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- 2026-04-26 05:47:49
- Opinion
- [Column] Legal disputes over rebate penalty reducing price
- by Lee, Hye-Kyung Dec 05, 2019 06:12am
- This year would be a year to remember as various issues regarding drug pricing broke out, such as ‘lump-sum price reduction on single-use eye drops’, ‘revised generic pricing system’, and ‘litigation against pricing reduction penalty for providing rebate’. Currently the drug pricing system is geared towards paradigm shift, starting with abolished ‘same substance same pricing’ policy. Pharmaceutical companies would be helpless but to seek for other survival tactics in the coming year while the drug pricing ecosystem changes. There are many issues to be talked about regarding drug pricing, but today it would be about a few updates on meaningful court decisions made on pricing reduction as an illegal rebate penalty. However, it would mainly be summarized points of the issues as the lower court made the decisions and the issues are still open for long-running disputes. As I introduced in a column titled ‘Rebate and Kick-back’ published December last year, the Korean Ministry of Health and Welfare (MOHW) imposed maximum reimbursement price reduction on 340 items from 11 pharmaceutical companies accused of providing rebate. Currently, the most of affected pharmaceutical companies have filed administrative litigation against the matter. The pricing reduction penalty has not been imposed for years and related legal dispute has not been talked, either. So the recent legal disputes were raised since various issues occurred with MOHW imposing penalty of the massive scale. Going through each dispute issue, the first issue is about whether to consider nature or property of drug pricing reduction penalty as a sanction or not, according to the Item 12 of Paragraph 4 of Article 13 of Regulation for Criteria for Providing Reimbursed Services in the National Health Insurance, stating “a drug that has been confirmed as having disturbed trade orders by offering money or good for sales promotion, etc”, or also known as former rebate regulation. The distinction of the sanction is crucial, because the ministry’s jurisdiction could change depending on the recognition of the discretionary sanction. In other words, when the court recognizes the penalty as discretionary sanction, the judiciary would then decide the penalty was legitimate respecting the administrative agency’s judgment, if without a significant flaw, but if not then the court could revisit the issue. On the issue, the lower court decided drug pricing reduction penalty imposed based on the former rebate regulation ‘could not be seen as sanction, but rather the maximum reimbursement price adjustment should be judged as discretion of reasonable penalty.’ Therefore, the court meant that it would be considered as a legitimate penalty within the discretionary jurisdiction only when the jurisdiction is considered reasonable. With the said premise, the court ruling made decision on jurisdiction of discretionary authority for each specific disputed issue. First, the court ruled that the Minister of Health and Welfare was not obligated to lay down detailed basis of maximum reimbursement price calculation to affected companies, when imposing the price reduction penalty. The court did not see the legitimate reason as for the minister to consider the company as direct subject, because the regulation defines subjects for notice on reimbursed drug are mutually applied among healthcare institute, National Health Insurance Service (NHIS), policyholder, and dependent. Among drugs provided from Pharmaceutical Company B to Hospital A, should the price be reduced only for drugs prescribed by the rebate-received medical profession? Or should maximum reimbursement prices of all drugs supplied by Company B and prescribed by Hospital A be reduced? The court stated all drugs from Company B could be subject for the maximum price reduction. Rebate provision itself is highly likely to have been provided to promote sales of a specific company’s product, and there was no objective evidence to prove the rebate was provided for a specific product instead. So the court decided the Ministry of Health and Welfare’s penalty was within its jurisdiction of discretionary authority. Then what about a case of Hospital A providing both reimbursed and non-reimbursed drugs. How should the maximum reimbursement price reduction rate be calculated? Should the rebate on non-reimbursed drug be disregarded from the calculation of price reduction rate? The court decided proportionally dividing rebate amount on reimbursed drug, while completely disregarding non-reimbursed drug, was a faulty calculation of maximum reimbursement price reduction rate. The calculation formula for the price reduction rate was wrongful as rebate could have been provided for the non-reimbursed drug, and removing the amount provided to non-reimbursed drug from the calculation would have resulted in excessive reduction rate. Lastly, if the rebate provided to a pharmacist was for the cost of the provider’s prescription drug, would it be possible to reduce the maximum price including the rebate cost? Besides from violating Pharmaceutical Affairs Act, the court saw that the company’s act of providing rebate is difficult to relate back to prescription and sales of the prescription drug. The principle and the norm of dispensing and sales of prescription