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- 2025-12-18 06:00:32
- Policy
- Cost of cell&gene therapies for clinical patients set
- by Lee, Jeong-Hwan Apr 10, 2025 05:56am
- The government has set out to create standards for the 'cost of clinical trial drugs' to be used as an indicator when giving patients expensive cell and gene therapy drugs at the clinical trial stage. This is to rationally calculate the cost that patients must pay when they are administered investigational drugs for therapeutic purposes. The government plans to look at the cost calculation methods for investigational drugs that are in operation overseas, such as in the US and Europe, and analyze the current state of the system in Korea to create cost standards for each detailed item of investigational drugs. On the 8th, the Korea Institute of Drug Safety & Risk Management announced that it would begin research on establishing a standard for the cost of investigational drugs. The current Pharmaceutical Affairs Act stipulates that drugs in the clinical trial stage can be used for therapeutic purposes. The problem is that there is no reasonable standard for pricing drugs that must be charged to patients, as the manufacturing costs of cell therapies and gene therapies are often high. This is because there are various detailed items that are included when calculating the cost according to the characteristics of each drug, such as cell therapy and gene therapy. The cost of investigational drugs is the price minus the cost of facility and environmental management and research and development and refers to the cost directly incurred in the manufacture of investigational drugs used for individual patients. The KIDS will investigate the cost calculation methods for investigational drugs that are being used in overseas countries such as the US and Europe to establish the cost calculation standards for patient claims for investigational drugs, and examine the cost calculation details when claiming the cost of investigational drugs for therapeutic use in domestic clinical trials. The cost calculation method will also be analyzed by comparing the cases when importing investigational drugs and domestic contract manufacturing drugs. KIDS will also seek to discover the specific cost calculation items used for cell therapies and radiopharmaceuticals that take into account their characteristics, such as the manufacturing process of pharmaceuticals. Based on this, KIDS plans to prepare a detailed cost standard for each item used to calculate the price of investigational drugs. KIDS explained, “We will study whether detailed items such as raw material costs, material costs, labor costs, manufacturing expenses, and quality inspection costs should be included in the cost calculation of manufactured drugs. We will consider the purpose of the cost stipulated in the Prime Minister's Decree on the Pharmaceutical Affairs Act & Regulation on Safety of Drugs.” It added, “We will also look at the details of the raw material costs, such as whether the raw material is autologous or allogeneic, the type of source, such as blood, cord blood, skin, or adipose tissue, and the method of collection, such as surgery or blood collection. The goal is to establish standards that can be used by suppliers of investigational drugs when calculating costs.”
- Policy
- Health and Welfare Committee meeting may not be held in APR
- by Lee, Jeong-Hwan Apr 08, 2025 05:57am
- The Constitutional Court sentenced former President Suk Yeol Yoon to dismissal at 11:22 a.m. on the 4th, setting the stage for an early presidential election. The election date must be announced by Acting President Duck-Soo Han within 10 days of the president's impeachment. This means that the date of the early presidential election will be confirmed before the 14th of this month. The National Election Commission announced that it would begin accepting registrations for the 21st presidential election on the 4th, immediately after the Constitutional Court decided to cite the impeachment motion. The dismissal of the president has made it difficult for the National Assembly's standing committees to hold meetings. The secretaries of the ruling and opposition parties of the NA’s Health and Welfare Committee are likely not to hold a standing committee meeting in April. First, the National Election Commission announced the method of registering as a preliminary candidate, the campaigning method, and the taboo acts. A person who wants to become a preliminary candidate must submit to the National Election Commission documents certifying eligibility, such as a family relationship certificate, a document certifying criminal record, and a certificate of formal education, and pay a deposit of KRW 60 million (20% of the KRW 300 million deposit required of candidates). Assuming that all 60 days of the early presidential election period are used, the official candidate must register by the 10th to 11th of next month. The winner of the early presidential election will immediately begin his or her term without going through the Presidential Transition Committee. A prospective candidate may set up an ▲election office, ▲distribute campaign business cards, ▲create and send out promotional materials to no more than 10% of the total number of households in the country, ▲wear or carry a sash or sign, and ▲publish and sell (except through door-to-door sales) one copy of a prospective candidate's campaign pledge book in the usual way. Even if they are not a candidate or an election official, those who are allowed to campaign can do so at any