---
title: "Saroglitazar in Primary biliary cholangitis: cost-effectiveness analyses and utility weights"
description: "Published cost-effectiveness analyses and health-state utility weights for Saroglitazar in Primary biliary cholangitis, each value quoted from the article: 6 cost-effectiveness analyses and 4 studies reporting utility weights. Analyses: Obeticholic acid plus ursodeoxycholic acid versus ursodeoxycholic acid alone in primary biliary cholangitis with an inadequate response to ursodeoxycholic acid, United States: Samur et al. (2017); Obeticholic acid versus standard of care in nonalcoholic steatohepatitis, United States: Gal et al. (2023); Resmetirom versus standard of care in metabolic dysfunction-associated steatohepatitis with fibrosis stage F2 or F3, United States: Le et al. (2025); Resmetirom versus placebo in nonalcoholic steatohepatitis with liver fibrosis, United States: Javanbakht et al. (2023); 2 further articles. Utility weights: Utility weights for liver disease states and adverse events, nonalcoholic steatohepatitis: Gal et al. (2023); Utility weights for cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver transplant, metabolic dysfunction-associated steatotic liver disease: Le et al. (2025); Utility weights for cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver transplant, nonalcoholic steatohepatitis: Javanbakht et al. (2023); Utility weights for compensated cirrhosis, decompensated cirrhosis, hepatoma, and the first year after liver transplant, nonalcoholic steatohepatitis: Mahady et al. (2012). Every value is a verbatim quote from the primary article it is shown with."
canonical: "https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/cost-effectiveness-analyses"
published: "2026-10-22T07:49:06-04:00"
modified: "2026-10-22T07:49:06-04:00"
---
# Saroglitazar in Primary biliary cholangitis: cost-effectiveness analyses and utility weights
Published cost-effectiveness analyses and health-state utility weights that a model of this product could cite, adapt, or compare against, grouped by how each article relates to the product and its indication. Every value is quoted from the article it cites, and section 3 lists the searches that found the articles.
## Overview
| Item | Detail |
| --- | --- |
| Literature searched | Tufts Medical Center Cost-Effectiveness Analysis Registry, searched October 21, 2026; the queries are listed in section 3. |
| Cost-effectiveness analyses | 6 |
| Studies reporting utility weights | 4 |
## 1 Cost-effectiveness analyses
### 1.1 Analyses of Saroglitazar
No evidence found.
### 1.2 Treatments for the same indication
#### Obeticholic acid plus ursodeoxycholic acid versus ursodeoxycholic acid alone in primary biliary cholangitis with an inadequate response to ursodeoxycholic acid, United States: Samur et al. (2017)
Relevance: Evaluates obeticholic acid added to ursodeoxycholic acid against ursodeoxycholic acid alone in primary biliary cholangitis with an inadequate response to ursodeoxycholic acid in the United States, the second-line add-on whose FDA approval section 2 reports as withdrawn.
Access: Not open access
Not quoted: The perspective, discount rate, and cost year are reported in the full text, which this page does not quote.
> “Our objective was to evaluate the long-term clinical impact and cost-effectiveness of OCA as a second-line treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA.”
> “We developed a mathematical model to simulate the lifetime course of PBC patients treated with OCA+UDCA versus UDCA alone. Efficacy data were derived from the phase 3 PBC OCA International Study of Efficacy trial, and the natural history of PBC was informed by published clinical studies.”
> “The discounted quality-adjusted life years with UDCA and OCA+UDCA were 10.74 and 11.78, respectively, and the corresponding costs were $142,300 and $633,900, resulting in an incremental cost-effectiveness ratio of $473,400/quality-adjusted life year gained.”
> “The results were most sensitive to the cost of OCA.”
> “OCA is a promising new therapy to substantially improve the long-term outcomes of PBC patients, but at its current annual price of $69,350, it is not cost-effective using a willingness-to-pay threshold of $100,000/quality-adjusted life year; pricing below $18,450/year is needed to make OCA cost-effective.”
Source: [Samur et al. (2017)](https://pubmed.ncbi.nlm.nih.gov/27906472/)
### 1.3 The same disease in other populations or settings
No evidence found.
### 1.4 Related diseases and analogous treatments
#### Obeticholic acid versus standard of care in nonalcoholic steatohepatitis, United States: Gal et al. (2023)
Relevance: Evaluates obeticholic acid against standard of care in nonalcoholic steatohepatitis from a United States payer perspective over a lifetime horizon, the drug whose FDA approval for primary biliary cholangitis section 2 reports as withdrawn.
