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- 2026-07-22 03:12:18
- 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.
- Opinion
- [Desk’s View] On exempting innovative pharmas from price cuts
- by Lee, Tak-Sun Mar 10, 2026 08:56am
- Fostering the pharmaceutical and biotech industry while ensuring the soundness of the national health insurance budget is no easy task.The two are intertwined like a double-edged sword. Cutting drug prices indiscriminately to save money risks stifling the industry, yet allowing skyrocketing drug prices to go unchecked in the name of industry growth will quickly drain the health insurance coffers.That is why the government’s push to cut generic drug prices is undoubtedly a card played as the health insurance coffers are running dry. Yet, it is equally impossible to neglect the pharmaceutical and biotech industry, which is only now beginning to gain stature.The ‘Korea Innovative Pharmaceutical Company’ certification system emerged after long deliberation between fostering industry and maintaining fiscal soundness. The government aimed to identify and nurture the so-called ‘pharmaceutical companies capable of developing new drugs’ through this certification.However, 15 years have passed since the system's establishment in 2011, and one can't help but wonder if it has effectively achieved its original goal of fostering companies. The number of certified innovative pharmaceutical companies has now risen to 49, yet very few have developed drugs capable of competing on the global stage.The pharmaceutical industry claims the current certification doesn't offer ‘significant enough benefits to push promising companies forward.’ Rather, it's seen as merely ‘enough to keep them afloat within their group.’The most significant benefit pharmaceutical companies perceive from the Innovative Pharmaceutical Company certification is preferential drug pricing. Holding this title grants preferential treatment in pricing calculations for first generics or incrementally modified new drugs. For instance, while a standard company's first generic listing is priced at 59.5% of the highest price, an Innovative Pharmaceutical Company can set its price at 68%. Considering that drug prices directly translate to sales revenue, this means that certified companies can earn 7.5% more than non-innovative companies.However, this pricing preference is only a temporary benefit. After one year, the premium disappears, and “non-innovative” pharmaceutical companies end up with the same drug prices as the certified innovative ones.Even so, starting from the same line with even a slightly higher price is undeniably advantageous. This is why many pharmaceutical companies celebrate or despair over the results of the innovative pharmaceutical company review, which takes place every two years.If the innovative pharmaceutical company certification system is to better fulfill its purpose of ‘screening and fostering’ firms, the direction should be to tighten the review standards while expanding the benefits.In other words, the government should identify companies that truly have the capability to develop new global drugs while providing full support until they actually develop them.Some argue that innovative pharmaceutical companies should be exempt from unilateral price cuts made for listed drugs. From the perspective of fostering domestic pharmaceutical companies, this isn't entirely wrong. But would any company spend tens or hundreds of billions of won on new drug R&D while facing the risk of declining sales just to be saved from price cuts on existing drugs? Just for the title of being a certified innovative pharmaceutical company?However, even such benefits, if granted only to the 49 certified innovative pharmaceutical companies, would trigger backlash from non-innovative companies. There is already distrust in the field regarding the standards used to certify innovative pharmaceutical companies.But still, current discussions on drug price cuts for already-listed products and on reforming the innovative pharmaceutical company system need to be somewhat aligned. Rather than pushing through generic drug price cuts in a hasty manner despite strong opposition from the industry, perhaps it would be better to take a little more time and discuss them along with substantive benefits for innovative pharmaceutical companies. At the same time, the criteria for selecting innovative pharmaceutical companies should be reorganized so that they are truly centered on companies that genuinely engage in R&D.From a cautious standpoint, that may be the only way to both foster the industry and maintain health insurance sustainability.
