What to Know About Entresto

Novartis's new heart failure drug, sacubitril and valsartan

(Entresto)

, was recently approved by the FDA.

Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in patients with chronic HF (NYHA Class II-IV) and reduced ejection fraction (EF). With this broad indication, the drug will have a patient population of about 2.2 million Americans. Novartis will also be conducting a trial to determine whether Entresto is effective in those with preserved EF, which accounts for about half of HF cases.

Traditional pharmacologic options for HF include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), diuretics, and beta-blockers. Despite this variety of treatment options, about half of patients who develop HF die within 5 years of diagnosis.

HF costs the United States an estimated $32 billion each year, and roughly

80% of that cost is related to hospitalization.

The anticipation for Entresto was based on the PARADIGM-HF study, which compared the drug with the ACE inhibitor, enalapril, in roughly 8,500 HF patients with reduced EF. The primary outcome was a composite of death from cardiovascular causes or a first hospitalization for HF, and the trial was stopped early because of the overwhelming benefit seen with Entresto.

The results showed that death or hospitalization for HF occurred in only 21.8% of patients in the Entresto group compared with 26.5% in the enalapril group. The Entresto group had higher proportions of patients with hypotension and nonserious angioedema, but lower proportions of renal impairment, hyperkalemia, and cough than the enalapril group. The most common side effects among patients treated with Entresto were low blood pressure, high blood potassium levels, and renal impairment.

Entresto will cost about $12.50 a day, or about $4500 for a year for 2 tablets taken daily, according to Novartis. The manufacturer is considering a risk-sharing model with some health plans, meaning it could charge more if the drug keeps patients out of the hospital and charge less if it doesn’t. This idea is still in the early stages.