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- 2026-06-06 11:22:08
- InterView
- Pneumonia prevention strategies need to be redesigned for the elderly
- by Son, Hyung Min Mar 23, 2026 08:41am
- As pneumonia emerges as a major disease that simultaneously causes death and functional decline in older adults, the need to redesign prevention strategies is growing.In particular, since the prognosis following pneumonia is more severe in older adults, there is a call to shift from a treatment-centered approach after diagnosis to a focus on prevention.Chang-oh Kim, Professor of Geriatric Medicine at Severance HospitalIn a recent interview with DailyPharm, Professor Chang-oh Kim of the Division of Geriatrics at Severance Hospital discussed the clinical risks of pneumonia in older adults, changes in vaccine strategy, and the need to improve the National Immunization Program (NIP).According to Statistics Korea, pneumonia was the third leading cause of death in Korea in 2024, following cancer and heart disease.Given the rapidly aging demographic structure of the country, the disease burden of pneumonia is likely to increase further in the future.In particular, pneumococcal infections carry a high risk of progressing to severe illness in older adults. It is known that the mortality rate from pneumococcal bacteremia among those aged 65 and older is approximately 60%, while meningitis reaches 80%. Even among survivors, there are numerous cases where neurological sequelae or functional impairment persist.Despite this burden, the adult immunization system remains limited. In the Korea Disease Control and Prevention Agency’s prioritization assessment for vaccines to be included in the national program, the pneumococcal vaccine ranked highly for those aged 65 and older, but that priority has not yet been sufficiently reflected in the actual system.Currently, Korea has approved 23-valent polysaccharide vaccine (PPSV23) and 13-, 15-, 20-, and 21-valent protein conjugate vaccines (PCV). In its 2025 recommendations, the Korean Society of Infectious Diseases recommends either a single PCV20 dose or sequential PCV15 and PPSV23 vaccination in adults aged 65 and older and in high-risk groups. This is interpreted as a trend toward reorganizing prevention strategies to focus on serotypes with a high disease burden.Need to expand adult NIP rises… ‘Finer age segmentation also proposed as an option’Professor Kim explains that despite changes in pneumococcal prevention strategies, the institutional framework has not fully reflected these changes.According to Professor Kim, while protein-conjugated vaccines are systematically administered to children through the National Immunization Program (NIP), the system for adults still relies on out-of-pocket payments. This has created a blind spot where adult vaccination is pushed down the priority list.Professor Kim pointed out, “Adult vaccination lies in a blind spot both institutionally and in terms of awareness. Policy support is needed so that prevention can be naturally incorporated into a treatment-centered healthcare structure.”He particularly stressed the need for a more finely segmented age-based approach. Professor Kim explained that while older adults are currently defined as those aged 65 and older, in actual clinical practice, functional decline often becomes distinctly apparent after the mid-70s.Professor Kim said, “While the number of vaccines intended for inclusion in the NIP is continuously increasing, financial limitations also exist. In that respect, a more realistic approach would be to segment age criteria more finely.”He added, “Considering the disease burden, hospitalization rate, severity, and functional decline in older adults, the social and economic benefits that can be gained through vaccination are substantial. We need to more actively consider expanding adult NIP. “Pneumonia in older adults: the problem lies after onset, not in diagnosis”Professor Kim defined pneumonia in older adults not as a simple infectious disease but as “a disease that can lead to risk of death and long-term functional decline.”In older adults, age-related decline in immune function acts as a basic vulnerability factor. As immune defenses weaken, pathogens such as pneumococcus can invade more easily, and even after infection, the inflammatory response cannot be effectively controlled, making severe progression more likely. The risk is further exacerbated by the presence of various underlying conditions, such as diabetes, cardiovascular disease, and chronic lung disease.The nonspecific nature of clinical symptoms is also cited as a problem.Professor Kim explained, “In elderly patients, typical pneumonia symptoms like fever or cough often do not appear; instead, they frequently seek medical care due to impaired consciousness or generalized weakness. As a result, delays in diagnosis and treatment are common.”Aspiration risk due to impaired swallowing function is also a major factor. Food or secretions can enter the airway and lead to aspiration pneumonia, which further increases disease severity.Above all, functional decline after recovery remains a major issue. Even if the infection itself improves, many patients experience reduced muscle strength and physical function, leading to a significant decline in their ability to perform activities of daily living, and many do not recover to their prior state.Kim emphasized, “In older adults, the prognosis following the onset of pneumonia is more critical than the pneumonia itself. This is why we must shift from a treatment-centered to a prevention-centered approach.”He added, “The key in pneumococcal prevention is not only preventing what happens after invasive infection occurs, but also reducing pneumonia itself by suppressing bacterial colonization and transmission at the mucosal stage.”He also mentioned changes in vaccine strategy. Recently, prevention strategies have evolved with the emergence of vaccines such as the 20-valent pneumococcal conjugate vaccine (Prevnar 20) that offers expanded serotype coverage. Compared with PCV13, PCV20 includes seven additional serotypes—8, 10A, 11A, 12F, 15B, 22F, and 33F—selected with consideration of invasive disease potential, disease severity, and antibiotic resistance.Professor Kim explained, “In the past, polysaccharide vaccines garnered attention due to the large number of serotypes they covered, but today, reducing infections through mucosal immunity has become more important. Protein-conjugated vaccines have now advanced to a stage where they can sufficiently fulfill this role.”He continued, “Considering these factors, the Korea Society of Infectious Diseases also recommends the 20-valent vaccine, and I believe discussions on improving the National Immunization Program (NIP) should be made based on these recommendations.”Korean studies have also shown that about 51% of adult invasive pneumococcal disease is caused by serotypes included in PCV20, supporting the importance of prevention strategies that reflect the actual disease burden.Professor Kim emphasized, “There are more than 100 pneumococcal serotypes, but what matters is not the number but how many of the serotypes with a high disease burden are covered. If dominant serotypes are covered, even a limited number of serotypes can prevent a significant portion of all infections.”