drug is decided by doctor’s prescription, so the court judged it is unlikely to see the correlation between rebate provided to pharmacist and ‘promotion of dispensing and sales of prescription drug’, except for a special occasion. Therefore, the court stated reduction rate should be calculated without the rebate cost provided to the pharmacist. As for the last decision, the court reviewed standard and process of imposing maximum reimbursement price adjustment penalty more specifically than other previous rebate decisions, which sets judging standard to see if the maximum reimbursement price reduction penalty was reasonable based on the ministry’s discretionary authority. The decisions were made during respective first trials and they are waiting for the appeal. Attention on the issues is heightened to see if the preceding decisions would be sustained in the appeal. In fact, there is a possibility of the change in decision during the appeal, and whichever decision is made at the Supreme Court later, the cases would definitely be the precedents setting a standard of the rebate-induced drug pricing reduction penalty. The heated legal disputes seem inevitable for the healthcare sector, as it is Korea’s new economic growth engine with visible rapid expansion in quality and quantity. Besides, the highly political and technical drug pricing is right in the center of the dispute. Previously mentioned drug pricing paradigm shift seems like it would bring more interesting topics on the table than just the rebate case. Surely the drug pricing policy would attract even more attention in the coming year 2020.
- Opinion
- [Column]GPP can’t be off anymore
- by Jung, Heung-Jun Nov 27, 2019 06:40am
- GPP is a hot potato in the pharmaceutical society. It is unlikely that a executive of the pharmaceutical association with experience in business would completely deny the introduction of GPP. This is because the government and the public have been asking the pharmaceutical association for decades. But the drive is making slow progress. This is because it is difficult for the Korean pharmaceutical society to roll their arms first for a policy that members are not happy with. Former Executive Committee, Chan-hui Cho held a debate to discuss the GPP, but the members' response was cold. The core of GPP is to elevate pharmacy's work level. This ranges from patient services related to medication to systematic and clean management of pharmacies. It is basic not to make unauthorized persons illegal activities, such as dispensing or selling generic drugs. This system aims to induce improvement by certifying excellent pharmacies through evaluation and to raise the level of work of all pharmacies. But members' response to the GPP is not favorable. They recognize the necessity, but they are not very active in accepting, or even view it as another unnecessary regulations. Some used to run a pharmacy at their convenience, but once the GPP is in place, they have to be more careful to meet the criteria and to include being assessed by an outside agency for certification. Nevertheless, the positive side of the GPP certainly exists. First, they can reduce underage pharmacies which do damage to the entire pharmacist society There are many pharmacies that operate in good faith in accordance with desirable pharmacists, but there are some that do not. Because of these pharmacies, the overall status of the pharmacist society falls. The protection of these pharmacies by the Korean pharmaceutical society is nothing less than the surrender of the rights of the whole members. Second, they can increase public confidence in pharmacies and pharmacists. Support of the public is essential for the pharmacist's petition project such as ingredient prescription. It is important to understand that the current situation with low confidence or expectation in pharmacies is the biggest obstacle to the development of pharmacist functions. Members often avoid GPP because of incorrect information or realistic concerns. The idea is that the GPP is tricky to implement a corporate pharmacy or objectionable because it will cost a lot of interior expense. In particular, there seems to be a misunderstanding that hardware elements such as interior and automatic dispenser are important conditions for becoming a pharmacy. Not like that. In order to provide good service, software factors such as pharmacist knowledge and careful care of patients are more important. And the certification system should be made to reflect these software elements well. This can lead to the development of the pharmacist's function, which is the true purpose of the system. In order for the GPP to be settled in a desirable manner, it is correct that the pharmacist society faithfully carries out these concerns and preemptively implements them. Recently, the Anti-Corruption and Civil Rights Commission recommends that the Ministry of Welfare undertake a study on the implementation of the GPP. It is a pity to respond aggressively to the changes of the times and to the demands of the people. We must abandon the current situation where the pharmacist society seems to stand up to the consumer's demands, and change to the stage where the pharmacists renew and gain the trust of the people. Change is always painful. But the power to change on its own is the driving force to open the future. Even now, we expect the pharmacist society to gather wisdom and courage to be on the right track of change.
