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- 2025-12-17 23:40:15
- Policy
- Non-reimbursed approvals of off-label drugs
- by Jung, Heung-Jun Oct 29, 2025 06:10am
- The number of non-reimbursed approvals of off-label drugs: while 208 applications for off-label use were rejected, 2,186 were approved between 2020-2025.The number of approvals for non-reimbursed use of drugs beyond their authorized indications (off-label) has been more than 10 times the number of rejections over the past six years. While 208 applications for off-label use were rejected, 2,186 were approved, often because the benefits outweighed the risks. On October 27, the Health Insurance Review & Assessment Service (HIRA) publicly disclosed, for the first time, the number of non-reimbursed approvals for off-label drugs, including over-the-counter (OTC) medicines. Applications for non-reimbursed off-label drug use must first be reviewed by an IRB (Institutional Review Board) established in a hospital or by an academic society. For OTC medicines, HIRA commissions the Ministry of Food and Drug Safety (MFDS) to review safety and efficacy, while anti-cancer drugs are approved by the Cancer Disease Review Committee (CDRC), which holds monthly. Unlike anti-cancer drugs, only the records of rejections for OTC medicines had been disclosed until now. This had been criticized as a problem, making it difficult for healthcare institutions to file applications for off-label non-reimbursed use. There was also a persistent request to disclose approval records for OTC medicines to ensure fairness. HIRA pre-announced a partial amendment to the 'Partial Revision to Operational Regulations for Approval of Non-Reimbursed Off-Label Drug Use' in September and proceeded with public consultation. The newly disclosed approval cases totaled 2,186 from 2020 to the present, broken down as follows: 472 cases in 2020, 572 in 2021, 266 in 2022, 485 in 2023, 276 in 2024, and 115 this year. Meanwhile, a total of 377 rejection cases were disclosed over 13 years, from 2013 to 2025. Specifically, from 2020, when approval cases began to be disclosed, 208 cases were rejected. Examining the trend of rejections by year shows: 33 rejections in 2020, 86 in 2021, 38 in 2022, 44 in 2023, 6 in 2024, and 1 this year. This data indicates a significant reduction in rejection cases over the last two years. The disclosed rejection data for this year includes one additional rejection for Mabthera (rituximab). The application was filed citing expectations that the drug would be more cost-effective, have fewer side effects, and offer higher therapeutic efficacy than alternative drugs. Yet, it was denied because the submitted evidence did not substantiate the claims.
- Policy
- MOHW ‘will support pharma amid U.S. drug tariff plans’
- by Lee, Jeong-Hwan Oct 29, 2025 06:10am
- The Ministry of Health and Welfare (MOHW) has pledged to strengthen support measures for Korean pharmaceutical and biotech companies potentially impacted by the U.S. Trump administration's drug tariff policy. However, no specific policies or systems have been announced yet. The government plans to respond once the details of the U.S. administration's proposed drug tariff measures are announced. The MOHW also stated it is implementing various budget projects to foster and localize the materials, parts, and equipment (MPE) industry, which includes active pharmaceutical ingredients for biopharmaceuticals. This information comes from reviewing the Ministry's response submitted to the National Assembly's Health and Welfare Committee on the 27th for its NA audit. In response to concerns over potential damage from the U.S. plan to impose 100% tariffs on pharmaceuticals, the ministry said, “We will expand measures to strengthen export competitiveness, including financial support and new market development for affected companies.” The ministry explained that while President Trump mentioned plans for a 100% drug tariff, no official government announcement specifying the scope or items subject to the tariff has been made yet. The ministry elaborated, “If high tariffs are imposed, it will inevitably impact exports to the U.S. by domestic pharmaceutical and biotech companies. We need to confirm the details of the U.S. administration's specific drug tariff announcement.” It further announced, “The Ministry of Health and Welfare, together with the Ministry of Trade, Industry and Energy, held an emergency meeting with export companies on September 29 regarding the announcement of pharmaceutical tariffs to gather industry opinions. We will strengthen countermeasures for companies affected by tariffs in the biohealth sector to minimize the impact on domestic companies.” Regarding plans to foster the bio-materials and equipment sector as the “second semiconductor MPE” industry, the ministry emphasized that “this holds high importance from a national health security perspective.” The ministry stated it is supporting companies with costs for performance evaluations, such as testing, analysis, and certification, as well as consulting for overseas approvals, to promote the domestic production of vaccines and raw materials, which Korea is currently heavily import-dependent. For 2024, KRW 2.1 billion was allocated to support performance testing of domestically produced vaccine APIs. The ministry also announced new initiatives for the next year, pledging to continue nurturing the bio-materials and equipment sector. “The government's plan for next year includes new projects for the domestic production of bio raw materials and components, reflecting our ongoing commitment to fostering the bio MPE industry. We will provide support through budgeted projects, including KRW 10 billion for stabilizing the supply of bio raw materials and components, KRW 1.5 billion for diversifying raw material procurement, KRW 500 million for stockpiling essential medicines, and KRW 8.1 billion for advancing the manufacturing of export-oriented pharmaceuticals.”
