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2026-05-04 04:46:03
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Policy
Strengthen the guarantee of 21 new drug by the third quarter
by
Kim, Jung-Ju
Sep 30, 2022 05:53am
From January to the third quarter of this year, a total of 21 new drugs were newly listed on the drug benefit list or improved access to use due to expanded insurance benefit standards. Among them, two new drugs were newly listed on the drug benefit list this month. The number of domestic patients estimated to benefit or suffer from the government's policy to strengthen the guarantee of new drugs this year is 1,323,065, and the cost of drugs is 451.75 billion won. In particular, with the emergence of ultra-high-priced drugs that focus on the minority, the government's drug guarantee and accessibility policy are becoming more flexible according to social trends and needs. A total of 21 drugs (based on the representative content) have been strengthened due to the expansion of standards among new drugs and registered drugs that succeeded in listing new drug pay lists from January to this month. On a monthly basis, Vyzulta and Skilarence were newly registered in February, and Besponsa's standards expanded, and the coverage began to be strengthened. In March, Xospata 40mg and five new osteoarthritis treatments, including Lutathera, Keytruda, Vitrakvi Rozlytrek, newly registered ultra-high-priced treatment kymriah in April, and Tecentriq in May. Looking at the recent drug coverage, the coverage of Kadcyla, a breast cancer treatment, expanded in the third quarter, starting with the new registration of Fexuclu, a treatment for erosive gastritis. In August, Zolgensma, a new drug for spinal muscular dystrophy, which was called an ultra-high-priced new drug and attracted social attention for a long time, was newly registered, widening the scope of drug coverage. Zolgensma's estimated number of patients in Korea is only seven but expected demand The cost of drugs reached 13.87 billion won, making it difficult to guarantee for a long time. Nevertheless, the fact that this drug was able to be paid can be said to be the result of our society's flexible expansion of coverage by recognizing the social importance, even if the number of patients is small. Subsequently, Sonazoid, radiation drugs for PET, Doppa check, Donerion and Dongesive, which are used for Alzheimer's-type dementia, were newly listed, and the standards for prostate cancer treatment Xtandi and urinary tract epithelial cancer treatment Keytruda, which had high patient needs, were expanded. This month, Pfizer Lorviqua and the chronic migraine drug Emgality succeeded in paying, allowing 350 and 2,344 patients, respectively, to receive benefits. The annual fiscal requirement estimated here is an absolute financial forecast. Among them, since RSA-applied drugs are calculated based on the indicated price, it is estimated that the actual amount required will be less than this considering the refund rate. In addition, the contents of the contract between the insurer and the company, such as the substitute drug and the sharing of required costs, were not reflected.
Policy
Reevaluation deadline for listed drugs extended 5 months...
by
Kim, Jung-Ju
Sep 30, 2022 05:53am
The government finalized its plan to extend the deadline for reimbursed price reevaluations of listed drugs that are subject to conduct bioequivalence tests and made a final report to the top legislative organization for the national health insurance. The finalized plan will extend the data submission period of listed drugs that are subject to reevaluations by 5 months, and companies that submit review results during the objection period for the Drug Reimbursement Evaluation Committee’s review after exceeding the submission deadline will also be accepted. The objection period on the Drug Reimbursement Evaluation Committee’s judgment will be around the end of May, and the final announcement period for the drug price cuts is scheduled for December next year. The Ministry of Health and Welfare held a Health Insurance Policy Deliberation Committee meeting on the 29th and reported the ‘Changes regarding the reevaluation of the upper limit (standards) set for pharmaceuticals.’ The reevaluation of listed drugs was made as a follow-up measure after the introduction of the stepped new drug pricing system that links approvals with drug price to ensure the quality of generic drugs and countermeasures against the flood of generics in the wake of the detection of impurities in valsartan-containing drugs in 2018. Since July 2020, all new generics introduced are applied a stepped pricing system under the new drug pricing system when determining its insurance price. The essence of the standard is to prove the results after conducting in-house bioequivalence tests. However, due to the spread of COVID-19, the bioequivalence tests that were to be conducted by the companies were not progressable due to difficulty recruiting subjects and the increase of confirmed COVID-19 cases among subjects which led to discontinuation or delays in trials and disrupted system implementation. Industry voices on the