Will the SGLT-2i Jardiance be reimb for CKD in 2H?

HIRA’s review underway…whether it will expand treatment options for kidney disease gains attention

Suglat follows Forxiga’s footsteps and withdraws from market…Jardiance becomes the only original SGLT2i produced by a multinational pharmaceutical company

Attention is focused on whether the SGLT-2 inhibitor Jardiance can settle as a reimbursed prescription option for chronic kidney disease in the second half of the year.

 

According to industry sources, the Health Insurance Review and Assessment Service is currently reviewing the reimbursement expansion of Boehringer Ingelheim and Lilly Korea’s Jardiance (empagliflozin).

 

After the pharmaceutical companies submitted their applications in the first half of the year, HIRA began discussions in earnest after collecting expert opinions from relevant academic societies.

 

The drug is for reducing the risk of progression of kidney disease or death from cardiovascular disease, regardless of the presence of type 2 diabetes, and the drug was approved for additional indication in Korea in October last year.

 

As a result, Jardiance is now approved as a treatment for 3 conditions - diabetes, chronic heart failure, and chronic kidney disease.

 

Chronic kidney disease is estimated to affect one in every 9 adults in South Korea.

 

Patients with CKD are known to have 7.2 times higher the risk of death than those without chronic kidney disease.

 

If not treated appropriately in the early stages, patients can progress to end-stage kidney disease (ESKD), which increases the risk of death.

 

This is why the treatment of CKD is primarily aimed at delaying the progression of the disease, ultimately reducing progression to end-stage kidney disease.

 

Jardiance’s efficacy in CKD was demonstrated through the Phase III EMPA-KIDNEY study, a large-scale SGLT-2 inhibitor clinical trial that was conducted on a broad patient population.

 

The EMPA-KIDNEY trial included 6,609 participants with chronic kidney disease, many with comorbidities across the spectrum of cardiovascular, kidney, or metabolic conditions, regardless of Type 2 diabetes.  Unlike previous SGLT-2 inhibitor studies, which focused specifically on patients with urinary albumin-to-creatinine ratios (UACRs), this study included patients with low UACR as well.

 

The study met its primary endpoint, demonstrating a significant 28% reduction in the relative risk of kidney disease or cardiovascular death compared with placebo, and the effect was consistent across subgroups stratified by UACR, confirming a consistent treatment effect in patients with and without albuminuria The results also showed a statistically significant reduction in all-cause hospitalizations (14%) compared with a placebo, which was one of the pre-specified key secondary confirmatory endpoints, reducing the burden of hospitalization for CKD patients.

 

Overall safety results were similar to the previously recognized safety profile.

 

Meanwhile, Jardiance is expected to become the only original SGLT-2 inhibitor produced by a multinational pharmaceutical company in the country.

 

Following AstraZeneca Korea's decision to withdraw Forxiga (dapagliflozin) from the market last December, Astellas Pharma Korea also recently announced the discontinuation of Suglat (ipragliflozin) in Korea.