Cost-Effectiveness of Sotagliflozin for Patients With Type 1 Diabetes and Chronic Kidney Disease, With and Without Dynamic Pricing
Author(s)
Jason Shafrin, PhD1, Jaehong Kim, PhD2, Shanshan Wang, MPH3, Moises Marin, MA3, Slaven Sikirica, MBA4, Mariam Anderson, MS5;
1FTI Consulting, Senior Managing Director, Center for Healthcare Economics and Policy, Los Angeles, CA, USA, 2FTI Consulting Inc., Center for Healthcare Economics and Policy, Atlanta, GA, USA, 3FTI Consulting Inc., Center for Healthcare Economics and Policy, Washington, DC, USA, 4Lexicon Pharmaceuticals, Inc., HEOR, Basking Ridge, NJ, USA, 5Lexicon Pharmaceuticals, Inc., Medical Sciences and Outcomes, Philadelphia, PA, USA
1FTI Consulting, Senior Managing Director, Center for Healthcare Economics and Policy, Los Angeles, CA, USA, 2FTI Consulting Inc., Center for Healthcare Economics and Policy, Atlanta, GA, USA, 3FTI Consulting Inc., Center for Healthcare Economics and Policy, Washington, DC, USA, 4Lexicon Pharmaceuticals, Inc., HEOR, Basking Ridge, NJ, USA, 5Lexicon Pharmaceuticals, Inc., Medical Sciences and Outcomes, Philadelphia, PA, USA
Presentation Documents
OBJECTIVES: Patients with type 1 diabetes (T1D) face a 50-70% lifetime risk of chronic kidney disease (CKD). Glycemic control, measured by glycated hemoglobin (HbA1c), is critical for reducing diabetes-related complications and slowing CKD progression. This study evaluated the cost-effectiveness of sotagliflozin as an add-on to insulin therapy for patients with T1D and CKD.
METHODS: A Markov model was constructed to estimate the cost-effectiveness of sotagliflozin+insulin therapy among patients with T1D and concurrent grade 3 CKD versus insulin alone. Efficacy data (inTandem3 randomized controlled trial) indicated that sotagliflozin+insulin lowered HbA1c by 0.46 percentage points relative to insulin alone. Key outcomes included CKD stage by year, life-years (LY), quality-adjusted life-years (QALYs), healthcare cost changes, and incremental cost-effectiveness ratio (ICER). To account for dynamic pricing due to genericization, outcomes when sotagliflozin pharmacy costs were assumed to decrease by 60% 14 years after treatment initiation was also analyzed. Costs were inflated to 2024 USD and discounted at 3%.
RESULTS: Sotagliflozin demonstrated survival benefits for patients with T1D and CKD (LY: 13.08 vs. 11.81, difference: +1.27) by slowing the progression to end-stage renal disease (ESRD; percentage of patients reaching ESRD: 4.0% vs. 4.9%, difference: -0.9%). This improvement increased QALYs among patients treated with sotagliflozin+insulin compared to insulin alone (QALYs: 7.70 vs. 7.06, difference: +0.64). Excluding dynamic pricing, costs increased by $82,441 ($494,201 vs. $411,760), largely due to increased pharmacy costs ($72,587). With dynamic pricing, costs increased by $72,914 ($484,674 vs. $411,760, pharmacy cost increments: $69,060). Without dynamic pricing, the ICER was $130,791 per QALY, compared to $115,677 with dynamic pricing. In both cases, the ICERs were below the commonly accepted $150,000/QALY threshold.
CONCLUSIONS: Sotagliflozin with insulin offers a cost-effective strategy for improving health outcomes in patients with T1D and CKD. Not accounting for dynamic pricing may underestimate the value of add-on therapies like sotagliflozin.
METHODS: A Markov model was constructed to estimate the cost-effectiveness of sotagliflozin+insulin therapy among patients with T1D and concurrent grade 3 CKD versus insulin alone. Efficacy data (inTandem3 randomized controlled trial) indicated that sotagliflozin+insulin lowered HbA1c by 0.46 percentage points relative to insulin alone. Key outcomes included CKD stage by year, life-years (LY), quality-adjusted life-years (QALYs), healthcare cost changes, and incremental cost-effectiveness ratio (ICER). To account for dynamic pricing due to genericization, outcomes when sotagliflozin pharmacy costs were assumed to decrease by 60% 14 years after treatment initiation was also analyzed. Costs were inflated to 2024 USD and discounted at 3%.
RESULTS: Sotagliflozin demonstrated survival benefits for patients with T1D and CKD (LY: 13.08 vs. 11.81, difference: +1.27) by slowing the progression to end-stage renal disease (ESRD; percentage of patients reaching ESRD: 4.0% vs. 4.9%, difference: -0.9%). This improvement increased QALYs among patients treated with sotagliflozin+insulin compared to insulin alone (QALYs: 7.70 vs. 7.06, difference: +0.64). Excluding dynamic pricing, costs increased by $82,441 ($494,201 vs. $411,760), largely due to increased pharmacy costs ($72,587). With dynamic pricing, costs increased by $72,914 ($484,674 vs. $411,760, pharmacy cost increments: $69,060). Without dynamic pricing, the ICER was $130,791 per QALY, compared to $115,677 with dynamic pricing. In both cases, the ICERs were below the commonly accepted $150,000/QALY threshold.
CONCLUSIONS: Sotagliflozin with insulin offers a cost-effective strategy for improving health outcomes in patients with T1D and CKD. Not accounting for dynamic pricing may underestimate the value of add-on therapies like sotagliflozin.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EE257
Topic
Economic Evaluation
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Urinary/Kidney Disorders