need for deadline extensions and deferred evaluations increased further due to the time taken in designating reference drugs necessary to demonstrate the bioequivalence of sterile drug products. Accordingly, the MOHW and the Ministry of Food and Drug Safety discussed flexibly adjusting the reevaluation procedure and schedule to facilitate smoother operations since May. In comprehensive consideration of the special circumstances that include preserving the consistency in insurance finances and the drug pricing system, equity with new products, and the prolonged COVID-19 outbreak, the MOHW decided to partially modify the data submission deadline and evaluation period, but with the goal of completing the schedule within 2023. According to the HIPDC report, the data submission deadline for existing items had been extended with a condition in consideration of the COVID-19 situation. The extension will be applied to 10,000 tablet preparations among oral prescription drugs and suppositories that are subject to bioequivalence tests. Among these drugs, if their bioequivalence tests have been delayed due to COVID-19, etc., the company may submit the test result report to the MFDS by February next year or submit the review results by end of May to HIRA within the planned objection period on HIRA’s Drug Reimbursement Evaluation Committee review, will be deemed to have met the final requirements. If the companies are unable to demonstrate bioequivalence within the set period, their drug’s price will be reduced as of July 1st next year. Authorities plan to identify progress made for bioequivalence tests by company and month within the second half of the year so that submission of bioequivalence test reports will not be concentrated in a specific period, and encourage prompt data submission to the MFDS upon completion. Adjustments to the reevaluation period will also follow. The government will also adjust HIRA's reevaluation period in consideration of the current designation status of reference drugs and MFDS's review schedule. The data submission deadline to HIRA is by July next year, and HIRA's evaluation period will be adjusted from July next year to November. With the changes, the drug price reduction announced for unproven products will be made around December next year. The MOHW will continue to monitor the progress of bioequivalence tests and the designation status of reference drugs and consult with MFDS and other related associations on issues to guide companies to disperse the submission of their reports.
Policy
Research service for re-evaluation of listed drug benefits
by
Lee, Tak-Sun
Sep 30, 2022 05:53am
The HIRA will conduct a study on the re-evaluation of drug benefit adequacy with the aim of ending in February next year. Through this, it will be used as a policy to promote re-evaluation projects. The HIRA announced on the 27th that it would bid for a research service to rationalize the evaluation of drug benefit adequacy. Ticketing is scheduled to take place on October 5. The research period is four months from the date of signing the contract, and the goal is to end in February next year. The budget was allocated 60 million won. The HIRA explained that through this study, it will come up with a reasonable target selection and evaluation standard improvement plan to stably establish a benefit adequacy re-evaluation system, operate an effective system, enhance predictability of stakeholders, and prevent unnecessary issues. Re-evaluation of drug benefit adequacy is being conducted by the first comprehensive health insurance plan (2019-2023). Therefore, the relevant grounds will be lost next year. This year, The HIRA has prepared criteria for selecting the grand prize, but there is no research to support this. In the first half of last year, the HIRA set the criteria for the long-standing registration year when selecting the subject for re-evaluation, and decided to evaluate the clinical usefulness first, considering cost-effectiveness and social demands if necessary. This is why this study is necessary because the re-evaluation does not achieve the purpose of reducing insurance finances immediately. The HIRA is suspended from administrative litigation and execution by pharmaceutical companies in all three components and Choline alfoscerate in 2020. The committee pointed out that the achievement of the purpose of the system is insufficient and that the reduction of insurance finances is being delayed. Accordingly, this study plans to conduct policy proposals for selecting targets for re-evaluation and improving evaluation criteria and methods through analysis of domestic and foreign reimbursed drugs, and adequacy re-evaluation system. The main contents of the study are policy suggestions for analyzing the current status and revaluation (post-management) system in Korea, analyzing the overseas revaluation (post-management) system and status, and re-evaluating the rational drug benefit appropriateness (spending efficiency). The HIRA expected that this service study will be used as a policy for selecting targets related to the promotion of drug benefit adequacy re-evaluation projects and managing reimbursed drugs.