- InterView
- [Reporter’s View] MOHW-Industry clash over reform plan
- by Lee, Jeong-Hwan Mar 17, 2026 09:22am
- The biggest justification for the drug pricing reform plan, which the Ministry of Health and Welfare is accelerating, is “improving the structure of the domestic pharmaceutical industry with a focus on domestically developed new drugs.”Minister Eun Kyoung Jeong and Second Vice Minister Hyung-Hoon Lee have expressed their ambition to create a drug pricing environment that properly rewards pharmaceutical companies that generate innovative value through new drugs, as well as those that are willing to develop medicines essential for public health and life despite low profitability.The ministry has also emphasized the need for a swift overhaul of Korea’s pharmaceutical ecosystem, in which more than 100 companies obtain generic approvals for each active ingredient in a scattered and individual manner, resulting in excessive sales-promotion competition.The domestic pharmaceutical industry, however, is strongly opposing the reform plan, questioning its effectiveness. Companies that have built clinical achievements in new drugs and improved drugs and contributed to the development of Korean new drugs argue that the reform plan, which centers on price cuts for already listed generics and preferential pricing for innovative pharmaceutical companies, will, in fact, bring considerable regression to the domestic pharmaceutical industry.They point out that both the reform plan first unveiled by the Ministry on November 28 of last year and the revised version presented at the Health Insurance Policy Deliberation Committee’s subcommittee meeting on the 11th of this month are far removed from policies that genuinely benefit the “real pharmaceutical companies” that have demonstrated tangible achievements in advancing the domestic pharmaceutical industry and improving public health.A closer look at the domestic industry’s position shows that there is no disagreement with the broad policy direction of rewarding companies that have produced new drug R&D outcomes and contributed to manufacturing drugs vulnerable to supply instability, while cutting prices for those that have not, thereby encouraging new drug creation and a stable supply of essential medicines.The problem is that the Ministry of Health and Welfare’s reform plan cannot escape criticism that “the devil is in the details”—a cliché, but one that rings true.The main point of criticism from pharmaceutical companies regarding the Ministry’s reform plan is the “price cuts for already listed generics.”The Ministry has proposed a policy that uniformly cuts the prices of already listed generics without significant differentiation between pharmaceutical companies that have consistently maintained innovation and continued financial investment, and those that have relied on contract manufacturing of generics to generate profits.That is precisely the clause in the reform plan first disclosed on November 28 last year, which proposed lowering the current generic pricing ratio of 53.55% uniformly to the 40% range.Later, in the revised proposal presented at the HIPDC subcommittee on the 11th, the ministry adjusted the generic pricing ratio from the 40% range to the low-to-mid 40% range, while at the same time establishing a provision to temporarily defer price cuts for already listed generics for certified innovative pharmaceutical companies and companies deemed equivalent to innovative pharmaceutical firms.However, this was accompanied by a proviso stating that the deferment would not apply to ingredients with ‘21 or more listed products.’Pharmaceutical companies argue that the price reduction deferral for innovative pharmaceutical companies does not offer significant merit or benefit, and that, given the proviso regarding the 21-product threshold, the actual benefit effectively converges to zero.They argue that the price reduction deferral provision for innovative pharmaceutical companies appears, at first glance, to be a perfectly fine and sweet piece of fruit, but when you cut it open and look inside, it is rotten to the core—a regulation that has no real substance.Pharmaceutical companies also express dissatisfaction with the preferential drug pricing regulations designed by the Ministry of Health and Welfare, claiming that they are constrained by a piecemeal surcharge system and cannot generate any substantial price benefits, no matter how hard they try. The logic goes that if the government truly wants to build an innovative pharmaceutical ecosystem, it must go beyond mere drug price markups. Through inter-ministerial consultations, the government needs to dramatically strengthen tax benefits and create policies that allow pharmaceutical companies to see tangible benefits, such as regulatory exemptions for those contributing to the production of high-quality medicines, so that companies can generate profits that can then be reinvested into new drug R&D.Then why are the Ministry of Health and Welfare and the pharmaceutical industry clashing so sharply over the same reform plan when they share the same policy objective?Ultimately, it is due to insufficient public-private consultation between the government and the industry before the draft reform plan was disclosed on November 28, resulting in a drug pricing system that started strong but fizzled out.Despite growing backlash from the pharmaceutical industry immediately after the draft was released, the Ministry of Health and Welfare did not engage in any meaningful consultations with pharmaceutical companies until the revised proposal was prepared. The only face-to-face case between the ministry and the pharmaceutical industry was a single working-level consultation in which officials from around 20 pharmaceutical companies were gathered and asked to submit fragmented opinions.Multiple pricing managers at pharmaceutical companies say, “We have worked in market access and drug pricing policy for 10 or even over 15 years, but we have never seen the ministry put forward such a sweeping and unilateral drug pricing reform plan and then make so little effort at mutual consultation.”There is also strong criticism saying, “We don’t understand why the Ministry is turning a deaf ear and continuing with unilateral administration. If this continues, a pricing system will be established in which generic prices for domestic pharmaceutical companies are cut in order to fund innovative new drugs from global pharmaceutical companies. That would be the exact opposite of the ministry’s stated policy goal of fostering the domestic pharmaceutical industry and building a pharmaceutical environment based on new drugs.”There are even accusations that the ministry is merely kowtowing to the Trump administration’s pressure regarding reciprocal drug tariffs, having drafted a drug pricing reform plan out of fear of offending the US, and is now refusing to respond to any requests for revisions.The one thing the domestic pharmaceutical industry is asking of the ministry is a pause on the drug pricing reform plan that has been pushed forward hastily without mutual consultation.Pharmaceutical companies are calling on the ministry that, if it truly intends to design and operate the reform plan with the real goal of pharmaceutical industry innovation, it should stop insisting on a unilateral and coercive proposal and instead set a final timetable even now, promptly launch a public-private joint governance framework on the drug pricing reform plan, and derive a fully revised version.The unwavering stance of solid domestic pharmaceutical companies dedicated to innovation is that the reform plan and amendments presented by the Ministry of Health and Welfare to date are absolutely insufficient to create global blockbuster-level domestic new drugs, resolve crises involving essential medicines and medicines with unstable supply, solve the problem of generic drug proliferation, and eradicate rebate competition caused by pharmaceutical companies trapped in contract generic manufacturing, all of which are necessary to protect both a healthy domestic pharmaceutical environment and the public’s right to health.The words of one pricing manager that I heard while covering the reform continue to ring in my ears. “If the goal of this price cut is simply to reduce drug spending in the National Health Insurance budget, then there is nothing more to say. But we cannot agree at all with the ministry’s claim that its administrative rationale is preferential treatment for innovative pharmaceutical companies and building a new drug ecosystem. If the goal is to foster the pharmaceutical industry and reward real pharmaceutical companies, why are drug prices being cut across the board? Why does the ministry insist on turning a blind eye to the reality where only global big pharma companies end up laughing while domestic pharmaceutical companies are sweating bullets, calculating their losses? Rather than engaging in media stunts, wouldn’t it be the proper attitude for an administrator to put their heads together with industry practitioners and design a proper system?”
