Evaluation of Patients with Heart Failure to Determine Eligibility for Treatment with Sacubitril/Valsartan: Insights from a Veterans Administration Healthcare System

Abstract

Study Objective Despite evidence that supports the use of sacubitril/valsartan – the first angiotensin II receptor blocker–neprilysin inhibitor – for mortality reduction in patients with heart failure (HF), it remains underprescribed. The objective of this study was to evaluate eligibility for initiation of sacubitril/valsartan treatment in patients with HF within the largest Veterans Administration healthcare system in the United States. Design Cross‐sectional study. Setting Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS). Patients A total of 2985 patients with a HF diagnosis who were alive as of November 1, 2017. Measurements and Main Results Eligibility for sacubitril/valsartan initiation was based on inclusion and exclusion criteria from the Prospective Comparison of Angiotensin Receptor–Neprilysin Inhibitor with Angiotensin‐Converting–Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM‐HF) trial and the VA Criteria for Use. The proportion of eligible patients was estimated, and characteristics of eligible patients were compared with those in the PARADIGM‐HF trial. Of the 2985 patients with HF who were alive as of November 1, 2017, 965 (32.3%) had HF with reduced ejection fraction (HFrEF). Of these patients with HFrEF, 263 (27.3%) fulfilled eligibility criteria and were considered candidates for sacubitril/valsartan initiation. Of the 702 patients who did not fulfil eligibility criteria, the most common reasons were New York Heart Association functional class I (35.3%) and B‐type natriuretic peptide level of 100 pg/ml or lower (22.2%). Compared with patients in the PARADIGM‐HF trial, VAGLAHS patients were older (70.4 vs 63.8 yrs) and more likely to be male (98.5% vs 79.0%), and a higher proportion had New York Heart Association functional class III symptoms (35.4% vs 23.1%). Of the 965 patients with HFrEF, 34 (3.5%) had an active sacubitril/valsartan prescription as of November 1, 2017, of whom 27 (79.4%) did not meet criteria. Conclusion Whereas 27% of patients with HFrEF were eligible to initiate sacubitril/valsartan, only 3.5% of these patients were prescribed the medication. Although sacubitril/valsartan reduced morbidity and mortality in clinical trials, it remains underused within this VA healthcare system. This analysis provides important insights into the VA and other healthcare systems regarding the opportunity for optimizing guideline‐directed HF therapy.

Clinical Representativeness of the PARADIGM-HF Study in an Outpatient Cohort of Patients with Heart Failure, Including Chagas Disease, Treated According to Guideline-directed Medical Therapy: Prospective Study, in a Single Center in Brazil

“…In addition to the ineligibility criteria such as problems such as renal dysfunction, hypotension and low proportion of target doses, the low prescription rate for sacubitril/valsartan is another aggravating factor. In the Veterans Administration Health System in the United States, among 27% of eligible patients, only 3.5% received the prescribed medication [19]. In another real-world clinical setting in a recent publication, with 1355 patients with HF, 20% were eligible for use of sacubitril/valsartan and only 13% received the medication [20].…”

Prior Authorization, Copayments, and Utilization of Sacubitril/Valsartan in Medicare and Commercial Plans in Patients With Heart Failure With Reduced Ejection Fraction

“…Although sacubitril/valsartan (Entresto) reduces mortality and heart failure (HF) admissions in New York Heart Association (NYHA) class II/III HF with reduced ejection fraction (HFrEF), its adoption into clinical practice has been slow. 1–5 Prior authorization (PA) and copayment amount have been identified as potential barriers that may reduce drug access and impact clinical outcomes. 6–8 Since drug policies and drug utilization patterns may differ between insurance plan types, our study aimed to characterize PA and copayment policies and sacubitril/valsartan use between insurance plan types to identify their influence on sacubitril/valsartan utilization.…”