- Policy
- HIRA “Low-price drug incentive brings ₩2.7 savings'
- by Lee, Jeong-Hwan Oct 29, 2025 06:10am
- The Health Insurance Review and Assessment Service (HIRA) defended its position regarding the argument against the ‘low-price drug purchase incentive’ payment system, stating that the system has consistently contributed to national health insurance cost savings. However, it acknowledged that improvements are needed regarding the unresolved issue of incentives being disproportionately concentrated on medical institutions at the general hospital and tertiary hospitals. HIRA's policy is to expand the cost-saving effect on the health insurance budget by devising a plan to allow hospital-level medical institutions and primary care clinics to participate in the low-price drug purchase incentive system. On the 26th, HIRA disclosed this plan regarding the low-price purchase incentive to the office of Representative Joo-young Lee of the Reform Party, Rep Lee raised concerns about the systemic contradictions and low effectiveness of the low-price drug purchase incentive policy. The low drug price purchase incentive system provides incentives to medical institutions based on the difference between the actual purchase price of drugs and the upper limit set for drug costs. Ultimately, this policy incentivizes lowering the actual transaction price of drugs in the market relative to the NHI drug price ceiling. This directly leads to reductions in the actual transaction prices of drugs, affecting pharmaceutical companies' cash cows. Rep Lee believes this incentive system hinders the development of the domestic pharmaceutical industry and diminishes the cost-saving effects of the national health insurance program because it focuses on price rather than drug quality. The pharmaceutical industry and drug wholesalers also argue that the low-price purchase incentive system is inherently flawed because it is linked to reductions in the actual transaction price of drugs. Critics argue that the lower the actual transaction drug price becomes for low-price purchase incentives, the more directly it leads to subsequent reductions in actual transaction drug prices, discouraging all from voluntarily lowering drug prices. Medical institutions have long pointed out that for small and medium-sized hospitals, neighborhood clinics, and pharmacies—not tertiary hospitals—the actual volume of low-price purchases is small, resulting in a low perceived incentive effect. In response to Rep. Lee's criticism that the low-price purchase incentive system is ineffective and undermines drug quality, HIRA stated, “It has the effect of reducing national health insurance finances.” HIRA explained that the low-price purchase incentive program was introduced to motivate healthcare institutions to purchase low-priced drugs and manage drug costs appropriately. It further elaborated, “The financial savings effect through this system is being sustained, as evidenced by the steady influx of new institutions participating in each round.” In fact, new institutions accounted for an average of 31.5% of all institutions receiving low-price purchase incentives recently. The low-price purchase incentive program has reduced national medical expenses by KRW 2.7012 trillion over the past decade, yielding annual savings of approximately KRW 200 to 300 billion. While recognizing the financial benefits, HIRA also admitted that the incentives are concentrated on medical institutions at the general hospital level or above, noting that improvement is needed to ensure fairer participation. HIRA concluded, “Since institutions with strong purchasing power, such as general hospitals, receive most of the incentives, we will seek ways to encourage participation from smaller hospitals and clinics, thereby contributing to the appropriate management of drug costs in Korea.”
- Policy
- How did CPAC evaluate Wegovy's adolescent indication?
