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- 2025-12-23 08:51:40
- Policy
- NHI big data was used to evaluate safety of JAK inhibitors
- by Lee, Tak-Sun Nov 02, 2022 05:36am
- Soon-Ae Shin, Deputy Minister of the NHIS Big Data Headquarters held a press conference with its press corp on the 1st to explain the HQ’s main projects and plans. Big data from the National Health Insurance was found to have been used to evaluate the safety of JAK inhibitors, based on which its use has been restricted in high-risk patients in Korea. This is the first time that NHI big data had been used for safety evaluation of pharmaceuticals in Korea. The National Health Insurance Service’s Big Data Strategy Headquarters held a press conference with the press corp on the 1st at its Wonju headquarters to deliver this news. Soon-Ae Shin, Deputy Minister of the NHIS Big Data Headquarters, said, “We established a consultative body with the Ministry of Food and Drug Safety to conduct joint research on information related to the real use of pharmaceuticals and conducted a safety evaluation on JAK inhibitors used for rheumatoid arthritis, etc with the consultative body for the first time this year.” The NHIS performed a comparative analysis on the incidence of major cardiovascular diseases and mortality rate of TNF blockers and JAK inhibitors using NHI big data. In June, based on the results derived using big data and expert deliberations, the MFDS revised the approved label for JAK inhibitors so that patients 65 years of age or older, patients at high cardiovascular risk, and patients at risk of malignancies could only use JAK inhibitors if they see inadequate treatment effect from existing treatment options. Since last September, reimbursement standards have also been revised accordingly and applied to prescriptions. Jong-Hun Park, Deputy Minister of NHIS’s Big Data Strategy HQ, said, “We conducted big data research for two to three months per MFDS's request. Although the decision was made after expert deliberations by the Central Pharmaceutical Affairs Council, our study has also contributed to the policy decision-making process.” The NHIS is also known to be conducting safety evaluations on other pharmaceuticals using big data. The MFDS evaluated JAK inhibitors after acquiring safety information from overseas sources including the US FDA in September last year. The US FDA had restricted the use of JAK inhibitors to specific patients that do not respond or show intolerance to TNF blockers, as it can increase the risk of severe heart-related events including heart attacks. Europe has also first limited the use of tofacitinib, a JAK class inhibitor, to high-risk groups who have suitable treatment alternatives, and is reviewing the need for applying additional measures on other JAK inhibitors. Until now, the MFDS had used data on adverse reactions that had been collected separately for drug safety evaluations. The added reflection of NHI big data in drug safety evaluations is expected to allow customized measures to be made in Korea that reflects the domestic environment. Deputy Minister Shin said, “ We expect our research to verify drug safety and efficacy based on NHI big data to expand further around the consultative body.” NHIS also plans to support the research and development of real-world evidence (RWE) on pharmaceuticals ㅕusing big data. In other words, it aims to organically link NHI big data for use from the drug development stage to post-marketing research. In the preclinical development stage, big data is expected to be used to analyze the characteristic of the target disease and patient group, analyze existing treatment (drug prescription, etc.) patterns, explore combinations for drug development, drug repositioning, etc. In the clinical trial stage, it is expected to be used for clinical trial design support, estimation of a number of clinical trial subjects, support of the control group to ultimatley reduce the clinical trial period and improve the efficiency of clinical trials. Also, the NHIS added that big data can be used in various areas in the post-marketing stage as well, including for comparative evaluation between competitors, feasibility study of research topics, and post-marketing monitoring of drugs subject to re-examinations.
