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- 2025-12-19 14:19:20
- Policy
- ‘Expanding dual pricing under review to mitigate risks’
- by Jung, Heung-Jun Oct 23, 2025 06:11am
- The Ministry of Health and Welfare has expressed its commitment to actively review plans to expand the dual drug pricing system to resolve risks associated with the introduction of innovative new drugs. The MOHW expressed consensus on the need for the expansion as a countermeasure to the Most-Favored-Nation (MFN) drug pricing system introduced by the Trump administration in the United States. Responding to a written inquiry from lawmakers Ye-ji Kim and Jia Han of the People Power Party during the National Assembly audit on the 21st, the MOHW stated that it is reviewing measures for improvement. The lawmakers asked what concrete measures the government plans to take to mitigate risks posed by other countries, referencing Korea’s drug prices. The Ministry stated, “As the domestic launch of new drugs could be postponed or delayed if Korea becomes a reference country, we agree on the need to expand the dual pricing system to enhance patient access to treatments. We will prepare countermeasures.” It explained that it is reviewing plans to expand the current dual drug pricing system by gathering industry opinions. The Ministry expressed its commitment to the task, stating, “We will actively review plans to expand the dual drug pricing system to resolve the risk related to introducing innovative new drugs domestically.” Regarding the proposal to expand the risk-sharing system beyond anticancer drugs to cover new drugs for chronic diseases and other conditions, it responded that it would review reasonable systemic improvements. “In August last year, we revised the system to allow new drugs for severe, irreversible chronic diseases that significantly impair quality of life to also apply for RSA. We will continue to review rational policy improvements through expert consultation and on-site feedback.”
- Policy
- MOHW to institutionalize a fast-track listing system
- by Jung, Heung-Jun Oct 23, 2025 06:10am
- The Ministry of Health and Welfare (MOHW) has announced plans to institutionalize a fast-track reimbursement system based on the outcomes of the ongoing “approval–evaluation–negotiation” pilot program, aimed at accelerating patient access to innovative new drugs. It also stated its intention to expedite the reimbursement decision process for drugs for severe diseases that have submitted applications. The ministry responded so to Rep Mi-hwa Seo’s inquiry on strengthening access to new drugs during the National Assembly audit on the 21st. “We are currently conducting a pilot program that concurrently operates the regulatory approval (MFDS), reimbursement evaluation (HIRA), and price negotiation (NHIS) processes to support faster access. We will analyze the program’s performance and collect feedback from the field to review options for institutionalizing the system.” Furthermore, to provide optimal drug coverage within limited finances, the MOHW plans to include rational improvements to cost-effectiveness evaluations and implement a periodic drug price adjustment system, and strengthen compensation for R&D investments. The Ministry of Health and Welfare stated, “We aim to enhance coverage for severe and rare diseases by making cost-effectiveness evaluations more rational. We also plan to establish a periodic drug price adjustment system to proactively prepare for future increases in drug costs and strengthen appropriate compensation for R&D investment to foster an innovation ecosystem that promotes new drug development." The ministry expressed plans to expedite reimbursement decisions for specific drugs for severe diseases, such as third-line treatments for metastatic colorectal cancer. The MOHW responded, “‘Fruzaqla Cap (Takeda Pharmaceuticals Korea)’ is being reviewed for reimbursement as a third-line treatment for metastatic colorectal cancer. We will expedite its review procedures and make a prompt decision.” The ministry acknowledged the need for improvement regarding third-generation thrombolytic agents that are reimbursed overseas but not yet introduced in Korea. The Ministry stated, “We agree on the necessity of introducing third-generation thrombolytic agents, which reduce the burden of existing thrombolytic therapy. Currently, the second-generation agent Actilyse is listed, and the third-generation agent Metalyse was approved in October, but we confirm that no reimbursement application has been submitted. Once submitted, we will ensure the review proceeds smoothly.”
