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- 2026-04-20 23:21:47
- Opinion
- [Reporter's View] NHI "red light", societal consensus needed
- by Lee, Jeong-Hwan Apr 17, 2026 09:03am
- South Korea’s National Health Insurance (NHI) finances are expected to enter a deficit in 2026. While the fund was in surplus for five consecutive years since 2021, the end of the COVID-19 pandemic, the transition to endemic status, and the onset of a super-aged society have led to a sharp increase in medical expenditures, causing the surplus to plummet annually.The government has established and implemented various policies to ensure the soundness and sustainability of NHI finances. One example is the reduction of pharmaceutical costs through generic drug price cuts, which recently sparked a conflict with the domestic pharmaceutical industry.However, health insurance experts argue that the government must resolve larger fundamental issues rather than focusing on administrative measures to create fiscal room through drug price cuts.While the increase in medical utilization and benefit expenditures due to a super-aged population is an unavoidable natural growth factor, experts criticize that the failure to aggressively resolve distortions in the medical delivery system or the lack of measures to eradicate excessive medical care ("medical shopping") is a man-made disaster that exacerbates the problem through inadequate administration despite being preventable.Furthermore, health insurance experts view the solutions for securing the soundness of NHI finances as having been consistently discussed as an agenda for over a decade, and the correct answers are already somewhat determined.Ultimately, this means that procedures must be established for the government, medical providers (doctors), and medical consumers (patients and the public) to form a consensus and agree on a policy direction that boldly lowers or suspends the benefit coverage rate for excessive medical care and overhauls the payment system centered on the fee-for-service model from its roots.Of course, there is a high probability that opinions will differ regarding the priorities for allocating NHI finances. However, before coordinating such detailed disagreements, the government should take the lead in establishing societal consensus.The etymology of "consensus" originates from the Latin words con- (together) and sentire (to feel). It refers to members of society sharing common feelings and thoughts.NHI finances are a social insurance system operated by the state with public consent, and the key lies in how to create, maintain, and distribute limited public resources. Ultimately, it means that the NHI can be operated without conflict only when it is based on consensus.At this crossroads, where NHI finances are being depleted and the deficit is set to increase significantly, the Ministry of Health and Welfare (MOHW), the ministry in charge, must engage in bold, active administration. This is necessary so that the entire public and medical providers can share the common view that NHI sustainability must be significantly strengthened before social conflict is triggered by fiscal deterioration.This implies that the Ministry of Health and Welfare (MOHW) should take the lead in improving the perception that a "red light" has been turned on for NHI finances and that all members of our society must share some of the burden to solve the problem.
- Opinion
- [Desk’s View] Unmet needs remain in immuno-oncology
- by Eo, Yun-Ho Apr 13, 2026 09:12am
- Immuno-oncology has now become quite a fairly common term. It is a term even ordinary people are likely to have heard at least once. More than a decade has already passed since the term was first introduced to Korea. At present, immuno-oncology drugs have expanded their indications across various cancer types and established themselves as a major pillar of cancer treatment. Whether the growing number of indications receive coverage has become an important gateway that determines treatment access.The extent to which the clinical value of new treatment options should be reflected during reimbursement review remains a persistent concern. For the government, it is a matter of striking a balance between the financial burden and the clinical benefits offered by new drugs.The upcoming Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service is one place where this question constantly comes up for debate. At this month’s meeting, reimbursement for the ‘Opdivo (nivolumab)’ and ‘Yervoy (ipilimumab)’ combination as first-line treatment for hepatocellular carcinoma and non-small cell lung cancer will be presented for deliberation. At the meeting held last October, the combination was rejected for both liver and lung cancers.In hepatocellular carcinoma, following Tecentriq (atezolizumab) plus Avastin (bevacizumab), Imfinzi (durvalumab) plus Imjudo (tremelimumab) have also been added to the reimbursement list. In non-small cell lung cancer as well, an immuno-oncology-based treatment strategy has already taken hold, with ‘Keytruda (pembrolizumab)’ already reimbursed as monotherapy and combination therapy for 4 years.With immuno-oncology drug combinations already reimbursed, attention is now turning to whether reimbursement criteria will be set for the new Opdivo-Yervoy combination, as the addition must be more than simply another treatment option to pass review.In this regard, hepatocellular carcinoma remains a cancer type with frequent recurrence, poor prognosis, and high mortality rates, and many patients begin treatment with impaired liver function. Due to these disease characteristics, key evaluation criteria include whether the treatment option can provide deep and durable responses, long-term survival, and long-term survival benefit regardless of liver function status.The Opdivo and Yervoy combination is the treatment option that has demonstrated the longest survival data in first-line treatment for hepatocellular carcinoma. In clinical trials, it recorded a median overall survival (mOS) of 23.7 months, with a survival rate of 31% at 48 months. In addition, in an Asian patient subgroup analysis, a median overall survival (mOS) of 34.0 months, a 3-year survival rate of 49%, an objective response rate of 37%, and a complete response rate of 10% were reported. Compared with existing immuno-oncology combinations, whose mOS typically does not exceed 20 months, these are significant results.In particular, the Opdivo-Yervoy combination significantly reduced the risk of death by 25% versus the control arm, even in patients with impaired liver function classified as ALBI grade 2/3, demonstrating a degree of mortality risk reduction comparable to that seen in patients with preserved liver function.Its use in non-small cell lung cancer also warrants attention. Although Keytruda-based regimens have effectively become the cornerstone of first-line treatment, it is difficult to say that they fully address the treatment needs of all patient subgroups. In practice, there are still patient groups, such as those with PD-L1-negative tumors or squamous histology, for whom long-term survival benefit under existing immuno-oncology treatment settings has been reported only to a limited extent.As the Opdivo-Yervoy combination demonstrates consistent survival improvements in these patient groups, regardless of PD-L1 expression or histology, it has been discussed as a viable alternative.Ultimately, the core of the Cancer Disease Deliberation Committee review should not be on whether another option should be added to the reimbursement list. Real deliberation should be made on whether the current reimbursement system is offering a sufficient range of treatment choices in practice, and to what extent unmet treatment needs in specific patient groups should be reflected in deliberations. It would be difficult to accept a conclusion that the current system is sufficient merely because options already exist. When it comes to immuno-oncology drugs, unmet needs remain.
