The number of patients with multidrug resistant bacteria such as Carbapenem-resistant Enterobacteriaceae (CRE) is rising rapidly in Korea, but no antibiotic is available to treat them, an expert said.

Choi Won-suk, a professor at the Infectious Disease Division of Korea University Ansan Hospital, said so at a debate on how to respond to the recent surge in infections with multi-drug resistant bacteria at the National Assembly’s meeting hall on Thursday.

Professor Choi Won-suk of the Infectious Disease Division at Korea University Ansan Hospital speaks at a debate on how to respond to the recent surge in infections with multidrug-resistant bacteria, at a National Assembly hall, on Thursday.

“About 700,000 people worldwide die from antibiotic resistance every year, and by 2050, 10 million people are expected to die from it annually," Choi said. “Resistance to antibiotics is a very serious problem.”

According to Professor Choi, the number of CRE infections rapidly increased from 5,717 in 2017 to 11,954 in 2018. As of Sept. 1 this year, 9,577 cases of CRE infections have been reported.

“A hundred antibiotics are registered in Korea, but only about 10 of them are effective against antibiotic-resistant bacteria,” he said. “This is the same as there is no antibiotic to treat the multidrug resistant infection. It is worrisome because doctors cannot treat multi-drug resistant infections.”

Choi noted that although antibiotics have not been developed much around the world, Korea has too few antibiotics to use. “Among over 10 types of recently developed antibiotics, only two arrived in Korea,” he said. The two locally authorized drugs are MSD’s Zerbaxa (ingredient: ceftolozane/tazobactam) and Dong-A ST’s Sivextro (tedizolid).

Zerbaxa failed to get insurance coverage because it could not prove its cost-effectiveness during the government’s economic assessment of reimbursement. The Health Insurance Review and Assessment Service said it recognized the clinical necessity of the drug but the high cost of the drug made the cost-effectiveness unclear. It costs about 300,000 won ($250.7) per month for a patient.

Sivextro was the only antibiotic that won insurance benefit in the past 10 years. However, its low price yielded a small profit. After winning reimbursement in 2016, the company kept delaying the market release of the drug and finally gave up.

In other countries, some antibiotics’ patents have expired, and their generic copies have been released. In Korea, however, no drug company launched antibiotic products because of the low marketability, Choi added.

“If a drug remains in the non-reimbursable area, a doctor chooses a drug based on the price. If the government keeps the strict process of introducing an antibiotic and reviewing reimbursement, it will be harder to secure a new treatment option,” he warned.

Choi Kyung-ho, deputy director of the Pharmaceutical Benefits Division at the Ministry of Health and Welfare, said the government was aware of the significance of managing multidrug-resistant bacteria.

“The government grants reimbursement based on a drug’s cost-effectiveness, considering the HIRA’s fiscal soundness. However, Zerbaxa was not superior to other alternatives, and it was not proper to guarantee its high price,” Choi said.

The government will do its best to find alternative treatment options such as designating some antibiotics as “shortage-prevention drugs,” he said. “We will find out how other countries handle antibiotics in the economic assessment and whether we can apply any of them in Korea.”

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