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- 2026-03-10 05:36:44
- Company
- Kisqali attempts reimb in early breast cancer
- by Eo, Yun-Ho Jan 26, 2026 04:39pm
- Following Verzenio's failed attempt to expand coverage for early-stage breast cancer, Kisqali has now stepped forward to tackle the same challenge.According to Dailypharm coverage, Novartis Korea submitted an application last September to expand coverage for Kisqali (ribociclib), a CDK4/6 inhibitor, as adjuvant therapy in patients with high-risk Stage II and Stage III HR+ (hormone receptor positive)/ HER2- (human epidermal growth factor receptor 2 negative) early breast cancer. The company submitted the application last September and is awaiting its application to be reviewed by the Health Insurance Review and Assessment Service's Cancer Disease Review Committee later this year.With Verzenio (abemaciclib), which shares the same CDK4/6 inhibition mechanism, having failed to clear the Cancer Disease Review Committee hurdle, attention is now focused on whether Kisqali can achieve a different outcome.In the early breast cancer setting, Verzenio struggled from its first attempt. After a six-month wait following its application submission, the drug was first reviewed by the Cancer Disease Review Committee in May 2023, but reimbursement criteria were not established. Lilly resubmitted the application 5 months later in October, and the drug was reviewed again in March and July of last year—only to meet the same outcome.This suggests that Kisqali’s reimbursement journey may also be challenging. In particular, the lack of overall survival (OS) data, which proved to be a major stumbling block for Verzenio, remains a key issue. In early-stage cancer, generating OS data is inherently difficult.While Kisqali is expected to improve OS, direct data is not available yet. Invasive disease-free survival (iDFS) is used as a clinically meaningful surrogate endpoint with a strong correlation to OS in early breast cancer due to the disease characteristics. Kisqali demonstrated encouraging results in the NATALEE study.Study results showed that for the primary endpoint, iDFS at 4 years was 88.5% for the Kisqali combination therapy group and 83.6% for the endocrine therapy alone group, representing an absolute improvement of 4.9 percentage points. The risk of invasive disease progression or death was reduced by 28.5% in the Kisqali group compared to the endocrine therapy alone group.Furthermore, according to the 5-year NATALEE data presented at ESMO 2025, the Kisqali combination therapy reduced the risk of invasive disease progression or death by 28.4% compared to endocrine therapy alone. The 5-year iDFS was 85.5% in the Kisqali combination group and 81.0% in the endocrine therapy alone group, demonstrating a clinically meaningful 4.5% improvement.Meanwhile, treatment for early-stage breast cancer patients involves local therapies such as surgery or radiation therapy, along with systemic adjuvant therapies like chemotherapy and endocrine therapy. Endocrine therapy-based treatment is the standard therapy for HR+/HER2- early-stage breast cancer.In the early 2000s, aromatase inhibitor monotherapy or tamoxifen, combined with ovarian function suppression therapy for premenopausal patients, was recommended for HR+/HER2- early breast cancer patients. The goal of adjuvant therapy is to eliminate micrometastases, reduce the risk of recurrence, and prolong patient survival.For high-risk early-stage breast cancer patients (stages II-III) with a high risk of recurrence, the risk of recurrence continues to rise over time even after completing standard endocrine therapy following surgery, presenting limitations in improving long-term prognosis. Reported recurrence rates range from 6–22% within five years and 22–52% over 20 years, highlighting a persistent unmet medical need.
