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- 2026-04-15 11:06:02
- Policy
- Doctor's note not needed for requesting vaccination leave
- by Kim, Jung-Ju Mar 30, 2021 06:06am
- From now on, ‘vaccination leave’ on request would be able for those receiving vaccination against COVID-19, even without a doctor’s not. COVID-19 Central Disaster and Safety Countermeasures Headquarters (CDSCH) discussed promoting the COVID-19 vaccination leave for adverse reaction as reported by the Ministry of Health and Welfare (MOHW) Central Disaster Management Headquarters (led by Minister Kwon Deok-Cheol) and Ministry of Employment and Labor (MOEL, Minister Kim Woo Ho). The need of giving vaccination leave has been raised since there have been cases of workers interfered by post-vaccination fever and body ache. According to the vaccination adverse reaction monitoring results, 32.8 percent of the vaccine receivers responded that they felt discomfort, while 2.7 percent of them visited healthcare institutions. 1.4 percent out of the total vaccine receivers reported to healthcare institutes through the adverse reaction monitoring system according to the Infectious Disease Control and Prevention Act. Surveying about 5,400 vaccine receivers from 20 randomly selected nursing hospitals, about 75 people (1.4 percent) requested to take a day off from the work. Adverse reactions were usually expressed within 10 to 12 hours after vaccination and recovered within 48 hours. Major adverse reactions were pain at the vaccinated spot (28.3 percent), muscle ache (25.4 percent), fatigue (23.8 percent), headache (21.3 percent). and fever (18.1 percent). Also, the younger the receiver was the higher the rate of discomfort complains was reported. Based on the discussion with related government body and the survey result, the Central Disaster Management Headquarters prepared a plan to promote the use of vaccination leave, so the people would feel safe to get inoculated. The vaccination leave is to be issued for the vaccine receivers, who requested for the leave due to an adverse reaction. The leave request can be processed only with the receiver’s request and without a doctor’s note. And regarding the day of inoculation and required time, the government recommended using an official vacation or paid vacation days. Considering that the adverse reaction begins within 10 to 12 hours after vaccination, one day of vacation is given the day after the vaccination, and if there is an actual symptom of adverse reaction, an additional one day can be used. On the day of vaccination, it is recommended and instructed to give leave for the time required for vaccination. This is taking into account that general adverse reactions improve within two days, and one should visit a healthcare institute if the adverse reaction continues for 48 hours or more. Vaccination leave would come in effect from coming Apr. 1, according to the previously established vaccination plan and schedule. Inoculation of social welfare facility workers will begin from the first week of April, and social welfare facilities will take measures to utilize sick leave, paid leave, and work exclusions, depending on the conditions of each business and facility. If the facility manager deems that it is necessary to exclude work, the business should grant a paid leave. Moreover, the relevant industry organizations would assertively negotiate with healthcare institutes, such as nursing hospitals, where the vaccination is ongoing, to use the vaccination leave. While the vaccinations for school nurses and essential social force like police, firefighters and military are scheduled from the first week of April and June, respectively, the vaccination leave would be applied based on the interpretation of the regulation by the Ministry of Personnel Management and the Ministry of the Interior and Safety. The flight attendants, scheduled to receive vaccination in May, would also receive vaccination leave through the government’s negotiation with the airlines. The government also plans to recommend and guide private enterprises to grant paid leave or utilize sick leave, if available, for the vaccination leave without losing the pay. MOEL plans to disseminate guidelines for workplaces and actively guide them through Regional Employment and Labor Office. And the Ministry of Trade, Industry and Energy (MOTIE) is planning to call for request cooperation by various relevant organization and association like Korea Chamber of Commerce and Industry and Korea Employers Federation. The Ministry of SMEs and Startups plans to actively guide and induce participation by related associations and organizations through regional offices and affiliated agencies. In addition, the government plans to revise the Infectious Disease Control and Prevention Act to establish a legal basis stipulating the post-vaccination leave.
