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- 2026-05-04 20:02:02
- Policy
- Evusheld will be included in Govnt's supplementary budget
- by Lee, Jeong-Hwan May 12, 2022 06:06am
- The government is setting out to secure a supplementary budget for the introduction of ‘Evusheld (tixagevimab, cilgavimab),’ an antibody combination treatment used to prevent COVID-19 infection in the immunocompromised that see a low effect from vaccinations. With the National Assembly also agreeing on the need to introduce Evusheld, its introduction will gain momentum as soon as the supplementary budget submitted by the government passes the National Assembly. The government plans to hold a Cabinet Meeting on the afternoon of the 12th to pass the supplementary budget. In the proposed supplementary budget, attention is focused on the budget managed by the Korea Disease Control and Prevention Agency which includes the proposal to introduce Evusheld, an antibody treatment for the immunocompromised. Evusheld is administered to people who show inadequate response to COVID-19 vaccines such as cancer patients and dialysis patients to increase their prevention against COVID-19 infections. The drug was approved in December last year by the US FDA, and in the UK by NHRA in March this year. France, Australia, and Singapore also signed advance purchase agreements for Evusheld as preventive therapy for COVID-19. On the other hand, The Korean government had received criticism for being late in its response because Korea only announced that it will review the introduction of the drug and did not specify when. Accordingly, the government plans to include about ₩40 billion to purchase 20,000 courses of preventive antibody treatments needed for the prevention of infection and serious COVID-19 in the supplementary budget for the immunocompromised. Severe immunocompromised patients, such as organ transplant patients receiving immunosuppressive treatment and blood cancer patients, are eligible for support. If approved, Evusheld’s distribution is not expected to be difficult as Samsung Biologics is currently manufacturing the whole amount. Samsung Biologics has been supplying Evusheld to the global market under the long-term strategic manufacturing partnership signed with AstraZeneca in September 2020. The companies further expanded the size of the contract in December last year to strengthen the strategic partnership
- Policy
- “Dualized RWD collection for Kymriah is inefficient”
- by Lee, Tak-Sun May 11, 2022 05:55am
- With the registration of the ultra-expensive one-shot treatment Kymriah, the opinion was raised that a plan should be prepared to ensure the efficiency of the system by standardizing the dualized real clinical data (RWD) collection required by different institutions. That the separate collection of data by the Ministry of Food and Drug Safety and the Health Insurance Review and Assessment Service is a burden on the medical staff. Ji-Hye Byun, Assistant Research Fellow of the Evidence-based Research Division at HIRA claimed so in the 22nd issue of ‘HIRA’ that was recently published. Kymirah is the world’s first chimeric antigen receptor T-cell (CAR-T) therapy that was developed by Novartis Korea. The drug was approved as the first advanced biopharmaceutical under the ‘Advance Regenerative Bio Act’ in March of last year. The drug injects genetic information that can recognize specific antigens of cancer cells to the surface of an immune cell (T cell) collected from the patient and is indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Its listing had raised much attention, being a ‘one shot’ treatment that can bring an effect with a single administration and is an ultra-high-priced drug that costs 500 million won per shot. The government listed the drug for insurance benefit at 360 million won per shot in April and decided to cover the drug price with the National Health Insurance. However, the issue is that each organization requested RWD as a condition in the approval and listing process. The MFDS designated Kymirah as an advanced biopharmaceutical and ordered the company to conduct a 15-year long-term follow-up study on the drug. Also, the company needs to submit a post-management form to HIRA at the time of administration, 6 months after administration, and 12 months after administration. The global registry, EU’s EBMT will also be collecting treatment information on domestic patients, Byun said, “As a result, the HCPs will have to bear the burden of inputting and submitting RWD of similar content to three institutions - the MFDS, HIRA and EU EBMT- after patient treatment. We need to improve the domestic RWD collection system to become more efficient.” Byun explained that in Europe, the authorities are working to understand the differences in the RWD collection environment of each country and establish governance for RWD utilization among all patients. EU’s EBMT was also established as a single registry to serve the multi-purpose of post-marketing safety research, reimbursement management, and clinical research. Byun added that HIRA already owns the infrastructure to manage such information, and argued that it is necessary to use this infrastructure to separate the additional information necessary as RWD and devise a way to link it with the hospital's electronic medical record system.
