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- 2026-04-03 16:43:01
- Policy
- When will Keytruda’s reimb be reviewed by DREC?
- by Lee, Tak-Sun Jul 17, 2025 06:13am
- Attention is focused on when Keytruda, for which reimbursement standards were set for 11 indications in February, will be submitted to the Drug Reimbursement Evaluation Committee (DREC) for review. This is because, although the reimbursement standards were established by the Health Insurance Review and Assessment Service's Cancer Review Committee, the barrier of DREC remains. According to industry sources on the 15th, HIRA is currently evaluating the estimated additional claims for Keytruda. This process is conducted to decide whether to apply the preliminary drug price reduction system for drugs with an expanded scope of use. The preliminary drug price reduction system for drugs with expanded scope of use is a system designed to quickly increase patient access to treatment by omitting cost-effectiveness evaluations. It applies a pre-determined reduction rate to reduce the insurance price ceiling for drugs by up to 5% in consideration of the estimated additional claims resulting from the expansion of reimbursement criteria. However, this system is applied only when the expected claims amount is between KRW 1.5 billion and KRW 10 billion. If the expected claim amount exceeds KRW 10 billion, the drug price is adjusted through negotiations between the National Health Insurance Service regarding the expansion of the drug's approved indications. In February, the National Health Insurance Service set reimbursement criteria for 11 additional indications for Keytruda. MSD requested reimbursement expansion in 2023, and after 5 attempts, the expansion was finally approved by the National Health Insurance Service on the company’s 6th attempt. At that time, the reimbursement criteria were set for stomach cancer, esophageal cancer, endometrial cancer, colorectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small intestine cancer, and bile duct cancer. After setting the reimbursement criteria, HIRA reported it to the MOHW. After review, MOHW requested HIRA to review the preliminary drug price reduction for drugs with an expanded scope of use. It is expected to take some time before the application can be submitted for DREC review, as the relevant work must be completed first. Some predict that it will be difficult for the matter to be submitted to the DREC even in August. This is because the analysis of the expected claims amount will take a long time due to the large number of indications, and the pharmaceutical companies must also go through the process of accepting the preliminary drug price reduction. Even if it passes DREC review, negotiations with the National Health Insurance Service remain, and it is uncertain whether its reimbursement will be granted and listed within the year. Due to the complicated reimbursement process, some in the industry believe that the introduction of indication-specific pricing should be considered. However, health authorities remain cautious about introducing such a system. Whichever the cause, the patients are likely to face a long wait. However, it is a positive sign that HIRA recently added 12 indications for Keytruda to the partial reimbursement list as part of anticancer combination therapies, reducing the financial burden on patients. With the partial reimbursement, the other therapies included in the combination, excluding Keytruda, are covered by health insurance.
- Company
- How Denmark gave birth to the golden goose Wegovy
- by Cha, Jihyun Jul 17, 2025 06:13am
- Novo Nordisk, the Danish company that developed the obesity treatment Wegovy that shook the world, rose to the top in Europe in terms of market capitalization in 2023. It surpassed France's luxury goods group LVMH, which had held the top spot in the European stock market for over two years. At the time, Novo Nordisk’s market value was approximately KRW 790 trillion. This surpasses Denmark's gross domestic product (GDP) last year. It is truly a case of “one well-developed new drug” sustaining the country. Novo Nordisk is based in Denmark. Denmark has a population of 6 million and a land area only half that of Korea, but its biotechnology is considered among the best in Europe. The foundation of this technological prowess is Medicon Valley. Medicon Valley, located between Copenhagen and Malmö in Sweden, is the largest life science hub in Northern Europe. It is recognized as a model example of a biotech cluster where research and development infrastructure, capital, and talent are closely interconnected. Medicon Valley, a Nordic bio ecosystem that operates as one across borders According to industry sources on the 14th, Medicon Valley is the largest bio cluster in Northern Europe, covering the Copenhagen metropolitan area in Denmark and the Skåne region in Sweden. Denmark and Sweden have built a joint life science ecosystem centered on the Øresund Strait. It began to take shape in earnest in the mid-1990s, with Copenhagen, Lund, and Malmö serving as its core hubs. Medicon Valley's strength lies in its clustering effect. Industry, academia, medicine, and capital are concentrated within a single ecosystem, and they are organically connected to accelerate innovation. The core players in the bio ecosystem are physically close to each other and operate a system that promotes organic cooperation. One of the biggest factors supporting Medicon Valley's competitiveness is its high concentration of companies. There are more than 500 life science companies in the area. Many of them are global pharmaceutical companies or promising biotech companies. From leading global biopharmaceutical companies such as Novo Nordisk, Lundbeck, and LEO Pharma to startups rapidly growing in areas such as AI-driven drug discovery, antibody and cell therapies, and digital health, a diverse range of companies are concentrated in the region. Leo Pharma headquarters in Ballerup, Denmark, and Novo Holdings headquarters near Copenhagen city center The concentration of these companies brought qualitative synergies that go beyond mere quantity. When companies of different sizes and at different stages of development are physically close to each other, technological collaboration, talent circulation, information sharing, and business commercialization naturally occur. This enables innovation at a speed, efficiency, and scale that cannot be achieved by a single company or research institute alone. The dense structure of Medicon Valley goes beyond a simple locational advantage to serve as a foundation for collective intelligence that