time by sending text messages, posting on websites, or sending e-mails, and can campaign by phone or in person on days other than the election day. However, in order to conduct election campaigns by sending text messages through automatic mass communication or by entrusting an email transmission agency to send emails, one must register as a candidate or a candidate-to-be. Automatic mass communication is a method of sending messages to more than 20 recipients at the same time or to fewer than 20 recipients by automatically selecting recipients using a program. As the grounds for the presidential impeachment election confirmed, in accordance with Article 90 of the Public Official Election Act, it is not possible to install or post banners or other facilities that specify the name of a political party or the name, photo, or content that can be inferred from the name of a candidate (including a person who is seeking to be a candidate) to influence the election. The National Assembly is also likely to refrain from holding standing committee meetings this month. This is because the early presidential election has a greater weight than the holding of a standing committee meeting for the examination or processing of the bills under its jurisdiction. First of all, the Health and Welfare Committee is likely to not hold a Legislative Subcommittee and plenary session on its bills in April. An opposition member of the Health and Welfare Committee said, “With the early presidential election confirmed, there is a high probability that the bill review under the jurisdiction of the Health and Welfare Committee will be delayed. Although an agreement between the ruling and opposition party secretaries is necessary, I don't think the subcommittees on bills that were normally held during peacetime will be held.”
- Policy
- Pemzayre, high-priced drug post-management system candidate
- by Lee, Tak-Sun Apr 08, 2025 05:56am
- Handok 'Pemzayre Tab,' Handok's bile duct cancer (cholangiocarcinoma) treatment, is expected to be subjected to the post-management system for high-priced drugs. Pemzayre Tab is likely to be added to the reimbursement list in May. Consequently, a submission system for evaluating treatment outcomes as part of the post-management evaluation will be established. According to industry sources on the 7th, Pemzayre passed the Health Insurance Review and Assessment Service (HIRA's) Drug Reimbursement Evaluation Committee (DREC) in January. The company is negotiating with the National Health Insurance Service (NHIS) for drug pricing negotiations. Considering the 60-day drug pricing negotiations period, Pemzayre will likely to be added to the reimbursement list in May. This drug is the first targeted drug in South Korea with cholangiocarcinoma indication. Pemazyre is indicated for patients with locally advanced or metastatic who have FGFR2 gene fusions. Pemzayre has been in used the United States, Europe, and Japan. If it is reimbursed, this drug will be used in adult patients with locally advanced or metastatic cholangiocarcinoma who have FGFR2 gene fusions or rearrangements and have undergone one or more systemic therapy. Based on its anatomical origin, cholangiocarcinoma is classified into intrahepatic cholangiocarcinoma (iCCA), arising from bile ducts within the liver, and extrahepatic cholangiocarcinoma, developing from bile ducts outside the liver. Because this cancer is frequently diagnosed at an advanced stage with a poor prognosis, there is a critical unmet need for targeted therapies. FGFR2 fusion or rearrangements are known to be found in 10-16% of patients with iCCA. In recognition of this urgency, the Korean Ministry of Food and Drug Safety (MFDS) designated this as an orphan drug in November 2021. The MFDS granted marketing approval via expedited review in April 2023. Following approval, the drug quickly entered the reimbursement procedure. After successfully establishing reimbursement criteria in August last year and passing the DREC review in January this year, its chances of inclusion in the National Health Insurance system have markedly increased. However, pricing remains a significant issue. The product, which contains 14 tablets per package, has a supply cost of approximately US$19,000 per product. Given that the treatment course may extend for up to 42 days, its reimbursement could significantly burden health insurance expenditures. Accordingly, the government is expected to manage this drug under the "High-Priced Drugs Reimbursement Management Criteria." Currently, six drugs, Kymriah, Zolgensma, Spinraza, Yescarta, Luxturna, and Tecartus, are subject to these criteria. The criteria for high-priced drugs include ▲Newly listed with high prices and uncertain cost-effectiveness that require further verification ▲Incur substantial annual per capita expenditures, or generate annual health insurance claims that could severely impact the national health insurance budget ▲Expected to provide long-term benefits from a single administration, necessitating additional safety confirmation and long-term evaluation ▲Based on their impact on healthcare, deemed necessary for management. Once a drug is designated as a target under the high-priced drug post-management system, a post-administration response evaluation must be conducted, and the resulting data must be submitted. Based on this data, the HIRA will then perform performance evaluations and ongoing monitoring of treatment effectiveness. If a drug is under patient-based performance risk-sharing agreements, the NHIS will use it to calculate drug reimbursement amounts.
