Pfizer’s Zavicefta, sole CRE antibiotic in KOR, gets reimb

Pfizer held a press conference to commemorate the reimbursement coverage of Zavicefta in Korea

Zavicefta showed non-inferiority compared to existing antibiotics, including carbapenem and meropenem

CRE patients are steadily increasing, with 30,000 patients reported in 2022. “It is necessary to manage patients with antibiotic resistance”

From the left, Professor Lee Dong-gun, Professor Yoon Young-kyung, and Pfizer Korea Medical Lead Choi Heeyeon.

A new antibiotic has been added to the insurance reimbursement listing a year after Zerbaxa.

 

Zavicefta, developed by Pfizer, is the only antibiotic that can be used to treat carbapenem-resistant Enterobacteriaceae (CRE).

 

Experts have stressed the use of this drug only when necessary because there is a growing number of patients with antibiotic resistance.

 

Pfizer Korea hosted a press conference at JW Marriot Seoul on the 21st to commemorate the reimbursement coverage of the new antibiotic drug, Zavicefta.

 

Zavicefta is a combination of ‘ceftazidime,’ a third-generation cephalosporins-class antibiotic, and ‘avibactam,’ used to maintain microbial clearance.

 

Zavicefta is the only antibiotic that can treat CRE infections in Korea.

 

It can be used for treating patients with Gram-negative infections, including CRE.

 

Starting on February 1st, Zavicefta has been covered by reimbursement for the treatment of gram-negative infections such as carbapenem-resistant Enterobacteriaceae, according to the Ministry of Health and Welfare (MOHW) announcement.

 

Zavicefta is covered by reimbursement under one of the following conditions: ▲Complicated intra-abdominal infections, ▲Complicated urinary tract infections, ▲Pneumonia contracted within the hospital that is unresponsive to antibiotic treatment or when there is proof of multi-drug resistant P.

 

aeruginosa or carbapenem-resistant Enterobacteriaceae.

 

Zabicefta demonstrated non-inferiority compared to standard therapy in phase 3 clinical trials enrolling patients with various infections.

 

In the RECLAIM study enrolling patients with complicated intra-abdominal infection, the clinical cure rate of the Zabicefta treatment group was 82.5%, similar to the 84.9% of the meropenem treatment group.

 

In the RECAPTURE study enrolling patients with complicated urinary infections, the clinical cure rate of the Zabicefta was 90.3%, showing non-inferiority to the 90.4% of doripenem.

 

Furthermore, Real World Data (RWD) has demonstrated the effectiveness of Zavicefta.

 

In a clinical study involving patients with CRE infections and immune suppression, Zabicefta showed a clinical cure rate of 64.4% in patients with complicated intra-abdominal infection, 88.3% in patients with complicated urinary tract infections such as pyelonephritis, and 68.4% in patients with pneumonia contracted within the hospital such as ventilator-related pneumonia.

 

Based on these results, the 2022 Infectious Diseases Society of America (IDSA) guidelines recommended Zavicefta as a preferred treatment option for CRE or complicated urinary tract infections, including difficult-to-treat pyelonephritis-related Enterobacteriaceae.

 

Due to the growing number of CRE patients, the need to manage patients with antibiotic resistance is urgent Experts have raised concerns about the prevalence of multi-drug resistant infections and the growing number of resistant patients, emphasizing the need to secure adequate treatment options.

 

New treatments are necessary when a patient develops antibiotic resistance, but there is concern that patients may eventually run out of treatment options.

 

“It has been nine years since Zavicefta was developed.

 

Upon reviewing patient cases, the rate of resistance stands at 10%,” Professor Yoon Young-kyung from the Department of Infectious Diseases at Korea University Anam Hospital stated.

 

“In light of the growing number of antibiotic-resistant patients, it is recommended that Zavicefta should be used for patients with absolute needs to prolong its effectiveness,” Yoon emphasized.

 

CRE infections that show resistance to carbapenem-class antibiotics are becoming prevalent globally.

 

The number of CRE patients, 5,717 in 2017, doubled to 11,954 in 2018.

 

Subsequently, it surpassed 23,000 in 2021 and recorded 30,546 in 2022, according to the Korea Disease Control and Prevention Agency (KDCA).

 

“Medications used to treat infectious diseases are different from those used to treat conditions like diabetes or hypertension, where treatment begins after diagnosis, minimizing misuse.

 

However, with antibiotics, there's a concern for misuse.

 

Therefore, healthcare professionals and academia need to collaborate in exploring ways to use antibiotics appropriately,” Professor Lee Dong-gun of the Department of Infectious Diseases at Seoul St.

 

Mary's Hospital said.