- LOGIN
- MemberShip
- 2025-12-23 10:39:30
- Policy
- MFDS sets next year's budget at ₩669.4 billion
- by Lee, Hye-Kyung Sep 01, 2022 05:56am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) had compiled its budget plan for 2023 at ₩669.4 billion, a ₩5.4 billion (0.8%) increase from the ₩664 billion that had been set for this year. The next year’s budget proposal is focused on the definite implementation of the new administration’s national tasks – reinforcing food safety management and supporting innovative growth of the bio-health industry – and preparing a safe basis for the future of the new food and drug industry. The MFDS' budget proposal for 2023 was mainly allocated to 4 major areas – fostering a safe food and healthy dietary life environment, reinforcing safety management and basis for innovative growth in the biohealth sector, building a safe supply system for essential medicines, and expanding regulatory science research to lead future safety regulations. From the ₩174 billion set out for safety management and the basis for innovative growth in the biohealth, ₩13.1 billion was allocated to support the Korea Institute of Drug Safety & Risk Management, ₩6 billion to support the National Institute of Medical Device Safety Information, ₩7.9 billion to advance the quality of pharmaceuticals, ₩2.3 billion to strengthen international cooperation and competitivity for regulatory approval of pharmaceuticals, ₩1.8 billion to support licensing review, ₩1.9 billion to establish a support and management system for innovative medical devices, and ₩2.8 billion in building a computer modeling-based medical device. The MFDS plans to establish a common data model collection system to collect and analyze real-world data (RWD) from medical institutions and reinforce verification of drugs’ side effects, and conduct long-term follow-ups on implantable medical devices with the next year's budget. Also, technical support will be provided to develop and disseminate a demo model for the actual production of syringes implementing Quality by Design (QbD) principles to foster an optimal foundation for process design to ensure drug quality and safety. Also, to expand international cooperation for global regulatory standards, the MFDS plans to issue an English version of the Korean pharmacopeia and work to join the Pharmacopeial Discussion Group (PDG), and conduct customized professional education for drug license reviewers to strengthen their capabilities. Also, to reinforce verification of in vitro diagnostic devices such as COVID-19 diagnostic kits, etc., the MFDS will strengthen performance assessments of the products in distribution, and promote the research and development of a safety assessment system for computer modeling based medical devices to drive regulations on high-tech medical devices in the global market. Also, ₩14.2 billion was allocated to building a stable supply system for essential medicines. The ministry will stockpile appropriate amounts of orphan drugs to stably supply such drugs at the right time to patients in need, and expand state-led consigned production of essential medicines that have been discontinued supply due to low demand in Korea. Also, to establish a basis for the stable supply of medical devices that are rare or in emergent need, the MFDS will increase pre-purchases and stockpiling of medical devices while operating regional depots to facilitate prompt supply, and establish an integrated system that can supply and manage emergency medicines for crisis response and facilitate smooth procurement and management of treatments, etc. in public health crises like COVID-19. In addition, in order to establish a stable supply system for import-dependent essential medicines, the ministry will continue to pursue R&D to manufacture finished products in Korea. Also, it will expand regulatory science research to lead to future safety regulations. Furthermore, the ministries will join forces to prepare for the future environment by participating in pan-ministerial medical device R&D throughout the entire cycle to support the commercialization of safe medical devices. In response to the digital era, the ministry will establish a 'Smart Food QR' platform that issues unique QR codes for each food that provides combined safety management functions and consumer-oriented information ranging from e-label, real-time safety information to history and convert information such as food labeling and distribution history as data.
