SGLT2 Jardiance likely to receive expanded reimb for CKD

Jardiance's ceiling price has been adjusted through the pre-drug price reduction program for expanded usage scope drugs

Product photo of Jardiance

The SGLT-2 inhibitor Jardiance (empagliflozin, Boehringer Ingelheim) is expected to be reimbursed for the treatment of chronic kidney disease (CKD).

 

This drug is currently reimbursed for the treatment of diabetes and chronic heart failure.

 

If expanded reimbursement is approved for CKD, the volume of usage is likely to be increased.

 

Furthermore, its market presence is expected to be strengthened in the SGLT-2 inhibitors market.

 

According to industry sources on June 19, the agenda related to Jardiance's expanded reimbursement to include CKD passed the Drug Reimbursement Evaluation Committee (DREC) held on the 12th.

 

Once it undergoes the National Health Insurance Service's simplified negotiation process and reports to the Health Insurance Policy Deliberation Committee, Jardiance is anticipated to be reimbursed for treating CKD.

 

Since the company already completed drug price estimation process, reimbursement may be approved as early as July 1.

 

It has been reported that Jardiance's expanded reimbursement for CKD was approved for the pre-drug price reduction program for expanded usage scope drugs.

 

This program is designed to quickly enhance patient access to treatments by omitting the cost-effectiveness evaluation and applying a pre-reduction rate table, with a maximum 5% reduction in the ceiling cap, considering the estimated additional claim amounts due to the expanded reimbursement criteria.

 

If a drug's ceiling price is adjusted via this program, its company will only have to undergo negotiations related to supply requirements, such as those required for other reimbursed medicines.

 

Jardiance's company applied to the Health Insurance Review & Assessment Service (HIRA) for expanded reimbursement for Jardiance's CKD indication in the first half of last year.

 

Jardiance was the first SGLT-2 inhibitor to file.

 

Jardiance Tab 10mg is currently indicated for the treatment of 1.

 

Type 2 diabetes mellitus, 2.

 

chronic heart failure, and 3.

 

chronic kidney disease.

 

Jardiance Tab, which was listed for reimbursement as a diabetes treatment in 2017, has also been reimbursed for chronic heart failure since February 2024.

 

Since January this year, the reimbursement criteria have been expanded, allowing patients with heart failure with preserved ejection fraction (HFpEF) who have symptoms and signs of heart failure and a left ventricular ejection fraction exceeding 40% to receive national health insurance benefits.

 

Currently, the only SGLT-2 drugs covered for diabetes and chronic heart failure patients, besides Jardiance, are Forxiga (dapagliflozin) and HK inno.N's DapaN Tab, which transferred Forxiga's indications.

 

However, there is currently no drug reimbursable for CKD.

 

If the reimbursement expansion procedure for Jardiance is completed, it is expected to be the only SGLT-2 inhibitor with coverage for CKD reimbursement.

 

The efficacy of Jardiance has been demonstrated through clinical trials, showing a statistically significant 28% relative risk reduction in the progression of kidney disease or cardiovascular death compared to placebo.

 

The clinical trials that Jardiance significantly reduced a relative risk in the progression of kidney disease or cardiovascular death compared to placebo by 28%.

 

The expanded scope of use will provide advantage in competition with generic drugs.

 

Jardiance's substance patent expires in October this year.

 

Therefore, tens of domestic generic drugs are likely to enter the market.

 

Jardiance, jointly sold by Boehringer Ingelheim and Yuhan, recorded outpatient prescription sales of KRW 66.3 billion last year, according to UBIST.