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- 2026-04-03 13:34:14
- Company
- Shingrix sales KRW 42B… leads shingles vaccine mkt
- by Nho, Byung Chul Apr 29, 2025 05:56am
- In the shingles vaccine market, the genetically engineered recombinant zoster vaccine Shingrix has achieved sales of KRW 42 billion in just over 3 years since its launch, maintaining its lead in the market for 2 consecutive years. Based on pharmaceutical distribution performance, GSK's Shingrix recorded sales of KRW 360 million, KRW 38.4 billion, and KRW 42 billion in 2022, 2023, and 2024, respectively, leading the market. The sales figures for attenuated vaccines SK Bioscience's SKYZoster and MSD's Zostavax in 2023 were KRW 18.7 billion and KRW 17.4 billion, respectively. Among the two attenuated vaccines, it is noteworthy that the later-launched SKYZoster surpassed Zostavax’s sales, which was launched 8 years earlier. Zostavax was approved by the MFDS in April 2009, and SKYZoster in September 2017. As the first-ever vaccine to receive FDA approval, Zostavax maintained its position as the only shingles vaccine available in the domestic market from its launch until SKYZoster was released. However, its lead has been threatened by the launch of the recombinant zoster vaccine Shingrix, a strong competitor. In 2023, it even fell behind SKYZoster, a later-generation attenuated vaccine, further losing its market position. In 2023, SKYZoster generated sales of KRW 26.2 billion, surpassing Zostavax by KRW 3.9 billion. Nevertheless, the market trend is shifting from first-generation attenuated vaccines to second-generation genetically engineered vaccines, resulting in a significant decline in the performance of first-generation vaccines. Zostavax's sales plummeted from KRW 43.2 billion in 2020 to KRW 17.4 billion in 2024. During the same period, SKYZoster’s sales also plummeted from KRW 29.1 billion to KRW 18.7 billion. Attenuated vaccines and genetically engineered vaccines exhibit stark differences in terms of advantages and disadvantages, which serve as a key determinants in sales growth. Zostavax and SKYZoster are attenuated vaccines that weaken the virulence of the virus. It has a preventive efficacy of around 60–70% in people aged 50–60 and offers high convenience as a single dose. However, their preventive efficacy decreases with age, potentially dropping to 30% in those over 70. Genetically engineered vaccines, which create antigens similar to the virus, pose no risk of infection. It demonstrates strong preventive efficacy, with a protection rate of 97.4% in those in their 60s and 91.35% in those in their 70s, achieving over 90% protection across all age groups. In addition, its safety has been demonstrated in clinical trials targeting individuals aged 18 and older with weakened immune systems, making it suitable for administration to those with compromised immunity, such as cancer patients or organ transplant recipients.
- Opinion
- [Reporter's View] Enhanced GMP reg for sterile drug products
- by Lee, Hye-Kyung Apr 28, 2025 05:55am
- Starting December 27, production·good manufacturing practices (GMP) regulations for sterile medicinal products produced by aseptic processing will be strengthened. The Ministry of Food and Drug Safety (MFDS) amended the 'Regulations on Good Manufacturing Practices (GMP) for Medicinal Products' in 2023. The revision had been conducted to modify the production·good manufacturing practices (GMP) regulations for sterile medicinal products following the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) ahead of the reevaluation by the PIC/S. The guidelines state the establishment of contaminant management methods through GMP regulations and the latest sterile manufacturing equipment and technology. However, considering all pharmaceutical companies to have adequate preparation time to establish contaminant management methods, the MFDS announced the implementation of the regulations on sterile medicinal products two years after the notification. Companies must establish a contaminant management strategy for sterile medicinal products starting in December and undergo risk assessment for PIC/S regulations and gap analysis. To accomplish these tasks, manufacturing plants' divisions must begin working together 1-2 years before implementing the regulations. Research and related technology investments are needed to prepare for the 'Pre-Use Post Sterilization Integrity Testing (PUPSIT).' Until now, manufacturing companies that have not established contaminant management strategies will not be able to meet the standards for strengthened GMP measures starting in December. Due to this update, manufacturing companies with old manufacturing equipment announced suspending their productions. Several companies, including Pharma I, Pharma B, Pharma G, Pharma D, Pharma A, and Pharma K, have reported to the MFDS. These companies anticipated replacing old equipment following the PIC/S would cost billions in Korean won. Therefore, they resorted to switching to CMO and discontinuing injectable line facilities that do not generate profits compared to investments due to low reimbursement ceiling caps. In fact, there were calls for facility investment costs and pricing support even during the briefings held for manufacturers ahead of the revision of the sterile medicinal products GMP regulation. However, the MFDS believed that the 2+1-year grace period would give manufacturers sufficient time to adapt, and it did not introduce any additional support measures. As the regulation’s enforcement date approaches, companies are beginning to withdraw from injectable production, and organizations such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) have stepped in to survey the state of the industry. There are currently approximately 110 aseptic-preparation manufacturers in South Korea. Of these, about 10% have already announced plans to suspend production. If many manufacturers shut down their facilities simultaneously before the implementation date, there could be a shortage of injectable products. If this includes designated National Essential Medicines, the crisis could escalate uncontrollably. Instead of pointing to the fact that the MFDS already completed briefings, public comment, and a grace period during the regulation revision process, it needs to listen to what manufacturers require. Related parties must jointly consider support measures for aseptic‐preparation companies, such as assistance with developing contamination‐control strategies and options like price increases for injectable products. There will inevitably be challenges in securing new personnel or installing new facilities under the new system, such as freeze dryers and sterilization equipment.