- Policy
- Bylvay to be redeliberated for reimbursement in Korea
- by Lee, Tak-Sun Apr 07, 2025 05:51am
- Ipsen Korea’s Bylvay Cap, which has been undergoing an accelerated listing process as the first drug included in the pilot project for the parallel operation of the approval-benefit evaluation-drug price negotiation system, has failed to receive recognition as being eligible for reimbursement by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). However, DREC’s result - 'redeliberation - has allowed the company to reattempt review at the next DREC meeting. HIRA announced on the 3rd that it will hold the 4th 2025 DREC meeting and redeliberate the reimbursement of Bylvay Cap. Ipsen Korea’s Bylvay Cap is a drug used to treat pruritus in patients with progressive familial intrahepatic cholestasis (PFIC), and it has attracted attention as the first drug selected for the pilot project for the parallel operation of the ‘approval-assessment-negotiation linkage’ system. The pilot project for the parallel operation of the ‘approval-assessment-negotiation linkage’ system was introduced to shorten the period from drug approval to reimbursement, and as the name suggests, the approval, evaluation, and negotiation process for a single drug is carried out all at once to shorten the period of listing. However, the evaluation stage has slowed down the process. The reimbursement of another drug included in the pilot project, Qarziba Inj, was also once delayed at the DREC review stage. Qarziba has been reimbursed by health insurance since December last year, but Bylvay has yet to pass the DREC review process. Last month, HIRA said that it was conducting an in-depth review of the clinical usefulness and cost-effectiveness of Bylvay after gathering the opinions of relevant experts and academic societies, saying that an assessment of the adequacy of reimbursement was underway. Some academics have expressed concern that not only is the speed of listing Bylvay Cap problematic but that the indications under reimbursement review are also narrow. On this day, the results of the deliberation on the Leqvio pre-filled syringe (inclisiran, Novartis Korea), which was on the agenda with the Bylvay Cap, showed that the reimbursement was appropriate if the company accepted an amount lower than the assessed amount. Accordingly, if Novartis accepts the assessed amount, the matter will move on to the negotiation stage with the National Health Insurance Service.