Policy
Withdrawal of Hanmi's Olita permit, cancellation of benefit
by
Lee, Tak-Sun
Sep 29, 2022 05:50am
The benefit of Olita, a new domestic drug, will be canceled following the withdrawal. It has been six years since it was approved as the new domestic drug No. 27 in May 2016. Since Hanmi Pharmaceutical already announced the suspension of development in April 2018, the withdrawal of the license and cancellation of the benefit were scheduled, but it withdrew from the market due to global competitive drugs. According to the industry on the 28th, Hanmi Pharmaceutical's non-small cell lung cancer treatment drugs Olita 200mg and Olita 400mg will be removed as of the 1st of next month. It is a procedure following the withdrawal of permission. Olita has maintained permits for existing patients permission was withdrawn on 12 August. Hanmi Pharmaceutical, which received phase 3 from the Ministry of Food and Drug Safety, decided to suspend Olita's development in April 2018. This is because it was expected that it would be difficult to recruit phase 3 clinical patients as a competitive drug called Tagrisso quickly entered the market.The return of Olmutinib rights by Beringer Ingelheim and its Chinese partner Zai Lab affected the suspension of development. Tagrisso of AstraZeneca, a competitive drug, started selling around the world and received benefits in Korea, making it difficult to recruit patients necessary for phase 3 progression. Although Olita's domestic application was November 15, 2017, a month earlier than Tagrisso's (December 15, 2017), Tagrisso's benefit is a problem for Olita's domestic development because it had to proceed with a phase 3 clinical trial, which is a condition of permission. However, while the development was suspended, the permission was maintained for patients taking Olita at the time, but the permission and cancellation were a matter of timing because they did not meet the conditions of the permission, phase 3.
Policy
Boryung Zepzelca, conditional approval with phase 2 data
by
Lee, Hye-Kyung
Sep 29, 2022 05:49am
It has been confirmed that Boryung's new small cell lung cancer drug Zepzelca has received conditional approval only with phase 2 clinical data. Based on the Ministry of Food and Drug Safety's notice, anti-cancer drugs have been subject to conditional approval for phase 3 since January this year, and the revision of the Pharmaceutical Affairs Act has clarified the criteria for conditional approval only with phase 2 data. The HIRA benefit evaluation will be available if the company applies for conditional approval. If the adequacy is evaluated in the HIRA, it can be converted into a reimbursed drug through drug price negotiations with the NHIS. Until the benefit is applied, patients will be able to receive Zepzelca on a nonreimbursed basis only for permits. On July 6, the Central Pharmaceutical Affairs Review Committee, which was unveiled by the Ministry of Food and Drug Safety on the 27th, discussed the efficacy of Zepzelca's conditional approval. According to the minutes, the Ministry of Food and Drug Safety judged that the number of patients was reasonable because the phase 3 clinical trial proposed by Boryung was a multinational clinical trial. In addition, Zepzelca submitted a risk management plan as a rare drug, and added that it focused on hematological toxicity and hepatotoxicity in safety items. At the meeting, Boryung said, "We plan to proceed only with global clinical trials at the moment, and if we believe that domestic clinical trials are necessary, we will decide after discussing with developers." "In the United States, discussions have been held with the FDA several times since the phase 2 clinical trial, and conditional items have been approved and are currently on the market," he explained. Phase 3 clinical trials are currently underway, and plans to submit phase 3 clinical data as soon as clinical trials are completed in the future. Boryung announced its plan to launch Zepzelca in the first half of next year, which is an indication of "metastatic small cell lung cancer that failed primary platinum-based chemotherapy." Zepzelca is a new anti-cancer drug developed by Spanish pharmaceutical company PharmaMar S.A., and Boryung has exclusive rights to develop and sell in Korea since 2017. After being designated as a rare drug by the U.S. Food and Drug Administration (FDA) in 2018, it was released in July of the same year with conditional rapid approval and priority screening approval in June 2020. In the United States, only small cell lung cancer is allowed. Boryung said, "Although it was a phase 2 result, it showed effectiveness compared to existing treatments, and showed a low tendency in hematological adverse reactions in terms of safety," and expected, "If it is marketed, patients' choice opportunities will be expanded."
