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- Policy
- Pressures to reform Korea's drug pricing system
- by Lee, Tak-Sun Jul 2, 2025 06:10am
- President Trump's signing of the executive order on May 12 to lower prescription drug prices in the United States to the same level as other countries has deepened the concerns of Korea’s authorities as well. This is because the U.S.&160;Pharmaceutical Research and Manufacturers of America and others are demanding that Korea raise drug prices and improve its system. If the U.S. government directly demands improvements to Korea's drug pricing system during tariff negotiations, this may increase the new government's concerns as there will be no clear solutions to resolving the issue, On the 27th (local time), the Pharmaceutical Research and Manufacturers of America (phRMA) submitted a statement to the US Trade Representative (USTR) urging the improvement of unfair drug pricing policies by foreign governments, including South Korea, as leverage in trade negotiations. The USTR claimed that Korea imposes difficult review requirements on foreign pharmaceutical companies, delays market entry, and suppresses drug prices below fair market value. This statement gained attention because it was released after President Trump signed an executive order on May 12, known as the most-favored-nation (MFN) policy. The MFN policy aims to lower the price of prescription drugs in the US to the same level as other countries. Under the executive order, the US Secretary of Health and Human Services must establish a program that allows US patients to purchase drugs directly from pharmaceutical companies at MFN prices. In its statement, the phRMA identified South Korea, Australia, Canada, France, Germany, Italy, Japan, Spain, the United Kingdom, and the European Union as countries with unfair drug pricing policies. These countries are likely to become MFN countries, which will serve as a reference for U.S. drug price reductions. It is analyzed that the Trump administration is likely to demand that MFN countries, with which the US pharmaceutical industry is currently engaged in tariff negotiations, improve their drug pricing systems in order to push through the reduction of prescription drug prices in the US. When President Trump signed the MFN policy executive order, he instructed the USTR and the Department of Commerce to take action to prevent other countries from unfairly lowering their drug prices below market prices. The Korean government is concerned that the US MFN policy will result in ‘Korea Passing,’ where companies bypass Korea when making new drug releases and withdraw from the market. However, during Trump's first term, the US drug price reduction policy was abandoned due to opposition from US pharmaceutical companies, so the situation requires continued monitoring. However, if the US actually demands improvements to the drug pricing system during tariff negotiations, there are no clear measures that South Korea can take in response, which is expected to increase the South Korean government's concerns. The measures the South Korean government can take include significantly adjusting the ICER (Incremental Cost-Effectiveness Ratio) threshold, and expanding risk-sharing agreement programs to adjust prices. However, given the high proportion of drug expenditures in the health insurance budget, there are limits to regulatory relaxation. Flexible application of the ICER threshold or expansion of RSA programs has already been implemented last year as part of efforts to compensate for the value of innovative new drugs. If the U.S. government pushes for significant improvements to the drug pricing system under the guise of trade pressure, the new government's health authorities would have few cards to play, leaving them with even more challenges ahead. A government official stated, “We are currently monitoring and closely watching the U.S. government's implementation of the MFN policy. We are preparing for the worst-case scenario, such as the withdrawal of U.S. pharmaceutical companies' products from the market.”
- Company
- ‘TNF-α inhibitors, a cornerstone for rheumatoid arthritis'
- by Whang, byung-woo Jul 2, 2025 06:09am
- Rheumatoid arthritis is a chronic autoimmune condition that causes inflammation in the joints, leading to pain and deformity. Its prevalence in Korea is estimated to be approximately 0.5&8211;1% Recently, with the development of new treatments and improved awareness of the disease, early diagnosis rates are on the rise. In fact, over the past 5 years, the number of rheumatoid arthritis patients diagnosed in Korea has increased by more than 30%, with the elderly aged 50 and older accounting for 79% of all patients, highlighting the aging population. As a result, it has become important to go beyond simple treatment and focus on addressing elderly patients. Professor Sang-heon Lee of the Rheumatology Department at Konkuk University Hospital, an expert with the latest insights in the field, emphasized the importance of selecting the right treatment and management for the growing number of elderly patients with rheumatoid arthritis. According to Professor Lee, rheumatoid arthritis was once considered incurable, but with the advent of new treatments, perceptions have changed, increasing early diagnosis and treatment of the disease in general. Professor Lee said, “With the message that rheumatoid arthritis is a treatable disease spreading, early diagnosis rates are also increasing. In the past, we only checked the condition of the patient's joints with the naked eye, but the development of imaging diagnostic technologies such as joint ultrasound and MRI, rendered early diagnosis possible.” Another change is that, along with the overall aging population, the proportion of elderly patients with rheumatoid arthritis is also increasing. Professor Lee explained that elderly patients require a multifaceted approach to treatment, including management of complications, compared to younger patients. He emphasized, “Just as machines lose functionality over time, elderly patients often have multiple comorbidities due to the decline of various bodily functions. Complications such as cardiovascular disease, cerebrovascular disease, and diabetes are common, and immune function is also impaired, so caution is necessary when using immunotherapy agents.” 