- Policy
- "Synthetic Biology" that Moderna used
- by Kang, Shin-Kook Nov 02, 2022 05:36am
- Deputy Prime Minister Choo Kyung-hoThe Act on Research Promotion and Support for Synthetic Biology' proposed legislation in the first half of next year. Support measures will be prepared for Synthetic Biology, which is evaluated to double the efficiency of research and development of innovative new drugs and materials. Deputy Prime Minister for Economic Affairs and Minister of Strategy and Finance Choo Kyung-ho presided over an emergency economic ministers' meeting at the Seoul Government Complex on the 1st and discussed plans to secure new growth engines such as bio. Considering the characteristics of Synthetic Biology, which is accompanied by innovation and risk, the government will propose a new law in the first half of next year to promote technology development and manage transparency at the national level. The name of the bill is the 'Act on the Promotion and Support of Synthetic Biology Research'. The government has decided to prepare a "National Synthetic Biology Initiative" this month to create a bio-innovation ecosystem based on Synthetic Biology and to respond strategically to global technology hegemony competition. This will include a comprehensive policy direction from a long-term perspective that encompasses R&D, infrastructure construction, industrial use, and ecosystem creation to secure core technologies. The government will establish 'Biofoundry', a key infrastructure to accelerate innovation in Synthetic Biology technology and strengthen domestic bio-manufacturing competitiveness. Biofoundry will be invested 300 billion won over five years from 2024 to 2028, and will be organized by the Ministry of Science and Technology. In addition, the government decided to revitalize the "Korea Synthetic Biology Development Council" to create a private-centered Synthetic Biology development ecosystem and gather domestic industry, academia, and research capabilities. Currently, 58 organizations, including 20 companies, 26 universities, and 12 contributing associations, are participating in the council. The government will hold a joint Korea-U.S. Synthetic Biology conference in December to lay the foundation for research cooperation with the U.S., a leading technology player in Synthetic Biology, and promote cooperation among major research institutes. Synthetic Biology means creating a life system by synthesizing genes. Synthetic Biology technology is evaluated as a key technology that can change the flow and landscape of all fields of the red, green, and white bio industries, and has also been designated as one of the top 10 core technologies in the U.S. Innovation Competition Act. In fact, Moderna shortened the development period by using Synthetic Biology in the process of developing the COVID-19 mRNA vaccine.
- Policy
- LG Chemical completed Vimovo's domestic copyright
- by Lee, Tak-Sun Nov 01, 2022 06:02am
- LG Chem has acquired the domestic copyright of the complex "Vimovo," which combines NSAIDs-based anti-inflammatory analgesics (Naproxen) and PPI-based gastroesophageal reflux disease treatment ingredient Esomeprazole. Vimovo is a product released in Korea by AstraZeneca Korea in 2012 and has been jointly selling it with LG Chem. As Vimovo's global copyright was recently transferred to a German pharmaceutical company, LG Chem seems to have bought domestic copyrights. According to industries on the 31st, Vimovo 500/20mg, which has been transferred and transferred by LG Chem, will be registered from the 1st of this month. LG Chem acquired the product from AstraZeneca Korea. Until now, Vimovo had been copyrighted by AstraZeneca Korea in Korea. LG Chem has been a joint sales partner since the beginning of marketing. LG Chem's acquisition of Vimovo this time is interpreted as a chain phenomenon that occurred when Vimovo's global copyright moved. In 2018, AstraZeneca sold its global copyright to Vimovo (excluding the United States and Japan) to German pharmaceutical company Grünenthal. As joint sales cooperation became difficult, LG Chem is believed to have acquired Vimovo's domestic copyright. Vimovo has attracted attention since its launch in 2012 as a product that minimizes concerns over gastrointestinal side effects by combining PPI drugs with NSAIDs-based anti-inflammatory analgesics. In particular, synergy was expected in that it combined AstraZeneca's original Esomeprazole ingredient product Nexium. Hanmi Pharmaceutical's Naxozol came out the following year and competed against each other. In 2014, Chong Kun Dang launched "Naxen S," a generic drug, and four companies, including SK Chemicals, began selling improved new drugs, and the NSAIDs-PPI complex market entered a multilateral competition system. According to the amount of out-of-house prescriptions based on UBIST last year, Vimovo rose 20% year-on-year to 20 billion won and Naxozol rose to 22.8 billion won, slightly higher in Naxozol. In the case of the generic Naxen S, it was only 3.4 billion won. Although Vimovo's patent is now expired, it is still dominant in the market. Attention is focusing on whether LG Chem, which took over the copyright, will be able to rise to the top of the market with momentum.
- Policy
- It doesn't mean that we're considering a reduction
- by Lee, Tak-Sun Nov 01, 2022 06:02am
- Minister Cho Kyu-hongThe Ministry of Health and Welfare explained in writing about Minister Cho Kyu-hong's answer to the government audit site on the 6th about Korea's generic insurance drug price, which was set at an expensive price. The remarks at the time came as Choi Jae-hyung, a lawmaker of the People's Power, responded to a question that "the price of generic drugs in Korea is too high than overseas, so the price of drugs should be lowered." Minister Cho agreed and said, "Each country's generics prices are closely related to the country's health and medical policies, and we have improved the drug price system so that the drug price policy can be implemented in stages to reduce health insurance finances and ease users' economic burden." The Ministry of Health and Welfare said in a written response to a recent question by Rep. Jeon Hye-sook of the Democratic Party of Korea that the remarks at the time "did not answer that they would consider a lump-sum reduction in the weak." She explained, "The intention is to manage the price of generic drugs at an appropriate level in consideration of the financial burden of health insurance and the economic burden of patients and to continuously improve the drug price system." The MOHW added, "The improvement of the insurance drug price system will be carried out after collecting sufficient opinions by comprehensively considering securing the sustainability of health insurance, improving patient access to treatments for severe and rare diseases, efficient spending management, and the impact on the pharmaceutical industry." After the remarks by the head of the National Assembly were made public, the pharmaceutical industry's strong opposition is believed to have put it on the condition of its impact on the pharmaceutical industry and sufficient collection of opinions.