boosts the efficiency and speed of the entire bio industry. The academic and hospital infrastructure of the Danish bio cluster serves as the driving force behind the ecosystem. Medicon Valley is home to universities with some of the best research capabilities in Europe. The University of Copenhagen, the Technical University of Denmark, the University of Southern Denmark, and Lund University in Sweden are located within the cluster. These universities are not just educational institutions, but also core technology providers and launchpads for startups and industrialization in the bio ecosystem. Distribution of universities and research institutions in Medicon Valley (Source: Medicon Valley Alliance, MVA) Hospitals are the gateway to the Medicon Valley ecosystem. They are essential spaces for refining technologies developed at universities for practical application in patients and serve as trusted clinical validation partners for companies. In addition to Odense University Hospital, one of Denmark's three major university hospitals, and Rigshospitalet, a national central hospital, there are many university hospitals and regional hospitals specialized in clinical research, joint research, and technology validation. Most hospitals in Medicon Valley are directly connected to universities, enabling them to perform educational, research, and treatment functions simultaneously. In particular, it is common for biotech and medical device companies to test their initial technologies in hospital testbeds and then improve and commercialize them based on real-world data. A national clinical support system organically connects the hospital network, enabling the entire process, from clinical trial approval procedures to subject recruitment and data analysis, to proceed efficiently. National University of Southern Denmark, located in Odense, Denmark The collaboration between the University of Southern Denmark and Odense University Hospital is cited as an ideal model of industry-academia-hospital collaboration. Among these, SDU Robotics is a representative example of field-oriented medical innovation where technology development is directly applied to clinical settings. SDU Robotics is a robotics research center affiliated with the School of Engineering at the University of Southern Denmark, and companies such as Universal Robots (a collaborative robot developer) and MiR (an autonomous mobile robot company) were established through this center. The University of Southern Denmark and Odense University Hospital jointly operate multiple research centers. These institutions are physically located just 4 km apart, enabling them to swiftly coordinate the entire process from technology development to clinical validation. The two institutions collaborate on research and productization based on a 50:50 partnership, with developed technologies tested directly within the hospital and systematically validated for commercial viability. Thiusius Rajeeth Savarimuthu, Professor and Head of SDU Robotics, stated, “The ability of SDU Robotics to transition research outcomes into actual clinical applications is thanks to the collaboration between researchers with expertise in engineering and medicine. This collaboration has been further strengthened with the official launch of a joint research center between the university hospital and SDU's School of Engineering.” #Money flows even without government funding…The technology commercialization formula of Medicon Valley In Medicon Valley, technology does not end in the laboratory. Ideas invented at universities and hospitals are quickly turned into biotech, and then supported by a professional startup support platform and private funding system. The BioInnovation Institute (BII) is one representative institution. BII is a non-profit startup support organization fully funded by the Novo Nordisk Foundation. BII provides grants of up to 3 million kroner (approximately KRW 6 billion) to early-stage technology-based startups without requiring equity. Additionally, it operates a comprehensive support system covering shared experimental infrastructure, dedicated mentoring, investor connections, and business development strategy formulation. In fact, BII is attracting promising technology startup teams not only from Denmark but from all across Europe. To date, BII has produced over 100 startups, which have secured follow-on investments exceeding 500 million euros (approximately KRW 70 billion). Unlike many countries, including South Korea, where biotech startups still rely on government R&D projects or one-time grants, the BII model is unique in that it is led by the private sector and forms a cycle of startups and industrialization. Pic of BioInnovation Institute (BII) Another major strength of Medicon Valley is the establishment of a private-sector-led continuous investment ladder. The Novo Nordisk Foundation is Europe's largest foundation supporting the life sciences sector, with annual funding exceeding KRW 1 trillion. The foundation provides Proof of Concept (PoC) funding not only to BII but also to researchers at major universities such as the University of Copenhagen, the Technical University of Denmark, and the University of Southern Denmark. In subsequent stages, top European biotech venture capital firms such as Sofinnova Partners, Life Sciences Partners (LSP), and Novo Holdings continue to invest in companies spun out of BII or technology-based companies within Medicon Valley, from Series A to Series C. The process from incubation to technology verification to initial investment to follow-up VC is designed within a single ecosystem, providing a foundation for biotech companies to grow without any funding gaps. Ultimately, the core of Medicon Valley lies in the fact that each entity does not act independently. Technology is born in laboratories, verified in hospitals, commercialized by companies, and provided with growth momentum by private capital, all within a single cluster. For example, when cell therapy technology developed at the University of Copenhagen enters early clinical trials through joint research with a hospital, nearby biotech companies jointly develop or acquire the technology to promote its commercialization. During this process, the Novo Nordisk Foundation or BII provides initial funding, and venture capitalists follow up with subsequent investments if the technology shows promise. Distribution of major life science companies in Medicon Valley (Source: Medicon Valley Alliance·MVA) The physical proximity of industry, academia, hospitals, and capital is also a key factor enabling the cluster to function organically. Hospitals, universities, and