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- 2025-12-18 22:53:35
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- 'Drug access still stagnant despite improved survival'
- by Son, Hyung Min Sep 25, 2025 06:10am
- While innovative new drugs have raised survival rates for patients with cancer, rare diseases, and other difficult-to-treat conditions and are transforming the treatment paradigms, industry voices argue that domestic patients' access to such drugs remains limited. Both the introduction rate and approval rate of global new drugs fall short of the OECD average, highlighting the urgent need for fundamental institutional reforms. On the 24th, the Korean Research-based Pharmaceutical Industry Association (KRPIA) held a commemorative event at Some Chavit in Banpo, Seoul, to celebrate its 25th anniversary. At this event, KRPIA held a roundtable event to share the current status of patient access to global new drugs in Korea. Just 20 years ago, cancer was considered untreatable. However, with the rise of innovative drugs from multinational pharmaceutical companies—including immuno-oncology therapies, targeted therapies, antibody-drug conjugates (ADCs), and bispecific antibodies—the landscape has changed dramatically. In some cancer types, survival rates have now improved to 70–80%, rendering the new drugs a prime example of extending patient life. In-hwa Choi, Executive Director of KRPIA 20 million people are newly diagnosed with cancer globally each year, and this number is projected to nearly double by 2050. The number of deaths is also expected to reach 18 million. Consequently, sustained and equitable access to innovative cancer drugs is more critical than ever. In-hwa Choi, Executive Director of KRPIA, stated, “Fundamental system improvements that prioritize patient access are necessary. While Korea’s health insurance system is exemplary, its single-payer structure creates inherent complexity and delays in reimbursement decisions for new drugs.” Choi acknowledged recent policy efforts—including expanded risk-sharing arrangements, exemption of pharmacoeconomic evaluations, and pilot programs linking drug approval with reimbursement—as positive developments. Choi noted, “Patients are still left with a long await.” KRPIA member companies supply around 1,450 innovative medicines in Korea, accounting for 83% of all new drugs in the domestic market. They also provide 92 treatments for rare and intractable diseases, expanding access for vulnerable populations such as the elderly, women, and children. KRPIA analyzed that new drugs extend patients' life expectancy by over 35%, reduce cancer mortality rates, and facilitate social reintegration, yielding annual socio-economic cost savings of KRW 126 trillion. Young-Shin Lee, Vice Chairman of KRPIA Nevertheless, patient access to new drugs in Korea remains stagnant. Only 5% of global innovative drugs are introduced in Korea within a year of launch, just one-fourth of the OECD average. Korea’s drug approval rate (30%) also falls below the OECD average (49%) and the G20 average (46%). Young-Shin Lee, Vice Chairman of KRPIA, stressed, “Innovation cannot be achieved by merely altering existing garments. The link connecting innovation to patients is the system; without systemic improvements, new drugs cannot meaningfully reach patients.“ The government, National Assembly, academia, media, and patients must jointly seek institutional solutions to ensure the social value of innovative drugs is properly conveyed to patients. KRPIA will also continue communication and cooperation as a responsible policy partner."
