How did Zerbaxa get recognized for its benefit?

The HIRA released the evaluation results on its website

Coliseum methane sulfonic acid is designated as an alternative drug

There is an item that Rep.

 

Choi Jae-hyung of the People's Power, who has been criticized by the pharmaceutical industry for insisting on lowering generic drug prices during the parliamentary audit, is praising his salary registration.

 

It is the super antibiotic Zerbaxa.

 

At the HIRA parliamentary audit held on the 13th, he said, "200 to 300 people die every year from antibiotic resistance, and Zerbaxa's benefit was a meaningful decision." He also argued that generic drug prices should be lowered to secure health insurance finances, saying that it is necessary to make a forward-looking decision to set the price of such super antibiotics.

 

Zerbaxa is an antimicrobial agent used to treat complex intra-abdominal infections, complex urinary tract infections, and hospital-infected pneumonia.

 

In June, the HIRA recognized the appropriateness of the benefit, which was different from the review of benefit rejection in 2019 with unclear cost-effectiveness.

 

The reason why the evaluation results have changed is that the drug has become possible to omit PE in the meantime.

 

In October 2020, the government revised related regulations to allow the omission of PE data on tuberculosis treatments, antibacterial drugs, and emergency detoxification drugs included in national essential drugs.

 

The results of the recent evaluation of benefit adequacy for low-dose owners released on the HIRA website show this well.

 

Zerbaxa was recognized for its appropriateness in a review by the Pharmaceutical Affairs and Evaluation Commission held on June 2.

 

As a result of the evaluation at the time, "The applied product is a drug that has been approved for the treatment of complex intra-abdominal infection, complex urinary tract infection (including pyelonephritis), and hospital infection pneumonia (including ventilator-related pneumonia)." This is clinically useful, but the cost-effectiveness corresponding to the cost is unclear because the cost required compared to the alternative drug is expensive, he added.

 

He judged, "It is an antimicrobial agent that is a national essential drug, meets the conditions for PE performance in excluded countries, and is listed in more than three excluded countries, so it is appropriate to benefit when considering the price registered in excluded countries." Although it is a drug that can omit submission of PE data, it is necessary to consider it when negotiating drug prices because the number of patients is higher than that of rare disease treatments or anticancer drugs and the financial impact of antibiotic resistance is uncertain.

 

These contents were reflected when Benefit was applied.

 

The Health Insurance Policy Review Committee of the Ministry of Health and Welfare explained Zerbaxa's benefit registration and judged that "the company's application price is more cost-effective than the Japanese drug price, which is the lowest price in A7.

 

Among the A7 countries, it was listed in the U.S., Japan, Italy, and the U.K., and the average price for a bottle was 108,383 won.

 

However, the expansion cap RSA contract was signed to reduce financial uncertainty.

 

Through negotiations with the NHIS, if the cap exceeds a certain amount, the amount will be refunded to the corporation.

 

The Drug Evaluation Committee selected Coliseum methane sulfonic acid as an alternative drug when determining cost-effectiveness.

 

Two drugs are registered in Korea, with the upper limit of 20,349 won per bottle and 17,922 won per bottle, respectively, due to Seoul Medical's Colistate Inj and SCD's Colis Inj.

 

The difference was large compared to Zerbaxa, which was listed at 60,098 won per bottle.

 

The Drug Evaluation Committee cited that Coliseum methane sulfonic acid as an alternative drug has efficacy in bladder inflammation and pyelonephritis and that it is a drug that is recognized for "all existing antibiotics-resistant" beyond the scope of the permit.

 

However, Zerbaxa was inevitably expensive compared to this Coliseum methane sulfonic acid, making it difficult to satisfy the cost-effectiveness.

 

Instead, PE was exempted and the benefit adequacy was recognized while satisfying the lowest price adjusted by the A7 country.