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- 2026-06-10 21:10:43
- Policy
- Keytruda reimb extended… estimated claims of KRW 2 trillion
- by Jung, Heung-Jun Jan 14, 2026 09:31am
- While coverage has been strengthened with the expansion of reimbursement this month of the immuno-oncology drug Keytruda (pembrolizumab), the reimbursement expansion is expected to generate a record-high projected claims amount of KRW 238.4 billion, lighting warning signals for the management of Korea’s National Health Insurance finances.At the end of last year, the Ministry of Health and Welfare announced estimates that approximately KRW 1 trillion would be saved through its drug pricing system reform.However, when viewed in terms of net financial impact, the increase in claims for this single drug now accounts for roughly 20–25% of the savings generated from price cuts on listed generics.This is why calls are growing for stronger post-listing control, as more multi-indication blockbuster drugs enter Korea’s reimbursement system.According to industry sources on the 13th, the estimated reimbursement claims for MSD Korea’s immuno-oncology drug Keytruda represent the largest amount ever recorded, exceeding the KRW 2.2 trillion recorded for Paxlovid.This reflects the significant impact the drug is expected to have on national health insurance finances. Previously, Keytruda had been reimbursed for four cancer types, including non-small cell lung cancer. However, starting this year, reimbursement has been expanded to cover 17 regimens across nine cancer types, including head and neck cancer.The number of patients covered is expected to gradually increase from 3,258 to 6,680. Accordingly, the projected claim amount is expected to rise from KRW 178.8 billion in the first year to KRW 238.4 billion.In 2022, Keytruda successfully expanded coverage for first-line treatment of non-small cell lung cancer, among other indications. At that time, the Ministry of Health and Welfare estimated annual claims of KRW 1.762 trillion.Since then, Keytruda, which already generates annual sales exceeding KRW 400 billion as a single product, has continued to expand its reimbursement coverage, growing its market presence.The fact that coverage, previously concentrated on NSCLC, now extends to various cancer types, including female cancers, is welcome news for patients. However, the burden on health insurance finances is inevitably growing.The NHIS also states it will strengthen post-monitoring in consideration of the financial impact. As similar cases are expected to increase gradually, it is also contemplating enhanced post-approval management measures.An NHIS official said, “For new drugs with expanded reimbursement coverage, post-management is conducted through the price-volume linkage system. While other institutions may also have financial management measures in place, NHIS is considering additional post-management strategies as well.”
- Policy
- MFDS approves Servier’s Voranigo Tab in KOR
- by Lee, Tak-Sun Jan 14, 2026 09:31am
- The Ministry of Food and Drug Safety (MFDS, Minister Yu-kyoung Oh) announced on the 13th that it has approved Servier’s imported orphan drug ‘Voranigo Tab (vorasidenib) 10mg·40mg.’This drug is indicated for the treatment of Grade 2 astrocytoma or oligodendroglioma that have a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) gene mutation in pediatric and adult patients aged 12 years and older weighing at least 40 kg, following surgery, including biopsy, major resection, or complete resection.A biopsy refers to the procedure in which a portion of tissue or cells is collected and examined under a microscope for diagnostic purposes.IDH (Isocitrate Dehydrogenase) mutations cause the abnormal production of excessive metabolic substances (2-HG), which promote the growth and survival of cancer cells.Astrocytoma and oligodendroglioma are types of gliomas, tumors arising from glial cells in the brain and spinal cord. Gliomas are a major category of brain tumors.Voranigo is an IDH-targeted therapy that inhibits mutated IDH1 and IDH2, thereby reducing the production of the carcinogenic substance 2-hydroxyglutarate (2-HG) and suppressing tumor cell proliferation. The Ministry of Food and Drug Safety expects the new approval to provide a new treatment opportunity for patients with brain tumors that are positive for IDH1 or IDH2 mutations.
