BUDGET IMPACT ANALYSIS OF DONISLECEL FOR ELIGIBLE ADULTS WITH TYPE I DIABETES IN THE UNITED STATES: AN ANALYSIS FROM A PAYER PERSPECTIVE
Author(s)
Beverly Fuerte, PharmD1, Vietbao H. Phan, PharmD2, Mumbi E. Kimani, MA, PhD2, Linh Dao, BA1, Chanhyun Park, MEd, RPh, PhD1;
1University of Texas at Austin, College of Pharmacy, Austin, TX, USA, 2Thomas Jefferson University, College of Population Health, Philadelphia, PA, USA
1University of Texas at Austin, College of Pharmacy, Austin, TX, USA, 2Thomas Jefferson University, College of Population Health, Philadelphia, PA, USA
OBJECTIVES: In the United States, 1.7 million adults aged 20 years or older had type I diabetes (T1DM) and required insulin in 2021. Despite intensive insulin management, achieving the American Diabetes Association (ADA)-recommended hemoglobin A1c (HbA1c) goal of <7% remains a challenge for a majority of T1DM patients. We estimated budget impact of allogeneic islet cellular therapy, donislecel, on the cost burden of T1DM over 5 years.
METHODS: A hypothetical health plan of 1,000,000 members was used to model market uptake of donislecel and healthcare expenditures related to T1DM over a 5-year time horizon. We estimated the number of donislecel-eligible adults with T1DM in the plan (n=414). The standard-of-care comparators included two regimens: continuous glucose monitoring (CGM) with multi-dose insulin injections (MDI) and CGM with continuous subcutaneous insulin infusion (CSII). All parameters were derived from U.S. peer-reviewed literature, clinical trials, national databases, and clinical guidelines. A one-way sensitivity analysis assessed key parameters (e.g., rates and costs of treatment-emergent events) on results.
RESULTS: Among 414 donislecel-eligible adults with T1DM, 19 were projected to be treated by year 5. With nearly three initiations per year, one to two patients would remain insulin-dependent with minimal risk of hypoglycemia, and one would need reinfusion within 365 days. The total incremental per member per month (PMPM) increase in total budget spending and total drug cost was $0.33 and $0.66, respectively. This was partially offset by a PMPM decrease of $0.33 in total adverse treatment cost impact. Results were most sensitive to hypoglycemic events in CGM and CSII-treated patients.
CONCLUSIONS: The inclusion of donislecel as a treatment option for T1DM management resulted in a $4 million increase in healthcare costs within a 5-year time horizon. However, the annual healthcare expenditure per T1DM patient is projected to decrease over time with donislecel as a treatment option for high-risk patients.
METHODS: A hypothetical health plan of 1,000,000 members was used to model market uptake of donislecel and healthcare expenditures related to T1DM over a 5-year time horizon. We estimated the number of donislecel-eligible adults with T1DM in the plan (n=414). The standard-of-care comparators included two regimens: continuous glucose monitoring (CGM) with multi-dose insulin injections (MDI) and CGM with continuous subcutaneous insulin infusion (CSII). All parameters were derived from U.S. peer-reviewed literature, clinical trials, national databases, and clinical guidelines. A one-way sensitivity analysis assessed key parameters (e.g., rates and costs of treatment-emergent events) on results.
RESULTS: Among 414 donislecel-eligible adults with T1DM, 19 were projected to be treated by year 5. With nearly three initiations per year, one to two patients would remain insulin-dependent with minimal risk of hypoglycemia, and one would need reinfusion within 365 days. The total incremental per member per month (PMPM) increase in total budget spending and total drug cost was $0.33 and $0.66, respectively. This was partially offset by a PMPM decrease of $0.33 in total adverse treatment cost impact. Results were most sensitive to hypoglycemic events in CGM and CSII-treated patients.
CONCLUSIONS: The inclusion of donislecel as a treatment option for T1DM management resulted in a $4 million increase in healthcare costs within a 5-year time horizon. However, the annual healthcare expenditure per T1DM patient is projected to decrease over time with donislecel as a treatment option for high-risk patients.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE9
Topic
Economic Evaluation
Topic Subcategory
Budget Impact Analysis
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)