- by Lee, Tak-Sun Oct 28, 2025 06:13am
- The Ministry of Food and Drug Safety (MFDS)'s Central Pharmaceutical Affairs Council (CPAC) meeting report on the approval of Wegovy (semaglutide, Novo Nordisk) for a 12-and-above adolescent indication has been released, garnering attention. While CPAC members generally acknowledged the need for the adolescent obesity indication for Wegovy, they agreed that stringent post-marketing safety monitoring is required. The MFDS recently added Wegovy's indication for use as an adjunct to chronic weight management in adolescents aged 12 and older. Wegovy can now be used for obese adolescent patients aged 12 or older with an initial Body Mass Index (BMI) corresponding to the adult threshold of 30 kg/m2 or higher, and whose body weight exceeds 60 kg. The CPAC advisory report, held on July 24, was released on that day. Nine of the twelve members who attended the meeting unanimously agreed on the validity of the efficacy and safety for the adolescent obesity indication. One member stated, "Although there are concerns about misuse and abuse, this is a necessary drug for severely obese adolescents." Another member said, "The adverse events for the GLP agonist class will likely be similar," adding, "Obesity is a disease, and as it is expected to increase, there is a medical necessity." The consensus favored the benefits to patients outweighing concerns about misuse. Another member noted, "While the adult indication includes overweight patients with comorbidities, the adolescent indication is limited to obese patients, which suggests the risk of misuse and abuse might be lower than in adults. However, thorough management in clinical settings appears necessary." Consequently, the MFDS stated it would review the suggestion to include warnings about suicidal ideation in the drug's approval information. In fact, warnings regarding suicidal ideation have been included in the precautions for use. A clause was added to the general precautions stating: "Suicidal behavior and ideation have been reported in clinical trials of other medicines for the treatment of obesity or overweight. Patients receiving this drug for chronic weight management must be monitored for the emergence or worsening of depression, suicidal ideation or behavior, and/or any abnormal changes in mood or behavior. Use of this drug should be discontinued in patients who experience suicidal ideation or behavior. This drug should not be used in patients with a history of suicidal behavior or active suicidal ideation." Furthermore, a plan for post-marketing surveillance (PMS) in adolescents was also approved. The expansion of Wegovy's adolescent indication was primarily driven by the STEP TEENS Phase 3 clinical study. Thiswas a multi-center, randomized, double-blind study involving 201 adolescents aged 12 to less than 18 who were obese or overweight with at least one weight-related comorbidity. The clinical results met the primary endpoint. The percentage change in BMI showed a 16.1% reduction in the Wegovy 2.4mg group (134 patients), compared to a 0.6% increase in the placebo group (67 patients). The percentage of patients achieving 5% or more weight loss, a secondary confirmatory endpoint, was higher in the Wegovy 2.4 mg group (72.5%) compared to the placebo group (17.7%). Additionally, the secondary exploratory endpoint of weight change (kg) showed a 15.3 kg decrease in the Wegovy 2.4 mg group, compared to a 2.4 kg increase in the placebo group. The proportion of patients achieving 15% or more weight loss was also higher in the Wegovy 2.4 mg group (53.4%) than in the placebo group(4.8%). Novo Nordisk Korea stated, "Wegovy is the first GLP-1-based, once-weekly obesity treatment to be approved for adolescents," stressing that it "will improve treatment access for adolescents."
- Policy
- NHIS actively reviews unifying drug price-reduction system
- by Jung, Heung-Jun Oct 27, 2025 06:09am
- The National Health Insurance Service (NHIS) expressed its intent to actively review improvements to unify the timing of various post-market drug price-reduction systems, which are currently applied inconsistently. However, regarding introducing the International Nonproprietary Name (INN) name prescribing, it offered a general response stating that a cautious approach is necessary, requiring social consensus and policy judgment. On the 24th, the NHIS responded so to an inquiry from Rep. Jia Han of the People Power Party regarding the rationalization of the post-market drug price management system. The criticism is that various drug price reduction systems—such as actual transaction price reductions, price-volume agreement negotiations, and reimbursement reevaluation—are applied at different times, causing confusion and unpredictability in the field. The NHIS stated, “The post-listing control system is crucial for sustainable NHIS finances and drug cost management. However, we are aware of concerns that differing application timings between systems hinder predictability in the field.” It added, “In accordance with the Second Comprehensive National Health Insurance Plan, the government is conducting policy research to explore rational improvements to the post-listing control system. The NHIS will actively review and support reasonable improvement measures.” Rep. In-soon Nam of the Democratic Party of Korea inquired about the NHIS's stance on introducing INN prescribing. The NHIS appeared to take a cautious step back, stating it is a matter requiring prudence. The NHIS stated, “While prioritizing patient safety, we need to review limited and gradual adoption centered on essential medicines prone to supply instability, based on feedback from experts, academic societies, and stakeholders. Rep. Nam also inquired about the reasons for opposition from the medical community, such as infringement on doctors' prescribing rights and distrust regarding bioequivalence testing. In response, the NHIS stated, “Given the differing opinions, sufficient discussion among stakeholders and expert review are required. The matter must be approached with social consensus and careful policy judgment.”