10 Years since the launch of Simponi IV Formulation, GO-FURTHER study results gain attention The emergence of TNF (tumor necrosis factor)-α inhibitors is an indispensable part of the paradigm shift in the treatment of rheumatoid arthritis. These drugs have been used in clinical practice for more than 25 years and are still considered effective in treating approximately 70% of all patients. Professor Lee stated, “The various treatment options developed since then have established themselves as alternatives for patients not adequately treated with TNF-α inhibitors. As such, TNF inhibitors remain the cornerstone of rheumatoid arthritis treatment. Even after patent expiry, biosimilars for TNF-α inhibitors are being launched most actively.” Among such TNF-α inhibitors, Simponi (golimumab) was introduced in Korea in 2012 as a subcutaneous (SC) injection formulation, and in May 2015, an intravenous (IV) injection formulation was launched, offering faster symptom improvement, longer dosing intervals, and easier monitoring by healthcare professionals, and establisehd a strong market presence. Professor Lee explained, “Simponi IV is a TNF-α inhibitor developed as a fully human monoclonal antibody, offering superior antibody purity and significantly reduced injection-related adverse reactions. While infliximab requires approximately two hours for administration, Simponi can be administered in about 30 minutes, and the dosing interval is every two months, significantly reducing the number of clinic visits.” Professor Lee is particularly interested in the advantages of Simponi for the increasing number of elderly patients with rheumatoid arthritis. A subanalysis of the GO-FURTHER study showed that Simponi IV showed more improvement in elderly patients aged 65 years or older. Specifically, in a subanalysis of the GO-FURTHER study that divided patients with active rheumatoid arthritis into two groups&8212;those under 65 years of age and those 65 years of age and older&8212;Simponi demonstrated higher initial symptom improvement compared to the placebo group in the elderly patient group during the first 6 months. At week 14, 61.0% of patients achieved ACR20, which was approximately six times higher than the placebo group (11.1%), and at Week 24, 69.5% of patients achieved ACR20, demonstrating significant clinical value of Simponi compared to the placebo group (33.3%). Professor Lee said, “Although the overall numerical differences were not significant in younger patients, there were more meaningful differences in response speed and response rates in high-risk patients. Elderly patients often have reduced physical function due to inflammation, so when they respond to treatment, the improvement is much greater. In this regard, Simponi has clinical advantages for elderly patients.” In terms of safety, Simponi IV did not show any new concerns in elderly patients. He said, “Generally, super-elderly patients over the age of 70 are at high risk of infection, so careful monitoring is necessary regardless of the drug used. The safety data for Simponi in elderly patients is generally consistent with previous reports, and injection-related side effects were rare and mostly mild.” “More treatment options emerge for rheumatoid arthritis... TNF-α inhibitors remain the cornerstone” From a broad perspective, the development of new drugs with various mechanisms of action for the treatment of rheumatoid arthritis has led to a wider range of options. In this regard, Professor Lee predicted that TNF-α inhibitors will remain competitive due to their accumulated treatment experience and safety data. Professor Lee stated, “At present, TNF-α inhibitors will continue to maintain their position as the cornerstone of rheumatoid arthritis treatment because of their over 25 years of accumulated clinical experience and identification of most major side effects, which allow physicians to prescribe them with confidence.” While new oral treatments like JAK inhibitors have emerged, concerns about long-term safety mean that TNF-α inhibitors remain the most trusted treatment option at this point. “JAK inhibitors are highly effective, but as they regulate intracellular signaling, there are concerns about long-term safety, such as cancer development. At least 5 to 10 years of additional data will be required to verify this.” In addition, Professor Lee emphasized the importance of personalized treatment for rheumatoid arthritis. He explained, “While most patients are initially prescribed TNF-α inhibitors as first-line therapy, they may not be suitable for all patients. In cases where there are contraindications for TNF-α inhibitors, such as a history of tuberculosis or heart failure, alternative medications with different mechanisms of action are considered.” Ultimately, the strategy of selecting the optimal medication based on the patient's individual condition and risk factors, and switching medications when necessary, is crucial. Finally, the professor noted, “While anyone can prescribe medications, managing complications or the progression of comorbidities associated with aging, as well as appropriately addressing side effects, requires the experience and knowledge of specialized medical professionals. Early treatment that strongly suppresses inflammation in the initial stages can prevent disease recurrence and enable long-term management. Therefore, it is crucial to extinguish the inflammatory ‘sparks’ in the early stages through prompt treatment.”