companies are located within 30 minutes to an hour of each other. The Novo Nordisk headquarters is located in Bagsvaerd, approximately 15 km from the center of Copenhagen, Lundbeck is in the Østerbro district of Copenhagen, and Leo Pharma is in nearby Valby. The distance between these companies is within a 20-30 minute drive, and they are also within a 30-minute commute from universities and hospitals. This proximity enables the entire process from startup to commercialization, including technical reviews, clinical discussions, and investor meetings, to be completed within a single day. This goes beyond mere physical density, serving as a decisive factor in enhancing the intensity and speed of collaboration. Since technology, people, and capital can respond and circulate quickly within the same living area, the commercialization cycle of technology is shortened, and the execution power of innovation is enhanced. Medicon Valley also leads the way in securing high-level talent in the biotechnology and medical fields. With top European universities specializing in life sciences and medicine concentrated within the cluster, a steady stream of highly skilled professionals is produced across various fields, from basic science to biomedical engineering, healthcare, and AI-driven biotechnology. Additionally, companies, hospitals, and university research labs are closely connected, allowing talent to freely move between different institutions and organizations to accumulate practical experience. This talent circulation structure within the ecosystem facilitates the recruitment of specialized personnel and short-term project-based hiring within institutions, thereby enhancing their R&D agility and efficiency. Reducing regulations and speeding up approvals...The government's framework for bio innovation The Danish government's active policy support also plays an important role in the rapid functioning of the Medicon Valley ecosystem. The Danish government launched a public-private strategic group (Life Science Growth Team) and began implementing a life science growth strategy to foster the bio industry, a key growth engine for the country. This organization subsequently led to the establishment of a national life science strategy and the Life Science Office, which is directly under the Prime Minister's Office. The Life Science Office coordinates policies across all ministries, including health, education, industry, and foreign affairs, and serves as a government control tower overseeing the entire cycle from research and development to clinical trials and commercialization. The Danish government has also been actively recruiting global talent. It operates a fast-track visa system for highly skilled personnel in the life science field and provides support for foreign researchers to settle in Denmark, creating an environment that naturally attracts doctoral and master's degree researchers from around the world. In addition, it is expanding English-based higher education programs and international joint research projects, providing an open research ecosystem for researchers from countries outside Europe. Danish Medicines Agency introduces a fast-track system for early-stage clinical trials (Source: Korea Bio Association) Recently, the Danish Medicines Agency announced plans to introduce a fast-track review system for initial early-stage trial applications, with decisions on approval to be made within two weeks starting next month. The Danish Medicines Agency will collaborate with the Medical Research Ethics Committee (MREC) to notify applicants of approval decisions for all single-country Phase I and Phase I/II clinical trial applications within 14 days. This measure is part of the 2030 Danish Life Science Strategy. The 2030 Danish Life Science Strategy is a blueprint for the development of the bio industry announced by the Danish government at the end of last year, which includes comprehensive policy measures to make Denmark a leading life science powerhouse in Europe by 2030. Denmark plans to lower the barriers to clinical trials for biotech startups and global pharmaceutical companies and enhance the competitiveness of its research environment to boost the overall capabilities of the industrial ecosystem. In addition to shortening the clinical approval process, Denmark is laying the groundwork for various institutional measures to strengthen the competitiveness of the biotech industry. Denmark has already introduced a national pilot program to jointly evaluate research combining pharmaceuticals and medical devices. This program is an attempt to reduce institutional gaps in the approval process for combination products that combine pharmaceutical and medical devices. The country will also expand the use of AI and machine learning-based data analysis in clinical trials. By utilizing new technologies in clinical design and patient response prediction, Denmark plans to accelerate the development of personalized pharmaceuticals by upgrading relevant laws and technical systems by 2025.
- Company
- Oral lung cancer drug market race
- by Son, Hyung Min Jul 16, 2025 06:10am
- Late entrants, such as Leclaza and Lorviqua, are expanding their presence in the Korean lung cancer targeted therapy market, continuing rapid growth. While prescription sales for some EGFR and ALK-positive non-small cell lung cancer (NSCLC) treatments are stagnating or declining, newer drugs in these categories are showing a clear upward trend, driven by expanded reimbursement or additional indications. 3rd-generation targeted therapies for first-line treatment…distinct growth trend According to market research firm UBIST, on July 16, Leclaza's Q2 outpatient prescription sales reached KRW 20.6 billion, a 92.5% year-over-year (YoY) increase. This marks the first time Leclaza's quarterly prescription sales have surpassed KRW 20 billion. Leclaza is a 3rd-generation tyrosine kinase inhibitor (TKI) developed by Yuhan Corp. EGFR-positive lung cancer treatments are categorized into: first-generation drugs with AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib); second-generation with Boehringer Ingelheim's Giotrif (afatinib) and Pfizer's Vizimpro (dacomitinib); and third-generation with Leclaza (lazertinib) and Tagrisso (osimertinib). All of these are oral treatment options. Given their oral formulation, outpatient prescriptions are possible. However, considering inpatient prescription sales (which include prescriptions for hospitalized patients), their actual prescription volume is estimated to be even larger. Prescription sales of EGFR-positive lung cancer treatments (unit: KRW 100 