Leqvio is set to challenge the market with its superior drug tolerance, administered twice yearly, compared to existing treatments.

According to the pharmaceutical industry on November 15, Novartis Korea launched the siRNA therapy Leqvio (inclisiran) on November 11.

Lecvio is the first-in-class siRNA drug approved in South Korea. It is approved as an adjunct to dietary therapy for patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia.

Leqvio uses naturally occurring siRNA to block PCSK9 protein production and lower LDL cholesterol levels. It has the advantage of its twice-yearly administration by doctors, reducing the challenges associated with self-injection.

Novartis is reportedly working to establish prescription access for Leqvio in general hospitals.

Industry sources said that Drug Committee (DC) approvals for Leqvio are proceeding across hospitals nationwide, with some hospitals already completing the process.

Novartis' Leqvio was launched in South Korea after the product became available. Novartis is expected to start building its prescription sales as the DC reviews advance within general hospitals.

With Leqvio prescriptions anticipated, there is growing interest in how Novartis’ domestic sales strategy will unfold.

Although specific details have not yet been announced, it is anticipated that Novartis will consider either utilizing its own sales line or engaging in co-promotion with a Korean company.

Leqvio's competing drug, Amgen’s Repatha, is co-marketed with Jeil Pharmaceutical. However, given Leqvio’s potential focus in general hospitals, Novartis may utilize its internal sales team.

Will Leqvio lead the prescription trend? It will depend securing reimbursement

Experts anticipate that Leqvio will have a market presence despite cost hurdles, as cholesterol management trends evolve to prioritize patient convenience along with clinical effectiveness.

For hypercholesterolemia patients, maintaining LDL-cholesterol (LDL-C) at recommended levels consistently and early on is crucial in reducing the risk of atherosclerotic cardiovascular disease (ASCVD).

Long-term strategies are anticipated to shift toward minimizing the frequency of medication doses for patients, with an increased focus on injection therapies that allow healthcare providers to monitor patient progress directly.

"While statins require daily use and Repatha requires 26 injections annually, Leqvio is administered in twice-yearly injections by a doctor," Dr. Byeong-Keuk Kim, a cardiologist at Sinchon Severance Hospital, said. "Doctors face difficulty when patients who don’t respond well to statins. Now, we could have Leqvio as a treatment option."

"Leqvio’s six-month dosing schedule could improve drug adherence, potentially resulting in a sustained decrease in LDL-C levels and lower cardiovascular risk in clinical practice," Dr. Kyung Woo Park, a cardiology professor at Seoul National University Hospital, said.

However, with the competing PCSK9 inhibitor Repatha already reimbursed, Novartis' primary aim would be on obtaining reimbursement for Leqvio.

Repatha’s reimbursed cost is approximately KRW 121,000 per injection, with recommended dosing every two weeks or once monthly at 420 mg (three dosages), bringing annual treatment costs to KRW 1.45 million.

Novartis is working on Leqvio's reimbursement listing. The company aims to continue negotiations with the government to establish reimbursement for Leqvio at about KRW 3 million, aligning with Repatha’s annual price.

"While Leqvio may be chosen by elderly patients facing adherence challenges or those with poor prognosis, many others already experience significant improvements by combining existing therapies with regular exercise. For some, even a once-monthly Repatha injection successfully maintains desired levels. In my opinion, balancing high costs against the administration convenience needs further discussion," a cardiology professor at a major hospital in Gyeonggi-do said.