- Policy
- Will Enhertu be reimb for HER2-low cancer in Korea?
- by Whang, byung-woo Apr 28, 2025 05:55am
- Results of the deliberation on the reimbursement expansion of the new antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) for HER2-low breast cancer and lung cancer are drawing attention. Pic of Enhertu According to industry sources, the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee (CDDC) is scheduled to hold a meeting on the 30th to review 2 additional indications for Enhertu. The indications under review are ▲HER2-low metastatic breast cancer and ▲HER2-mutated non-small cell lung cancer (NSCLC). If the reimbursement expansion is approved, this is expected to expand treatment access for breast cancer and lung cancer in Korea. Both indications were approved by the Ministry of Food and Drug Safety in May last year based on the DESTINY-Breast04 and DESTINY-Lung02 clinical studies. Notably, the trials demonstrated the efficacy of Enhertu in HER2-low breast cancer, where treatment options were previously for HER2-negative status patients, and marks the emergence of the first and only targeted therapy for HER2-mutated lung cancer. Additionally, Enhertu has expanded its indication to include HER2 ultra-low expression in the United States by the FDA, suggesting its potential as a new standard treatment option for patients with metastatic breast cancer across the entire spectrum of HER2 expression, including HER2-positive, HER2-low, and HER2 ultra-low expression breast cancer. The main point of the CDDC review was also focused on how to evaluate Enhertu's efficacy in HER2-low expression breast cancer, where existing HER2-targeted therapies have shown limited efficacy, despite the significant improvement in treatment outcomes for HER2-positive breast cancer achieved by existing HER2-targeted therapies. Previously, HER2-positive breast cancer was defined as “HER2-positive if IHC 3+ or IHC 2+ and ISH-positive, and HER2-negative if IHC 0, IHC 1+, or IHC 2+ and ISH-negative.” Joohyuk Sohn. Professor of Medical Oncology at Yonsei Cancer Center, said, “With the domestic approval of Enhertu's indication for HER2-low metastatic breast cancer, patients previously classified as HER2-negative with limited treatment options now have a new treatment option. This is expected to further improve the treatment landscape for HER2-positive metastatic breast cancer in Korea.” Enhertu is the first anti-HER2 agent to demonstrate treatment benefits in HER2-low metastatic breast cancer, redefining the definition of HER2-low and presenting a new paradigm for metastatic breast cancer treatment. Another key point is that patients with HER2-low breast cancer account for nearly half - approximately 45% to 55% - of all breast cancer patients. Additionally, HER2-low breast cancer accounts for approximately 60% of HER2-negative breast cancer cases. Apart from the benefits of Enhertu, this means that the financial burden on health insurance due to the large number of patients would also likely need to be taken into consideration to a certain extent. If reimbursement is expanded to include indications such as HER2-low breast cancer and HER2-mutated non-small cell lung cancer, this is expected to increase Enhertu’s insurance claims amount significantly. This is why there are industry views that the reimbursement expansion will depend on the financial sharing plan proposed by the pharmaceutical company. However, when Enhertu was listed for reimbursement in Korea last April as a treatment for HER2-positive metastatic breast cancer and gastric cancer, the government had flexibly applied the ICER threshold to grant its reimbursement. In March, Daiichi Sankyo reportedly applied for and held a drug briefing session on Enhertu’s use in HER2-mutated non-small cell lung cancer. Drug information briefing sessions were introduced in 2010 to enhance the transparency and objectivity of evaluations by facilitating mutual sharing of information between pharmaceutical companies and reviewers regarding new drugs. Daiichi Sankyo also utilized this system during the initial approval of Enhertu. Enhertu was jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. In South Korea, it is co-developed and promoted by Daiichi Sankyo Korea and AstraZeneca Korea, with distribution handled by Daiichi Sankyo Korea.