- Policy
- Reimb re-evaluation active ingredient results to be unveiled
- by Jung, Heung-Jun Jan 14, 2026 09:31am
- The announcement of active ingredients subject to this year's reimbursement re-evaluation is expected to change slightly from the previously mentioned seven ingredients. This is due to changes in the re-evaluation selection criteria.According to industry sources on the 14th, an agenda regarding the 2026 reimbursement re-evaluation is scheduled to be tabled at tomorrow's Drug Benefit Evaluation Committee (DBEC) meeting.Furthermore, the re-evaluation selection criteria are expected to be discussed. The criteria regarding the number of countries where the drug is listed and the scale of the claimed amount will be removed. Ingredients that need re-evaluation of their clinical usefulness are expected to be included.When the government announced the drug price system reform plan last November, it pre-announced a restructuring of the criteria to include: ▲ active ingredients for which health authorities in A8 countries have initiated clinical or reimbursement adequacy re-evaluations ▲ cases where data or clinical evidence conflicting with previously reported efficacy has been published ▲ medications for which the necessity of re-evaluation has been suggested by academic societies and experts.This means that instead of classifying by listing countries or claim scale as in the past, active ingredients assessed to require a review of clinical usefulness will be designated for re-evaluation.The Health Insurance Review and Assessment Service (HIRA) is expected to listen to the opinions of institutions and academic societies and further strengthen its monitoring role regarding changes in claiming trends.If the reimbursement re-evaluation criteria are revised after passing through the DBEC and the Health Insurance Policy Review Committee, the preparation of additional procedures, such as an expert advisory committee for reviewing ingredient designation, is also anticipated.Additionally, the results of the reimbursement re-evaluation will be simplified to either "reimbursement exclusion" or "selective reimbursement." This means that the breakthrough of maintaining reimbursement through voluntary drug price cuts by pharmaceutical companies will no longer exist.If clinical adequacy cannot be proven, it is expected to lead to either an exit from insurance coverage or a change in patient co-payments.The seven ingredients discussed as targets for this year's re-evaluation at last year's HIPDC subcommittee were Ginkgo biloba leaf dried extract, dobesilate calcium hydrate, kallidinogenase, meglumine gadoterate, diacerein, Afloqualone, and octylonium bromide.Because the reimbursement re-evaluation criteria are changing, some fluctuations are expected in the seven ingredients selected based on the previous criteria. Meanwhile, this DBEC meeting is the first since the replacement of the 10th-term members. The committee has launched with 74 members, including Professor Seung Hyuk Choi of Samsung Medical Center, Professor Kim Seong-hwan of Seoul St. Mary's Hospital, Professor Seh-Hyon Song of Kyungsung University College of Pharmacy, and Professor Hyunah Kim of Sookmyung Women's University College of Pharmacy.
- Policy
- Three-month import suspension for Pfizer’s Prevnar 20
- by Lee, Tak-Sun Jan 13, 2026 06:58am
- Pfizer’s pneumococcal vaccine ‘Prevnar 20 Prefilled Syringe’ is subject to a three-month import suspension in Korea.The administrative action was imposed for importing and selling products that differed from the product specifications and standards described in the marketing authorization.On the 12th, the Ministry of Food and Drug Safety (MFDS) announced that it will suspend the import operations of Prevnar 20 Prefilled Syringe (Pneumococcal Diphtheria CRM197 Protein Conjugate Vaccine) for three months, from today through April 11.The MFDS explained that the action was taken because the company imported and sold products that differed from the product standard and specifications described in the marketing authorization.In June last year, the MFDS issued a safety letter and temporarily suspended the use of Prevnar 20 products that were supplied with injection needles that did not match the approved specifications.The vaccine is designed to be administered by attaching the enclosed needle to the syringe. While the approved needle length is 25 mm, the enclosed needles supplied were shorter, at 16 mm.At the time, the action was taken shortly after the product had entered the market. The current administrative penalty is understood to be a follow-up action based on the results of that investigation.Prevnar 20 is Pfizer’s first new pneumococcal vaccine in 14 years. It adds seven serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, 33F) to the existing Prevenar 13 vaccine.