- Company
- Celltrion acquires Eli Lilly's U.S. plant for $460M
- by Sep 25, 2025 06:09am
- Celltrion has signed an agreement with Eli Lilly and Company (United States) for the acquisition of a biopharmaceutical manufacturing plant in Branchburg, New Jersey, for approximately $460 million. According to the Financial Supervisory Service, on September 23, Celltrion plans to make a total investment of KRW 700 billion, covering costs such as the factory acquisition price and initial operational expenses. The company plans to pursue facility expansion on the plant's idle land, which would require at least an additional investment of over KRW 700 billion. The total investment for the acquisition and expansion will be at least KRW 1.4 trillion. The company explained that the acquiring entity is the U.S. subsidiary, considering its local operations and strategic geographic location. Both companies will cooperate to finalize the factory acquisition procedures by the end of the year. The plant to be acquired is a large-scale campus spanning approximately 150,000 square meters, comprising four buildings: a manufacturing facility, a warehouse, and technical and operational support buildings. The facility is a fully operational, cGMP-compliant drug substance (DS) production plant that can be operated immediately upon acquisition. This will significantly shorten the time to production and reduce costs compared to building a new plant, which would take more than five years and cost over a trillion KRW. The plant also has approximately 36,000 square meters of idle land for capacity expansion, allowing the company to respond to future market demand. Celltrion plans to quickly begin expanding its facilities for the production of key products on the secured, idle land. Once the expansion is complete, the company anticipates having a production capacity that is 1.5 times that of its Plant 2 in Songdo, Incheon. Celltrion stated that this acquisition agreement completes its comprehensive plan to address U.S. tariff risks. "We have already taken short- to medium-term measures to counter tariffs, such as relocating two years' worth of inventory to the U.S. and expanding contracts with local Contract Manufacturing Organizations (CMOs)," a Celltrion official said. "With the addition of a fundamental solution, securing a local production plant, Celltrion is now poised to be free from all potential tariff risks in the future." The company explained that once the facility changes and expansions are realized, its flagship products supplied in the U.S., as well as future products, will be exempt from tariff impacts early on. Notably, the agreement also includes the complete employment transfer of local personnel with expertise and experience in plant operations. This agreement will enable the company to maintain seamless plant operation, ensuring the continuation of operational stability and productivity. A company official said, "Constructing a new plant requires a massive investment and several years just to prepare for initial operations and secure and train personnel. In contrast, by acquiring an existing cGMP-compliant plant with a skilled local workforce, Celltrion can significantly reduce this burden," and added, "During future expansion, we will also be able to actively utilize the talent infrastructure of New Jersey, which has a large pool of pharmaceutical and biotech professionals." The official continued, "By signing a CMO contract with Lilly at the same time, we have not only secured a local production base in the U.S. but also a powerful growth engine," and added, "Under the agreement, Celltrion will steadily supply drug substance produced at the plant to Lilly, which will enable us to expand our revenue and recover our investment early."
- Company
- Concurrent reimb review likely for Mounjaro and Ozempic
- by Eo, Yun-Ho Sep 24, 2025 06:25am
- Two anti-obesity drugs that have drawn intense attention may soon undergo reimbursement evaluations for their diabetes indications at the same time. With Novo Nordisk Korea’s Ozempic (semaglutide) already scheduled for review at the upcoming October meeting of the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee, there is growing speculation that Eli Lilly Korea’s Mounjaro (tirzepatide), which submitted its reimbursement application more recently, may also appear on the agenda. In fact, HIRA recently requested Lilly to promptly submit additional supplementary data for Mounjaro’s reimbursement evaluation. Novo Nordisk had already submitted its supplementary data earlier this month. As in all other markets, when supply increases while demand remains constant, prices fall. The pharmaceutical market is no exception. In the era of high-priced medicines, the government has shown a tendency to review two or even three new drugs simultaneously if multiple drugs in the same class are expected to seek reimbursement around the same time. Because of the high cost of these drugs, price competition between manufacturers allows the government to leverage the market’s natural mechanism. Under the national health insurance system, any savings can create opportunities to expand coverage elsewhere. Thus, given Mounjaro’s reimbursement application was filed in July, the government may likely wish to conduct reimbursement evaluations for the diabetes indication simultaneously for the two drugs. It remains to be seen how the fierce competition between the two drugs in the obesity market will extend into the diabetes market. A Novo Nordisk representative said, “We decided to initiate supply of Ozempic in Korea prior to reimbursement to address the unmet needs in type 2 diabetes treatment. We are working closely with the authorities to secure prompt reimbursement approval and further improve patient access.” A Lilly representative said, “We applied for reimbursement listing in order to provide Mounjaro to patients in a fast and sustainable way. We are currently doing our utmost to secure reimbursement for Mounjaro and are continuously collaborating with health authorities.”