- Policy
- 'Distrust in MFDS rises after Leqembi safety issue'
- by Jung, Heung-Jun Oct 22, 2025 06:09am
- The Ministry of Food and Drug Safety (MFDS) has been criticized for losing public trust due to inadequate safety verification of the dementia drug Leqembi (Lecanemab) and poor post-marketing adverse event management measures. On the 18th, during the National Assembly audit of the MFDS, Representative Jin-sook Jeon of the Democratic Party of Korea criticized, “The MFDS has caused a crisis of trust at every stage of the approval and post-marketing management of dementia drugs. It must take responsibility and apologize before the public’s life.” Although Minister Yu-Kyoung Oh explained during last year's audit that ‘Aduhelm was not being used in Korea,’ the Korea Orphan Drug Center confirmed that a total of 5,847 vials were supplied for self-treatment at patients' request from 2021 to 2024. Jeon said this could constitute false reporting or perjury before the National Assembly. Rep. Jeon criticized, “Similarly, 448 vials of Leqembi were supplied for self-treatment before its official domestic launch. Despite knowing this, the MFDS answered ‘it was not in use.. MFDS’s safety management system failed to function during the pre-approval phase for Leqembi.” He further stated that the MFDS, which promised thorough post-marketing surveillance, is relying solely on reports from the pharmaceutical company. Jeon explained that surveillance is being conducted based on how much of the ‘post-marketing surveillance’ management plan submitted by the pharmaceutical company during the approval process has been quantitatively achieved. This is criticized as a dereliction of duty, entrusting patient safety to the pharmaceutical company. Rep. Jeon stated, “The U.S. FDA identified 6 deaths (4 unique cases after deduplicating) during the initial administration phase in its 2024 routine drug surveillance process and took safety measures, increasing MRI follow-up scans from three to four times. However, no separate follow-up measures have been made by our MFDS to date.” Domestically, 135 adverse events were reported within a year of its approval, with 12 (9%) classified as serious adverse events. Major adverse events included ▲ cerebral edema ▲ microbleeds ▲ hemosiderin deposition, identified as ‘amyloid-related imaging abnormalities (ARIA)’, posing risks of long-term brain damage and atrophy. Rep. Jeon stated, “The Yoon Suk-yeol administration appointed Director Yu-Kyoung Oh under the pretense of ensuring science and trust. However, the MFDS's science has vanished, and its trust collapsed. Minister Oh must apologize to the public for undermining the public’s trust.” She further proposed alternatives, stating, “New mechanism drugs, high-risk biological products, and conditionally approved drugs must be legislated to mandate external expert consultations.. The lack of post-marketing surveillance obligations for self-administered drugs requested by patients must be addressed to strengthen safety monitoring. Guidelines for regular inspections of adverse effects from self-administered drugs must also be established.”
- Policy
- Parliamentary inspection of the MFDS to highlight
- by Lee, Jeong-Hwan Oct 21, 2025 06:19am
- President Lee Jae Myung During the upcoming parliamentary inspection of the Ministry of Food and Drug Safety (MFDS), the National Assembly is expected to highlight the need to increase the number of reviewers and support the formation of dedicated teams to provide customized approval services, all aimed at shortening the review period for domestically developed new drugs. This move follows President Lee Jae Myung's directive to increase the number of drug reviewers by 300 to foster the K-Bio industry. On October 20, both ruling and opposition members of the National Assembly's Health and Welfare Committee are focusing on the issue of increasing and expanding the new drug approval review staff, which is deemed necessary for developing the domestic pharmaceutical and bio-industry, during the MFDS parliamentary inspection scheduled for October 21. President Lee Jae Myung ordered the expansion of the new drug review workforce, including biopharmaceuticals, during the 2nd Core Regulation Rationalization Strategy Meeting held at the Presidential Office in Yongsan, Seoul, on October 16. President Lee specifically emphasized the increase in MFDS review staff, stating, "The