- Opinion
- [FOCUS]Government sophistication to generic regulations
- by Chon, Seung-Hyun Nov 25, 2019 06:21am
- A few years ago, a multinational pharmaceuticals announced “high quality” by launching generics in the domestic market. It is the aspiration to show good quality generics based on strict production management, product monitoring and quality assurance system that have long been recognized in the global market. At the time, the head of the licensing review department of the Ministry of Food and Drug Safety, who got the news, rejected that "the quality of generic products is meaningless." Generics must pass strict standards from drug substances to finished product manufacturing facilities. In addition, a conformity test should be made in a bioequivalence study demonstrating that the generics are equivalent to the rate and concentration of original drug absorption. "Generic products that have passed all government-set standards and have been approved for sale should be regarded as equal in quality.“ The MFDS is trying to tighten restrictions on generics after last year's issue of Valsartan impurity. The MFDS announced the legislative draft of the “Revision of Partial Rules on the Safety of Pharmaceuticals,” etc. on the 18th. It contains a significant tightening of the licensing requirements for all fair commissioned manufacturing generics. It means that the GMP evaluation data, standards and test method data, which have been exempted from the consigned generic permit screening data, must be submitted. It is noteworthy that MFDS referred to “high quality generics” as the background for strengthening generic regulations. According to the Regulatory Impact Analysis Report of the revised regulations, the MFDS said that they will secure the trust of the people providing 'high quality' medicines and improving the soundness of drug distribution through the quality improvement of generics for each clause that strengthens the regulation of generics. The intention is to supply high-quality generics by strengthening generic regulations. It also means that there is differences in quality between generic products. This is contrary to the conventional view that "quality is equal if it passes the strict licensing process." It seems possible that even with the MFDS, there may be some low quality generics. It is also ambiguous to see how the strengthening of permit standards is related to quality improvement. Submission of GMP assessment data by authorized generic means re-release of data that has already been verified by the MFDS. GMP assessment data need not be submitted when consigning a product that is identical to a previously approved generic. However, one year after the proclamation of amendment, the authorized generics will also be required to produce three manufacturing units (batch) and submit relevant GMP data for approval. The submission of GMP evaluation data by authorized generics disappeared just five years ago. The MFDS implemented ‘the GMP Compliance Certification System’ in 2014, which permits Pharmaceutical production that all factories producing pharmaceuticals requires passing the standards set by the MFDS every three years. At this time, regulations for mandatory production of licensed drugs were relaxed. It was made possible for the establishment within the validity period of the conformity assessment to replace the data on the evaluation of the GMP implementation with the conformity assessment. They have already laid the foundation for strengthening quality management by introducing the ‘Certificate of GMP Compliance of a Manufacturer', and in the situation where the approved facility has determined the suitability of licensed drugs, it is decided that it is redundant regulation to receive the GMP evaluation data of the authorized generics again. The same applies to co-bioequivalence regulations currently underway. On April 15, the MFDS announced a partial revision of the “Regulations on the Authorization, Declaration, and Review of Pharmaceuticals,” which includes tightening regulations on co-bioequivalence regulations. According to the amendment, regulations will be tightened so that up to three authorized generic manufacturers are allowed to one original manufacturer one year after the notification. This means that up to four generics will be granted for each bioequivalence test. After three years, consiged bioequivalence is completely banned. Four years after the notification, only one generic may be approved in one bioequivalence study. As a result, after four years, the same product from the same manufacturing facility must be tested for bioequivalence separately. I don't know what it is related to run separate bioequivalence tests on the same product with ‘high quality generics’. Goal of the MFDS is clear that it tightens regulations of generics. Because of the serious difficulty of generics, the intention is to reduce the number of generics in the market by raising licensing barriers. It is clear that the overflow of generic manufacturing contractors is the cause of generic upheaval. It is also clear that generic upheavals were triggered by changes in government permit regulations. Wouldn't it be better to admit that the government's policies encouraged generic upheaval and try to persuade the reasons for changing the policy stance? Rather, the cause of “quality improvement,” which is not related to the regulations, can lead to confusion in the industrial field. This leads to distrust in government policy. Of course, the government may adjust the regulatory intensity in response to changing market conditions. However, companies need to be able to believe and follow only by providing a clear justification and justification for the new policy. If the government produces a policy without justification and changes the policy stance, in the turn of a hand, credibility falls.