- InterView
- ‘Broader access to CAR-T cell therapy needed for DLBCL’
- by Son, Hyung Min Mar 12, 2026 08:34am
- Diffuse large B-cell lymphoma (DLBCL) is a highly aggressive hematologic malignancy in which a significant number of patients achieve a cure with first-line therapy, but prognosis worsens sharply once relapse or treatment resistance occurs.In particular, patients who relapse or become refractory within 12 months after first-line therapy often struggle to achieve meaningful outcomes with conventional high-dose chemotherapy followed by autologous stem cell transplantation alone. Experts therefore stress the importance of shifting treatment strategies at an earlier stage.Against this backdrop, Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel) is emerging as a new alternative based on clinical evidence accumulated in second- and third-line treatment settings.Professor Yun-seok Choi of Seoul St. Mary’s Hospital and Tony Li, Executive Director and Head of Medical Affairs at Kite International Region (Gilead’s oncology subsidiary), emphasized in a recent meeting with Dailypharm, “For DLBCL, the time to relapse and the number of treatment lines directly correlate with prognosis. This is why we must actively consider introducing CAR-T cell therapy at the second-line treatment stage.”Tony Li, Head of Medical Affairs at Kite International Region; Yun-seok Choi, Professor of Hematology-Oncology at Seoul St. Mary’s HospitalDLBCL is the most common subtype of aggressive non-Hodgkin lymphoma. Despite the standard first-line therapy R-CHOP (rituximab, cyclophosphamide, vincristine, prednisone), a substantial number of patients either relapse or become refractory to treatment.The problem is that after just one relapse, treatment response rates and survival prospects decline rapidly. High-dose chemotherapy and autologous hematopoietic stem cell transplantation, which have been the mainstay second-line therapy, require stringent patient selection and still carry a considerable risk of relapse even after treatment.In Korea, Yescarta was approved in August last year for DLBCL and primary mediastinal B-cell lymphoma (PMBCL), and its reimbursement criteria were established in January for third-line treatment by the Cancer Disease Deliberation Committee. However, reimbursement criteria for second-line use in patients who relapse or become refractory within 12 months of first-line therapy have not yet been established.Experts highlight unmet needs in the DLBCL treatment landscape, emphasizing the clinical value of Yescarta and the need for earlier CAR-T introduction in the second-line setting.Q. What are the practical difficulties or limitations of conventional treatments for DLBCL patients who relapse or become refractory after first-line therapy?[Professor Choi] Traditional second-line therapy consists of high-dose chemotherapy followed by autologous stem cell transplantation. However, this approach can only be applied to patients who meet certain conditions, such as being relatively young and having good overall health. Furthermore, relapsed DLBCL is often biologically aggressive, making treatment challenging.[Executive Director Tony Li] Standard first-line regimens like R-CHOP are highly effective, with about 70% of patients achieving a cure. However, treatment becomes increasingly difficult for patients with relapsed or refractory disease. Cure rates inevitably decline with each subsequent treatment line.Stem cell transplantation requires high-dose chemotherapy before the transplant, meaning patients must be in excellent physical condition to endure the entire process. They must be able to withstand the process of receiving anticancer treatment, responding to it, and then undergoing the transplant. Even among patients who successfully undergo transplantation, about 50% eventually relapse, and the prognosis for these patients is not optimistic.Q. In some countries, CAR-T or bispecific antibodies are reimbursed as second-line therapy. What clinical value does Yescarta have in real-world practice?Tony Li[Executive Director Tony Li] Yescarta has been approved in more than 20 countries and is recommended as a Category 1 option for second-line treatment of DLBCL in the National Comprehensive Cancer Network (NCCN) guidelines. This demonstrates that Yescarta has established itself as an evidence-based treatment option in the global clinical setting.Yescarta’s efficacy as a second-line therapy was demonstrated in the ZUMA-7 clinical trial. In this prospective controlled trial comparing Yescarta with standard stem cell transplantation therapy, Yescarta achieved results surpassing the existing standard therapy for the first time in 25 years. The median event-free survival (EFS), the primary endpoint, was 8.3 months in the Yescarta group, representing a significant improvement of approximately four times compared to the 2 months observed in the transplant group.It is also the first and only currently available CAR-T therapy to demonstrate statistically significant overall survival (OS) in a second-line setting.The drug also has accumulated meaningful long-term data. ZUMA-7 has accumulated nearly four years of follow-up data, showing a flattening of the OS curve. In the third-line setting, the 5-year follow-up results from ZUMA-1 confirmed that approximately 43% of patients survived, suggesting the potential for long-term survival.[Professor Choi] DLBCL is a disease with a high likelihood of death if the condition is not adequately controlled in the first line. This is the natural course of DLBCL observed in clinical practice.Even when high-dose chemotherapy followed by autologous stem cell transplantation is performed, the success rate is about 50%, meaning the number of patients rescued by this treatment is limited. In ZUMA-7, the OS curve for the standard-treatment group did not reach a complete plateau.In this context, Yescarta demonstrated statistically significant survival benefits compared to standard treatment, reducing the risk of death. Particularly significant is that CAR-T therapy has, for the first time in the history of DLBCL salvage therapy, presented survival data in a patient population with high mortality risk.Furthermore, the 5-year follow-up analysis of ZUMA-1 reported a 5-year OS estimate of 42.6% for patients treated with Yescarta. This suggests that approximately 4 out of 10 patients can expect long-term survival. Additionally, the fact that Yescarta demonstrated a survival benefit in the second-line setting in the ZUMA-7 study is also significant.Q. In January, reimbursement criteria for third-line Yescarta were established. How might this change third-line treatment strategies?[Professor Choi] Comparing the OS curves, Yescarta's data shows a relatively higher position compared to Kymriah (tisagenlecleucel). Although this was not confirmed through a direct head-to-head trial, many clinicians believe Yescarta may have stronger anti-lymphoma activity, not only in DLBCL but also in follicular lymphoma. This perception could influence drug selection decisions to some extent going forward.Another factor is that Yescarta transports cells to manufacturing facilities without freezing them, which reduces certain regulatory burdens associated with human cell handling permits (such as GMP) required for some CAR-T therapies, potentially enhancing accessibility from the healthcare provider's perspective. This characteristic could also influence future drug selection and market share to some extent.Q. I understand that some countries overseas have approved Yescarta’s reimbursement as a second-line treatment. What are the benefits of using Yescarta in second-line therapy?[Executive Director Tony Lee] In the A8 countries referenced by Korea for drug pricing, Yescarta is reimbursed for both second- and third-line treatments. Clinical study results have consistently shown that using CAR-T therapies at earlier stages is associated with superior treatment outcomes. This trend was reported in studies ranging from ZUMA-1 to ZUMA-7.Additionally, the ZUMA-12 study, which evaluated Yescarta's efficacy in the first-line treatment of LBCL patients, also yielded positive results. The ZUMA-23 study, comparing standard therapy with Yescarta in first-line treatment, is also underway.The healthier the T cells, the higher the likelihood of producing effective CAR-T therapies. This is because patients are less exposed to chemotherapy at earlier stages, meaning their overall condition is likely better, and their immune function is more preserved. These conditions provide the rationale for earlier use of CAR-T therapy, as better treatment outcomes can be expected when CAR-T is administered under such circumstances.Q. Why is reimbursement for Yescarta necessary in second-line treatment?Yun-seok Choi[Professor Choi] Yescarta is a therapy that has demonstrated clinical efficacy in the second-line setting through clinical studies. Based on this evidence, it is evaluated as a meaningful treatment option for clinicians.For immunotherapies that rely on T-cell activation, T-cell fitness is extremely important. While it is challenging to quantitatively assess a patient's T-cell status, this remains an area of ongoing research.Anticancer drugs used in lymphoma treatment are agents that can selectively affect lymphocytes. Therefore, the more a patient is repeatedly exposed to anticancer therapy, the more the fitness of the patient's T cells, which serve as the material for CAR-T, or the patient's own T cells that should attack cancer cells when dual-specific antibodies are administered, inevitably decreases.Considering this, T-cell–based immunotherapy should ideally be introduced earlier, when immune function is still relatively preserved. Applying CAR-T therapy under normal immune conditions can yield better treatment outcomes, offering advantages in terms of long-term patient prognosis and quality of life.Reimbursement decisions should also consider treatment outcomes rather than focusing solely on drug prices. Patients who responded well in the ZUMA-1 and ZUMA-7 studies were able to return to daily life and resume economic activity. Given the unique disease course and therapeutic innovation in DLBCL, reimbursement decisions should proceed more quickly.Q. With the emergence of various new drugs like bispecific antibodies and early-stage CAR-T cell therapy, treatment options have broadened. Specifically, what are the criteria for patient groups where early-stage CAR-T therapy is deemed more urgent and suitable than conventional standard therapy?[Professor Choi] Patients at the second-line treatment stage, particularly cases where patients relapse within 12 months after first-line therapy. Through large-scale clinical trials, only Yescarta demonstrated effective results in patients who relapse or become refractory within 12 months after first-line treatment. It is the sole option with an approved indication for this patient group. Bispecific antibodies currently lack prospective evidence focused specifically on this patient population.However, CAR-T is not an immediately available treatment, requiring turnaround time (TAT).Should evidence for bispecific antibodies accumulate in the future, making both options available, clinicians will need to carefully consider treatment strategies. A cautious approach is warranted, weighing CAR-T's TAT against the biological aggressiveness of DLBCL in the relapse patient population and the rationale for bispecific antibodies in this setting.Q: What insights do you believe the global experience accumulated with Yescarta could provide for the domestic treatment environment?[Executive Director Tony Lee] The approval of Yescarta as a third-line therapy in Korea is a significant advancement, which can serve as a starting point that can open new treatment opportunities for both patients and healthcare providers. As experience with Yescarta accumulates in the third-line setting, we expect Korean healthcare providers' understanding of the drug's efficacy and characteristics to deepen.In addition, real-world data (RWD) continue to accumulate globally, and this evidence may support future discussions on second-line reimbursement in Korea. Given that approval and reimbursement have already been granted in several countries, we anticipate that discussions in Korea will also proceed based on an evaluation of the drug's clinical value.Q. How do you expect the DLBCL treatment landscape to evolve?[Professor Choi] About 70% of DLBCL patients can expect cure, but the remaining 30% fall into a high-risk group. Future research will likely focus on more precise identification of high-risk patients and tailored treatment strategies based on risk level.In particular, we anticipate a shift where T-cell-based immunotherapies, such as CAR-T, move to earlier treatment lines and are introduced earlier for high-risk patients.
