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- 2026-05-18 18:33:06
- Opinion
- ‘Need to change perceptions on menopausal hormone therapy’
- by Son, Hyung Min May 18, 2026 09:11am
- With the US Food and Drug Administration (FDA) recently removing the Black Box Warning imposed on menopausal hormone therapy (MHT) products, the likelihood of a shift in perception is growing within Korea’s obstetrics and gynecology clinical field.While there has long been a strong tendency to avoid treatment due to concerns about the risk of breast cancer and cardiovascular disease, there is now a growing emphasis on the need for personalized treatment that takes into account the patient’s age, time of menopause, and risk factors.In particular, experts pointed out that the findings of the US Women’s Health Initiative (WHI) study had been excessively generalized to women in early menopause, and stressed that the long-term health benefits of early treatment, such as the prevention of cardiovascular disease, osteoporosis, and dementia, should also be considered.In a recent meeting with DailyPharm, Eun Sil Lee, Professor of Obstetrics and Gynecology at Soonchunhyang University Seoul Hospital, and Tae-Hee Kim, Professor of Obstetrics and Gynecology at Soonchunhyang University Hospital Bucheon, assessed that this FDA action could serve as an opportunity to fundamentally redefine existing perceptions of MHT, going beyond the mere removal of warning labels.(From the left) Professor Eun Sil Lee (Obstetrics and Gynecology, Soonchunhyang University Seoul Hospital) and Professor Tae-Hee Kim (Obstetrics and Gynecology, Soonchunhyang University Hospital Bucheon)The two professors particularly pointed out that although the 2002 WHI study was conducted on a patient population different from actual women in early menopause, the findings were subsequently applied uniformly to women of all ages, creating excessive fear toward hormone therapy.Based on the study results, the FDA introduced Black Box Warnings for MHT products in 2003. Following this, concerns over breast cancer, cardiovascular disease, and dementia risks spread rapidly, causing hormone therapy prescriptions to decline sharply worldwide. However, as more age-specific and menopause timing-based reanalyses accumulated in recent years, the FDA initiated procedures last November to remove the warning.Experts point out that the WHI study results were overgeneralized.The WHI study included women with an average age of 63, many of whom already had a significant number of risk factors for cardiovascular disease. Another limitation cited is that the study used a combination of hormones that is no longer widely used today. Subsequent age-specific analyses showed that for women who began treatment within 10 years of menopause, particularly those in their 50s, there was no clear increase in the risk of cardiovascular disease or dementia, and some studies even suggested possible preventive effects.In practice, MHT has long been used as a representative menopause management therapy, having been proven effective not only in alleviating menopausal symptoms such as hot flashes, sleep disturbances, and depression but also in preventing osteoporosis. However, following the publication of the WHI study, concerns about breast cancer risk spread rapidly, leading to a strong trend in Korea toward discontinuing or avoiding the treatment.Recently, there has been growing discussion that MHT should be reevaluated from a “well-aging” perspective, one that goes beyond simple symptom management to include cardiovascular health, osteoporosis prevention, and the management of healthy life expectancy. As life expectancy increases and women spend longer periods living after menopause, experts argue that both risks and benefits of treatment should be evaluated in balance.The two professors emphasized, “MHT should not be oversimplified solely in terms of breast cancer risk. It should instead be approached from the perspective of personalized treatment that comprehensively considers patient age, menopausal timing, and overall health status. When treatment begins at the appropriate time, positive effects can be expected not only for quality of life improvement but also for long-term health management.”Q. How do you evaluate the FDA’s recent removal of the MHT Black Box Warning?Professor Tae-Hee Kim (Obstetrics and Gynecology, Soonchunhyang University Hospital Bucheon)Professor Tae-Hee Kim: I view this FDA action as an important opportunity to reevaluate the previously excessive perception of MHT risks based on evidence.The patients included in the WHI study had a median age of 63 and included women with cardiovascular risk factors. They differed from actual women in early menopause who typically begin hormone therapy. Moreover, the study used hormone combinations that are rarely used today, making it difficult to generalize the results to all patients.I think this decision carries significance in reorganizing overly emphasized risks so that women in early menopause who may benefit from hormone therapy do not avoid treatment excessively.”Professor Eun Sil Lee: The previous black box warning stated that prescribing MHT increased the risk of breast cancer, cardiovascular disease, and dementia, which significantly heightened patients’ fears. In fact, the frequency of hormone therapy use decreased significantly following the WHI study.However, subsequent age-specific analyses yielded different results. For women in their 50s who began treatment within 10 years of menopause, there was no clear increase in risk. On the contrary, the possibility of preventing cardiovascular disease or dementia was raised. Ultimately, this means that the timing of when hormone therapy is started is what matters.Q. How should the safety of MHT be evaluated?Professor Tae-Hee Kim: Previously, there was a strong perception that taking hormones increased the risk of cardiovascular disease and dementia, but in fact, these findings should be viewed as results from women who started treatment in their 60s and 70s.On the other hand, data is accumulating showing that starting treatment in one’s 50s, during the early stages of menopause, may actually have preventive effects against cardiovascular disease and dementia. Ultimately, the key issue is not simply whether or not to take hormones.Factors such as age, menopausal timing, and cardiovascular risk factors must all be considered comprehensively. I believe safety is determined by individualized treatment strategies tailored to each patient.Professor Eun Sil Lee: I believe the most important factors when evaluating safety are the patient’s age and the timing of menopause.In reality, women in the early stages of menopause often do not have a relatively high risk of cardiovascular disease. Rather, during this period, as hormone levels drop sharply, vascular health deteriorates, and changes such as decreased bone density, sleep disorders, and feelings of depression begin to manifest in earnest.Conversely, if a patient has already progressed into her 60s with advanced atherosclerosis, the approach may differ. In advanced atherosclerosis, hormone therapy could potentially affect thrombosis risk. In the end, the key issue is who starts treatment and when.In actual clinical practice, many patients with severe menopausal symptoms hesitated to pursue treatment due to fears such as ‘Won’t this increase my dementia risk?’ or ‘Won’t this cause cardiovascular disease?’ But recently, the concept of individualized treatment considering age, risk level, and menopausal timing has become increasingly important.Ultimately, I believe the safety of MHT is not an issue that can be explained in a one-size-fits-all manner; it must be assessed by comprehensively considering the patient’s health status and the timing of treatment.Q. How are differences in safety between products distinguished in actual clinical practice?Professor Eun Sil Lee: The approach to hormone therapy fundamentally differs depending on whether the patient has a uterus. Women without a uterus can use estrogen-only therapy, but women with a uterus must use progesterone in combination to prevent endometrial cancer.The characteristics of treatment differ depending on which progesterone is used. Appropriate therapy inevitably varies according to patient age, symptoms, risk level, and preference.Professor Tae-Hee Kim: Rather than saying a specific product is absolutely better, it is more accurate to view each hormone therapy as having distinct characteristics.It is important to select the most suitable medication by considering the patient’s lifestyle, symptoms, and health status. Ultimately, individualized treatment through consultation with a specialist is key.Q. How do you evaluate the breast cancer risk associated with MHT prescriptions?Professor Eun Sil Lee (Obstetrics and Gynecology, Soonchunhyang University Seoul Hospital)Professor Eun Sil Lee: In reality, differences exist depending on the medication. European studies showed that combinations of estrogen and natural progesterone did not demonstrate a clear increase in breast cancer, while some synthetic progesterone combinations showed tendencies toward increased risk.However, even if long-term use carries some increased risk, the absolute risk itself is interpreted as not very large. Above all, regular screenings are crucial.Women receiving hormone therapy tend to undergo regular screenings more consistently, and management is possible through early detection. Ultimately, I think accurate explanations are needed so patients do not abandon treatment based solely on vague fear.Professor Tae-Hee Kim: Many women have a vague fear that taking hormone therapy will cause breast cancer. But actual data show that the issue is not that simple.Even in the WHI study, women without a uterus did not show an increase, but rather a tendency toward reduced breast cancer incidence. European studies also found differences in breast cancer risk according to progesterone type. Some medications showed no significant increase.Of course, it cannot be said that taking hormones absolutely prevents breast cancer. However, the important point is that breast cancer mortality did not increase. In fact, overall mortality was lower.Benefits such as improved quality of life, fracture prevention, and cardiovascular disease prevention must also be considered together. Individualized treatment based on family history and risk level is important.Q. How do you predict MHT prescriptions will change in the Korean market going forward?Professor Tae-Hee Kim: I believe changes in perception toward MHT will clearly emerge in Korea as well. In particular, as life expectancy increases, interest is continuing to grow not only in living longer, but in aging healthily—that is, in ‘well-aging’ and ‘anti-aging.’Women now live for more than 30 to 40 years after menopause. Ultimately, how healthily this period is managed has become extremely important. From that perspective, hormone therapy should be viewed not merely as symptom control for hot flashes or sleep disorders, but as part of a healthy lifespan management strategy.Most important is the timing of treatment initiation. Starting treatment within 10 years after menopause or before age 60 is absolutely advantageous. Diseases such as cardiovascular disease, dementia, and osteoporosis become difficult to reverse once they progress. Therefore, we must approach them from a preventive perspective, which requires starting management from the early stages of menopause.In actual clinical practice, many patients experience major declines in quality of life due to osteoporotic fractures, fall risk, sleep problems, and joint pain. Hormone therapy can help improve these issues as well.Professor Eun Sil Lee: I believe the current prescribing environment is likely to expand further. However, rather than simply increasing prescriptions across the board, “personalized treatment” tailored to each patient’s characteristics will become more important.After menopause, vascular health deteriorates rapidly due to a decrease in estrogen. Atherosclerosis begins to progress, and bone density also decreases rapidly. Therefore, in women in the early stages of menopause, hormone therapy can play a positive role in preventing osteoporosis and maintaining vascular health.Conversely, the approach may differ for older women in whom atherosclerosis has already progressed significantly. Ultimately, this means that the patient’s age, vascular condition, and the timing of menopause must all be taken into account.Recently, the FDA has also emphasized the need for an approach that takes age and the timing of menopause into account. In fact, the FDA has recommended starting treatment within 10 years of menopause or before the age of 60.Most importantly, patient perception itself must change. Until now, the perception that ‘hormone therapy is always dangerous’ has been too strong. But now patients are beginning to think about both quality of life and healthy lifespan.Going forward, rather than simply enduring menopausal symptoms, interest in how to maintain health after menopause is likely to increase further. In that process, it will become important for patients to consult sufficiently with medical professionals and choose treatments suited to themselves.