million, source: UBIST). Dark Blue-Iressa (gefitinib), Orange-Tarceva (erlotinib), Yellow-Giotrif (afatinib), Gray-Vizimpro (dacomitinib), Sky Blue-Leclaza (lazertinib), Green-Tagrisso (osimertinib). Leclaza, approved in Korea in January 2021, was officially launched into the market with reimbursement coverage in the same year. Leclaza secured KRW 4.1 billion in prescription sales in just two quarters, recorded KRW 17.4 billion the following year, and successfully surpassed KRW 40 billion last year. Leclaza's outpatient prescription sales in the first half of the year alone reached KRW 38.2 billion, nearing its full-year prescription sales for 2024. Analysis suggests that Leclaza's increase in prescription sales is attributed to its approval as a first-line treatment for EGFR-positive lung cancer in July 2023. Previously, for patients to use Leclaza with reimbursement, they needed to have T790M positivity confirmed through a re-biopsy after using first- or second-generation TKIs. With Leclaza, Tagrisso, and other third-generation TKIs now covered as first-line treatments starting this year, the range of choices for medical professionals and patients has expanded to include the entire spectrum of first- to third-generation targeted therapies. Another strength of Leclaza is its potential for combination with Rybrevant. Recently, combination therapies such as Tagrisso + platinum-based chemotherapy and Rybrevant + platinum-based chemotherapy have obtained approval from overseas regulatory agencies as first-line treatments for lung cancer. Leclaza, which targets EGFR mutations in exons 19 and 21, and Rybrevant, which targets exon 20, are attracting attention as a combination of targeted therapies. Currently, the Leclaza + Rybrevant combination therapy is approved as a first-line treatment for lung cancer in Korea, the U.S., Europe, and Japan. AstraZeneca's Tagrisso maintains its market leadership. Tagrisso's Q2 prescription sales were KRW 47.3 billion, a 46.4% increase from the same period last year. Tagrisso's Q1 prescription sales increased by 53.7% year-on-year to KRW 43 billion, and its Q2 sales expanded by 46.4% to KRW 47.3 billion. Tagrisso is the only TKI that can be used in patients with early-stage lung cancer. In February 2021, Tagrisso was approved in Korea for adjuvant treatment after complete tumor resection in EGFR exon 19 and exon 21 mutated non-small cell lung cancer patients. In the Phase 3 ADAURA study, the Tagrisso treatment group showed a 51% reduction in the risk of death compared to conventional treatment. During the same period, the growth of first·second-generation TKIs stagnated. Among them, Boehringer Ingelheim's Giotrif had the highest prescription sales. Giotrif recorded KRW 2.9 billion in outpatient prescription sales in Q2 2025, maintaining the highest performance among first and second-generation drugs. However, its quarterly prescription sales have consistently decreased from KRW 5.2 billion in Q1 2023, falling by half in just over a year. Iressa also showed a downward trend during the same period, falling from KRW 4.5 billion to KRW 2.1 billion. Tarceva's prescription volume decreased to KRW 700 million, and Vizimpro's to KRW 100 million in Q2 last year. The establishment of third-generation targeted therapies as first-line options contributed to the decline in their prescription sales. ALK market also shifting…Lorviqua chases Following the EGFR treatment market, the ALK-positive NSCLC treatment market is also showing signs of change. A generational shift is underway, with second-generation drugs performing well and third-generation treatments expanding their reach. The market leader in this segment is Alecensa. Alecensa's Q2 prescription sales reached KRW 8.4 billion, representing an 18.3% year-over-year increase. Alecensa has shown steady growth since its prescription sales surpassed KRW 5 billion in Q3 2020. This treatment has maintained an average quarterly prescription sales of over KRW 8 billion since 2021. Prescription sales of ALK-positive NSCLC treatment market by quarters (unit: KRW 100 million, source: UBIST). Blue-Xalkori, Gray-Alecensa, Orange-Alunbrig, Yellow-Lorviqua. Alecensa is a second-generation ALK-positive targeted therapy developed by Roche. Targeted therapies used for ALK-positive lung cancer are categorized into three generations: first-generation, represented by Pfizer's Xalkori; second-generation, including Alecensa and Takeda's Alunbrig; and third-generation, represented by Pfizer's Lorviqua. Alecensa's increasing potential for use in early-stage lung cancer patients has given it the green light to maintain its market-leading position. According to clinical data disclosed at the European Society for Medical Oncology (ESMO 2023) annual meeting, Alecensa showed effectiveness in adjuvant chemotherapy after surgery. Alecensa successfully added the early-stage lung cancer indication in Korea in September of last year. Pfizer's Lorviqua recorded KRW 4.3 billion in Q2 prescription sales, a 53.6% increase year-on-year. Lorbrenda's quarterly prescription performance has steadily increased from KRW 2.3 billion in Q1 2023, nearly doubling in two years. Lorviqua, a third-generation ALK inhibitor, has rapidly expanded its presence due to its excellent ability to control brain metastases and systemic efficacy. Additionally, the expansion of its reimbursement coverage for first-line treatment, starting this year, is also cited as a major factor in its growth. Alunbrig recorded KRW 2.7 billion in outpatient prescription sales in Q2 this year. This is a 22.9% decrease compared to KRW 3.5 billion in the same period last year. Alunbrig initially generated demand by emphasizing its convenience of administration, central nervous system penetration rate, and response rate during its early introduction. However, its competitiveness appears to be weakening recently due to Lorviqua's rapid growth. Xalkori's Q2 prescription sales decreased by 6.6% to KRW 1.4 billion compared to last year. Xalkori, a first-generation ALK inhibitor, has shown a continuous decline in prescriptions since the emergence of subsequent drugs. This is because late entrants have proven superior efficacy and safety compared to Xalkori. Second and third-generation targeted therapies are known to have lower drug toxicity and reduced incidence of adverse reactions compared to first-generation therapies. They are known to demonstrate superior therapeutic efficacy. Additionally, second and third-generation targeted therapies have the advantage of higher CNS penetration, including into the brain.
- Opinion
- [Reporter's View] Gov’t cooperation leads to a price cut?
