALP level distribution and costs associated with ALP levels and pruritus were derived from US claims analyses comparing patients with normal ALP vs patients with ALP above normal and those with a pruritus diagnosis vs controls.
RESULTS: Using an average ALP normalization rate of 25.0%, $1,382,391 and $1,382 were avoided in cohort-level and per-patient annual costs, respectively. In analyses of patients with ALP above normal but below 1.67 × ULN, a normalization rate range of 25.0%-75.0% for these patients led to cost avoidance of $532,000-$1,596,000 for the full cohort.
Using a pruritus resolution/near-resolution rate of 26.5%, $3,777,310 were avoided in cohort-level annual costs.
CONCLUSIONS: In the US, achieving ALP normalization and pruritus resolution/near-resolution with seladelpar as second-line treatment for PBC may yield short term avoidance of direct medical costs. Further evaluation of longer term humanistic and economic outcomes is required to fully characterize value. These findings highlight the importance of clinically meaningful biomarkers in guiding treatment decisions and linking improved outcomes to economic value.
METHODS: A decision tree cost calculator was developed from a healthcare payer perspective with a one-year time horizon. Outputs were cohort-level (1,000-patient) and per-patient direct medical costs avoided with seladelpar vs no treatment.
Two analyses were conducted: analysis 1 (ALP normalization) and analysis 2 (pruritus reduction). Each considered second-line-eligible PBC patients. In analysis 2, all patients were assumed to have a pruritus diagnosis. ALP normalization and pruritus resolution/near-resolution rates were from RESPONSE (NCT04620733). In the base case, the RESPONSE average ALP normalization rate or pruritus resolution/near-resolution rate was applied. Further ALP normalization analyses considered a population with ALP above normal but below 1.67 × upper limit of normal (ULN).
ALP level distribution and costs associated with ALP levels and pruritus were derived from US claims analyses comparing patients with normal ALP vs patients with ALP above normal and those with a pruritus diagnosis vs controls.
RESULTS: Using an average ALP normalization rate of 25.0%, $1,382,391 and $1,382 were avoided in cohort-level and per-patient annual costs, respectively. In analyses of patients with ALP above normal but below 1.67 × ULN, a normalization rate range of 25.0%-75.0% for these patients led to cost avoidance of $532,000-$1,596,000 for the full cohort.
Using a pruritus resolution/near-resolution rate of 26.5%, $3,777,310 were avoided in cohort-level annual costs.
CONCLUSIONS: In the US, achieving ALP normalization and pruritus resolution/near-resolution with seladelpar as second-line treatment for PBC may yield short term avoidance of direct medical costs. Further evaluation of longer term humanistic and economic outcomes is required to fully characterize value. These findings highlight the importance of clinically meaningful biomarkers in guiding treatment decisions and linking improved outcomes to economic value.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE168
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
SDC: Rare & Orphan Diseases