- Opinion
- [Reporter's View] Dilemma of off-label prescribing
- by Son, Hyung Min Apr 10, 2026 08:26am
- For patients who have used all cancer treatment options, the only remaining path is often clinical trials. This is because a system has become rigid, so that even if a treatment with expected efficacy exists, institutional constraints prevent it from being prescribed.Theoretically, off-label prescribing is permitted. In South Korea.To use an off-label drug, a hospital's Institutional Review Board (IRB) must first deliberate on the case, after which the Health Insurance Review and Assessment Service (HIRA) determines whether to approve. However, critics point out that IRBs are limited to specific hospitals, and because deliberation standards are applied at a very high level, significant hurdles remain before actual approval is secured.Furthermore, the problem is that this pre-approval system and the list of available treatments operate differently across hospitals. Even under identical patient conditions, a prescription may be possible at one specific hospital but impossible at another.Consequently, the decision to treat depends not on the patient’s clinical status but on the medical institution's decision. Patients must search for a hospital that can provide treatment, rather than choosing the treatment itself.As a result, it is difficult for patients even to know under what circumstances treatment is possible or to what extent it is allowed. This structure, in which treatment availability varies by hospital and situation despite the same disease and conditions, causes significant confusion.This issue is even more pronounced among patient groups outside approved indications. It is not uncommon for patients with the same biomarker to be excluded from treatment simply because they do not fall within the authorized indication. In a system where off-label use is effectively blocked, the options available to these patients become extremely limited.Within this framework, the only option left for patients is to participate in clinical trials. However, clinical trials are not a realistic option for everyone. Participation conditions are stringent, and accessibility varies widely by region and institution. Most importantly, for patients who might be missing their treatment window, a clinical trial is less a choice and more a last resort.Under these circumstances, the discussion on expanding off-label prescribing is emerging as an alternative rather than simply an option. Instead of dismissing this as a risky or unrealistic approach, it is necessary to consider it as a solution to guaranteeing treatment opportunities within a limited fiscal environment. At the very least, restructuring is required to ensure that the system does not block treatment opportunities.This is not a regulatory issue, but it is a minimum requirement to reduce confusion caused by a lack of standards and to provide patients with a predictable treatment environment. If the structure where clinical trials are the only remaining option persists, fair treatment opportunities can hardly be guaranteed.
- Opinion
- "Preventing itch-scratch cycle…Dupixent for prurigo nodularis"
- by Son, Hyung Min Apr 10, 2026 08:26am
- Changes are emerging in the treatment landscape for prurigo nodularis, a condition of patients with an itch so intense it persists until they bleed, destroying their lives.With the introduction of the biologic 'Dupixent (dupilumab),' which targets the mechanism of the disease, there is a growing call for a reestablishment of treatment strategies, moving beyond the traditional symptom-focused approach.Tae Young Han, a professor of dermatology at Nowon Eulji University HospitalTae Young Han, a professor of dermatology at Nowon Eulji University Hospital, said during a recent meeting with Daily Pharm, "Prurigo nodularis accompanies the most severe itch among all dermatologic conditions, significantly deteriorating quality of life of a patient," adding, "With the introduction of a targeted therapy, such as Dupixent, changes to the treatment paradigm is anticipated."Prurigo nodularis is characterized by tens to hundreds of hard nodules accompanied by chronic, extreme itching. In over 80% of cases, the itch lasts more than six months, and for more than half, it persists for over two years. The psychological burden, including sleep disorders and depression, is so severe that quality of life is significantly compromised. The problem is the low awareness of the disease. It is often confused with atopic dermatitis, leading to diagnostic seeking where the correct diagnosis is significantly delayed. Missing the optimal treatment window can lead to chronicity and an increased risk of comorbidities.The mechanism of the disease differs from simple skin conditions. The key is a Type 2 inflammatory response where the immune and nervous systems interact. Interleukins such as IL-4, IL-13, and IL-31 trigger and amplify the itch, forming a vicious cycle. Sanofi’s Dupixent, developed based on this pathological mechanism, has emerged.Dupixent inhibits both IL-4 and IL-13 signals. This approach blocks the root cause of the disease rather than merely alleviating inflammation. It reduces itch, leading to decreased scratching and eventual improvement in skin lesions.Global clinical trials showed that the proportion of patients achieving significant itch reduction (WI-NRS reduction of 4 points) was approximately 3 times higher with Dupixent than with placebo, with rapid improvement starting in week 3. By week 24, the proportion of patients achieving clear or almost clear skin was significantly higher than that of the control group.Professor Han stated: "While existing treatments only non-specifically suppress inflammation, Dupixent is significant in that it directly inhibits the key cytokines of Type 2 inflammation to reach the root cause," and that "Reducing the itch leads to less scratching, which eventually improves the lesions."Q. How severe is the itch and the resulting decrease in quality of life?The most prominent feature is the itch's extreme intensity. The scale of itch is evaluated with the WI-NRS (0–10 scale): 0 means no pruritus and 10 means very severe pruritus.Many patients score 8 or higher, indicating very severe itch. Patients often describe not just itching, but stinging, pain, and a stabbing sensation.In terms of the DLQI (Dermatology Life Quality Index), prurigo nodularis patients experience a much greater decline in quality of life than even psoriasis patients. Many suffer from anxiety, depression, and sleep disorders. Some patients even express suicidal ideation, saying they "want to die because it itches so much."Q. How is the current treatment carried out?Previously, there were no treatments directly targeting the Type 2 inflammatory response. We typically start with topical steroid ointments. If the nodules are too firm so that ointments cannot be absorbed, direct steroid injections are made into the nodules. If the nodules are too numerous, phototherapy is used, and if that is insufficient, immunosuppressants are used.However, many patients are elderly (60s–80s), making