- Opinion
- [Reporter’s View] Era of drugs better known than diseases
- by Son, Hyung Min Mar 10, 2026 08:55am
- A notable shift has recently emerged in clinical practice where drug names are increasingly being known before the diseases they treat.For example, when discussing obesity treatment, many people now think first of ‘Wegovy (semaglutide)’ or ‘Mounjaro (tirzepatide)’ rather than the disease itself. A similar trend is emerging for major immune disorders like atopic dermatitis. This change is also evident in the field of cancer treatment. It is now commonplace to hear specific drug names mentioned before the broader category of immuno-oncology drugs.Whereas diseases were traditionally recognized first, followed by treatments, we now frequently see drugs becoming symbolic markers that define or represent the disease itself.This shift cannot be explained simply by increased brand recognition. As more new drugs actually shift treatment paradigms, these therapies have taken on the role of driving disease awareness.For certain conditions, the emergence of specific treatments has altered diagnostic and therapeutic strategies, leading the drug name to become synonymous with the disease's treatment.The role of pharmaceutical companies has also evolved. Whereas disease awareness preceded the introduction of treatments, it is now common for disease awareness activities to proceed alongside new drug development. With treatment development and disease education occurring simultaneously, the drug name naturally becomes central to shaping disease awareness.The shift does have positive aspects. When innovative treatments emerge for diseases with limited therapeutic options, they inherently attract patient and clinician attention, serving as catalysts for heightened disease awareness. Indeed, for some conditions, social awareness of diagnosis and treatment has increased significantly following the introduction of such drugs.However, there are also concerns. If the structure where drug names become known before the disease itself solidifies, there is a risk that awareness could center around specific treatments rather than fostering a deeper understanding of the disease itself. While medicine inherently evolves through diverse treatment strategies and multiple options, public perception can be simplified around a single brand name.The influence of new drugs continues to grow. At the same time, the role of the pharmaceutical industry is expanding beyond developing therapies to shaping disease awareness itself. This means companies are becoming entities that shape disease perception, going beyond just treatment developers.Consequently, the social responsibility that the pharmaceutical industry must shoulder is also growing. As the influence of new drugs expands, so does the need to examine how this power operates and what its implications mean for the healthcare environment and patients. Now that pharmaceutical innovation can reshape disease awareness itself, the industry must consider its public responsibility towards patients and society, alongside its private corporate interests.
- Opinion
- ‘LEO Pharma serves as a KOR–DEN healthcare bridge’
- by Son, Hyung Min Feb 20, 2026 10:04am
- Korea and Denmark share similarities. Both nations operate universal healthcare systems and face the dual challenges of introducing innovative treatments while maintaining fiscal sustainability. The policy environment in both countries shares the dilemma of preserving public value while promoting research and development.Building on these shared priorities, the two nations have expanded multilayered partnerships involving governments, companies, and research institutions across various healthcare fields, including infectious disease response, aging populations, digital health, and chronic disease management.Established in 2011, LEO Pharma Korea has served as a bridge within the Korea–Denmark healthcare collaboration framework, particularly in dermatology. Through close engagement with Korean clinicians and evidence-based medical research, the company has executed a patient-focused innovation strategy while functioning as a strategic hub connecting the results to the Danish market.Against this backdrop, Frederik Kier, Executive Vice President of International Operations at LEO Pharma, who was appointed in June last year, recently visited Korea. His visit focused on reviewing the Korean subsidiary's strategy and discussing the direction of Korea–Denmark pharmaceutical and biotech collaboration with Mikael Hemniti Winther, Ambassador of Denmark to the Republic of Korea.Dailypharm recently met with Ambassador Winther and Executive Vice President Kier at the Danish Ambassador's residence in Seongbuk-dong, Seoul, to discuss bilateral healthcare cooperation, Korea’s strategic role, and the practical implementation plans for patient-focused innovation.“Designing public value and innovation together”… Emphasizing Korea-Denmark healthcare cooperationMikael Hemniti Winther, Ambassador of Denmark to the Republic of Korea.Ambassador Winther identified how Korea and Denmark's commonality lies not just in systems but in values. He emphasized that both nations have democratic systems and operate their healthcare systems on the basis of social agreement on welfare and public responsibility.Ambassador Winther said, “The Danish government views patients not as customers but as individuals for whom it bears responsibility. Policies are designed around that responsibility.”Denmark established a universal healthcare system early and has operated a healthcare infrastructure centered on public hospitals. Within this structure, pharmaceutical companies have served as a vital link, acting as a critical link that translates public research outcomes into real-world therapies beyond mere supply.He explained, “Denmark has pursued a welfare society relatively early on. Health insurance and the healthcare system serve as its core pillars. The system functions only when high-quality treatments are available for the patients. To achieve this, the government and pharmaceutical companies need to collaborate toward common goals.”He added, “The welfare system entails enormous costs. The key challenge is how to design incentives that encourage innovation while maintaining competition and transparency.”He also emphasized the culture of cooperation between the government and pharmaceutical companies. In Denmark, public research institutes, universities, hospitals, and companies are organically connected, and industry opinions are partially reflected in the system design process.He explained that cooperation between Korea and Denmark can also be understood within this context. The two countries continue