Policy
Janssen's Talquetamab, approved for Phase 3 in Korea
by
Lee, Hye-Kyung
Sep 28, 2022 06:05am
While Janssen's Talquetamab is undergoing phase 3 clinical trials around the world, phase 3 approval has been granted to 44 patients in Korea. On the 26th, the Ministry of Food and Drug Safety approved the Talquetamab subcutaneous injection and Daratumumab subcutaneous injection (Tal-DP) or Daratumumab subcutaneous injection and Daratumumab subcutaneous injection (Dalatum-3) in clinical trial subjects with at least 1st prior therapy. Currently, multinational clinical trials are underway for patients with recurrent or refractory multiple myeloma, and the total number of clinical trials is 810. In Korea, clinical trials will be conducted at Severance Hospital, Samsung Medical Center, Hwasun Chonnam National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, Seoul National Cancer Center, Gil Hospital, Chonbuk National University Hospital, and Dong-A University Hospital. A double antibody is an antibody that simultaneously recognizes two different antigens. Treatments are characterized by targeting both factors that cause disease. For example, it can act on immune cells and cancer cells at the same time to catch two rabbits, strengthening immunity and attacking cancer cells. Representative double-antibody anticancer drugs include Amgen's acute leukemia treatment BLINCYTO (Blinatumomab) and Roche's hemophilia type A treatment HEMLIBRA (Emishzumab). Talquetamab targets both GPRC5D and CD3 of T cells, a new multiple myeloma target, with off the shelf T cell-redirecting double antibody. According to data released by ASCO last year by Janssen, subcutaneous administration of phase 2 recommended doses in 30 patients with recurrent or refractory multiple myeloma with a median value of 6 months or more was 70%, and 60% of patients achieved VGPR (very good partial response). Subjects of clinical trials previously received the sixth treatment at a median value, and 87% did not respond to the last treatment. Reactions were observed in 70% of patients, including 65% of patients who were non-responsive to three drugs and 83% of patients who were non-responsive to five drugs, and during the 6.3 months of the follow-up period, patients have not yet reached the median of the response period.
Policy
Generic for Acelex will be released
by
Lee, Tak-Sun
Sep 27, 2022 05:51am
A new domestic anti-inflammatory drug developed by Crystal Life Science Generic drugs of the domestic anti-inflammatory drug Acelex developed by Crystal Life Science will be on the market from next month. It has been seven years since Acelex was licensed in Korea, and attention is being paid to whether generic, like the original, will be able to expand its market. This is because Celecoxib has high market dominance among coxib families. According to industries on the 26th, eight Acelex generics will be listed on the 1st of next month. Generic companies are Daewoong Pharmaceutical, Hutecs, Ilhwa, CrystalLife Science, Kuhil, Edenpharma, CMG Pharma, and Hana. Except for Daewoong Pharmaceutical, seven items will receive an additional amount of 522 won for one year, including first generics, and will be adjusted to 470 won on October 1 next year. Daewoong will be listed at 597 won, but will also be adjusted to 470 won on October 1 next year. Generic is in competition with original, but Acelex generic is in partnership with original. This is because Crystal Life Science, an affiliate of Crystal Genomics, produces products like the original company. Therefore, the original company's production performance will expand only when generic sales increase. Original and generic market expansion, by having common goals. Cerebrex 400 billion won in annual performance record. 2016, patent expiration as a generic is reimbursed. Acelex is properly lost the use of force and with earnings of less than 10 billion won per year. The sluggishness of Arcoxia and Acelex is due to the fact that the indication is limited to osteoarthritis and that the marketing ability was not great to destroy Cebrex's position. Since large companies such as Daewoong Pharmaceutical are included in Acelex generics this time, generics are expected to expand the overall market size, allowing both original and generics to create synergy.