- Policy
- Lot release for Pfizer's COVID-19 vaccine was completed
- by Lee, Tak-Sun Mar 30, 2021 06:05am
- The MFDS announced that it has released a national lot of 250,000 people (500,000 batches) of Comirnaty that Pfizer Korea has applied for on the 28th (Sun). The national lot release is a system that the state confirms once more the quality of the vaccine is assessed comprehensively by evaluating the results of the 'validation test' for each vaccine manufacturing unit (lot) and the 'data review' that produced and submitted the test results as permitted by the manufacturer to determine the quality of the vaccine before distribution to the market. The MFDS established the test method through verification of the manufacturer's test method data from November last year for the rapid release of the national lot of Comirnaty, and thorough introduction of equipment necessary for the test such as ultra-high performance liquid chromatography, etc. It explained that it has been preparing a national lot release. In addition, it added that the MFDS has newly established an RNA analysis room and secured an additional cryogenic freezer to store samples for national lot release to ensure that the test can proceed smoothly. The MFDS confirmed the effectiveness, safety, and quality through a verification test of about 500,000 batches of Comirnaty and a review of data on manufacturing and testing. The MFDS verified the effectiveness by conducting potency tests, confirmation tests, and content tests to measure the amount of the genetic material showing the effect and the amount of lipid nanoparticles surrounding the genetic material. It also revealed that the product was not contaminated by conducting a purity test and an endotoxin test. In addition, quality consistency was confirmed by reviewing the quality test data issued by the manufacturer's quality assurance manager. Comirnaty is an RNA vaccine. It is a vaccine made by wrapping genetic material (mRNA) containing COVID-19 antigen protein information with Lipid Nano Particles (LNP). It has a mechanism to induce an immune response. An official from the MFDS said, "We will do our best to ensure that the Korean people can receive the vaccine with confidence by thoroughly verifying COVID-19 vaccine introduced in Korea by maximizing the relevant infrastructure such as experts and equipment necessary for the release of the national lot." This lot released Pfizer COVID-19 vaccine is planned to be inoculated to elderly people aged 75 or older starting April 1.
- Policy
- From drug approval to follow-up management
- by Lee, Hye-Kyung Mar 29, 2021 04:20pm
- The NHIS established drug price management from January 1 of this year, and began step-by-step management for stable supply of drugs and drug cost management. Along with the establishment of the Drug Price Management Office, the TF of the Drug Management Department was established, and an improvement plan to apply various research services conducted so far to the field is prepared. The full-cycle management plan for released by the NHIS is divided into steps such as item permission, reimbursement registration, distribution and supply, and follow-up management. First of all, the drug product approval stage is under the responsibility of the MFDS, but the NHIS began negotiations on previously listed drugs in connection with the clinical re-evaluation of the MFDS from last December. According to the order of the MOHW, it is underway for 230 items of 130 drugs subject to clinical reevaluation, except for Choline alfoscerate 122 items extended until April 12, Ateroid by Alvogen Korea, Mesocan 50mg by Chodang, and Aju Vesseldue-F Soft Cap decided to withdraw the item during the negotiation process. As a result of negotiating payback in conjunction with clinical reevaluation for the first time, 47% of clinical reevaluation items are withdrawn or negotiated, and the remaining 53% are negotiating. The NHIS said, "The MFDS will proceed with a contract to recover drug costs for drugs that are not effective through monitoring the results of the review of drug safety and effectiveness." In the reimbursement registration stage, the drug price negotiation rules were revised after the Lipiodol status in 2019, which contained the obligation to supply drugs, and from October last year, a negotiation procedure was introduced for all drugs, and contracts for mandatory provisions such as supply and quality management were signed. The drug price negotiation management system was reorganized to reinforce management such as negotiations following the introduction of the comprehensive evaluation system and to negotiate registered drugs in connection with the reevaluation