- Policy
- Gov’t works to stop the shortage of essential drugs
- by Lee, Jeong-Hwan Apr 07, 2025 05:50am
- The government will come up with improvement measures within this year to eradicate and alleviate the instability in the supply of national essential drugs, which has been occurring frequently since the COVID-19 pandemic. The government plans to begin the groundwork for overhauling the entire system, including the method for designating national essential drugs, the operation of the council of relevant government ministries and agencies, and government policy support and preferential measures for stable supply. This is done by examining the current status of the essential drug systems in major countries overseas and seeking ways to improve the stability of supply based on an analysis of the current status of Korea’s operation of the essential medicine system. On the 6th, the Ministry of Food and Drug Safety announced that it would begin research on ways to collaborate on the classification and stable supply of essential medicines. This is a response to the growing risk of health security crises and the increasing frequency of shortages of essential drugs such as cold medicines that arose as countries around the world have adopted a national drug policy centered on their own countries since the COVID-19 pandemic. Since 2017, the government has designated and managed drugs that are essential for medical sites such as disease control and radiation disaster prevention, and therefore must be supplied stably as national essential medicines. The Minister of Health and Welfare and the Minister of Food and Drug Safety designate the essential medicines in consultation with the heads of relevant central administrative agencies. However, as front-line pharmacies are constantly experiencing difficulties in obtaining essential medicines, citizens are repeatedly unable to purchase essential drugs such as cold medicine and fever reducers when they need them. The Ministry of Food and Drug Safety examines the purpose of the essential medicine system in advanced pharmaceutical countries and investigates the classification method by type, such as the nature of the product and its intended use. The plan is to look into the current state of the system, including the selection criteria, procedures, and collection of advisory opinions, and analyze the current use of policy support and preferential measures for the stable supply of essential medicines, as well as the current state of operation of organizations such as selection and advisory councils and committees. Based on this, the research team will seek direction for the advancement of Korea's national essential drug policy. As the number of national essential medicines that were first designated around government stockpiles has gradually increased to include items that require a stable supply in the private medical field, the overall goal is to find improvement measures that reflect the characteristics of each national essential medicine. Afterward, the government will prepare a plan to improve the criteria for designating national essential medicines, review the classification plan by use, and come up with a plan to reorganize the list, as well as an operational plan to maintain its suitability in the field. The research will comprehensively review the necessity of each product in the product group when designating and re-evaluating national essential medicines. In addition, it will consider the need to distinguish the system from similar systems and review the scope of designation and exclusion of national essential medicines. Ultimately, it will establish a plan for reorganizing and operating the Stable Supply Council and Sub-Council to facilitate discussions on the designation of national essential medicines and stable supply. The MFDS explained, “We will identify the government policy tools and the collaboration needs with relevant ministries and agencies that can be used to enable the council to determine and implement policies for the stable supply of essential medicines. We will also identify the improvements needed to strengthen the capacity to support the stable supply of national essential medicines, and find ways to strengthen the human and material infrastructure for this.”
- Policy
- COVID-19 Vaccine Damage Compensation Act passes NA
- by Lee, Jeong-Hwan Apr 04, 2025 05:58am
- A special law that compensates and supports patients who have suffered damage after COVID-19 vaccination was passed at the plenary session of the National Assembly on the afternoon of the 2nd. Also, a partial amendment to the Framework Act on Health and Medical Services, which includes the establishment of a Health and Medical Manforce Planning Estimation Committee under the direct control of the Minister of Health and Welfare, passed the plenary session along with the special act. The National Assembly passed the 'Special Act on Compensation for Damage Caused by COVID-19 Vaccination' with 263 in favor and 2 abstentions out of 265 members present. The Act on the Medical Manpower Planning Committee was passed at the plenary session with 247 in favor, 11 against, and 8 abstentions out of 266 members present. The Special Act expands the scope of vaccine damage compensation, such as by presuming that there is a causal relationship if the temporal correlation between COVID-19 vaccination and the disease occurrence is proven. The government has been administering vaccinations and providing state compensation in accordance with the current Infectious Disease Control and Prevention Act. However, the need for the Special Act was raised as there were indications that the damage caused by COVID-19 vaccination was not being properly compensated, due to limited causality of the damage being accepted. The Special Act, which passed the plenary session, was passed by the National Assembly Health and Welfare Committee in January with consensus from the ruling and opposition parties. The Medical Manpower Planning Committee Act, which will deliberate the number of medical school enrollees from 2027, has also passed the National Assembly, but it is unlikely to serve as a clue to resolve the conflict between the government and the medical community in Korea. The amendment proposes the establishment of the Medical Manpower Planning Committee, an independent deliberation body under the direct control of the MOHW, to deliberate on the estimation of medical personnel by job type. The committee members will consist of no more than 15 experts recommended by medical provider representative organizations, consumer representative organizations, and relevant academic societies, with the majority of the members recommended by providers, such as the Korean Medical Association (KMA), and the chairman of the committee will be elected from among the members recommended by the academic community. In addition, the revised act ensures the independence of the committee and ensures transparency by disclosing the minutes and reference materials, and the appointment of a Medical Manpower Planning center to ensure the professionalism of the planning work. When the committee estimates the size of the medical personnel required, the Health and Medical Services Policy Deliberation Committee, chaired by the Minister of MOHW, will then determine the number of medical school students.