- Policy
- "Long-waited patent expiration"…17 Xeljanz generics
- by Jung, Heung-Jun Oct 24, 2025 06:16am
- Product photo of Xeljanz Pfizer Korea's rheumatoid arthritis treatment 'Xeljanz (tofacitinib)' is set to be included on the National Health Insurance reimbursement list next month, joining the market competition. According to the industry on October 23, 12 pharmaceutical companies and 17 items will receive reimbursement coverage as of November 23, the next day after Xeljanz's substance patent expiration. The products to be listed include Daewoong's Xeltofa Tab (5mg, 10mg), Il-Yang Pharms' Ellanz Tab 5mg, Tofacell Tab. Chong Kun Dang's Tofacell Tab (5mg, 10mg), Sam Il's Tofajakt Tab 5mg, SK Chemicals' Tocinib Tab 5mg, Hanlim Pharm's Zekpaz Tab 5mg, HLB Pharma's HLB Tofacitinib Tab (5mg, 10mg), Samjin Pharm's Tofanus Tab (5mg, 10mg), Unimed Pharm's Ziae K Tab 5mg, Alvogen Korea's Gencinib Tab (5mg, 10mg), Whan In Pharm's Tofasiz Tab 5mg, and Genu Pharma's Zakmoon Tab 5mg. Overall, the list includes five high-dosage (10mg) and twelve 5mg items. Chong Kun Dang's Tofacell Tab and HLB Pharma's HLB Tofacitinib 10mg are priced at KRW 10,859, positioning them at the highest ceiling price. Of these 5mg items, SK Chemicals' Tocinib Tab and Hanlim Pharm's Zekpaz received a high ceiling price estimation of KRW 7,697. Low-dosage items were approved for ▲rheumatoid arthritis ▲psoriatic arthritis ▲ankylosing spondylitis ▲ulcerative colitis, whereas high-dosage items were approved for ulcerative colitis only. A total of 68 items have received approvals. As several generic drugs are set launch and be included in the reimbursement list, the market for Xeljanz is expected to become more intense. According to UBIST, Xeljanz's sales last year amounted to KRW 14.4 billion, up 8.3% from the previous year's KRW 13.3 billion.
- Policy
- NA presses for reimb of Vyloy, Imjudo, Yescarta
- by Jung, Heung-Jun Oct 24, 2025 06:14am
- The National Assembly directly mentioned drugs for severe diseases like Vyloy, Imjudo, Yescarta, and pressed the Ministry of Health and Welfare to promptly grant the drug’s reimbursement expansions. The Ministry responded, “We will expedite the process,” which is expected to act as a tailwind for HIRA's reimbursement decision discussions. In written inquiries on the 22nd, lawmakers In-soon Nam, Myung-ok Seo, and Bo-yoon Choi each called for broader and faster access to high-cost treatments for severe diseases. Rep. In-soon Nam of the Democratic Party of Korea stated, “The government promised in its last presidential election pledge to reduce patient burdens through strengthened early diagnosis and treatment for severe disease patients, along with rapid coverage listing,” and inquired about plans for priority coverage of CAR-T therapy used as second-line treatment in blood cancers. The MOHW responded, “Yescarta applied for reimbursement as a second-line treatment last August, and the Health Insurance Review and Assessment Service (HIRA) is currently processing the decision on reimbursement eligibility. We will expedite the process for determining reimbursement eligibility for blood cancer treatments.” Rep Myeong-ok Seo of the People Power Party asked the Ministry about its commitment to pursuing reimbursement for targeted therapies for advanced or metastatic gastric cancer. The MOHW stated, “Vyloy applied for reimbursement this July as a first-line treatment for CLDN18.2-positive, HER2-negative advanced or metastatic gastric cancer. HIRA is currently processing the decision on reimbursement eligibility,” and expressed its intent to expedite the process. Rep. Bo-yoon Choi of the People Power Party inquired whether there are plans to expand the reimbursement evaluation method for the liver cancer treatment Imjudo. The criticism was that the current system, centered on periodic cost comparisons by treatment cycle, does not sufficiently reflect the unique characteristics of single-dose, one-shot treatments. In response, the MOHW stated, “The company applied for reimbursement in March, and HIRA is currently processing the decision on its reimbursement eligibility. In September, HIRA’s Drug Reimbursement Evaluation Committee raised the need to review the drug cost comparison criteria, and we are currently reviewing the details.”