- Company
- Hemophilia A drug 'Obizur' available at major hospitals
- by Eo, Yun-Ho Apr 28, 2025 05:54am
- Product photo of Obizur Obizur, a treatment for acquired hemophilia A, is now available for prescription at general hospitals. According to industry sources, Takeda Korea's 'Obizur (susoctocog alfa),' a treatment for acquired hemophilia A (AHA) in adult patients, has passed drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul St. Mary's Hospital, and Sinchon Severance Hospital, and other medical institutes, such as Kyung Hee University Medical Center and Seoul National University Bundang Hospital. Obizur has consistently expanded prescription areas since its inclusion on the insurance reimbursement list in March. Obizur was designated Korea's orphan drug in July 2021, and it was considered for reimbursement evaluation immediately after obtaining domestic approval in March. Under the AHA indication, this drug restores the missing coagulant VIII, unlike existing medications designed to bypass it. A recombinant product was created by removing the B-domain from porcine coagulation factor VIII, which is highly homologous to the human protein. Because autoantibodies less readily recognize it, it can substitute for inactivated human factor VIII, aiding coagulation and helping to control bleeding. Through this mechanism, it is the only AHA therapy whose factor-VIII levels can be reliably monitored by the standard assay, enabling individualized dosing. Meanwhile, in a prospective, nonrandomized, open-label Phase 2/3 study evaluating the efficacy of Obizur in 28 patients with AHA, all participants treated with the product demonstrated a positive response for every initial bleeding episode at the 24-hour assessment. Positive response was defined as cessation or reduction of bleeding accompanied by clinical improvement or factor-VIII activity exceeding target levels. At the final dosing assessment (within two weeks of administration), the overall treatment success rate was 85.7% (24/28 patients), with higher success rate observed in those receiving it as first-line treatment. The patient group who received Obizur as a first-line treatment achieved a 94% success rate (16/17 patients), while the second-line patient group showed a 73% success rate (8/11 patients). No serious adverse events or deaths related to the product were reported.
- Company
- 'Early diagnosis·3 combo therapy·tolerance' for COPD Tx
- by Whang, byung-woo Apr 28, 2025 05:54am
- "With South Korea entering a super-aged society, the number of patients with chronic obstructive pulmonary disease (COPD) will continue to rise. As the population ages, early detection and treatment to prevent high-risk patients from worsening are critically important." At the end of last year, the Korean COPD treatment guidelines were revised for the first time in six years, simplifying patient classification and adding blood eosinophil count criteria to treatment-strategy establishment. The aim was to simplify the guidelines compared with the previous version, making treatment more straightforward in clinical practice. The initial treatment strategies now categorize patients into low-risk and high-risk groups. Dr. Yong Bum Park, Professor of the Pulmonary Department at Kangdong Sacred Heart Hospital (chair of the COPD guidelines revision committee), emphasized the need for appropriate treatment approaches and policy improvements in response to the growing COPD patient population. COPD is a condition in which abnormalities occur in the 'airways' necessary for breathing or in the alveoli at the lung periphery, influenced not only by smoking but also by indoor and outdoor air pollution, occupational hazards, and genetic factors. Dr. Yong Bum Park, Professor of the Pulmonary Department at Kangdong Sacred Heart Hospital Korea's National Health and Nutrition Examination Survey shows that approximately 13% of the population aged 40 and over has COPD. With an aging population, it is reported that one in two men aged 65 and above in Korea suffers from COPD. Dr. Park explained, "Although COPD prevalence appears high at 12%, according to Health Insurance Review & Assessment Service (HIRA) criteria, at most 5% have been diagnosed with COPD, and of those, fewer than 2% are registered as patients and managed in hospitals." Therefore, the most critical aspect of COPD treatment is early diagnosis. For this reason, the Korean Academy of Tuberculosis and Respiratory Diseases has proposed to the government that pulmonary function testing be included in the national health screening program. It has been pointed out that if treatment is initiated at an advanced stage of the disease, more medications will be required, increasing not only the individual burden due to exacerbations but also the overall national burden. In fact, a domestic study estimated the socio-economic burden of COPD patients at approximately KRW 1.4 trillion. Dr. Park said, "The socio-economic burden reaches about KRW 1.4 trillion for patients receiving care in hospitals alone, which