- InterView
- "Generic price cuts to signal pharma industry transition"
- by Lee, Jeong-Hwan Jan 26, 2026 01:19pm
- Jeong Kyung-sil, Head of the Office for Healthcare Policy under the Ministry of Health and Welfare (MOHW)"It is true that Korea's generic prices are over-valued compared to other countries. To ensure a stable supply of short drugs, we cannot rely on a generic-centric industry structure. Criteria must be established to drive the transition from generic production to new drug development. The government's drug price policy aims to improve the industry structure, rather than a matter of National Health Insurance funding, by funding pharmaceutical companies that contributed to innovation."Jeong Kyung-sil, Head of the Office for Healthcare Policy under the Ministry of Health and Welfare (MOHW) explained, related to the aim of the drug price reform plan, "The administrative direction of the new drug pricing reform is to improve the direction of the domestic pharmaceutical industry by adjusting generic prices that are high-priced compared to other nations."The MOHW notes that, since the 2012 drug price cuts, the domestic industry has failed to deliver sufficient innovation or new drugs as of 2026. Consequently, there is a significant need to send a clear message to domestic pharmaceutical companies toward innovation through this reform.Regarding the review of "ingredient-name-prescribing" for National Essential Medicines, the MOHW plans to implement a policy related to simplifying post-notification for substitution drugs. Then, it will be reviewed once society-wide needs about supply instability grow.Addressing the legislative delay of the bill prohibiting non-face-to-face treatment platforms like Doctor Now from operating as drug wholesalers, Jeong said, "The law has been incorrectly framed. Jeong stated the law does not ban the platform business itself but prohibits unfair trade practices with potential conflicts of interest. Furthermore, it should be discussed at the National Assembly."During a recent meeting with the Korea Special Press Association, Jeong stated MOHW's views on drug price reform plan, limited ingredient-name-prescribing, and the wholesale platform ban."Regarding drug price cuts, opinions on ways to relieve the burden on the pharmaceutical industry will be gathered"Jeong said that the reform is inevitable because today's Korean pharmaceutical industry remains preoccupied with generic manufacturing and sales.Even among 40 designated "Innovative Pharmaceutical Companies," there are cases where generic sales account for 90% of revenue, proving that high generic pricing does not lead to innovation.The MOHW intends to adjust generic prices set above overseas levels and use those resources to support pharmaceutical companies that contribute to new drug innovation and the resolution of supply instability.However, acknowledging industry backlash and demands for predictability, the MOHW plans to continue collecting opinions to reduce the impact on companies.Jeong said, The goals of reducing drug pricing are intended to reduce unnecessary drug expenditures and evolve the pharmaceutical ecosystem," and added, "Both the Office for Healthcare Policy and the industry agree on." "It is true that Korea's generic prices are over-valued compared to other countries. The Ministry decided that the current drug pricing system is designed to favor a generic-centric market. Therefore, the reform is intended to lower the drug price and encourage innovations," and added, "For example, the industry will advance if fostering innovative pharmaceutical companies and supporting R&D are accompanied."Jeong said, "During the drug price reform 13 to 14 years ago (2012 general price cuts), generic prices were maintained at a higher level than those in developed countries. While some pharmaceutical companies have successfully improved their fundamental competitiveness since then, others have shown no improvement," and added, "This is an evidence that maintaining high generic prices does not inherently lead to innovation. While the framework of the announced reform plan is unlikely to change significantly, the MOHW is currently reviewing ways to mitigate the impact on the industry by actively soliciting and considering the opinions of pharmaceutical companies.""Ingredient-name-prescription, first to simplifying substitution drug prescription…whole-sale ban has been incorrectly framed"Regarding the Medical Service Act's inclusion of non-face-to-face treatment effective December 24, Jeong assessed that the Pharmacy Act amendment, including coverage of wholesale bans and mandatory DUR checks, has been put in the wrong frame.Jeong explained that while traditional players operate within an institutional framework, new platforms have entered a regulatory vacuum. The law is intended to fill this legal gap rather than specifically target platforms.The MOHW plans to coordinate specific adjustments to the non-face-to-face treatment pilot program in sync with the upcoming revisions to an article of the Medical Service Act.Regarding the President Lee Jae Myung administration's national task of limited ingredient-name-prescribing, the MOHW said that this agenda will be discussed only after the administration of simplified post-notification for substitution drugs for pharmacists, which is set to begin on the 2nd of next month."While the pilot program has been ongoing, revised measures could be implemented early, ahead of the official December enforcement, as we are working on articles and gathering feedback from expert advisory groups," Jeong added, "It depends on the speed of drafting the article of the Act."Jeong also explained, "The bill has been incorrectly framed as similarity to Doctor Now or Tada Ban," and added, "While traditional healthcare entities operate within a strict institutional framework, the emergence of telemedicine platforms created a regulatory vacuum. She emphasized that the law is not intended to prohibit the platform industry itself, but rather to fill a legal gap and prevent potential unfair trade practices or conflicts of interest.Jeong emphasized, "While other existing players (doctors, pharmacists, etc.) were operating within an institutional framework, a new player (platform) entered, and the platform alone became able to do anything without any regulation," and added, "It is a concept of creating an overall system for the legal and institutional gap that has arisen, not a concept of only stopping platforms."Jeong said, "It has currently passed the standing committee and the Legislation and Judiciary Committee in the National Assembly, and the lawmakers who passed the bill have not significantly changed their positions to date. However, the MOHW has no authority to step forward. Ultimately, it is a structure that can only be discussed at the National Assembly level. It is difficult to call the wholesale operation of non-face-to-face treatment platforms innovation. It is a law to prevent unfairness, not to stop the platform business itself."Jeong concluded by stating, "Regarding the wider use of generic substitution, we will create tools to make it more convenient to utilize, and whether to mandate ingredient-name-prescribing requires social consensus," and added, "If we were to discuss mandating ingredient-name-prescribing, we should start by reviewing drugs with unstable supply. Nowadays, generic substitution can be used much more flexibly than before. Since the problem of supply-unstable drugs is linked from production to supply, whether to implement ingredient-name-prescribing should be discussed later."