- Policy
- Parties disagree with non-face-to-face medical service bill
- by Lee, Jeong-Hwan Sep 24, 2025 06:25am
- Lee Su-jin, the chief secretary of the Democratic Party of Korea (left), requested that Kim Mi-ae, the Chief Secretary of the People Power Party, hold a review committee for the "one-point" bill on non-face-to-face medical services.The government's effort to pass a "one-point" bill on non-face-to-face medical services through the National Assembly's Health and Welfare Committee, Judiciary Committee, and plenary session this month has failed. The chief secretary of the Democratic Party of Korea, Lee Su-jin, on behalf of Vice Minister of Health and Welfare Lee Hyung-hoon, requested that Kim Mi-ae, the Chief Secretary of the People Power Party and chair of the First Legislative Subcommittee, hold an additional subcommittee meeting today (September 24). However, they failed to reach an agreement. An official from the Democratic Party of Korea's office on the Health and Welfare Committee explained, "We continued to negotiate with Chief Secretary Kim Mi-ae's office to hold an additional one-point subcommittee on the non-face-to-face medical service bill, but they ultimately did not agree so that it won't be held." Consequently, this means that the amendment to the Medical Services Act, which includes: ▲The formal institutionalization of the non-face-to-face medical service pilot program ▲The legalization of a public electronic prescription delivery system for medical services ▲Allowing first-time medical consultations within a broader metropolitan area ▲Limiting drugs and prescription days for first-time non-face-to-face medical consultations ▲Allowing drug delivery for a limited group of patients within their residential area ▲Mandating doctors to confirm the DUR (Drug Utilization Review) during non-face-to-face medical services. It is now expected to get another chance for review in November, after the National Assembly's annual audit concludes next month. During the legislative subcommittee meeting on the afternoon of September 22, the non-face-to-face medical service bill was reportedly nearing passage, as most contentious points had been resolved. Kim Mi-ae, the chair of the legislative subcommittee, even hinted at bill passage, saying immediately after the meeting, "We've reached over 80% agreement. It will be possible to pass it within the regular session." The Ministry of Health and Welfare's request for an additional subcommittee meeting to expedite the bill's passage was not realized due to the legislative subcommittee chair's disagreement. An official from the Democratic Party's office said, "We tried to negotiate with the People Power Party's office, but we ultimately received a no," and added, "We were told that there was an internal party directive to halt all bill discussions due to the planned filibuster at the plenary session this month." Meanwhile, the People Power Party has announced its plan to filibuster all bills scheduled to be introduced at the plenary session on September 25, which is a legal method of obstructing legislative proceedings under the National Assembly Act. This is the People Power Party's response to the Democratic Party proposed amendments to the Government Organization Act along with key bills.
- Policy
- MFDS to review Tylenol safety following Trump’s remarks
- by Lee, Tak-Sun Sep 24, 2025 06:24am
- The Ministry of Food and Drug Safety (MFDS) announced that it will carefully review safety concerns regarding Tylenol, following remarks made by US President Donald Trump. On the 22nd (local time), President Trump held a press conference at the White House, stating, “Acetaminophen, widely known as Tylenol, may increase the risk of autism in children when taken during pregnancy. The US Food and Drug Administration will inform physicians about this and, if necessary, recommend restricting Tylenol use during pregnancy.” According to reports, the FDA is currently considering relabeling acetaminophen. Trump’s announcement has fueled debate about Tylenol’s safety, especially since the drug has long been considered a safer option for pregnant women and fetuses compared to other pain relievers. The MFDS also plans to conduct its own review. In an official statement released in the afternoon, MFDS said: “Regarding the US government’s announcement on Tylenol, we will request the company to submit its opinions and data on this matter and carefully review the relevant evidence and materials.”