is a substantial burden. I believe it is crucial to detect these patients early." Even though COPD carries a significant socio-economic burden once diagnosed, the general public remains poorly informed about the disease, making early diagnosis through national screening necessary. Dr. Park emphasized, "If pulmonary function testing were implemented as part of the national health screening, it would detect COPD and all conditions associated with impaired lung function, such as asthma or pulmonary fibrosis. With early diagnosis, patients with symptoms can receive pharmacotherapy or preventive measures, such as vaccinations, management of risk factors like smoking, and rehabilitation through exercise, to halt disease progression and exacerbations." Guidelines for COPD treatment were revised after six years…has been simplified categorizing patients from three patient groups to low-risk‧high-risk patient groups Not only in Korean but also in global COPD guidelines, pulmonary function testing is specified as essential for diagnosis. In December 2024, the domestic COPD guidelines were revised for the first time in six years, simplifying patient classification and adding a blood eosinophil count criterion to inform treatment strategy for promptly managing diagnosed patients. While the previous 2018 guidelines classified COPD patients into three groups based on FEV1 (forced expiratory volume in one second), number of exacerbations in the past year, the mMRC dyspnea scale, and the COPD Assessment Test (CAT), the revised guidelines now categorize patients into only two risk categories, high-risk and low-risk, based solely on the number of exacerbations in the past year. Dr. Park explained, "Over the past 3-4 years, combination therapy with LABA+LAMA is superior to LABA or LAMA monotherapy in terms of quality of life, lung function, symptom improvement, and reduction in exacerbation frequency, reducing the need for multiple low-risk subgroups. Therefore, patients are now categorized into high-risk and low-risk groups, and the initial treatment strategies have been updated accordingly." Although the guideline revision is intuitive, key points are worth highlighting. The revised guidance identifies exacerbation history as a crucial variable and incorporates a blood eosinophil count criterion for medications. As a result, for high-risk patients, if the blood eosinophil count is below 300 cells/㎣, LABA+LAMA combination therapy is recommended. If it is 300 cells/㎣ or higher, triple combination therapy with ICS+LAMA+LABA is advised. Dr. Park noted, "Patients in the high-risk group with a blood eosinophil count of 300 cells per microliter or more are known to respond well to inhaled corticosteroids (ICS), so ICS use is recommended. Notably, triple combination therapy combining ICS+LAMA+LABA into a single inhaler has demonstrated efficacy in reducing mortality, improving lung function, and enhancing quality of life, which is why triple combination therapy is recommended for high-risk patients." "Training is crucial for COPD inhaler treatment…Triple combination therapy offers better drug tolerance" The most common COPD triple combination therapy is Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol). In the IMPACT Phase 3 trial, triple combination therapy with Trelegy reduced the treatment risk of all-cause mortality by 42% compared with LAMA+LABA therapy. In a post-hoc analysis, patients receiving Trelegy triple combination therapy experienced a 38% reduction in on-/off-treatment all-cause mortality risk compared with those on LAMA+LABA therapy. Dr. Park mentioned, "Even in the overall trial results, about half of high-risk patients continue to experience symptoms, exacerbations, and dyspnea despite triple therapy," and added, "Nevertheless, compared with previous medications, the newer triple combination therapies, especially single-device formulations like Trelegy, are much more convenient for patients to use." One of the key issues in COPD treatment is drug adherence. Unlike oral therapies for hypertension or diabetes, COPD treatment relies heavily on inhalers, making patient education and support more challenging. Moreover, improper inhaler technique can reduce efficacy, underscoring the importance of training. Dr. Park said, "Previously, triple combination therapy required two separate inhalers, but now the advantage is that three medications can be delivered evenly through a single device. In patients who had used two devices or LABA+LAMA dual combination therapy, switching to triple therapy improved symptoms and reduced exacerbation rates." Finally, Dr. Park again emphasized the importance of early diagnosis in a growing COPD patient population. "In South Korea, only about 2-5% of patients are currently managed, while the remaining 95-98% are not even aware that they have COPD," Dr. Park added, "Once the disease progresses to severe stages and exacerbations begin, the socio-economic burden increases significantly, so we must establish methods for early COPD diagnosis."