these treatments difficult. Phototherapy requires standing naked in a closed booth for several minutes, which is a burden.Immunosuppressants carry risks for patients with decreased kidney function or a history of cancer. Consequently, treatment is often limited to ointments, making it hard to achieve a sufficient response.Under international guidelines (IFSI, US, and EU), biologics like Dupixent are recommended immediately if phototherapy or immunosuppressants are difficult to apply. In fact, biologics are considered the most effective options.Q. What is the clinical value of Dupixent compared to existing treatments?While conventional treatments focus on nonspecifically controlling overall inflammation, Dupixent differs mechanistically by directly inhibiting IL-4 and IL-13, the primary mediators of Type 2 inflammation, which is the core mechanism underlying the development of prurigo nodularis. By addressing the underlying cause of the disease, Dupixent approaches the condition at its root.Because Dupixent targets the fundamental cause to effectively reduce itching, the natural result of decreased pruritus is reduced scratching behavior, which subsequently improves skin lesions. When these immunological abnormalities are controlled, it is possible to break the itch-scratch cycle that forms between the nervous system and the inflammatory response.Furthermore, Dupixent has a robust safety profile from other indications. In fact, prurigo nodularis is strongly associated with repetitive scratching. Some patients even present with both atopic dermatitis and prurigo nodularis, as severe scratching from atopic dermatitis can progress to similar lesions. For such patients, including the elderly or those with underlying medical conditions, Dupixent can be used with relatively little burden, as it holds multiple indications for conditions such as atopic dermatitis, asthma, and chronic rhinosinusitis. Q. What improvements, in terms of patient symptoms, are seen after Dupixent treatment?Clinical studies report a rapid reduction in itching within three weeks of starting treatment. In actual clinical practice, significant relief of pruritus is observed within three to four weeks, leading to a noticeable improvement in the patient’s quality of life. In particular, it serves as a critical treatment option for patients who find it difficult to use immunosuppressants due to medical histories such as hepatitis, dialysis, or tumors.The administration protocol is specified as a continuous cycle every two weeks. By breaking the vicious itch-scratch cycle, Dupixent reduces scratching and improves skin lesions. Once this fundamental cycle is broken, cases have been observed in which the improved condition is maintained even after treatment is discontinued.Q. Would you like to provide advice for patients with prurigo nodularis and for medical staff treating them?Because the name prurigo nodularis is unfamiliar, many patients don't recognize their condition. Patients who do not seek dermatology often mistake their symptoms for simple eczema, being left without a correct diagnosis. They often wander between clinics. If a patient gets an accurate diagnosis from a dermatologist, symptoms can be improved. My advice is that with the emergence of new options such as biologics, patients should pursue treatment.
- Opinion
- [Desk View] An odd policy ensuring high-priced biosimilars
- by Lee, Tak-Sun Apr 06, 2026 03:51pm
- If the government's recent decision to cut generic drug prices is aimed at reducing the National Health Insurance (NHI) financial burden, excluding biosimilars from this reform would be contradictory.As high-priced original biologics place a significant strain on NHI finances, promoting the use of lower-priced biosimilars could yield substantial financial savings. Patients could also significantly reduce their financial burden through affordable biosimilars.Major countries are implementing policies to increase biosimilar prescribing rates and dramatically reduce medical expenses. Japan has set a biosimilar market share target of 80% and provides financial rewards for prescriptions.France also encourages biosimilars to account for 70% of outpatient prescriptions and pays physicians a portion of the savings as an incentive.In contrast, South Korea's biosimilar prescription rate is merely 21% as of 2021.Unlike other developed nations, Korea has neither specific targets for prescription rates nor supporting policies. Ironically, the prescription rate remains low, despite the presence of two companies, Celltrion and Samsung Bioepis, that are globally competitive in the biosimilar field.The government attributes the low domestic biosimilar prescription rate to a preference for original drugs. While this is partially correct, it is also partially flawed.Another reason is that the government initially set biosimilar prices high to increase export competitiveness, resulting in a lack of price competitiveness with originals in the domestic market.When a biosimilar is listed for reimbursement, its price is set at up to 80% of the original drug's maximum price. After one year, both the original and the biosimilar are lowered to 70% of the maximum price. This means that the identical pricing structure is also applied to biologics.Consequently, biosimilars sometimes voluntarily lower their prices below the original to gain market competitiveness. However, in a market as small as Korea, the margin for voluntary price reductions by biosimilar manufacturers is limited.For this reason, biosimilar prices, which are 40% to 50% of the original price in global markets, remain at approximately 90% of the original drug price in Korea.This situation reinforces the preference for original drugs due to the negligible price difference and creates reverse discrimination, where only domestic patients bear the burden of high-priced biosimilars.To increase the biosimilar prescription rate, it is necessary to lower the price ratio relative to the original. Under the drug pricing reform, generic drugs will be set at approximately 45% of the original drug's maximum price. However, biosimilars are expected to maintain a guaranteed 70%. It is unrealistic to guarantee a 70% price point while hoping to drive up prescription rates through "low-cost biosimilars" at 40% to 50% of the reference price, as seen in other countries.Because biosimilar prices are kept above a certain level, the margin for price reductions on original drugs is also limited. This places a heavy burden on NHI finances. Even if the prices of cheap generics are cut, the contribution to fiscal savings will be low if the prices of expensive biologics remain unchanged.Despite these issues, the government conversely raised the price weighting from 70% to 80% in 2016 to support the competitiveness of the biosimilar industry. However, it must be recognized that the consumption volume of biologics in the domestic market has changed significantly since 2016. Biologics have now taken over major therapeutic markets, led by products like Prolia, which dominates the osteoporosis market thanks to its efficacy and convenience, and by various