- Opinion
- [Reporter's View] The dark side of improved diabetes med convenience
- by Son, Hyung Min May 14, 2026 09:28am
- "I lost OOkg with Wegovy," "My appetite completely vanished after taking Munjaro."Personal stories about obesity treatments are now easily seen on social media platforms like YouTube. Content detailing how much weight was lost, what the side effects were like, and which drugs are more effective is being consumed just like any other everyday lifestyle content.Most experts emphasize that obesity is not a simple issue of body shape but a chronic disease that requires medical treatment. In reality, obesity is linked to various metabolic disorders such as diabetes, cardiovascular disease, and fatty liver, necessitating a therapeutic approach that considers Body Mass Index (BMI) and the presence of comorbid conditions.However, the reality is that the perception of obesity treatments is increasingly shifting toward 'weight-loss drugs' rather than treatments for a disease.The pharmaceutical industry's emphasis on improving medication convenience has also played a significant role in this trend.The rapid expansion of the GLP-1 class obesity treatment market is due to the convenience of once-weekly administration. Compared to past treatments that required daily oral intake or injections, the burden of use has been significantly lowered, leading to expanded patient access and market growth.Improvements in medication convenience are evaluated as meaningful changes in terms of patient accessibility and treatment persistence. Indeed, reducing medication burden in chronic disease management improves treatment adherence and patient quality of life. Accordingly, the pharmaceutical industry continues to develop drugs that maintain efficacy for longer periods with fewer administrations.Currently, the pharmaceutical industry is accelerating the development of various forms of obesity drugs, including oral pills, once-monthly injections, and patches. In a situation where even injections are accepted without much hesitation, the threshold for use is likely to drop even further once new drugs with drastically improved convenience emerge.The problem is that improved medication convenience does not carry the same meaning as improved medication compliance.Medication compliance is a concept closer to a patient who consistently maintains therapy according to the proper use and dosage. However, in the current obesity treatment market, 'how easily it can be used' is emphasized first, while discussions on who should use it and how are relatively lacking.In the online market, health-functional foods and overseas direct-purchase products, some with names similar to those of GLP-1 agents, are spreading rapidly, even though they are unrelated. Some of these products are consumed for weight loss purposes despite lacking sufficient medical validation or safety assessments.Of course, there is no reason to deny the clinical value of obesity treatments themselves. GLP-1 class treatments are changing the paradigm of obesity management by accumulating diverse data, including reductions in cardiovascular disease risk beyond weight loss. They are undoubtedly an important option for patients who require treatment.As treatments become more popular, what needs to grow alongside the consumption craze is a clear understanding of medical treatment. As convenience and accessibility increase, social standards regarding prescription criteria and medical necessity must become clearer. At the very least, there is a need to guard against obesity treatments becoming firmly established as merely 'diet shots that anyone can easily administer.'
- Opinion
- [Desk’s View] Are Korean modified drugs really beneficial?
- by Lee, Tak-Sun May 11, 2026 09:18am
- Generics with modified formulations are currently the hottest trend in product development among domestic pharmaceutical companies. In particular, products that convert tablets into orally disintegrating tablets (ODTs) to improve ease of administration are steadily emerging.ODTs, which dissolve in the mouth, are undoubtedly convenient for elderly patients, children, and those with swallowing difficulties. For these patients, there is no reason not to welcome the product development efforts of domestic pharmaceutical companies.However, whether it is really necessary for multiple companies to simultaneously develop orally disintegrating tablets containing the same active ingredient remains well in question, given the relatively small target patient population.For example, in the case of pitavastatin ODTs used to treat hyperlipidemia, not only the originator but also numerous generic companies have entered development competition, even though the 2mg tablet market is already saturated with 42 products.Behind the competition in ODT development lies pricing. In Korea, drug prices are calculated based on the criteria of identical active ingredients, identical dosage forms, and identical strengths. Under the stepwise pricing system, if there are more than 20 identical formulations meeting these conditions on the market, the price of the next product to be listed is set 15% lower than the previous lowest price.Since there are already 42 pitavastatin 2mg tablets, prices are inevitably set lower than the current minimum of KRW 462. However, ODT formulations, being classified as different formulations, can receive the highest price of KRW 561 for that ingredient.However, one must consider whether charging the highest price with a different formulation can truly satisfy a company’s profit needs when the patient population itself is small. Moreover, if multiple pharmaceutical companies compete, the market share will inevitably shrink.Naturally, to meet their profit targets with orally disintegrating tablets, pharmaceutical companies will target general populations as well, not just those who have difficulty swallowing tablets. As a result, a significant number of general patients may end up being prescribed ODTs.If a patient taking two or more medications has different dosage forms for each, this may increase inconvenience, as the patient must swallow one pill with water and dissolve another to take it, creating additional hassle.This means that a drug designed for the convenience of a specific patient group may actually cause inconvenience for the general patient population. This is because the choice of medication rests solely with the medical staff.The development of pharmaceuticals with improved convenience is on the rise. Although the market for combination drugs, which combine multiple medications into a single formulation, is already saturated, new combinations continue to emerge. Incrementally modified combination drugs are also granted pricing premiums. If ODTs prove commercially successful, development will likely evolve further.Pharmacy shelves are already filled with such products, and pharmacists have identified Korean modified drugs as a growing inventory burden. Given that hundreds of millions of won have been invested in developing these drugs, this cannot help but be a waste of social resources.While the emergence of more convenient medications is a positive development for patients, too many products are being released in Korea relative to the size of the market. In this highly competitive environment, it is unclear whether formulation changes and combination products truly contribute to the sustainability of the national health insurance system.If drug pricing is driving this competition in product development, the government may need to reassess whether the current pricing system truly aligns with patient needs.