- Company
- K-CAB·Entresto awaiting the Supreme Court rulings
- by Kim, Jin-Gu Jul 2, 2025 06:09am
- Patent disputes involving blockbuster drugs, K-CAB (tegoprazan) and Entresto (valsartan/sacubitril), are reaching their final stages. Observations suggest that the Supreme Court's final ruling could come as early as the second half of this year. K-CAB's annual prescription sales amount to KRW 200 billion, while Entresto's are KRW 70 billion. In other words, the patent barriers for these blockbuster drugs could be lifted, depending on the Supreme Court's decision. K-CAB Crystal Form and Substance Patent Disputes Head to Supreme Court… Will KRW 200 Billion Patent Barrier Be Lifted? According to the pharmaceutical industry on July 2, HK inno.N and generic companies are awaiting the Supreme Court's ruling in their disputes over K-CAB's substance patent and crystal form patent. For the crystal form patent, generic companies won both the first and second instances. Approximately 80 companies filed declaratory judgment actions to circumvent K-CAB's crystal form patent and won in the first instance. Generic companies continued their winning streak in the second trial following HK inno.N's appeal. HK inno.N, having lost in the second trial, chose to appeal to the Supreme Court. Cases were successively filed with the Supreme Court starting in March this year. In May, a presiding Supreme Court Justice and the presiding panel were assigned. The panel is currently reviewing the legal arguments for the appeal. Industry observers predict that a Supreme Court ruling could come as early as this year. In contrast, in the substance patent dispute, HK inno.N has consistently won. The Intellectual Property Court of Korea has issued successive rulings in favor of HK inno.N since May this year. Generic companies that lost in the second trials have submitted appeals to the Supreme Court. In some appeals, the Supreme Court's final judgment has already been rendered. In May, the Supreme Court dismissed the appeals filed by generic companies without deliberation, upholding the original judgment. Dismissal without deliberation is a system in which the Supreme Court rejects an appeal without conducting a full review of the merits if it determines that there are no specific grounds, such as legal violations, in the original judgment. However, an analysis suggests it is difficult to interpret this as HK inno.N having definitively secured victory in the substance patent dispute. This is because if generic companies present arguments different from those of LitePharmTech and HLB Pharmaceutical, there remains a possibility for the Supreme Court to initiate a full review of the merits. In such a case, some view that the final ruling could change. The timing of the early launch for generics will be determined by the Supreme Court's final ruling on both the crystal form patent and substance patent disputes. This means that the patent barrier for K-CAB, which has grown to an annual market size of KRW 200 billion, could be lifted as early as this year. K-CAB's substance patent is set to expire in August 2031, and its crystal form patent is scheduled to expire in March 2036. If the Supreme Court rules in favor of the generic companies in both the substance patent and crystal form patent disputes, generic companies could launch their products immediately. In contrast, if, as in the first and second instances, generic companies win the crystal form patent dispute and HK inno.N wins the substance patent dispute, the generic launch date would be August 2031. If the Supreme Court rules in favor of HK inno.N in both the crystal form patent and substance patent disputes, a generic launch would not be possible until 2036. Entresto Patent Dispute Nearing Conclusion with One Case Each Pending in 2nd·3rd Trials...Crystal Form Patent Appeal is Key The Entresto patent dispute is also heading towards its final stages. Generic companies filed invalidation and declaratory judgment actions against six Entresto patents starting in January 2021. Generic companies won all cases in the first trial. After losing in the first trial, Novartis appealed three of the six patents. Novartis lost the appeal related to the use patent. Novartis subsequently appealed to the Supreme Court but received a dismissal without deliberation ruling in April last year. With this, generic companies have overcome the use patent, which expires in July 2027. Novartis also lost the appeal related to the crystal form patent and appealed to the Supreme Court. In April this