[헬스코리아뉴스 / 임도이] “It will be a lifetime regret for not allowing Eun-chan to receive CAR-T treatment, but I hope that CAR-T treatment will become more accessible so that she does not lose her life like Eun-chan.”
The Korea Leukemia Patients Association, an organization for patients with leukemia, has urged the rapid registration of health insurance for ‘KIMRIAH’, the first CAR-T treatment for end-stage leukemia and lymphoma, and reasonable financial sharing by pharmaceutical companies. This is because, even at this moment, many blood cancer patients are about to die because an innovative new drug has come out, but benefits are not applied.
The world’s first chimeric antigen receptor T-cell (CAR-T) treatment, ‘Cymriaju’ (ingredient name: Tisagen Lexel) can save blood cancer patients who are about to die, so it is another miracle after ‘Gleevec’, a leukemia treatment. It is the world’s first personalized CAR-T treatment that is being evaluated as a drug. In Korea, it received marketing approval from the Ministry of Food and Drug Safety in May of this year.
A ‘chimeric antigen receptor T cell’ is a gene that fuses a receptor site of an immune cell (T cell) and a characteristic antigen recognition site on the surface of a cancer cell into a patient’s T cell. It is a cell with a function that specifically recognizes and attacks.
‘Cymria’ is an anticancer drug that introduces genetic information to the surface of immune cells (T cells) collected from a patient so that it can recognize specific antigens of cancer cells and then injects it back into the patient’s body.
This drug is an innovative immune cell anticancer drug that showed clearly improved benefits with a single administration for patients with relapsed and refractory hematologic cancer, where other treatment options are limited, and is a drug (Breakthrough designation) in the United States and a priority in Europe. Each was designated as a pharmaceutical (PRIME) and then approved.
The permit dates for each country are August 2017 in the United States, August 2018 in Europe, and March 2019 in Japan.
According to Novartis, this anticancer drug is a one-shot anticancer drug that has all the characteristics of cell, gene, and immunotherapy. With just one treatment, it can achieve complete remission in patients with terminal hematologic cancer who have no other treatment options, and achieve a sustained response. see.
It is used for relapsed and refractory patients with Diffuse Large B Cell Lymphoma (DLBCL) and pediatric Acute Lymphoblastic Leukemia (pALL) under the age of 25.
The problem is drug prices. This drug produces long-term survival in 8 out of 10 patients with terminal acute lymphoblastic leukemia and 4 out of 10 patients with end-stage lymphoma with a single treatment, but one treatment cost is about 500 million won in the United States It is a very expensive drug that costs 45 million won and about 350 million won in Japan. Because of this, there were many predictions that negotiations with insurance authorities such as the Health Insurance Review and Assessment Service and the National Health Insurance Corporation would not be easy.
Eun Chan-gun’s mother, who recently lost her son to leukemia, said, “It will be a regret for the rest of my life not to allow Eun-chan to receive CAR-T treatment, but I hope that CAR-T treatment will become more accessible so that she does not lose her life like Eun-chan.” reported through the blog.
Eun Chan-gun, 13, who was preparing to receive ‘Kymria’ treatment at Samsung Medical Center due to a recurrence of acute lymphoblastic leukemia, was scheduled to collect T cells on June 9 this year, but eventually died on June 10 due to poor health. .
In a phone call with Health Korea News on the 9th, an official from the Korea Leukemia Patients Association said, “If the clinical trial for ‘Kymria’ had been conducted in Korea like Japan, or if the Korean Food and Drug Administration’s approval was issued in March 2019, like Japan, two years ago, our country It would have been a medical environment where CAR-T treatment was possible as quickly as in Japan, and health insurance would have been applied as quickly as in Japan,” he said, expressing regret for Eun Chan’s death.
Currently, many patients with hematologic cancer in Korea are introducing treatment cases in the United States and are desperately appealing for the prompt insurance coverage of ‘Kymria’.
On August 30, 2017, when the world’s first CAR-T treatment ‘Cymria’ was approved by the US FDA, the case of ‘Emily Whitehead’, which was cured by ‘Cymria’ treatment, was introduced to the domestic media. Emily Whitehead, a 5-year-old girl at the time, was diagnosed with acute lymphocytic leukemia in May 2010 and received chemotherapy. At that time, ‘Emily Whitehead’ learned about ‘Kymria’, which started the phase 1 clinical trial, and on April 17, 2012, received the world’s first ‘Kymria’ treatment. Five years later, on May 10, 2017, the cancer cells disappeared, and 9 years later, Emily Whitehead is still living a healthy life.