- Company
- LEO Pharma’s topical JAKi Anzupgo approved in KOR
- by Son, Hyung Min Sep 24, 2025 06:24am
- 레오파마 Global dermatology specialized pharmaceutical company LEO Pharma (General Manager Jung-Bum Shin) announced on the 23rd that its chronic hand eczema treatment Anzupgo (delgocitinib) was officially approved by the Ministry of Food and Drug Safety on the 8th. With the approval, adult patients in Korea suffering from moderate-to-severe chronic hand eczema (CHE) will now have access to a new treatment option that offers both efficacy and convenience. Chronic hand eczema is a multifactorial inflammatory skin disease characterized primarily by itching and pain, defined as eczema persisting for more than 3 months or recurring at least twice within a year. It is among the most common skin disorders affecting the hands, and a significant proportion of cases progress to chronic disease. Globally, CHE affects about 1 in 10 adults and can severely impair quality of life by imposing functional, occupational, and psychological burdens. Approximately 70% of patients with severe CHE struggle with daily activities, which directly affects their employment and income. Anzupgo is the only non-steroidal topical cream formulation approved for adult patients with moderate-to-severe CHE who do not respond to or are unsuitable for topical corticosteroids. The product contains no parabens or steroids and works by inhibiting the JAK-STAT signaling pathway involved in various inflammatory responses. By blocking the activity of JAK1, 2, 3, and TYK2, the drug helps reduce skin inflammation and itching. Multiple clinical trials have demonstrated broad efficacy across all subtypes of moderate-to-severe CHE. Until now, treatment options for CHE have been limited, with strong topical corticosteroids used most frequently. However, long-term use carries risks such as skin barrier damage, atrophy, and telangiectasias. Due to this reason, in cases that show insufficient short-term improvement, guidelines have recommended combining topical calcineurin inhibitors or systemic corticosteroids. Currently, the only approved oral therapy for severe chronic hand eczema is alitretinoin, used for patients unresponsive to at least 4 weeks of potent topical corticosteroids. It improves symptoms through skin regulation, anti-inflammatory, and immunomodulatory actions, and is known to be effective for the long-term management of chronic severe hand eczema with a high risk of recurrence. However, its use has been constrained by risks including hepatotoxicity, thyroid dysfunction, dyslipidemia, and teratogenicity. In the head-to-head DELTA FORCE trial that directly compared oral alitretinoin with Anzupgo, the Anzupgo group achieved a statistically superior improvement in HECSI scores at week 12 (-67.6). It also demonstrated higher achievement rates in HECSI-90 and IGA-CHE TS (score 0/1). Over the 24-week treatment period, Anzupgo showed a better safety profile and lower incidence of adverse events compared to alitretinoin, confirming both strong efficacy and good tolerability. Jung-Bum Shin, General Manager of LEO Pharma Korea, stated: “Chronic hand eczema not only causes physical suffering but also serious social and emotional challenges. We are pleased to be able to provide the much-needed treatment option, Anzupgo, in Korea with its approval.” Shin added, “We will do our best to ensure Anzupgo contributes to changing the treatment paradigm for chronic hand eczema and improving patients’ quality of life in Korea.” LEO Pharma has been continuing the global launch of Anzupgo, having secured official approval in Korea following approvals in Europe, the UK, Switzerland, the UAE, Canada, Australia, and the US.
- Policy
- Contraindication guidelines to flu vaccine cut down in KOR
- by Lee, Tak-Sun Sep 23, 2025 06:07am
- The Ministry of Food and Drug Safety (MFDS) plans to significantly reduce the list of contraindications for influenza (flu) vaccines. The MFDS has decided to create a new set of recommended guidelines because the previous contraindications were deemed inconsistent with current clinical practice and international standards. The MFDS collected public opinion on the recommended guidelines for contraindications and precautions for inactivated influenza vaccines until September 19. Most flu vaccines are inactivated vaccines (made from killed viruses). The new recommendations reduced the number of contraindications to two: ▲Individuals with a severe hypersensitivity reaction to any of the vaccine's components (active ingredients and excipients) or to egg ingredients (ovalbumin, egg protein), formaldehyde, or polysorbate ▲Individuals who have previously had a severe hypersensitivity reaction (e.g., anaphylaxis) to an influenza vaccine. In addition to contraindications, a new category for cautious administration group was also established. This category includes three key points: ▲Caution should be exercised when administering intramuscular injections to individuals with thrombocytopenia or coagulation disorders, as bleeding may occur ▲For individuals who have a history of developing Guillain-Barre syndrome or other neurological disorders within six weeks of a previous influenza vaccination, the benefits and risks of vaccination should be carefully considered ▲Vaccination should be postponed for individuals with a severe febrile illness or acute illness. According to the current vaccination approval, the listed contraindications are over 10, where items may vary. For example, ▲Individuals with fever or severe malnutrition ▲Patients with cardiovascular diseases, kidney disease or liver disease whose disease states are in aggressive state, middle state, or active state ▲Patients with acute respiratory disease or active infectious disease. However, in clinical practice, these patient groups, particularly those with chronic diseases, are strongly encouraged to get vaccinated. The MFDS official explained, "The influenza vaccines were approved a long time ago, so they don't align with today's reality or international standards. This is why we have prepared these new recommendations." The new recommendations were established at the request of pharmaceutical companies. Meanwhile, approximately 28 million doses of flu vaccine are scheduled to be supplied in the second half of this year. Seven domestically manufactured products, including those from companies such as Green Cross and SK Bioscience, as well as seven imported products from companies like GSK and Sanofi, will be available. Sanofi announced that it has been supplying its trivalent flu vaccine, 'Vaxigrip,' nationwide since September 3.