> “Patient-level simulation and cohort-level Markov models were implemented in the same framework.”
> “The prototype analysis assessed the cost-effectiveness of obeticholic acid versus standard of care from a US payer perspective over a lifetime horizon with costs and effects discounted at 3% per annum.”
> “Efficacy and adverse event parameters were obtained from the 18-month interim analysis of the REGENERATE trial.”
> “The prototype analysis was performed using a PLS. For obeticholic acid versus SoC, respectively, total costs were $911,651 versus $244,263, total LYs were 15.651 versus 14.935, and total QALYs were 12.325 versus 11.637”
> “Incremental costs, US$ 667,389”
> “Incremental QALYs 0.688”
> “ICUR (cost per QALY gain), US$ 969,949”
Source: [Gal et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC10635953/)
#### Resmetirom versus standard of care in metabolic dysfunction-associated steatohepatitis with fibrosis stage F2 or F3, United States: Le et al. (2025)
Relevance: Estimates the cost-effectiveness and maximal annual price of resmetirom in metabolic dysfunction-associated steatohepatitis with fibrosis stage F2 or F3 from a United States payer perspective, a disease for which saroglitazar is approved in India.
> “This economic evaluation used an agent-based state-transition microsimulation model with a yearly cycle and 14 distinct histologically defined health states”
> “The simulated cohort included US adults who entered the model with MASH and fibrosis stage F2 or F3.”
> “The analysis was conducted from the payer perspective, with costs and QALYs discounted at 3%/year. Costs were presented in 2023 US dollars, adjusted for inflation using the US Consumer Price Index–Medical Care Component.”
> “For the base-case, drug cost was based on the manufacturer’s suggested price ($19 011/year).”
> “Compared with SoC, resmetirom was associated with a gain of 0.26 QALYs/patient. Lifetime drug cost was $54 754, and treatment saved $18 499 in MASLD-related medical costs for a total incremental cost of $36 255 per patient. The ICER was $140 134/QALY.”
> “At willingness-to-pay (WTP) thresholds of $50 000/QALY, $100 000/QALY, and $150 000/QALY, the maximal annual prices of resmetirom were $10 914, $15 406, and $19 879, respectively.”
> “Without discontinuation, the ICER would be $318 740/QALY, supporting a price between $5645 and $10 619 per year at WTP thresholds of $50 000/QALY and $150 000/QALY, respectively.”
Source: [Le et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC12205400/)
#### Resmetirom versus placebo in nonalcoholic steatohepatitis with liver fibrosis, United States: Javanbakht et al. (2023)
Relevance: Evaluates resmetirom against placebo, including the daily price at which it remained cost effective, in nonalcoholic steatohepatitis with liver fibrosis from a United States commercial payer perspective, a disease for which saroglitazar is approved in India.
> “An early economic model was developed to reflect the clinical pathways typically followed by patients with NASH and liver fibrosis. Use of resmetirom, compared with placebo, was assessed. The Markov model structure was informed by a previous modeling study and a randomized, double-blind, placebo-controlled, phase II trial of resmetirom.”
> “This early analysis explored the potential cost effectiveness of resmetirom for the treatment of NASH from a US commercial payer perspective.”
> “Costs and outcomes were assessed over a lifetime time horizon with results presented in terms of cost per quality-adjusted life-year (QALY) gained.”
> “Costs and benefits were discounted at a rate of 3% as recommended by ICER in the US”
> “Resmetirom treatment resulted in increased costs of US$66,764 per patient, while increasing QALYs by 1.24. The incremental cost-effectiveness ratio was US$53,929 per QALY gained, indicating resmetirom treatment would potentially be cost effective at a willingness-to-pay (WTP) threshold of US$100,000.”
> “Resmetirom treatment remained cost effective at a US$100,000 WTP threshold up to a daily price point of US$72.00.”
> “Economic modeling using phase II data indicates that resmetirom treatment has an 86.20% probability of being cost effective at a willingness-to-pay threshold of US$100,000 per quality-adjusted life-year from a US commercial payer perspective.”
Source: [Javanbakht et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC9929016/)
#### Pioglitazone or vitamin E with lifestyle modification versus lifestyle modification alone in nonalcoholic steatohepatitis with advanced fibrosis, Australia: Mahady et al. (2012)
Relevance: Evaluates pioglitazone and vitamin E added to lifestyle modification in nonalcoholic steatohepatitis in Australia, a disease for which saroglitazar is approved in India, using a model with advanced fibrosis, cirrhosis, and hepatocellular carcinoma states.