immune-oncology agents that have revolutionized cancer treatment.The problem is that these biologics are high-priced compared to synthetic drugs. Despite market growth, competition among biosimilars is also intensifying, and the domestic pricing structure limits the potential for cost savings.The government should first consider abolishing the identical pricing policy and lowering the price weighting.Incentive policies for biosimilar prescriptions, like those in other developed nations, may be necessary. In fact, this is needed not only for biosimilars but also for generic drugs. Significant fiscal savings result from replacing high-priced original drugs.Fundamentally, the government should favor prescribing low-cost generics or biosimilars to encourage companies to lower their prices voluntarily.However, it is unclear why the government continues to push for maintaining the original-generic (biosimilar) identical pricing mechanism while favoring a collective generic price reduction policy. In particular, the rationale for the government's push for a collective reduction in generic prices while maintaining a high-price guarantee policy for biosimilars remains unclear.
- Opinion
- "Joint bioequivalence licensing system is driving abundant generics"
- by Lee, Jeong-Hwan Mar 31, 2026 08:45am
- Director Lee Jae HyunWhile the government announced plans to divert from the multi-item generic structure and improve the pharmaceutical industry’s trend by focusing on new drugs through drug pricing reforms, criticism has emerged that there is a need to innovate by diagnosing blind spots in the "approval system" beyond pricing alone.In Korea, it has been pointed out that the so-called '1+3 system,' under which the government grants marketing authorization for generics based on a single joint bioequivalence (BE) study conducted by one contract manufacturer and up to three consigned pharmaceutical companies, must be discarded.Furthermore, it has been suggested that, for the long-term development of the domestic pharmaceutical industry, the government must make a policy decision to allow South Korea's world-class clinical physician workforce to enter new drug development.In an interview on the 29th at the Sungkyunkwan University Center for Pharmaceutical Regulatory Sciences in Yeongdeungpo, Seoul, Director Lee Jae Hyun (Professor at Sungkyunkwan University College of Pharmacy) emphasized, "Why we are seeing hundreds of generics for a single active ingredient today is not due to high drug prices, but because of the joint bioequivalence licensing system."Regarding the '1+3 system,' which grants generic marketing authorization even to companies that did not conduct in-house BE tests but instead outsourced them to a contract manufacturer, Lee evaluated it as a "policy with no global precedent."Lee questioned whether a company can truly be called a "pharmaceutical company" if it simply purchases BE test data conducted by others, obtains authorization for identical twin generics, and profits by releasing them to the market after merely changing the brand name and packaging.Lee noted, "Although it was reduced to '1+3' (from the previous unlimited structure), the concept of joint BE licensing is preposterous. Even a '1+1' system, where only one consigned license is granted per contract manufacturer, makes no sense. Lee stated, "This is the fundamental cause of generic proliferation, which undermines the fundamentals of regulatory science. Why do drugs with identical shapes, ingredients, and dosages have different manufacturers, brand names, and packaging?"Lee emphasized, "If one set of BE data exists, marketing authorization should be granted only to that specific pharmaceutical company. As long as this joint BE licensing system remains in place, a structure in which generic substitution is hindered, and generics proliferate, will persist. We should not allow companies to outsource production just by hanging up a 'pharmaceutical company' sign. We must abolish these mismanaged licensing and joint BE policies."Lee explained, "If the licensing policy is corrected, drug price management can also be designed much more rationally. A policy could be designed that grants 'branded generic' rights only to the original and the first generic, while all other generics are authorized as 'no-brand generics' using the ingredient name rather than a brand name," adding, "Policies to increase generic utilization could become possible, and the controversy over INN (International Nonproprietary Name) prescribing would disappear, as the product name itself would be authorized as the ingredient name."Director Lee also believes that to develop Korea-Blockbuster new drugs, Korea’s abundant clinical physician workforce must be funneled into new drug development, where basic science is essential.While the stages of new drug development include discovery, demonstrating efficacy and safety through clinical trials, and obtaining marketing authorization, Lee suggests establishing policies to recruit physicians, one of Korea's greatest strengths, in the actual development of new drugs.Director Lee suggested, "New drugs are not developed by government pricing policies or pharmaceutical companies. They emerge from the advancement of a country's life sciences and the continuous increase in research on new drug substances," adding, "I believe the cultivation of talent for developing new drugs ultimately lies in the utilization of the physician workforce. Implementing administration that actively utilizes Korea's globally powerful resource in the clinical trial field is the shortcut to becoming a powerhouse in new drugs."Lee stated, "We must allow doctors to engage in new drug activities through policies such as designating university hospitals as new drug development centers, providing military service benefits to participating doctors, and expanding national-level support for new drug ventures and startups within those institutions. It is difficult to develop new drugs solely within the pharmaceutical industry or regulatory science. A policy decision is needed to use doctors as the foundation for blockbuster new drugs."Lee added, "Furthermore, we need to consider amending the outdated Pharmaceutical Affairs Act. Korea's Pharmaceutical Affairs Act has not been changed from a generic-centered legal structure since the 1950s. While a pharmaceutical company is defined as one that manufactures and produces drugs, there is no system where a new drug developer can receive product approval as a pharmaceutical company."Lee concluded, "We need to create a Pharmaceutical Affairs Act to manage pharmaceutical personnel, have a Drug Safety Management Act handle synthetic drugs and new drug approvals, and separate biological products from synthetic drugs through a "Biopharmaceutical Act" or an "Advanced Biologics Act," adding, "This is a matter that requires a shift in the government's regulatory paradigm. It is time to consider shifting the manufacturer-centered Pharmaceutical Affairs Act into a basic act and separately operating laws for drug distribution management, synthetic drug licensing, and biological products."