Ministry of the Interior and Safety may object, asking why we are increasing the number of public officials, but let's disregard that and proceed." This was a response to MFDS Minister Yu-Kyoung Oh's previous announcement to significantly expand the review workforce and strengthen existing review services, including prior consultation, face-to-face consultation, and supplementary meetings, to transform the MFDS into a regulatory service agency centered on demand, focusing on the pharmaceutical companies seeking new drug approvals. Minister Oh requested an increase of 300 MFDS reviewers to accelerate the review process (targeting 240 days), a request which President Lee accepted. Members from the Democratic Party of Korea and the People Power Party on the Health and Welfare Committee agree on the need to improve the review environment for rapid domestic new drug marketing authorization. They are expected to pursue related questioning during the parliamentary inspection. Rep. Nam In-soon (Democratic Party) plans to highlight the necessity of increasing the hiring of not only pharmacists but also physicians for dedicated review roles, following President Lee and Minister Oh's push for expanded review staff. The increase of 300 MFDS reviewers requires an annual labor cost of KRW 15 billion, and the plan is to cover this cost by increasing review service fees. Members on the Health and Welfare Committee are expected to specifically question MFDS on its plan to secure the necessary funding by raising the review fees for both synthetic drugs and biopharmaceuticals. A Health and Welfare Committee official said, "The MFDS review staff, at about 300 people, is much smaller compared to the U.S. FDA's approximately 9,000 staff and the European EMA's approximately 4,000 staff," and added, "Given the future blueprint of creating domestic global new drugs and fostering global pharmaceutical companies, we plan to question the need to foster new drug approval review team and the specific policy direction."
- Policy
- Keytruda, Dupixent begin negotiations for reimb expansions
- by Jung, Heung-Jun Oct 17, 2025 06:10am
- The immuno-oncology drug Keytruda (pembrolizumab) and the atopic dermatitis treatment Dupixent Pre-filled (dupilumab) have entered price negotiations, moving one step closer to expanding reimbursement in Korea. Both MSD Korea’s Keytruda and Sanofi-Aventis Korea’s Dupixent received reviews deeming reimbursement adequate for expanded indications at the September meeting of the Drug Reimbursement Evaluation Committee. Keytruda added an impressive 11 new indications, including gastric cancer, esophageal cancer, endometrial cancer, colorectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small intestine cancer, and biliary tract cancer. Previously, it was covered for 7 indications across 4 cancer types: non-small cell lung cancer, Hodgkin lymphoma, melanoma, and urothelial carcinoma. The addition of 11 indications is expected to increase annual claims by approximately KRW 400 billion. Due to increased usage, Keytruda became subject to monitoring for fourth-quarter price-volume agreement negotiations this year. Dupixent, a treatment for severe atopic dermatitis, received approval for expanded reimbursement for ‘severe type 2 inflammatory asthma in adults and adolescents’. Dupixent, the only targeted biologic for atopic dermatitis in Korea, had its indications expanded in March this year to include ‘additional maintenance therapy for adult COPD patients with elevated blood eosinophil counts inadequately controlled by standard inhaled therapy’. According to Sanofi's performance data, Dupixent's global sales for the second quarter of this year reached approximately KRW 6.617 trillion. This represents a 15.6% increase compared to the same period last year. Sanofi is continuing to expand its indications for Dupixent through additional clinical studies. According to the market research institution IQVIA, sales in 2023 reached KRW 143.2 billion . This represents an increase of over 36% compared to the previous year, showing an upward trend. Due to its increased use in Korea, it is also included as a subject for monitoring for fourth-quarter PVA negotiations alongside Keytruda. If negotiations with the National Health Insurance Service proceed without breakdown and lead to expanded coverage, this is expected to further bolster the upward sales trend.
