Dimensions and criteria of value assessment frameworks for generic drugs: A scoping review and thematic analysis

Abstract

Objectives

Although generic drugs offer comparable patient benefits and cost advantages to original drugs and are widely utilized in emerging nations, concerns persist regarding their product quality, bioequivalence, and clinical outcomes. Additionally, there is a lack of consensus on the value assessment for generic drugs, particularly in determining whether lower prices correspond to equivalent value. Our objective is to systematically describe and contrast the prevailing tools, scales, frameworks and etc. for assessing generic drugs, while integrating their core dimensions and criteria as a reference for emerging nations. Methods: This study systematically reviewed evaluation tools, scales, and frameworks etc. for generic or off-patent drugs. Given that meta-analysis is limited to qualitative research, thematic analysis was employed to comprehensively synthesize the primary concepts of generic drug evaluation. The literature search was conducted using PubMed, EMbase, CNKI, and WanFang Data, with a cut-off date of July 25, 2024. Additionally, thematic analysis was conducted to identify themes and subthemes related to the evaluation of generics across the included records. Results: A total of nine evaluation tools, scales, and frameworks for generic drugs were included in this study. Variations were observed in their dimensions, criteria, application procedures, and methods of calculating criteria weights among participants. Ultimately, four core themes and 16 subthemes for the evaluation of generics were synthesized through thematic analysis. Conclusions: The four themes and sixteen subthemes can be regarded as primary dimensions and criteria for evaluating the value of generic drugs. They serve as a benchmark for value assessment frameworks, thereby promoting advancements in healthcare systems in regions where generic drugs are widely utilized.

Public Interest Summary

Although generic drugs provide comparable patient benefits and cost advantages to original drugs and are widely used in emerging nations, concerns persist regarding their product quality, bioequivalence, and clinical outcomes. Our objective is to systematically describe and contrast the prevailing tools, scales, frameworks, and other relevant methodologies for assessing generic drugs, while integrating their core dimensions and criteria. This study incorporates a total of nine evaluation tools, scales, and frameworks for generic drugs, synthesizing them into four core themes and 16 subthemes for the evaluation of generics. These four themes and sixteen subthemes can be regarded as primary dimensions and criteria for assessing the value of generic drugs. They serve as a benchmark for value assessment frameworks, thereby promoting advancements in healthcare systems in regions where generic drugs are widely utilized.