- by Eo, Yun-Ho Jul 16, 2025 06:10am
- There are times when cooperation ends up causing losses. In an ironic twist, pharmaceutical companies that participated in the government's infertility support program have now found their products caught in the net of the Price-Volume Agreement (PVA) system, leaving them little choice but to face rapid drug price cuts. The government's infertility support program, aimed at addressing the low birthrate issue, has been steadily expanded over the past years. Last year alone, it was expanded 3 times, and in January 2024, the previous eligibility criterion of “household income at or below 180% of the median income” was abolished, and subsidies for in vitro fertilization and artificial insemination were provided regardless of income. In February, the number of reimbursements covered by national health insurance was increased from a maximum of 16 sessions per person for in vitro fertilization (9 times for fresh embryos and 7 for frozen embryos) to a maximum of 20 sessions per person (without distinction between fresh and frozen embryos). In November, the government also expanded the co-insurance rate for infertility treatments, which had previously been differentiated by age (30% for those aged 44 and under and 50% for those aged 45 and over), to a uniform 30% regardless of age. With the expanded infertility support, demand also increased significantly. The supply of infertility treatments could not keep up with demand, leading to supply disruptions and shortages. Follicle-stimulating hormone (FSH) preparations, which are essential for infertility treatment, are used to induce hyperovulation in assisted reproductive technology (ART) such as in vitro fertilization or artificial insemination. The issue is that most follicle-stimulating hormone preparations are hormone preparations (biological drugs) with complex manufacturing processes, making it difficult to increase production to meet the increased demand. From 2023 to the present, companies have reported supply disruptions or shortages for 7 follicle-stimulating hormone preparations to the Ministry of Food and Drug Safety. However, major FSH preparations that had expanded their supply to meet the rising demand have now been selected for PVA (Price-Volume Agreement) negotiations starting this July. The outcome will almost certainly lead to drug price reductions. Demand for infertility treatments is expanding globally beyond domestic markets. China has expanded public health insurance coverage for in vitro fertilization (IVF) in major cities like Beijing and other provinces starting in 2023 as part of efforts to address low birth rates. The United States is also expanding support policies, including the first federal-level executive order in February 2025 to enhance access to IVF, moving beyond previous state-level initiatives. In other words, it is not easy for any pharmaceutical company to ensure a smooth supply of the lacking IVF drugs in line with policy trends. The fact that many pharmaceutical companies are giving up is evidence of this. It is time for the government to provide appropriate compensation for those who cooperate with national healthcare initiatives.
- Company
- What benefit will BeOne Medicines’ Tevimbra bring?
- by Whang, byung-woo Jul 16, 2025 06:10am
- Tevimbra (tislelizumab), the first immune-oncology drug to be reimbursed for the treatment of esophageal cancer, is expanding its indications to penetrate the market. In a market already dominated by established immune-oncology drugs such as Keytruda (pembrolizumab) and Opdivo (nivolumab), pricing and scalability are expected to be key strategic factors. On the 15th, BeOne Medicines Korea held a press conference to highlight the significance of the 5 additional indications it received approval -- esophageal cancer, stomach cancer, and first- and second-line treatment for non-small-cell lung cancer – and the improved treatment access. Tevimbra employs a dual mechanism of action that blocks the binding of PD-1 and PD-L1, effectively inhibiting PD-L1 while minimizing binding to Fc-gamma receptors (FcγR), thereby offering a differentiated mechanism of action compared to existing immunotherapy drugs. Professor Se Hoon Lee, Department of Hematology and Oncology at Samsung Medical Center Tevimbra was approved last November as an immuno-oncology drug with a PD-1 inhibition mechanism that demonstrated clinical efficacy in esophageal squamous cell carcinoma, and in April, it became the first immuno-oncology drug to be reimbursed for esophageal cancer. At the end of June, the drug was approved by the Ministry of Food and Drug Safety for additional indications for esophageal cancer, gastric cancer, and non-small cell lung cancer. Specifically, it has received additional approvals for the treatment of esophageal squamous cell carcinoma (ESCC), gastric or gastroesophageal junction adenocarcinoma (G/GEJ), and non-small cell lung cancer (NSCLC), enabling its use as a first- or second-line treatment for a total of 5 indications across 3 solid tumor types. Tevimbra demonstrated efficacy and safety in the RATIONALE clinical trial series (RATIONALE-303, 304, 305, 306, 307), which served as the basis for its approval. Professor Se Hoon Lee of the Department of Hematology and Oncology at Samsung Medical Center stated, “In the RATIONALE-307 study, the Tevimbra combination therapy group demonstrated efficacy with a 4-year overall survival rate of 32%, an objective response rate (ORR) of 75%, and a progression-free survival (PFS) of up to 9.6 months. This is meaningful data as it showed potential in patients with squamous non-small cell lung cancer (NSCLC), a group in which existing immunotherapies have demonstrated more limited efficacy.” Professor SunYoung Rha, Department of Medical Oncology at Yonsei Cancer Hospital Additionally, Professor Lee explained, “Tevimbra demonstrated long-term survival potential with a median overall survival of over 3 years in patients with non-squamous NSCLC who were EGFR/ALK-negative and had high PD-L1 expression in the RATIONALE-304 study. Notably, the study included patients with stage IIIB disease, expanding the drug’s clinical applicability.” Additionally, Tevimbra demonstrated clinical benefits in the overall patient population with esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma, and consistent results were observed in pre-specified subgroups based on PD-L1 expression. Professor SunYoung Rha of the Department of Medical Oncology at Yonsei Cancer Hospital said, “Tevimbra significantly extended overall survival and reduced the risk of death by 20% regardless of PD-L1 expression. Especially, it demonstrated consistent survival benefits in patients with peritoneal metastasis, making it a meaningful treatment option.” Professor Rha further noted, “Peritoneal metastasis is present in approximately 40% of all gastric cancer patients and is classified as a high-risk group with poor prognosis. However, existing immunotherapy drugs have shown limited efficacy in this patient population, and Tevimbra can be a new hope for these patients.” BeOne Medicines, "Will swiftly proceed with Tevimbra’s drug pricing discussions" With some of Tevimbra’s indications approved and reimbursement granted, competition among treatments is expected to begin in earnest. Ji-Hye Yang, General Manager of BeOne Medicines Korea Although there are already immunotherapy drugs available, the two experts also believe that Tevimbra will play a significant role, given the unmet demand. So what will be Tevimbra’s position in the market? Under the same reimbursement conditions, it is expected that patients with peritoneal metastasis among gastric cancer patients and stage III B patients who are difficult to treat with surgery or radiation with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer will be given priority consideration for using Tevimbra. In particular, there are observations that BeOne Medicines will compete on drug prices to obtain rapid approval, as it will immediately seek reimbursement for the additional indications Tevimbra has been approved for. Ji-Hye Yang, General Manager of BeOne Medicines Korea, said, “While it is difficult to disclose exact figures regarding reimbursement pricing, we are committed to securing coverage faster than any other immunotherapy currently available in Korea. We plan to work closely with the Health Insurance Review and Assessment Service to set an appropriate price so that more patients can benefit clinically."f