Access: Free full text
> “Using a third-party payer perspective, a deterministic Markov model was developed to compare costs and health benefits of lifestyle modification alone or with pioglitazone or vitamin E in a cohort of patients aged 50 years with biopsy-proven NASH and fibrosis level 3 or greater.”
> “We assumed an annual cycle length over a lifetime horizon.”
> “Our cost data are reported in 2010 Australian dollars ($A) (Table 2).”
> “Discounting was performed in accordance with standard Australian guidelines at 5% with a range of 3%-8%”
> “Our outcome measure was the incremental cost-effectiveness ratio (ICER), with $A50,000 or less considered cost-effective.”
> “In comparison with lifestyle modification alone, treatment with either pioglitazone or vitamin E in addition to lifestyle modification was cost-effective, with incremental cost-effectiveness ratios of $A2748 and $A8475 per quality-adjusted life year (QALY) gained, respectively.”
> “In a direct comparison, pioglitazone was more cost-effective than vitamin E (ICER $A2,056/QALY gained).”
> “Sensitivity analyses indicated that pioglitazone was not cost-effective if either the total drug cost was greater than $A16,000 per annum, or the annual probability of developing cirrhosis in advanced fibrosis was less than 2%.”
Source: [Mahady et al. (2012)](https://doi.org/10.1002/hep.25887)
#### Hypothetical pharmaceutical treatment versus usual care in nonalcoholic fatty liver disease with fibrosis stage F2 to F4, United States: Rustgi et al. (2022)
Relevance: Estimates the cost-effectiveness and economically justifiable price of a hypothetical pharmaceutical treatment against usual care in nonalcoholic fatty liver disease with fibrosis stage F2 to F4 in the United States, a disease for which saroglitazar is approved in India.
Access: Free full text
> “A Markov model was constructed to estimate the clinical outcomes, costs, and quality of life impact of a hypothetical pharmaceutical intervention.”
> “We quantified costs, life-years (LYs), and quality-adjusted life-years (QALYs) over a lifetime horizon (i.e. up to 50 years).”
> “All estimated costs reflected a payer perspective, and all outcomes were considered both undiscounted and discounted at a 3% annual rate”
> “Lifetime clinical outcomes, life-years, quality-adjusted life-years (QALYs), costs (2020 $US), incremental cost-effectiveness ratios (ICERs), and economically justifiable prices (EJPs) were quantified. Only patients with fibrosis stage F2–F4 were assumed eligible to initiate pharmaceutical treatment.”
> “Assuming an annual drug cost of $36,000, total discounted medical costs were $574,238 and $120,312 for drug and usual care, respectively, with discounted QALYs estimated to be 9.452 and 9.272 for the two comparators. This yielded an ICER of $2,517,676/QALY gained.”
> “The EJP of the drug at an ICER threshold of $150,000/QALY gained was $2,633, a 93% reduction from a base case.”
> “Sensitivity analyses suggest that, without a substantial decrease in the drug price, ICERs would exceed $500,000/QALY gained even with the most favorable efficacy assumptions.”
Source: [Rustgi et al. (2022)](https://doi.org/10.1080/13696998.2022.2026702)
## 2 Utility weights
### 2.1 Utility weights from analyses of Saroglitazar
No evidence found.
### 2.2 Utility weights for the same indication
No evidence found.
### 2.3 Utility weights for the same disease in other populations or settings
No evidence found.
### 2.4 Utility weights for related diseases and analogous treatments
#### Utility weights for liver disease states and adverse events, nonalcoholic steatohepatitis: Gal et al. (2023)
Relevance: Health state and event utilities and adverse event disutilities for liver disease states in nonalcoholic steatohepatitis, from a United States model of obeticholic acid.
Access: Free full text
Not quoted: The utility weights are reported in Supplementary Tables 4 and 5 of the electronic supplementary material, which the article page does not carry.
> “The CEM includes both health state and event utilities, as well as disutilities for AEs, based on NASH-specific data for liver disease health states, as outlined in Supplementary Tables 4 and 5.”
Source: [Gal et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC10635953/)
#### Utility weights for cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver transplant, metabolic dysfunction-associated steatotic liver disease: Le et al. (2025)
Relevance: Utilities for cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and post-transplant states, from a United States model of metabolic dysfunction-associated steatohepatitis that drew the cirrhosis, hepatocellular carcinoma, and transplant values from people with hepatitis C.
> “For cirrhosis, DC, HCC, and LT, we drew utilities from patients with hepatitis C.”
> “The utility after LT was derived from the 15-dimensional instrument answered by first-time transplant patients.”