- Policy
- "Korea Passing concerns…'dual pricing system' under review"
- by Lee, Jeong-Hwan Oct 17, 2025 06:10am
- Minister of Health and Welfare Jeong Eun Kyeong Minister of Health and Welfare Jeong Eun Kyeong announced that the Ministry would strengthen administrative efforts for 'fast track National Health Insurance (NHI) listing of new drugs' and review the introduction of a 'dual pricing system' to prevent global pharmaceutical companies from "Korea Passing" of their new drugs. On October 14, Minister Jeong stated this during a Parliamentary Inspection, responding to an inquiry from People Power Party Rep. Jia Han regarding the U.S. Trump administration's 'Most-Favored-Nation Prescription Drug Pricing.' Rep. Han stated concern, "If the Trump administration's new drug pricing system is fully implemented, patient access to new drugs in Korea could be significantly constrained," and added, "Global pharmaceutical companies like Pfizer and AstraZeneca have also stated participation in the most-favored-nation price system." Rep. Han further pointed out, "Recently, a key breast cancer treatment, Faslodex, was considered for withdrawal due to drug price issues, and some rare and intractable disease treatments cannot be introduced into Korea at all," and added, "If the most-favored-nation price system is implemented, Korea could devolve into a 'country with cheap drugs but no new drugs.' If major pharmaceutical companies delay launching or withdraw from Korea due to drug price transparency and low market potential, patients will lose access to life-saving new treatments." Rep. Han said, "South Korea's drug prices are about one-fifth of the OECD average, and its share of the global pharmaceutical market is only 1.7%, compared to the U.S. at 58.4%," and added, "If global pharmaceutical companies bypass Korea due to low drug prices and small market size, we would see withdrawal before launch, as already seen with some original drugs." Minister Jeong acknowledged the issue of delayed introduction or withdrawal of new drugs caused by the most-favored-nation price system and responded that the Ministry would strengthen Fast Track NHI listing and review the introduction of a dual pricing system. Minister Jeong said, "We are informed that the risk of delayed introduction or withdrawal from the domestic market for new drugs could increase due to the most-favored-nation price system. " She added, "We will strive to establish a reinforced compensation system for new drugs so that they can be swiftly listed on the NHI." Minister Jeong also said, "South Korea's drug pricing system is excessively transparent and is used as a reference price by other countries, which leads to disadvantages," and concluded, "To compensate for this, we are reviewing a dual pricing system and will work to improve our drug price disclosure methods and system."
- Policy
- Bylvay granted orphan drug designation for Alagille syndrome
- by Lee, Tak-Sun Oct 16, 2025 06:21am
- From this month, Bylvay Cap (odevixibat, Ipsen Korea)—which was recently listed for reimbursement as a treatment for progressive familial intrahepatic cholestasis (PFIC)—has been designated as an orphan drug for treating cholestasis-associated symptoms in patients with Alagille syndrome. The orphan designation is expected to accelerate the indication expansion, as it provides benefits such as expedited review and exemption from application fees. As a result, Bylvay is now poised to compete with GC Biopharma’s Livmarli oral solution (maralixibat chloride), which is currently in the final stage of pricing negotiations for reimbursement for Alagille syndrome in Korea. According to industry sources on the 15th, the Ministry of Food and Drug Safety announced the designation of Bylvay Cap as an orphan drug for treating Alagille syndrome, effective as of the 1st of this month. Bylvay Cap obtained domestic marketing authorization last August as a treatment for pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) aged three months or older. This month, it also succeeded in securing reimbursement listing for the same indication. This drug was selected for the parallel approval-evaluation-negotiation pilot program, enabling it to shorten the time to approval and reimbursement listing compared to other drugs. Its recent designation as an orphan drug for Alagille syndrome is expected to further expedite the process for adding this new indication. Orphan drug designation grants access to expedited review and waives application fees. Additionally, even before final approval, the drug can be supplied to patients through the Korea Orphan & Essential Drug Center. Currently, the only approved treatment for Alagille syndrome in Korea is GC Biopharma’s Livmarli oral solution, which was approved in February 2023 for the treatment of cholestatic pruritus in patients aged three months and older with Alagille syndrome (ALGS). Livmarli is also designated as an orphan drug in Korea. In August, Livmarli passed review by the Health Insurance Review and Assessment Service’s (HIRA) Drug Reimbursement Evaluation Committee and is now in final pricing negotiations with the National Health Insurance Service (NHIS). Once listed for reimbursement, Alagille syndrome patients will be able to use Livmarli with insurance benefits in Korea. Alagille syndrome is a condition where the number of bile ducts within the liver is significantly reduced, preventing bile from being excreted from the liver and causing it to accumulate and cause complications in the cardiovascular, skeletal, ocular, and dermatologic systems. The disease primarily affects children, and due to the lack of effective treatments, it causes significant suffering for patients and their families. There are currently an estimated 136 patients with the condition in Korea. During its review, the Central Pharmaceutical Affairs Council deemed the orphan drug designation for Bylvay to be appropriate, considering the drug’s safety, efficacy, and supply feasibility. The fact that Bylvay has also been designated as an orphan drug for Alagille syndrome in the United States and Europe was also taken into account. As such, once Bylvay obtains formal approval for the Alagille syndrome indication, it is expected to directly compete with GC Biopharma’s Livmarli, which is nearing reimbursement approval. Furthermore, the orphan drug designation is anticipated to somewhat improve patient access.