- Policy
- Gov’t to fully investigate its COVID-19 research support
- by Lee, Tak-Sun Nov 01, 2022 06:02am
- The Ministry of Health and Welfare announced that it will conduct a full investigation on all of the projects it had supported for the clinical trial research of COVID-19 treatments and vaccines by the first quarter of next year. Since 2020, a total of 10 companies were selected for the government's COVID-19 treatment and vaccine clinical support project. Although these companies received state support for clinical research, only two succeeded in commercialization. Due to this lack of results, the question of whether the state’s support was excessive has been rising. With the People Power Party determining the project as a project badly managed example of the previous administration, what the results of the MOHW investigation will be is receiving keen attention. At the NA Audit that had been held on the 20th, the MOHW agreed to Rep. Gi-Yoon Kang’s criticism that "the development of COVID-19 vaccines and treatments should continue, but sanctions are needed for companies that were found to have caused market disruption or embezzled business expenses.,” and promised it will investigate related projects by the 1st quarter of next year. The MOHW said, “We plan to continue supporting the development of COVID-19 vaccines and treatments through the K-Bio Vaccine Fund worth a total of KRW 500 billion in 2023, but agree with the representative that measures are needed for companies that have done wrong through measures such as market disruptions or embezzlement." The ministry added, "We will conduct an investigation by the 1st quarter of next year to see if there were any problems in the process of research and evaluations conducted on companies that participated in the COVID-19 treatment and vaccine clinical support project, and report the results to Rep. Kang’s office.” 10 companies were selected for the COVID-19 treatment and vaccine clinical support project that had been carried out 3 times since 2020. The selected companies were Celltrion, GC Pharma, Daewoong Pharmaceutical, Genexine, SK Bioscience, GeneOne Life Science, Cellid, Eu Biologics, HK Inno.N, and Quratis. This was a megaproject whose budget reached KRW 232.8 billion from 2020 to 2021. However, among the 10 companies, only Celltrion and SK Bioscience succeeded in commercialization. Celltrion succeeded in developing an antibody treatment for COVID-19 and SK Bioscience succeeded in developing a vaccine for COVID-19. The other companies have discontinued development or are having difficulty commercializing their products. The members of the People Power Party had focused on this issue at the NA Audit. In particular, they raised their voice on whether GC Pharma received preferential treatment in receiving state support for its discontinued plasma therapy candidate. Kang had previously pointed out that “Even though the clinical trial for GC Pharma’s COVID-19 plasma therapy had been discontinued abroad after the US National Institutes of Health determinized the drug lacked efficacy, the company still applied for conditional marketing authorization for the candidate to the MFDS in Korea. In the process, GC Pharma’s stock price rose from KRW 90,000 to KRW 300,000.” Rep. Jong-Hean Baek of the People Power Party also said, “GC Pharma stopped developing treatments even after receiving support for KRW 5.8 billion, which accounts for 60% of the total of KRW 9.7 billion spend spent on researching its COVID-19 plasma therapy. Wasn’t this just the company’s attempt to defraud the government or raise their stock price?" However, GC Pharma is known to have returned KRW 1.97 billion of the supported fund to the Korea Health Industry Development Institute (KHIDI). The recent police investigation into Il-Yang Pharmaceutical for raising its stock price by inflating its COVID-19 treatment research results is adding to the suspicions. The MOHW also stressed, "If problems such as market disruption or embezzlement of business expenses of companies that received government support are revealed in the course of investigations conducted by the police or other investigative agencies in the future, we will conduct a further investigation."
