Adoption of the antifibrotic medications pirfenidone and nintedanib for patients with idiopathic pulmonary fibrosis
Abstract
Abstract Rationale In October 2014, the antifibrotic medications pirfenidone and nintedanib became the first medications approved by the U.S. Food and Drug Administration for use in patients with idiopathic pulmonary fibrosis (IPF). Since approval, there has been no nonregistry analysis of the real-world adoption of these medications in everyday clinical practice. Objectives To evaluate the adoption, persistence, and out-of-pocket (OOP) costs of pirfenidone and nintedanib since their approval in the United States in 2014. Methods A retrospective cohort analysis was performed by identifying privately insured and Medicare Advantage beneficiaries with IPF. We then split the patients into three cohorts: those who were untreated and those who filled a prescription for either pirfenidone or nintedanib between October 1, 2014, and July 31, 2019. The primary outcome was adoption of the medications. Secondary outcomes included medication persistence and prescription drug costs. Results A total of 10,996 patients with IPF were identified in the data set. A minority of patients (26.4%) with IPF identified in the cohort had started either medication since approval in 2014, with the adoption of both medications being comparable at around 13.2%. Those receiving the medications were younger (72 vs. 73.9 yr; P < 0.0001) and healthier (3.9 vs. 4.9 comorbidities; P < 0.0001) than those not receiving treatment. Men were significantly more likely to receive treatment than woman (30.0% vs. 21.9%; P < 0.0001). Among treated patients, 42.8% discontinued the medications during the study period. Patients’ OOP expenses per month were high for both drugs (mean, $397.51 for nintedanib; mean, $394.49 for pirfenidone). Conclusions The adoption of both the antifibrotic medications in the United States in everyday practice has been low since approval and may be associated with the high OOP cost.
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The limited efficacy and tolerability challenges of pirfenidone and nintedanib contribute to low treatment uptake, frequent discontinuation, and impaired quality of life.
“Their limited efficacy, combined with tolerability challenges, contributes to low treatment uptake, frequent discontinuation of both treatments, and impaired quality of life.6-8”
From Deupirfenidone Compared with Pirfenidone and Placebo in Idiopathic Pulmonary Fibrosis (ELEVATE-IPF): a Phase 2b Randomized Placebo-Controlled Trial (2026) · cites this paper as [7]
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- Authors
- Dempsey, T. M., Payne, S., Sangaralingham, L., Yao, X., Shah, N. D., & Limper, A. H.
- Affiliations
- Department of Pulmonary and Critical Care Medicine
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery
- Mayo Clinic (US)
- Corresponding author
- Dempsey, Timothy M.
- ORCID
- Venue
- Annals of the American Thoracic Society
- Publisher
- Oxford University Press (OUP)
- Published
- 2021-07-01
- Volume
- 18
- Issue
- 7
- Pages
- 1121-1128
- ISSN
- 2325-6621 (ISSN-L)
- 2329-6933
- OpenAlex
- W3122584685
- Cited by
- 101
- References
- 33
- Citations by year
- 2026: 24 · 2025: 21 · 2024: 22 · 2023: 14 · 2022: 11 · 2021: 9
- FWCI
- 9.09
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of the American Thoracic Society (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Keywords
- idiopathic pulmonary fibrosis, pirfenidone, nintedanib, antifibrotic agents, treatment persistence, out-of-pocket costs, prescription drug costs, Medicare Advantage beneficiaries, real-world applications, drug approval
- MeSH terms
- Aged, Pharmaceutical Preparations, Female, Medicare, Humans, Indoles, Male, Pyridones, Retrospective Studies, United States, Treatment Outcome, Idiopathic Pulmonary Fibrosis
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