- Policy
- Cervarix waves white flag to Gardasil… exits KOR mkt
- by Lee, Tak-Sun Jan 26, 2026 01:19pm
- The supply of GlaxoSmithKline’s (GSK) cervical cancer vaccine Cervarix Prefilled Syringe will be discontinued in Korea.The company has decided to withdraw from the Korean market amid a sharp decline in demand. With Cervarix exiting the market, MSD, which holds Gardasil 9, is expected to monopolize this market.The Ministry of Food and Drug Safety announced that GSK reported the discontinuation of Cervarix supply on the 23rd.GSK stated, “Due to a sharp decline in domestic demand, the company has decided to inevitably discontinue supply of Cervarix Prefilled Syringe.”Supplies of Cervarix will continue until July.GSK explained, “Following the supply discontinuation, Cervarix Prefilled Syringe may continue to be administered at medical institutions until the expiration date of existing stock, in accordance with approved vaccination schedules. Currently, MSD’s human papillomavirus vaccine is in supply in Korea.”Currently available human papillomavirus (HPV) vaccines in Korea include MSD Korea’s Gardasil (quadrivalent), Gardasil Prefilled Syringe (quadrivalent), Gardasil 9 (9-valent), Gardasil 9 Prefilled Syringe (9-valent), and GSK’s Cervarix Prefilled Syringe (bivalent).However, MSD has long dominated the market in terms of market share.Based on 2023 import data, Cervarix recorded imports of USD 812,132, compared with USD 12.56 million for Gardasil Prefilled Syringe and USD 44.32 million for Gardasil 9 Prefilled Syringe. This places Cervarix’s import market share at just 1.4%. Analysts attribute this to Cervarix’s lower competitiveness, as it protects against fewer HPV strains than Gardasil.Given Gardasil’s overwhelming market influence, the two products can hardly be considered equal competitors. Gardasil also holds a significantly higher market share in overseas markets. This is why Cervarix withdrew from the U.S. market in 2016 and has since been supplied primarily to developing countries.For the time being, no product appears poised to challenge Gardasil 9 in the Korean market, suggesting MSD's monopolistic structure will persist. Gardasil 9's domestic patent expires next February. This could lead to supply price increases, potentially negatively impacting consumers.In fact, Gardasil 9 drew criticism after raising its supply price for two consecutive years in 2021 and 2022. The current average cost per dose in Korea is reportedly in the low KRW 200,000 range.Meanwhile, competition has begun to emerge in China, where Wantai received approval last year from the National Medical Products Administration (NMPA) for an HPV vaccine, which protects against nine HPV strains like Gardasil 9.
- Policy
- UAE recognizes MFDS as reference body
- by Lee, Tak-Sun Jan 26, 2026 01:19pm
- Going forward, pharmaceutical products seeking registration in the United Arab Emirates (UAE) will be able to do so based solely on Korean regulatory approval.On the 16th, the Ministry of Food and Drug Safety (MFDS, Minister Yu-Kyoung Oh) announced that the Emirates Drug Establishment (EDE), the UAE’s medical products regulatory authority, has officially recognized Korea’s MFDS as an official Reference Regulatory Authority (RRA) in the field of medical products.Established in September 2023, the EDE is the UAE’s regulatory body responsible for the approval and safety management of pharmaceuticals, medical devices, cosmetics, health supplements, and other products within the UAE.This recognition represents a tangible outcome of the practical implementation of the Memorandum of Understanding (MOU) on biohealth cooperation signed and bilateral meetings between the MFDS and EDE following the Korea-UAE summit on November 18 last year. At the request of MFDS Minister Yu-kyoung Oh, the designation was formally conveyed through a letter from Fatima Al Kaabi, Director General of the UAE EDE. The MFDS stated that the move signifies that regulatory cooperation between the two countries has advanced beyond collaboration to a stage of institutional trust.Previously, pharmaceutical companies seeking UAE approval were generally required to obtain authorization from advanced regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). With MFDS now recognized as a reference authority, companies can apply for UAE approval based solely on Korean MFDS approval. As a result, applicants may benefit from shortened review timelines, simplified regulatory procedures, and exemptions from manufacturing site inspections. This is expected to significantly shorten the time to enter the UAE market and enhance the global competitiveness and credibility of Korean products.Given that the UAE functions as a regulatory and distribution hub for the Middle East and North Africa (MENA) region and the Gulf Cooperation Council (GCC), the recognition is expected to serve as a stepping stone for future entry into the Middle Eastern market for pharmaceuticals and medical devices.This measure is particularly significant because it is based on the Ministry of Food and Drug Safety's (MFDS) full listing as a WHO World-Class Regulatory Authority (WLA) last August and the mutual trust built between the two agencies. The UAE has recognized the MFDS as possessing regulatory capabilities equivalent to those of advanced regulatory authorities, extending this recognition to medical products ranging from pharmaceuticals to biopharmaceuticals and medical devices.Since the establishment of the EDE, the MFDS has pursued multifaceted diplomatic efforts alongside the Embassy of the Republic of Korea in the United Arab Emirates (Chargé d'Affaires Jong-kyung Park) to secure recognition as a reference authority. These efforts included high-level meetings, signing memoranda of understanding, ministerial-level discussions, and bilateral meetings between agency heads.MFDS Minister Yu-kyoung Oh stated, “We are pleased that the UAE’s EDE has officially recognized the MFDS as a reference authority for medical products as a follow-up outcome of the Korea-UAE summit. With MFDS’s regulatory expertise now formally acknowledged in a key Middle Eastern hub country, we will actively support the global expansion of K-Biohealth products, including our pharmaceuticals, medical devices, and cosmetics.”