- Opinion
- [Reporter's View] Contradiction of "K-passing" and a new drug powerhouse
- by Lee, Jeong-Hwan May 06, 2026 03:28pm
- The President Lee Jae Myung administration is promoting the growth of the pharmaceutical and biotech industry with goals of 'Rising as a leading country in global pharmaceuticals,' 'Strengthening treatment accessibility for patients with severe and rare/intractable diseases,' and 'Expanding fair value compensation for innovative new drugs.'The government's stance on the end goal of the drug pricing system reform plan, which recently passed the Health Insurance Policy Review Committee, is to transform the inherent nature of Korea's pharmaceutical and biotech industry, aiming to 'develop new drugs·stably supply essential medicines·expand patient accessibility to reimbursement.'Despite the government's policy vision, South Korea is facing "New Drug Korea-Passing." The South Korean government is not immune to the phenomenon in which pharmaceutical companies that have developed innovative new drugs delay or abandon their launches in the Korean market.While "New Drug Korea-Passing" has long been practiced primarily by global pharmaceutical companies, the rapid improvement in domestic firms' drug development capabilities suggests a future in which Korean deciding to bypass Korea. One of these examples is Cenobamate (brand name Xcopri), a new epilepsy drug developed by SK Biopharmaceuticals and Dong-A ST.It is a contradiction that South Korea, while seeking to become a global pharmaceutical powerhouse, must now worry about the availability of patient treatment, given the "Korea-Passing" phenomenon.The bigger issue is that it is difficult to find any serious deliberation at the government level to establish a solution.The cause of "New Drug Korea-Passing" is "low National Health Insurance (NHI) reimbursement prices for new drugs." Criticism follows that Korea's maximum reimbursement prices for new drugs are only half the OECD average and about 1/30 of those in the United States.When pharmaceutical companies accept Korea's low drug prices, other countries may use them as a reference, leading companies to abandon the relatively small Korean market. Ultimately, the victims of these decisions are the patients who must bear the full burden.The reason the South Korean government tries to set new drug prices as low as possible is not entirely incomprehensible. Since they attempt to set prices using the NHI fund, composed of citizen contributions, as the sole source of financing, it is inevitably difficult to determine a price that fully reflects the value of an innovative drug.Ultimately, the conclusion is reached that to realize a pharmaceutical and biotech powerhouse and solve the "New Drug Korea-Passing" problem, substantial financial resources are required to set prices that reflect the proper value of new drugs.This means that government efforts to secure separate financial resources outside of the NHI fund to determine new drug prices are needed immediately. The solution to achieving both the conflicting tasks of securing the sustainability and soundness of NHI finances while strengthening patient access to medicines also involves breaking away from the single-source NHI funding structure.The consequence of failing to manage the national task and securing separate funds has consistently manifested as a reduction in pharmaceutical spending through generic drug price cuts, repeated in the same pattern every time. This is why criticism arises that, while intense strategic posturing continues between the Ministry of Health and Welfare (MOHW), global pharmaceutical companies, domestic pharmaceutical companies, and patient groups over how to distribute limited resources, only innocent generic companies are hit.Unless the structure that relies entirely on the NHI fund to expand innovative drug reimbursement, amid an era of super-aging and the increasing launch of ultra-expensive new drugs, is reformed, there is no place for the MOHW, the domestic pharmaceutical industry, or patients.Various methods for creating separate funds beyond the NHI can be discussed. These include establishing funds dedicated to ultra-expensive medicines, similar to the UK's Cancer Drugs Fund, or implementing policies that allow a portion of tobacco taxes or lottery proceeds to be used for innovative drug reimbursement.Legislative bills for such policies have been proposed in the National Assembly for over a decade. The key is the government's will. Responsibility should not be placed solely on the MOHW. It requires a policy decision from the Ministry of Economy and Finance, the Ministry of Planning and Budget. Furthermore, the Prime Minister and the President. Are they not the drivers who set the policy goals of leaping into a pharmaceutical and bio-tech powerhouse and strengthening patient access to new drugs?In the National Assembly, policy seminars calling for the rapid reimbursement of innovative new drugs and the expansion of reimbursed indications are held daily, and the heavy responsibility for solving the problem is habitually returned to the Bureau of Health Insurance Policy of the MOHW. Can we continue to demand a solution for the expansion of new drug reimbursement and the "Korea-Passing" problem from the MOHW alone?It is time for the fiscal authorities, besides the MOHW, to take the lead with proactive measures to solve the task of securing separate funds through social consensus, and to immediately resolve the contradiction where being a 'new drug powerhouse' and "Korea-Passing" coexist. The President's political slogan, "I'll do it," should not be an exception when it comes to strengthening access to innovative drug reimbursement and expanding financial resources.
- Opinion
- [Reporter’s View] Beyond generics to new drugs
- by Choi Da Eun Apr 30, 2026 08:24am
- The Korean pharmaceutical industry’s push into new drug development has reached a turning point. Companies are moving away from a business model centered on generics and contract manufacturing (CMO), expanding into next-generation anticancer drugs and obesity treatments, signaling a clear shift toward innovation-driven growth to improve the company’s structure with a focus on new drugs.Whereas it was once common to acquire candidate compounds from global pharmaceutical companies and focus on late-stage clinical trials or commercialization, there is now a growing movement to take the lead directly, from early discovery through Phase 1 and 2, and even late-stage clinical trials. This strategy aims to go beyond simply securing a pipeline to internalize the entire new drug development cycle.This shift is led by major pharmaceutical and biotech companies such as Hanmi Pharmaceutical, Daewoong Pharmaceutical, JW Pharmaceutical, HK inno.N, Celltrion, and Samsung Bioepis. These firms are diversifying portfolios across oncology, obesity, and immunology by expanding pipelines of new drug candidates.A notable trend is the growing emphasis on in-house development. Companies are increasingly attempting to internalize the entire R&D cycle, moving beyond simple pipeline acquisition toward full-spectrum innovation, from early-stage compound discovery through Phase 1 and 2 clinical trials, and on to late-stage clinical trials. This marks a strategic shift away from a focus on in-licensing toward internalizing the entire R&D cycle.For example, Celltrion and Samsung Bioepis are accelerating