- Policy
- Coverage of 19 new drug items will be reinforced this year
- by Kim, Jung-Ju Aug 31, 2022 05:40am
- [Nineteen new drugs have been newly listed on the pharmaceutical reimbursement list or expanded reimbursement standards from January to this month this year. Among the drugs, 4 items were newly listed drugs, and 2 were already-listed drugs receiving reimbursement expansions. An estimated 1,320,371 patients will benefit from the new drug coverage enhancement policy this year, and the amount of pharmaceutical expense is expected to be in the ￦437.76 billion range. First, 19 new drugs have been newly listed on the pharmaceutical reimbursement list or expanded reimbursement standards (indication, administration standards) from January to this month this year. By month, coverage expansions this year started with the new listing of Vyzulta Eye Drops and Skilarence Enteric Coated Tab and the reimbursement standard expansion of Besponsa Inj in February. In March, five osteoarthritis treatments including Zospata Tab 40mg, Lutathera Inj, and Resyno-ONE Inj were newly listed, and the reimbursement standard for Keytruda Inj was extended. In April, Vitrakvi Cap and Sol, Rozlytrek Cap, and the ultra-high-priced treatment Kymriah Inj. were newly listed, followed by the reimbursement standard expansion of Tecentriq Inj in May. Last month, the reimbursement standards for Tecentriq Inj and Kadcyla Inj has been expanded and Fexclu Tab newly listed, improving treatment accessibly for 726,658 patients. The estimated cost spent by the newly increased patients is expected to be around ￦97.6 billion. With the new listing of the ultra-high-priced one-shot treatment Zolgensma and other reimbursement standard expansions, access and coverage to drugs have been further widened and diversified this year. Although only 7 patients are eligible to receive Zolgensma in Korea, being an ultra-high-priced drug, the estimated cost of treatment has been set at ￦13.87 billion for the 7 patients. On the other hand, Sonazoid Inj is expected to cost ￦0.5 billion per year to benefit 7,000 patients in Korea. Dopa check Inj will cost ￦90 million for 455 patients, Donerion Patch and Donhesive Patch will cost ￦9.2 billion to benefit 28,600 patients. Xtandi Soft Cap, which had already been listed but was approved to expand reimbursement standards, will further benefit 649 patients and cost ￦11.3 billion, and Ketyruda will benefit 649 patients and cost an additional ￦10.9 billion.
- Policy
- Reevaluation of Amosartan plus & Twotops Plus
- by Lee, Tak-Sun Aug 30, 2022 05:55am
- Hanmi's Amosartan plus & Twotops plus cause the same formulation, whether or not listed. The Ministry of Health and Welfare announced the plan to revalue the addition in November 2020, and said that IMD will maintain its addition if the number of companies with the same product registered, individual single agents, complex agents, and administrative routes, ingredients, and formulations is less than one. Amosartan plus was scheduled to end its addition on September 1, but it was maintained with such an improved new drug preferential measure because there was no other drugs. The Company does in law would be unfair to do. This is because Telmidipine Plus was registered in March 2020 before the announcement of the additional revaluation. In addition, Telmidipine plus the joint development of pharmaceuticals, Ildong is produced. For this reason, Ildong filed a lawsuit to suspend and cancel the execution of the drug price reduction in response to the Twotops Plus additional termination. The application for suspension of execution to accept the drug price is maintained, but the last defeat in the litigation on the merits of a trial held in Seoul Administrative Court on Tuesday to cut drug price inevitable now. Accordingly, from 30 days after the date of judgment, Twotops Plus 40/5.12.5mg will be reduced from 792 won to 713 won, Twotops Plus 80/5/12.5mg from 956 won to 860 won and Twotops Plus 80/10/12.5mg will be reduced from 1,018 won to 919 won. In the end, Ildong's joint development drug registration was a negative factor in the additional re-evaluation. The additional revaluation plan announced by the Ministry of Health and Welfare in November 2020 is evaluated to contain preferential treatment for IMD rather than the plan first disclosed in the previous year. However, in all cases, it can be seen that IMD preferential treatment has retreated compared to before the additional revaluation. This is because before the additional revaluation, the addition of less than three identical companies could be maintained. Therefore, Ildong was likely to maintain additional value like Hanmi.