- Opinion
- ‘Revisiting Xeljanz safety concerns based on accumulated long-term data’
- by Son, Hyung Min Mar 31, 2026 08:45am
- Eun-mi Song, Professor of Gastroenterology and Hepatology, Ewha Womans University Seoul HospitalAs treatment strategies for ulcerative colitis shift toward maintaining long-term remission, the criteria for selecting treatment options are also changing.In particular, as Janus kinase (JAK) inhibitors establish themselves as key treatment options alongside biologics, safety concerns surrounding Pfizer’s ‘Xeljanz (tofacitinib),’ including major adverse cardiovascular events (MACE) and thrombosis, have been consistently raised.Amid this context, as results from domestic cohort studies involving Korean patients accumulate, there is a growing movement to reassess its safety in real-world clinical settings.Professor Eun-mi Song of the Department of Gastroenterology at Ewha Womans University Seoul Hospital, who led this study, recently told Daily Pharm, “Initially, there were significant concerns about side effects due to the mechanistic characteristics of JAK inhibitors. Looking at actual clinical data, contrary to expectations, the safety profile is comparable to that of existing biologics.”Ulcerative colitis is a disease characterized by chronic inflammation of the colon's mucosa, with recurring symptoms including diarrhea, bloody stools, and abdominal pain. Unlike acute colitis, it is a chronic condition with no clear cause that involves repeated cycles of remission and relapse, requiring many patients to continue treatment for the rest of their lives.The number of patients in Korea is also rapidly increasing. Due to Westernized dietary habits and environmental changes, prevalence is rising, particularly among younger patients aged 20–40. As the number of patients in this age group increases, which is highly active in society, the need for long-term disease management also grows.At the same time, the treatment landscape is evolving. While a step-up strategy, gradually increasing treatment intensity, was previously the norm, an ‘accelerated step-up’ strategy, which adjusts treatment intensity more quickly based on the patient’s condition, is now being applied in clinical practice. Treatment goals are also evolving beyond simple symptom relief toward the fundamental suppression of inflammation, such as achieving endoscopic remission.The problem lies in the high recurrence rate. Since more than 80% of patients experience recurrence and some progress to severe disease, the continuity of treatment, which maintains stable suppression of inflammation even after initial remission, is identified as a key factor determining long-term prognosis.Accordingly, efforts are ongoing to establish strategies for maintaining long-term remission while also validating drug safety in real-world clinical settings.In particular, JAK inhibitors have faced persistent safety concerns since their introduction, including risks of MACE, thrombosis, infections, and malignancies.However, it has been pointed out that these risks were primarily derived from data on rheumatoid arthritis, which involves a large proportion of elderly patients, and that there are limitations to applying them directly to the ulcerative colitis patient population, which has a relatively high proportion of younger patients.Furthermore, in actual clinical practice, the patterns of adverse reactions may vary depending on patient comorbidities, age, and concomitant therapies, reinforcing the need for the collection of real-world data from domestic patient populations.Against this backdrop, a large-scale population-based cohort analysis was conducted in Korea. Using data from the National Health Insurance Service (NHIS), the study compared the risk of serious adverse events (SAEs) between the Xeljanz group (521 patients) and the TNF inhibitor group (1,295 patients) in patients with moderate-to-severe ulcerative colitis from May 2019 to April 2022.Analysis revealed that the overall incidence rate of SAEs was 4.41 per 100 person-years in the Xeljanz group and 5.33 in the TNF inhibitor group, showing no statistically significant difference between the two treatment groups. In particular, no differences were observed between the groups in the risk of thromboembolism, opportunistic infections such as herpes zoster and tuberculosis, or malignancies.Professor Song stated, “The occurrence of complications is influenced more by individual risk factors, such as the patient’s age or underlying conditions, than by the drug itself. If treatment and monitoring are conducted in conjunction with consideration of each patient’s risk level, Xeljanz is a viable long-term treatment option.”Q. Given the reimbursement criteria, the top-down approach seems ideal, but the step-up approach still predominates in real life.In Korea, ulcerative colitis treatment is moving toward an ‘accelerated step-up’ approach, which is a practical compromise between top-down and traditional step-up strategies. This involves closely monitoring patient response and rapidly escalating to more potent therapies when initial treatments are insufficient, enabling early remission.In the past, treatment typically began with 5-aminosalicylic acid (5-ASA) agents, followed by sequential use of immunomodulators in a stepwise approach; however, in recent practice, steroids or immunomodulators are used from the outset in patients with severe symptoms. In particular, if the disease continues to worsen despite this initial intervention, biologics or small-molecule agents (JAK inhibitors) such as Xeljanz are introduced early on, in accordance with domestic health insurance reimbursement criteria.Q. When considering switching, what specific criteria are used to make the change?Disease severity is the primary factor. Physicians assess symptom severity, endoscopic inflammation, and laboratory results to evaluate disease status. The first criterion is selecting the treatment with the highest expected efficacy based on severity, followed by safety considerations.The criteria for selecting ulcerative colitis treatments have evolved to comprehensively consider