- Policy
- Will regulations emerge for Wegovy prescriptions?
- by Lee, Jeong-Hwan Oct 16, 2025 06:20am
- Health and Welfare Minister Eun-kyeong Jeong acknowledged the excessive prescription of the popular obesity drug Wegovy in some frontline medical institutions and pledged to devise measures to improve prescribing practices through consultation with the medical community. The minister also said that MOHW will cooperate with the Ministry of Food and Drug Safety (MFDS) to designate Wegovy and other obesity injections as drugs of concern for misuse and abuse, raising the level of regulatory control and strengthening post-marketing adverse event monitoring systems. Minister Jeong made the remarks on October 15 in response to on-site inquiries from Rep. Nam-hee Kim of the Democratic Party of Korea during a National Assembly audit session. Rep Kim pointed out the problem that Wegovy, launched domestically last year and enjoying explosive popularity, is being prescribed without restriction beyond the approved indications. She further pointed out that prescriptions have been issued even to pregnant women and children under 12, both of whom are contraindicated for Wegovy. Rep. Kim asked Minister Jeong, “Do you believe the prescribing standards for Wegovy are being properly followed in clinical practice? There are numerous cases where it has been prescribed to children and pregnant women, despite clear restrictions.” Rep. Kim questioned, “This cannot be left unchecked. The lack of adequate legal grounds to regulate doctors and pharmacists is a problem, and some doctors sacrificing patient safety for profit is also a problem. The public's health must not be compromised, and national health insurance funds must not be wasted due to side effects from unprincipled prescribing and indiscriminate abuse of drugs.” Minister Jeong responded, “I believe Wegovy is being quite excessively and inappropriately prescribed in clinical settings. It is important to adhere to the dosing guidelines, but under the current Medical Service Act, physicians are granted discretionary authority in their prescriptions. Prescribing to children and pregnant women is certainly problematic,” she acknowledged. She also pointed out that there are limits to oversight because Wegovy is a non-reimbursed medication. “We will actively consult with the medical community to explore ways to adjust these excessive prescribing behaviors.” She added, “The Ministry of Food and Drug Safety has a system to designate and manage drugs of concern for misuse and abuse. We will utilize this system to collaborate on developing measures for drug management and post-marketing adverse reaction surveillance systems.”
- Policy
- MOHW Minister Jeong 'Will expedite orphan drug listings'
- by Jung, Heung-Jun Oct 16, 2025 06:20am
- The Ministry of Health and Welfare announced it will support the expedited listing of new drugs to enhance access to rare disease treatments and develop tailored measures for each rare disease. It also plans to collaborate with the Korea Disease Control and Prevention Agency to expand the legal designation of rare diseases. During the National Assembly Health and Welfare Committee audit held on October 14, Rep. Gae-ho Lee of the Democratic Party of Korea urged the ministry to take measures to strengthen support for rare diseases. Rep. Lee said, “Around 7,000 rare diseases have been identified worldwide, but only 1,314 are legally recognized as rare diseases in Korea. Patients also face significant challenges in accessing new therapies, and coverage under the national insurance system remains limited,” he added, calling for a comprehensive review by the ministry. In response, Minister Jeong stated, “We are well aware that rare diseases are marginalized, leading to insufficient access to new drugs and inadequate welfare support. We conduct annual demand surveys to expand the list of rare diseases and will consult with the Korea Disease Control and Prevention Agency to ensure this process is conducted meticulously.” She added, “We will also ensure new drugs can be listed promptly. Since medical and welfare needs vary by rare disease, we believe strengthening tailored countermeasures is necessary and will actively pursue this.”
