Expanded reimb for Jardiance's CKD indication imminent

A SGLT-2 inhibitor

HIRA is considering pre-drug price reduction system for Jardiance…the first among SGLT-2 drugs

Jardiance Tab

It is to be watched whether the SGLT-2 inhibitor Jardiance (empagliflozin, Boehringer Ingelheim) will be approved for expanded reimbursement to include chronic kidney disease (CKD) indication, in addition to diabetes and chronic heart failure indications.

 

The evaluation by the Health Insurance Review & Assessment Service (HIRA) is expected to be nearing end following the reimbursement expansion filed in the first half of last year.

 

According to industry sources on May 26, HIRA is reportedly reviewing expanded usage scope and pre-drug price reduction system for Jardiance's CKD indication.

 

The pre-drug price reduction system for expanded usage scope drugs is designed to quickly enhance patient access to treatment 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.

 

Once the pharmaceutical company submits financial impact analysis data and HIRA determines the pre-reduction rate through practical review, the Drug Reimbursement Evaluation Committee (DREC) will deliberate.

 

If the pharmaceutical company accepts the deliberation results, the revised reimbursement criteria notification is completed after negotiation with the National Health Insurance Service (NHIS).

 

The company applied to HIRA for reimbursement expansion for Jardiance's CKD indication in the first half of last year.

 

Jardiance was the first SGLT-2 inhibitor to file.

 

The approved indications for Jardiance 10mg tablets are: 1.

 

Type 2 diabetes mellitus, 2.

 

chronic heart failure, and 3.

 

chronic kidney disease.

 

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

 

Since January, 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 drug with CKD reimbursement coverage.

 

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 competition in the market for SGLT-2 has been intensified due to the expiration of dapagliflozin patent in 2023 and the launch of generic drugs, Jardiance's expanded reimbursement scope to include CKD will give Jardiance a competitive advantage.

 

Generic drugs are expected to launch following Jardiance's substance patent expiration in October.

 

However, Jardiance's heart failure and kidney disease indications are expected to remain protected, so expanded reimbursement is anticipated to minimize the impact of generic entry.

 

The pharmaceutical industry anticipates that the reimbursement expansion for Jardiance's CKD indication will be approved after July or by the end of the year.