NHI big data was used to evaluate safety of JAK inhibitors

First attempt at using NHI data to reevaluate safety of pharmaceuticals in Korea

Seeks to expand safety and efficacy verification research with the NHIS-MFDS consultative body

Soon-Ae Shin, Deputy Minister of the NHIS Big Data Headquarters held a press conference with its press corp on the 1st to explain the HQ’s main projects and plans.

Big data from the National Health Insurance was found to have been used to evaluate the safety of JAK inhibitors, based on which its use has been restricted in high-risk patients in Korea.

 

This is the first time that NHI big data had been used for safety evaluation of pharmaceuticals in Korea.

 

The National Health Insurance Service’s Big Data Strategy Headquarters held a press conference with the press corp on the 1st at its Wonju headquarters to deliver this news.

 

Soon-Ae Shin, Deputy Minister of the NHIS Big Data Headquarters, said, “We established a consultative body with the Ministry of Food and Drug Safety to conduct joint research on information related to the real use of pharmaceuticals and conducted a safety evaluation on JAK inhibitors used for rheumatoid arthritis, etc with the consultative body for the first time this year.” The NHIS performed a comparative analysis on the incidence of major cardiovascular diseases and mortality rate of TNF blockers and JAK inhibitors using NHI big data.

 

In June, based on the results derived using big data and expert deliberations, the MFDS revised the approved label for JAK inhibitors so that patients 65 years of age or older, patients at high cardiovascular risk, and patients at risk of malignancies could only use JAK inhibitors if they see inadequate treatment effect from existing treatment options.

 

Since last September, reimbursement standards have also been revised accordingly and applied to prescriptions.

 

Jong-Hun Park, Deputy Minister of NHIS’s Big Data Strategy HQ, said, “We conducted big data research for two to three months per MFDS's request.

 

Although the decision was made after expert deliberations by the Central Pharmaceutical Affairs Council, our study has also contributed to the policy decision-making process.” The NHIS is also known to be conducting safety evaluations on other pharmaceuticals using big data.

 

The MFDS evaluated JAK inhibitors after acquiring safety information from overseas sources including the US FDA in September last year.

 

The US FDA had restricted the use of JAK inhibitors to specific patients that do not respond or show intolerance to TNF blockers, as it can increase the risk of severe heart-related events including heart attacks.

 

Europe has also first limited the use of tofacitinib, a JAK class inhibitor, to high-risk groups who have suitable treatment alternatives, and is reviewing the need for applying additional measures on other JAK inhibitors.

 

Until now, the MFDS had used data on adverse reactions that had been collected separately for drug safety evaluations.

 

The added reflection of NHI big data in drug safety evaluations is expected to allow customized measures to be made in Korea that reflects the domestic environment.

 

Deputy Minister Shin said, “ We expect our research to verify drug safety and efficacy based on NHI big data to expand further around the consultative body.” NHIS also plans to support the research and development of real-world evidence (RWE) on pharmaceuticals ㅕusing big data.

 

In other words, it aims to organically link NHI big data for use from the drug development stage to post-marketing research.

 

In the preclinical development stage, big data is expected to be used to analyze the characteristic of the target disease and patient group, analyze existing treatment (drug prescription, etc.) patterns, explore combinations for drug development, drug repositioning, etc.

 

In the clinical trial stage, it is expected to be used for clinical trial design support, estimation of a number of clinical trial subjects, support of the control group to ultimatley reduce the clinical trial period and improve the efficiency of clinical trials.

 

Also, the NHIS added that big data can be used in various areas in the post-marketing stage as well, including for comparative evaluation between competitors, feasibility study of research topics, and post-marketing monitoring of drugs subject to re-examinations.