not only the patient’s clinical characteristics but also safety in relation to comorbidities, as well as the patient’s individual preferences and lifestyle patterns. While treatment options were limited in the past, the recent introduction of new drugs with diverse administration routes and schedules has made it possible to design sophisticated treatment plans tailored to each patient’s specific situation.Q. How was the Xeljanz cohort study conducted?This large-scale, population-based cohort study of Korean ulcerative colitis patients was designed to directly compare Xeljanz with TNF inhibitors, which have been in clinical use for a relatively long period and are considered to have an established safety profile, as the control group.The study results confirmed that the safety profile of Xeljanz is comparable to that of existing biologics, namely TNF inhibitors. Initially, due to its mechanism of action, it was anticipated that the Xeljanz group would have a relatively higher risk of viral infections or thrombosis, however, actual analysis revealed no statistically significant difference in the incidence of serious adverse events between the two treatment groups.However, a major limitation of this study is that specific data on initial drug dosing were not obtained during the study, preventing precise analysis of dose-dependent safety and efficacy differences. Previous studies, such as ORAL Surveillance, have already suggested that dosage differences in JAK inhibitors can have a significant impact on safety outcomes, and there remains a possibility that this study could also reveal differences in clinical outcomes based on dosage.Q. Despite the periodic release of safety data on Xeljanz, concerns regarding risks still persist.Even among healthcare professionals, there is a vague fear of complications when prescribing JAK inhibitors like Xeljanz. However, clinical data reported domestically and internationally to date show that these concerns do not translate into actual risks. In conclusion, it has been confirmed that effectively controlling the inflammatory state early on with Xeljanz, which has a potent and rapid effect, actually contributes to reducing the risk of disease-related complications and ensuring long-term patient safety.Furthermore, compared to Western populations, the absolute probability and incidence of thrombosis in Asian patient groups have been observed to be relatively lower. While Western populations exhibit higher thrombosis rates due to factors such as larger body frames and a higher proportion of obese individuals, Asian populations show a similar trend of increased risk compared to the general population, yet the absolute number of cases tends to be lower.Previous safety warnings regarding JAK inhibitors were primarily based on data from rheumatoid arthritis, which involves a large number of elderly patients in their 50s and 60s. However, since the ulcerative colitis patient population consists mostly of younger individuals, the risks of thrombosis and other complications, which were raised in the rheumatoid arthritis data dominated by elderly patients, were found to be relatively lower.Q. Do clinical experiences in actual prescribing practice show similar patterns to study findings in terms of efficacy and safety?Combined results from domestic multicenter studies and real-world clinical experience indicate that the safety concerns raised during the early stages of the introduction of JAK inhibitors, including Xeljanz, do not pose a significant problem in real-world clinical settings. In particular, regarding herpes zoster, which was expected to carry a high risk based on the mechanism of action, no serious safety issues as previously feared emerged, thanks to thorough preemptive vaccination of healthcare providers and close monitoring. On the contrary, the greatest strength of Xeljanz perceived in clinical practice was its very rapid and potent efficacy, providing immediate therapeutic benefits to patients in urgent need of rapid symptom improvement.Q. What are the limitations of the current treatment environment, including reimbursement?While Western practice emphasizes top-down strategies for improved long-term outcomes, Korea faces practical constraints regarding the application of early, potent treatment due to the National Health Insurance system and financial limitations.Thus, greater flexibility in enabling early use of potent therapies, especially for severe patients, is considered essential for improving treatment outcomes. Furthermore, recent accumulated data have demonstrated that switching between different JAK inhibitors yields clinically significant efficacy. Consequently, it is anticipated that switching between different JAK inhibitors, even if a patient shows an inadequate response to a specific JAK inhibitor, may provide meaningful clinical benefits, offering additional options for patients who do not respond adequately to a specific agent.Q. What is the clinical significance of JAK inhibitors in ulcerative colitis?Despite their relatively recent introduction, small-molecule therapies have become a core pillar, playing a central role in the treatment of ulcerative colitis. While there was once a vague apprehension regarding these treatments even among clinicians, the experience and data shared by professors who have prescribed drugs such as Xeljanz in actual clinical practice confirmed that the risk of complications, which had been a concern, was lower than expected and manageable.In particular, for moderate-to-severe patients who struggled with the burden of even daily outings due to recurring cycles of symptom improvement and flare-ups, oral small-molecule agents, which offer high convenience, have become a practical alternative that dramatically improves quality of life. With the recent expansion of available treatment options to 3 or more, led by the introduction of Xeljanz, and ongoing new drug development, it is crucial for patients to maintain hope and work closely with healthcare professionals to establish a treatment strategy optimized for their individual needs in order to maintain long-term remission.
