Entresto's outpatient prescriptions exceed ₩30 billion

the reason why competitors are eyeing the drug

Exceeds ₩30 billion in outpatient prescriptions sales only 5 years after release

Additional 6.6% price cut to be implemented this year… patent challenges continue

Novartis to respond by adding HFpEF indication · reimbursement expansion

Pic.

 

of Entresto

Sales of Novartis’ chronic heart failure treatment ‘Entresto’ exceeded ₩30 billion only 5 years into its release.

 

In the midst of drug price cuts and domestic patent challenges, Entresto is seeking greater growth this year by expanding the scope of indications and reimbursement benefits.

 

According to the market research institution UBIST on the 29th, outpatient prescription sales of Entresto recorded ₩32.3 billion, a 37.3% growth from the ₩23.5 billion made in the previous year.

 

The product made such growth in only 4 years since its release in October 2017.

 

Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) valsartan and neprilysin inhibitor sacubitril.

 

The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction in combination with other heart failure treatments.

 

Entresto received marketing authorization in April 2016 and was officially launched with reimbursement in October 2017.

 

Entresto’s explosive growth was well expected.

 

The drug demonstrated its efficacy and safety in acute heart failure in addition to chronic heart failure, and academic societies in Korea and abroad recommend Entresto as a standard of care.

 

Also, the American Heart Association recommended Entresto as the standard of care for heart failure with reduced ejection fraction (HFrEF).

 

Until now, ACE or ARB inhibitors were mainly used in patients with chronic heart failure.

 

Replacing this demand, Entresto quickly increased its share in the market.

 

Its outpatient prescription sales, which started at ₩300 million in 2017, increased 20 times to ₩6.3 billion the next year.

 

In 2019, its sales doubled once more to ₩15 billion, then rose to exceed ₩30 billion only 2 years since then.

 

To slow down such growth, pharmaceutical companies in Korea have aggressively set out to challenge Entresto’s patent.

 

13 domestic companies including Hanmi Pharmaceuticals and Chong Kun Dang filed patent challenges last year.

 

The Intellectual Property Trial and Appeal Board ruled in favor of the generic companies in the trial to confirm the passive scope of rights of Entresto’s crystalline patent.

 

By overcoming the key patent among 5 of Entresto’s patents, the domestic generic companies are speeding up their challenges.

 

Also, Entresto’s price will undergo additional price cuts.

 

The Ministry of Health and Welfare is working to cut Entresto’s price by 6.6% as of February 1st under the ‘‘Amendment to the drug reimbursement list and reimbursement ceiling price table.’ Entresto is subject to pricing cuts under the ‘Use amount-price linkage-type B’ where a product whose use increased over 10% in an amount over ₩5 billion undergo price cuts.

 

The price of Entresto, which was listed at ₩2,243 at the time of first listing, will be reduced to ₩1,910 through three pricing adjustments.

 

Novartis plans to continue its strong growth by adding indications and expanding Entresto’s reimbursement standards.

 

Its indication for HFpEF is one of the company’s key areas of interest.

 

Although around half of all patients with heart failure suffer HFpEF, which is defined as a left ventricular ejection fraction of 40% or higher, no appropriate treatment had existed for the condition yet.

 

Novartis demonstrated that Entresto can reduce the risk of hospitalization from heart failure and cardiovascular death through the PARAGON-HF trial.

 

The UF Food and Drug Administration additionally approved the HFpEF indication for Entresto in January last year.

 

In line with the added indication, Novartis is working to expand the scope of Entresto’s reimbursement to first-line therapy in HFrEF.