- Policy
- Reblozyl was approved after 1 yr of designation of rare drug
- by Lee, Hye-Kyung May 11, 2022 05:55am
- Reblozyl 25mg, a treatment for patients with beta-Mediterranean anemia, was officially approved for items a year after designation as a rare drug. The MFDS approved Reblozyl applied by BSM Pharmaceutical Korea. Reblozyl is equipped with▲ the treatment of adult beta-Mediterranean anemia patients who need red blood cell transfusion as an indication, and ▲MDS-RS with minimum, low, and moderate risk of ring ferrous hematopoietic stem cell or low, moderate risk of ring ferrous hematopoietic and thrombocytopenia with increased myelogenesis/myeloproliferative tumor (MDS/NMP-T) Reblozyl was designated as a rare drug on April 1 last year. Beta-Mediterranean anemia, also called Cooley's anemia, is a blood disorder genetic disease that reduces the production of hemoglobin, an iron-containing protein of red blood cells, and delivers oxygen to cells in the body. Although iron treatment through red blood cell transfusion and chronic blood transfusion therapy for survival are used to treat patients, the risk of thrombosis increases to an abnormal level. Reblozyl obtained FDA marketing approval in 2019 based on clinical results of placebo administration of 112 out of 336 patients with beta-Mediterranean anemia. At the time of FDA approval, 21% of patients administered with Reblozyl had a 33% higher blood transfusion reduction rate than 4.5% of patients administered with placebo. Common side effects of Reblozyl include headache, bone pain, joint pain, fatigue, cough, abdominal pain, diarrhea, and dizziness, and high blood pressure may occur within the dose period. Thrombotic monitoring should also be accompanied when administered. It should be prohibited if a pregnant or breastfeeding woman takes Reblozyl because it can harm the fetus or newborn.
- Policy
- President Yoon said he was grateful to the people
- by Lee, Jeong-Hwan May 11, 2022 05:55am
- President Yoon Seok-yeol said on the 10th, "I am deeply grateful to the medical staff for their respect and dedication to the people who have endured great pain in the process of overcoming the COVID-19 pandemic over the past two years." At the inauguration ceremony of the 20th president held in front of the main building of the National Assembly, President Yoon said, "We will rebuild the country as a country where the people are the true owners based on liberal democracy and market economy." In Yoon's inaugural address, "freedom" said a total of 35 times. President Yoon's ambition is to ensure the value of freedom as much as possible to make it a country where the people are the true owners and fulfill their responsibilities and roles in the international community. President Yoon insisted that the universal value of freedom should be shared as something to be done to resolve excessive collective conflicts between countries and within countries and to overcome the democratic crisis. "We must properly and accurately recognize the value of freedom," Yoon said. "We must rediscover the value of freedom. Looking back on human history, the place where free political rights and free markets were breathing has always been prosperous," he said. "If any individual's freedom is violated, even the freedom of all members of the community is threatened," he said. President Yoon said, "Freedom is by no means a winner-take-all. To be a citizen with freedom , a certain level of economic fundamentals and opportunities for fair education and access to culture must be guaranteed," he said, adding that he cannot be called a free citizen without such a thing. If someone's freedom is violated or fails to meet the conditions necessary to become a free citizen, all free citizens should help in solidarity," he stressed. "Science, technology and innovation will protect our liberal democracy, expand freedom, and sustain a dignified life," President Yoon said. "We should cooperate and unite with many countries that have achieved technological progress and innovation by respecting freedom and creativity." "We are in the 10th largest economy group in the world. Therefore, we should take an attitude as a global leader in actively supporting and defending universal international norms based on freedom and human rights values," he said. He added, "I will make sure to create a country where the people are the true masters, a country that is responsible and respected in the international community based on the values of freedom, human rights, fairness and solidarity."