- Opinion
- [Reporter's View] Advanced cancer patients face Tx gaps
- by Son, Hyung Min Mar 26, 2026 09:29am
- The cancer treatment landscape is shifting rapidly. However, the benefits of this trend are not equally applied to all patients. In particular, patients with advanced cancer repeatedly pushed to the back of the line regarding treatment access, even when viable treatment options exist.The structure is evident in the field of breast cancer. Driven by the expansion of national cancer screening programs, patients with early-stage breast cancer now account for approximately 70% of all cases, many of whom are managed as healthy survivors capable of long-term survival post-treatment. This represents undeniable progress in terms of early diagnosis and clinical outcomes.However, this progress does not translate consistently across all stages of the disease. The issue is not confined solely to metastatic (Stage IV) patients. Limitations in treatment access begin as early as the advanced stages, where the risk of recurrence is high.Disparity is observed in the adjuvant therapy stage. Recently, indications for several therapies were expanded to include adjuvant treatment for early-stage breast cancer, yet reimbursement has failed to keep pace. While regulatory approval has been granted, actual clinical use remains restricted.Adjuvant therapy is designed to suppress recurrence. The key is to preemptively eliminate micrometastases that may remain even after the visible lesion has been surgically removed. Although treatment at this stage can determine long-term prognosis, the current structure makes practical application difficult due to the heavy financial burden on patients.Ultimately, this gap inevitably leads to recurrence. Recurrence is not merely a progression of the disease. Recurrence destabilizes every aspect of a patient's life. As treatment resumes, the burden of medical expenses surges, and constraints on economic activity due to prolonged treatment become unavoidable. The burden of family caregiving also intensifies once again.Given that a significant portion of patients in certain cancer types are in their 40s and 50s, this is not just an individual issue but a cost borne by society as a whole.Despite this, the current system is closer to a model that allocates more resources to managing the aftermath of recurrence than to reducing it. Preventive treatments are restricted due to cost, while the treatment costs and social burdens incurred after recurrence are less considered.Industry experts point to a simple reason. The high volume of patients. As the patient population grows, the fiscal burden increases, ultimately raising the threshold for reimbursement.It does not mean that this issue cannot be disregarded. If the structure of restricting treatment access simply because of high patient numbers persists, the burden will eventually return to the patients and society at large.The problem is that this trend is not limited to a specific cancer type. Adjuvant therapy indications are continuously expanding, not only in breast cancer but also in major solid tumors such as gastric cancer. While treatment strategies to reduce recurrence are evolving rapidly, actual access is failing to keep pace.The issue is not about the availability of treatments. It lies in a structure where access is not granted in a timely manner when treatment is most critical. Therefore, it is time for a more realistic view that sees intervention at the stage of reducing recurrence as a structural necessity rather than a mere cost issue.
- Opinion
- [Reporter's View] KIMES calls for policy making
- by Hwang, byoung woo Mar 26, 2026 09:29am
- 'The 41st Korea International Medical & Hospital Equipment Show (KIMES 2026)' unveiled the Korean medical device trend shift.More companies are showcasing Artificial Intelligence (AI), which is now regarded as essential, and the technology is shifting to 'how AI is utilized.'A prominent feature of this year’s exhibition is the presentation of specific visions for the stage after adopting technology. Rather than simply emphasizing AI's accuracy, major companies provided detailed explanations of interoperability with hospital systems (PACS/EMR), the repurposing of accumulated data, and revenue structures based on Software as a Service (SaaS) models.This means that the medical AI industry has moved past the initial stage of debating 'whether to adopt' and has entered a maturity phase, focusing on clinical utility and sustainable business models. However, a brutal reality confirmed at the show is that this technological advancement is not immediately translating into market expansion.While there is a consensus that new technology is necessary in the field, the pace of implementation often falls short of expectations due to cost burdens and institutional limitations.This trend in the industrial field aligns with the direction of the recently launched "Second Stage of the Korea Interagency Medical Device R&D Project."While the first stage focused on establishing a technological foundation and building a pipeline for domestic medical devices, the second stage clearly defines a 'market entry-centered' support structure that covers clinical trials, licensing, and commercialization to ensure these technologies take root in actual medical settings.It is encouraging that government policy and industrial trends are aligned with the same goal. The second stage serves as a 'verification stage' to confirm whether developed technologies can avoid being shelved and instead have their value recognized in the market. However, industry workers remain concerned about the disconnect between each stage.The reason for this concern is that the process leading from technological development to hospital adoption, reimbursement application, and market expansion often fails to connect organically, frequently stopping at individual stages.Ultimately, the success or failure of the domestic medical device industry will depend not on the perfection of the technology itself, but on how the 'connection structure' is designed to allow that technology to flow into the actual market.Industry experts suggest that leaving the integration of technology entirely to the market may take too long and face inherent limitations. They point out that more proactive consideration is needed, especially since the global market is currently competing on a similar level.In fact, the platform strategies and subscription models emphasized at KIMES will inevitably face constraints on expansion unless the reimbursement system and institutional support functions are provided.The industry goals identified at KIMES 2026 and the policy direction of the second interagency project are in alignment. However, a gap in speed and execution remains between these two trends. How effectively this policy-wise and field-wise gap can be bridged will likely be the key variable determining the global competitiveness and market growth rate of Korea's medical devices in the future.It is now time for policy-making that ensures R&D achievements do not remain confined to show booths but lead to outcomes in patient clinics.