of the drug price addition by the MOHW. The MOHW plans to link the drug price re-evaluation project, negotiate previously listed drugs, make rational evaluation of high-priced rare disease treatments, and prepare management plans. In order to manage the distribution and supply stages, the Research Service for Improving the Drug Supply and Purchasing System was completed in 2018-2019, and the specific implementation plan will be in charge of the full cycle TF. Follow-up management after drug registration is the last step in the full-cycle management. In particular, ultra-high-priced drugs such as Kymriah, which take more than ₩500 million for a single administration, are challenging to pay. The NHIS is contemplating a new payment plan for ultra-high-priced drugs in preparation for this. The NHIS plans to develop an efficient drug expenditure plan by developing a financial demand prediction model based on the analysis of the drug expenditure structure and analyzing the financial expenditure according to the characteristics of diseases and drugs (patent expiration, etc.). The NHIS Drug Price Management Office, Part 4, 1TF
- Policy
- 68% of the people said they plan to get vaccinated
- by Kim, Jung-Ju Mar 29, 2021 06:38am
- As vaccinations are being carried out in stages due to COVID-19 outbreak, 8 out of 10 people agree with the government to strengthen quarantine. In addition, 68% of the respondents answered that they will receive vaccinations in the future, indicating that they are aware of the importance of the vaccine. COVID-19 Central Disaster Management Headquarters and the Ministry of Culture, Sports and Tourism announced the results of COVID-19 Awareness Survey' today (24th). This survey was conducted for two days from the 17th to the 18th in order to increase the effectiveness of the quarantine policy based on public perception through public opinion surveys on quarantine policies such as social distancing. A survey was conducted on 1,000 adult men and women over the age of 18 residing nationwide on the awareness of COVID-19 and the extent to which quarantine regulations were practiced. The confidence level is 95% and the margin of error is ±3.1%. As a result of the survey, it was found that in the current situation of COVID-19, 83.1%, most of the citizens, agreed to strengthen the quarantine regulations. Regarding the perceptions related to COVID-19, 53.6% said the current situation was safe, and 45% said it was not safe. The possibility of infection of COVID-19 was perceived as low at 60.5%, but if infected, 86.6% perceived the damage as serious. 87.1~81.1% of the measures that demanded responsibility for violations of quarantine rules, such as claiming compensation for violations of the quarantine regulations, raising the fine for negligence, and excluding various support were positively confirmed. Among them, the necessity of claiming reimbursement rights was 87.1%, the necessity of raising the fine for negligence was 81.1%, and the necessity of excluding various kinds of support was 84.5%. Regarding the degree of practice of the quarantine rules, most of them responded that they are keeping the quarantine rules well, but others are less observing them than they are. In the case of banning private gatherings, 80.7% of respondents said they were doing very well, while only 18.7% said that others are doing very well. In the questionnaire on wearing a mask, 75.9% answered that they were wearing it well, but only 37.4% said that others were wearing it well. Most of the respondents, 87.3%, are under stress from COVID-19, and the main causes were 85.7% of uncertainty at the time of the end, 42.7% of social controversy, and 38.6% of the quarantine rules followed by myself. 61.1% of the opinions that individual behavior should be restricted rather than closure of multi-use facilities, 63.2% of opinions that the number of persons banned from private gatherings at different distances should be restricted. The survey was 63.2%. Regarding the current social distancing stage, 51.4% of respondents said,'I have heard and seen, but do not know well', and 52.1% of the reorganization proposals were recognized at a similar level. 73.2% of respondents agreed on the business hours restriction, 47.7% said that 22:00 was appropriate, and 25.5% said that 9pm (21:00) was appropriate. The willingness to receive vaccinations related to the COVID-19 vaccination was high, with 67.8% responding. As for the main reason for getting vaccination, 79.8% of the people cited the prevention of infection in their families. Following this, 67.2% responded in the order of social group immunity formation, and 65.3% in the order of their own infection prevention.