the development of antibody-drug conjugate (ADC) anticancer drugs, thereby expanding their footprint into the field of biopharmaceuticals. This is an attempt to leap to the next stage by leveraging the technological capabilities and capital accumulated through biosimilars.In particular, obesity treatments and anticancer drugs are emerging as next-generation growth engines. Although these are fields with fierce competition in the global market, they are also areas where the landscape can rapidly shift depending on technological innovation. Multi-mechanism-based obesity treatments and next-generation ADC anticancer drugs are cited as representative fields where domestic companies can compete based on their technological prowess.Hanmi Pharmaceutical is taking one of the most aggressive approaches, expanding both bispecific antibody oncology pipelines and obesity drug programs simultaneously. The company is aiming to secure global competitiveness by leveraging multi-mechanism obesity drugs and anticancer platforms as its two main pillars.JW Pharmaceutical has demonstrated the ability to independently advance late-stage development by bringing a gout treatment candidate to Phase 3. This is significant because it demonstrates that these companies have internalized development capabilities not just to acquire a pipeline, but to reach the stage immediately prior to commercialization.HK inno.N is strengthening its in-house R&D capabilities by combining the introduction of obesity drug candidates with an open innovation strategy. This is a hybrid strategy that leverages external technology while aiming to secure an independent pipeline in the long term.Chong Kun Dang is developing innovative drugs through its subsidiary Achelra, while Yuhan Corporation is advancing biologics via ImmuneOncia. These specialized subsidiaries aim to improve research efficiency and success rates.The strengthening of new drug development capabilities reflects both technological advancement and improved financial stability among Korean companies. However, the industry is still in a transitional phase. Some companies are balancing between in-licensing and in-house development, but cases where clinical trials successfully lead to commercialization remain limited. A gap between expectations and actual outcomes persists.Nevertheless, the reason domestic pharmaceutical companies are shifting course is clear. With generic drug price cuts and intensifying competition among contract manufacturing organizations (CMOs), the limits to growth under the existing business model have become evident. Ultimately, the prevailing view is that it is difficult to secure a meaningful foothold in the global market without proprietary new drugs.The fact that domestic pharmaceutical companies have entered a stage where they are charting their own course in new drug development is clearly a significant change. With accumulated manufacturing expertise, global expansion experience, and strengthening R&D infrastructure, the industry’s structure is gradually evolving.Whether the challenge of shifting the R&D structure from a focus on generics and biosimilars to new drugs will remain a temporary trend or become a turning point for securing a presence in the global market depends on clinical outcomes and commercialization capabilities.This effort is not merely business expansion but a structural transformation of the industry. Market evaluation should therefore consider both outcomes and the process of capability building. If this trend continues, the leap from a generic powerhouse to a powerhouse in new drug development will no longer be a distant prospect.
- Opinion
- [Reporter’s View] Medical Devices Act binds payment within 6 months
- by Hwang, byoung woo Apr 29, 2026 03:49pm
- An amendment to the Medical Devices Act, centered on the introduction of a “payment within 6 months” standard, is set to take effect in Korea. Although the regulation aims to enhance transaction transparency, it is likely to act as a variable requiring changes in overall cash flow management and transaction structures within the actual distribution sector.There is no disagreement regarding the direction of improving unfair trading practices and increasing transparency.However, questions remain as to whether the system’s design is practical enough to function effectively in the actual industry.The amended Medical Devices Act, scheduled to take effect on December 31, 2027, centers on strengthening the distribution management system, including restrictions on related-party transactions, explicit payment deadlines, mandatory written contracts, and reporting requirements on the status of related medical institutions.Structurally, this means that regulatory mechanisms for ‘normalizing distribution order,’ focused on improving unfair trade practices and strengthening transparency in the distribution process, have become more specific.The issue arises when these mechanisms are applied to real-world situations.The current medical device distribution system is not a simple supply structure, but an ecosystem in which hospitals, sellers, and financial structures are intricately intertwined.Against this backdrop, some in the industry are voicing concerns about the impact these regulatory changes will have on actual business environments, pointing out that payment practices extending beyond a certain period have long existed in transactions with hospitals.In this situation, the ‘payment within six months’ standard is, in principle, interpreted as a device to enhance transaction transparency. However, if exception criteria and application methods are not sufficiently specified, it may become a burden on some companies’ cash flow management or transaction structures.If financial pressure materializes, some distributors will have no choice but to reduce transaction volumes or delay shipments. This is highly likely to lead not to an improvement in distribution order but to a contraction in transactions.The purpose of restricting related-party transactions is also clear. However, given the diverse distribution structures formed in Korea’s medical device market, some hold the view that existing transaction methods cannot simply be interpreted as unfair transactions.Ultimately, the core of this legislative amendment places greater emphasis on ‘on-the-ground implementation’ rather than merely ‘introducing regulations.’For the system to actually function, not only the direction of regulation but also the application method and detailed criteria are important. Without meticulous planning that takes into account the scope of exceptions, the possibility of phased implementation, and the impact on different industry scales, it is difficult to rule out the possibility that the policy’s intent could lead to market confusion.In this regard, the opinion-gathering process before implementation is expected to serve as an important forum for discussion that can improve the completeness of the system before it takes effect. Above all, it is important to narrow the gap in perspectives between industry and policy authorities and find points of contact that can actually work.A system is completed not when it is created, but when it works in the field.Whether the amendment to the Medical Devices Act remains just another regulation or becomes a turning point that changes the distribution order depends on how it is designed from this point forward.
