Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report.
Document Type
Article
Publication Date
3-14-2025
Identifier
DOI: 10.1208/s12248-025-01050-9
Abstract
Therapeutic drug monitoring (TDM) for dose modification of biologics has the potential to improve patient outcomes. The US Food and Drug Administration (FDA) and the American Association of Pharmaceutical Scientists (AAPS) hosted the first US-based public workshop on TDM of biologics with contributions from a broad array of interested parties including healthcare providers, clinical pharmacologists, test developers, bioanalysis and immunogenicity scientists, health economics and outcomes research (HEOR) experts and regulators. The key insight was that despite a body of evidence to support TDM in certain therapeutic areas, there remain substantial challenges to widespread clinical implementation. There is a lack of consensus regarding the integration of TDM in clinical guidelines, and a lack of consensus on the cost-effectiveness of TDM; both factors contribute to the difficulty that healthcare providers face in obtaining reimbursement for TDM (both coverage of testing itself, and coverage of potential dosing modifications). The HEOR experts outlined alternative routes to obtaining reimbursement and suggested advocating for changes in coverage policies to promote TDM use in the clinic. Reaching alignment across policy makers, patients and advocacy groups, payers, and healthcare providers, on specific treatment settings where TDM will be clearly beneficial, was identified as an important step to advancing TDM implementation for the benefit of patients.
Journal Title
The AAPS journal [electronic resource]
Volume
27
Issue
2
First Page
62
Last Page
62
MeSH Keywords
Humans; Biological Products; Drug Monitoring; United States; United States Food and Drug Administration; Cost-Benefit Analysis
PubMed ID
40087239
Keywords
TNF inhibitors; biologic; health economics and outcomes research; therapeutic drug monitoring
Recommended Citation
Shubow S, Gunsior M, Rosenberg A, et al. Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report. AAPS J. 2025;27(2):62. Published 2025 Mar 14. doi:10.1208/s12248-025-01050-9
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