- Policy
- Lorviqua reimb at ₩52,819, Emgality at ₩295,250
- by Kim, Jung-Ju Aug 30, 2022 05:55am
- ◆Lorviqua Tab= Lorviqua is a treatment that received domestic marketing authorization as monotherapy to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC). The company applied for reimbursement after receiving approval from the Ministry of Food and Drug Safety on July 29th. The Health Insurance Review and Assessment Service deliberated the agenda at the Cancer Disease Deliberation Committee on January 12th, and at the Drug Reimbursement Evaluation Committee on April 7th. At the time, HIRA had determined the drug adequate for reimbursement and waived pharmacoeconomic evaluations. The drug is listed in 7 of the A7 countries. The agenda was then passed on to the National Health Insurance Service, where the company conducted negotiations on the drug price and expected claims amount until May. As a result, the parties agreed on employing the ▲Refund type where the company refunds a certain rate (reimbursement rate) of the amount of the claims to NHIS, and the▲Expenditure Cap type where the amount that exceeds a certain cap is refunded, of the RSA. The insured price will be set at ₩52,819 for the 25mg strength and ₩158,457 for the 100mg strength starting on the 1st of next month. ◆ Emgality 120mg prefilled pen·prefilled syringe inj = Emgality was approved by the MFDS as a migraine prevention treatment on September 5th, 2019. The industry applied for reimbursement to HIRA on March 31st, after which the agenda was listed and deliberated by DREC on May 12th. At the time, the economic evaluation subcommittee acknowledged the clinical need for the drug and that the drug is subject to cost-effectiveness analysis. After pharmacoeconomic evaluations, the cost-effectiveness ratio was determined to be in an acceptable range. In countries abroad, the prefilled pen inj is listed in 6 of the A7 countries, and prefilled syringe in 2 of the A7 countries. The agenda was passed on to the National Health Insurance Service, where the company conducted negotiations on the drug price and expected claims amount from May to July. Both the pen and syringe was listed for reimbursement at ₩295,250. However, in consideration of the fact that the drug is more expensive than its alternative (oral treatment), the discontinuation standard has been set so that patients discontinue treatment if the number of migraine days is not reduced by 50% or more from baseline (before administration) during response evaluations, and the administration period was set to a maximum of 12 months.
- Policy
- Zemimet’s price drops 9.7% in 5 years…discounted 5 times
- by Lee, Tak-Sun Aug 30, 2022 05:54am
- LG Chem’s incrementally modified new diabetes treatment, ‘Zemimet Tab,’ has once again been subject to Price-Volume Agreement negotiations this year and its price will be discounted as of the 1st of next month. This is the fifth price cut made through the PVA system for the drug since its reimbursement approval. Its price had fallen nearly 10% during the period. According to the industry on the 29th, Zemimet Tab was applied Type C of PVA negotiations, the ceiling price of all four strengths of Zemimet SR Tab were discounted. The discount rate varies by strength but was in the 1.1% to 1.5% range. This is already the fifth price discount made through the PVA system, indicating the exponential increase of Zemiglo users in Korea. Although the system was established to secure and expand NHI finances, on the company’s part, the company should inevitably feel frustrated as the system hampers product growth. In the case of Zemimet ST Tab 50/500mg, its price has been lowered every year from 2018 to this year through the PVA system. The ceiling price, which had been ₩815 during the initial listing, had fallen to ₩736. This is a 9.7% discount. The industry had been raising voices that PVA negotiations for drugs like Zemimet SR Tab need to be limited to reflect the R&D efforts made by homegrown new drugs. The industry suggested that a maximum number of negotiations should be limited to three, or other incentives are provided for new homegrown drugs from Korea Innovative Pharmaceutical Companies. However, the NHIS is negative about only granting incentives to domestically developed drugs for reasons of equity. During the correspondents’ briefing that was held on the 23rd, Haemin Jeong, Deputy Minister of NHIS Pharmaceutical Management Department, said, “The NHIS agrees on the need for Korea Innovative Pharmaceutical Companies to receive preferential treatment in consideration of the social and industrial values of such companies, but a more cautious approach is required to apply measures like easing price cuts to the PVA system.” He added, “The PVA system adjusts drug prices to share the financial risk held by drugs whose expenses exceed a certain level, and drugs that affect NHI finances must be managed, regardless of whether it is a drug produced by Korea Innovative Pharmaceutical Companies or not. Providing preferential treatment for such innovative pharmaceutical companies is difficult in reality in terms of equity due to international trade issues, and would require discussion with relevant organizations.” Although Jeong’s response was limited to the provision of incentives for Innovative Pharmaceutical Companies, the response can also be interpreted as that it is difficult to give preferential treatment to domestically-developed drugs through the PVA system.