- Company
- Sanofi begins nationwide supply of flu vaccine Vaxigrip
- by Son, Hyung Min Sep 23, 2025 06:07am
- Sanofi announced on the 22nd that it has begun nationwide supply of its trivalent influenza vaccine Vaxigrip from September 3rd, ahead of the 2025–2026 flu vaccination season. According to the Korea Disease Control and Prevention Agency’s analysis of influenza surveillance results for the 2024–2025 season, last year’s flu epidemic began later than the previous year, peaking in early January 2025. However, the scale of the epidemic was 20–30% greater than the year before and was the highest level since 2016. In particular, a secondary outbreak occurred among school-aged children and adolescents after the winter break, while prevalence also expanded among middle-aged adults, and those aged 65 and older increased about 20% compared with the 2023–2024 season. Considering these trends, large-scale epidemics could repeat in the upcoming season, highlighting the need for early vaccination. Influenza is more than just a respiratory disease; it can lead to severe complications such as worsening of underlying conditions, pneumonia, and cardiovascular deterioration. In particular, high-risk groups—infants and young children, pregnant women, patients with chronic conditions, and the elderly—face higher risks of hospitalization, severe complications, and death following infection, requiring particular attention. Sanofi is the only imported vaccine manufacturer that has participated in Korea’s National Immunization Program (NIP) for 4 consecutive years. This year’s supply of Vaxigrip is available at public health centers, contracted medical institutions, and major hospitals and clinics nationwide. Beginning this year, Korea’s NIP flu vaccine program shifted from quadrivalent to trivalent formulations, and Sanofi secured rapid approval and distribution to provide vaccines in a timely manner. Vaxigrip is a finished imported vaccine supplied domestically by Sanofi, a company with over 100 years of vaccine development history, which manufactures it in France in its entirety, from bulk solution to packaging. The vaccine’s immunogenicity and safety profile have been confirmed through 6 large-scale global clinical trials across four continents (Europe, Asia, South America, and Oceania), which enrolled more than 13,000 participants, including children, patients with underlying conditions, and the elderly. ▲Efficacy in reducing influenza-related complications was confirmed in infants and young children aged 6 to 35 months in one trial, and ▲ in another trial targeting only coronary artery disease patients, efficacy in preventing cardiovascular disease complications was confirmed. Furthermore, ▲consistent preventive efficacy and safety profiles were confirmed across all age groups, including high-risk populations, as demonstrated by a clinical trial confirming vaccine effectiveness and safe use in pregnant women. Together, these results establish consistent preventive efficacy and safety across all age groups, including high-risk populations. According to related studies, using a flu vaccine that precisely matches the viral antigens circulating during that season can prevent hospitalizations or deaths from influenza or pneumonia in patients with chronic conditions such as diabetes, heart disease, or lung disease by approximately 43-56%. Furthermore, in a clinical trial specifically targeting patients with coronary artery disease, vaccination in patients with myocardial infarction or high-risk coronary artery disease reduced the combined risk of all-cause mortality and myocardial infarction or stent thrombosis by 28%. It also reduced the risk of all-cause mortality and the risk of death from cardiovascular events by 41% each.