- Opinion
- [Reporter's view] The Korean bio-health industry in Anomie
- by Lee, Jeong-Hwan Nov 20, 2019 11:50pm
- World-class standards of medical technology is Korea's long-standing pride. Advanced bio-new drugs are the future growth fuel that the world pursues, and the Korean pharmaceutical industry is gradually shifting its development focus from generics to new drugs with technology. Expectations and concerns coexist in the public's spotlight toward the medical and biopharmaceutical industries that will affect the future of Korea. It is rare to oppose the achievement of 'high-tech medical and bio-new drugs' that will lower regulatory barriers, speed up the introduction of new technologies, and ultimately directly benefit society and the public. On the other hand, the question of whether to agree to the provision of personal health information necessary for the development of advanced medical and biologic new drugs is not easily nodded in assent. The order to make high-tech medical and new medicine without medical big data is to offer the best dinner without high quality and abundant raw materials. In this respect, The Korean bio-health Industry fell in Anomi. New norms and social values appropriate for advanced medical and biologic drugs and the fourth industrial revolution must be established, but it is the current status of our society that existing traditional norms and values rarely innovate. In other words, the social values, which are essential for the high-level medical care and advanced new drug industrialization, are in a state of confusion and irregularity. Recently, the 4th Industrial Revolutionary Committee urged the government to advance laws and regulations, and to strengthen the capacity for review and licensing. Specifically, the government said that it would reduce social unrest by strengthening public relations about the objective scientific achievements that the biohealth industry would bring along with the revision of the Personal Information Protection Act, medical law, and bioethics law. KIET stated that the Korean bio, IT, and AI industries with excellent technology have fallen into ‘the prisoner's dilemma’, pursuing their own interests among medical world, civil society, and the government. It is a diagnosis that civil society, which has high technology development and government-industrial distrust, is not able to agree on providing sensitive health and medical personal information, and is hindering the development of telemedicine or biomedicine. After all, how to rescue Korea's bio-health industry in an anomalous state is the solution for advanced medical and biomedicine drugs. Citizen anxiety is likely to grow as regulatory innovations take place, and it can create fear that personal information is being used by government or some industries for other purposes. The government should work with expert groups to make concrete plans to break down civil distrust, and quickly resolve the public's lack of cutting-edge bio-information through various public participation external events. Regulatory innovation and industrial development should not be focused on keywords, it made The public, the government, and the industry struggling with each other, and darken the state-of-the-art medical and biopharmaceuticals the future We should be able to explain transparently and specifically how my medical information is used and protected in the development of the biohealth industry and how the individual can finally benefit. Also, it is time to break down chaos and anomie by creating a way for individuals to participate in the biohealth industry.
- Opinion
- [Column] Imposing fine enough to prevent rebate?