- Policy
- "Will establish preferential pricing for drug R&D"
- by Lee, Jeong-Hwan Oct 23, 2025 06:12am
- Minister of Health and Welfare Jeong Eun Kyeong Minister of Health and Welfare Jeong Eun Kyeong is drawing attention after stating, "It is necessary to reform the pharmaceutical company compensation system through a drug pricing system linked to R&D investment. The Ministry will prepare measures to improve the drug pricing system." Minister Jeong also promised, "The Ministry will prepare multi-faceted support measures, including finance, tax, and human resources, for domestic pharmaceutical companies, including those designated as Innovative Pharmaceutical Companies." Regarding plans to reduce drug prices through the Re-evaluation of Foreign Drug Prices and the Reimbursement Appropriateness Re-evaluation, Minister Jeong acknowledged the following: the high level of domestic generic drug prices compared to major overseas countries, and the need for appropriate drug price management within limited National Health Insurance finances to ensure optimal drug coverage. She responded, "The Ministry will review drug price management after consulting with citizen groups, patient organizations, the pharmaceutical industry, and academic societies to ensure fair management and acceptance." Minister Jeong made these statements on October 22 in response to written inquiries during the parliamentary inspection from Democratic Party Representatives Nam In-soon and Lee Kai Ho, and People Power Party Representative Suh Myeong-ok. Rep. Nam and Rep. Suh pointed out the necessity of drug price incentives to encourage domestic pharmaceutical companies' New Drug R&D investment. The Ministry of Health and Welfare stated that the pharmaceutical and bio-industry is a national strategic industry and that national-level investment expansion is needed for it to become the next growth engine. In particular, the Ministry agreed on the need to reform the drug pricing system and compensation structure to strengthen the reward for the innovative value of new drugs and incentivize R&D investment, aiming to foster pharmaceutical companies with global new drug development capabilities. Minister Jeong stated, "We will prepare drug pricing system improvement measures after gathering opinions from industry experts and academic societies." She added, "We will comprehensively review the sound growth of the pharmaceutical and bio-industry and the sustainability of National Health Insurance finances by closely examining the status of domestic and foreign drug pricing systems, policy improvement areas, and global trade situations, while considering social acceptance." Regarding plans to foster domestic pharmaceutical and biotech companies, Minister Jeong explained, "The government has established three core tasks to achieve the vision of making Korea a global top 5 nation in the K-BIO and Pharmaceutical sector," and added, "We will shift to consumer-oriented regulations, accelerate innovative growth by linking technology, human resources, and capital, and support the co-growth of anchor and biotech companies to strengthen global competitiveness." Minister Jeong further stated, "We plan to establish detailed implementation plans for each task through consultation with relevant ministries and will execute follow-up measures without fail, reviewing opinions gathered from forums," and added, "We will improve the Innovative Pharmaceutical Company Designation System to reflect changes in the industry ecosystem. We will support the strengthening of domestic companies' competitiveness through field-centered workforce training and support programs for attracting overseas talent." Regarding the push for the Re-evaluation of Foreign Drug Prices and the Reimbursement Appropriateness Re-evaluation, Minister Jeong gave a principled answer, stating that the Ministry will consider industry opinions during the review process. Minister Jeong said, "Drug expenditure in Korea continues to increase due to the growing number of elderly and chronic disease patients." She added, "Domestic generic drug prices are high compared to major overseas countries. We will reasonably manage drug prices after listing by gathering feedback from the field, including the pharmaceutical industry." She concluded, "The Ministry is currently conducting the reimbursement appropriateness evaluation for eight APIs this year," and added, "We are preparing a fairer and systematic implementation plan based on the results of the five-year re-evaluation effort. We will review it after sufficient consultation to ensure social acceptance."
- 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.”