- Opinion
- "Vabysmo PFS shifts the retinal disease treatment persistence·efficiency"
- by Son, Hyung Min Apr 27, 2026 09:03am
- "The key to retinal disease treatment is not just in simple vision improvement, but in how stably and long-term the disease can be managed."As retinal disease treatment shifts from a short-term effect-centered approach to a long-term management strategy, the introduction of pre-filled syringe (PFS) formulations is shifting the practices.In particular, the 'Vabysmo (faricimab)' PFS formulation, launched as a reimbursed drug on the 1st of this month, is expected to lead to changes in treatment persistence and the clinical environment, including extended dosing intervals and improved procedural efficiency.Director Soon Il Choi of Nune Eye HospitalDirector Soon Il Choi of Nune Eye Hospital recently met with DailyPharm to highlight these changes, assessing that the retinal disease treatment paradigm is being reorganized around long-term management.At the center of this change are dual-mechanism therapies. Until now, treatments for wet age-related macular degeneration (nAMD) and diabetic macular edema (DME) were dominated by single-mechanism therapies that inhibit only VEGF.Before the emergence of high-dose formulations, the patient burden was significant, as dosing intervals were limited to about 2 months and required repeated direct intravitreal injections.Vabysmo is a bispecific antibody that simultaneously inhibits vascular endothelial growth factor (VEGF)-A and angiopoietin-2 (Ang-2), offering a differentiated approach compared to existing treatments. While VEGF-A is a key factor in angiogenesis, Ang-2 is known to promote vascular instability and leakage.Choi explained, "Blocking both pathways can contribute to maintaining blood vessels in a more stable state, going beyond simply inhibiting blood vessel formation."This mechanistic difference is highly likely to lead to improvements in anatomical indicators in clinical practice. Experts expect faster, more stable changes in reducing retinal fluid or normalizing macular thickness, which can lead to extended dosing intervals and sustained treatment persistence. The efficacy of Vabysmo has been confirmed in various clinical trials and real-world data.Choi stated, "Since the vision improvement effects of existing treatments have already reached a certain level, the perceived difference may be limited," and added, "How quickly and stably the retina maintains a dry state is a key factor determining long-term prognosis."Choi suggested that Vabysmo could be more actively considered for: ▲patients who relapse even with a slight increase in treatment intervals ▲patients with insufficient response to existing agents ▲patients with high retinal fluid or high volatility; ▲patients with repeated findings suggestive of vascular instability ▲patients who could previously maintain relatively long intervals but are seeing a shortening of the drug's duration of effect.Choi analyzed, "The advantages of Vabysmo can be expected in clinical situations requiring dual-pathway mechanisms, such as when stable disease control is needed. It can also be considered for patients with high intraretinal or subretinal fluid, high volatility, or those with concerns related to inflammation or fibrosis."As the central axis of treatment shifts from vascular inhibition to vascular stabilization, another change is simultaneously underway in the clinical environment: formulation changes."PFS formulation, significance in terms of procedure standardization and infection control"The Vabysmo PFS formulation, reimbursed since the 1st of this month, is evaluated as an element that changes the clinical process itself beyond just improving convenience.The existing vial formulation requires several steps, such as drawing the medication into a syringe, changing the needle, and removing air. The PFS is pre-filled with the medication and can be used immediately after opening.Choi emphasized, "Since an intravitreal injection is a procedure where medication is administered directly into the eye, even minor contamination can lead to serious complications. Reducing the preparation process is a very important change in lowering the risk of infection."According to Choi, although complications such as endophthalmitis do not occur frequently, prevention is critical because they can have a fatal impact on vision when they do occur. In this regard, simplifying the preparation process is meaningful for ensuring safety beyond mere convenience.In high-volume practices, this difference plays an even larger role. In ophthalmology clinics, tens of thousands of intravitreal injections are performed annually, making it crucial to minimize variables that may arise during repeated preparation steps.Choi stated, "Intravitreal injection is a frequently performed procedure. In our hospital, about 20,000 intravitreal injections are performed annually. In an environment with a high number of procedures, the effect of reducing a single step leads to system stability, not just saved time."Choi added, "Looking at overseas cases, there are reports that about 85% switched to PFS within about two months after the PFS formulation was released. If the reimbursement criteria are the same and there are no special restrictions on supply, most will likely switch to the PFS formulation."The PFS formulation also affects the actual procedural process.The Vabysmo PFS features an extra-thin-wall needle to deliver a higher flow rate at the same pressure. The injection process can be carried out more smoothly and quickly.Choi mentioned, "For elderly patients, it is not easy to keep the eye fixed during the procedure, so it is important that the injection process is fast and smooth. These factors affect the actual patient experience."Another characteristic of the Vabysmo PFS is that it comes with a filter needle. This structure filters out fine particles and contaminants, simultaneously increasing procedural precision and safety. This needle consists of a dedicated filter needle approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).Choi added, "Other products do not include a needle, but Vabysmo includes the needle in the product package. Maintaining consistent needle quality is a very important factor for medical staff," and added, "It can provide a consistent procedural environment in terms of handling and stability."This mechanistic evolution and formulation improvement ultimately converge in one direction: the treatment persistence.Macular degeneration and diabetic macular edema are diseases that must be managed over years or even decades. According to the Health Insurance Review and Assessment Service (HIRA), the number of patients with macular degeneration in Korea increased by more than 150% over the past five years, from about 200,000 in 2020 to about 560,000 in 2024.In this process, the treatment interval, procedural burden, and frequency of hospital visits are key variables determining patient compliance. Currently, Vabysmo has extended the dosing interval up to a maximum of 16 weeks. Choi believes this is highly significant because it can substantially reduce patients' long-term treatment burden.Choi said, "From the patient's perspective, receiving an injection directly into the eye is a significant psychological burden. Because this treatment must be repeated for a long time, it is important to determine whether the frequency of hospital visits and injections can be reduced. Receiving treatment every month versus every three months is a completely different experience for a patient. This difference determines whether long-term treatment is maintained."In conclusion, Choi emphasized, "For some treatments, inflammation issues can pose a clinical burden regardless of efficacy. Vabysmo is an option that can be used with relative peace of mind regarding safety and efficacy. In cases where preserving vision in one eye is critical, such as 'last eye' patients, safety is even more important than treatment effect, and Vabysmo can be a reliable treatment option in both aspects.