- InterView
- [Reporter’s View] Precision over severity required for the GMP regulation
- by Hwang, byoung woo Mar 11, 2026 08:29am
- The system for revoking GMP (Good Manufacturing Practice) compliance certification is approaching a turning point.This policy, often referred to as a “one-strike-out” rule, reflects the government’s intention to apply a zero-tolerance principle against companies that obtain GMP certification through intentional data manipulation or fraudulent means.The system was born in response to incidents of arbitrary manufacturing, where companies falsified manufacturing records and produced drugs disregarding established procedures.The government’s intent is understandable. GMP is the most fundamental system underpinning trust in the pharmaceutical industry, and it is only natural that strict standards are applied to quality control in the manufacturing process.Some evaluations suggest that implementing this system has elevated the status of quality control organizations within pharmaceutical companies and provided an opportunity to reorganize their data and documentation management systems.However, as time passes, new questions have emerged in the field. There is growing reflection on whether strong regulations are actually functioning in a way that strengthens the quality culture.Some in the industry point out that the regulatory structure, which fails to sufficiently differentiate the types and severity levels of GMP violations, may not align with on-site realities.Questions are being raised about whether it is reasonable for intentional quality manipulation or serious manufacturing violations to be discussed within the same regulatory framework as simple management oversights, without distinguishing their relative gravity.For these reasons, discussions are currently underway in the National Assembly to amend the Pharmaceutical Affairs Act, proposing the introduction of intermediate measures within the system for revoking GMP certification. The core focus is on refining the units of administrative penalties that can be imposed for GMP violations beyond the current system.There is also growing interest in whether such discussions can preserve the intent of the system while adding greater regulatory precision.In fact, global pharmaceutical regulatory environments have recently been moving toward risk-based management. This approach determines the level of response by comprehensively considering factors such as the intent of the violation, its impact on patient safety, and the likelihood of recurrence.Compared to the US or Europe, which apply regulations in stages depending on the severity of the violation, the one-strike-out system has drawn criticism that it could excessively stifle the field, regardless of its necessity.Of course, this does not mean deregulation is the solution. Pharmaceutical quality regulation is an area where public trust can collapse from a single incident.Therefore, what matters more than the intensity of regulation itself is its precision. Quality regulation should function not as a system that stifles the field, but as one that strengthens a culture of quality.The GMP one-strike system also faces the same question. Beyond delivering a strong message, it needs to be examined whether it actually functions as a policy that improves real quality standards.Ultimately, what matters is not the mere existence of regulation, but the direction it creates. This reporter hopes that the proposed reform will bring the precision needed to both breathe life into the industry and safeguard the final bastion of pharmaceutical safety.
- InterView
- [Reporter’s View] Polypharmacy management no longer a pilot project
- by Jung, Heung-Jun Mar 04, 2026 05:41pm
- Launched in 2018 as the “Proper Medication Use Support Program,” the National Health Insurance Service’s polypharmacy management project has now entered its ninth year.Although it remains designated as a pilot program, the time has come for the government to make the decision and transition it into a full-scale program.With the Integrated Care Support Act taking effect this year, the government must expand community-based medical and care services. This is a critical window to formally incorporate the polypharmacy management program, which has long remained outside the institutional mainstream.Elderly individuals who require integrated care services often take multiple medications due to frequent hospitalizations or outpatient visits. To achieve a truly home-centered, integrated care model, proper management must begin at an earlier stage.In other words, minimizing medication-related issues that arise (or may arise) as elderly patients move between medical institutions and home is essential to improving the overall quality of home-based services.For this reason, the hospital-based polypharmacy management model should be prioritized for transition to a full-scale program. Since 2020, participation and patient coverage have steadily expanded, while multidisciplinary collaboration among physicians, pharmacists, and nurses has become well established.Because the program operates through inpatient/discharge and outpatient models, it can significantly contribute to managing patients returning to their residences after receiving medical services.If the support is integrated care for elderly patients who have already received primary management, local governments can provide the service relatively easily. It also enables a smoother link between hospital-based and community-based models.The effectiveness of the polypharmacy management program has been sufficiently demonstrated over the past 9 years. Research results show not only a reduction in the risk of adverse drug reactions but also cost savings.Considering the financial benefits from reduced patient readmissions and additional outpatient visits, the budget required for full-scale implementation would not be substantial.At a time when the sustainability of the national health insurance system is becoming increasingly important, strengthening polypharmacy management can serve as a safeguard against unnecessary spending. While expanding participating institutions remains important, the program should now be scaled into a nationwide service through full implementation.A pilot program is meant to test effectiveness and reduce trial and error. After 9 years of validation, it is now time to transition to full-scale implementation, starting with the hospital model and gradually incorporating insurance funding.