- Company
- ‘Reimb needed for Ozempic, a powerful weapon for diabetes’
- by Hwang, byoung woo Sep 23, 2025 06:07am
- Diabetes treatment has moved beyond blood glucose control and entered the era of “personalized strategies,” With the Korean Diabetes Association’s 2025 clinical guidelines removing the long-standing recommendation of metformin as the first-line therapy and instead advising initial treatment based on patient characteristics and comorbidities, attention is now turning to the need for reimbursement of GLP-1RA therapy Ozempic (semaglutide). During an interview with Dailypharm, Professor Choi Sung-Hee, Director of Public Relations for the Korean Diabetes Association and professor at Seoul National University Bundang Hospital, stressed the importance of insurance policies in enabling treatment strategies tailored to individual patient needs. KDA revises guidelines and opens the era of personalized care The 2025 revised guidelines of the Korean Diabetes Association boldly removed the recommendation of metformin as the first-line therapy, which had long been considered the standard, shifting instead toward patient-centered, personalized treatment. Sung-Hee Choi, Professor of Endocrinology and Metabolism, Seoul National University Bundang HospitalThe revision goes beyond simple glucose control to include consideration of comorbidities (cardiovascular and renal) through a personalized treatment approach. In other words, it is no longer necessary to always start with metformin; the doctor may consider combination therapy from the outset according to the patient’s condition and clinical profile. Professor Choi explained, “Diabetes patients present in highly diverse situations, and some cannot tolerate metformin well. Depending on individual conditions such as impaired kidney function or obesity, it may not be necessary to use metformin first, and in severe cases, combination therapy could be considered from the beginning,” highlighting the flexibility of the new guidelines. Professor Choi added that in actual clinical practice, some patients cannot take metformin, and depending on comorbidities such as impaired kidney function, heart failure, or severe obesity, GLP-1 receptor agonists or SGLT2 inhibitors have already been emerging as first-line options. The KDA has sought to move away from a purely glucose-lowering focus, pushing for a paradigm shift toward comprehensive management of comorbidities such as hypertension and dyslipidemia. Professor Choi stated, “For patients with impaired renal function, heart failure, or obesity/severe obesity, the role and clinical value of GLP-1RAs and SGLT2 inhibitors are becoming increasingly significant. This guideline revision carries significant implications for diabetic patients with such complications.” The treatment paradigm is being reshaped to meet the increasing incidence of obesity-related diabetes. Professor Choi cited the publication of the Diabetes & Obesity Fact Sheet as an example, underscoring the seriousness of obesity in younger generations. In particular, the number of obese diabetes patients in their 20s to 40s is rapidly increasing, with the obesity rate among young men being especially pronounced. Professor Choi explained, “The key to realizing personalized treatment is early detection and proactive management of high-risk patients. Since semaglutide-based anti-obesity drugs, which can simultaneously manage diabetes and obesity, were derived from diabetes treatments, early intervention to control obesity is the key to preventing chronic complications.” Ozempic's value verified through clinical evidence...“Expect it to benefit obese diabetics” Against this backdrop of rising obesity-related diabetes, the role of Ozempic (semaglutide) is gaining attention. Professor Choi said, “Ozempic is a viable option for obese diabetic patients. While existing therapies have shown limited weight loss effects in this group, Ozempic excels not only in lowering blood glucose but also in promoting significant weight reduction.” Indeed, across the SUSTAIN trial series (phases 1–9), Ozempic significantly improved HbA1c and body weight compared to DPP-4 inhibitors, sulfonylureas, other GLP-1 analogs, and even insulin. “Ozempic-based regimens have consistently outperformed traditional combinations in obese diabetic patients, and this has been demonstrated in multiple studies. Furthermore, the recently published FLOW trial was particularly impressive, as it confirmed with large-scale clinical data the kidney-protective effects of GLP-1RAs that had previously only been hypothesized.” The FLOW study directly focused on kidney function and found that Ozempic reduced the rate of decline in estimated glomerular filtration rate (eGFR) and the progression to end-stage renal disease (ESRD) by approximately 24%. She further highlighted the strengths of Ozempic in diabetic patients at high risk of atherosclerotic cardiovascular disease. “Diabetic patients with obesity or severe obesity face very high risks of atherosclerotic cardiovascular events. Ozempic has robust clinical data across this area,” she said. “For diabetic patients with still unmet medical needs, such as obesity and cardiovascular disease, Ozempic represents a powerful new weapon.” Accessibility remains a hurdle due to non-covered status… Emphasis on the need for reimbursement without restrictions Ozempic is currently approved in Korea as a diabetes treatment but remains