- Policy
- Kyowa Hakogirtin Postelligeo 20mg is expected to be approved
- by Lee, Hye-Kyung Aug 30, 2022 05:54am
- Posteligeo 20mg, a rare two-type non-Hodgkin lymphoma treatment of Kyowa Hakogirin, is expected to be approved. It has been four years since the U.S. Food and Drug Administration (FDA) approved the treatment of mycosis fungoids (MF) or Sézary syndrome (SS) in August 2018. According to the pharmaceutical industry on the 26th, the Ministry of Food and Drug Safety recently completed Potseligeo's safety and efficacy review. It has been four years since the U.S. Food and Drug Administration (FDA) approved the treatment of mycosis fungoids (MF) or Sézary syndrome (SS) in August 2018. According to the pharmaceutical industry on the 26th, the Ministry of Food and Drug Safety recently completed Posteligeo's safety and efficacy review. Analysts say that as the review has been completed, it is highly likely to receive permission soon if there are no other variables. Posteligeo is a monoclonal antibody component that acts on C-C chemokine receptor-4 (CC chemokine receptor type 4) found in cancer cells to produce therapeutic effects. At the time of U.S. approval four years ago, it received the title of the first approval as an SS treatment. The duration of survival (PFS) without exacerbation of the disease in phase 3 clinical trials was more than twice as long in the Posteligo group (7.6 months) as in the Zolinza group (3.1 months). The proportion of patients whose tumor size was reduced to a specific level (ORR) was 28% in the Posteligo group and 5% in the Zolinza group. Abnormal cases caused by Posteligeo administration include rashes, injection site reactions, fatigue, diarrhea, and musculoskeletal pain. Meanwhile, Posteligeo was approved by the European Commission in November 2018 as a treatment for adult patients with Mycosis Fungoides and Sézary Syndrome who received at least one systemic therapy after FDA's approval.
- Policy
- "Raise the prescription rate for high-risk patients to 50%"
- by Lee, Jeong-Hwan Aug 29, 2022 06:03am
- Experts have pointed out that high-risk patients with COVID-19 should be first administered oral treatments such as Paxlovid or Lagevrio etc. before hospitalization. In other words, if the prescription rate of oral COVID-19 treatments remains in the current 20% range, experts believe that the prescriptions will not be sufficient to prevent the increase in severe disease and deaths amid the resurgence of COVID-19. Therefore, the experts believe that the prescription rate in high-risk COVID-19 patients needs to be increased to at least 30% and to at most 50%. Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters stated so at the regular briefing held on the 26th. Jeong added that there is no obstacle to providing prompt medical treatment for COVID-19 patients as over 10,000 one-stop medical institutions nationwide are in operation, and 1 out of 3 local hospitals and clinics are providing one-stop treatments. However, pointing out that in 25% of the medical institutions the progress to hospitalization is not smooth, Jeong expressed the view that this problem should be resolved quickly, and treatment be administered during the waiting period prior to hospitalization. Jeong said, “Smooth progress to hospitalization is of course important, but regardless of this, the high-risk group should unconditionally be administered prescription drugs. The prescription rate has been improved much, but the rate should not remain at the current 20% range." “The rate has improved much, from 4% last Spring to 20%, but the statistics need to be improved so that the rate is improved to 1 in 2 or 1 in 3 patients receiving prescriptions to implement the targeted, precision quarantine for high-risk patients that we hope to achieve. Achieving this goal will lead to a gradual decrease in the severity or fatality rate in COVID-19 patients in the future.”