- Policy
- Yescarta’s second indication passes CDRC review
- by Lee, Tak-Sun Jan 23, 2026 08:39am
- Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel) has secured reimbursement criteria, but only for its second indication.The Health Insurance Review and Assessment Service (HIRA) reviewed the reimbursement criteria for oncology drugs, including Yescarta, at the 1st Cancer Disease Review Committee meeting of 2026, which was held on the 21st.Following deliberation, reimbursement criteria were established only for the second indication of Yescarta, ‘Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) after two or more prior systemic therapies’.However, reimbursement criteria were not established for Yescarta’s first indication, ‘treatment of adult patients with DLBCL who relapse or are refractory within 12 months after first-line chemo-immunotherapy.’ Among the new drugs reviewed at the meeting, Yescarta was the only product to secure reimbursement criteria. Amgen’s Imdelltra and Janssen’s Rybrevant failed to establish reimbursement criteria. Rybrevant had drawn attention as a drug used in combination with Yuhan’s Leclaza (Lazertinib).In contrast, all drugs reviewed for reimbursement expansion, rather than new listing, successfully secured reimbursement criteria. These included Jakavi, pomalidomide products, Cabometyx, and Cyramza.Drugs that pass the Cancer Disease Review Committee will now proceed to the Drug Reimbursement Evaluation Committee for assessment of reimbursement adequacy. If approved, they will undergo final procedures through price negotiations with the National Health Insurance Service.
- Policy
- Celltrion drops export permit for FDA-Cleared HIV drug
- by Lee, Tak-Sun Jan 23, 2026 08:39am
- Celltrion has withdrawn the Korean export authorization for an HIV-1 infection treatment drug approved by the U.S. Food and Drug Administration (FDA).The company had pursued overseas HIV treatment markets, including the U.S., through the export authorization, but the move is being interpreted as a change in business strategy. Going forward, Celltrion is expected to focus more heavily on its biosimilar business.According to the Ministry of Food and Drug Safety, Celltrion Pharm withdrew the export license for ‘Temixys Tab 300/300mg (lamivudine/tenofovir disoproxil fumarate)’ as of the 7th. It also withdrew the export approval for the triple-combination HIV drug ‘Telumio Tab (tenofovir disoproxil fumarate, lamivudine, dolutegravir sodium)’.Temixys is a combination drug that combines the active ingredients of GSK's existing original antiviral drug, Zeffix (lamivudine), and Gilead's antiviral drug, ‘Viread (tenofovir)’. It is a product developed by Celltrion for use in combination with other antiretroviral agents to treat HIV-1 infection in adults and children weighing at least 35 kg.Celltrion announced that it received FDA approval for the sale of Temixys on November 16, 2018. This signaled competition with Gilead's ‘Truvada’ in the U.S. HIV treatment market.Prior to FDA approval, Celltrion had obtained export drug authorization from the Ministry of Food and Drug Safety on October 25 of that year, completing preparations for overseas sales.At the time, Celltrion stated it would supply high-quality treatment at a reasonable price compared to the original drug to HIV patients in the U.S. who were unable to access adequate medication due to high drug prices and insurance structures.The company also expressed plans to enter the international procurement market by securing supplier qualification from major global HIV drug procurement organizations, including the World Health Organization (WHO), the Global Fund, USAID, and the United Nations agency UNDP.To this end, the Celltrion Group explained that it had established a new chemical development team within Celltrion and launched a global chemical project.However, the withdrawal of this export license for the AIDS treatment suggests a shift in the company’s business strategy, 7 years after FDA approval. Domestic production of the AIDS treatment will now be discontinued following the authorization withdrawal. Celltrion is expected to focus more intensely on its biosimilar business going forward.