- Policy
- 'Social discussions needed for indication-based pricing'
- by Lee, Jeong-Hwan Apr 28, 2025 05:54am
- Won-Joon Cho, head of the Democratic Party There have been calls for caution regarding the introduction of an “indication-based drug pricing system,” to improve patient access to multi-target anticancer drugs that treat various types of cancer. The concern is that if the insurance drug price for a specific disease among the multiple indications of an anticancer drug increases, the insurance drug price for other diseases may decrease, thereby hindering patient access. Suggestions were also made that it is necessary to discuss whether the introduction of an indication-based drug pricing system is a good alternative, whether expanding the risk-sharing agreement (RSA) is a more realistic option in the short term, or whether other policy approaches are needed, and to go through a process of reaching social consensus. On the 25th, Won-Joon Cho, senior expert on health and welfare policy and head of the Democratic Party's presidential election pledge task force, made the following statement regarding the indication-based drug price system. Recently, a debate on “Eliminating inequality in access to innovative new drugs and improving regulations” was held at the National Assembly, hosted by Democratic Party lawmakers Mi-hwa Seo, Yoon Kim, and Jong-tae Jang and organized by the Korean Research-based Pharmaceutical Industry Association (KRPIA). At the debate, there was a wide argument on how the current single drug pricing system in Korea is limiting patients' access to high-cost anticancer drugs like Keytruda and Opdivo, despite their approval for various indications, and that an indication-based drug pricing system should be introduced to address this issue. Won-Joon Cho noted how certain lung cancer treatments have over 30 indications and that he understands why an indication-based drug pricing system is being proposed. However, he pointed out that it is important to consider the paradoxical issue that raising the price of the drug for a specific indication could reduce patient access to the drug itself or lower the likelihood of its health insurance reimbursement listing. Cho explained, “If the price for a specific indication becomes excessively high, it could paradoxically reduce patients' access to medications or lower the likelihood of insurance coverage. Theoretically, while drug prices may decrease for some indications, others will inevitably increase.” He added, “On a practical level, there are concerns about whether the Health Insurance Review & Assessment Service (HIRA) will be able to track and manage (drug price claims, etc.) for each indication and whether errors in entering indications and false claims can be controlled. The drug price negotiation process is also likely to become complicated and opaque.” Cho explained that this is why it is necessary to carefully examine whether introducing a system that differentiates drug prices by indication is the best alternative whether there are other policy alternatives, and the need to secure empirical evidence. He stated, “At this point, we need to discuss whether a differential drug pricing system based on indications is a significantly better alternative than the current drug pricing system, whether expanding the RSA is a more realistic alternative for now, or whether a different approach is necessary. Any discussion of institutional changes must be preceded by verification and evaluation, and there must be sufficient empirical evidence based on case studies.”
- Company
- ‘Multiple-indication drugs improve survival rates’
- by Son, Hyung Min Apr 28, 2025 05:54am
- Hosted by KRPIA The Korean Research-based Pharmaceutical Industry Association (KRPIA) announced on the 24th that it successfully hosted a “Policy Forum on Eliminating Inequality in Innovative New Drugs and Improving Regulations” with Representative Mi-hwa Seo, Representative Byeong-Hoon So, Representative Yoon Kim, and Representative Jong-tae Jang (Health and Welfare Committee) of the Democratic Party of Korea. The policy forum, held at the National Assembly Office Building, aimed to explore measures to improve access to innovative new drugs for patients with severe and rare diseases so they can receive timely treatment, and to gather opinions from various sectors. The symposium was attended by co-hosts Rep. Mi-hwa Seo and Rep. Yoon Kim, as well as keynote speakers Jung-yong Hong, Professor of Oncology at Samsung Medical Center, and Professor Jung-hoon Ahn, Professor of Health Convergence at Ewha Womans University. The discussion panel included key figures from the government, the medical community, patient groups, the media, and the pharmaceutical industry, such Lee Jung-kyu as, Director of the Health Insurance Policy Division at MOHW; Hyung-min Kim, Director of the Department of Drug Management at the National Health Insurance Service; Ji-yong Moon, Professor at Konkuk University Medical Center; Gi-jong Ahn, Representative of the Korea Alliance of Patients Organization; Yoonho Eo, reporter at Dailpyharm; and Hyeryun Bang, Director at AstraZeneca Korea. The discussion was moderated by Dong-Cheol Seo, Director of the Korea Institute for Pharmaceutical Policy Affairs. In her opening remarks, Rep Mihwa Seo said, “When patients miss their chance for treatment, the costs go beyond simple medical losses and become enormous social costs,” emphasizing that “the fundamental reasons for the low accessibility of new