- by Kim, Jung-Ju Nov 13, 2019 01:09am
- Korean government’s plan to revise illegal rebate penalty regulation and replace insurance reimbursement suspension with fine on an accused drug product came under fire. However, the government is committed to protect drug access considering patient’s safety and convenience. For the justification of rebate regulation against rebate, the government points its finger on financial factor, other than pure objective of treatment, intervening the process of selecting and purchasing drug products, and negatively affecting on patient’s health, National Health Insurance (NHI) and general medical expense. The objective of rebate regulation is to induce adequate use of drug and transparent trading. The execution of rebate regulation should be able to achieve the objective, and the regulators should maintain fairness when executing it. The existing penalty against rebate is to revoke NHI reimbursement listing and to impose fine depending on the number of committed offenses. The proposed revision of the regulation starts from lowering of upper limit healthcare expense (drug price) to suspension of healthcare reimbursement, as well as imposing of fine, depending on the number of committed offenses. The major differences are utilization of drug price reduction, increase in amount of fine, and excluding revocation of reimbursement listing. It seems appropriate not to remove the responsible drug product from reimbursement listing for the sake of patient’s stable drug access, because it would be far-fetched to correlate illegal practice and quality of the drug. Furthermore, the regulators should contemplate on how effective the revised penalties would be to eradicate the illegal practice, compared to the revocation of reimbursement listing. The purpose of the regulation should not only stress on punitive aspect, but also stress on preventive aspect. Reduction of drug price and increased fine are undeniably punitive. However, the issue is the severity level of the penalty sufficient enough to bring preventive effect. When the level of penalty is bearable, then companies with agenda would rather take the chance of committing offense. Other issues are drug price reduction, reimbursement suspension period and the unclear definition of the ‘period’ when imposing fine. Positively speaking, they could be seen as ‘flexibility’ in administrative measure, but negatively speaking, ‘voluntariness’ of the administrative measures are questionable. It is easy to predict who would exploit and abuse the regulatory standard (interpretation of the term). Also, the term ‘one year-worth of reimbursement cost’ addressed in the regulation summing the amount of fine is ambiguous. Depending on the point of the ‘year’, the accused company’s absolute amount of fine and countermeasure differ vastly. At the moment, dual penalty system is applied on the rebate giver, a pharmaceutical company, and the receiver, a doctor or healthcare institute. But the off-balance between regulations against the giver and the receiver, as addressed by the National Health Insurance Act, are under fire. The regulators are reinforcing financial penalty on rebate-giving product, instead of imposing regulation on the product itself to maintain access to the treatment. On the other hand, regulators suspends license of the rebate-receiving healthcare provider, and also confiscates illegally obtained financial gain. How about some more attention on re-evaluating the fairness between reimbursement revocation on a drug product and suspension of doctor’s license? Or between drug price reduction and reimbursement cost refund, and financial gain confiscated from healthcare providers? Effective execution and fair penalties of rebate regulation should be revisited at this point in time. Moreover, we should not forget to contemplate on revising the regulation to prevent rebate practice in long-term and fundamental fashion, taking the unique qualities of the pharmaceutical industry’s rebate practice and distribution environment into account. Although the ultimate consumer of a drug product is patient, it is undeniable that doctors are in control over the pharmaceutical options. Keeping in mind that a drug is also a commercial product, the regulators would also have to face the reality of marketing without some form of rebate. The point is to bring down healthcare provider’s openness of receiving rebate and the level of rebate provision. Besides the problem within rebate practice, National Health Insurance’ payment system and healthcare provision system should be reformed to achieve fair and good healthcare.