- Policy
- First RSV vaccine Arexvy to soon be released in Korea
- by Lee, Hye-Kyung Apr 01, 2025 05:52am
- With the release date of the first RSV (respiratory syncytial virus) vaccine in Korea confirmed the MFDS has also set a fee for its national lot release approval. GSK Korea announced that it will launch the RSV-LRTD vaccine ‘Arexvy’ in May. Once the pharmaceutical company releases the vaccine, full-scale vaccination is expected to become possible from June. Arexvy is the first RSV vaccine in Korea approved by the Ministry of Food and Drug Safety in December last year for the purpose of preventing lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and over. According to industry sources on the 1st, the MFDS also set a national lot release approval fee for the first supply of RSV vaccine in Korea. According to the “Partial Amendment to the Notification of Fees for Permits for Medicines, etc.,” the MFDS has set a national lot release approval fee upon the approval of a new type of biological drug. The new fees have been set at KRW 895,000 for electronic civil services and 995,000 won for in-person and mail civil services for respiratory syncytial virus vaccines (recombinant). National Lot Release is a process in which the MFDS comprehensively evaluates the results of the MFDS's inspection and the manufacturer's manufacturing and testing results for each manufacturing lot of a biological drug to once more ensure that the quality of the biological drug is verified before it is released on the market. Last year, the government agreed on the need to consider the introduction of RSV vaccines into the NIP (National Immunization Program). In a written inquiry during the National Assembly's audit last year, the Korea Disease Control and Prevention Agency said, “Currently, there are no RSV vaccines approved in Korea,” and “We will closely monitor the situation, including the MFDS's approval, related research, and overseas trends, and consider the need to introduce it into the NIP ahead of its domestic approval through expert consultations.” According to the medical community, the number of patients hospitalized for LRTD due to RSV in Korea last year was about 11,000, which is not a small number, and the condition is even more fatal for the elderly and infants. When adults are infected with RSV, they may have no symptoms or recover after experiencing cold-like symptoms, but in the case of the elderly with weak immunity, it can lead to pneumonia, chronic obstructive pulmonary disease, and congestive heart failure. Although Arexvy is the first RSV vaccine to be commercialized in Korea, Pfizer's Abrysvo and Moderna's mRESVIA are awaiting MFDS approval.
