Sotagliflozin Demonstrates Cost-Effectiveness in T2D and Heart Failure

William Weintraub, MD
Credit: Diagnostic and Interventional Cardiology

New research leveraging data from the landmark SOLOST-WHF trial suggests sotagliflozin (Inpefa) represents a cost-effective option for patients with diabetes and recent worsening of heart failure.

Using a Markov model to estimate the lifetime impact of sotagliflozin on data from the National Inpatient Sample, investigators found use of the agent had up to an 89.7% probability of cost-effectiveness in patients with type 2 diabetes and worsening heart failure at the high end of common willingness-to-pay thresholds.¹

“Our research team believes that this study is an important contribution to the economic evaluation of sotagliflozin, a novel SGLT inhibitor, from the perspective of the U.S. healthcare system. Our results demonstrated that in people with diabetes and recent worsening heart failure, sotagliflozin is cost-effective at commonly accepted willingness-to-pay thresholds,” said lead investigator William S. Weintraub, MD, director of Population Health Research at MedStar Health Research Institute.²

A phase 3, double-blind, randomized, placebo-controlled trial, SOLOIST-WHF enrolled 1222 adult patients recently hospitalized for worsening heart failure. Although the trial were terminated prematurely due to funding during the COVID-19 pandemic, results of the study provided evidence of the benefit from the SGLT1/2 inhibitor on clinical outcomes in this patient population, which led to a subsequent approval in May 2023.^3,4

With a composite of cardiovascular death, hospitalizations, and urgent visits for heart failure serving as the primary endpoint, results suggested use of sotagliflozin was associated with a lower incidence of primary outcome events (51.0 vs 76.3 per 100 patient-years; Hazard ratio [HR], 0.67; 95% Confidence interval [CI], 0.52 to 0.85; P < .001), lower rate of death from cardiovascular causes (10.6 vs 12.5 patient-years; HR, 0.84; 95% CI, 0.58 to 1.22), and lower rate of all-cause mortality (13.5 vs 16.3 patient-years; HR, 0.82; 95% CI, 0.59 to 1.14) relative to placebo therapy. Based on results, investigators determined the overall number needed to treat to prevent a primary outcome event was 4.⁴

Led by Weintraub, the current study leveraged data from the trial to create a Markov model to estimate the lifetime impact of sotagliflozin using cost data from the National Inpatient Sample. For the purpose of analysis, life expectancy information from census data and modified by the mortality rate from SOLOIST-WHF.¹

Weintraub and colleagues found the lifetime quality-adjusted life-years (QALYs) were 4.43 with sotagliflozin and 4.04 with placebo. Further analysis indicated the lifetime costs were $220,113 and $188,198 in the sotagliflozin and placebo groups, respectively.¹

Based on these data, investigators determined the point estimate incremental cost-effectiveness ratio per QALY gained was $81,823. Additionally, results suggested he probability of being cost-effective was 3.6%, 67.5%, and 89.4% at willingness-to-pay thresholds of $50,000, $100,000, and $150,000, respectively, per QALY gained.¹

In addition to this study, another recent study on sotagliflozin detailed the cost-effectiveness of the agent among patients with diabetes and a recent worsening heart failure event. In this study, which leveraged data from SOLOIST-WHF and a real-world cohort, results indicated sotagliflozin was a cost-effective addition to standard of care for these patients.²

“The data published in these two peer-reviewed journals reinforce our position that in addition to providing meaningful clinical benefits to heart failure patients, INPEFA provides significant financial value for payors and the U.S. healthcare system,” said Craig Granowitz, MD, PhD, Lexicon’s senior vice president and chief medical officer.²

References:

1. ^{Weintraub WS, Kolm P, Dolman S, Alva M, Bhatt DL, Zhang Z. Cost-Effectiveness of Sotagliflozin in SOLOIST-WHF. JACC Heart Fail. Published online June 1, 2024. doi:10.1016/j.jchf.2024.04.018}
2. ^{Lexicon Pharmaceuticals. Analysis of INPEFA® (Sotagliflozin) cost-effectiveness published in JACC: Heart failure, the peer-reviewed journal of the American College of Cardiology. Lexicon Pharmaceuticals. June 18, 2024. Accessed June 18, 2024. https://www.lexpharma.com/media-center/news/2024-06-18-analysis-of-inpefa-r-sotagliflozin-cost-effectiveness-published-in-jacc-heart-failure-the-peer-reviewed-journal-of-the-american-college-of-cardiology.}
3. ^{Campbell P. FDA approves Sotagliflozin for treatment of heart failure. HCP Live. May 26, 2023. Accessed June 18, 2024. https://www.hcplive.com/view/fda-approves-sotagliflozin-for-treatment-of-heart-failure.}
4. ^{Bhatt DL, Szarek M, Steg PG, et al. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021;384(2):117-128. doi:10.1056/NEJMoa2030183}