Heart failure drug Entresto continues to grow rapidly

Prescription performance in the third quarter was 14.8 billion won, a 36% increase compared to the previous year due to increased benefits

Competitive product Verquvo released

Facing all-round challenges in the heart failure field, including patent disputes with generic companies

Entresto

Novartis' heart failure treatment Entresto continues to grow rapidly thanks to increased benefits.

 

Although it has been six years since it was launched in Korea, prescriptions are increasing by more than 30% every quarter compared to last year.

 

However, Entresto faces challenges from several successor products.

 

Recently, Verquvo, a new heart failure drug with a new mechanism, was released, and SGLT-2 inhibitor diabetes treatments are expanding their indications to the heart failure area.

 

Additionally, generic companies are actively challenging Entresto's patent evasion and invalidation.

 

Quarterly prescription volume approaching 15 billion won, still growing rapidly 6 years after launch.

 

According to UBIST, a pharmaceutical market research firm, on the 28th, Entresto's out-of-hospital prescriptions in the third quarter were KRW 14.8 billion.

 

It increased by 36% in one year compared to 10.9 billion won in the third quarter of last year.

 

Six years have passed since its release in the fourth quarter of 2017, but it is still showing high growth.

 

It grew by more than 30% every quarter compared to the same period last year.

 

It exceeded 5 billion won in the first quarter of 2020, and expanded to more than 10 billion won in the second quarter of 2022.

 

If the current trend continues, it is expected to exceed 15 billion won in the fourth quarter of this year.

 

The analysis is that there was no suitable treatment for heart failure before the launch of Entresto and that the company was able to quickly increase prescriptions by enjoying a monopoly position without competing drugs after the product launch.

 

The steady expansion of the salary range is also considered a factor in maintaining high growth.

 

Entresto's coverage has been expanded to 'first-line treatment of HFrEF with a left ventricular ejection fraction of 40% or less' since July of this year.

 

Domestic chronic heart failure patients can now use Entresto from the first treatment, even if they do not take a stable dose for more than 4 weeks in combination with standard treatment such as ACE inhibitors or ARBs.

 

In March last year, coverage was expanded to primary treatment for hospitalized patients with acute decompensated heart failure.

 

For patients who were hemodynamically stabilized after hospitalization for acute decompensated heart failure, benefits were recognized when administered Entresto even if ACE inhibitors or ARB drugs were not administered.

 

Competition is expected with follow-up new drugs, SGLT-2 diabetes drugs, generic drugs, etc.

 

However, opinions differ on how long this growth trend will continue in the future.

 

This is because we face challenges from a variety of competing products.

 

First of all, Verquvo, another heart failure treatment from Bayer, was released last September with insurance coverage.

 

It is expected that full-fledged prescriptions will be made once the drug passes the Pharmacist Committee (DC) at major general hospitals.

 

Verquvo is a treatment for chronic heart failure with a new mechanism.

 

It is a mechanism that promotes the synthesis of cyclic guanoic acid monophosphate (cGMP) within cells.

 

Unlike existing ACE I or β-blockers, which suppress the activation of the neuro-hormonal system due to myocardial and vascular dysfunction, it improves myocardial and vascular function by directly stimulating sGC to promote cGMP synthesis.

 

In the pharmaceutical industry, as it is a treatment option with a new mechanism that has emerged for the first time in a long time since Entresto, it is predicted that prescriptions will rapidly expand in clinical settings in the future.

 

SGLT-2 inhibitor-type diabetes treatments such as Forxiga and Jardiance are also expected to pose a challenge.

 

Both drugs recently received approval for expanded indications for heart failure.

 

Subsequently, an application was made to expand benefits based on efficacy and effectiveness.

 

Forxiga was applied for reimbursement for heart failure with reduced cardiac output and chronic renal failure, and Jardiance was applied for heart failure with reduced cardiac output and heart failure with preserved left ventricular ejection fraction.

 

In the case of Forxiga, as it has also obtained indications for heart failure with preserved left ventricular ejection fraction and reduced mildness, it is expected that applications for reimbursement in this area will continue in the future.

 

Last year, related academic societies in the United States and Korea successively recommended Forxiga and Jardiance as treatments for heart failure.

 

The American College of Cardiology (ACC), American Heart Association (AHA), and Heart Failure Society of America (HFSA) jointly recommended SGLT-2 inhibitors, such as Farxiga, as a treatment for mild or preserved heart failure in the 2022 revised heart failure guidelines (recommendation level) 2a).

 

The Korean Society of Heart Failure also recommended SGLT-2 inhibitors in patients with preserved ejection fraction, regardless of the presence or absence of diabetes (recommendation grade 1).

 

Entresto is also facing patent challenges from generics.

 

(From left) Product photos of Verquvo, a new heart failure drug, and Forxiga and Jardiance, SGLT-2 inhibitor diabetes drugs.

 

All three products are evaluated as competitors to Entresto

Domestic pharmaceutical companies, including Hanmi Pharmaceutical, Chong Kun Dang, Samjin Pharmaceutical, Hana Pharmaceutical, and Angook Pharmaceutical, are pursuing lawsuits to avoid the Entresto patent.

 

Last year, Hanmi Pharmaceutical was the first to succeed in capturing all five Entresto-related patents.

 

Afterward, 9 additional companies won.

 

Novartis disagreed with the first trial result and appealed.

 

We are currently awaiting the patent court's ruling.

 

The Patent Court announced November 9 as the date for the second trial of the Entresto crystalline patent lawsuit.

 

The verdict was originally scheduled to be handed down in September but was postponed for about two months.

 

In the case of two pharmaceutical patents expiring in 2029, the first trial victory for generic companies has been confirmed.

 

If the patent challengers win in the second trial and succeed in neutralizing the remaining patents, the launch of the generic Entresto is expected to come closer.