- Company
- Pharma in Hyangnam "Unstable employment cannot yield good medicine production"
- by Chon, Seung-Hyun Jan 23, 2026 08:39am
- Landscape of Hyangnam Pharmaceutical ComplexThe pharmaceutical industry gathered at the Hyangnam Pharmaceutical Complex to appeal for a halt to the government's drug price reduction plans. Workers at the complex, where many small and mid-sized pharmaceutical companies are located, expressed fears of job instability, and the possibility of future labor struggles was raised.The "Emergency Response Committee for Drug Price System Reform for the Development of the Pharmaceutical and Biotech Industry" (the Committee), composed of major industry organizations, held a labor-management meeting on the 22nd at the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi Province. The Committee requested a reconsideration of the government's reform. The committee is consisted of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), the Korea Biomedicine Industry Association, the Korea Pharmaceutical Traders Association, the Korea Drug Research Association, and the Korea Pharmaceutical Industry Cooperative.The event was organized for the Committee and the labor-management of the Hyangnam complex to review the risks and impact that the reform plan, which includes large-scale price cuts, would have on the industry and production sites.The event's participants warned, "The large-scale drug price cuts pushed by the government are a declaration of abandonment of the future of the domestic pharmaceutical industry, run counter to the demand of these days for job stability, and collapse the national health safety net."In November last year, the MOHW reported to the Health Insurance Policy Review Committee its plan to lower the price calculation rate for generics and patent-expired drugs from 53.55% to around 40%. The reform is scheduled to be finalized by the Health Insurance Policy Review Committee in February and implemented in July. A month after a press conference held at the KPBMA in Seocho-gu on the 22nd of last month, the pharmaceutical industry once again publicly stated dissatisfaction against the government.The "Emergency Response Committee for Drug Price System Reform for the Development of the Pharmaceutical and Biotech Industry" (the Committee), composed of major industry organizations, held a labor-management meeting on the 22nd at the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi Province. Participants stated, "If the government's reform is implemented as is, it will result in the virtual collapse of the domestic pharmaceutical industry and lead to fatal consequences that jeopardize the health and lives of the public." Hyangnam Pharmaceutical Complex is Korea's largest pharmaceutical production hub, housing 39 business sites from 36 companies.Attendees unanimously agreed that rapid price cuts could deal a severe blow to the entire industry, including job instability, a contraction in R&D investment, and a weakened production base.Participants stated, "If rapid and unprecedented price cuts are implemented, the damage will be concentrated on domestic pharmaceutical companies, including those in Hyangnam, making a loss of up to KRW 3.6 trillion." The industry fears that deteriorating profitability will hinder investment in facilities for quality innovation, infrastructure improvements, and R&D.Oh Sang-jun, Chairman of the Southern Gyeonggi branch of the Chemical Workers' Union under the Federation of Korean Trade Unions (FKTU), voiced his opinion, saying, "Workers may fear job instability due to the government's price cuts. If employment is unstable, good medicine cannot be produced. The government should stop pushing unilaterally and instead consult with pharmaceutical workers to implement an effective drug pricing policy. If necessary, we will resort to struggle."Labor and management representatives from the five organizations in the Committee predicted that more than 10% of the industry's 120,000 workers would inevitably face unemployment. They also pointed out that a contraction in the production of low-profit essential medicines and domestic ethical drugs would ultimately increase reliance on expensive imported drugs, causing serious problems for public health.The labor-management representatives emphasized, "Stop the unilateral push for drug price cuts and guarantee job stability in the domestic pharmaceutical industry," and added, "Officials in charge of healthcare safety should actively foster the industry." Officials from companies in the Hyangnam complex also repeatedly highlighted the side effects.Wonsuk Lee, CEO of Daehan Nupharm, urged, "The reform plan is becoming a profitability shock to small and mid-sized domestic pharmaceutical companies, highly dependent on generics. Small businesses will be unable to handle even the fixed costs for facility investment and quality control. Before pushing an unreasonable plan that ignores the industry's reality, please prepare a reasonable alternative through communication."Lee Deok-hee, Chairman of the Il-dong Pharmaceutical labor union, said, "We have had the unfortunate experience of conducting restructuring due to liquidity limits while continuously making bold investments of 20% of sales to grow future competitiveness," and added, "Price cuts will lead to permanent workers becoming temporary workers and indirect employment leading to dismissals, which could greatly shake the job stability and the very existence of the pharmaceutical industry."On this day, the Medicine and Cosmetics Division of the National Federation of Chemical Workers' Unions under the FKTU issued a statement calling for a "full reconsideration of the drug price system reform and the protection of pharmaceutical jobs."The Medicine and Cosmetics Division urged: ▲reconsideration of the reform, ▲the establishment of a social discussion body involving pharmaceutical workers and unions, and ▲the preparation of measures to protect jobs and ensure employment stability.Lee Dong-in, Executive Secretary of the division, suggested the possibility of a struggle, stating, "We will respond strongly against job instability and restructuring caused by the reform," and added, "We will inform the public of the voices of pharmaceutical workers through various means and continuously raise issues regarding the reform plan."Yunhong Noh, President of the KPBMA, argued, "If the reform is forced through in its original form, the industrial foundation will collapse, and the production of essential medicines will contract. Hyangnam, which is home to small- and mid-sized companies, could face job instability and economic contraction due to changes in the business environment," and "A policy that ignores the voices of the industrial field can never succeed."Cho Yong-jun, Chairman of the Korea Pharmaceutical Industry Cooperative, appealed, "The generic drug price reform plan could pose serious business risks to small and mid-sized pharmaceutical companies," and added, "Rather than a unilateral cut, a phased approach is needed after analyzing the practical impact on employment and investment. Rapid change destroys even the best policy's ecosystem. Companies should be allowed enough time to improve their system."