- Opinion
- Anzupgo emerges as a new option in chronic hand eczema
- by Son, Hyung Min Apr 26, 2026 01:45pm
- As the steroid-centered stepwise approach in the treatment of chronic hand eczema reveals its limitations, the non-steroidal topical JAK inhibitor ‘Anzupgo Cream’ is emerging as a new turning point in treatment.In particular, as it is gaining attention as an option to fill the treatment gap before moving on to systemic therapy following treatment failure, the need to redefine treatment strategies in actual clinical practice is being raised.Andrea Bauer, Professor of Dermatology at University Hospital Carl Gustav Carus Dresden, GermanyAndrea Bauer, Professor of Dermatology at University Hospital Carl Gustav Carus Dresden, Germany, recently spoke with Dailypharm about the paradigm shift observed in the treatment of chronic hand eczema.Chronic hand eczema is an inflammatory skin condition that causes red patches, cracking, itching, and pain on the hands. It is aggravated by water, detergents, allergic reactions, and stress, and in severe cases, it can make daily life difficult.Professor Bauer stated, “Chronic hand eczema is defined as a condition in which symptoms persist continuously for more than three months or recur at least twice within one year. It is a disease with a high prevalence, affecting approximately 10% of the total population in European countries, and there are globally agreed-upon diagnostic criteria.Traditional treatment for chronic hand eczema has been based on a step-wise approach.Treatment begins with moisturizer-based management, followed by topical corticosteroids (TCS) and calcineurin inhibitors (TCI). Subsequently, phototherapy or oral alitretinoin may be used, and in severe cases, biologics or JAK inhibitors may be used off-label.The problem is that each step has clear limitations.Until now, treatment options for chronic hand eczema have been limited, leading to the predominant use of potent topical steroids. However, long-term use carries risks of various side effects, including skin barrier damage, skin atrophy, and telangiectasia.Alitretinoin, an oral therapy approved for chronic severe hand eczema, is used in patients who do not respond to at least four weeks of potent topical steroid treatment. It improves symptoms through skin regulation, anti-inflammatory, and immunomodulatory actions, and is known to be effective for the long-term management of chronic severe hand eczema, which has a high risk of recurrence.However, long-term use raises concerns about various side effects such as headaches, elevated lipid levels, and teratogenicity, limiting continued treatment.Professor Bauer said, “Steroids carry a risk of skin atrophy when used for more than 3–4 weeks, making long-term use difficult, and alitretinoin is limited in use not only due to headaches and lipid abnormalities but also because of the risk of birth defects in women of childbearing age. Ultimately, there had been a clear treatment gap with no distinct alternative before moving to systemic therapy following the failure of topical treatment."Anzupgo cream blocks the JAK-STAT pathway… addresses limitations of topical therapy"Anzupgo Cream (delgocitinib) has been proposed as an option to fill this gap.Anzupgo Cream is the only non-steroidal topical cream formulation approved for the treatment of moderate to severe chronic hand eczema in adult patients who do not respond to topical steroid preparations or for whom such treatment is not appropriate.Anzupgo Cream does not contain parabens or steroids. It helps alleviate skin inflammation and itching by inhibiting the JAK-STAT signaling pathway, which is involved in various inflammatory responses, thereby suppressing the activity of JAK1, 2, and 3, as well as TYK2. Anzupgo Cream was approved in Korea last September and was officially launched in the domestic market this year.Professor Bauer said, “Unlike oral JAK inhibitors, it has minimal systemic exposure, giving it an advantage in terms of safety. In clinical studies, adverse event rates were similar to or lower than those in the placebo group.”He continued, “Another important advantage is that it absorbs quickly and has good usability, leading to high patient adherence.”Anzupgo cream has demonstrated broad efficacy across all subtypes of moderate to severe chronic hand eczema in multiple clinical studies.In the clinical trials designated DELTA 1 and 2, adult patients with moderate to severe chronic hand eczema who applied Anzupgo Cream twice daily for 16 weeks showed significant relief from itching starting on the first day of application and from pain starting on the third day, compared to the placebo. Furthermore, at the 16-week mark, the proportion of patients achieving the Hand Eczema Severity Index (HECSI-75) was significantly higher compared to the placebo group.In the subsequent DELTA 3 extension study, the long-term efficacy and safety of Anjupgo Cream were further evaluated, confirming generally good tolerability and consistent clinical improvement even with long-term administration. The initial treatment effect was stably maintained in the 52-week data, which included the 16-week main study and the 36-week extension study.Recent expert consensus positions Anzupgo cream as the only non-steroidal topical option between steroid failure and systemic therapy.Professor Bauer stated, “In German clinical practice, we are also observing cases where skin that has thickened due to chronicity returns to a near-normal state upon application of Anjupgo Cream. Patient satisfaction is high as it gradually improves wrinkled and rough skin.”The professor emphasized the importance of treatment timing.Professor Bauer noted, “If the condition remains uncontrolled after 1–2 cycles of steroid treatment or recurs immediately after discontinuation, treatment should be switched without delay. As the disease becomes more chronic, treatment becomes more difficult, so early intervention is key.”He explained, "Anjupgo Cream can be effective in various subtypes of chronic hand eczema, such as bullous and hyperkeratotic types. In particular, patients with prominent inflammatory symptoms show a rapid response. For patients with hyperkeratotic eczema who have thickened skin, absorption may take some time, but consistent use will yield results.”
