Heart failure is a significant cause of hospital admissions in the U.S., characterized by high morbidity, mortality, and economic costs. Recent advancements in pharmacotherapy for heart failure with reduced ejection fraction (HFrEF) have led to the development of new disease-modifying therapies. One such innovative therapy is the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril-valsartan.
The PARADIGM-HF clinical trial revealed that sacubitril-valsartan reduced the risk of cardiovascular death or hospitalization due to heart failure (HF), particularly in ambulatory patients with an HFrEF of 40% or less. This discovery positions it as a highly cost-effective treatment option.
In February 2021, the U.S. Food and Drug Administration expanded the labeling of sacubitril-valsartan to include all adult patients with chronic HF. This decision was informed by the understanding that the benefits are most evident in patients with left ventricular ejection fraction (LVEF) below normal. However, the upper bound of below-normal EF is not explicitly defined.
A recent economic analysis of treatment with sacubitril-valsartan versus renin-angiotensin system inhibitors (RASis) in patients with HF across a wider range of EFs found the treatment to be of high economic value for patients with EF≤50%. The treatment demonstrated intermediate value up to an EF of 60% or less before accounting for any price concessions that payers may receive.
The economic value of sacubitril-valsartan is comparable to sodium-glucose cotransporter 2 inhibitors (SGLT2is), as noted by Cohen et al. However, these analyses do not consider the affordability of the medications for individuals. Economic assessments of these novel medications suggest they could add billions to US healthcare spending. Without efforts to lower drug prices, the use of costly, intermediate to low-value care may be reinforced.
Sacubitril-valsartan increases quality-adjusted life years (QALYs) at an incremental cost-effectiveness ratio consistent with high economic value for patients inclusive of reduced and mildly reduced EFs (≤50%). For those with EFs of 60% or less, sacubitril-valsartan could potentially add 0.53 QALYs at an incremental lifetime cost of $40,892 compared to RASi, resulting in an ICER of $76,852 per QALY.
Sacubitril-valsartan is estimated to be of at least intermediate value, considering the current undiscounted wholesale acquisition cost price across a broad HF population with EFs below normal, when below normal is defined as an EF of 60% or less. Thus, sacubitril-valsartan is a significant development in the treatment of heart failure, offering a cost-effective solution that could potentially improve patient outcomes.
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