- Company
- Paxlovid prescriptions exceed ₩10B in Q2 amid resurge
- by Kim, Jin-Gu Jul 16, 2025 06:09am
- Quarterly prescriptions for the COVID-19 treatment Paxlovid have surpassed KRW 100 billion. Since entering the prescription market in October last year, usage has rapidly increased, with cumulative prescriptions reaching KRW 23.7 billion. This is believed to be due to the resurgence of COVID-19 in South Korea in March and April this year. According to the market research institution UBIST on the 15th, Paxlovid's domestic prescription sales in the second quarter reached KRW 11.4 billion. Paxlovid is an oral antiviral drug that helps inhibit the proliferation of the COVID-19 virus. It is mainly prescribed to high-risk patients who are at risk of developing severe illness. Initially, the government directly purchased and distributed the drug free of charge, but in June last year, the government halted new supplies, shifting distribution to general medical institutions with prescriptions. In October last year, Paxlovid was approved for reimbursement and entered the prescription market in earnest. The insurance price ceiling was set at KRW 941,940, with the patient’s coinsurance rate set at 5%. Patients can now obtain a prescription for the drug at an out-of-pocket cost of around KRW 50,000. After entering the prescription market, Paxlovid has rapidly expanded its prescription sales. Paxlovid's prescription sales, which amounted to KRW 4.1 billion in the fourth quarter of last year, doubled to KRW 8.2 billion in the first quarter of this year in just 3 months. In the second quarter of this year, it increased by 40% to exceed KRW 10 billion. Cumulative prescription sales to date have reached KRW 23.7 billion won. Monthly Paxlovid prescriptions This is analyzed as a result of the resurgence of COVID-19 in the first half of this year. According to the Korea Disease Control and Prevention Agency's weekly COVID-19 report, the number of COVID-19 patients reported by 221 hospitals under sample surveillance remained at an average of 70 throughout the fourth quarter of last year, but surged to 143 in the first week of January this year. After a brief lull, the number began to rise again in March. In the first week of April, the number increased to 185, marking the beginning of a resurgence, which continued through May. The number of severe COVID-19 patients requiring hospitalization, for whom Paxlovid prescriptions are concentrated, also increased significantly after April. During this period, monthly Paxlovid prescription sales also rose sharply. In particular, sales reached KRW 48 billion in April alone. The prescription performance of Paxlovid in the second half of the year is expected to vary depending on the COVID-19 outbreak situation after July. The industry predicts that Paxlovid prescriptions may increase again if COVID-19, influenza, and colds spread simultaneously in the fall, as in previous years. COVID-19 cases in Korea (sample surveillance)
- Policy
- Will the general diabetes criteria be revised after 14 yrs?
- by Lee, Tak-Sun Jul 16, 2025 06:09am
- The National Health Insurance Service (NHIS) is currently reviewing a comprehensive revision of the general principles for diabetes drug reimbursement criteria, which have been in place for 14 years. It is garnering significant attention from the industry. Following recent trends, significant changes are anticipated, including the removal of metformin and sulfonylurea (SU) as first-line agents and a reorganization of approved dual therapies. However, concerns about increased national health insurance expenditure make the government's ultimate decision an attention. According to industry sources, on July 14, the Health Insurance Review & Assessment Service (HIRA) is reviewing a comprehensive revision of the general principles for diabetes drug reimbursement criteria, as requested by organizations such as the Korean Association of Internal Medicine. The current general principles for diabetes drugs, which designate metformin and SU as first-line agents, were first established in 2011. At the time, the Ministry of Health and Welfare (MOHW) formulated these principles to align with prescription patterns, encourage cost-effective drug use, and reduce the financial burden on the national health insurance. However, after 14 years, the general principles for diabetes drugs are now considered outdated. Indeed, this year, the Korean Diabetes Association revised its "9th Edition Diabetes Treatment Guidelines," removing the detail that metformin is the first-line treatment for type 2 diabetes. Instead, the guidelines recommended prioritizing the use of the latest drugs based on the patient's pathophysiology and clinical characteristics. The Korean Diabetes Association explained that this revision is an evidence-based guideline with clear levels of evidence and benefits. Not only in Korea but also in developed countries like the United States, metformin is no longer recommended as a first-line agent. The Korean Diabetes Association is said to have gathered these opinions and requested a comprehensive revision from HIRA earlier this year. HIRA is reportedly reviewing the comprehensive revision proposal. The pharmaceutical industry is also requesting a comprehensive revision, arguing that the current general principles are contrary to the latest medical practices and trends. Analysis suggests that the revised principles are highly likely to include comprehensive changes to the general principles, from the status of metformin and SU as first-line treatments to the approved dual therapies. However, if SGLT-2 inhibitors, DPP-4 inhibitors, or GLP-1 analogues are recommended as first-line treatments instead of metformin or SU, there is a high possibility of a significant increase in national health insurance expenditure.Therefore, health insurance authorities are expected to review the cost-effectiveness of these measures closely. An official from the pharmaceutical industry said, "If the current general principles for diabetes drug reimbursement criteria are comprehensively revised, it will have a significant impact on the market, and pharmaceutical companies will inevitably have to consider their profit and loss," and added, "I believe the NHIS will also establish measures to minimize financial expenditure."
