Novartis' 'Leqvio' for dyslipidemia lands at Big 5 hospitals

Completed landing at Samsung·SNU·Severance·Asan hospitals

The drug offers convenience in managing LDL-c with twice-yearly administration

Product photo of Leqvio

The new drug Leqvio, a twice-yearly treatment for dyslipidemia, is now available for prescriptions at tertiary general hospitals.

 

According to industry sources, Novartis Korea's siRNA drug Leqvio (inclisiran) passed the drug committees (DC) of the 'Big 5' hospitals, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital.

 

Considering that the drug was approved in June last year, prescription settings are relatively established stably.

 

The remaining issue is the drug's reimbursement status.

 

Novartis applied for reimbursement listing immediately after obtaining approval for Leqvio.

 

However, the company has shown a difference in opinion against the government regarding reimbursement criteria during the review process.

 

The main issue under discussion for setting reimbursement criteria is whether the drug's indication to 'reduce cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD)' would be approved.

 

The competing product 'Repatha (evolocumab)' has already been reimbursed, so the government may not see expediting Leqvio's reimbursement as an urgent agenda.

 

Repatha is currently approved in 41 countries, and Leqvio in 39 countries.

 

Notably, Leqvio can be administered by healthcare professionals in hospitals twice a year.

 

This reduces the number of required injections and ensures professional administration instead of self-injection.

 

In fact, among patients (including those with atherosclerotic cardiovascular disease, ASCVD) who have received Leqvio for up to 6.8 years, 78.4% have reached their target LDL-C levels.

 

A U.S.

 

real-world study found that ASCVD patients with high drug adherence (fully adherent) experienced a 27% lower risk of major adverse cardiovascular events (MACE) compared to those with lower adherence.

 

Moreover, the high-adherence group incurred lower annual healthcare costs than the low-adherence group, indicating that the dosing convenience provided by Leqvio not only reduces the risk of recurrent cardiovascular events but also alleviates the economic burden on ASCVD patients.

 

If the reimbursement criteria for Leqvio in ASCVD are not set, official approval would eventually have to await the results of a cardiovascular outcome trial (CVOT), a process that could take several years.

 

For instance, the market for statin-ezetimibe combination products alone is estimated at around KRW 1 trillion, and when combined with the funding allocated for statins and PCSK9 inhibitors, the total expenditure on LDL-C lowering could range from KRW 1.5 trillion to 2 trillion.

 

Yet, only 24% of ASCVD patients in Korea are currently achieving their LDL-C targets.

 

Professor Suh Jon of the Department of Cardiology at Soonchunhyang University Bucheon Hospital said, "For high-risk patients, drug adherence in lipid-lowering therapy is crucial.

 

In reality, adherence to current treatment options is low, with only about 3 out of 10 patients reaching their LDL-C targets.

 

It clearly shows an unmet need for a new treatment option in lipid-lowering therapy."