- Policy
- KPBMA proposes 'drug shortages·API·AI new drug' budget
- by Lee, Jeong-Hwan Apr 01, 2025 05:52am
- Amid both ruling and opposition parties discussing the allocation of a supplementary budget plan, the Korean pharmaceutical industry has begun requesting a supplementary budget for two key initiatives: the "Production Support Business for Drugs with Supply Instability" and the "Direct Support Business for the Production of Active Pharmaceutical Ingredients." In particular, the industry requested increased funding to train professionals and build infrastructure for AI-driven new drug development. The industry proposes a supplementary allocation of approximately KRW 32.05 billion for this fiscal year alone. On March 31, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) submitted a supplementary budget request to the National Assembly, which includes the budget for stabilizing the drug supply chain and supporting AI-developed new drugs. Specifically, the Korean pharmaceutical industry is seeking KRW 900 million to support production companies managing supply instability and KRW 2 billion for direct support to companies producing active pharmaceutical ingredients. For AI-developed new drugs, the proposal outlines KRW 150 million for education and promotional activities, KRW 17 billion for establishing an automated research facility aimed at discovering innovative new compounds, and KRW 12 billion for establishing a virtual AI new drug research center. ◆Reinstating a previously reduced budget of KRW 900 million for drugs in short supply=an allocated budget of KRW 900 million for production support of pharmaceuticals of supply instability is intended to support one additional pharmaceutical company to abolish the issue of drugs in short supply. Although a large-scale pharmaceutical shortage has been resolved, the requested budget aims to prevent sporadic events of individual pharmaceutical shortages. The budget is intended to overcome shortages of essential medications, including compounding acetaminophen, general cold remedies, as well as drugs for motion sickness, constipation, hypertension, and pediatric cold medications, to prevent further disruptions in patient care. Initially, the budget for supporting supply was set at KRW 1.8 billion but was later cut by KRW 900 million. The final allocation is set as KRW 900 million. The KPBMA maintains that reinstating the reduced KRW by 900 million and potentially increasing it is necessary to add one designated pharmaceutical company and support facilities·equipment. ◆API Production Support=a KRW 2 billion budget increase has been requested to boost the domestic production of active pharmaceutical ingredients (APIs). Requests have been made to allocate a budget to improve the self-sufficiency rate of domestically produced APIs. Following the COVID-19 pandemic, the reliance on imported raw materials has risen significantly, raising concerns about potential disruptions in domestic drug production and supply. The KPBMA insists that although the government has implemented preferential pricing for drugs using domestic raw materials, API manufacturers still report that the policy’s benefits have not been fully realized. The KPBMA calls for budget allocations to support the expansion of core production facilities, maintenance of equipment, and workforce training. Furthermore, a supplementary budget of KRW 2 billion is being proposed to establish a monitoring system for the stockpiling·statistical tracking of frequently used APIs. ◆Requesting supplementary budget of an additional KRW of 29.15 billion for AI new drug discovery=A supplementary budget proposal requests an additional 150 million AI new drug discovery related to AI-based new drug development education·promotion. This budget aims to train interdisciplinary professionals for utilizing AI-based digital technology for new drug development. This budget aims to train field-ready professionals who can be immediately deployed to new drug development using AI-based digital technology. It is expected to support establishing and operating Korea’s only AI new drug development education platform (LAIDD), coupled with project-based problem-solving training. Through top-tier project mentoring from leading experts across academia, industry, and research, the program aims to nurture professionals capable of addressing complex challenges in drug discovery. Amid rapid digital transformation of the bio-health sector and accelerated progress in AI new drug development, demand for advanced IT-BT interdisciplinary talent has surged. Because this area lacks comprehensive training programs, the KPBMA has proposed addressing this issue. ◆Building AI-automated Autonomous Data Lab (ADL)=The KPBMA has proposed a supplementary budget request of KRW 12 billion to establish and deploy an AI-automated new drug research center, Autonomous Data Lab (ADL), for this year. The lab will be built to utilize AI agents with specialized expertise and proactive thinking in various new drug development fields, aiming to boost the efficiency of domestic new drug development. The total project cost is set at KRW 51 billion, to be allocated KRW 17 billion for stage 1 this year, KRW 17 billion for stage 2 in 2026, and KRW 17 billion for stage 3 in 2027. The budget reflects on the synthesis process for candidate compounds with enhanced pharmacological properties in early-stage drug development. Synthesis process is a high-cost and high-value-added area. Recent advances in AI have enabled the development of synthesis design and optimization technologies, which have further evolved into autonomous laboratory systems when combined with robotics. The proposal aims to promote the domestic adoption of these technologies. ◆A virtual AI new drug research center=The KPBMA has proposed a supplementary budget request of KRW 12 billion to establish and deploy a virtual AI new drug research center. This center will use AI agents with specialized expertise and proactive thinking in various new drug development fields, aiming to boost the efficiency of domestic new drug development. The total project cost is set at KRW 36 billion, to be allocated over three years from this year through 2027. The KPBMA proposed that while adopting AI technology is essential for enhancing Korea’s new drug development competitiveness, there remains a shortage of AI experts with the specialized knowledge required for drug research. The KPBMA states that technological advancement allows AI to conduct new drug research independently without additional staffing. Thus, establishing a virtual AI new drug research center that can be integrated throughout the entire drug development process may be needed.
