Reimb discussions begin for No.2 GIFT drug Nefecon

A new drug for IgA nephropathy

HIRA review initiated… gains attention as a treatment option that overcomes limitations of conservative therapy

Global Phase III trial demonstrated a 50% reduction in kidney function loss

Reimbursement discussions have begun for Nefecon (budesonide), the second drug designated under Korea’s GIFT (Global Innovative products on Fast Track) program and the first treatment for IgA nephropathy.

 

According to industry sources, the Health Insurance Review and Assessment Service (HIRA) is expected to soon begin evaluation of the reimbursement application submitted late last year by Everest Medicines Korea.

 

The specific indication under review is “treatment of adult patients with primary IgA nephropathy (immunoglobulin A nephropathy, IgAN) who have a proteinuria level of ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g).” Nefecon was designated as the second GIFT drug by the Ministry of Food and Drug Safety (MFDS) in November 2024.

 

With GIFT No.

 

1, Bylvay (odevixibat), essentially granted reimbursement, attention is now gathering on whether Nefecon will also be added to the reimbursement list.

 

IgA nephropathy is an autoimmune glomerulonephritis in which immune complexes deposit in the glomeruli, causing chronic inflammation and kidney damage.

 

Among severe patients with high proteinuria and low glomerular filtration rate, approximately 50% progress to ESRD (end-stage renal disease) or death within three years.

 

Even after kidney transplantation, recurrence occurs in 20–60% of patients, severely impacting survival and quality of life.

 

Until now, treatment has primarily involved conservative approaches such as RAS (renin–angiotensin system) inhibitors to control blood pressure, with dialysis or kidney transplantation considered only after significant renal function decline.

 

This represents a major unmet need.

 

The active ingredient in Nefecon, budesonide, is already marketed in Korea.

 

Similar to antibody-drug conjugates (ADCs), which are targeted anticancer drugs designed to deliver cytotoxic anticancer agents used in chemotherapy to only the target site—cancer cells—thereby improving efficacy and safety, this is a targeted therapy designed to target Peyer's patches in the ileum, the final part of the small intestine.

 

The initial stage of IgA nephropathy is the production of Gd-IgA1 (galactose-deficient IgA1).

 

Since Gd-IgA1 is primarily produced in the Peyer's patches of the ileum, Nefecon targets this.

 

In other words, it is designed to fundamentally treat the cause of IgA nephropathy by reducing the production of Gd-IgA1, the causative agent of the disease.

 

This is also why regulatory agencies such as the US FDA, European EMA, China NMPA, and MFDS designated Nefecon for accelerated review and granted expedited approval.

 

In a global Phase III clinical trial, 9 months of Nefecon treatment reduced kidney function loss by 50%, with similar effects observed after two years of follow-up.

 

Data presented at ASN 2023 further projected that 9 months of Nefecon therapy could delay the need for dialysis by 12.8 years.

 

Jin-hyang Jeong, Secretary-General of the Korea Organization for Rare Diseases, stated at a policy forum hosted on the 19th by lawmaker Ji-a Han of the People Power Party, “In Korea, IgA nephropathy patients are typically diagnosed at an average age of 34, in their prime working years.

 

They face the lifelong risk of dialysis or kidney transplantation.” Jeong added, “Rather than spending the budget to maintain patients after renal function is lost, it is far more cost-effective to intervene earlier to prevent kidney damage.

 

Special reimbursement coverage should be applied for severe IgA nephropathy patients.” Meanwhile, Nefecon received its first global approval from the U.S.

 

FDA in December 2021 under the brand name Tarpeyo as the first and only approved treatment for IgA nephropathy.

 

In Europe, it was conditionally approved in July 2022 under the brand name Kinpeygo and received full approval in July 2024.

 

As of September 2025, Nefecon is reimbursed in the U.S., U.K., Italy, and China.