- Opinion
- [Reporter's View] NHI "red light", societal consensus needed
- by Lee, Jeong-Hwan Apr 17, 2026 09:03am
- South Korea’s National Health Insurance (NHI) finances are expected to enter a deficit in 2026. While the fund was in surplus for five consecutive years since 2021, the end of the COVID-19 pandemic, the transition to endemic status, and the onset of a super-aged society have led to a sharp increase in medical expenditures, causing the surplus to plummet annually.The government has established and implemented various policies to ensure the soundness and sustainability of NHI finances. One example is the reduction of pharmaceutical costs through generic drug price cuts, which recently sparked a conflict with the domestic pharmaceutical industry.However, health insurance experts argue that the government must resolve larger fundamental issues rather than focusing on administrative measures to create fiscal room through drug price cuts.While the increase in medical utilization and benefit expenditures due to a super-aged population is an unavoidable natural growth factor, experts criticize that the failure to aggressively resolve distortions in the medical delivery system or the lack of measures to eradicate excessive medical care ("medical shopping") is a man-made disaster that exacerbates the problem through inadequate administration despite being preventable.Furthermore, health insurance experts view the solutions for securing the soundness of NHI finances as having been consistently discussed as an agenda for over a decade, and the correct answers are already somewhat determined.Ultimately, this means that procedures must be established for the government, medical providers (doctors), and medical consumers (patients and the public) to form a consensus and agree on a policy direction that boldly lowers or suspends the benefit coverage rate for excessive medical care and overhauls the payment system centered on the fee-for-service model from its roots.Of course, there is a high probability that opinions will differ regarding the priorities for allocating NHI finances. However, before coordinating such detailed disagreements, the government should take the lead in establishing societal consensus.The etymology of "consensus" originates from the Latin words con- (together) and sentire (to feel). It refers to members of society sharing common feelings and thoughts.NHI finances are a social insurance system operated by the state with public consent, and the key lies in how to create, maintain, and distribute limited public resources. Ultimately, it means that the NHI can be operated without conflict only when it is based on consensus.At this crossroads, where NHI finances are being depleted and the deficit is set to increase significantly, the Ministry of Health and Welfare (MOHW), the ministry in charge, must engage in bold, active administration. This is necessary so that the entire public and medical providers can share the common view that NHI sustainability must be significantly strengthened before social conflict is triggered by fiscal deterioration.This implies that the Ministry of Health and Welfare (MOHW) should take the lead in improving the perception that a "red light" has been turned on for NHI finances and that all members of our society must share some of the burden to solve the problem.
- Opinion
- [Desk’s View] Unmet needs remain in immuno-oncology
- by Eo, Yun-Ho Apr 13, 2026 09:12am
- Immuno-oncology has now become quite a fairly common term. It is a term even ordinary people are likely to have heard at least once. More than a decade has already passed since the term was first introduced to Korea. At present, immuno-oncology drugs have expanded their indications across various cancer types and established themselves as a major pillar of cancer treatment. Whether the growing number of indications receive coverage has become an important gateway that determines treatment access.The extent to which the clinical value of new treatment options should be reflected during reimbursement review remains a persistent concern. For the government, it is a matter of striking a balance between the financial burden and the clinical benefits offered by new drugs.The upcoming Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service is one place where this question constantly comes up for debate. At this month’s meeting, reimbursement for the ‘Opdivo (nivolumab)’ and ‘Yervoy (ipilimumab)’ combination as first-line treatment for hepatocellular carcinoma and non-small cell lung cancer will be presented for deliberation. At the meeting held last October, the combination was rejected for both liver and lung cancers.In hepatocellular carcinoma, following Tecentriq (atezolizumab) plus Avastin (bevacizumab), Imfinzi (durvalumab) plus Imjudo (tremelimumab) have also been added to the reimbursement list. In non-small cell lung cancer as well, an immuno-oncology-based treatment strategy has already taken hold, with ‘Keytruda (pembrolizumab)’ already reimbursed as monotherapy and combination therapy for 4 years.With immuno-oncology drug combinations already reimbursed, attention is now turning to whether reimbursement criteria will be set for the new Opdivo-Yervoy combination, as the addition must be more than simply another treatment option to pass review.In this regard, hepatocellular carcinoma remains a cancer type with frequent recurrence, poor prognosis, and high mortality rates, and many patients begin treatment with impaired liver function. Due to these disease characteristics, key evaluation criteria include whether the treatment option can provide deep and durable responses, long-term survival, and long-term survival benefit regardless of liver function status.The Opdivo and Yervoy combination is the treatment option that has demonstrated the longest survival data in first-line treatment for hepatocellular carcinoma. In clinical trials, it recorded a median overall survival (mOS) of 23.7 months, with a survival rate of 31% at 48 months. In addition, in an Asian patient subgroup analysis, a median overall survival (mOS) of 34.0 months, a 3-year survival rate of 49%, an objective response rate of 37%, and a complete response rate of 10% were reported. Compared with existing immuno-oncology combinations, whose mOS typically does not exceed 20 months, these are significant results.In particular, the Opdivo-Yervoy combination significantly reduced the risk of death by 25% versus the control arm, even in patients with impaired liver function classified as ALBI grade 2/3, demonstrating a degree of mortality risk reduction comparable to that seen in patients with preserved liver function.Its use in non-small cell lung cancer also warrants attention. Although Keytruda-based regimens have effectively become the cornerstone of first-line treatment, it is difficult to say that they fully address the treatment needs of all patient subgroups. In practice, there are still patient groups, such as those with PD-L1-negative tumors or squamous histology, for whom long-term survival benefit under existing immuno-oncology treatment settings has been reported only to a limited extent.As the Opdivo-Yervoy combination demonstrates consistent survival improvements in these patient groups, regardless of PD-L1 expression or histology, it has been discussed as a viable alternative.Ultimately, the core of the Cancer Disease Deliberation Committee review should not be on whether another option should be added to the reimbursement list. Real deliberation should be made on whether the current reimbursement system is offering a sufficient range of treatment choices in practice, and to what extent unmet treatment needs in specific patient groups should be reflected in deliberations. It would be difficult to accept a conclusion that the current system is sufficient merely because options already exist. When it comes to immuno-oncology drugs, unmet needs remain.
