3 variables affecting the growth of 'Entresto'

Sales rise 24% over the year

KRW 71 billion prescription sales last year…continued to grow fast due to expanded indications

Variables include patent disputes nearing the end·competing drugs becoming widely prescribed·drug price being reduced due to the PVA

Product photo of Entresto

Novartis' chronic heart failure treatment 'Entresto (sacubitril/valsartan)' has maintained high growth, with prescription sales exceeding KRW 70 billion last year.

 

Analysis suggests that expanded indications in 2022 and 2023 have led to skyrocketed growth.

 

However, it is unknown whether this growth rate will continue this year.

 

Numerous patent disputes raised by generic companies are ending, and Entresto's competing drug, Verquvo (vericiguat), has started to generate prescription sales.

 

Earlier this year, the drug price was reduced by 5% due to the price-volume agreement (PVA).

 

According to the market research firm, UBIST, Entreso's prescription sales from last year amounted to KRW 71 billion, up 24% from the previous year.

 

Entresto is the first-in-class dual blocker ARNI combining valsartan, an angiotensin II receptor blocker (ARB) inhibitor, and sacubitril, a neprilysin inhibitor.

 

Although it was launched seven years ago, Entresto maintains a high growth rate.

 

Novartis launched Entresto with reimbursement in October 2017.

 

In 2019, its prescription sales exceeded KRW 10 billion.

 

In 2020, it recorded KRW 22.4 billion, up 56% from the previous year.

 

Following that, it repeatedly showed skyrocketed growth by generating KRW 32.4 billion in 2021, KRW 42.5 billion in 2022, and KRW 57.5 billion in 2023.

 

Entresto

It has been reported that obtaining expanded indications in 2022 and 2023 has contributed to the skyrocketed growth.

 

At the time of launch in 2017, Entresto received reimbursement coverage as a 'therapy for patients with chronic heart failure with reduced ejection fraction (HFrEF).' This drug was reimbursed for cases where patients receive standard therapy in combination with an ACE inhibitor of ARB inhibitor for over four weeks.

 

In March 2022, the use of Entresto was expanded to include first-line treatment.

 

It can be used to treat patients who have not previously been treated with either an ACE inhibitor or an ARB inhibitor.

 

By July of the following year, Entresto became available for prescription to both hospitalized patients and outpatients.

 

However, it is uncertain whether such a growth rate will continue this year.

 

The most significant variable is the patent dispute with generic companies.

 

Numerous patent disputes that began in 2021 are nearing the end.

 

After January 2021, genetic companies filed for trials against Entresto's crystalline form patent, salt·hydrate patent, two use patents, and two ingredient patents.

 

Generic companies won the first trials.

 

After losing the first trials, Novartis appeal against three cases: crystalline form patent, use patent, and salt·hydrate patent.

 

However, generic companies won the second trial as well.

 

They won a dispute against the crystalline form patent and use patent.

 

For the use patent, Novartis filed for the Supreme Court but received a 'discontinuance of a trial' ruling.

 

Two rulings remain.

 

The crystalline form patent dispute awaits the Supreme Court ruling, while the salt·hydrate patent case at the Intellectual Property Court of Korea has concluded and is awaiting the final verdict.

 

The pharmaceutical industry projects that two cases of patent disputes will receive the final ruling within this year.

 

If patent-challenging companies also win the remaining trials after their victory in the first and second trials, generic drugs are expected to launch early.

 

The other variable is the competing drug.

 

Bayer received approval for Verquvo in November 2021 for the treatment of patients with chronically impaired left ventricular contractility and left ventricular ejection fraction (LVEF) of less than 45%.

 

In September 2023, the drug was covered with reimbursement.

 

Last year, the drug landed at major general hospitals and began generating prescription sales.

 

Verquvo generated prescription sales of KRW 1.3 billion last year.

 

Verquvo is a treatment for heart failure that obtained approval six years after Entresto.

 

It draws attention to the mechanism different from Entresto.

 

Entresto blocks the harmful effects of neurohormonal activation upon myocardial and vascular dysfunction.

 

In contrast, Verquvo is a novel soluble sGC stimulator that promotes the synthesis of cGMP (cyclic guanosine monophosphate), which regulates heart contraction, vascular tension, and heart reformation.

 

Additionally, the reduction in drug prices due to the PVA is considered another variable.

 

As of January 1, the price of Entresto reduced from KRW 1,683 to KRW 1,599, down 5.0%.

 

Novartis signed an agreement with the National Health Insurance Service (NHIS) in December 2024 regarding the type-NA PVA.

 

The drug price of Entresto has been reduced eight times since it was added to the reimbursement list at KRW 2,243 in 2017 until January this year.

 

This includes adjustments made through the PVA agreement and voluntary reductions.

 

During the process, the total reduction in the drug price amounts to 32.8%.