drugs in Korea lie in the rigidity of the overall system, including the procedural complexity of the reimbursement listing system, the economic evaluation-centered assessment model, and the uniform drug price structure. The government must assume a responsible role in addressing all factors that have a substantial impact on patients' lives.” In his greeting, KRPIA Chair Kyung-Eun Bae said, “New drugs with multiple indications greatly contribute to improving patient survival rates and quality of life, but their value is not fully reflected due to the structural limitations of the domestic reimbursement system. I hope that patients' treatment opportunities will be expanded by reflecting the differences in therapeutic effects, number of patients, and availability of alternative treatments for each indication, even for the same drug.” In his keynote speech, Jung-yong Hong, Professor of Oncology at Samsung Medical Center, addressed the structural issues of clinical value and accessibility imbalances in innovative new drugs under the theme of “Regulatory Improvement Tasks for Addressing Inequality and Improving Accessibility of Innovative New Drugs in Korea.” He pointed out that innovative new drugs with different mechanisms of action from existing treatments are effective for various indications, meet unmet medical needs, and have received high prescription recommendation ratings in global guidelines, but patients in Korea are unable to obtain actual treatment opportunities due to limitations in the reimbursement system. In particular, he mentioned that reimbursement for drugs with multiple indications is delayed compared to other countries and raised the need for policy attention and institutional reform to improve accessibility. In the second presentation, Jung-hoon Ahn, Professor of Health Convergence at Ewha Womans University, emphasized the need for a value-based drug pricing system, focusing on the fact that the therapeutic effects and social value of drugs vary depending on their indications. For this, Ahn introduced the “blended pricing” system, in which drug prices vary depending on the number of patients, the availability of alternative treatments, and cost-effectiveness, even for the same drug. He explained that this system, which is already in place in several countries, could serve as an alternative solution that not only reflects the value and usage of each indication but also enhances the sustainability of health insurance finances and patient access. The subsequent panel discussion delved into in-depth discussions on field experiences and potential institutional improvements. Gi-jong Ahn, Representative of the Korea Alliance of Patients Organization, said, “It is difficult for patients to understand why certain indications are not covered by health insurance and therefore cannot be used. Despite financial concerns, considering the examples of countries that have introduced blended pricing systems, South Korea also needs to consider introducing such a system quickly and improve access to treatment. Jung-kyu Lee, Director of the Health Insurance Policy Division at MOHW, said, “Many newly approved drugs have multiple indications,” adding, “The government agrees that it is time to review the blended pricing system.” He added, “We will carefully examine whether this is a problem with existing practices or a limitation of the system, and if there are systemic problems, the health authorities will comprehensively review and discuss improvement measures with the Health Insurance Review and Assessment Service and the National Health Insurance Service.” Hyung-min Kim, Director of the Department of Drug Management at the National Health Insurance, said, “Careful system design is required based on financial stability, patient accessibility, and connectivity with other systems.”
- Company
- Janssen’s Rybrevant challenges the NSCLC throne
- by Whang, byung-woo Apr 25, 2025 05:59am
- The Rybrevant-Leclaza combination therapy, which has emerged as the standard of care in the field of lung cancer, is set to enter the market in earnest, backed by clinical data. With three additional indications for EGFR-mutated non-small cell lung cancer added this year, the company plans to leverage its leadership in the field of lung cancer. Kihyung Lee, Professor of Hemato-oncology at Chungbuk National University HospitalOn the 22nd, Janssen Korea held a press conference to highlight the indication expansion of Rybrevant (amivantamab) and the clinical value of its combined use with Leclaza (lazertinib). Results of 3 major Phase III clinical studies of Rybrevant in the treatment of EGFR-mutated non-small cell lung cancer were shared at the conference. Kihyung Lee, Professor of Hemato-oncology at Chungbuk National University Hospital, who presented at the event, said, “A significant number of patients with EGFR exon 19 deletion and exon 21 (L858R) substitution mutations experience resistance during treatment with existing EGFR-TKIs, with limitations in selecting subsequent treatment options.” He added, “Rybrevant has presented a new treatment method for EGFR-mutated non-small cell lung cancer through the use of combination therapy.” Rybrevant is the first targeted therapy for EGFR exon 20 insertion mutation non-small cell lung cancer, and it not only targets EGFR exon 20 insertion mutations but also simultaneously targets MET mutations. Professor Lee said, “Rybrevant inhibits tumor growth and progression by suppressing tumor cells that show not only EGFR