Unstoppable sales growth of Entresto

despite of undergoing multiple drug pricing reductions

Entresto reached 57.5 billion won in prescription sales. Since its release in 2017, Entresto has consistently shown 30% annual growth in sales

The price of Entresto has been reduced by 21% in the past six years due to the price-volume agreement

Entresto.

Novartis Korea’s Entresto, a heart failure treatment, repeatedly shows significant growth.

 

Entresto has consistently achieved over 30% growth in sales each year since its release in October 2017, having passed six years.

 

Since its release, Entresto has undergone five price reductions to suppress the steep increase in prescription sales.

 

However, as Entresto’s simultaneous reimbursement range expanded, efforts to suppress sales were ineffective.

 

Prescription sales of Entresto exceeds 50 billion won.

 

The drug has shown a steep growth of more than 30% annually IQVIA, a drug market research agency, reported on the 8th that Entresto’s outpatient prescription sales reached 57.5 billion won last year, showing a 35% year-over-year (YoY) increase from 42.5 billion won in 2022.

 

Entresto is a new class of drugs called angiotensin receptor neprilysin inhibitor (ARNI), a combination of Valsartan, an angiotensin II receptor blocker (ARB) inhibitor, and Sacubitril, a neprilysin inhibitor.

 

After receiving reimbursement approval, Entresto was released in October 2017.

 

The annual prescription performance of Entresto (Unit 100 million won, Source: UBIST).

After its release, Entresto continued to experience rapid growth.

 

Entresto’s prescription sales grew from 5.5 billion won in 2018 to 14.3 billion won the following year, a 2.6-fold increase.

 

Despite the exacerbation of Covid-19 in 2020, Entresto continue to experience an upward trend in sales.

 

Annual prescription sales increased by more than 30%, from 20 billion won in 2020 to 30 billion won in 2021 and further to 40 billion won in 2022.

 

Last year, its sales exceeded 50 billion won and are now approaching 60 billion won.

 

Entresto underwent pricing reductions five times until last year, a 21% ↓ from 2243 won to 1774 won Entresto has undergone five price reductions, including adjustments made through the price-volume agreement and voluntary price reduction.

 

The price of Entresto was initially listed at 2243 won for 500 mg, 1,000 mg, and 2,000 mg in October 2017.

 

It was subsequently reduced by 1.9% reduction to 2,200 won in September 2019, by 7.0% reduction to 2,046 won in June the following year, and by an additional 6.6% reduction to 1,910 won in February 2022.

 

In January 2023, the price was reduced by 6.2% to 1,792 won due to the price-volume agreement.

 

In July of the same year, it was further reduced by 1.0% to 1,774 won due to price adjustments related to expansion of reimbursement.

 

During this period, the total reduction in drug pricing was 20.9%.

 

The trend of Entresto's drug pricing reductions (Source: HIRA).

Although it hasn’t been updated to last year’s prescription, Entresto saw two additional price reductions this year.

 

In January last year, it saw a 5% reduction from 1,774 won to 1,690 won due to the volume-price agreement.

 

In January, Novartis voluntarily reduced the price of Entresto by 0.4% to 1,683 won as Luxturna was reimbursement listed.

 

The reduction in drug pricing was nullified by additional expansion applications The analysis suggests that despite consistent decreases in drug prices, there has been a significant increase in prescription volume due to expansions in reimbursements.

 

In 2017, Entresto got reimbursed as a ‘treatment for patients with heart failure with reduced ejection fraction (HFrEF) and decreased heart rate.’ The reimbursement was limited to patients who underwent a combination therapy of standard treatment and stable doses of ACE inhibitor or ARB inhibitor for over four weeks.

 

In March 2022, Entresto was approved as a first-line treatment, making it available for patients who had not previously been treated with ACE inhibitor or ARB inhibitor.

 

In July of the following year, Entresto was approved for prescription to both hospitalized patients and outpatients.

 

There have also been suggestions for the possibility of additional expansion.

 

In 2021, the United States Food and Drug Administration (FDA) approved Entresto for the indication of treating patients with heart failure with preserved ejection fraction (HFpEF).

 

Analysis suggests Korea can expect Entresto’s reimbursement to be expanded to include HFpEF, a condition affecting half of the heart failure patients.

 

Will the upward growth in sales continue?

 

Factors such as generic companies challenging patents and competing drugs affect this trend The pharmaceutical industry anticipates that Entresto will likely continue its upward trend in sales, especially given the possibility of additional expansion.

 

There could be two factors affecting this trend.

 

The first is the outcome of patent challenges by Korean pharmaceutical companies.

 

A patent dispute related to Entresto is awaiting the Supreme Court’s ruling.

 

If the Supreme Court rules in favor of the patent-challenging companies, it could lead to the early release of generic versions.

 

In this case, Entresto’s drug pricing could potentially see a 30% reduction in the first year.

 

Since 2021, companies like Elyson Pharm have filed successive challenges to Entresto patents, with generic companies winning in all first-instance rulings.

 

Novartis has appealed three of these cases.

 

The verdict for one of the appeals was reached in the second instance, ruled in favor of generics as in the first-instance.

 

Subsequently, Novartis has submitted an appeal to the Supreme Court.

 

Entresto's potential competing drugs: Verquvo, Forxiga, and Jardiance.

 

As for Forxiga, AstraZeneca Korea has decided to withdraw Forxiga from the Korean market.

Another factor is the emergence of competing drugs.

 

Last September, Bayer released Verquvo as a reimbursed treatment for chronic heart failure.

 

This therapy, containing the active ingredient vericiguat, promotes the synthesis of cyclic guanosine monophosphate within cells, regulating heart contraction, vascular tension, and cardiac remodeling.

 

It represents a novel mechanism for improving myocardial and vascular function.

 

By the end of last year, prescription sales were approximately 20 million won.

 

With approval from major hospital pharmacy committees last year, Bayer expects significant prescriptions starting this year.

 

Additionally, SGLT-2 inhibitor drugs are considered potential competing products for Entresto.

 

Last year, Forxiga (dapagliflozin) and Jardiance (empagliflozin) received approval for the indication of chronic heart failure.

 

However, their reimbursements are currently limited to patients with heart failure accompanied by diabetes.

 

Industry experts anticipate that these two drugs will receive expanded reimbursement for treating patients with chronic heart failure and reduced ejection fraction regardless of having diabetes.

 

The government is analyzing the financial effects related to expanding reimbursement for SGLT-inhibitor drugs.