- InterView
- "Precision medicines accelerate for treating atopic dermatitis"
- by Son, Hyung Min Feb 26, 2026 07:47am
- Korea's treatment landscape for atopic dermatitis is facing a clear turning point. For the past 10 years, treatment strategies have centered on moisturizers, topical therapies, and immunosuppressants, which have remained the standard of care. The rapid introduction of new drugs, such as biologics and JAK inhibitors, is fundamentally changing the management of moderate-to-severe patients.Professor Yang-Won Lee of the Department of Dermatology at Konkuk University Medical CenterProfessor Yang-Won Lee of the Department of Dermatology at Konkuk University Medical Center, recently appointed as the President of the Korean Atopic Dermatitis Association, emphasized, "We have entered an era where the paradigm of atopic treatment is shifting," adding, "Insurance, policy, and clinical applications must be adjusted by reflecting the changes in patient groups and waves of new drug introductions."The patient population for atopic dermatitis in Korea has changed significantly compared to the past. The prevalence has increased, and in particular, the proportion of adult atopic patients has expanded greatly, making a realignment of treatment strategies inevitable. Adult patients face long disease courses and a high proportion of chronic cases, creating a need for long-term treatment options that satisfy both safety and efficacy.Related to this, the successive launches of biologics have provided a new alternative. Following the introduction of 'Dupixent (dupilumab, an IL-4/IL-13 inhibitor)' as the first interleukin agent in 2018, various biologics, including LEO Pharma's 'Adtralza (tralokinumab, an IL-13 inhibitor)', have emerged, expanding treatment options incomparably compared to the past.With the addition of new drugs that are Janus kinase (JAK) inhibitors, the field of systemic treatment for moderate-to-severe patients has effectively entered a new phase.However, despite the expanded treatment options, the common consensus in the field is that patient accessibility remains limited.Professor Lee identified the 'restriction on switching therapies' as an area for improvement. While switching between biologics and JAK inhibitors has been permitted under certain conditions, switching within the same class remains prohibited, which is pointed out as narrowing the range of choices for patients.Professor Lee expressed his concerns, stating, "Given the characteristics of atopic dermatitis patients who have complex pathophysiology, there seem to be many constraints on tailored treatment. This is an area that requires improvement."Q. How do you feel about starting your term as the new President, and what is your opinion?I have been active in the Korean Atopic Dermatitis Association for a long time. In particular, I participated from the very beginning in the process of creating a diagnostic code for severe atopic dermatitis in Korea, as none had existed previously. I also remember making my best efforts to ensure that severe atopic dermatitis could be covered under the 'Special Case Medical Expense Coverage System' system.It feels like those events were just yesterday, and I am honored to be serving as President. Iplant to improve the rights and interests of patients with atopic dermatitis, the treatments they desire, and research into the disease.Q. What are the primary goals or tasks that the Association will focus on during this term?There are largely two main goals. The first is improving the rights and interests of patients with atopic dermatitis. Recently, many new atopic dermatitis drugs, such as biologics and JAK inhibitors, have been launched. However, due to high costs, many patients suffering from the disease are unable to receive treatment with these new drugs.The Association will make every effort to ensure that health insurance and the 'Special Case Medical Expense Coverage System' system are applied to new drugs as quickly as possible.The other goal is to promote research on atopic dermatitis. As the Korean Atopic Dermatitis Association is an academic organization, I intend to fulfill my responsibilities, including supporting researchers dedicated to identifying the causes of atopy and developing treatments, and conducting collaborative research.Q. How do you think the patient population and disease patterns of atopic dermatitis in Korea have changed compared to the past? How do you think these changes have influenced the treatment paradigm?The first change is that the prevalence has increased. This is partly due to more patients proactively visiting dermatology clinics as the medical environment has developed, but environmental changes driven by industrialization and other factors also play a role.Another point is the increase in the number of adult patients with atopic dermatitis. As prevalence has increased and adult patients have become more numerous, the treatment paradigm has required new drugs that can ensure efficacy and safety for long-term treatment. In this context, the recently launched new drugs are playing a significant role.Atopic dermatitis can be divided into mild, moderate, and severe stages. Mild patients are treated proactively with moisturizers and topical treatments. For moderate-to-severe cases, topical treatments and systemic treatments are used together.Recently, new drugs such as biologics and JAK inhibitors have emerged, providing significant therapeutic benefit.Q. While treating moderate-to-severe atopic dermatitis patients, what are the limitations of existing treatment strategies. What are unresolved unmet needs?The biggest concern is the safety of existing conventional treatments.In many cases, moderate-to-severe patients become chronic and require long-term treatment. However, there are safety concerns regarding the long-term use of conventional therapies such as existing immunomodulators.Most of these issues are being addressed by new drugs such as biologics and JAK inhibitors. However, while the side effects of these new drugs are not severe, it seems necessary to be well-informed about the specific side effects of each drug to select the appropriate medication.Currently, many atopic dermatitis treatments are being developed, and clinical trials are underway. The main direction is the development of targeted therapies that can secure higher safety and efficacy. In my opinion, the treatment of atopic dermatitis will evolve toward reducing side effects and increasing therapeutic effects through the development of targeted therapies that precisely target its pathophysiology.Q. How can IL-13 single-target drugs change patient management?Atopic dermatitis is a complex disease involving multiple immune pathways, but at its core, IL-13 plays a critical role in inflammation and skin barrier dysfunction.Single-target IL-13 therapy, such as Adtralza, specialized for the pathophysiology, has the advantage of precisely regulating the core inflammatory pathway while minimizing unnecessary immunosuppression. In particular, with Adtralza, the physician can adjust the administration cycle after 16 weeks of treatment, providing advantages in terms of patient convenience and economic factors.Q. Is there anything that needs to be improved in terms of treatment accessibility, insurance policy, or education?I would like to speak about the issue of switching therapies. Since December 2024, switching between biologics and JAK inhibitors has been permitted under certain conditions, expanding the range of treatment options.However, switching between a biologic and another biologic, or between JAK inhibitors, is still not allowed, and I hope this part will be improved. Regrettably, this seems to limit the tailored treatment of patients with atopic dermatitis who have complex pathophysiologies.Q. Do you have any hope or advice you would like to send to patients and families suffering from atopic dermatitis?Many patients and guardians still have much distrust, believing that atopic dermatitis treatments are toxic or that only corticosteroids are used.With the recent development and launch of new drugs such as biologics and JAK inhibitors, the paradigm of atopic dermatitis treatment has changed and advanced. That progress is continuing today.I hope that patients suffering from atopic dermatitis do not hesitate due to negative experiences from the past and instead visit a nearby dermatologist to receive proactive treatment.