- Policy
- 6 new drugs newly listed or expanded coverage in 2021 so far
- by Kim, Jung-Ju Mar 29, 2021 05:58am
- According to the next month’s update for the pharmaceutical reimbursement list, total five items would be newly listed and improve patient access. And one already-listed drug gets to expand coverage. It is a result of enhancing the coverage based on social importance and patient needs. The South Korean government projected total 60,196 patients in the country would benefit from those drugs, costing them about 51.4 billion won annually. From January through April this year, total six pharmaceutical products have been newly listed or expanded coverage standard. January had none, but from February, the coverage on a Parkinson’s disease treatment Equfina Film Coated Tablet, a glaucoma treatment Eybelis Eye Drops and an ovarian treatment Zejula capsule have been improved. The coverage on Equfina Film Coated Tablet would benefit 7,000 patients a year, while costing 5.6 billion won. The coverage on Eybelis Eye Drops is estimated at 4.9 billion won annually, which would benefit 45,000 patients. The expanded coverage on Zejula Capsule would annually cost 2.5 billion won to provide treatment opportunity to 146 patients. From this month, the patient access on a multiple myeloma treatment Ninlaro Capsule improved with newly listed reimbursement. The government would spend about 9.6 billion won annually. Also, a neuroendocrine tumor treatment Lutathera Injection was newly listed in the same month, costing 8.8 billion won to benefit 6,890 patients annually. From Apr. 1, 20 billion won a year would be injected to treat 500 patients with a neovascular (wet) age-related macular degeneration (AMD) treatment Beovu Prefilled Syringe with reimbursement. The fact that each new coverage enhancement is to benefit a range of patient size from 45,000 at most to 146 patients at least proves the South Korean government’s healthcare coverage focus is now shifting from patient size and finance to value of a drug with high demand for reimbursement. It can be also interpreted as flexible policy and general social maturity to accept and provide an expanded coverage on expensive drugs used for rare disease treatment.
- Policy
- KRW 2.85 tln for KDCA COVID-19 vaccine supplementary budget
- by Kim, Jung-Ju Mar 29, 2021 05:58am
- The Korea Disease Control and Prevention Agency (KDCA) has secured an additional budget of 2.35 trillion won for procuring COVID-19 vaccines from overseas. This reflects additional 2.30 trillion won from this year. On Mar. 25, KDCA announced that this increase was reflected as the first supplementary budget in the year 2021. The total cost of vaccine purchase for 79 million people the government has contracted for is 3.81 trillion won, of which the additional cost in 2021, excluding the already secured budget, is 2.35 trillion won. Specifically, COVAX Facility (10 million), AstraZeneca (10 million), Pfizer (13 million), Janssen (6 million), Moderna (20 million) and NovaVax (20 million) are to supply the vaccines. To the date, the government has been sequentially expanding pre-purchase contracts according to the COVID-19 vaccine procurement plan, and has prepared necessary financial resources such as for upfront payments. The government has so far secured total 1.21 trillion won, including 356.2 billion won from last year’s contingency budget plan and 857.1 billion won from this year’s budget plan. Moreover, KDCA explained the additional cost of final vaccine payment was reflected on the new supplementary budget plan as the detailed calculation of the payments can be finalized after the negotiation over vaccine type, unit price and volume is concluded. KDCA elaborated the vaccines with already-signed contracts have been rolling out since February, and the agency would continue to roll out further doses of vaccines without an issue. And the new supplementary budget plan also reflects 1.10 trillion won for additional reserve for specific purpose, such as response against extended outbreak of COVID-19 and vaccine inoculation and related infrastructure cost. Due to finalized supplementary budget plan, the total expenditure in 2021 by KDCA was increased from 991.7 billion won to 3.34 trillion won.