- Policy
- Advanced biodrugs subject to reimb eval before approval
- by Lee, Jeong-Hwan Mar 31, 2025 05:59am
- 'Advanced biopharmaceuticals' will be added to the group of drugs that can receive drug reimbursement evaluations before receiving the government's official marketing authorization. The revision comes into effect from April 1st. On the 28th, the MOHW announced this through a notice of the product groups subject to the approval - insurance drug price evaluation linkage system. The current laws and regulations only allow the linkage between approval and evaluation of insurance drug prices for new drugs and orphan drugs in accordance with the Regulations on Approval and Review of Pharmaceutical Products, the Regulations on Approval and Review of Biological Products, and the Regulations on Approval and Review of Herbal Medicinal Preparations (Raw Drugs). The MOHW has decided to apply the approval-insurance drug price evaluation linkage system to advanced biopharmaceuticals based on the ‘Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ starting next month. As a result, companies with advanced biopharmaceuticals can now apply for drug reimbursement evaluations for their respective products before marketing authorization by submitting a copy of the manufacturing (import) item license as the safety and efficacy review report notified by the Ministry of Food and Safety. The approval-insurance drug price evaluation linkage system is one of the fast-track reimbursement systems for medicines implemented by the government to improve patient access to new drugs.
- Policy
- "Will maintain stability of essential·short supply drugs"
- by Lee, Jeong-Hwan Mar 28, 2025 06:39am
- The government will reportedly provide necessary administrative support for a stable supply of essential drugs and medications and improve the system so that innovative new drugs and new medical devices can quickly introduced into medical practices. Preferential pricing for national essential drugs that use domestically sourced raw materials will be implemented in the first half of this year. In contrast, the government will continuously increase the prices of drugs that are in supply instability. For innovative new drugs, specific innovation criteria will be applied during cost-effectiveness evaluations, and the policy of offering preferential pricing for drugs developed by companies with a high proportion of R&D investment will be maintained. Additionally, detailed timelines have been established for initiatives aimed at ensuring fair compensation for essential medical services and for innovating non-reimbursable and private insurance to safeguard the sustainability of the National Health Insurance budget. On May 27, the Ministry of Health and Welfare (MOHW) convened the 6th Health Insurance Policy Review Committee for 2025. It reviewed and approved this year’s implementation plan under the '2nd National Health Insurance Comprehensive Plan (2024–2028).' Maintaining stability of essential drugs·providing preferential pricing of innovative new drugs The government will continue to ensure a stable supply of essential medicines and therapeutic materials while improving the regulatory system to enable the rapid market entry of innovative new drugs and medical devices. To secure supply stability, the government will implement preferential pricing to nationally essential drugs that use domestically sourced raw materials, and drugs with supply instability will have their prices promptly increased continuously. In addition, a system for monitoring, analyzing, and addressing shortages of therapeutic materials will be established. Establishment of monitoring·analyzing materials of supply instability and response measures For innovative new drugs, cost-effectiveness evaluations will incorporate specific innovation criteria (revised on August 2024). Drugs developed by pharmaceutical companies with a high R&D investment ratio will receive preferential pricing. Innovative medical devices that have undergone an extended deferment period and rigorous clinical evaluation and have subsequently received MFDS approval will be allowed immediate market entry. The government will also expand the access to and use of National Health Insurance data for public interest research, scientific studies, and self-directed health management while supporting international cooperation through organizations such as the WHO and OECD in matters related to health insurance systems and initiatives. Enhancing the Supply of Essential Medical Care·Ensuring Fair Compensation To eliminate low-reimbursement structures and address overall imbalances