- Company
- Potential changes to reimb policy for new anticancer drugs
- by Moon, sung-ho Jul 16, 2025 06:08am
- Multinational pharmaceutical companies are actively pursuing to secure reimbursement for their anti-cancer drugs as first-line treatment options. Based on accumulated clinical research, companies are competitively applying for reimbursement from the government, putting in all efforts to accomplish this by the second half of this year. Recently, several argued that the current reimbursement review paradigm, which has focused on 'life extension,' should undergo a significant transformation to center around the 'improvement of quality of life.' In other words, they argue that reimbursement should be discussed primarily for first-line treatment options, rather than late-stage treatments for specific cancers, with a focus on directly improving quality of life. According to the pharmaceutical industry, on July 14, multinational pharmaceutical companies have recently applied to the Health Insurance Review & Assessment Service (HIRA) for reimbursement of their anti-cancer drugs as first-line treatment options. For instance, 'Astellas Pharma Korea' is one of them. Astellas recently re-applied for reimbursement for the Padcev (enfortumab vedotin)-Keytruda (pembrolizumab, MSD) combination therapy as a first-line treatment for urothelial carcinoma. In addition, they concurrently applied for Padcev monotherapy for second-line or later treatment. Notably, Astellas re-applied for both first-line and second-line or later treatments at once, bringing both therapies to the Cancer Disease Review Committee (CDRC) discussion table. While the monotherapy, used in second-line or latertreatment, had passed the CDRC and was undergoing cost-effectiveness evaluation, the combination therapy obtained domestic approval and rapidly gained presence in clinical settings. Therefore, the analysis suggests that Astellas resubmitted both together. In other words, both the combination therapy and monotherapy are now on the CDRC table for discussion. Dr. In-Keun Park of Asan Medical Center, Seoul (Department of Oncology), said, "Using Padcev earlier in the treatment has an advantage in terms of overall survival (OS) compared to using it later." He added, "Realistically, due to cost issues, the dosage is often adjusted (contrary to clinical standards). In some cases, patients are even reducing their body weight to lower the drug dosage due to drug costs." Dr. Park added, "In clinical practice, the proportion of patients who transition from first-line to second-line treatment, and from second-line to third-line treatment, decreases sharply," and emphasized, "Considering that first-line combination therapies are already introduced and used in Korea, discussions for reimbursement of first-line combination therapies can no longer be delayed." Furthermore, the competition for reimbursement of first-line treatments to secure market dominance in the gastric cancer treatment market in the second half of this year is accelerating. Keytruda passed the CDRC in the first half of this year and is currently undergoing cost-effectiveness evaluation at a subcommittee of the Drug Reimbursement Evaluation Committee (DREC). As the only immunotherapy that can be used not only in HER2-negative but also HER2-positive patients, Keytruda, as a first-line option in Stage 4 gastric cancer treatment, is expected to grow significantly depending on whether reimbursement is applied. Additionally, BeOne Medicines Korea (formerly BeiGene Korea) has also applied to HIRA for reimbursement for five new indications, including gastric cancer, for its immunotherapy Tevimbra (tislelizumab). This means that BeOne Medicines Korea had immediately applied for HIRA after obtaining domestic approval by the MFDS in June. Additionally, Astellas has also re-applied for reimbursement for 'Vyloy (zolbetuximab),' a Claudin 18.2 gastric cancer targeted therapy. The company has recently been promoting this drug alongside Padcev. This re-application comes approximately four months after Astellas failed to achieve reimbursement listing from the CDRC in February. An Astellas official explained, "Korean medical professionals and patients sincerely hope for rapid reimbursement of Vyloy in the treatment of HER2-negative and Claudin 18.2-positive metastatic gastric cancer, where there are no other treatment options." He added, "We have faithfully reflected HIRA's supplementary requests and completed the re-application for reimbursement. We will do our best to ensure that the best treatment option is quickly introduced to patients." As multinational pharmaceutical companies continue to aim for reimbursement of anti-cancer drugs as first-line treatment options, the government authorities will likely face an increased load of responsibility for evaluation. This is because reimbursement of initial treatments naturally leads to increased financial burden on the national health insurance. However, reimbursement cannot be denied for treatments with proven efficacy in clinical research due to the financial burden. Therefore, opinions are emerging that the government's reimbursement discussion paradigm must undergo a significant transformation. They imply that a shift in the discussion focus from 'life extension' to 'improvement of quality of life.' In fact, until now, both the government and pharmaceutical companies have primarily discussed reimbursement by first applying it to second-line and subsequent treatments, then expanding coverage to first-line treatment. However, with recent cases demonstrating both clinical efficacy and OS benefits from first-line treatment, the prevailing opinion is that it is no longer easy to maintain this approach. For instance, Rybrevant (amivantamab, Johnson & Johnson) is an example. Recently, results from the MARIPOSA Phase 3 trial were announced, showing that the combination therapy with Rybrevant and Lazertinib (Yuhan Corp) as a first-line treatment for non-small cell lung cancer could extend OS by over 50 months. Based on these results, Johnson & Johnson applied for reimbursement for the Rybrevant-Lazertinib combination therapy as a first-line option to HIRA in the first half of this year. Therefore, the pharmaceutical industry is suggesting that the medical community and the government must find a common ground through discussions on a paradigm shift in reimbursement, starting with anti-cancer drugs. It suggests revising the reimbursement system to encourage more proactive treatment from the initial stages, shifting the focus from life extension to quality of life. An anonymous pharmaceutical industry official said, "The current reimbursement system for anticancer treatment is in a transitional period. With an increasing number of options proving treatment efficacy from the initial stages, the time to discuss reimbursement primarily for fourth or fifth-line treatments seems to have passed," and added, "It seems we are transitioning to an era where priority is given to actively treating patients early on to improve their quality of life ultimately, rather than focusing on treatments that merely extend life slightly." He added, "Currently, we are at a stage of confusion regarding the reimbursement priority between initial treatment and subsequent retrospective treatments. It's a question of whether to focus on life extension, or to recognize efficacy based on progression-free survival (PFS) in initial treatment even if OS is not extended." He stressed, "While the financial costs will undoubtedly be greater, it's now time for a specific policy direction."