- Policy
- Lee administration’s bio-industry support plan revealed
- by Kang, Shin-Kook Jan 12, 2026 03:58pm
- The government is launching large-scale investment and policy support for the bio industry this year as part of its efforts to restore economic growth and secure future growth engines.On January 9, the government held the 2026 National Economic Growth Strategy Public Briefing at the Chungmu Room of the Blue House, presided over by President Jae-myung Lee, where it finalized and announced this year’s national growth strategy.Under the bio-industry development policy, the government will establish a National Bio Innovation Committee under the Prime Minister and announce a provisional Bio Industry Policy Roadmap in the first quarter of this year.President Jae-myung Lee is attending the 2026 National Economic Growth Strategy Public BriefingThe National Bio Innovation Committee will integrate and operate the National Bio Committee (chaired by the President) and the Bio-Health Innovation Committee (chaired by the Prime Minister).To support new drug development and commercialization, the government will expand regulatory review staff and accelerate approval timelines for medical products, while simplifying clinical trial and data submission procedures.The government's plan is to reduce the current approval review periods—420 days for new drugs, 406 days for biosimilars, and 398 days for new medical devices—to 240 days. Furthermore, criteria for exempting biosimilars from Phase III trials will be established this year.Comprehensive support measures covering finance, R&D, regulation, and location will also be implemented to help bio companies expand their global reach. First, ‘Bio Sector Mega Project’ will be established and promoted through the National Growth Fund. R&D support will also be provided for the entire lifecycle (development-clinical trials-approval) of advanced medical devices in six promising fields (medical robots, implants, etc.).Support for open innovation will be expanded to promote joint technology development between pharmaceutical companies and biotech ventures. The government will also pursue the enactment of a provisional Digital Healthcare Act to enhance the use of healthcare data and will upgrade existing bio-health clusters, such as advanced medical complexes, through infrastructure sharing and joint research.Furthermore, it will apply regulatory exemptions for data utilization to AI bio innovation hubs and establish a National Bio Data Integration System to lay the groundwork for data sharing and utilization. To this end, it will also push for the enactment of the proposed Bio Data Act.
- Policy
- Max ICER for cancer drugs exceeds KRW 50 million
- by Jung, Heung-Jun Jan 09, 2026 08:36am
- As a result of cost-effectiveness evaluations of drugs submitted for economic assessment, the median incremental cost-effectiveness ratio (ICER) for anticancer drugs has remained relatively stable at around KRW 40 million over the past 10 years.However, over the last four years, the maximum ICER has exceeded KRW 55 million, suggesting that the ICER threshold is declining depending on the drug.According to the 'Cost-effectiveness results of drugs submitted for pharmacoeconomic assessment' released by the Health Insurance Review and Assessment Service (HIRA) on January 8, the median ICER for anticancer drugs has not fluctuated significantly, even after the acceptance limits were raised in 2014.Median ICER values for anticancer drugs: The median ICER for anticancer drugs from 2014 to 2021 was KRW 45.32 million. For the 2018–2022 period, it was KRW 39.99 million; for 2019–2023, KRW 39.93 million; and for 2020–2024, KRW 42.94 million.Since 2022, HIRA has announced the median, minimum, and maximum ICER values for general drugs, anticancer drugs, and orphan drugs across four reporting cycles.The median ICER for anticancer drugs from 2014 to 2021 was KRW 45.32 million. For the 2018–2022 period, it was KRW 39.99 million; for 2019–2023, KRW 39.93 million; and for 2020–2024, KRW 42.94 million.overlapping periods, the median ICER for anticancer therapies is consistently in the low-to-mid KRW 40 million range.Notably, the maximum ICER value, which had never previously exceeded KRW 50 million, surged to KRW 55.36 million in the 2020–2024 data. This suggests that the authorities are flexibly recognizing the cost-effectiveness of essential anticancer drugs and strengthening coverage.Maximum ICER values for anticancer drugs.The anticancer ICER data for 2020–2024, announced last month, covers eight active ingredients. The drugs that broke through the KRW 50 million ceiling are likely those subject to 'flexible threshold application,' such as Enhertu or Trodelvy, before and after innovative ICER standards were introduced.Given the timing and pricing, Enhertu, a targeted therapy for breast cancer, appears to be the most likely candidate for the record-high maximum value.Upward trend of ICER values over the past decade is also observed in orphan drugs. Specifically, the minimum ICER for rare disease drugs has increased sharply. This reflects the growing prevalence of high-priced orphan drugs compared to the past.The minimum ICER for rare disease drugs rose from KRW 23.16 million (2014–2021) to KRW 39.97 million (2020–2024). The cost-effectiveness of orphan drugs is now approaching KRW 40 million, with a strong upward trajectory.In the 2020–2024 ICER evaluation results, the median for orphan drugs was not disclosed because it included only three rare disease drug active ingredients, which could have led to the identification of specific products.