- Policy
- Only 40% of asthma pts undergo Pulmonary function testing
- by Lee, Tak-Sun May 06, 2022 05:46am
- Although it is recommended to take pulmonary function test at least once a year to manage diseases in asthma patients, only less than half of all patients are tested. The HIRA announced on the 3rd that it will analyze and disclose the results of the 2020 (8th) asthma adequacy evaluation to mark World Asthma Day. As a result of the evaluation, the rate of Pulmonary function test was steadily increasing, but only 42.4% of the patients subject to evaluation were tested, which was still low. For early detection of asthma exacerbation and management of diseases such as drug control, Pulmonary function tests should be performed at least once a year. (Guidelines for Asthma Treatment, Korean Academy of Tuberculosis and Respiratory Diseases 2020) By age, the pulmonary function test rate in their 70s was the highest at 48.5%, and those in their 90s and older were the lowest at 27.6%. By gender, 40.9% of women and 44.2% of men showed a lower rate of pulmonary function tests for women of all ages than men. The ratio of ICS prescription patients was also low at 55.9%, showing low results for both tests and prescription indicators. Inhalation steroids are the most effective preventive drugs for maintaining asthma control and should be used in all possible asthma patients. (Guidelines for Asthma Care, Korean Academy of Tuberculosis and Respiratory Diseases 2020) Institutions with pulmonary function test equipment showed better results in all evaluation indicators than institutions without. Asthma is a chronic respiratory disease that can prevent the deterioration of the disease and hospitalization if it is treated effectively in an outpatient clinic. In 2019, the prevalence of asthma over the age of 19 in Korea was 3.2% and 5.0% over the age of 65, and the asthma hospitalization rate was 65 per 100,000 people, higher than the OECD average of 34.4. Since the number of patients receiving treatment is less than the prevalence of asthma estimated by the national health statistics, it is more important to conduct lung function tests for early diagnosis of asthma. Kim Yang-joong, a member of the HIRA, said, "There are some types of respiratory tests that can be easily taken," and explained, "Not only suspected asthma patients but also patients undergoing treatment are encouraged to take respiratory tests at least once a year." The HIRA is unveiling a hospital with good results in the adequacy evaluation of asthma so that it can be continuously managed at a nearby local hospital.
- Policy
- New cost of Tecentriq is 2,271,109 won
- by Kim, Jung-Ju May 02, 2022 06:02am
- Tecentriq, an immuno-cancer drug from Roche Korea, will be expanded from next month due to a combination treatment with Avastin. The new insurance drug price is 2,271,109 won per 20mL for Tecentriq, 218,782 won per 100mg for Avastin, and 712,098 won for Avastin 400mg. The MOHW announced that the "Amendment to the Pharmaceutical Benefit List," which aims to expand the standard for immuno-cancer drugs, was passed after presenting it as a resolution by the 10th Health Insurance Policy Review Committee today (29th). These drugs were listed in January 2018 as the current NSCLC secondary therapy and urinary tract epithelial cancer treatment, and have also been receiving benefits for small cell lung cancer since August 2020. The benefit expansion this time is ▲ a case for primary treatment of progressive non-small cell lung cancer without PD-L1 gene expression and specific gene (EGFR or ALK gene) mutations, and ▲combination therapy with Avastin as a treatment for patients with irreversible hepatocellular carcinoma who had not previously undergone systemic therapy. Alternative drugs include Nexavar (Sorafenib) and Lenvima (Lenvatinib) in hepatocellular carcinoma, and Keytruda (Pembrolizumab) is a representative alternative to non-small cell lung cancer. Janssen Korea applied for the expansion of benefit standards for hepatocellular carcinoma in October 2020 and non-small cell lung cancer in April 2021. In response, the board held a cancer disease review committee in February and July 2021, respectively, and passed it in January this year. It considered that in the case of hepatocellular carcinoma, the quality of life improved in terms of side effects compared to the existing alternative therapy, but since it is expensive with Bevacizumab, the drug benefit evaluation committee needs to discuss the cost effectiveness. In the case of non-small cell lung cancer, it was judged that it was necessary to set salary standards in consideration of clinical literature, but to proceed with follow-up procedures simultaneously with the competitive drug Keytruda. As a result of the committee's deliberation, hepatocyte cancer is at a level that can accept the economic evaluation result (ICER) in terms of cost effectiveness, and in the case of non-small cell lung cancer, the cost is low compared to Keytruda, an alternative drug. The drug is listed in all A7 countries. The company moved to the NHIS and negotiated the new insurance drug price and the expected amount of claims from the end of January to the end of last month. As a result of the negotiations, Tecentriq agreed to 2,271,109 won, down 1.1% from the previous price, with Refund and Expenditure Cap, which the pharmaceutical company refunds to the NHIS for a certain percentage of initial drug treatment and a certain percentage of the cap excess. Avastin also succeeded in agreeing to 218,782 won per 100 mg and 712,098 won for 400 mg, down 5.4% from the previous one, considering the upper limit adjustment criteria and insurance financial impact as the range of use was expanded as a combination therapy. The MOHW and the HIRA set the scope of insurance benefits in consideration of the MFDS' permits, textbooks, guidelines, and academic opinions, and set the recognition period up to two years by applying the same standards as other immuno-cancer drugs.