mutations but also MET mutations and amplification. It also has a differentiated mechanism of action that induces cancer cell death through immune mechanisms such as natural killer cells and macrophages.” Rybrevant + Leclaza shows improvement in OS following PFS The basis for adding the new indication for Rybrevant in EGFR-mutated non-small cell lung cancer was 3 Phase III clinical studies: MARIPOSA-1, MARIPOSA-2, and PAPILLON. According to the final results of the MARIPOSA Phase III clinical study presented at the European Lung Cancer Congress (ELCC 2025) held in March, showed that the combination therapy of Rybrevant and Leclaza was superior to Tagrisso monotherapy. The MARIPOSA study is a clinical trial comparing the efficacy and safety of Leclaza + Rybrevant combination therapy with Tagrisso monotherapy, which is currently used as a first-line treatment for EGFR-positive non-small cell lung cancer. The clinical results showed that the median progression-free survival (PFS) in the Leclaza+Rybrevant group was 23.7 months, which was longer than the 16.6 months recorded in the monotherapy group. In the analysis of overall survival (OS), the secondary endpoint, the Leclaza+Rybrevant group showed a favorable trend compared to the Tagrisso monotherapy group. Se-Hoon Lee, Professor of Hemato-oncology at Samsung Medical Center Se-Hoon Lee, Professor of Hemato-oncology at Samsung Medical Center, said, “At a median follow-up of 37.8 months, the Rybrevant combination showed a significant improvement in OS compared with osimertinib monotherapy.” He added, “The objective response rate of Rybrevant was 86% in patients with EGFR exon 19 deletion and exon 21 substitution mutations, and the median duration of response was 25.8 months, which means that combination therapy with Rybrevant can be considered a major treatment strategy.” With Leclaza + Rybrevant confirming its superiority in OS, the EGFR-positive non-small cell lung cancer treatment market is now likely to see combination therapy become the standard treatment. Currently, this combination therapy has been approved as a first-line treatment in South Korea, the United States, Europe, Japan, the United Kingdom, and Canada. Particularly, while combination therapy that combines platinum-based chemotherapy with targeted therapy has been approved for EGFR-positive NSCLC in the past, this is the first time a targeted therapy+targeted therapy option has been approved, signifying its significant development. More options available for EGFR-positive NSCLC, but tailored selection remains a challenge However, despite the combination rising as a possible standard treatment, there are cost barriers to its immediate use in clinical practice. With four options now available, including monotherapy and combination therapy, determining the optimal sequence of treatment is also a key consideration. Professor Lee said, “It is a difficult issue, but with 100 patients that all have different characteristics, I think their conditions must be taken into consideration. Rather than categorizing specific groups, I expect that the most beneficial treatment for each will be selected according to each patient's condition.” In addition, Janssen Korea expressed its commitment to improving access to combination therapy with Rybrevant. Yeon-hee Kim, Oncology Business Unit Director at Janssen Korea, added, “We are making various efforts to expand access to Rybrevant combination therapy. We will do our best to ensure that health insurance reimbursement coverage is provided through flexible and active cooperation during the reimbursement review process.”
- Policy
- ‘Should apply blended pricing and reimbursement rates’
- by Lee, Jeong-Hwan Apr 25, 2025 05:59am
- With multiple drugs with multiple indications, such as multi-targeted immunotherapy drugs, being approved in Korea, there have been claims that the introduction of an “indication-based drug pricing system” is necessary to improve patient access to treatment and ensure equity. In particular, the argument was made that ‘blended pricing,’ which sets different prices for each indication, could reflect the value of each indication while maintaining a single price, thereby increasing social acceptability, and that it could be introduced without conflicting with the current drug pricing system in Korea, which is based on a single price structure. Ultimately, after taking the first step with “blended pricing,” the industry recommended that the government should introduce a “differentiated reimbursement rate system” based on real-world data accumulated for each indication in order to reflect the value of drugs for each disease and speed up reimbursement for patients. Jung-hoon Ahn, Professor of Health Convergence at Ewha Womans University Graduate School, will present these views at a policy discussion forum titled “Resolving Inequality in Innovative New Drugs and Regulatory Reform” co-hosted by the Democratic Party of Korea lawmakers Mihwa Seo, Byung-Hoon So, Yoon Kim, and Jong-Tae Jang on the 24th. The forum is organized by the Korean Research-based Pharmaceutical Industry Association (KRPIA). Professor Ahn will give a presentation on the reimbursement policy for drugs with multiple indications. Professor Ahn pointed out that there are an increasing number of cases in which drugs with multiple indications are being approved in the field of anticancer drugs. In fact, as of 2018, 75% of tumor treatment drugs in the United States were approved as drugs with multiple