- Company
- Controversy over 7-day packaging Rx drugs
- by Nho, Byung Chul Mar 29, 2021 05:58am
- Packed with 56 Omethyl Cutielet Soft Caps. In the case of a prescription for 60 days (two months), a photo of 4 pieces is attached to one box. Although it is the product of the same company, the packaging units of Lipitor (28 tablets) and Norvasc (30 tablets) are different., and packaged every 7 days (clockwise at the top left)Due to the packaging unit different from the domestic prescription style, drug prescription and storage difficulties for pharmacists and patients in countries are increasing and improvement is required. According to the pharmacy, it is difficult to dispensing some high-frequency, long-term prescription drugs because the packaging unit is set for 7 days (28 days) rather than 10 days (or 30 days). Representative drugs related to this include Korea United Pharm's Omethyl Cutielet Soft Caps 2g and Pfizer Korea's hyperlipidemia treatment Lipitor 10mg. The packaging units of Omethyl Cutielet and Lipitor are 56 packets and 28 tablets, respectively. A pharmacist at Pharmacy A in Gangnam-gu, Seoul said, "Most of the drugs for hyperlipidemia are long-term prescriptions for 1 to 2 months. These drugs are packaged in 56 or 28 tablets, so another same product is opened and attached." . This is because the pattern of prescription days is different between Korea and foreign countries. In Korea, the unit is mainly used for 10 days (30 days, 30 tablets), but in Europe, it is based on 7 days (28 days, 28 tablets). However, in order to solve this problem, most pharmaceutical companies' production sites have replaced the 'packaging unit change device' to prevent the occurrence of the problem. The cost may vary depending on the facility line, but it seems that it usually costs about 10 million won. If the change part is modified, both 10 and 7 units can be packaged in both directions. An official from Korea United Pharm said, "It has been confirmed that there have been cases of phone calls from front-line pharmacists to related departments such as customer services at the head office. However, there is no plan to modify the packaging unit." Pfizer Korea said, "Lipitor 10·20mg is also available in 90T bottle type. Changing the packaging unit may be difficult to apply in a short period of time because various factors in the production process must be considered. However, in order to improve the discomfort of domestic pharmacists and patients, We will figure out what is possible, and we will work hard and take action.”
- Company
- Boehringer is interested in open innovation with Yuhan
- by Mar 29, 2021 05:58am
- Boehringer Ingelheim emphasized the importance of open innovation and announced that it has a long-term partnership with Yuhan. It also mentioned the possibility of further open innovation for R&D materials in Korea. In addition, they expressed their will to do their best in the development of COVID-19 treatment and anticancer drugs targeting KRAS. Boehringer Ingelheim held an online global annual press conference on the morning of the 24th (local time in Germany) and announced last year's results and forecasts for this year. In spite of COVID-19 crisis, Boehringer Ingelheim showed good performance last year with its flagship items, Jardiance and Ofev. Total sales amounted to €19,570 million, an increase of 3% from the previous year. During the same period, operating profit rose 22.2% to €4,620 million. SGLT-2 inhibitor Jardiance posted the highest sales in the human medicine division at €2.48 billion, and Jardiance is expected to expand the range of treatment to heart failure and kidney disease. Ofev showed remarkable growth last year. It recorded €2,060 million, an increase of 41% year-on-year, ranking second in revenue contribution for the first time. Carinne Brouillon, director of the human medicine business unit, said "It's not because of COVID-19, because Ofev isn't related to COVID-19 comorbidity, This is because there is more room for finding and treating target patients with the development of diagnostic technology than in the past." Boehringer Ingelheim plans to focus on developing COVID-19 treatments, and it started development from the beginning of last year. BI767551, which is being developed as an inhalant, entered a phase 1/2a clinical trial in December last year in collaboration with the University of Cologne Hospital in Germany, the University of Marburg, and Deutsches Zentrum für Infektionsforschung. It is also developing COVID-19 neutralizing antibody that can be used in combination with BI767551, a low molecular weight substance that inhibits the replication of COVID-19, and a therapeutic agent for preventing microcoagulation. It also invests in the development of new drugs for diseases with high unmet medical demand.Boehringer Ingelheim showed high interest in KRAS anticancer drugs. It is developing therapeutics that target a wide range of KRAS mutations. The company said, "There is a lot of interest in KRAS mutant cancer. It is an important mutant gene that causes pancreatic cancer, colon cancer, and lung cancer, but there is no licensed agent yet." Boehringer Ingelheim said that it has a broad portfolio that can be used in combination with other substances as well as candidates that can target all important KRAS mutations as candidates that block SOS1 protein, so it could be the core of KRAS mutations. It also emphasized collaboration with partnerships for IMD development. Boehringer Ingelheim is building partnerships with pharmaceutical companies around the world, and a new drug for non-alcoholic steatohepatitis (NASH) is being developed with Yuhan in Korea. Yuhan technically exported the NASH candidate material to Boehringer Ingelheim in 2019. Director Carinne Brouillon said, "We have a long-term strategic partnership with Yuhan, Korea's leading pharmaceutical company, and we are working closely with R&D in the NASH sector." the director added, " As there are many interesting R&D activities in Korea, we are interested in additional open innovation if there is a good opportunity that matches the area we focus on or explore."
