Economic impact of sotagliflozin among patients with heart failure and type 2 diabetes: Budget impact analysis from the US payer perspective.

Background: Heart failure (HF) is a leading cause of mortality in the United States, often complicated by comorbidities like diabetes mellitus. These patients face high hospitalization risks, impacting clinical outcomes and health care resources. The Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF) trial showed that sotagliflozin, a sodium-glucose cotransporter inhibitor, reduced rehospitalizations in patients with HF and diabetes mellitus. Although clinically beneficial, the economic impact of sotagliflozin from a payer perspective remains unclear, warranting further pharmacoeconomic analysis to guide managed care decisions.

Objective: To quantify the budget impact of sotagliflozin for US payers over a 5-year time horizon.

Methods: A payer-perspective budget impact model was developed to assess the financial impact of incorporating sotagliflozin for the treatment of patients recently hospitalized for HF with comorbid type 2 diabetes (T2D) over 5 years to US payer health plans. The study used a population reflecting the SOLOIST-WHF clinical trial, with economic parameters adjusted by payer mix (all payer, commercial, Medicare, and Medicaid). Health care resource utilization included hospitalization, emergency department (ED) visit, and adverse events' care. Economic outcomes examined the medical and pharmacy budget impact for payers at the per-user, per member per month (PMPM), and total plan costs levels.

Results: For a hypothetical 1-million-member all-payer plan, 1,516 patients hospitalized for HF with comorbid T2D would be eligible for sotagliflozin. For all-payer plans, annual per-user costs increased by $4,996 because of higher pharmacy costs ($8,260) but were partially offset by lower medical costs (-$2,608) because of reduced rehospitalization and ED visits from sotagliflozin. PMPM total budget impact of sotagliflozin would be $0.08 PMPM in year 1 and $0.38 in year 5, corresponding with total plan cost of $75,736 in year 1 and $378,681 by year 5. Commercial payer PMPM costs were lower ($0.02 in year 1; $0.11 in year 5), and higher for Medicare ($0.23 PMPM in year 1, increasing to 1.13 PMPM in year 5). Breakeven rebate rates ranged between 31.5% and 79.4%.

Conclusions: Although sotagliflozin increases pharmacy costs for recently hospitalized HF patients with T2D, approximately 21%-68% of pharmacy costs were offset from reduced rehospitalization and ED visits.