Cutting Through Cost Barriers for Heart Failure Medications

Volume 25, Issue 1

For many years, the landscape of drug therapy for heart failure remained unchanged. Angiotensin-converting enzyme (ACE) inhibitors were studied in the late 1980s, beta-blockers in the early 1990s, and mineralocorticoid receptor antagonists (MRAs) in the late 1990s. And then… nothing. For more than a decade, numerous drugs were tested and failed to demonstrate a meaningful benefit in reducing residual death and morbidity related to heart failure. 

The next watershed moment happened in 2015 with the publication of the PARADIGM trial, which demonstrated the angiotensin receptor-neprilysin inhibitor (ARNI) combination, sacubitril/valsartan, effectively reduced rates of cardiovascular death and hospitalization for heart failure compared to enalapril. 

Following that data, in the last several years, we’ve seen substantial research establishing the SGLT2 inhibitors as highly effective treatments for heart failure across the spectrum of ejection fraction. And most recently, vericiguat was approved as an adjunct therapy for patients with worsening heart failure. 

Unfortunately, newer drugs carry branded copays and cost both the patient and the health care system more money. Hence, pharmacoeconomic studies are important to establish the incremental gains in clinical outcomes are worth the cost of newer therapies. 

In this week’s issue of Talking Therapeutics, we explore a new study which evaluated the cost effectiveness of quadruple therapy for heart failure with a reduced ejection fraction (HFrEF). 

Point 1: Quadruple Therapy Is Cost Effective

In this new study, the authors performed a cost-effectiveness analysis using simulated populations of 1000 patients with HFrEF. The simulated populations were based on the participants in the PARADIGM trial. From the perspective of the US health care system, researchers compared quadruple therapy (an ARNI, beta-blocker, MRA, and SGLT2 inhibitor) to both triple therapy (an ACE inhibitor, beta-blocker, and MRA) and double therapy (an ACE inhibitor and beta-blocker). 

The authors found quadruple therapy increased life-years by 1.73 and 2.87 as compared with triple therapy and double therapy, respectively. Furthermore, there was an increase in quality-adjusted life-years of 1.12 and 1.85 years, respectively, for quadruple therapy vs triple and double therapy. The incremental cost-effectiveness ratios of quadruple therapy vs triple therapy and double therapy were $81,000 and $51,081, respectively, and both these numbers were less than the cost-effectiveness threshold of $150,000. 

Study authors concluded quadruple therapy for patients with HFrEF was cost effective when compared to double and triple regimens. They recommended further efforts to optimize access and treatment implementation for patients eligible for quadruple therapy. 

Point 2: Omecamtiv Denied FDA Approval

Meanwhile, news broke this week that the US Food and Drug Administration (FDA) has denied the new drug application for omecamtiv, a cardiac myosin activator that has been studied in patients with HFrEF. This is relevant to the cost discussion, as this agent would have carried another branded copay and would have further increased costs above what we are already paying for ARNI and SGLT2 inhibitor therapies.

I agree with the FDA’s decision from a cost perspective, as the data for omecamtiv were not as a robust as that of other heart failure medications. I think our focus right now needs to be on ensuring that all eligible patients receive quadruple therapy.