- InterView
- [Desk View] Need for transparency toward drug price reform
- by Chon, Seung-Hyun Feb 23, 2026 09:15am
- The Ministry of Health and Welfare (MOHW) has reportedly delayed a decision on the drug pricing reform agenda at the Health Insurance Policy Deliberation Committee. In November last year, the MOHW reported to the HIPDC a plan to lower the price calculation rate for generics and patent-expired drugs from the current 53.55% to 40%, announcing a final decision in February and implementation by July of this year. While it was expected that the reform plan would be finalized at the HIPDC subcommittee held on the 20th to initiate the institutional reform, the process has been delayed by at least a month.The industry appears relieved by the MOHW's decision to defer the HIPDC discussion. Expectations are emerging that the ministry may have felt burdened by the prospect of forcing through the reform while receiving strong opposition from the pharmaceutical sector. On the 10th, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) unanimously adopted a resolution during its board of directors meeting, urging the deferment of the resolution and implementation of the drug pricing system reform.Through its resolution, the KBPMA Board of Directors urged the government to ▲ delay the vote and implementation of the large-scale drug price reduction plan by the Health Insurance Policy Deliberation Committee ▲an impact assessment on how these cuts would affect public health and employment ▲the abolition of the market-linked actual transaction price implementation plan ▲ support measures to help small and medium-sized pharmaceutical companies upgrade their business structures ▲a formal governance structure between the government and industry to regularly discuss drug pricing policies and industrial growth.Labor organizations have also voiced opposition against the government regarding the reform. On the 29th, the Federation of Korean Trade Unions (FKTU) issued a statement warning, "The government must transparently disclose the basis and financial effects of the drug pricing system reform and immediately establish a social discussion structure where the opinions of stakeholders are reflected," adding, "We will not remain passive regarding any attempts to rollback labor conditions or increase job insecurity under the guise of this policy."The Korean Democratic Pharmaceutical Union (KDPU), primarily composed of labor unions from multinational pharmaceutical companies, also formalized its opposition last month by holding a picket protest in front of the Health Insurance Review and Assessment Service (HIRA) in Seocho-dong, Seoul.Critics point out that the government has not disclosed specific details since announcing the reform, further fueling anxiety among pharmaceutical companies.The MOHW has not released a specific position regarding the industry's demands for deferment or cancellation of the reform. An industry official stated, "The MOHW has not once presented a specific figure for the generic price reduction since reporting the reform plan in November last year."If the generic price standard is adjusted from 53.55% to 45%, the maximum price of a generic is mathematically calculated to drop by 16.0%. If the reform standard is set at 40%, the price drops from KRW 53.55 KRW to KRW 40, increasing the reduction rate for the maximum generic price to 25.3% compared to the previous standard. Given that the profit margin for a single generic product would drop by more than 20%, pharmaceutical companies' losses would inevitably be substantial. However, because specific reduction rates have not been presented, pharmaceutical companies are unable to estimate loss scenarios resulting from the reform.A detailed roadmap for whether price cuts will apply to currently listed drugs has also not been disclosed. If the reformed pricing system is applied to currently listed drugs, pharmaceutical companies' losses will be even greater. For example, if the price of a product with annual sales of KRW 10 is reduced from 53.55% to 40%, KRW 2.5 billion in annual revenue would evaporate.The MOHW plans to sequentially implement the reformed pricing system, starting with listed generics that have maintained a calculation standard of over 50% for more than 13 years since the blanket price reduction in 2012. The vision is to adjust approximately 3,000 items over three years, starting from the second half of next year, and sequentially reduce 1,500 items that have maintained a rate of 45% or higher starting from the second half of 2027.According to this scenario, the targets for price reduction differ across generic products with the same ingredient, depending on their market entry timing. For example, a total of 156 items have been approved for the single-agent antiplatelet agent clopidogrel, with approvals ranging from 2005 to 2021. The clopidogrel generic market formed, with 19 items approved in 2005 and 29 in 2006. From 2014 to 2018, 5 to 9 generics entered the market each year, and in 2019, new approvals surged to 17. At that time, as the government set out to reform the pricing system, including tiered pricing and criteria, there was a flood of new approvals.If the government pursues price reductions for generics listed before 2012, it is estimated that 64 items approved between 2005 and 2011 would be subject to price cuts, while 92 items approved from 2012 onwards would be excluded. In this case, a very strange situation would arise where different pricing systems apply to the same product. Issues of equity would inevitably surface, as the system would disadvantage only specific products and companies.The industry also raises the possibility that targets for price reductions could be categorized by ingredient based on when the generic market opened. This is a scenario in which, if even one generic were listed before 2012, all drugs containing that ingredient would be categorized as targets for price reduction. In this case, the losses pharmaceutical companies would incur from price cuts would be even greater. If the criteria requirements, such as bioequivalence tests, are also applied, the scale of losses could expand exponentially.In its press release announcing the drug pricing system reform, the MOHW problematized the 'generic-centered industrial ecosystem.' The justification is that to create a virtuous cycle of an innovative ecosystem through R&D activation, an urgent overhaul of the drug pricing system is needed to balance appropriate compensation for value. The view is that only when pharmaceutical companies move away from a generic-centered business model and focus on new drug development can South Korea become a pharmaceutical powerhouse.However, the ministry has yet presented any measures regarding the anxiety over the threat to pharmaceutical companies' survival. Communication is necessary. Deferring the resolution process for the drug pricing reform by a month or two, to observe the industry's response, does not mean the efforts at communication are recognized. The government must specifically disclose its policy goals and content and engage in substantive communication with the industry. If the government’s policy is justified and legitimate, it should at least make an effort to persuade companies. The communication process must also be transparently disclosed. Under the President Lee Jae Myung administration, which makes Cabinet meetings and business reports public, we hope that policies will not be pursued in secret.
- InterView
- "Leclaza comb included in the U.S. guideline"
- by Cha, Ji-Hyun Feb 20, 2026 10:04am
- Professor Se Hoon Lee of the Division of Hematology-Oncology at Samsung Medical CenterThe global status of Korea-made novel anticancer drug 'Leclaza' (ingredient: lazertinib) is shifting. The shift was brought by the 2026 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Non-Small Cell Lung Cancer (NSCLC), which included the combination therapy of Leclaza + 'Rybrevant' (ingredient: amivantamab) as a 'Preferred Regimen' for first-line treatment, while Leclaza monotherapy was included as an option that is 'Useful in Certain Circumstances.'Analysis suggests that this is highly significant as the first Korea-made novel drug has been included in the NCCN Category 1 first-line treatment bracket. DailyPharm met with Professor Se Hoon Lee of the Division of Hematology-Oncology at Samsung Medical Center, who led the follow-up studies of the Phase 3 MARIPOSA trial, to discuss the significance of this guideline revision and the evolving treatment strategies in clinical practice.OS data changed the standard... "Combination therapy enters the stage of discussion"Yuhan's Leclaza and Janssen's RybrevantLeclaza is a third-generation NSCLC treatment targeting Epidermal Growth Factor Receptor (EGFR) mutations, which received domestic approval in January 2021 as South Korea's 31st novel drug. The Leclaza-Rybrevant combination therapy was approved by the U.S. Food and Drug Administration (FDA) in August 2024 as a first-line treatment for adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.Professor Lee identified the foundation of this revision in the Overall Survival (OS) data.Professor Lee stated, "The Phase 3 MARIPOSA trial, which served as the basis for this revision, was a study comparing the Leclaza-Rybrevant combination therapy against the existing standard of care, 'Tagrisso' (ingredient: osimertinib) monotherapy. Given that monotherapy has already established itself as the standard treatment, demonstrating whether clinical benefits actually translate into OS improvement was paramount, especially considering the inevitable toxicity burden of combination therapy."Professor Lee added, "If it were a comparison between monotherapies with similar efficacy and toxicity profiles, a shift in the standard could be discussed based on Progression-Free Survival (PFS) results alone. However, for combination therapies, the criteria for decision differ," and added, "It is meaningful that by confirming statistical significance for OS through this study, the grounds for discussing combination therapy