year, the deliberation period expired. This means that, unlike the use patent dispute, a full review of the merits will proceed, and a ruling could potentially come within the year. The appeal for the salt·hydrate patent is still pending in the second trial. A hearing date has not yet been set. Industry observers predict that once a ruling is issued for the crystal form patent appeal, a ruling of similar conclusion will follow. If the crucial crystal form patent appeal ruling is handed down this year, the possibility of a generic early launch will further increase. Entresto's crystal form patent is set to expire in September 2040. The salt·hydrate patent is set to expire in November of next year. Suppose the Supreme Court rules in favor of the generic companies in the crystal form patent appeal, as in the first and second instances. In that case, the challenging companies can launch their products immediately. Although the salt·hydrate patent dispute is still ongoing, the product launch becomes possible based on the victory in the first trial. Once the salt/hydrate patent expires in November next year, related risks will also be resolved. Dukarb Patent Dispute Nearing Conclusion...Will Zemiglo Dispute End in 2nd Trial? Patent disputes surrounding Boryung's hypertension combination drug Dukarb (fimasartan/amlodipine) and LG Chem's diabetes treatment Zemiglo (gemigliptin) are also nearing their conclusions. In the case of Dukarb, a Supreme Court ruling was recently issued. The Supreme Court remanded the Dukarb patent invalidation lawsuit appeal on the 26th of last month. This overturned the second trial ruling and sided with the generic companies. Following the Supreme Court's decision, the Dukarb patent dispute will be re-litigated at the original court, the Intellectual Property Court of Korea. The pharmaceutical industry expects that since the Supreme Court found legal issues in the second trial's judgment, the Intellectual Property Court of Korea is highly likely to overturn its previous ruling and side with the generic companies. Once the Intellectual Property Court of Korea issues ruling, the Dukarb patent dispute, which has lasted over four years, will effectively conclude. If generic companies secure a final victory at the Intellectual Property Court of Korea, the launch of generics for Dukarb's core 30/5mg dosage product will become possible. Dukarb was launched in four dosages: ▲30/5mg ▲30/10mg ▲60/5mg ▲60/10mg. Among these, the 30/5mg dosage is reported to account for over 60% of Dukarb's total sales. Furthermore, the combination composition patent, which is at the heart of the Dukarb dispute, applies only to this dosage. Generic companies launched Dukarb generics after the expiration of the fimasartan single-agent (Kanarb) substance patent in February 2023. However, generics for the 30/5mg dosage could not be launched due to the combination composition patent. As a result, Dukarb generics have struggled to gain traction in the prescription market. In Q1 this year, the combined prescription sales of Dukarb generics amounted to only KRW 700 million. The Zemiglo patent dispute is nearing its second trial ruling. The Intellectual Property Court of Korea has scheduled the verdict for the Zemiglo patent invalidation lawsuit for the 21st of next month. Generic companies filed invalidation trials and declaratory judgment actions against the Zemiglo use patent starting in May 2023. Generic companies prevailed in the first instance. The Intellectual Property Trial and Appeal Board issued rulings in favor of the generic companies in April and September 2024, respectively. LG Chem appealed. Generic companies also won in the subsequent appeal. The Intellectual Property Court of Korea sided with the generic companies in the appeal against the declaratory judgment ruling. LG Chem decided not to appeal this ruling to the Supreme Court. The appeal against the patent invalidation ruling is scheduled for a verdict next month. Some in the industry predict that even if generic companies win in the second trial, LG Chem will likely forgo appealing to the Supreme Court. This is because LG Chem had already lost and chose not to appeal the previous judgment related to the declaratory order. This ruling could significantly accelerate the launch of Zemiglo generics. The Zemiglo use patent, challenged by generic companies, expires in October 2039. In addition to this patent, two other patents remain: a salt·hydrate patent that expires in October 2031 and a substance patent that expires in January 2030.
