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  • New antibiotics need to be introduced
  • by Eo, Yun-Ho | translator Choi HeeYoung | Apr 20, 2020 06:32am
Adrian Towse, Director of Health Economics Research Centre (HERC)
UK Government announces new payment model, pointing out the limits
Speciality must be considered
Antibiotic resistance is a global health issue published by the World Health Organization (WHO).

Multi-drug-resistant Gram-negative bacteria has increased worldwide and have become a serious problem in recent medical-related infections. In particular, the World Health Organization has designated Carbapenem-resistant Pseudomonas aeruginosa as one of the top priority pathogens for new antibiotic research and development.

There is an alternative. In Korea, 'Zerbaxa (Ceftolozane/Tazobactam)' has been introduced, and other next-generation antibiotics are also being prepared for approval by the MFDS.

The problem is insurance benefits. This is because antibiotic drugs are not easy to prove cost-effectiveness compared to the old drug, and it is difficult to prove clinical superiority due to the characteristics of the drug. In this situation, the government recently came up with a solution.

Although it is difficult to evaluate the value of drugs by economic evaluation, detailed standards for drugs such as antibiotics that require insurance benefits have been established and related standards have been reorganized. However, the process remains until the decision of the drug and the enforcement of the standard for administrative adjustment.

Director Emeritus of the Office of Health Economics in the UK.
Dailypharm met with the world's leading authority on antibiotic health and economic evaluation, Professor Adrian Towse, director of Health Economics Research Centre (HERC) and heard about how to evaluate the value of new antibiotics.

-How important do you think developing and introducing new antibiotics is to address the threat of antibiotic-resistant bacteria?

Antibiotic stewardship and infection control measures are important, but improving them alone will not prevent the spread of antibiotic-resistant infections. There is a situation in which infection cannot be cured with existing antibiotics, and will continue to be so.

Without a new antibiotic, the world would face a health crisis. Not only do many people die from infections that were previously treatable, but the risk of untreated infections will make many routine operations (hip replacement surgery, chemotherapy, etc.) increasingly dangerous.

The WHO also revealed that the existing new drug pipeline worldwide is failing to meet the demand for new drugs to address the resistance problem.

-Why do you think large pharmaceutical companies are giving up the antibiotic business?

This is because antibiotic development is not profitable. Antibiotics have low drug prices and low sales volume. The healthcare system signals companies that they want other types of treatment with higher prices and higher sales. There is no reason to invest in antibiotic development.

The UK government announced the world's first new payment model for antibiotics in July last year. Please elaborate on this model, including the background of the introduction and expected outcomes.

The UK is currently piloting a model that includes two important elements:

First, another approach to antibiotic value estimating. This economic model takes an approach to the expanded value-adding method that includes the elements presented in the OHE report mentioned above and the UK Government's EEPRU ( Policy Research Unit in Economic Evaluation of Health & Care Interventions). In particular, this model includes the benefits of preventing the spread of resistant bacteria in the evaluation.

Another method of contracting is that the total amount of new antibiotics used will be very small, and at the same time, a contract model called a 'subscription model' will be used to avoid the high price that would hinder the proper use of new drugs. This includes the condition that companies pay an appropriate amount each month in exchange for making and using the product, regardless of the amount of antibiotics used.

-Korea's new drug valuation emphasizes superiority and cost effectiveness over existing treatments. What HTA factors should be considered to increase access to new antibiotics?

In the case of new antibiotics, the main value is to preserve the existing antibiotics for longer without spreading the infection to other patients or citizens.

The economic evaluation seeks evidence for clinical superiority, but the antibiotic new drug trial is bound to be conducted as a clinical trial demonstrating non-inferiority for two reasons: realistic and ethical.

This is because it is practically difficult to find and recruit patients infected with antibiotic-resistant bacteria, and it is not appropriate to withhold medications with evidence of treatment in patients who are ethically at risk of death from infection.
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