as a standard treatment option have been established."According to the Phase 3 MARIPOSA OS results presented at the European Lung Cancer Congress (ELCC) last March, the Leclaza-Rybrevant combination therapy demonstrated statistical significance, reducing the risk of death by approximately 25% (HR 0.75, 95% CI 0.61–0.92) compared with Tagrisso monotherapy.The median Overall Survival (mOS) has not yet been reached (not reached). This means that more than half of the patients in the combination therapy group survived during the follow-up period, and a sufficient number of death events did not occur to calculate a median value. Considering that the mOS of Tagrisso monotherapy was confirmed at 36.7 months, there are projections that once the mOS for the Leclaza-Rybrevant combination therapy is finalized in the future, the gap between the two groups could widen to more than a year.Professor Lee also expected that this revision could serve as a starting point for restructuring international treatment guidelines. He noted, "The NCCN guidelines are be revised relatively quickly among global guidelines, so this change is highly likely to become the starting point for revisions of other international guidelines in the future. While European guidelines may take a more cautious approach as they consider economic evaluations simultaneously, I expect the general direction itself to unfold similarly."Changes in the guidelines are also influencing the domestic clinical field.Professor Lee stated, "Following the changes in global guidelines, a shift in perception regarding first-line treatment strategies is emerging in the domestic medical field. Since OS has improved by more than a year, many medical professionals believe that combination therapy should be considered a priority."He added, "Compared to when the MARIPOSA study's PFS data was first released, I can feel that the perception of medical staff is changing over time. While individual opinions vary, it is a clear trend that as more experts gather to discuss, the proportion of those considering combination therapy is gradually expanding."Comparison of monotherapies…attention on safety differencesThe double-blind, Head-to-Head direct-comparison data between Leclaza and Tagrisso monotherapy are gaining attention.Generally, it has been perceived that studies directly comparing two drugs with proven efficacy are difficult to establish. Regarding a standard treatment that has already preempted the market, a result showing inferiority could pose significant commercial risks, and the practice of randomly assigning patients when a standard treatment is established can provoke ethical controversies.Professor Lee explained, "As the FDA required the individual contribution of each component drug in the combination therapy study to be proven, a design involving a direct comparison of monotherapies within the same study could be included," added, "This data is unique globally and is precious data that will be difficult to replicate in the future."As this was an exploratory analysis, it has limitations regarding the number of patients. However, the professor explained that the reliability of the interpretation is enhanced by the fact that the two drugs were directly compared under the same conditions within the same clinical trial, rather than through indirect methods that compare results from different studies. Such data can serve as evidence for fine-tuning treatment strategies in clinical practice.The direct comparison showed that the two drugs had similar efficacy, as evidenced by their survival curves, but differences in their safety profiles were observed. Among these, the point of clinical interest is cardiac toxicity.Professor Lee stated, "Tagrisso showed a tendency toward more reports of cardiac-related adverse events such as heart failure or QT prolongation compared to Leclaza," added, "It has been suggested that this may be due to Tagrisso's characteristic of more broadly inhibiting HER2 (ERBB2), which is associated with cardioprotection."Professor Lee further explained, "While the incidence of cardiac toxicity itself is low at less than 2%, it is a clinically important consideration as it is a life-threatening adverse event," added, "Peripheral neuropathy is observed more frequently in Leclaza monotherapy, but this is not a life-threatening adverse event, and its clinical impact tends to be limited."Consistent survival benefit confirmed in Asian patients... "Combination will become the basic option"Leclaza is also securing consistent clinical data in the Asian patient population. This contrasts with the FLAURA2 study, which evaluated the Tagrisso-chemotherapy combination, where the efficacy in the Asian subgroup excluding China appeared limited.In the FLAURA2 study, the OS Hazard Ratio (HR) for the Asian subgroup excluding China was 1.00 (95% CI 0.71–1.40), showing no additional survival benefit compared to monotherapy. In contrast, the MARIPOSA study reported an OS HR of approximately 0.77 for the total population, including Asian patients, confirming a death risk reduction effect.Professor Lee stated, "The mechanism explaining the HR difference observed in the Asian patient population is not yet clear, making it difficult to draw conclusions based on subgroup analysis alone. However, since consistent OS improvement was confirmed in the total population, including Asian patients, in the MARIPOSA study, these differences need to be scrutinized through further research in the future."Professor Lee believes the focus on first-line treatment strategies is gradually shifting toward combination therapy.Professor Lee said, "In the past, monotherapy was the default, with combination therapy considered for some patients; however, recently, there is a spreading view that combination therapy should be the baseline strategy, with monotherapy applied selectively," added, "This is similar to the trend where the combination of immunotherapy and chemotherapy has become the standard of care in NSCLC."Furthermore, Professor Lee stated, "In my opinion, a strategy of first checking the response with monotherapy for about three to six weeks and then switching to combination therapy for patients who need it is desirable," added, "However, in a reimbursement system, it is important to secure the option of combination therapy, so an approach starting with combination therapy whenever possible can be rational."Ultimately, Professor Lee predicted that future first-line treatment strategies will be restructured as a matter of choice between combination therapies. He concluded, "If both Leclaza + Rybrevant and Tagrisso + chemotherapy combination therapies are included in the reimbursement system, the focus of discussion will move beyond simply whether to use combination therapy to which of the two combination strategies to choose,'' and concluded, "At that stage, further discussions will be necessary, considering not only survival indicators but also the mechanistic differences, immunological changes, and molecular biological characteristics of each treatment strategy."
- InterView
- "Psoriasis, stage-specific strategy emerges…Sotyktu"
- by Son, Hyung Min Feb 13, 2026 08:28am
- The treatment paradigm for psoriasis is rapidly shifting. While the past was characterized by a structure transitioning from systemic therapies for severe patients to biologics, the recent emergence of oral therapies is segmentizing treatment strategies.In particular, with the introduction of BMS's selective TYK2 inhibitor 'Sotyktu (deucravacitinib),' discussions regarding intermediate-stage treatments that can be utilized before biologic, are in full-scale.Professor Dong Hyun Kim of the Department of Dermatology at Cha University Bundang Medical Center (CBMC)DailyPharm met with Professor Dong Hyun Kim of the Department of Dermatology at Cha University Bundang Medical Center (CBMC) to discuss changes in the psoriasis treatment landscape and remaining challenges for improvement.Psoriasis is a chronic inflammatory skin disease caused by immunological abnormalities. It is characterized by silvery-white scales (dead skin cells) accumulating over red rashes. As symptoms worsen, lesions merge extensively into plaque psoriasis, which accounts for 80–90% of all psoriasis patients.While the domestic prevalence is estimated at approximately 3% (about 1.5 million patients), fewer than 15% actually visit medical institutions. Despite the heavy mental and social burden, as lesions often appear on exposed body parts, a significant treatment gap persists.Psoriasis is more than just a skin condition. It is highly associated with metabolic diseases such as psoriatic arthritis, hypertension, diabetes, and dyslipidemia. Reports suggest that the risk of systemic disease in psoriasis patients is 1.5 to 2.5 times higher than in the general population. This is why long-term, systematic management is needed.Recently, with the introduction of various advanced therapies, including biologics and small-molecule drugs, treatment goals are steadily rising.Sotyktu, the first selective TYK2 inhibitor to emerge in this space, is known for its mechanism of selectively targeting and inhibiting TYK2 signaling, a key inflammatory pathway in psoriasis development. By doing so, it suppresses the release of pro-inflammatory cytokines and chemokines. Notably, as an oral option, Sotyktu may be highly utilized for patients who are averse to injectable treatments.Professor Kim explained, "The recent changes in the treatment landscape are significant not just because of the increase in new drugs, but because we can now design customized strategies for individual patients."Q. How has the psoriasis treatment landscape changed compared to the past?In the past, methotrexate or cyclosporine were the center of first-line systemic therapy. However, it was difficult to maintain sufficient dosages due to concerns over long-term side effects such as hepatotoxicity. As a result, there was a strong tendency to treat moderate patients primarily with topical agents.Recently, the arrival of biologics and small-molecule treatments, such as TYK2 