Patients and their families criticized the delay in approval of the health authorities, saying, “If the Korean Ministry of Food and Drug Safety had given permission for ‘Kymria’ a little earlier, the drug price would have been reduced like in Japan by now, which would have helped insurance finance and patient treatment.” are doing
Patients and their families are also pointing out the issue of equity with other new drugs in terms of the procedure and time of benefit application.
An official from the Korea Leukemia Patients Association said, “Even though Yuhan’s non-small cell lung cancer treatment Leclaza (ingredient name: Lazertinib), the 31st domestic drug, received approval from the Ministry of Food and Drug Safety on January 18 of this year, Benefits are being applied from this month due to drug price negotiations.” He added, “We took action to apply benefits as quickly as ‘Lekraja’ to Kimria, who applied for health insurance benefit registration using the permit-benefit evaluation linkage system on March 3 of this year. should be done,” he urged.
However, it is still unclear whether this wish will be realized. Currently, the 5th Cancer Disease Review Committee of the HIRA is expected to be held on July 14 to determine the aptitude for the ‘Kimlia’ benefit.
The problem is that even if the cancer disease review committee passes at this time, the health insurance reimbursement cannot be completed until November of this year at the earliest because it has to go through the drug reimbursement evaluation committee of the HIRA, drug price negotiation with the Corporation, and the health review process of the Ministry of Health and Welfare. Since most patients with relapsed or refractory end-stage acute lymphoblastic leukemia and lymphoma die within 3 to 6 months, there is concern that a significant number of 200 patients treated annually will die in this case.
A patient group official said, “Patients who cannot afford the drug cost of about 460 million won per treatment (as of May 20, 2021, uninsured medical expenses for ‘Kymria’ as of May 20, 2021 disclosed on the Samsung Seoul Hospital website) are There is a treatment that can save lives, but there is no treatment fee, so we are in a sad situation where we have to wait for health insurance to be applied and die.” explained that
Patients and their families are also urging Novartis Korea to abandon excessive greed for drug prices.
The reason pharmaceutical companies developed new drugs is to save human lives, but it is a serious human right to pursue only profits, with numerous patients on the verge of death within 3 to 6 months without treatment. that is infringement. For reference, two Swiss multinational pharmaceutical companies, Novartis and Roche, are famous for developing treatments for rare and incurable diseases that are difficult for patients to access.
Because of this, complaints also arise among patients, saying, “If you die without knowing that there is a cure, you will feel less resentment, but if you can’t get treatment because of the price even though there are drugs that can be treated, you even think that pharmaceutical companies are making fun of their patients.”
In this regard, the Korea Leukemia Patients Association said, “We clearly recognize the reason for the existence of a pharmaceutical company that saves patients’ lives by developing and marketing new drugs, and Novartis has come up with a reasonable CAR-T treatment financial sharing plan that is socially acceptable, so that the government can quickly improve health. We have to cooperate so that insurance can be applied,” he urged repeatedly.
It is noteworthy what kind of solution Novartis Korea will come up with in response to this appeal.
A Novartis Korea official said in a phone call with Health Korea News on the 9th, “I understand the needs of patients and I sympathize with them.” “We will do our best to discuss with the relevant authorities so that insurance benefits can be paid as quickly as possible.” stated the position.
Below are the needs of blood cancer patients and their families.
▶First, the agenda for the late-stage leukemia/lymphoma CAR-T treatment “Kymria” should be presented to the 5th Cancer Disease Review Committee scheduled to be held on July 14, 2021.
▶Second, as in the case of “Lecraza,” a late-stage lung cancer treatment, in which health insurance benefits were paid within 6-7 months using the ‘approval-benefit evaluation linkage system’, 「Kymria」 should promptly promote health insurance coverage.
▶Third, it is necessary to introduce a system that promptly registers health insurance for new drugs directly related to life such as 「Kymria」.
▶Fourth, Novartis Korea Co., Ltd. should come up with a reasonable financial sharing plan so that some immuno-oncology drugs, which are being delayed due to the recent controversy over expensive drugs and financial sharing, do not recur in the process of paying “Kymria” health insurance.
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