Evicenter
P&T meetings

Saroglitazar

Primary biliary cholangitis

Manufacturer
Zydus Therapeutics
Regulatory submission
NDA submitted by May 2026
81 sources

Section 5 of 6

Economic information and modeling report

12 evidence topics · 1 source

Modeling overview

Summary

An abstract-only preprint describes an illustrative Spanish managed-access model for saroglitazar. Its prices and spending estimates are modeled, not observed commercial prices or payer expenditure. The full model was unavailable for appraisal.

Budget impact model

Approach and framework

Perspective and time frame

Epidemiology and eligible population inputs

National population estimate and modeled cohort size

No evidence found.

Cost assumptions

Model outcomes

Willingness-to-pay thresholds
ParameterQuoted value
Lower threshold, euros per QALY“€25,000”
Higher threshold, euros per QALY“€30,000”
Expected net monetary benefit across modeled subgroups“negative”

Results

Base case
Modeled 24-month costs
OutcomeQuoted value
Net health-system cost“€4,371,005”
Savings versus financing without risk sharing“€586,495”
Scenario analyses
Stress scenario
Parameter or outcomeQuoted value
Monte Carlo simulation“10,000 iterations”
Stress percentile“95th-percentile”
Late-progression cases“19”
Incremental drug-side budget risk absorbed“75%”

Budget impact model discussion

Summary

Savings compare risk sharing with financing the same drug without risk sharing, not with usual care. Expected net monetary benefit remained negative at both tested thresholds. These results do not establish conventional cost-effectiveness.