- Policy
- NHI turns to deficit with a mere 2.6% coverage improvement
- by Lee, Jeong-Hwan Aug 26, 2022 05:35am
- With the new government preparing for complete reorganization and faceoff of the national health insurance coverage enhancement project ‘Moon Jae-In Care,' the ruling party criticized that Mooncare's implementation turned the current NHI balance into a deficit while raising the coverage rate by only a mere 2.6% points. Also, the party criticized that the National Health Insurance Service has planned incentives across all NHIS employees despite the 2.9% rise in health insurance premiums borne by the public and that the national subsidy rate of NHI general accounts does not meet the statutory standards. The ruling party requested disciplinary action against the National Health Insurance project managers under the Ministry of Health and Welfare and urged the NHIS to withdraw or return the incentives planned or paid to its employees. The People Power Party’s policy committee criticized as above while presenting the ‘Top 100 issue projects of the fiscal year 2021’ on the 25th. The People Power Party pointed out that the current NHI balance turned to a deficit from 2018 due to the government’s coverage enhancement policy while the coverage rate rose by only 2.6%p until 2020 compared to 2017. The NHI expenditures had increased from ₩4.7 trillion in 2017 to ₩5 trillion in 2018, then surged to ₩8.6 trillion in 2019, and the accumulated reserves of NHI finances that had reached ₩20.8 trillion in 2017 turned to a deficit in 2018 and continued on its decline. In particular, the People Power Party criticized that the previous government was unable to reach the 70% coverage rate it had aimed to achieve by 2022. The NHI coverage rate had increased from 62.7% to only 65.3% by 2020. In addition, the public’s national health insurance premium had increased by 2.9% on average every year except for 2017. Also, Moon administration’s national subsidy rate for NHI general accounts did not meet the statuary standards. The party also pointed to the Board of Audit and Inspection’s audit results of the NHI fiscal management status that showed that ₩250 billion’s worth of precious tax money had been wasted. The BAI had reported that the MOHW had excessively paid out loss compensations after implementing a loss compensation plan worth a total of ₩190.7 billion in anticipation of a decrease in medical treatment revenue arising from the reimbursement of 11 items including epigastric ultrasound and brain MRI. Due to the overpayment of loss compensations, a total of ₩90 billion had been paid out as loss compensation from 2018 to December 2021, ₩160.6 billion of which is suspected to be in violation of standards because a compliance check was not carried out due to NHIS's inadequate computerized system. Therefore, the People Power Party pressed for an improvement of the system, pointing out how the NHIS, which turned the NHI balance into a deficit and wasted the taxpayers' money due to negligent management and supervision, is planning a performance-based incentive for all its employees. Specifically, the NHIS had completed an internal review to pay out ₩29,084,898,000 in employee incentives. 17,010 employees will be receiving the incentives in September. The NHIS President will be receiving ₩59,298,000 and the Standing Auditor ₩38,232,000. The rate of incentive payment was set at 40.5% of the basic annual salary for the President and Executive Directors, 38.25% for the Standing Auditor, and 67.5% for its employees. In addition, the ruling party criticized that the NHIS had not prepared any measures despite the imminent depletion of NHI reserves that is expected by 2025, is negligent about the long-term financial prospect, and is obstructing the National Assembly’s long-term fiscal outlook. The party's remedial plan states, “We ask the government to discipline the health insurance project manager of the MOHW and the NHIS that infringed the National Assembly's right to review the NHI accounts. Also, the NHIS should immediately withdraw or return the incentives planned or paid to its employees. Also, a long-term fiscal forecast of over 40 years needs to be made to accurately disclose the reality of the increased burden that will be borne by the public in the future. In particular, the NHIS should cooperate and submit data for the National Assembly Budget Office's long-term fiscal forecast." “The NHIS President, who was appointed near the end of the last administration at the end of December 2021, had not even established a countermeasure for the deficit in health insurance that was made when Moon’s administration took office. The NHIS is holding a party amongst themselves after increasing public burden by raising the NHI premium rate in this economic crisis in the midst of COVID-19.”