- Policy
- Ozempic, Rezurock, HyalFlex covered from next month
- by Lee, Jeong-Hwan Jan 23, 2026 08:39am
- Novo Nordisk’s type 2 diabetes treatment Ozempic (semaglutide) and Sanofi’s graft-versus-host disease (GVHD) treatment Rezurock (belumosudil) will be covered by Korea’s National Health Insurance starting on the 1st of next month.In addition, new reimbursement standards will be set for Jeil Pharmaceutical’s antibiotic Fetroja (cefiderocol) and Shinpoong Pharmaceutical’s osteoarthritis treatment HyalFlex (hexamethylenediamine cross-linked sodium hyaluronate).On the 22nd, the Ministry of Health and Welfare announced an administrative notice for a partial amendment to the “Detailed Standards and Methods for the Application of Medical Care Benefits (Pharmaceuticals),” which includes the establishment of reimbursement criteria for Ozempic, Rezurock, HyalFlex, and Fetroja.The Ministry plans to gather opinions until the 26th and then submit the agenda for deliberation at the Health Insurance Policy Deliberation Committee meeting on the 29th.For Ozempic Prefilled Pen, new coverage criteria will be established for its use as an adjunct to diet and exercise therapy in combination with oral agents or insulin in adult patients with type 2 diabetes that is not adequately controlled.Coverage for its use as part of the oral combination therapy applies to patients with a glycated hemoglobin (HbA1c) level of 7% or higher despite 2-4 months of combined metformin and sulfonylurea therapy, provided their body mass index (BMI) is 25 kg/m² or higher, or they are unable to use insulin. These patients are allowed reimbursed use of a triple therapy that includes Ozempic.However, if blood glucose is significantly improved with triple therapy, dual therapy with only metformin may also be reimbursed.Its use in combination with insulin (+metformin) is covered when HbA1c remains 7% or higher despite 2-4 months of basal insulin (insulin alone or with metformin) or when HbA1c remains 7% or higher despite combination therapy with Ozempic and metformin (+sulfonylurea).However, objective documentation (treatment history, HbA1c, BMI, etc.) must be submitted at initiation. HbA1c and BMI must be monitored every three months.The coverage period per prescription is up to 4 weeks for the initial 3 months when dosage adjustment is necessary per the approved indications, then up to 3 months thereafter.Rezurock is reimbursed for adults and pediatric patients aged 12 years and older who have failed at least two prior systemic therapies (including ruxolitinib).If ruxolitinib cannot be used due to adverse reactions or contraindications, coverage applies after failure of two or more alternative systemic therapies.If disease progression is absent at the 6-month and 9-month evaluations, and a response is confirmed at the 12-month evaluation, an additional 3 months of treatment is approved with reimbursement.Thereafter, continuous administration is approved upon confirmation of response at each 3-month evaluation. Re-administration is also reimbursed for patients who discontinued due to improvement.However, treatment must be discontinued if GVHD progresses (symptoms worsen or new symptoms appear), unacceptable adverse reactions that render use of Rezurock impossible occur, or a new systemic therapy is initiated after Rezurock.In addition, objective data (such as medical records and blood test results) regarding the target of administration for the initial dose of Rezurock, as well as response evaluations for continued administration or discontinuation, must be submitted.In the case of HyalFlex, coverage applies to patients with knee osteoarthritis of radiographic severity Kellgren-Lawrence grade I–III (mild to moderate).In the case of Fetroja, coverage is applied for complex urinary tract infections and hospital-acquired pneumonia when treatment with carbapenem antibiotics has failed, or when multidrug-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacteriaceae, or carbapenem-resistant Acinetobacter species are confirmed. And a physician’s treatment report must be submitted.For DongKwang Pharm’s Sulbacin Inj and other sulbactam/ampicillin combinations, coverage is approved beyond the approved indications when infection with carbapenem-resistant Acinetobacter baumannii is confirmed. The maximum daily dose is 27g, and the treatment period is within 14 days. Coverage may be approved for periods exceeding 14 days upon reference to the physician’s treatment report.In addition, Hanwha Pharmaceutical's Hepa-Merz Inj and other L-aspartic acid-L-ornithine preparations are covered when symptoms of latent or overt hepatic encephalopathy are present.The general principles for calcium and vitamin D-containing oral combination preparations now include hypoparathyroidism due to procedures such as total thyroidectomy.