- Company
- Bonviva generics dodge a bullet from patent dispute
- by Kim, Jin-Gu Mar 26, 2021 05:38am
- The generic makers won the patent dispute over an antiarthritis Bonviva (ibandronate) and now they are finally free from the risk of sales ban and damage compensation. According to the pharmaceutical industry source on Mar. 23, the Intellectual Property Trial and Appeal Board issued a trial decision that the dosage regimen patent for Bonviva was invalid. South Korean companies launched Bonviva generics in 2012. Sales continued for several years without special patent disputes. Roche owned the dosage regimen patent for the original Bonviva, but did not file a patent lawsuit at the time of the generic launch. At the time, the Patent Court and the Supreme Court did not recognize the dosage regimen patent. As for the original maker, a patent dispute meant nothing when the company was bound to lose it. However, in 2015, the table has turned. The Supreme Court abolished the precedent of the Baraclude (entecavir) patent dispute, and fully recognized the dosage regimen patent. Bonviva’s dosage regimen patent, initially affected by the precedent, gained its validity. Regardless, Roche did not file a patent dispute immediately. The company did not intend to overturn the decision that it concluded that there were no problems at the time of release. But a problem arose when Bonviva's patent rights were transferred from Roche to a British pharmaceutical company Atnas Pharma in 2018. More assertive Atnas Pharma took a sharp turn on the matter and filed patent infringement suit against Bonviva generic makers in South Korea. At the same time, they claimed for a colossus compensation for the damage. The companies then were struck with the crisis. Although they have been selling Bonviva generics for years without any problems, they were faced with sales ban and also cough up the revenue earned so far. Accordingly, 10 generic companies such as Theragen Etex, Korea Arlico Pharm, Wooridul Pharmaceutical, ChoA Pharmaceutical, Korea Kolmar, Huvist, and Dongkwang Pharmaceutical, which sold Bonviva generics, decided to respond together. A trial was filed to nullify the Bonviva dosage regimen patent. Considering the gravity of issue, the Intellectual Property Trial and Appeal Board allocated the case to the Special Joint Trial Board. Generally, a patent trial is handled by three judges, but the Special Joint Trial is conducted by five judges. Ultimately, the Intellectual Property Trial and Appeal Board decided to invalidate the case. South Korean companies are now relieved. As of now, there is a high possibility that Atnas Pharma, holding the patent right, would request for an appeal. Patent Attorney Park Jong-hyuk of Park Jong-hyuk Patent Law Firm said, “After the Supreme Court recognized the dosage regimen patent in 2015, the method of judging non-obviousness in dosage regimen patent was somewhat formed through the tadalafil case. He emphasized, “The Intellectual Property Trial and Appeal Board conducted an elaborate trial for a long term through a Special Joint Trial Board, and determined requirement of a dosage regimen patent, necessity of test data, improper description and non-obviousness. The latest decision would be used as a standard to other similar cases related dosage regimen patent.” A pharmaceutical market research firm UBIST reported Bonviva's outpatient prescription last year was 2.9 billion won. In South Korea, Handok is in charge of sales. Adding the prescription volume of Bonviva Plus (5.4 billion won), which combined with cholecalciferol, Bonviva makes about 8.3 billion won per year. Currently, 93 Bonviva generics have been approved for marketing in South Korea. These drugs combined generate about 10.3 billion won.
