The HIRA is conducting RWE research on cancer & rare dz

starting next month

It must be done for at least five years to link drug price adjustments

Established guidelines until recently, full-fledged prospective research for three years

The HIRA will be conducting prospective clinical research to secure real world evidence (RWE) for cancer and rare disease treatments in earnest starting next month.

 

From last year to recently, the RWE guidelines were created through retrospective studies, and from this year to 2023,'prospective clinical research to prepare a platform for actual clinical basis for drug payment management' will be conducted.

 

The HIRA will complete the selection of the final researchers by this month and collect data on whether or not treatments for rare diseases, anticancer drugs, and expensive new drugs are showing effects in the actual clinical environment after listing.

 

Jin-Yong Lee, director of the Health Insurance Review and Assessment Research Institute, said in a briefing by the Journalists Association on the 3rd, "RWE research is the next-generation resource in domestic pharmaceutical policy, and it is a must." He said, "In pharmaceutical companies, Korea is a single market with a population of 50 million, and it has to go through for the registration of drugs in East Asia, but once listed, the drug price remains unchanged." He said that after marketing, RWE should be compared to see if the efficacy is the same as in clinical trials.

 

"After 2-3 years of drug price registration, if the effect is lower than the clinical result in the RWE study, the drug price should be reduced, and if the effect is high, the drug price should be increased." He also said that it will take at least five years for the results of the RWE study to be linked to drug price adjustment.

 

Regarding the opposition of pharmaceutical companies over the introduction of RWE in Korea, he said, "100 people participated in the clinical trial of a drug worth ₩100 million per dose, and the effect was 90%.

 

If the effect is reduced to 50% in the results of the medication, shouldn't the drug price be readjusted?" He explained, "It's actually happening in the US, and that's why the RWE issue came out in Korea." He said, "The HIRA will evaluate it directly, and if it does not work, we will lower the drug price, and if it works, we will approach it from the perspective of expanding the scope of indications and benefits, and adjusting drug prices." He added, "If clinical professors participate in prospective clinical research from December, they will select drugs and conduct RWE research together for 3 years." Prior to the start of prospective clinical research, the HIRA Forum was held to disclose the results of the retrospective RWE research conducted from May last year to July of this year based on request data and medical records for all gastric cancer and breast cancer patients in Korea.

 

It will be released.

 

He took office as the 7th Director of the Health Insurance Review and Assessment Research Institute on August 18th.

 

He is a person who worked as the head of the Department of Public Medicine at SNU Boramae Medical Center and worked on public quarantine in the field as the head of the Epidemiological Investigation Technical Support Team in response to COVID-19 in Seoul.

 

He said that he applied for the public recruitment of the director of the review and evaluation researcher after much thought.

 

He said that the institute, which has more than 200 members, is one of the largest national research institutes in Korea, and that the review and evaluation institute will be able to serve as a think tank for establishing health insurance policies.

 

To this end, it was planned to promote the registration of academic journals, establish a website dedicated to the HIRA policy trends, and form a specialized academic journal in the field of health insurance policy.

 

He said, "As the organization of the research center grows, we are determining what to do with the increase in manpower and work management." "Like the RAND Corporation of the United States, I will try to make this institute a think tank proactively proposing policies," he stressed.