non-reimbursed. Consequently, regardless of the drug's efficacy, a significant cost burden persists. Professor Choi said, “Reimbursement for Ozempic in type 2 diabetes is essential. Most patients cannot afford to use it without reimbursement. While obesity is important, in diabetic patients, Ozempic must enter the reimbursement framework, and reimbursement criteria must allow combination therapy with diverse agents.” Novo Nordisk Korea reapplied for reimbursement of Ozempic in the first half of 2025. Its insurance price has been agreed with the Health Insurance Review and Assessment Service in earlier negotiations; the final talks collapsed due to supply instability last time, raising hopes for a more favorable outcome this time. Regarding the reimbursement discussion for Ozempic, Professor Choi emphasized that reimbursement criteria should not impose restrictions to ensure personalized treatment for diabetes patients. Currently, even with dulaglutide, the only GLO-1RA class drug granted reimbursement, there are limitations, as it can only be combined with metformin or sulfonylureas under reimbursement. The opinion is that, after Ozempic becomes reimbursed, to achieve sufficient efficacy, an environment must be established where it can be freely combined with existing diabetes medications to see additional benefits, and then treatment can proceed by gradually reducing the number of combination drugs based on the patient's situation. “In hypertension, up to four drugs are commonly combined, but in diabetes, combination is usually limited to two, which is highly restrictive. At minimum, Ozempic must be allowed use in combination with standard oral agents such as DPP-4 inhibitors and SGLT2 inhibitors.” Professor Choi further noted, “While it is important to begin reimbursement under criteria similar to those of existing drugs in the same class, the real goal should be enabling broader combination therapy aligned with Ozempic’s evidence base. This approach will maximize therapeutic benefit.” Concluding the interview, Prof. Choi reiterated, “Diabetes is not merely a condition of elevated blood sugar, but a complex disease entangled with multiple metabolic complications.” “Based on diverse research findings, healthcare providers should be able to combine treatments with sufficient evidence, and if it aligns with guidelines, insurance should support various treatment options. Going forward, if there is sufficient scientific evidence, the government and pharmaceutical companies should engage in more bold negotiations to ensure domestic patients can benefit from advanced treatments.”
- Policy
- Will access to aHUS drugs improve in Korea?
- by Jung, Heung-Jun Sep 23, 2025 06:06am
- The prior approval criteria for receiving reimbursement of atypical hemolytic uremic syndrome (aHUS) drugs, which had long been criticized for impeding patient access, have been improved. This issue was raised during last year’s National Assembly audit as well. At that time, Rep. Yoon Kim (Democratic Party of Korea) pointed out the low approval rate for Soliris (eculizumab). With approval rates hovering at only 30–40% annually, patient access was significantly limited, leading to calls for easing the pre-approval requirements. The Ministry of Health and Welfare (MOHW) is currently collecting public opinion on the proposed partial amendment to the ‘Detailed Rules on the Standards and Methods for Applying Health Insurance Benefits (Drugs),’ from September 18 to 22. The revised proposal specifies the criteria for insurance reimbursement and relaxes or adds detailed requirements on hemoglobin and haptoglobin levels, etc. Previously, the reimbursement criteria required meeting all of the following: ▲ Platelet count below the lower limit of normal at the institution, ▲Presence of schistocytes, ▲ Hemoglobin < 10 g/dL, ▲and Lactate dehydrogenase (LDH) ≥ 1.5 times the upper limit of normal. The revised criteria are as follows: ▲Platelet count < 150×10⁹/L, ▲ Presence of schistocytes, ▲ Hemoglobin < 12 g/dL (or < 11 g/dL for children under 5), ▲ LDH above the upper limit of normal, ▲Haptoglobin below the lower limit of normal. For renal impairment, the wording was changed from “patients” to “cases,” but the thresholds remain the same: ▲≥20% decline in eGFR, ▲Serum creatinine above the age- and sex-specific upper limit of normal. The ADAMTS-13 testing requirement was also specified. Tests must be conducted before plasma exchange or plasma infusion, before the 4th treatment session, or at least 7 days after stopping treatment. However, the criterion based on serum creatinine levels was removed. In addition, a new criterion was added to allow reimbursement even if other requirements were not met. Specifically, if end-stage renal disease due to aHUS is suspected and the drug is required before or after kidney transplantation, coverage may be granted on a case-by-case basis. In addition, the following conditions were removed from the exclusion criteria: ▲ Hemolytic uremic syndrome caused by Shiga toxin, ▲Transplantation, ▲Fibrin thrombosis, ▲paroxysmal nocturnal hemoglobinuria, catastrophic hyperlipoproteinemia, ▲ Sepsis, ▲and other secondary hemolytic uremic syndromes. The revised proposal applies identical detailed recognition criteria to eculizumab (Soliris) and ravulizumab (Ultomiris). The MOHW plans to implement the revised criteria starting October 1, after completing the public opinion collection period.
