Fetroja, Rezurock win reimbursement, easing burden for patients with drug-resistant infections and cGVHD

Fetroja (cefiderocol), a treatment for multidrug-resistant Gram-negative bacterial infections, and Rezurock (velumosudil), a new drug for chronic graft-versus-host disease (cGVHD), have been added to the national health insurance reimbursement list.

On Thursday, the Ministry of Health and Welfare reviewed and approved the “Revised List of Reimbursed Drugs and Reimbursement Ceiling Price Table (New Drug Listing)” at the Health Insurance Policy Deliberation Committee (HIPDC) meeting, confirming reimbursement coverage for Fetroja and Rezurock. Both drugs are subject to risk-sharing agreements (RSAs), and reimbursement will apply starting Feb. 1.

Jeil Pharmaceutical received approval for a multi-drug resistant gram-negative bacterial infection treatment, Fetroja, from the Ministry of Food and Drug Safety in February 2025.

The drugs approved for coverage at this HIPDC meeting include two new drugs and two items subject to price negotiation. They share the common characteristic of being high-cost therapies for rare or severe diseases. While their clinical necessity is recognized, limitations in cost-effectiveness evaluations led the government to apply reimbursement-type and total amount–limited risk-sharing contracts concurrently.

Fetroja 1 gram (cefiderocol tosylate hydrate) by Jeil Pharmaceutical was listed for reimbursement as a treatment for hospital-acquired pneumonia (HAP), including complicated urinary tract infections (cUTI) and ventilator-associated pneumonia (VAP), caused by Gram-negative bacteria. However, coverage is restricted to cases in which carbapenem antibiotics have failed or carbapenem-resistant Gram-negative bacterial infection has been confirmed.

Fetroja is a broad-spectrum antimicrobial that covers multidrug-resistant Gram-negative bacteria and demonstrated non-inferiority to existing carbapenems in clinical trials. According to the ministry, the annual number of eligible patients is estimated at 1,869, with a maximum reimbursement of 210,097 won ($146) per vial. The estimated annual claim amount is 24.7 billion won, though the actual financial burden is expected to be lower due to the risk-sharing agreement.

Sanofi-Aventis Korea’s Rezurock 200mg tablets (belumosudil mesylate) received reimbursement approval for patients with chronic graft-versus-host disease who have failed prior second-line or later systemic therapies. Rezurock is an oral ROCK2 inhibitor. In a single-arm phase 2 clinical trial, it demonstrated clinical utility with a best overall response rate (bORR) of 74 to 77 percent and a median duration of response of 54 weeks.

The reimbursement ceiling price for Rezurock is 424,742 won per tablet, with an estimated annual patient population of 145. Although the annual per-patient drug cost reaches approximately 220 million won, patients’ out-of-pocket expenses are capped at 10.96 million won under the out-of-pocket maximum system. The projected annual claim amount is 31.38 billion won and will also be subject to a reimbursement-type or total amount–limited risk-sharing scheme.

The HIPDC determined coverage appropriateness based on a comprehensive assessment of the limited availability of alternative treatment options, the characteristics of rare and severe diseases, and the status of reimbursement in eight major countries (A8).

In the case of Fetroja, its designation as an essential national antimicrobial served as a key factor in the coverage decision. For Rezurock, its status as a new therapy with a treatment position comparable to rare disease drugs was viewed favorably.

However, both drugs are subject to conditions requiring the collection of real-world usage data and ongoing financial management, leaving open the possibility that coverage conditions may be adjusted during future reevaluations, the ministry said.