- Policy
- "Overseas transfer of KOR genomic data by China's Novogene"
- by Lee, Jeong-Hwan Oct 16, 2025 06:20am
- During the Parliamentary Inspection, Rep. Lee Ju-young questioned the possibility of Novogene Korea transferring Korean citizens Rep. Lee Ju-young of the Reform Party pointed out an issue regarding Novogene, a Chinese genomics analysis company that established a branch in Korea, that the company has no genetic analysis equipment in Korea. Rep. Lee's concern is that Novogene's holding company, BGI, was globally reported in 2021 for allegedly collecting and sharing genomic data from over 8 million pregnant women across 52 countries with the People's Liberation Army. This raises serious concerns regarding the export of domestic genomic information and poses a threat to national security. Furthermore, Novogene Korea is located in a building owned by the Korea Association of Health Promotion, where the tenancy rights reportedly include the authority to use the Association's big data. This suggests an increased risk that Novogene could directly pose a national security threat by exporting Korean citizens' genomic data. Rep. Lee suggests that the current 'Bioethics and Safety Act' does not regulate Novogene Korea's reporting, which has triggered these concerns. She urged the Ministry of Health and Welfare (MOHW) to prepare responses. Minister of Health and Welfare Jeong Eun Kyeong stated that she would examine the facts regarding the sharing of domestic genomic big data between Novogene Korea and the Association. On October 14, during the parliamentary inspection of MOHW, Rep. Lee questioned Minister Jeong regarding the overseas export of domestic patient genomic data by Novogene Korea and the related threat to national security. According to Rep. Lee, Novogene Korea has not been registered as a genetic testing institution because the current law does not require such registration. As a result, the company operates as a sales organization with only six employees without the necessary equipment for genomic analysis. Rep. Lee criticized this, arguing that it makes it inevitable that genomic samples collected domestically by Novogene Korea will be sent to the company's centers in Mainland China, Hong Kong, and Singapore for analysis. It may be concluded that domestic biological genomic information is being exported. Rep. Lee said, "Institutions like Novogene Korea, which perform research and not testing for purposes defined by the Bioethics and Safety Act, are not subject to reporting as a genetic testing institution," and added, "The legislative gap or regulatory blind spot was created when the regulation mandating reporting for research-purpose testing companies was deleted in 2013." Rep. Lee also pointed out, "Current law does not restrict the export of biospecimens for genetic analysis or limit the performance of genetic testing overseas," and added, "Even if there is a concern that genetic testing prohibited domestically might be carried out overseas or that domestic genomic information might be exported, there is no legal basis to sanction it." She further pointed out, "Novogene Korea is located in the Korea Association of Health Promotion building. The arrangement appears to be a co-sharing lab model with the tenant. The company has no equipment or personnel for genetic analysis or experimentation. It has six employees, all of whom are administrative or sales staff, and the CEO does not even reside in Korea." Minister Jeong Eun Kyeong promised to verify the allegation.Rep. Lee asked, "I requested the attendance of Novogene Korea's witness, but they submitted a statement of non-attendance. The Association's national genomic big data is clean data of the Korean people. It is highly valuable and risky if leaked, directly affecting the national security of the Republic of Korea. When were you briefed on this?" Minister Jeong replied, "I received a report confirming that Novogene Korea and the Association have a simple lease agreement and no history of information sharing or joint research," and added, "We need to verify how the Association's big data is being shared." Minister Jeong further said, "I will verify the details of whether Novogene Korea receives requests for genomic information analysis from other Korean hospitals or institutions and then sends those samples overseas for testing."