- Company
- Polivy’s reimbursement for DLBLC will soon be reviewed
- by Eo, Yun-Ho Jul 15, 2025 06:08am
- Polivy, the first first-line treatment introduced for diffuse large B-cell lymphoma (DLBCL) in 20 years, is entering the first stage of its renewed bid for reimbursement in Korea. According to industry sources, Polivy (polatuzumab vedotin), a treatment developed by Roche Korea for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), is expected to be reviewed by the Health Insurance Review and Assessment Service's (HIRA) Cancer Review Committee. After the company resubmitted the reimbursement application in May, the drug’s review schedule is progressing relatively quickly. Polivy originally sought reimbursement listing in 2021 for its first indication, as third-line treatment in combination with BR therapy (bendamustine and rituximab), but failed to pass the Health Insurance Review and Assessment Service's Cancer Review Committee review. Then in the first half of 2023, the company applied for reimbursement for its use as first-line treatment in combination with the so-called R-CHP therapy, which includes rituximab+cyclophosphamide, doxorubicin, and prednisone, but was again rejected by the Cancer Review Committee in February last year. Therefore, it remains to be seen whether Polivy, which has failed reimbursement listing twice in Korea, will be successful in gaining reimbursement this time. There is some optimism. The company added results from a 60.9-month follow-up analysis of the POLARIX study, which evaluated the efficacy of the Pola-R-CHP combination therapy in first-line treatment for DLBCL. The study, which was presented at the American Society of Hematology (ASH) 2024 Annual Meeting, was the first clinical trial in 20 years to expand the first-line standard of care for DLBCL. Key results showed that patients treated with the Polivy combination therapy demonstrated a significant improvement in overall survival (OS) compared to the control group treated with the standard R-CHOP. The lymphoma-related mortality rate was 9.0% in the Polivy combination therapy group and 11.4% in the R-CHOP control group. At approximately 5 years after treatment initiation, the risk of death in the Polivy combination therapy group was reduced by 15%, an improvement over the previous 3-year follow-up results (6% reduction in risk). Also, the Polivy combination therapy group (38.7%) required subsequent treatment (radiation therapy, systemic chemotherapy, CAR-T cell therapy, etc.) at a rate approximately 25% lower than the R-CHOP control group (61.7%). Diffuse large B-cell lymphoma is an aggressive form of blood cancer and the most common type of non-Hodgkin lymphoma. In South Korea, it is estimated that approximately 5,000 new patients are diagnosed with diffuse large B-cell lymphoma each year. It accounts for the highest proportion of non-Hodgkin lymphoma and is an aggressive type of lymphoma that requires immediate treatment due to its rapid progression. While over half of patients achieve remission with good treatment response rates, 30–40% of patients do not respond to standard therapy (R-CHOP) or experience recurrence after initial treatment. Despite the fact that most patients experience relapse within 2 years and have a survival period of only 6 months upon relapse, relapsed or refractory diffuse large B-cell lymphoma remains an area with limited effective treatment options.
- Policy
- Gov't pursues 'project to produce unstable supply drugs'
- by Lee, Jeong-Hwan Jul 15, 2025 06:08am
- The Ministry of Health and Welfare (MOHW) plans to continue its project of providing government funding for the production of drugs with unstable supply. The MOHW plans to proceed with the currently budgeted project to support one item, while also working to secure additional budget to support more items. A MOHW official recently met with the Korea Special Press Association to explain the direction of the project to support the production of drugs with unstable supply. The MOHW has selected 'Questran Powder for Suspension Boryung,' a bile acid sequestrant class hyperlipidemia treatment from Boryung, as an unstable supply drug to be stabilized and has decided to provide KRW 900 million in funding. This drug is the only hyperlipidemia treatment in South Korea that pregnant women and children can safely use, but its supply was halted in 2023 due to declining profitability. In response, Boryung will resume production with KRW 900 million in government support and KRW 900 million in-house investment, totaling KRW 1.8 billion. The National Assembly is also calling for budget increases in the project to support the production of drugs with unstable supply. Last year, the National Assembly's Health and Welfare Committee advocated for an additional budget increase of KRW 900 million to expand the supported items from one to two, as part of a national health security strategy to support domestic drug production and supply chains. However, the budget increase review did not happen, and the proposal was rejected. The MOHW plans to use 'Questran Powder for Suspension Boryung' as a starting point to secure the basis for the unstable drug supply support project and will maintain the project while increasing the number of supported items in the future. For 'Questran Powder for Suspension Boryung,' the company must meet a mandatory condition that it must complete the production of the requested quantity within three months if a production request from the MOHW follows within five years after the government budget support project ends. A MOHW official stated, "Only two pharmaceutical companies applied for this year's support project. It seems the promotion was insufficient." They added, "Although this is the first year of implementation, it will not be a one-off project." The official explained, "While the government provides KRW 900 million in funding and the private pharmaceutical company matches the same amount, it's not easy to fully equip production facilities with this budget. I do feel it's not a large sum," and added, "Nevertheless, I believe starting the drug supply shortage project with this item has significance." The MOHW also added, "The evaluation·verification of budget project investment returns will be based on whether the government's required production volume is met, which will be considered as having contributed to alleviating supply shortage to some extent." They concluded, "Research on resolving unstable supply chains has also been allocated a budget of KRW 50 million, and this will also begin in the second half of the year."