- Policy
- Pts with osteopenia need screening tx
- by Kim, Jung-Ju Aug 26, 2022 05:35am
- The National Evidence-based Healthcare Collaborating Agency (Director Han Kwang-hyeop, NECA) analyzed the drug effect in osteopenia patients and developed a fracture risk prediction model and published the results of the study on the 25th. As aging rapidly progresses worldwide, the prevalence of osteopenia and osteoporosis is rapidly increasing. In particular, osteopenia is estimated to be about half of the current elderly population, and the social and economic burden of this is rapidly increasing as the frequency of hip fractures gradually increases. NECA conducted a study on the necessity of preventive treatment for fractures in osteopenia patients so that fracture risk factors can be analyzed and preemptively treated in osteopenia patients and announced the results. As a result of analyzing the data of a 66-year-old woman who underwent a life-changing medical examination of the NHIS, the number of osteopenia patients has continued to increase since 2007, and in 2019, osteopenia patients accounted for half of 66-year-old women. As a result of analyzing the incidence of fractures according to the bone density level, the incidence of fractures in the patients with osteopenia and osteoporosis was higher than in the group with normal bone density. As a result of identifying fracture risk factors and establishing a predictive model in 66-year-old female patients with osteopenia among life-changing health examiners from 2008 to 2009, falls, diabetes, cerebrovascular disease, asthma, and past fracture risk factors were included. As a result of reviewing domestic and foreign literature on osteoporosis fracture incidence, NECA confirmed that osteoporosis drug treatment groups had a statistically significantly lower risk of fracture than those without drug treatment in osteopenia patients and significantly increased bone density. Therefore, even if the bone density is not as low as that of osteoporosis, it is necessary to select and treat patients at high risk of fracture. According to expert opinion surveys from the Korean Society for Bone and Mineral Research and The Korean Endocrin Society, all respondents said they needed to selectively administer drugs to patients with osteopenia, and that they needed to expand insurance benefits to make actual prescriptions more active. Kim Jung-hee, an associate professor of endocrinology and metabolism at Seoul National University Hospital, said, "We confirmed that osteopenia patients have a higher risk of fracture than normal bone density groups, and active treatment should be considered for osteopenia patients with high risk of fracture." Professor Kim said, "We hope that the fracture prediction model developed in this study will be used as a useful indicator for evaluating the risk of fracture in patients with osteopenia." Yoon Ji-eun, an associate researcher at NECA, who is in charge of joint research, said, "We expect it to be used as an important basis for clinical treatment guidelines that determine whether to administer osteoporosis drugs to patients with osteoporosis in the future."
- Policy
- MET mutant anticancer drug Tepmetko challenges
- by Lee, Tak-Sun Aug 25, 2022 05:52am
- Following the MET mutant anti-cancer drug Tabrecta, which landed in Korea last year, Tepmetko is also undergoing a review. MET mutations occur only in about 3-4% of non-small cell lung cancer patients, but the prognosis is poor, so there is a desperate need for treatments that are covered by benefits. According to an industry on the 24th, the HIRA is considering establishing a new benefit standard for Tepmetko 225mg. Tepmetko 225mg is an anticancer drug approved in Korea by Merck in November last year and is used to treat patients with local progressive or metastatic non-small cell lung cancer with MET Exxon 14 skipping confirmed. When MET Exxon 14 deficiency occurs, the MET pathway, which plays a necessary role in cell signal, proliferation, and survival, is said to be excessively stimulated and cause cancer cell proliferation. On the same day, Tepmetko of Novartis Korea was also approved, allowing MET mutant anticancer drugs to be used for the first time in Korea. The two drugs had a mechanism to block the MET phosphorylation reaction by binding to the phosphorylase region of the receptor in the cell. The two drugs appear to be undergoing a benefit process afterwards. Tepmetko was on the agenda of the Deliberation Committee for Severe Cancer Diseases on the 10th, but failed to set a benefit standard. Currently, the two drugs can be used as non-reimbursedment, but it is difficult for patients to access them easily in that the price is around 10 million won. They want to apply prompt benefit to related patients and medical sites. However, it takes a long time to apply the benefit, such as setting anti-cancer drug benefit standards. Since Tepmetko failed to pass the cancer disease review committee, Tepmetko cannot guarantee to pass the first stage of the benefit process. In particular, in the case of MET Exxon 14 defects, the use environment is not easy because the companion diagnosis method has not yet been developed. Attention is focusing on whether Tabrecta and Tepmetko, which were approved on the same day, will be able to successfully register their benefits.