- Opinion
- [Reporter’s View] Doctors agree Korea’s reimb is too slow
- by Eo, Yun-Ho Jul 2, 2025 06:09am
- Even prescribing physicians believe that the pace of new drug reimbursement listing in Korea is too slow. This is an issue not only for doctors or patients, but obviously for pharmaceutical companies as well. Recently, the Korean Research-based Pharmaceutical Industry Association (KRPIA) released the results of a survey of 100 medical professionals in Korea. In January, a global polling agency Ipsos Research surveyed domestic clinical experts from various medical departments to ask their opinions on access to new drugs in Korea. According to the survey results, all medical professionals unanimously answered that the period required for MFDS approval to health insurance coverage is “long,” with 74% stating it is “too long.” Regarding the appropriate period from approval to health insurance coverage, 81% of medical professionals answered “up to 10 months,” with 41% deeming “within 6 months” as appropriate. As of 2022, it took an average of 608 days (approximately 20 months) for innovative new drugs to be approved by the MFDS and listed for health insurance reimbursement in Korea. This is twice the appropriate period (10 months) cited by most medical professionals and significantly longer than what is required for other major countries such as Germany (281 days), Japan (301 days), and France (311 days). Furthermore, experts who directly treat patients on-site responded that the widespread introduction of innovative new drugs would be of practical help in treating patients. Eighty-three percent of medical professionals expected that “if drugs already in common use overseas are covered by health insurance in Korea, patient treatment outcomes will improve significantly.” A large proportion of medical professionals (85%) also responded that “if reimbursement criteria are relaxed to enable early or wider scope of use, even for drugs already covered by health insurance, this will significantly improve patient treatment outcomes.” In addition, 95% of medical professionals urged the MOHW to introduce a “fast-track listing procedure or system” for health insurance coverage, similar to the MFDS's Global Innovate Products on Fast Track (GIFT) system, which shortens the drug approval review period for severe or life-threatening diseases by up to 75%. Medical professionals who participated in the survey also expressed concerns about Korea's low access to new drugs. Ninety-four percent pointed out that “access to new drugs in Korea is lower than overseas,” and 97% answered that “the government must set appropriate and reasonable drug prices to prevent the ‘Korea Passing’ phenomenon, where multinational pharmaceutical companies abandon the launch of innovative new drugs due to domestic regulations on pharmaceuticals.” Although this is a recurring issue, the criticism carries more weight as it comes from the front lines of medical care. Of course, the government is not without effort. Every year, health authorities introduce various systems to improve the speed of drug listing. The “parallel approval-evaluation-negotiation pilot project” is already in its second phase. In addition, the deadlines for regulations of drugs that go through the general listing process are being shortened in general, in both the evaluation and negotiation stages of the Health Insurance Review and Assessment Service and the National Health Insurance Service. However, whether the process is really speeding up remains in question. The problem lies in the process of enforcing regulations. No matter how well the system supports prompt reimbursement of drugs, there are always factors that can cause delays. Ultimately, patients are the ones left to suffer. They are left to wait anxiously, without a clue about what will happen next. Measures to shorten the process of listing drugs for insurance reimbursement must be accompanied by greater transparency and disclosure.
- Company
- Asthma drug 'Trelegy 200 Ellipta Inhaler' becomes available
- by Eo, Yun-Ho Jul 1, 2025 06:03am
- The asthma treatment 'Trelegy 200 Ellipta Inhaler' is now available for prescription at tertiary general hospitals. According to industry sources, Trelegy 200 Ellipta Inhaler (fluticasone furoate·umeclidinium·vilanterol) has passed the drug committees (DC) of Korea's 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital. Trelegy 200 Ellipta Inhaler has been included in the insurance reimbursement list since March last year. It can be prescribed to patients with 'severe asthma that is not properly managed with combination therapy containing intermediate-dose or high-dose inhaler corticosteroid or long-acting beta2-agonists.' The efficacy of Trelegy 200 Ellipta was demonstrated through the Phase 3 CAPTAIN study, which compared Trelegy Ellipta and dual combination therapy FF/VI (fluticasone furoate/ vilanterol) in 2,436 adult asthma patients aged 18 and above whose asthma cannot be controlled despite treatment with dual combination therapy ICS/LABA. As the primary endpoint, each cohort’s Forced Expiratory Volume in 1 second (FEV1) changes at Week 24 were evaluated. The results demonstrated statistical significance as Trelegy Ellipta-treated cohort showed 110 mL more FEV1 compared with FF/VI-treated cohort. The safety profile of Trelegy Ellipta for asthma treatment in this study was consistent with the known profile of the individual drug components and their combinations. The most common side effects were nasopharyngitis v(13-15%), headache (5-9%), and upper respiratory tract infection (3-6%). Severe adverse responses occurred similar in all treatment groups. Dr. Jae-Won Jeong, a Professor at Inje University Ilsan Paik Hospital, explained, "Asthma is a chronic respiratory disease that requires lifetime management. It's important for patients who experience worsening of asthma to receive proper treatments." Additionally, Dr. Jeong said, "Major guidelines also recommend using triple combination therapy, with LAMA added to the ICS/LABA, as the optimal treatment option before the start of oral corticosteroid treatment for patients with severe asthma whose symptoms are not controlled with double therapy of ICS/LABA." Meanwhile, Trelegy 200 Ellipta is a once-daily single-inhaler triple combination therapy, approved in September 2022 as a maintenance therapy for Korean adult patients. It obtained approval in 10 countries, including the United States, Japan, Canada, and Taiwan, and is being prescribed globally. Additionally, Trelegy 100 Ellipta, approved for the first time in May 2018 in South Korea, is a once-daily single inhaler triple combination therapy for COPD and asthma. It was approved in June 2021 for national health insurance reimbursement as the COPD maintenance therapy. In March 2024, it expanded the scope of reimbursement for asthma indication.
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