Although the National Health Insurance Service (NHIS) has conducted a reevaluation on immunotherapies listed for reimbursement, the government agency decided to keep the outcome undisclosed.

On the contrary, the Health Insurance Review and Assessment Service (HIRA) disclosed the outcome of a consignment research done with the same topic. The NHIS’ decision to conceal the outcome has stirred up the relevant industries in South Korea.

On Feb. 10, the pharmaceutical and medical industry associates told NHIS has recently injected approximately 250 million won for a year-long research on clinical evidence-based reevaluation on listed immunotherapies, but decided to keep the outcome to themselves.

The research was led by the Chairperson of Lung Cancer Committee of Korean Cancer Study Group (KCSG), Professor Ahn Myung Ju at Samsung Medical Center Department of Hematology and Oncology.

The study reviewed the treatment efficacy of NHI-listed immunotherapies—Keytruda (pembrolizumab) and Opdivo (nivolumab)—in the real world clinical scene in South Korea, and focused on using the collected data to evaluate the treatments’ cost-effectiveness.

The study also designed post-management models by reevaluating the efficacy and cost-effectiveness based on the collected clinical data analysis. According to the study, the agency aims to set up management models based on the NHI finance monitoring.

Meanwhile, HIRA also conducted a similar research prior to NHIS.

HIRA started the ‘Reevaluation on Immune Checkpoint Inhibitor Treatments’ since 2018, compared to NHIS’ research started from November 2019, and presented the result in the middle of 2019.

Coincidentally, the HIRA research was also led by KCSG President, Professor Kang Jin-hyoung at Seoul St. Mary’s Hospital.

While the HIRA-sponsored Professor Kang’s research result is open to public, Professor Ahn’s NHIS research is not.

Professor Ahn Myung Ju at Samsung Medical Center reserved her comment but said, “From the get-go, NHIS and the researchers agreed to have the research outcome undisclosed. The study would never be open to public. I do not have other comments to make as the consignment contract clarified the confidentiality nature of the study.”

But the related industries are disputing over the reasons why NHIS is keeping the research result hidden from the public.

Some suspect the government agency feels the pressure of expanding the reimbursement standard to include first-line therapy based on the outstanding analysis result of the immunotherapies.

Moreover, the industry’s curiosity is heightening as some industry insiders say the NHIS study touched on wider range of subjects than the HIRA’s.

For instance, HIRA’s reevaluation targeted 1,189 patients with advanced or metastatic non-small cell lung cancer (NSCLC), who failed to respond to chemotherapies at top 20 healthcare institutes in South Korea. Apparently, Keytruda and Opdivo’s overall response rate (ORR) demonstrated 35.98 percent and 31.01 percent, respectively, which did not show statistically meaningful difference between those patient groups.

However, NHIS research targeted larger patient groups treated from all healthcare institutes around the country. The industry paid a closer attention to the study as it would provide detailed data of the treatments’ efficacy.

An oncology department professor, who requested to be anonymous, noted, “The result of a HIRA research on reevaluating immunotherapies was disclosed, whereas the result of a NHIS research on the same topic was turned undisclosed. It is difficult to comprehend the NHIS’ decision. Many of the industry associates think NHIS is silencing the positive reevaluation outcomes of the major immunotherapies’ efficacy.”

But NHIS official stated the immunotherapy reevaluation research is undisclosed, because of the principles of the market economy as the research included specific pharmaceutical companies.

NHIS also argued there are plenty of other researches kept undisclosed with the similar reasoning.

The government agency official added, “In accordance to the Article 9 of the Official Information Disclosure Act, the agency has decided to not open the research result to public, because the details contain various confidential data of specific drugs regarding clinical efficacy and cost-effectiveness.”