- Opinion
- From pharmacy practice to new drug review
- by Jung, Heung-Jun Mar 25, 2026 07:20am
- Even after a new drug is developed and released to the market, there is one hurdle that must be cleared for patients to fully benefit from it: the National Health Insurance reimbursement listing.How this initial step is handled, in reviewing whether a drug should be covered by health insurance, determines both patients’ access to treatment and the balance of Korea’s insurance budget.The organization guarding that crucial gate is the Department of Drug Management of the Health Insurance Review and Assessment Service (HIRA). It is also one of the operational departments where pharmacists can create synergy based on their understanding of pharmaceuticals.Assistant Directors Jae-young Choi (left) and Jin-woo Song of the New Drug Listing Division, Department of Drug ManagementDailyPharm met with Jin-woo Song (38) and Jae-young Choi (34), assistant directors working in the Department of Drug Management, by drawing on their clinical experience in hospitals and pharmacies. We were able to hear their candid thoughts on what their new roles entail after hanging up their pharmacist’s coats, as well as the challenges and satisfactions they face.Both have been with the agency for 1-2 years. What has your career as pharmacists been like?Jin-woo Song (hereinafter Song): After graduating from pharmacy school in 2023, I worked at the Pharmacy Department of Severance Hospital for 2 years. I gained experience in the Inpatient Dispensing Unit, Special Dispensing Unit, Pharmacy Information Unit, and Outpatient Dispensing Unit before joining HIRA last June.Jae-young Choi (hereinafter Choi): I also have experience working as a night-shift pharmacist at a hospital and in a community pharmacy after graduation. I joined HIRA in December 2024, so it’s been just over a year now.Among various career options, why did you choose to join HIRA?Song: While working at the hospital, I realized that I am well-suited to a well-established system-based institution. I became curious about how reimbursement criteria and procedures for pharmaceuticals are set and decided to move to HIRA.Assistant Director Jin-woo SongChoi: After graduation, I became increasingly interested in social pharmacy. I applied because I became interested in new drug listing and management of already listed drugs to improve patient access to treatments. I found the idea of approaching pharmaceuticals from the public sector appealing.Did you prepare anything specifically in order to join HIRA?Song: Since they make the hiring process very convenient for pharmacists, there was nothing specific I needed to prepare. If you have at least 1 year of experience at a university, research institute, pharmaceutical company, hospital, or pharmacy, you only need to submit a cover letter. The written test is waived. As long as you meet the requirements, you can take the interview, and even upon joining, you are hired at Grade 4 (assistant director).What kind of work are you doing in the Department of Drug Management?Song: I have been working in the New Drug Listing Division since June last year. My work involves the overall process related to reimbursement listing for new drugs. I handle cost-effectiveness reviews related to expanded criteria for risk-sharing agreement drugs as well as assessments of the appropriateness of renewing RSAs for such drugs.Choi: I’m part of the Agenda Team within the New Drug Listing Division. I joined in December 2024, so it’s been just over a year. When I’m assigned cases involving new drugs or RSA drugs, such as applications for reimbursement decisions, requests to expand reimbursement criteria, or evaluations related to contract expiration, I review them based on criteria like clinical utility and cost-effectiveness. I then present those results to the Drug Reimbursement Evaluation Committee.How has your experience in hospitals and pharmacies been helpful?Song: I handled many anticancer drugs and medications for severe diseases at a tertiary hospital. Many of the drugs I encountered back then are now being submitted for reimbursement listing. The drug information, reimbursement criteria, and guidelines I referred to while handling information management tasks have been very helpful.Choi: I worked at a pharmacy until just before joining the agency, so there wasn’t much direct overlap with my current duties. However, having studied pharmacy for many years, my background knowledge helps when exploring new areas.Assistant Director Jae-young ChoiHas your perception of HIRA changed since joining?Song: At first, I worried that the rigid organizational culture might be difficult to adapt to. But after experiencing it firsthand, I found that there is a very horizontal and mutually respectful organizational culture.Choi: It wasn’t until I was about to graduate from pharmacy school that I learned there were pharmacists working at HIRA and that they handled drug management tasks. After joining, I realized that the drug-related work HIRA handles is more diverse than I had imagined.What is the most challenging aspect of your work?Song: Newly launched drugs are expensive, so using them as treatments without reimbursement places a heavy financial burden on patients. We receive many requests for reimbursement, but the challenge is that we cannot simply grant the requests of those who are just waiting for reimbursement.Choi: The fact that I have to continuously study new diseases is both the best part and the most challenging aspect of the job.When do you feel a sense of accomplishment?Song: As part of the New Drug Listing Division’s duties, we review the appropriateness of reimbursement at the DREC. I feel a sense of accomplishment when the reimbursement appropriateness of an item I reviewed is approved.Choi: It’s the moment a new drug I’ve reviewed gets actually listed. I still lack experience and have a lot to learn. Going forward, I want to think more deeply about the social impact as I do my work.Do you have any advice for pharmacy students or pharmacists interested in joining HIRA?Song: While you may be fulfilling various roles in hospitals or pharmacies, there are tasks that can only be performed at HIRA. You’ll likely find a sense of fulfillment and accomplishment here that’s distinct from what you’d experience elsewhere.Choi: Given the nature of our work, I feel we’re doing things that are hard to experience elsewhere. If you’re interested in the public sector beyond clinical practice, I encourage you to apply during our recruitment period.