in health insurance fees, more than 1,000 fee items for surgeries, procedures, and anesthesia will receive targeted increases by the first half of this year. In particular, fees in high-difficulty areas and resource-intensive, such as pediatric and emergency services, will be significantly raised, with rapid adjustments planned for over 2,000 low-reimbursement items by 2027. Furthermore, the cost survey framework will be strengthened by establishing a fee-determination system linked to conversion indices and relative value scores, developing standardized cost-calculation guidelines, and expanding the panel hospital network. Reimbursement for high-difficulty medical procedures, such as additional age-based fees for pediatric surgery, will be reinforced, and public policy fee support for maintaining maternity care infrastructure will continue. The performance of pilot projects for alternative payment systems, which offer differential reimbursement based on the quality and outcomes of care rather than volume, will be evaluated, with ongoing efforts to sustain their implementation. Closing medical care access gaps and ensuring a healthy life To provide uninterrupted healthcare, long-term care, and support services across each region's acute, recovery, and chronic phases, the government will strengthen local medical institutions and expand integrated healthcare and care support. To establish a regionally comprehensive essential healthcare system, the government will provide support to key regional hospitals—such as national university hospitals and general hospitals—through funding for faculty salaries (KRW 26 billion) and for facilities and equipment (KRW 81.5 billion), as well as low-interest loans of KRW 120 billion for any additional necessary resources. These measures aim to enhance institutional capacity, expand the infrastructure for recovery-phase healthcare institutions, and reinforce long-term care support systems (including nursing and caregiving services) in preparation for an aging society. Efforts to promote routine health management to prevent complex and chronic diseases will be strengthened, with additional support provided in high-demand areas such as mental health, women's and pediatric care, and end-of-life care. Moreover, ongoing measures will continue to strengthen the healthcare safety net to address underserved areas. The government will strengthen the healthcare safety net to close access gaps. This includes the ongoing promotion of pilot projects for primary care for individuals with disabilities and in dental care, as well as the expansion of reimbursement for treatments targeting severe and rare diseases (with 20 new items expected to be added and the reimbursement scope broadened for 10 additional items), all designed to enhance access to healthcare for vulnerable populations and alleviate their financial burdens. Enhancing the financial sustainability of National Health Insurance The National Health Insurance system will be fostered sustainably by managing medical supply by ensuring adequate hospital beds, installing·operating high-quality medical equipment, and encouraging appropriate healthcare utilization through demand management. Non-reimbursable services and indemnity insurance management will also be strengthened to promote appropriate healthcare usage. For non-reimbursable services prone to overuse, measures such as applying managed reimbursement and requiring pre-service explanations and informed consent will be enforced. Reimbursement for non-reimbursable services related to cosmetic or plastic surgery will be limited, especially if provided alongside reimbursable services. Furthermore, to rationalize the co-payment coverage under private insurance and prevent distortions in the healthcare system, non-reimbursable services will be appropriately covered. At the same time, review processes are strengthened and transparency is enhanced. Moreover, financial management transparency will be boosted by expanding the disclosure of financial indicators, such as fund operation status (March) and financial settlement status (May), publishing annual five-year financial forecasts, and enhancing the accuracy of short-term forecasts, all aimed at improving the overall management framework. The MOHW stated, "Through the '2nd National Health Insurance Comprehensive Plan (2024–2028), we plan to reach a goal for strengthening essential medical care and establishing sustainable National Health Insurance," adding, "We will also integrate these initiatives with the '2nd Healthcare Reform Implementation Plan' and other reform projects and effectively implement."