Policy
Hutecs targets pitavastatin market with its lowest-price
by
Lee, Tak-Sun
Sep 27, 2022 05:51am
Hutecs Head Office in Hwaseong City Hutecs Korea Pharmaceutical throws a winning bid in the hyperlipidemia treatment pitavastatin market represented by the original drug Livalo. As the 21st latecomer introduced to the market, Hutecs’ generic is putting pressure on other competitor companies, being listed at a price lower than 85% of the current lowest price. According to industry sources on the 26th, Hutecs succeeded in listing both Lovalow 1mg and Lovalow 4mg with reimbursement. The ceiling price was set at KRW 295 for the Lovalow 1mg, and KRW 527 for Lovalow 4mg. The two products are both listed at the lowest price among the listed products. In particular, the price of Lovalow 4mg was set 28% lower than the current lowest price (KRW 715). Lovalow 4mg is the 21st product to be listed. Under the drug pricing regulations, from the 21st generic listed in the system, the price is set at 85% of the lowest price. However, the price of Lovalow 4mg was set even lower. With the listing, the ceiling price of the already listed Lovalow 2mg will also inevitably be discounted. This is because when a product from the same company with an identical route of administration, ingredient, and formulation, but with a different strength is already listed, the ceiling price of the lower strength is adjusted to be lower than that of the higher strength under regulations. Therefore, the price of Lovalow 2mg was lowered to KRW516 from KRW561. This is KRW 1 lower than that of Lovalow 4mg. As a result, Lovalow 2mg, which was the lowest priced product among the same ingredient drugs, is expected to become the second lowest priced product. Competition in the pitavastatin market is fiercer for the 2mg products. A total of 48 same ingredient products are competing in the market. With its 1mg and 4mg formulations being listed later in the market, Hutex seems to be throwing in the winning bid and extending its price competitiveness to the 2mg formulation market as well. Pitavastatin is a steady seller that has been long beloved in the hyperlipidemia treatment market. Its original, Livalo, had recorded KRW 79.7 billion (Data: UBIST) in outpatient prescriptions last year.
Policy
MFDS in discord regarding promotion of oral COVID-19 Txs
by
Sep 26, 2022 06:08am
The government is encouraging the use of oral COVID-19 treatments in high-risk groups, however, accessibility to such has been limited for healthcare professionals due to limitations in emergency use approvals. The Ministry of Food and Drug Safety is being criticized for being passive in making legal interpretations for emergency use authorized drugs, which is in discord with the government’s disease control and prevention measures. According to industry sources on the 26th, pharmaceutical companies are disallowed from conducting academic marketing for their oral COVID-19 treatments as the subject drugs were approved under Emergency Use Authorizations. Usually, when new drugs are released, companies conduct various activities to raise awareness of the drugs, making visits to hospitals to explain their drugs and holding webinars or symposiums to provide educational material. The new drugs in the market can only be actively used after the healthcare professionals gain a better understanding of the drugs and accumulate prescription experience. However, as COVID-19 treatments were granted emergency use according to the Special Act on the Promotion of Development and Urgent Supply of Medical Products in Response to Public Health Crisis, the authorities deemed that the drug are not allowed the advertising privileges granted under the Pharmaceutical Affairs Act. According to Article 68-5 of the Pharmaceutical Affairs Act, the imported pharmaceutical product’s name, manufacture method, and efficacy cannot be advertised unless the drug product has been approved or reported according to Article 42-1 of the Pharmaceutical Affairs Act. As drugs granted Emergency Use Authorization was not approved under Article 42-1 of the Pharmaceutical Affairs Act, the MFDS’s interpretation was that such drugs are not allowed to conduct advertisements. Due to this, the government is solely in charge of providing the necessary information on oral COVID-19 treatments in Korea. The Korea Disease Control and Prevention Agency is in charge of training healthcare professionals to provide medication guidance to patients, etc. However, it has been pointed out that the government’s education sessions are not enough to cover the expanded scope of institutions and pharmacies approved to prescribe and dispense oral COVID-19 treatments. Also, the participation rate, frequency, and effect of KDCA’s education sessions are relatively lower than that of pharmaceutical companies due to lack of promotions among other reasons. There are also opinions that more explanation is needed because the sessions are not carried out by medical professionals. Many healthcare professionals and pharmacists who still have not received a prescription or medication guidance yet have reported experiencing confusion. However still, officials of pharmaceutical companies that can communicate most closely with healthcare professionals have been passive in dealing with the issue due to concerns about violating the Pharmaceutical Affairs Act. As an active explanation of the drugs was prohibited, the officials can only respond when receiving inquiries from healthcare professionals. This is why the prescription rate has not risen much even though the government has greatly expanded the number of institutions that can prescribe oral COVID-19 treatments. According to the Central Disaster and Safety Countermeasure Headquarters (CDSCH), the prescription rate of oral COVID-19 treatments in those over the age of 60 as of the 2nd week of September, remained