inhibitors, has made long-term treatment feasible. While the past goal for Sotyktu might have been PASI 75 (75% improvement in psoriasis severity), we are now in an era where we expect PASI 90 or even 100. More patients are reaching a state where lesions are almost non-existent.Q. What are the mechanistic advantages of the oral agent Sotyktu?In psoriasis, pathological Th17 cells that overproduce interleukin (IL)-17 play a central role. IL-23 is the cytokine that continuously activates these Th17 cells, and TYK2 plays a critical role in transmitting this signal into the cell. Sotyktu is a treatment designed to block the root of the pathological inflammatory response by selectively inhibiting this TYK2 signaling.Globally, before Sotyktu’s launch, the apremilast was an advanced oral option. In Korea, only generics were used instead of the original drug, and because their efficacy was not superior compared to other options, they were not widely used in clinical practice. Sotyktu has been shown in clinical trials to be more effective than apremilast.Q. Given that psoriasis requires long-term management, what are the advantages of oral agents in chronic care?In practice, assuming the treatment method and efficacy are equal, patients may prefer treatments with longer administration intervals that require fewer hospital visits. However, there are clear differences between oral and injectable medications. The biggest advantage of oral drugs is high medication convenience. Nevertheless, to maintain therapeutic effects, it is crucial to take them consistently without interruption.In clinical settings, preferences vary by age group. Younger patients who are socioeconomically active due to employment, interpersonal relationships may find daily dosing burdensome or desire rapid results. Conversely, older patients tend to maintain medication adherence more consistently and choose options with a lower financial burden.Q. What factors do you comprehensively consider when selecting a treatment?In practice, we select treatments based not only on the severity of psoriasis but also on the patient's lifestyle and expectations. Domestic consensus generally evaluates IL-17 inhibitors and IL-23 inhibitors as having overall equivalent efficacy, with differences primarily in the speed of action. These features, dosing cycles, and patient preferences affect the choice.The health insurance in Korea is also a major variable. Biologics are generally expensive and mostly prescribed to patients covered under the "Special Calculation System". However, fewer than 10% of Korean psoriasis patients qualify for this system. Given that clinicians often struggle to apply this status, even in moderate-to-severe cases, oral agents like Sotyktu are a rational choice given patients' out-of-pocket costs.Sotyktu, taken as one pill a day, is characterized by its safety for long-term use. With patient co-pays at approximately KRW 200,000 to 250,000 per month and eligibility for private indemnity insurance, I believe it is an appropriate option for patients who require long-term treatment but do not yet meet the criteria for the Special Calculation System.Q. Which patient groups are considered for Sotyktu prescriptions as a primary treatment?The most important characteristic of the patient group for whom I prioritize Sotyktu is a resistance to injectable therapy. Previously, clinicians typically thought of biologics as the immediate next step after first-line systemic therapy failed. Now, I believe an "intermediate" treatment option has emerged between those steps.Sotyktu can be a suitable choice for patients who have failed systemic therapy but find the prospect of moving directly to biologics burdensome.While the concept of "intermediate-stage therapy" is not yet clearly defined, if a patient does not necessarily require biologics, an approach that first passes through this stage, reserving biologics for those with an insufficient response, can also be rational from a pricing perspective. Additionally, there is a tendency to prefer Sotyktu for scalp treatment.Since some patients do reach PASI 90, identifying the right patient is key. It is an option worth considering for those with severe symptoms in localized areas, such as the scalp, or for patients whose Body Surface Area (BSA) does not exceed 10% but who have severe local lesions.Q. How do you evaluate the data and efficacy of Sotyktu in Asian patients?Currently, Real-World Data (RWD) for Sotyktu is gradually accumulating across various hospitals and medical institutions in Korea. In cases where patients who participated in previous clinical trials had to stop treatment for a period due to insurance issues and later resumed with Sotyktu, those who previously responded well tended to maintain efficacy upon re-administration.While Asian patients may have different clinical characteristics compared to Western populations, they generally have lower body weights and often diligently combine oral treatment with topicals. Considering this, as more RWD is collected, we may observe clinical efficacy even better than that seen in clinical trials.I have a patient who was referred to our hospital and participated in a clinical trial to take Sotyktu. The patient had very severe symptoms at the time but has now continued treatment for nearly six years, with the effect remaining stably maintained.Q. Late-comer treatments are expanding indications beyond psoriasis and psoriatic arthritis. Do you expect the utility of TYK2 inhibitors to grow as their indications expand?Because TYK2 inhibitors are involved in multiple inflammatory signaling pathways, not just IL-23 but also interferons (IFN), I understand that clinical trials are currently underway to expand their indications.If indications are expanded, the scope of utility could include various inflammatory diseases, including autoimmune conditions such as lupus. From a dermatological perspective, I expect it will be most widely used for psoriasis and psoriatic arthritis for the time being. Beyond that, there is ample potential for its application to expand into inflammatory bowel disease (IBD) or various rheumatic diseases.Q. What aspects of the psoriasis treatment environment need improvement?As of now, many patients are not sufficiently aware of Sotyktu. Unlike in other countries, drug advertising is prohibited in Korea, so clinicians must directly explain the drugs to patients. Despite psoriasis being a disease with clear treatment effects, many patients discontinue treatment or repeat ineffective treatments due to vague fears about side effects.Another realistic issue is the insurance authorization process. To maintain Special Calculation status, PASI and BSA must be evaluated every six months, which involves tedious, time-consuming procedures such as charting and photography. Since there is no separate medical fee for this process, primary care physicians are sometimes hesitant to use it.Even though these treatments can be prescribed without specialized equipment, institutional conditions limit drug utility in the field. Consequently, since the psoriasis Special Calculation System began in 2017, there has been cases where patients crowding into university hospitals. In the future, I believe the government should establish fees for PASI/BSA evaluations and patient education so that primary care and regional medical institutions can manage psoriasis patients more systematically.
- InterView
- [Reporter's View] Medical AI must read 'NULL' values
- by Hwang, byoung woo Feb 05, 2026 07:48am
- When we discuss medical AI, we often think of lines of data, more detailed records, and more meticulous numbers. It is widely believed that a data set with complete electronic medical records and no missing values is a shortcut to improving performance.However, the medical field is different. In medical data, 'NULL' values are not simply omitted during data processing. It is rather an outcome of a clinical decision made by doctors who observe patients and then state 'the testing is no longer needed.When a patient is stable, it is common practice in the field to avoid frequent blood draws and imaging. In other words, unrecorded silence itself is the most powerful data proving the patient's stable condition.It means that the data's nature is not limited to recorded values but also includes unrecorded contexts.An issue often arises when a NULL space is mechanically filled. AI loses context when it adjusts a NULL value to man-made numbers to improve data analysis efficiency.It falls into the trap of Domain Shift, a phenomenon where the distribution of the training environment and the actual clinical field diverges. While it is a technical choice to create a clean table, the context of medical data is compromised in the process.In fact, research results showing that AI's prediction accuracy drops by nearly 10% when data is forcibly adjusted while ignoring clinical prescription patterns are highly suggestive.This is because the AI model experiences a form of "cognitive dissonance" when encountering numbers forcibly inserted where NULL should be. Ultimately, this results in erasing the subtle signals sent by medical staff to save patients.At this point, the perspective on Medical AI must change as well. A good Medical AI is not a model that uses complex algorithms, but one that reflects the field's decision-making structure without distortion. The sense of understanding the flow of the medical system is becoming more important than the technology of matching numbers.Now, as the government discusses the early introduction and expansion of Medical AI, the question of "what philosophy governs the data?" becomes as important as "how much data was collected?" Filling in NULL is not absolute. Sometimes, respecting the blank itself is the way to preserve the performance of Medical AI.It is now time to consider whether we are erasing the silence left by medical staff to save patients in the name of data refinement. What Medical AI needs now is not the technology to fill in numbers, but the insight to hear the voices of medical staff contained within those NULL values.
