Entresto’s reimb for HFrEF is extended again

in heart failure with reduced ejection fraction

Positions itself at the same level as an ACE inhibitor in patients with LVEF below 40%

Strengthens its position as a first-line therapy after solidifying its position as a treatment for hospitalized patients

The reimbursement standards for the heart failure treatment ‘Entresto’ has been extended once again.

 

According to industry sources, the reimbursement standards for Entresto (sacubitril) will be revised starting next month (July) to cover its use in combination with standard therapy (beta blockers, aldosterone antagonist, etc.) in patients with chronic heart failure with reduced ejection fraction whose left ventricular ejection fraction (LVEF) is below 40%.

 

This is an extension from the previous reimbursement standard that was limited to ‘patients who have been receiving stable dose for over 4 weeks,’ and also an additional extension in becoming a first-line therapy after last year when the drug’s reimbursement was extended to ‘patients who were hemodynamically stabilized after being hospitalized for acute decompensated heart failure and has not received ACE inhibitors or angiotensin II receptor blockers.’ In other words, Entresto can now be used in combination with other standard therapies in patients with an ejection fraction of 40% or less and is positioned at the same status as ACE inhibitors and angiotensin receptor blockers.

 

Entresto’s efficacy in HFrEF was identified in the Phase III PIONEER-HF study.

 

In the PIONEER-HF study, a significant reduction of NT-proBNP was identified from Week 1 of treatment, and the clinical efficacy of Entresto was consistent among various patient groups including patients newly diagnosed with heart failure and RASi-naïve patients.

 

Also, the 12-week open-label extension results that were presented at JAMA Cardiology 2019 showed that Entresto demonstrated consistent treatment effect and safety at Week 12.

 

The difference between the two treatment groups, such as readmission within 8 weeks, was not narrowed for 4 weeks, confirming the clinical necessity of the initial use of Entresto.

 

Entresto is currently recommended as the standard-of-care in heart failure treatment guidelines in Korea and abroad.

 

The European Society of Cardiology (ESC) and the American College of Cardiology (ACC) recommends Entresto as a first-line treatment option, and in January 2021, the 2021 update to the ACC Expert Consensus Decision Pathway amended the guidelines to recommend Entresto ahead of ARB or ACE inhibitors.

 

Also, the ESC’s Heart Failure Guidelines that was updated in August 2021 emphasized a combined treatment strategy that simultaneously initiates the use of 4 essential drugs including ARNI-class drugs (Entresto) that reduce the risk of death from heart failure.

 

Meanwhile, Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that directly works on the heart.

 

It works on two hormonal pathways, to activate the NP nerve hormones that benefit the cardiovascular system while inhibiting RAAS which is harmful for the cardiovascular system.