Abstract 16587: More Than Five Years After FDA Approval, There Remains Very Limited Adoption of New Evidence-Based, Highly Effective Medications for the Treatment of Patients With Heart Failure, Especially Among Those on Medicare

Abstract

Background: Over the past decade, the FDA has approved several new medications that are highly effective when added to existing standard therapy in the treatment of heart failure with reduced ejection fraction (HFrEF). It is possible that, despite the presence of substantial evidence regarding the clinical effectiveness of these new medications, their high cost and the complex medical reimbursement system in America may prevent their routine adoption. Methods: We analyzed 5,824 Intermountain Healthcare patients, age ≥18 years with a new clinical diagnosis of HFrEF (LVEF ≤35%), from 1/1/2015 onward, for the use of newly-approved sacubitril/valsartan or any sodium-glucose cotransporter-2 inhibitor (SGLT2-I). We collected baseline characteristics and medication utilization data. We followed the patients for 1.7±1.4 years for future major adverse cardiovascular events (MACE), including death, myocardial infarction (MI), stroke, and heart failure hospitalization (HFH). We identified differences between groups by multivariable Cox regression analysis. Results: Baseline characteristics and incidence of MACE, according to insurance status and the use of common HFrEF medications, are shown in the Table. Overall, only 344 (5.9%) and 169 (2.9%) of patients ever received a prescription for sacubitril/valsartan or an SGLT2 inhibitor, respectively. The figures show survival curves for MACE of patients receiving or not receiving the newly-approved medications. Conclusion: In this large, modern, real-world HFrEF population, the adoption of newly-approved evidence-based HFrEF medications is minimal in all patients and especially in Medicare patients. This lack of adoption is associated with a significant worsening in patient outcomes. These findings demonstrate a critical need to resolve our present healthcare financial crisis, which is almost certainly the reason for these findings.