- Opinion
- [Reporter's view] DC the absolute power behind hospital
- by Eo, Yun-Ho Nov 11, 2019 11:08am
- When each hospital’s Drug Committee (DC) is convened, pharmaceutical companies starts a fierce war to land a favorable drug deal. Just like any war in the world, the ‘DC war’ has a winner and a loser. Unfortunately, not always do the winners deserve a win or the losers deserve their defeat. To land a ‘drug code-in’ deal at some general hospitals, ‘inappropriate backdoor dealing’ is more important than outstanding evidences of a drug’s indication and efficacy. Such phenomenon is prevalent when an original’s patent is expired and new generic is released. A hospital’s DC mostly consists of doctors from each department and chief pharmacist. However, sometimes unheard-of drugs get their codes in and push out existing drugs, thanks to hospital foundation’s influence. To this date, a hospital with significantly influential DC brings in representative of a pharmaceutical company and demands for so-called ‘drug code maintenance fee’ on an original drug with expired patent. In fact, the hospital removed well-known original hypertension, hyperlipidemic and antithrombotic items for last two to three years. Their codes were removed, simply because the drug companies refused to pay the ‘maintenance fee’. The illegal rebate paid by drug companies is never handed straight to the foundation. Pharmaceutical industry insiders hint that the money is rerouted and laundered through separate corporations owned by the foundation or distribution companies with a close relationship, and finally gets to the foundation. DC lobbying exists between originals when there is a new generation or type of drug is launched. So for pharmaceutical companies to get a drug code-in deal, they need to coax foundation and doctors. Of course, the effort of Dual Penalty System and Fair Competition Agreement has brought some fairness to the business. Unless solid evidence of a drug is available, growing numbers of hospitals are not guaranteeing DC’s approval, regardless of a good connection between a healthcare provider and a pharmaceutical company. However, hospitals still associate DC with an absolute power. Even though it should be given that hospital’s drug coding depends on fair evaluation.
- Opinion
- [Eyes of a Reporter] Are you a ‘good company?’
- by An, Kyung-Jin Nov 08, 2019 08:45am
- Every year around this time, one book hikes up the best seller ranking at book stores. The book, ‘Trend Korea Series’ by Professor Kim Nando of Seoul National University, summarizes next year’s trend in Korea with a list of keywords. ‘Trend Korea 2020’ had a top ten consumer trend keyword list including ‘fair play’. The book explains how the notion of ‘good company’ has gotten popular among consumers over the years, therefore, ‘fair competitiveness’ would become a more vital factor affecting consumer’s choice. At a recent special lecture session, Professor Kim claimed “Growing up in a society where individuality is prevalent, Millennials wants to change their society with a small effort. Even when buying a product, they put value not only in the product itself, but also in the brand’s good influence towards the society”. With his theory, he further explained the lately popular boycott movement against problematic brand is not just a simple aggression, but an expression of desire to be fair and correct. During the lecture, I suddenly thought of a question. Which pharmaceutical company is actually a ‘good company?’ In Korean society, pharmaceutical companies have a relatively positive public image. The society appreciates how the companies provide needed drugs to patients and contribute in saving lives. How wonderful is it that their income made from drug sales is reinvested toward new drug R&D, and also on corporate social responsibility (CSR) activities. However, some companies have disappointed Koreans and crippled their trust in the industry in recent years. Last year March, a French pharmaceutical company announced it would suspend supplying a contrast agent used for liver cancer treatment due to low pricing in Korea. As a response, the Korean society got infuriated. A British multinational healthcare company has been the infamous company for a while as the one responsible for making humidifier disinfectant with severe health hazard. After developing an anticancer treatment significantly extending patient’s overall survival period, a large-scale pharmaceutical company experienced painful clash and dispute with patient groups as the company insisted on drug pricing at around few million won per month. Global companies are not alone on this topic. Prosecutors are still investigating a Korean bio company accused of manipulating ingredient report on its osteoarthritis gene therapy. An allegation of another Korean company, despite its title of ‘good company’ earned from the society, providing illegal rebate to healthcare provider for prescribing their products turned out to be true and the their executives were sentenced with jail term. Also there are many companies regularly making negative postings at vulnerable time for investors fearing it would affect stock price. In this capitalistic society, reproaching pharmaceutical companies for their profit-making decisions could be too harsh. Supplying needed drug or CSR activities can only be possible, when a company is sustainable. But, shouldn’t the executives of pharmaceutical companies feel more responsible about the society’s higher expectation of business ethics on health related companies? We can only hope that those pharmaceutical companies would repent their wrong choices and stand tall again as a ‘good company’, keeping their initial objective of ‘contributing to public health’ in mind.
- Opinion
- Anzupgo emerges as a new option in chronic hand eczema
- by Son, Hyung Min
- 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.”