- Policy
- AZ’s gMG candidate ‘gefurulimab’ receives GIFT designation
- by Lee, Tak-Sun Jan 09, 2026 08:36am
- AstraZeneca's ‘gefurumab,’ its new drug candidate for myasthenia gravis, has been selected for fast-track review support by Korea’s Ministry of Food and Drug Safety (MFDS).This designation is expected to accelerate its commercialization.On the 5th, the MFDS announced that AstraZeneca’s gefurulimab had been designated as the 63rd product under the GIFT (Global Innovative product on Fast-Track) program.GIFT is a fast-track review program operated by the MFDS since September 2022 to provide patients with new treatment opportunities through expedited product development support.Products eligible for GIFT designation include drugs for life-threatening diseases, rare diseases with no existing treatment alternatives, and innovative new drugs developed by certified innovative pharmaceutical companies.The MFDS designates GIFT products through a comprehensive evaluation of factors such as innovative therapeutic benefit, contribution to public-health crisis response, and the developer’s R&D efforts.Selection into GIFT reduces the review period by at least 25% (from 120 working days to 90 working days).This is achieved by applying a rolling review process, where submitted data are reviewed first, and close communication between reviewers and developers, which is facilitated through product briefings and supplementary explanations. Additionally, companies receive various supports for rapid commercialization, such as specialized regulatory consulting.AstraZeneca announced positive results last July from the Phase III PREVAIL trial, which evaluated the use of gefurulimab in adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG). Gefurulimab met the primary endpoint and all secondary endpoints in the trial.Gefurulimab is a terminal complement inhibitor that selectively binds to both complement protein C5 and serum albumin. It is a novel bispecific nanobody drug candidate optimized for self-administered subcutaneous injection to treat anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG).Generalized myasthenia gravis is a chronic autoimmune neuromuscular disorder, a rare disease causing muscle function loss and severe muscle weakness.Gefurulimab has been favorably evaluated for its convenience, as it allows once-weekly self-administration, compared with existing treatments for adult myasthenia gravis, such as Ultomiris and Soliris.AstraZeneca Korea's status as a Korean Innovative Pharmaceutical Company influenced gefurulimab’s selection for the GIFT program.This drug has not yet received approval from advanced overseas regulatory agencies such as the US FDA, Europe’s EMA, or Japan’s PMDA. The Ministry of Food and Drug Safety (MFDS) applied its fast-track review program ahead of these overseas agencies.However, the US FDA has designated this drug as an orphan drug and is providing support. The MFDS also designated this drug as a development-stage orphan drug this month.To date, 49 of the drugs designated as GIFT have received marketing authorization.
