Hyperlipidemia Drug Leqvio’s nears market entry in KOR

Drug price remains the greatest variable...Approved as a siRNA therapy in Korea... Up to 52% reduction in LDL-C compared to placebo

Improved patient dosing convenience compared to existing therapies such as Repatha, which is administered up to once a month

Industry expects the price to be in the KRW 2-3 million range...Competitors are priced at KRW 0.5 to 1.5 million

Expert "Clear demand exists among the elderly...Higher listing price may act as a hurdle"

Novartis’s Leqvio’s (Inclisiran), is preparing to enter Korea’s market as the first siRNA therapy, armed with its convenience of twice a year administration.

 

However, in a situation where there are already many treatments for hyperlipidemia available on the market, the high cost of Leqvio compared to existing treatments may act as a hurdle, regardless of its advantages.

 

Pic of Leqvio

Leqvio is a first-in-class siRNA therapy that was recently approved in Korea as an adjunctive therapy to diet in patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia.

 

It utilizes a naturally occurring siRNA to reduce LDL-C in the blood by inhibiting the production of PCSK9 protein, which raises LDL-cholesterol.

 

It is injected directly by a healthcare provider twice a year, reducing the fear and discomfort of self-injection.

 

In the three Phase 3 studies that confirmed the effectiveness of Leqvio - ORION-9, ORION-10, and ORION-11 -Leqvio reduced the LDL-C level by 47.9%, 52.3%, and 49.9% compared to placebo at Day 510, respectively.

 

In all 3 studies, the safety profiles of Leqvio and placebo did not show statistically significant differences.

 

In ORION-18, which was conducted on Asian patients including 24% Korean patients, Leqvio achieved a 57.17% LDL-C reduction compared to placebo at Day 330.

 

These results have been driving Leqvio’s rapidly growing global sales.

 

Leqvio’s global sales in the first half of the year amounted to $333 million, prompting Novartis to raise its full-year profit forecast.

 

The company is expected to target the market armed with its twice-a-year dosing advantage in Korea.

 

The question is how it can compete with the other competitors that are already being reimbursed.

 

Higher cost compared to competitors...receiving reimbursement crucial for market suceess For Novartis, its first and utmost priority will be to receive reimbursement.

 

According to industry sources, Novartis is considering a list price of KRW 1.5 million for a single dose of Leqvio.

 

If so, the cost of the twice-a-year treatment is expected to be in the range of KRW 2 to 3 million.

 

Considering how it is administered 3 months after the initial dose, and then every 6 months thereafter, the drug can cost even more in the first year.

 

Current direct competition is Amgen's Repatha (evolocumab), which has overlapping indications for hypercholesterolemia and mixed dyslipidemia.

 

Repatha’s sales had been around KRW 4.2 billion in 2021, KRW 7 billion in 2022, and KRW 10.5 billion in 2023, according to IQVIA.

 

Repatha is priced at KRW 121,000 per dose with reimbursement.

 

The recommended dose is 420 mg once every two weeks or once a month (three doses).

 

Therefore, it costs 1.42 million won based on the higher dose of 420 mg once a month.

 

The price gap becomes even wider when compared to Viatris’ Lipitor, which has expanded its indication and is recorded as a top-selling drug in Korea every year.

 

Lipitor is priced at KRW 640 per 10mg tablet, which means it costs KRW 233,600 when taken once a day.

 

Based on the largest dose of 80 mg, which costs KRW 1,523 per tablet, it still costs 558,895 won a year.

 

In the end, the therapeutic effect of Leqvio and the convenience it provides to patients who have difficulty managing their medications will be the key to its future market competitiveness.

 

"I think Leqvio will be in demand among elderly patients who have difficulty taking drugs consistently and those with poor prognosis.

 

However, most patients are seeing significant therapeutic effects with existing medications and exercise," said a cardiology professor from A Hospiatl in Gyeonggi-do.

 

In some cases, patients who are well-controlled on Repatha can maintain their levels well with once-a-month Repatha injections.

 

From a personal point of view, the cost versus convenience of dosing is a difficult decision."