indications, and in South Korea, 32 anticancer drugs with multiple indications are eligible for reimbursement. In South Korea, drug prices are determined based on the active pharmaceutical ingredient contained in the drug, making it difficult to set and reflect separate prices for individual indications. This means that even drugs with multiple indications are assigned a single insurance reimbursement ceiling. Professor Ahn expressed concerns that the value of individual indications is not sufficiently reflected in drug prices, leading to issues such as access to treatment for patients that are covered with the expanded indications in South Korea. Taking the multi-indication immunotherapy drug Keytruda as an example, he pointed out that while it is reimbursed in Italy, Switzerland, France, Australia, Japan, and Belgium for both first-line treatment of head and neck squamous cell carcinoma and second-line treatment of endometrial cancer, it is not reimbursed for either in South Korea. In response, Professor Ahn suggested the need to introduce or improve a drug pricing system for multi-indication drugs. Specifically, Professor Ahn proposed that while methods such as “individual approval for each indication” or “differentiated reimbursement rates” could transparently reflect the value of each indication, they require legal amendments or raise concerns about equity in reimbursement amounts between patients that are applied different indications, as well as the need for preparation in the current system, including settlement mechanisms. He emphasized that the blended pricing method is highly feasible under the current reimbursement and drug price system. The logic is that applying blended pricing within the framework of risk-sharing agreements (RSAs), which are legal contracts, would allow the value of drugs to be reflected according to their indications while managing the financial risk of drugs with uncertain cost-effectiveness. Professor Ahn stated, “The country has established a value-based drug pricing system. However, while value is recognized primarily based on the primary indication, appropriate values for individual indications are not reflected. As a result, pharmaceutical companies are delaying or abandoning the launch of subsequent indications, leading to reduced access to new treatments for patients.” “I propose collecting and analyzing real-world data on claims made for each indication to establish actual value evidence for drugs, and building a system that applies differential reimbursement rates that reflect the clinical value differences by indication based on accumulated data,” said Ahn. “This is a strategic approach that complements the limitations of Korea's single drug pricing system while flexibly realizing the effects of indication-based drug price adjustments.” He added, “We can start with a practical approach, such as blended pricing (indication-weighted average price), and gradually evolve toward a differentiated reimbursement rate system that reflects indication-specific value. Blended pricing maintains a single price while reflecting the value of individual indications, making it more acceptable within the social framework.”
- Policy
- "Will consider proposal for Indication-based pricing system"
- by Lee, Jeong-Hwan Apr 25, 2025 05:58am
- Lee Joongkyu, Director of the National Health Policy at the Ministry of Health and Welfare (MOHW), at the National Assembly policy forum Regarding introducing an 'indication-based pricing system' aimed at improving patient access to medications, Lee Joongkyu, Director of the National Health Policy at the Ministry of Health and Welfare (MOHW), stated, "While it is still too early to announce when to implement the system, it is an opportune time to consider reviewing the proposal." During the 'Discussion Forum on Resolving Inequalities in Innovative New Drugs and Regulatory Reforms' at the National Assembly on April 24, Director Lee explained, "Recently, multiple indications are frequently approved for new drugs, thus presenting issues that cannot be solved in previous methods." Director Lee highlighted that the National Health Insurance's operational direction is to provide medications that citizens need in a timely manner. In other words, introducing an indication-based pricing system aimed at improving patient access to medications still requires further discussion within the Ministry of Health and Welfare (MOHW). Directior Lee said that since the Korean health insurance system operates as a sole supplier than a multiple insurance system, there will be challenges related to purchasing medications and receiving reimbursement. Despite such challenges, Director Lee agreed that solving the patient access issue by improving policy is necessary rather than simply regarding it as a financial issue. Dr Lee remarked, "We must consider whether issues related to reimbursement method of pharmaceutical have been resulted due to insufficient measures from the perspective of the system rather than a National Health Insurance expenditure issue," and added, "In my opinion, it is about time to review the indication-based pricing system." "We cannot provide an exact implemenation timeline, but the MOHW will review the measure. The MOHW is aware that if coverage under the National Health Insurance is not provided, individuals will need to purchase medications at non-reimbursed price," and Dr. Lee added, "If there are issues with the supply of quality drugs, we will certainly consider proposals."