- Policy
- Plan to waive Phase 3 for comb therapies for HTN and DYS
- by Lee, Tak-Sun Jan 08, 2026 07:31am
- Ministry of Food and Drug Safety (MFDS)The Ministry of Food and Drug Safety (MFDS) has announced an exemption for Phase 3 clinical trials of combination therapies targeting hypertension and dyslipidemia, provided the components do not mutually interfere with efficacy or safety. This exemption is also expected to extend to triple-combination therapies that include diuretics.However, the MFDS explained that Phase 3 data will be waived only if meta-analysis data confirm that treatments for hypertension and dyslipidemia do not affect each other’s therapeutic effects or safety profiles.The MFDS has prepared a revision to the 'Guidelines for Clinical Trials of Combination Drugs' and is collecting industry feedback through January 13.The new addition outlines a plan to rationalize data submission requirements for developing combination drugs intended for comorbid conditions, organized in a Q&A format within the guidelines.According to the guidelines, the MFDS stated, "Regarding combination drugs for the treatment of comorbid hypertension and dyslipidemia, we have determined that therapeutic confirmatory clinical trials (Phase 3) can be exempted for specific drug classes based on the results of meta-analysis performed on accumulated domestic clinical trial data."The MFDS added, "To date, hypertension + dyslipidemia combinations developed in Korea have primarily consisted of ARBs (Angiotensin II Receptor Blockers) or CCBs (Calcium Channel Blockers) for hypertension, and Statins or Ezetimibe for dyslipidemia," and explained," Meta-analysis of previously submitted clinical results indicate that these hypertension and dyslipidemia treatments do not mutually affect therapeutic efficacy or safety."Based on these findings, the MFDS has finalized a policy to exempt therapeutic confirmatory clinical trial data for companies developing combination drugs composed of ARB or CCB and Statin or Ezetimibe. Nevertheless, the MFDS noted that even within these classes, toxicological patterns or pharmacokinetic profiles may vary by specific active pharmaceutical ingredient (API).The MFDS explained that a therapeutic confirmatory clinical trial may be requested in some cases because the toxicity profile and pharmacokinetics may vary depending on APIs. The MFDS stated, "Developers must present a review of the impact on safety and efficacy based on trial data regarding absorption, distribution, metabolism, and excretion (ADME), as well as pharmacokinetic drug-drug interaction studies," the MFDS added. "If significant drug-drug interactions are observed in pharmacokinetic studies and are judged to potentially affect safety or efficacy, a therapeutic confirmatory clinical trial may be requested."Regarding triple-combination drugs that include a diuretic in addition to these two components, the MFDS explained that while Phase 3 data submission is the general rule, exemptions are possible under specific conditions.The MFDS stated, "For hypertension-dyslipidemia combinations containing drugs in addition to the mentioned classes (e.g., diuretics), therapeutic confirmatory clinical trials must be submitted as before. However, if meta-analysis data for the specific drug class being developed confirms that the hypertension and dyslipidemia treatments do not influence each other's efficacy and safety, the requirement for Phase 3 data may be waived."In cases where the combination includes a new drug ingredient or involves changes to dosage and administration, additional safety and efficacy data will be required. The MFDS advised, "If a new drug is included in the proposed combination or if it deviates from the approved labeling (dosage, administration, etc.) of the individual treatments, additional safety and efficacy evaluations may be necessary," and added, "We encourage companies to consult with the Ministry in advance."
- Policy
- ImmuneOncia, Merck, and Bayer receive orphan drug designation
- by Lee, Tak-Sun Jan 07, 2026 08:46am
- Three new drug candidates, including ImmuneOncia's lymphoma treatment candidate danverstotug, have been designated as orphan drugs in Korea.Designation as orphan drugs increases the likelihood of expedited approval through fast-track review, potentially accelerating the commercialization of these products.On January 2, the Ministry of Food and Drug Safety (MFDS) announced the designation of three new drug candidates, danverstotug, mirdametinib, sevabertinib, as orphan drugs.Danverstotug is a novel lymphoma drug candidate being commercialized by ImmuneOncia, Yuhan Corporation's immune-oncology subsidiary.As an immunotherapy targeting relapsed/refractory NK/T-cell lymphoma, it demonstrated efficacy in a domestic Phase II clinical trial, based on which the company applied for orphan drug designation to the MFDS last July.According to the company, the Phase II study in patients with relapsed or refractory NK/T-cell lymphoma who had failed first-line therapy showed an objective response rate (ORR) of 79% and a complete response (CR) rate of 63%.The median progression-free survival (PFS) was 29.4 months, while overall survival (OS) rates were 85% at one year and 78% at two years. Adverse reactions were mostly mild, and 40% of all patients completed the two years of long term treatment.The company has completed the commercial manufacturing technology transfer for this drug to Lonza, a global contract development and manufacturing organization (CDMO). ImmuneOncia aims to launch the drug before 2030.Mirdametinib is a drug used for neurofibromatosis with plexiform neurofibroma that received US FDA approval in February last year. The drug is expected to compete with Koselugo (selumetinib, AstraZeneca), an existing therapy for neurofibromatosis.Mirdametinib was developed by US-based biotech SpringWorks Therapeutics, which was acquired by Merck (Germany) in April last year for USD 3.9 billion.Bayer’s sevabertinib is an investigational therapy for HER2-positive non–small cell lung cancer, an area with limited treatment options. The drug is gaining attention as a potential alternative for patients who do not respond to existing therapies. The US FDA has granted the drug accelerated approval status and is conducting a priority review.When designated as an orphan drug, data submission required for approval is simplified, allowing exemptions from bridging studies, conditional approval, and fee reductions. It also enables a fast-track approval process through priority review. The Ministry of Food and Drug Safety (MFDS) recently relaxed the requirements for orphan drug designation, lowering regulatory barriers. Previously, data demonstrating improved efficacy over existing alternatives was required, but under the revised rules, such data are no longer mandatory for orphan drug designation.
