The full-fledged administration of Kymriah, a Korean Novartis CAR-T treatment called an "ultra-high-priced anticancer drug," has begun. Hospitals have also become busy as the administration of treatments at four large hospitals in Korea has begun in earnest. At the beginning of last year's domestic approval, it was a wait-and-see attitude, but as the number of inquiries from patients increased at the same time as the benefit increased, it is eager to complete the facility.

According to the medical community, starting with Asan Medical Center in Seoul, Kyungpook National University Hospital, Chonnam National University Hospital, and Pusan National University Hospital are currently undergoing preliminary work for Kymriah administration, focusing on the metropolitan area and national and public university hospitals.

At the same time as health insurance was applied in April, there are currently four hospitals that have completed the certification process conducted by the MFDS and Novartis on their own.

Specifically, they include Seoul St. Mary's Hospital, SMC, Seoul National University Hospital, and Severance Hospital. Some professors from local university hospitals raised complaints about Novartis' first certification work at only four places, but the controversy subsided as public opinion prevailed that the introduction should not be delayed anymore. The situation has changed since April when Kymriah's benefit was applied.

"After Kymriah's domestic approval last year, Novartis first certified four large hospitals, raising equity issues at local university hospitals," said a professor of blood medicine at Seoul National University Hospital, who asked not to be identified. He supported public opinion, saying, "Some professors publicly raised problems by saying that they would introduce CAR-T treatments for other global pharmaceutical companies to be introduced after Kymriah." According to the MOHW, the number of non-Hodgkin lymphoma patients, including DLBCL, in 2017, is counted as 1904 per year. "Last year, the process of collecting patient cells and sending them to Novartis in the United States was not established," said a professor of blood medicine at another local university hospital. It is true that there were complaints as pharmaceutical companies pushed for it from Seoul's mega hospital. We are currently pushing for the introduction of Kymriah, and the full-scale discussion began last November. While full-scale discussions have been underway since this year, we have been in a hurry as we have been reimbursed," he explained.

A professor at a local national university hospital, who is promoting the introduction, said, "Since we have certified Kymriah from Seoul's super-large hospital, local hospitals are somewhat late. However, in the second half of the year, more than 13 university hospitals will be able to administer Kymriah, he said. "Novartis also has know-how while signing contracts with hospitals, so it will proceed quickly in the future."

"What's worrisome is that CAR-T treatments are being developed in Korea in addition to Kymriah," he said. "The same facility standards should be applied to them, but the evaluation process for the GMP standards of the MFDS is needed." Novartis explained that the university hospital that first introduced Kymriah was comprehensively considered such as the GMP certification situation of the MFDS.

An official from Novartis explained, "The hospital approved as a CAR-T center (Kymriah treatment available) is Samsung Medical Center, Seoul National University Hospital, Severance Hospital, and Seoul St. Mary's Hospital, and Asan Medical Center will soon open." He emphasized, "CAR-T treatment is a one-person customized treatment that requires completely new procedures, and various facilities, manpower, and technical aspects should be equipped for approval of the MFDS' management business, including human cells."

He added, "The certification process of the four hospitals has been completed and opened as a Kymriah center first, and soon, the center certification will be completed at Asan Medical Center in Seoul with permission for management such as human cells."