[International] Will Cell Therapy Offer a New Treatment?

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What would it be like if there’s a one-shot anticancer medicine that will make everyone free from incurable cancers? That would be such a huge benefit for humanity and those finding will be invaluable. From the first discover of vaccine to biosimilars*, humanity’s will to cure disease never changed. Every day, a new paradigm of disease therapy is suggested, but still, it’s in vain. However, some sort of therapy can make us free from cancer. ‘Cell therapy’ as it can be predicted from its name, is a medical therapy which utilizes cell. Cell therapy is a method of injecting or implanting viable cells into patient for medicinal effect. When healthy and genetically modified cells are infused in vivo, they generate production of new cells and supply other cells to repair damaged tissue to function normally. Different types of cells can be used for appropriate therapy and treatment target. Also, it can excel beyond the limit of orally taken drugs. Hitherto there are listable numbers of cell therapy medications developed: Yescarta, Zolgensma, Ryplazim, Tecartus and more.

*Biosimilar: a biologic medical product similar to another in market biological medicine

In March, an earnest post with the headline: “As a mom, I’m sincerely begging. Please apply health insurance to the anticancer drug Kymriah,” drew attention on the website of the National Petition of the Blue House. The writer, who is a family of a child suffering from Acute Lymphoblastic Leukemia, entreated requested health insurance coverage for the payment of cell therapy ‘Kymriah’. Kymriah is known as a mirage among cancer patients. Having a miraculous nickname of ‘one-shot anticancer drug’, Kymriah has the ability of 100% curing Acute lymphoblastic leukemia. To manufacture Kymriah, the T cell must be obtained from the patient’s vein, then the T cell is genetically modified to express CAR-T (Chimeric antigen receptor) cell. When these CAR-T expressing cells are infused in the patients’ body, the modified cells proliferate, detect and destroy malignant cells and also prevent the regeneration of cancer cells. However, its one dose cost requires about 600million won which is 521,900 $. Not only Kymriah, but also other cell therapies necessitate astronomical number of fees which cannot be insured by health insurance and is thus unaffordable. 

The exorbitantly pricey fee is because of the manufacturing process. Most of the research and production centers are based in America. Thus, to get the viable cell genetically modified, the cell must be obtained then transported half the world away and returned to the patient’s nation for its usage. Not only transporting, but also preserving cells in an optimal condition needs acute technology and money. As Kymriah is personalized medication designed and genetically modified for the patient who needs it, it needs strict, complicated and customized quality control after its production. But there are no facilities and labor forces prepared for the adequate quality assurance. It seems introducing Kymriah to domestic market seemed to be obscure. However, Kymriah is the sole hope for relapsed leukemia patients since there are no replaceable drugs. This is why the patients and their families are desperately requesting the health insurance coverage of Kymriah.

Until now, the only feasible way to reduce the medical expense is health insurance coverage. But including expensive clinical charge into health insurance can exacerbate financial affair of health welfare administration and overall national economy. Thus, cell therapy and other anticancer therapies cannot be rashly covered by health insurance. In the case of Europe, they employed outcome-based contracts which they reimburse depending on the therapeutic results of the medication. Also, annuities payment, monthly paying, is introduced as an alternative method. The situation in America is somewhat similar to South Korea. Even though they have technology for cell therapy, they don’t have any practical way to assuage the payer’s anxiety and affordability concerns. Instead, the United States national health insurance system somewhat covers the limited amount of the payment and most of the patients are hugely dependent on outright fundraising and aid from enterprises, since most cell therapies have experimental characteristics. 

Cell therapy is continuously receiving the spotlight from various science sectors; oncology, dermatology, immunology and more. Its easy application in diverse disease and potential replacement of oral medication are expected as an epoch-making way to overcome the limitations of existing drugs. Incurrence of degenerative disease and incurable illness due to the increased life expectancy is the main reason why demand for cell therapy is mounting. As cell therapy sector is very new in pharmaceutical industry, many Korean pharmaceutical companies are striving to facilitate suitable environment for research. Some experts view the current situation as promising since further research and domestic commercialization of cell therapy might be the ultimate solution to reduce the excessive therapy payment. 

Now we are in the era in which we can cure all the diseases those were believed to be refractory. Even though we are equipped with the best healthcare insurance and up to date medical technologies, no solutions are provided to the ones who are in need of desperate help. The nations right to be cured must be protected by the governments support. Government’s continuous observation and adequate aid and propulsion for the cell therapy development should be made for the commercialization of new therapy, being competent in pharmerging market and advanced welfare nation. Anyone can suddenly be struck down by a degenerative disease at any time, to the close ones and the loved ones which doesn’t seem to be a long way away. Individuals’ continuous attention toward rare obstinate ailment can be another way to improve the awareness of diseases.

By Kim Chaiwon Editor-in-Chief

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