- Company
- Problems with the most expensive CAR-T treatment Kymriah
- by Mar 26, 2021 05:38am
- The CAR-T treatment Kymriah (Tisagenlecleucel), which is considered the hope of terminal blood cancer patients, was launched in Korea after 4 years, but there are problems to be solved. Kymriah is treated in a completely different way from existing medicines, so it is not easy to calculate the drug price, and at a price of ₩500 million, there are many concerns about applying benefits. Kymriah is the first CAR-T treatment in Korea and is currently the most expensive drug. Indications are diffuse large B-cell lymphoma in adults and B-cell acute lymphocytic leukemia in children and young adults. In both cases, terminal patients who are ineffective after two or more treatments, recurrence, or recurrence after transplantation are targeted. CAR-T treatment is different from conventional drugs. Unlike conventional pharmaceutical products, CAR-T collects T cells in the patient's white blood cells at a hospital and then freezes them and sends them to the manufacturing site. Later, it will be sent to the hospital. When the hospital passes the raw material (patient T cells) to the pharmaceutical company, the company makes it into a finished product and sends it back to the hospital. Hospitals maximize the effectiveness of Kymriah by using lymphocyte depletion chemotherapy in patients to lower their white blood cell count. After about 4 to 5 weeks, all work is completed, and Kymriah is administered to the patient's body. Since Kymriah's steps in the manufacturing process are mandatory, the first task is how to calculate and handle these costs. Kim Won-seok, a professor of hematology and oncology at Samsung Medical Center, said at the Novartis Kymriah meeting held on the 23rd, "We have been discussing how to calculate incidental costs such as T-cell collection for patients for almost a year. There are no government guidelines, so this is the first time that we are making unexpected factors." Currently, Novartis is making payments by establishing Kymriah center in a hospital. The Kymriah Center is scheduled to open in May at Samsung Medical Center and Seoul National University Hospital respectively. However, in order to establish a center, hospitals must obtain permission for management business such as human cells in accordance with the newly established 'Advanced Renewable Bio Act'. Kymriah can be administered only in hospitals with centers. According to Novartis, the center will be expanded to Severance Hospital, Seoul St. Mary's Hospital, and the AMC. Since it is an ultra-high priced drug worth ₩500 million, it is not easy to apply the reimbursement. Kymriah is absolutely necessary in situations where life or death is critical, but from the perspective of the government, which has to spend the people's tax, it is questionable whether it is appropriate to spend hundreds of millions of dollars on the possibility of 50-60%. The second problem is to make a reasonable payment plan even for the super high-priced drugs that will come out more in the future. Professor Kang Hyung-jin of the Department of Pediatrics and Oncology at Seoul National University Hospital said, "The problem with Kymriah is how to take ultra-high-priced drugs with life as collateral. When Kymriah first appeared in the United States, patients were very happy. but there are completely different costs than before. Now, the number of patients is not very small, and the number of target patients will increase through additional clinical trials, so we have to think about how to solve the cost problem wisely. It's just the beginning.” Professor Kim also said, "Kymriah's treatment results are very remarkable. Half of the hopeless patients whose life expectancy is only 3-6 months can get new hope. According to the law, the patient's burden is uniformly 5%, but don't be too tied to it, and it's time to make flexible changes.” Professor Kang emphasized that it is imperative to create a virtuous cycle of costs. He said, "The cost of returning to Korea is very small among the costs paid by patients. MRI, CT, endoscopy, robotic surgery, and expensive drugs are all products of foreign companies, so much of the medical expenses are not recycled. Conversely, foreign countries circulate within them even if they spend medical expenses. This virtuous cycle structure is possible because ideas from hospitals and universities can be industrialized and come back." Kymriah is also a treatment developed by a research team at the University of Pennsylvania in the United States and commercialized by Novartis. This is a representative case in which the researcher's idea was made into a treatment. Professor Kang said, "In Korea, we need to raise a lot of human resources in hospitals and universities, and their ideas are industrialized through companies, so we need a breakthrough to create a structure in which medical costs can be circulated. And we will be able to pay enough for expensive drugs"