- Policy
- Upcoming drug price reduction
- by Lee, Jeong-Hwan Jan 23, 2026 08:39am
- Major domestic pharmaceutical companies and mid-sized firms are repeatedly requesting modifications to the drug price reform plan, which was announced by the Ministry of Health and Welfare (MOHW) for implementation this year. The requests include a delay in its implementation and adjustments to the price reduction rates.The MOHW has yet to provide a clear response regarding the industry’s requests for a delay, changes to the reduction rates, or revisions to the preferential pricing details. Instead, the MOHW appears to be maintaining its "original plan to finalize the decision at the Health Insurance Policy Review Committee within the first quarter."In response, members of the National Assembly's Health Insurance Policy Review Committee, from the opposition party, plan to mediate between the pharmaceutical industry and the MOHW by hosting policy forums.On the 22nd, Rep. Baek Jong-heon of the People Power Party, alongside Reps. Han Ji-ah and Ahn Sang-hoon, will co-host a policy forum on drug price system reform on the 26th,. The forum will be organized by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA).During the forum, Attorney Park Kwan-woo from Kim & Chang will analyze the impact of the MOHW's drug price reform on public health, and Attorney Kim Hyun-wook from Shin & Kim LLC will present on sustainable measures to improve the drug price system.In the subsequent panel discussion, representatives from large domestic pharmaceutical companies, as well as the Korea Pharmaceutical Industry Cooperative, representing mid-sized and small firms, will participate to demand a delay in implementation, adjustments to the reduction rates, and revisions to the MOHW's preferential pricing plan.Specifically, the industry representatives, including Yoon Jae-Chun, Vice Chairman of Daewoong Pharmaceutical; Young-Joo Kim, CEO of Chong Kun Dang Pharm; and Cho Yong-jun, Chairman of the Korea Pharmaceutical Industry Cooperative, will be attending. From academia and patient groups, Professor Hye-Young Kwon of the Department of Health and Medical Administration at Mokwon University and Yoon Gu-hyun, President of the Korean Association for the Study of Liver, will attend. Yeon-sook Kim, Head of the Pharmaceutical Management Division at the MOHW, will represent the government.Attention is focused on whether this forum, which aims to seek a balance between the sustainability of health insurance and the development of the pharmaceutical and biotech industries, can narrow the gap in perspectives between the industry and the government.Multiple industry sources are appealing to the MOHW to accept the industry's proposed modifications proactively. The top priority for the pharmaceutical industry is delaying the committee's approval of the reform plan, currently scheduled for next month (February).On November 28 last year, the MOHW publicly announced the reform plan, which centers on cutting generic drug prices, and reported the implementation schedule to the committee.Several domestic pharmaceutical companies maintain that the implementation plan is too rushed, failing to ensure the predictability necessary for business management.The pharmaceutical industry is also demanding that the price-reduction rates for already-listed drugs (generics) be minimized. While the MOHW plans to lower the current generic price calculation rate from 53.55% to the 40% range, the industry argues this cut is excessive and insists it should be set at 48% to 50%.Additionally, they have requested that the implementation timing for generics listed since the 2012 price cuts be pushed back sufficiently to ensure predictability, and that the details of the preferential pricing plan be revised through consultation with the industry.An official from a top-tier domestic pharmaceutical company said,"It is frustrating that specific consultations or coordination of opinions between the MOHW and the industry regarding the reform plan have not yet taken place," adding, "We have requested several times that the short time between the announcement and the implementation date undermines predictability. A delay in the committee's approval is necessary."Another official from a top-tier company added, "Although several forums regarding the drug price reform have been held in and around the National Assembly, the atmosphere remains unclear as to whether the government will modify its plan or accept the industry's demands. If the drug price reform aims to foster the domestic pharmaceutical industry, the MOHW needs to commit practical and proactive consultations with the sector."