- Policy
- It takes 218 days to register after applying for a new drug
- by Kim, Jung-Ju Oct 31, 2022 06:07am
- Among the new drugs introduced in Korea, drugs that started the payroll process from insurance application to registration last year took an average of 218 days. Among them, the treatment for rare diseases took 238 days and the anticancer drug took 227 days. Considering that the legal processing period is 7 months (210 days), the government emphasized that it is relatively quickly registered. The Ministry of Health and Welfare submitted the results of the tally to the question of the duration of new drug benefits demanded by Kang Ki-yoon, a member of the National Assembly's Health and Welfare Committee, during the last comprehensive parliamentary audit. According to the Ministry of Health and Welfare, the government has been operating Approval-Patent Linkage Systems, RSA, PE system, and drug price negotiation training system to strengthen access to new drug patients. Looking at the aggregated data, the actual average registration period from application for drug decisions to benefit registration over the past five years was about 6.2 months. This is the average value after calculating the time it takes to complete the notification from the application for the HIRA drug benefit adequacy to the passage of the Health Insurance Policy Review Committee for each drug. The Ministry of Health and Welfare evaluated, "Considering the seven months (210 days) of the legal processing period for drug registration, it is being registered relatively quickly." It took 227 days for anticancer drugs and 238 days for rare diseases. Comparing the recent five-year trend, there were delays by year or ups and downs in the required period. It is analyzed that this is because it varies depending on the appearance of ultra-high-priced drugs, the difficulties of benefits review (ICER value and acceptance of companies), and the number and type of drugs applied for registration. Even if the number of days is prolonged, it means that it is difficult to simply compare the period required by year, but it can be seen that new drugs are generally being paid at a level similar to the legal processing period. The MOHW said, "The new government is also revising related regulations to shorten the evaluation period by selecting 'quick registration of anticancer drugs, severe disease treatments, and applying risk-sharing drugs' as state tasks" and the government said it will collect opinions from various stakeholders on the "improvement of reference standards for foreign drug prices (A7) adjusters" that are being discussed so far. In the case of the A7 adjustment price reference standard, the government is using the adjustment price converted from foreign drug prices in the evaluation of new drug benefit adequacy to determine insurance drug prices. However, due to the long-standing and insufficient evidence of the foreign drug price reference standard, long-term improvement reviews are underway to enhance transparency and clarity of the adjusted price and supplement its validity. Earlier, the government held expert advisory meetings based on related research services from 2019 to 2020, and formed a public-private working-level consultative body, including related associations, to discuss improvement measures by holding six working group meetings. The Ministry of Health and Welfare said, "In the process of improving reference standards, such as revising related guidelines, we will fully collect opinions from various stakeholders such as patients, experts, and pharmaceutical companies."
- Policy
- Koselugo & Retevmo's benefit registration can be shortened
- by Lee, Tak-Sun Oct 31, 2022 06:06am
- The registration of drug benefits such as Koselugo and Retevmo, which are currently under evaluation, is expected to be shortened by 30 days. This is because the NHIS and the HIRA have decided to shorten the benefit registration period for drugs used in life-threatening diseases. Koselugo and Retevmo are drugs licensed through the Ministry of Food and Drug Safety's rapid screening system and are considered life-threatening or significant treatments. This fact was revealed in the HIRA's written answer to the question asked by Rep. Seo Young-seok of the Democratic Party of Korea during the parliamentary audit on the 20th. Seo asked about "a specific plan to strengthen the information sharing and cooperation system among related ministries related to enhancing the consistency between the rapid review system of the Ministry of Food and Drug Safety and the review of benefit registration." The HIRA said, "We want to shorten the insurance registration period of the drug by shortening the period required for negotiations on the NHIS' drug price at the same time as we evaluate the drug used for life-threatening diseases," adding, "We will try to provide related data to the NHIS so that patients can receive health insurance benefits as soon as possible." Currently, opinions are being collected on ways to shorten the period of benefit registration for severe and rare drugs without alternative drugs. The HIRA and the NHIS are set to take effect in November. The main content is that the HIRA provides preliminary data on the drug to the NHIS before the Drug Benefit Evaluation Committee, which will shorten the negotiation by 30 days by conducting preliminary negotiations. There are three life-threatening or serious disease treatments currently being reviewed by the HIRA: Koselugo, a type 1 treatment for childhood neurofibroma over the age of 3, Retevmo, a treatment for metastatic non-small cell lung cancer, and Rybrevent, a treatment for patients with local progressive or metastatic non-small cell lung cancer. However, Rybrevant has voluntarily withdrawn its application for a decision due to reasons such as the supplementation of data. If Koselugo and Retevmo are scheduled to be deliberated by the committee, they will engage in preliminary negotiations with the NHIS. Accordingly, if the appropriateness of the benefit is recognized, the main negotiation with the NHIS will end within 30 days. If it took 75 days from the holding of the existing committee to the drug price negotiation, the registration will be decided 45 days from now on.
