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Objective: The objective of this review was to examine the role of adverse drug events (ADEs) caused by pharmacological interventions in cost-effectiveness models for diabetes mellitus, diabetic retinopathy, and diabetic macular edema., Introduction: Guidelines for economic evaluation recognize the importance of including ADEs in the analysis, but in practice, consideration of ADEs in cost-effectiveness models seem to be vague. Inadequate inclusion of these harmful outcomes affects the reliability of the results, and the information provided by economic evaluation could be misleading. Reviewing whether and how ADEs are incorporated in cost-effectiveness models is necessary to understand the current practices of economic evaluation., Inclusion Criteria: Studies included were published between 2011-2022 in English, representing cost-effectiveness analyses using modeling framework for pharmacological interventions in the treatment of diabetes mellitus, diabetic retinopathy, or diabetic macular edema. Other types of analyses and other types of conditions were excluded., Methods: The databases searched included MEDLINE (PubMed), CINAHL (EBSCOhost), Scopus, Web of Science Core Collection, and NHS Economic Evaluation Database. Gray literature was searched via the National Institute for Health and Care Excellence, European Network for Health Technology Assessment, the National Institute for Health and Care Research, and the International Network of Agencies for Health Technology Assessment. The search was conducted on January 1, 2023. Titles and abstracts were screened for inclusion by 2 independent reviewers. Full-text review was conducted by 3 independent reviewers. A data extraction form was used to extract and analyze the data. Results were presented in tabular format with a narrative summary, and discussed in the context of existing literature and guidelines., Results: A total of 242 reports were extracted and analyzed in this scoping review. For the included analyses, type 2 diabetes was the most common disease (86%) followed by type 1 diabetes (10%), diabetic macular edema (9%), and diabetic retinopathy (0.4%). The majority of the included analyses used a health care payer perspective (88%) and had a time horizon of 30 years or more (75%). The most common model type was a simulation model (57%), followed by a Markov simulation model (18%). Of the included cost-effectiveness analyses, 26% included ADEs in the modeling, and 13% of the analyses excluded them. Most of the analyses (61%) partly considered ADEs; that is, only 1 or 2 ADEs were included. No difference in overall inclusion of ADEs between the different conditions existed, but the models for diabetic retinopathy and diabetic macular edema more often omitted the ADE-related impact on quality of life compared with the models for diabetes mellitus. Most analyses included ADEs in the models as probabilities (55%) or as a submodel (40%), and the most common source for ADE incidences were clinical trials (65%)., Conclusions: The inclusion of ADEs in cost-effectiveness models is suboptimal. The ADE-related costs were better captured than the ADE-related impact on quality of life, which was most pronounced in the models for diabetic retinopathy and diabetic macular edema. Future research should investigate the potential impact of ADEs on the results, and identify the criteria and policies for practical inclusion of ADEs in economic evaluation., Competing Interests: The authors declare no conflict of interest., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on Behalf of JBI.)

Objective: The objective of this review is to provide an overview of adverse drug events in cost-effectiveness analyses related to the pharmacological treatments of diabetes and diabetes-related complications., Introduction: The inclusion of adverse drug events in cost-effectiveness analyses is recognized in health technology assessments guidelines, but in practice, this is inconsistent. This inconsistency may affect the reliability of the evaluation and, therefore, indicate that the information provided for decision-making in health care is misleading. Reviewing if and how adverse drug events are incorporated in cost-effectiveness analyses is necessary to address this gap., Inclusion Criteria: Studies including participants who are receiving pharmacological interventions for diabetes, diabetic retinopathy, or diabetic macular edema will be considered for inclusion. We will include sources that focus on cost-effectiveness analyses using modeling framework, and are published in English between 2011 and the present. Other types of analyses and other types of conditions will be excluded., Methods: The information sources to be searched include MEDLINE, CINAHL, Scopus, Web of Science, the NHS Economic Evaluations Database, and the Health Technology Assessment Database. Studies in English will be considered for inclusion in the review. Potential sources will be assessed by 2 independent reviewers and imported into the JBI System for the Unified Management, Assessment and Review of Information. The results of the search and the study inclusion process will be reported in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. A specific data extraction form will be used to extract and analyze the data. Results will be presented in tabular and graphic formats with a narrative summary, and will be discussed in the context of current literature and guidelines., Competing Interests: The authors declare no conflict of interest., (COPYRIGHT © 2022 THE AUTHORS. PUBLISHED BY WOLTERS KLUWER HEALTH, INC. ON BEHALF OF JBI.)