at 27%. The prescription rate has more than doubled in 4 months with the encouragement of the disease control and prevention authorities, but the government believes it is necessary to further increase the prescription rate. The importance of prescribing oral treatments has risen after the prescriptions had significantly reduced the progression to severe disease in patients in the high-risk group over the age of 60 during the COVID-19 outbreak last summer. The CDSCH’s analysis of its disease control progress and response to the resurge of COVID-19 in the summer showed that the progression to severe disease decreased as the prescription rate for oral COVID-19 treatments increased for those aged 60 years or older. The rate of progression to severe disease, which had been 1.28% in February when the administrate rate was 6.4%, dropped to 0.42% with the rise of the administration rate to 21.7% in August. The disease control and prevention authorities are also busy preparing measures to address the issue of prescriptions being limited due to a lack of clinical information in the field. According to the 'Measures to Raise Prescriptions of Oral COVID-19 Treatments’ that had been reported by CDSCH last month, healthcare professionals were reluctant to prescribe oral COVID-19 treatments due to a large number of contraindicated drugs and lack of clinical information. Accordingly, the authorities are contemplating ways to increase accessibility to information by preparing educational materials and prescription guidelines. To address the continued criticism over the limitations in information, the authorities recently partially granted pharmaceutical companies to produce and distribute materials containing drug information. As such partial activities have clear limitations, voices for proactive allowance of pharmaceutical companies to conduct academic marketing on EUA drugs have also been rising. Contrary to the government's stance, the MFDS had been passive in making legal judgments regarding EUA drugs. At the time of introductions, pharmaceutical companies had made several inquires to the MFDS on what scope of information provision activities is allowed for their drugs. At the time, the MFDS only responded that “It is difficult for the ministry to provide a definite answer due to lack of information in determining the necessity and validity of providing information." The pharmaceutical companies received the response as a “don’t.” Regarding this, the MFDS said, “The COVID-19 treatments that were granted EUA are directly managed by the KDCA, and the KDCA has been providing various information for healthcare professionals and patients. We will consult with the department in charge to see if academic marketing is allowed." The Advisory Committee on Infectious Diseases also agrees on the need for the government to make proactive decisions and improve and expand healthcare professionals’ accessibility to information. During a phone interview with Dailypharm, Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters, said, “Despite the state’s efforts in encouraging the prescription of oral COVID-19 there are still many cases in which prescriptions are not available to patients who need them in the medical field. Adding pharmaceutical companies' information provision activities to the effort will help increase the prescription rate. It seems necessary that the government should take active action to overcome obstacles that may hinder engagement in such activities that would lead to an increase in the prescription rate, by requesting authoritative interpretation from the Ministry of Government Legislation.”
Policy
Lipiodol’s price reduced from 25th... 2-year suit dismissed
by
Kim, Jung-Ju
Sep 26, 2022 06:07am
The price of Guerbet Korea’s liver cancer contrast medium, Lipiodol Ultra-Fluid (iodized oil, 12.8g/10mL), which had been under legal dispute for the past 2 years after the government decided to remove the drug from the reimbursement list, will be reduced from the 25th this month. This is because the pricing discount that had been originally made by the government was reapplied upon the court’s dismissal of the lawsuit and the automatic termination of suspension of execution that followed. On the 19th, the Seoul High Court’s Administrative Court Department 6-1 decided to dismiss the administrative lawsuit filed by Guerbet Korea and notified the company and the MOHW of the termination of the suspension of execution. Accordingly, the MOHW announced that it would reduce the drug price as of the 25th as it had decided in 2020. Earlier in July 2020, the MOHW decided to lower the price of Lipiodol through ex officio adjustment upon the listing of its generic, Dongkook Pharmaceutical’s Fattiodol. Under the government’s pricing formula, the upper limit of the first product can be lowered by the government through ex officio adjustments when a generic with the same route of administration, ingredient, and formulation as the original listed. Guerbet Korea immediately filed a suit against the government, and the dispute continued until recently. The Seoul High Court’s Administrative Court Department 7 had previously decided to extend the suspension of execution that had been ordered by Administrative Court Department 12 so that the company could keep its original price. The suit was then passed on to Department 6-1, where it was dismissed. The scope of its reimbursement had also expanded in the long course of the continued litigations. As of July 6th, Lipiodol is reimbursed for lymphography, hysterosalpingography, and transarterial chemoembolization (TACE) in liver cancer. However, the price cut that will be made this time is irrelevant to the reimbursement extension, and the final price of KRW 133,000 will be applied per ample as it was originally reduced in July 2020.
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