S1981 Trends in Out-of-Pocket Spending for Drugs Under Medicare Part D in Moderate to Severe Inflammatory Bowel Disease and the Impact of the Inflation Reduction Act

Introduction: Treatments for moderate to severe inflammatory bowel disease (IBD) include biologics or small molecules. Most are branded with limited generic substitution, resulting in high out-of-pocket (OOP) expenses that can lead to premature drug discontinuation. We aimed to assess trends in OOP costs for key IBD therapies covered under Medicare Part D and evaluate the financial impact of the Inflation Reduction Act (IRA) $2,000 OOP cap implemented in 2025. Methods: We analyzed Medicare Part D Prescription Drug Plan Formulary and Pricing Files from Q3 (July–September) of 2019–2024 and Q1 of 2025. Eight available IBD drugs were included: adalimumab, tofacitinib, upadacitinib, ustekinumab, risankizumab, guselkumab, certolizumab and golimumab. Annual retail and OOP costs were estimated (maintenance doses for ustekinumab and risankizumab and both induction and maintenance doses for the rest) per drug using Medicare Part D benefit structures for each year. Costs were inflation-adjusted to 2025 U.S. dollars using a standardized conversion factor. Data analysis was performed in Stata 18; time trends were visualized using R. Results: Between 2019 and 2024, median annual OOP costs for most agents ranged from $4,000 to $13,000. In 2025, OOP costs dropped sharply to the $2,000 cap or below for all agents, while retail prices remained stable or slightly increased. Interrupted time series analysis demonstrated a significant policy-driven decline in OOP spending after 2025 across most drugs (excluding adalimumab and risankinumab due to insufficient data) with absolute reductions ranging from $3,283–$10,922 (P < 0.05). Conclusion: Implementation of the IRA's $2,000 OOP cap in 2025 was associated with a marked and immediate reduction in financial burden for high-cost IBD therapies. Our findings highlight the potential of policy interventions to improve medication affordability and support adherence for Medicare beneficiaries.

Publication Details

Journal
The American Journal of Gastroenterology
Published
2025-10-01
DOI
https://doi.org/10.14309/01.ajg.0001135384.39683.65
Primary Topic
Pharmaceutical Economics and Policy
Type
article
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article

S1981 Trends in Out-of-Pocket Spending for Drugs Under Medicare Part D in Moderate to Severe Inflammatory Bowel Disease and the Impact of the Inflation Reduction Act

The American Journal of Gastroenterology
Pharmaceutical Economics and Policy
article

S1981 Trends in Out-of-Pocket Spending for Drugs Under Medicare Part D in Moderate to Severe Inflammatory Bowel Disease and the Impact of the Inflation Reduction Act

article en

Abstract

Introduction: Treatments for moderate to severe inflammatory bowel disease (IBD) include biologics or small molecules. Most are branded with limited generic substitution, resulting in high out-of-pocket (OOP) expenses that can lead to premature drug discontinuation. We aimed to assess trends in OOP costs for key IBD therapies covered under Medicare Part D and evaluate the financial impact of the Inflation Reduction Act (IRA) $2,000 OOP cap implemented in 2025. Methods: We analyzed Medicare Part D Prescription Drug Plan Formulary and Pricing Files from Q3 (July–September) of 2019–2024 and Q1 of 2025. Eight available IBD drugs were included: adalimumab, tofacitinib, upadacitinib, ustekinumab, risankizumab, guselkumab, certolizumab and golimumab. Annual retail and OOP costs were estimated (maintenance doses for ustekinumab and risankizumab and both induction and maintenance doses for the rest) per drug using Medicare Part D benefit structures for each year. Costs were inflation-adjusted to 2025 U.S. dollars using a standardized conversion factor. Data analysis was performed in Stata 18; time trends were visualized using R. Results: Between 2019 and 2024, median annual OOP costs for most agents ranged from $4,000 to $13,000. In 2025, OOP costs dropped sharply to the $2,000 cap or below for all agents, while retail prices remained stable or slightly increased. Interrupted time series analysis demonstrated a significant policy-driven decline in OOP spending after 2025 across most drugs (excluding adalimumab and risankinumab due to insufficient data) with absolute reductions ranging from $3,283–$10,922 (P < 0.05). Conclusion: Implementation of the IRA's $2,000 OOP cap in 2025 was associated with a marked and immediate reduction in financial burden for high-cost IBD therapies. Our findings highlight the potential of policy interventions to improve medication affordability and support adherence for Medicare beneficiaries.

The American Journal of GastroenterologyVol. 120(10S2)
Openalex Percentile: Top 24%
Pharmaceutical Economics and Policy
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