RSA isn't enough to evaluate the benefit of first in class

Kang Hye-young, a professor at Yonsei University of Pharmacy, said, "Domestic reimbursement model, low flexibility in high-tech drugs."

It was pointed out that in order to enhance patient accessibility of first-in-class, which costs tens of millions to billions of won per dose, and maintain national health insurance financial soundness, the first-in-class customized reimbursement model should be found.

 

They argue that a system should be created that combines risk-sharing drugs (RSA), economic evaluation exemption, and separate fund (FUND) methods to review benefits for expensive anticancer drugs or rare genetic diseases that do not have alternative drugs.

 

Kang Sun-woo, a member of the Democratic Party of Korea, held a parliamentary debate to strengthen access to the first-in-class of rare genetic diseases on the 13th.

 

Kang Hye-young, a professor at Yonsei University of Pharmacy, announced the successful overseas cases of first-in-clas and the implications of the new system.

 

Currently, the market for treatments for rare incurable diseases has proven to be effective, but the rapid development of first-in-class drugs, which cost tens of millions to billions of won, is affecting the finances of each country's health insurance.

 

The limited health insurance budget has increased the burden that should guarantee access to drugs for a small number of patients suffering from rare diseases.

 

Professor Kang Hye-young pointed out that the problem is that Korea has not applied or added ICER thresholds in relation to the first-in-class at the stage of evaluating benefit of drugs and drug pricing.

 

First-in-class, which has excellent drug effectiveness and safety, requires a customized benefit model to flexibly evaluate drugs that satisfy clinical and technical innovation and social needs.

 

Professor Kang said that RSA is also limited to anti-cancer drugs and rare disease treatments, undermining the benefit equity of various incurable disease treatments.

 

It was suggested that the system should be created to increase patient accessibility rather than financial risk sharing based on the introduction of a suitable type of RSA for first-in-class.

 

It is pointed out that Korea has not used the fund yet in expanding its benefit using the fund.

 

Professor Kang said that when considering the benefit through funds, it is necessary to determine the subjects of funding, the scope of medicines eligible for support, and the scope of benefits.

 

"Our first-in-class customized the benefit policy should recognize drug innovation and ensure patient access to unmet medical needs," Professor Kang said.

 

"We need to prepare the system not only for quick approval of new drugs but also for smooth patient benefits."