- Policy
- The warning phrase deleting the possibility of Nucynta abuse
- by Lee, Hye-Kyung Oct 27, 2022 05:52am
- The "possibility of abuse," a warning phrase for narcotic painkillers containing Tapentadol, will be deleted. The permit includes a new disorder of resistance and opioid use, and monitoring and addiction patients consider consulting with experts. The Ministry of Food and Drug Safety announced that it will prepare a proposal for a change in permission based on the results of the European Medicines Agency's (EMA) review of safety information on tapentadol oral drugs and conduct an opinion inquiry by the 9th of next month. Tapentadol licensed in Korea are 6 items, including 50mg, 100mg, 150mg of "Nucynta" by Janssen Korea, 50mg of "Nucynta ER", 100mg, and 150mg. Tapentadol, the main active ingredient of Nucynta, is characterized by two mechanisms of action that activate opium-like receptors with one synthetic compound and inhibit norepinephrine reabsorption. Nucynta, which received an item license in June 2016, is actively prescribed when it was registered in the same year. The possibility of abuse is eliminated, and repeated use of this drug can cause Opioid Use Disorder (OUD). The new content is that the abuse or intentional misuse of the drug can cause excessive administration or death. The risk of developing opioid use disorder increases in patients with a personal or family history of drug use disorder (including alcohol use disorder) and patients with a history of smoking or other mental health disorders (e.g., major depression, anxiety, and personality disorder). The Ministry of Food and Drug Safety said, "If having a review opinion on the change of permission, please submit the reason and evidence."
- Policy
- Permission for Libtayo, a tx for skin squamous cell cancer
- by Lee, Hye-Kyung Oct 26, 2022 05:50am
- The Ministry of Food and Drug Safety (Director Oh Yu-kyung) announced on the 25th that it has approved Libtayo, a rare drug from Sanofi-Aventis Korea, for skin squamous cell cancer treatment. Libtayo is a monoclonal antibody targeting cell predetermined history 1 (PD-1)*, an immune gateway receptor for immune cells (T cells). Programmed cell death 1 (PD-1) is expressed in T cells, B cells, NK cells, and myeloid cells activated by inhibitory immune gate receptors belonging to the CD28 family, and plays a pivotal role in immune regulation. This drug blocks the mechanism of cancer cells avoiding immune cells (T cells) using PD-1, helping immune cells attack and remove cancer cells. The Ministry of Food and Drug Safety said, "We will continue to do our best to quickly supply treatments that have been sufficiently confirmed for safety and effectiveness based on regulatory science."
- Policy
- Price cut of Faslodex
- by Lee, Tak-Sun Oct 26, 2022 05:50am
- AstraZeneca's breast cancer treatment, Faslodex, will be a real match with Boryung's first generic Fulvet as it will be cut by 30% from the current upper limit starting next month due to a cut in drug prices following its entry into the generic. This is because the price has become almost similar to Boryung Fulvet, which has the same ingredients. This is a phenomenon caused by Boryung's addition to an innovative pharmaceutical company. According to industries on the 25th, AstraZeneca Faslodex will be sold at 376,724 won, down 30% from the current upper limit (538,178 won per pack) from the 1st of next month. Generic for Faslodex is Boryung Fulvet, which was registered on August 1st. Fulvet is the only generic for Faslodex in Korea imported by Boryung from India. Faslodex is a breast cancer treatment based on selective estrogen receptor decomposer (SERD) that recorded 7.5 billion won in sales based on IQVIA last year. It is used for hormone receptor-positive (HR+) breast cancer, which accounts for 80% of breast cancer, but it has not been long since it was approved in Korea in 2007, and started selling it in earnest after receiving a salary in 2019. In the meantime, it is analyzed that product competitiveness has also decreased with the emergence of new breast cancer drugs. The industry believes that there is a high possibility of growth in the future because oral CDK4/6 inhibitors such as Pfizer Ibrance and secondary treatment combined therapy are also receiving benefits. This is why Boryung introduced the first generic in India. Boryung also received additional benefits when it registered Fulvet's benefit in August. It was listed at 68% of the original upper limit. Given that general generics are set at 53.55%, the Fulvet price can be seen as high. It can be seen that the gap between the two products has almost disappeared as the original was cut to 70%. The original Faslodex is 376,724 won and the first generic Fulvet is 365,961 won, which are only about 10,000 won apart. Usually, there is a difference in drug prices because the original is set at 70% of the existing upper limit and the generic is set at 53.55%, but in the case of Fulvet, there is virtually no difference in drug prices from the first year. The two products will be the same at 288,194 won from August next year. Boryung is a leading anti-cancer drug manufacturer among domestic pharmaceutical companies, so it is predicted that it can sufficiently threaten the original with its sales power. In the future, competition between AstraZeneca and Boryung, Korea, is drawing attention.