- Company
- 'Drug pricing reform will improve patient access'
- by Son, Hyung Min Jan 22, 2026 08:22am
- As global pharmaceutical R&D trends rapidly shift toward high-priced anticancer and rare disease therapies, attention is focused on how the government's proposed drug pricing system reform will impact domestic patient access and the competitiveness of the pharmaceutical industry.On the 21st, Dailypharm held a Future Forum at the Catholic University of Korea's Songeui Campus Institute of Biomedical Industry. At the forum, Jaeho Jung, Head of Value and Access at Novartis, presented the perspective of multinational pharmaceutical companies on the proposed drug pricing reform.Jung said, “The reform plan is in line with global R&D trends. If appropriate value-based compensation and faster reimbursement listing are achieved, it will send a positive signal not only for patient access but also for Korea’s R&D ecosystem.”On the 21st, Dailypharm held its 55th Future Forum at the Catholic University of Korea's Songeui Campus Institute of Biomedical Industry.Development of high-cost anticancer drugs and rare disease treatments active... “Current drug pricing and reimbursement systems struggle to accommodate innovation.”Jung first highlighted the scale of clinical development in oncology and rare disease therapies. Currently, oncology accounts for 41% of all global clinical trials, of which 35% involve innovative drugs.The rare disease treatment market is expected to reach KRW 542 trillion by 2023, while rare cancer trials account for 74% of all ongoing rare disease studies.Despite this projected expansion of the high-cost new drug market, securing insurance coverage, which is a core value for patient access in Korea, remains inadequate. Among 460 new drugs approved in major countries from 2012 to 2021, the coverage rate averaged 28% across G20 nations and 29% in OECD countries, while Korea lagged at just 17%.Jung said, “Korea is facing a triple burden of ensuring universal welfare with limited resources, expanding access to new drugs, and guaranteeing patients’ right to treatment. The government has not been idle. The system has been continuously revised since 2007, but it has now reached its limits.”Examining the time required for reimbursement by treatment type, rare disease treatments took 23.6 months, anticancer drugs 31.6 months, and general new drugs 18.3 months. Even after new drug approval, a lengthy period remains before patients really gain reimbursement.At the same time, global R&D trends have driven the rise of antibody-drug conjugates (ADCs), bispecific antibodies, and biologics, many of which now hold multiple indications. Some immuno-oncology drugs have more than 20 approved indications.In response, the government has proposed reforms aimed at improving access to new drugs. These include an indication-based pricing, strengthening value-based drug reimbursement, and shortening the reimbursement listing period for rare diseases. In particular, the reimbursement listing period for rare disease therapies is expected to be reduced from an average of 240 days to within 100 days.Jung assessed, “With the proportion of high-cost new drugs rapidly increasing, it is difficult to guarantee patient access solely with limited national health insurance funds. As more drugs secure multiple indications, an indication-based pricing system is in line with global standards”He added, "The current system focuses on increasing reimbursement rates within the existing framework; it remains finance-centered from a patient access perspective. Although the government’s approach is understandable given budget constraints, the system must be operated with the patients in mind.”“Reform will create synergy, not suppress R&D”Jaeho Jung, Head of Value and Access at Novartis KoreaHe also expressed the view that the drug pricing reform could improve the domestic investment environment.Korean pharmaceutical companies, whose portfolios are largely centered on generics, have repeatedly voiced concerns that the proposed drug pricing reform could significantly stifle R&D.However, Jung emphasized the potential advantage that improved access to new drugs could expand investment by global pharmaceutical companies.He explained that currently, only two global pharmaceutical companies have production facilities in Korea, and attracting global-level R&D centers remains challenging.Jung stated, “Even when reviewing potential sites for our flagship one-shot treatment Kymriah, we received feedback that Korea was not suitable. If the system becomes more predictable and the value of R&D is properly recognized, direct investment and partnerships with Korean companies will expand.”He added, “If drug pricing improves in terms of value recognition and patient access, direct investment by global pharmaceutical companies will increase, as well as partnerships with Korean companies.”“Looking at Boston or New Jersey, which have rapidly emerged as global bioclusters, their R&D centers are well-established. This is because they are clustered together in terms of the collaborative R&D value. Looking at the domestic R&D environment, it feels like everyone is working hard, but individually. If the drug pricing reform system is well-established, I believe synergies will grow further, including joint R&D centers between global and domestic companies.”Furthermore, Jung pointed out that discussions on reimbursing high-value new drugs like ADCs and one-shot gene therapies have repeatedly faced difficulties within the existing framework. “The reform plan has a high potential to contribute to improving patient access, aligning with future global R&D trends.”Jung stated, “Operational execution is as crucial as the system's design. I hope a patient-centered system can take root through continuous dialogue between the government and industry.”