policy exchanges across various fields, including infectious disease response, aging populations, and digital health. The embassy regularly communicates with Danish companies operating in Korea.Ambassador Winther stated, “Currently, Danish companies are actively collaborating not only in the pharmaceutical sector but across diverse industries, sharing the fundamental values Denmark upholds. I believe there remains substantial potential for expanded collaboration going forward.”LEO Pharma's execution strategy… Securing leadership in ‘medical dermatology’Frederik Kier, Executive Vice President of International Operations at LEO PharmaEVP Kier described Korea’s importance from an industry perspective. LEO Pharma, he noted, has dedicated more than 115 years to dermatology, defining its mission as leadership in Medical Dermatology.EVP Kier stated, “LEO Pharma aims to become a global leader in dermatology and is offering a broad range of treatment options for patients with skin conditions in Korea. Our existing portfolio includes diverse product lines, from acne therapies to treatment for psoriasis and atopic dermatitis.”Marking its 15th anniversary in Korea, the company has expanded its presence in recent years. One prime example is its atopic dermatitis treatment ‘Adtralza (tralokinumab)’, which received domestic approval in 2023 and was added to the national health insurance reimbursement list in 2024.The EVP explained that Adtralza has secured differentiated data in improving lesions on exposed areas like the head and neck and hands, establishing itself as a meaningful option in clinical practice.EVP Kier said, “The Korean market already has various atopic dermatitis treatment options. Nevertheless, Adtralza deserves attention for its superior efficacy on exposed areas like the head, neck, and hands. These areas are known to be challenging to treat, and it is precisely in these areas that we believe Adtralza provides tangible and meaningful benefits to Korean patients.”LEO Pharma has also secured Korean approval for ‘Anzupgo Cream (delgocitinib),’ a topical pan-JAK inhibitor targeting chronic hand eczema, and added it to its dermatology portfolio. Anzupgo is a topical formulation that inhibits JAK1, JAK2, JAK3, and TYK2 and was developed for patients who do not respond sufficiently to existing therapies.EVP Kier explained, “Chronic hand eczema is an inflammatory disease that persists for more than 3 months or recurs frequently, with a significant patient population not responding adequately to existing topical treatments. It represents a clear area of unmet medical need. Anzupgo Cream demonstrated strong clinical efficacy and was shown to improve multiple eczema symptoms. We are currently in the final stages of preparation for its official launch in Korea.”LEO Pharma is also preparing reimbursement procedures for Spevigo (spesolimab), a treatment for acute exacerbations of generalized pustular psoriasis (GPP). The company recently acquired commercialization rights through a licensing agreement with Boehringer Ingelheim.EVP Kier described the developments as part of building an end-to-end portfolio spanning mild localized diseases to severe and rare dermatologic conditions.EVP Keir specifically highlighted the Korean market as a strategic operational base in Asia. In his view, Korea is not merely a sales market, but an operational hub for data generation through clinical trials involving Koreans and a joint promotional base for raising awareness on the necessity of long-term treatment among healthcare professionals.EVP Keir stated, “Chronic skin diseases are not conditions resolved with short-term prescriptions. Both clinicians and patients must share a common understanding of the need for long-term management.”He added, “LEO Pharma views providing therapies for diseases with significant unmet medical needs as its most important contribution. To further establish leadership in dermatology, we will continue developing new candidates and treatment options within these disease areas.”“Healthcare as both industry and diplomacy”… the need for government–private collaborationThe significance of the discussion extended beyond introducing LEO Pharma’s corporate strategy. Its weight lay in the shared recognition, based on the common ground that both Korea and Denmark are welfare states operating public healthcare systems, of how to design and implement healthcare as a pillar of national strategy.Ambassador Winther said, “Denmark holds Korea's healthcare system in high regard. To address common challenges like aging populations and fiscal burdens, cooperation between the government and private sectors will become increasingly vital going forward. Healthcare is not merely an industry but a policy domain that the state must shoulder responsibility for. We need a structure where intergovernmental policy dialogue and corporate activities are discussed together.”EVP Kier echoed this perspective. “Korea possesses an advanced healthcare system, and its medical professionals demonstrate high understanding and implementation capabilities regarding innovative therapies. LEO Pharma seeks to act not merely as a supplier but as a long-term partner aligned with Korean healthcare professionals.”Both Ambassador Winther and EVP Kier expressed confidence in the expansion of Korea–Denmark cooperation.Another key theme emerging from this discussion was LEO Pharma's expansion of its domestic communication scope.EVP Kier stated, “While engagement previously centered on patient groups in the past, it has recently expanded to include academic exchanges and clinical discussions with Korean medical professionals, broadening the scope of collaboration. This expansion of domestic communication contributes to enhancing understanding within the healthcare field and strengthening the practical implementation capabilities for innovative therapies.”EVP Kier also added that certain skin conditions significantly impact patients' social lives and work performance. He remarked, “These conditions require greater attention from the medical community and society at large. LEO Pharma will continue being committed to introducing innovative new drugs to Korea.”Ambassador Winther said, “Korea and Denmark face significant demographic and economic challenges. Through close cooperation among health authorities, governments, and the private sector, both nations can share experience and deliver greater benefits to patients,” he stated.He concluded, ”The values shared by companies rooted in Denmark are reflected not only in LEO Pharma's treatments but also in the overall operations of Danish companies in Korea. We hope LEO Pharma's activities will contribute positively to Korean society.”