- Policy
- NHIS publicly discloses RSA Refund-type drugs
- by Jung, Heung-Jun Jan 06, 2026 08:25am
- Going forward, fewer patients are expected to miss out on refunds simply because they are unaware of refund-eligible drugs under Korea’s Risk-Sharing Agreement (RSA) system.On the 2nd, the National Health Insurance Service (NHIS) disclosed the “List of Risk-Sharing Refund-Eligible Drugs.” The aim is to improve information accessibility for patients who are prescribed refund-type drugs.There have been demands in the past from the National Assembly for information on refund-type reimbursed drugs. During the NA audit the year before the last, concerns were raised that patients were missing out on reimbursements due to a lack of information.Previously, lists of RSA drugs had been shared with medical institutions for the purpose of supporting patients subject to full out-of-pocket payments. However, this marks the first time the NHIS has directly disclosed the list of refund-type drugs to the general public.An NHIS official stated, “Starting in January this year, we plan to disclose the list of refund-type drugs on a monthly basis. This was a frequent request from patients, and addressing that need is the primary purpose. Following requests from the National Assembly, we reviewed the matter and decided on regular disclosure.”According to the refund-type RSA drug list released by the NHIS, there are 61 drugs under refund-type RSA contracts. These drugs are from 26 multinational companies and 3 domestic companies.When classified by dosage, the number of refund-eligible drug items reaches 112. Among them, AstraZeneca Korea (AZ) accounted for the largest share with 14 items.When categorized by dosage, 11 of the 112 refund-type items are from domestic companies. Multinational companies account for over 90% of the refund-type contract drugs.Domestic companies with refund-type RSA drugs include Yuhan’s Leclaza (lazertinib), JW Pharmaceutical’s Hemlibra (emicizumab), Handok’s Defitelio Inj (defibrotide), Vyxeos Liposomal Inj, and Pemazyre Tab (pemigatinib).Domestic companies are divided into those with domestically developed new drugs and those with overseas new drugs introduced to Korea, where they hold the local marketing rights. Among the refund-type drug list, domestically developed new drugs like Leclaza and multiple new drugs marketed by Handok stand out.Among multinational companies, AZ and Novartis Korea each had the most drugs, with 6 each. When including dosage distinctions, AZ accounted for 14 items.AZ has refund-type contracts for Tagrisso, Lynparza, Imfinzi, Koselugo, Strensiq, and Fasenra, while Novartis’ refund-type drugs include Kymriah, Kisqali, Zolgensma, Luxturna, Ilaris, and Lutathera.Other companies with multiple refund-type drugs include: ▲Pfizer Korea (Ibrance, Lorviqua, Vyndamax Cap, Paxlovid) ▲Eli Lilly Korea (Verzenio Tab, Cyramza Inj, Jaypirca Tab) ▲BMS Korea (Yervoy, Onureg, Camzyos, Inrebic).The reduction in drug expenditure through the RSA refund-type contracts has been largely concentrated on high-priced anticancer drugs and rare disease treatments from multinational pharmaceutical companies.