Source: [Le et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC12205400/)
| Health state | Utility | Range |
| --- | --- | --- |
| “F4 or MASH-F4” | “0.80” | “0.72-0.88” |
| “DC” | “0.60” | “0.54-0.66” |
| “HCC” | “0.72” | “0.65-0.79” |
| “LT” | “0.73” | “0.66-0.80” |
| “Post-LT” | “0.80” | “0.72-0.88” |
Source: [Le et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC12205400/)
#### Utility weights for cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver transplant, nonalcoholic steatohepatitis: Javanbakht et al. (2023)
Relevance: Utilities for compensated and decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and post-transplant states from a U.S. model of chronic liver disease.
| Health state | Utility | Source of the value |
| --- | --- | --- |
| “CC” | “0.66” | “Younossi et al.” |
| “DCC” | “0.57” | “Younossi et al.” |
| “HCC” | “0.5” | “Younossi et al.” |
| “LT” | “0.66” | “Assumed to be the same as CC” |
| “PLT” | “0.73” | “Assumed to be the same as stage 3 fibrosis” |
Source: [Javanbakht et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC9929016/)
#### Utility weights for compensated cirrhosis, decompensated cirrhosis, hepatoma, and the first year after liver transplant, nonalcoholic steatohepatitis: Mahady et al. (2012)
Relevance: Utilities for compensated cirrhosis, decompensated cirrhosis, hepatoma, and the first year after liver transplantation from a model of chronic liver disease.
Access: Free full text
> “No prior health-related quality of life studies have been performed in patients with NASH-associated chronic liver disease, cirrhosis, or hepatic decompensation.”
> “Given that cirrhosis, decompensated liver disease, and HCC represent a common pathway of chronic liver disease, we assumed that the decrement in quality of life associated with these conditions is similar regardless of the initial cause.”
Source: [Mahady et al. (2012)](https://doi.org/10.1002/hep.25887)
| Health state | Utility (range) |
| --- | --- |
| “Well with F3/4 fibrosis” | “0.92 (0.65-0.95)” |
| “Compensated cirrhosis” | “0.82 (0.65-0.89)” |
| “Decompensated cirrhosis” | “0.6 (0.46-0.81)” |
| “Hepatoma” | “0.73 (0.5-0.8)” |
| “Liver transplant (1st year)” | “0.69 (0.62-0.86)” |
Source: [Mahady et al. (2012)](https://doi.org/10.1002/hep.25887)
## 3 Search strategy
| Dataset | Query | Results |
| --- | --- | --- |
| Ratios | saroglitazar | 0 |
| Methods | "primary biliary cholangitis" OR "primary biliary cirrhosis" | 2 |
| Ratios | "biliary cholangitis" OR "biliary cirrhosis" OR "obeticholic acid" OR elafibranor OR seladelpar OR ursodeoxycholic OR ursodiol OR bezafibrate OR fenofibrate | 47 |
| Weights | "biliary cholangitis" OR "biliary cirrhosis" OR "cholestatic" OR "cholestasis" | 5 |
| Ratios | resmetirom OR pioglitazone OR "obeticholic" OR lanifibranor OR semaglutide | 238 |
| Methods | "steatohepatitis" OR NASH OR MASH OR "fatty liver" | 37 |
| Ratios | "obeticholic acid" OR obeticholic | 2 |
| Methods | "sclerosing cholangitis" OR "autoimmune liver" OR "cholestatic liver" OR "cholestatic pruritus" | 4 |
| Weights | pruritus AND (liver OR hepatic OR cholestatic OR biliary) | 5 |
| Methods | saroglitazar | 0 |
| Ratios | PPAR OR "peroxisome proliferator" OR thiazolidinedione | 60 |
## Related pages
- [Saroglitazar: Primary biliary cholangitis](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis) · [Markdown](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis.md)
- [Saroglitazar in Primary biliary cholangitis: Terms and abbreviations](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/terms-and-abbreviations) · [Markdown](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/terms-and-abbreviations.md)
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- [Saroglitazar in Primary biliary cholangitis: Clinical evidence](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/clinical-evidence) · [Markdown](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/clinical-evidence.md)
- [Saroglitazar in Primary biliary cholangitis: Economic information and modeling report](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/economics) · [Markdown](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/economics.md)
- [Saroglitazar in Primary biliary cholangitis: References](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/references) · [Markdown](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/references.md)
- [Saroglitazar in Primary biliary cholangitis: prevalence by geography](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/prevalence) · [Markdown](https://www.evicenter.com/drugs/saroglitazar--primary-biliary-cholangitis/prevalence.md)