POPULATION HEALTH IMPACTS ASSOCIATED WITH NEW INDICATIONS: A CASE STUDY OF SGLT2-INHIBITORS
Author(s)
Antony Martin, PhD, James Chambers, MSc, PhD, Pei Jung Lin, PhD, Peter Neumann, ScD, Meng Li, MS, PhD;
Tufts Medical Center, Boston, MA, USA
Tufts Medical Center, Boston, MA, USA
OBJECTIVES: Therapeutic classes often evolve through new indication expansions, extending population health benefits beyond the initial approved use. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) represent an example, with indications spanning type 2 diabetes, heart failure, and chronic kidney disease. This study aimed to: (1) develop a framework for quantifying population health gains attributable to new indications; (2) apply this framework to recent SGLT2i indication expansions; and (3) explore potential health benefits foregone if indications had not been expanded.
METHODS: We developed a prevalence-based population health model to estimate aggregate life-years (LYs) and quality-adjusted life-years (QALYs) gained, and hospitalizations and deaths avoided from SGLT2i indications approved by the FDA between 2013 and 2025. Model inputs included disease prevalence and treatment effect estimates from pivotal trials, real-world studies, and cost-effectiveness analyses. The base-case analysis assumed 5% uptake, with sensitivity analyses at 2.5% and 10%. Scenario analyses assessed population health losses if indications were not expanded beyond the 9-year horizon, aligning with the Inflation Reduction Act price negotiation timeline for small-molecule drugs.
RESULTS: At 5% uptake, SGLT2i indication expansions generated an estimated 2.13 million LYs and 2.15 million QALYs gained, with 1.60 million hospitalizations and 0.60 million deaths avoided. Sensitivity analyses demonstrated that health gains scaled proportionally with uptake, with 1.07 million LYs and 1.07 million QALYs gained at 2.5% uptake and 4.27 million LYs and 4.29 million QALYs at 10% uptake. Without indication expansions beyond 9 years, an estimated 0.48 million LYs and 0.45 million QALYs would be lost, with an additional 0.30 million hospitalizations and 0.08 million deaths.
CONCLUSIONS: Since the initial SGLT2i approval, subsequent indication expansions have cumulatively generated substantial population health benefits.
METHODS: We developed a prevalence-based population health model to estimate aggregate life-years (LYs) and quality-adjusted life-years (QALYs) gained, and hospitalizations and deaths avoided from SGLT2i indications approved by the FDA between 2013 and 2025. Model inputs included disease prevalence and treatment effect estimates from pivotal trials, real-world studies, and cost-effectiveness analyses. The base-case analysis assumed 5% uptake, with sensitivity analyses at 2.5% and 10%. Scenario analyses assessed population health losses if indications were not expanded beyond the 9-year horizon, aligning with the Inflation Reduction Act price negotiation timeline for small-molecule drugs.
RESULTS: At 5% uptake, SGLT2i indication expansions generated an estimated 2.13 million LYs and 2.15 million QALYs gained, with 1.60 million hospitalizations and 0.60 million deaths avoided. Sensitivity analyses demonstrated that health gains scaled proportionally with uptake, with 1.07 million LYs and 1.07 million QALYs gained at 2.5% uptake and 4.27 million LYs and 4.29 million QALYs at 10% uptake. Without indication expansions beyond 9 years, an estimated 0.48 million LYs and 0.45 million QALYs would be lost, with an additional 0.30 million hospitalizations and 0.08 million deaths.
CONCLUSIONS: Since the initial SGLT2i approval, subsequent indication expansions have cumulatively generated substantial population health benefits.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE323
Topic
Economic Evaluation
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)