- Policy
- Combi of HBP+ Hyperlipidemia will be released again
- by Lee, Tak-Sun Apr 29, 2022 05:41am
- As Chong Kun Dang, Yuhan Corp., and GC Pharma, one of the top three traditional pharmaceutical companies in sales, are set to launch a combination of high blood pressure + hyperlipidemia, the market is expected to lead the prescription trend in the future. Currently, the market is led by improved complexes developed by Boryung, Hanmi Pharmaceutical, and Daewoong Pharmaceutical, and it is expected to rise further if Chong Kun Dang and Yuhan are joined. According to the MOHW on the 27th, as of May 1, Chong Kun Dang's Cantabell A, Yuhan Corp.'s Duowell Plus, and GC Pharma's Rozetel will be listed. Chong Kun Dang's Cantabell A is a combination of ARB-based Candesartan Cilexetil, CCB-based Amlodipine, and Atorvastatin, a component of hyperlipidemia treatment. Five dose products are available: price of Cantabell A(Candesartan 8mg, Amlodipine 5mg, Atorvastatin 10mg )is ,1318 won, Cantabell A 8/5/20mg,1320 won, Cantabell A 16/5/10mg, 1495 won and Cantabell A 16/5/20mg ,1497/10mg. It is expected that customized prescriptions for each patient will be possible as it has various capacities. Yuhan's Duowell Plus and GC Pharma's Rozetel are composed of ARB-based Telmisartan, hyperlipidemia treatment ingredients Rosuvastatin and Ezetimib. It's the first combination handled by Yuhan. Both products will have four different doses. Duowell Plus (Telmisartan 40)/ Rosuvastatin Calcium 5/Ezetimbe is listed at 1,518 won ; Duowell Plus 80/5/10 mg is listed at1,665 won; Duowell Plus 40/10/10 mg is listed at 1,784 won, and Duowell Plus 80/10/10/10 mg is listed at 1,931 won. GC Pharma further lowers the price, listing Rozetel 40/5/10mg at 1,199 won, Rozetel 80/5/10mg at 1,326 won, Rozetel 40/10/10mg at 1,516 won and Rozetel 80/10/10mg at 1,646 won. Currently, the products leading the high blood pressure-hypertension three-drug complex market are Dukaro (Amlodipine Besylate + Fimasartan Potassium Trihydrate Granule + Rosuvastatin Calcium), Hanmi Pharmaceutical's AmosartanQ, and Daewoong Pharmaceutical's Ollomax. Last year, the amount of outpatient prescriptions based on UBIST recorded 12.7 billion won for Dukaro, 11.4 billion won for AmosartanQ, and 8.8 billion won for Ollomax. Since most of them are new products that have been released for less than five years, it is expected that the market will be popular in the future from the combination of high blood pressure-hypertension. As Chong Kun Dang, Yuhan Corporation, and GC Pharma are also entering the market as a new combination, it is expected to quickly join the trend.
- Policy
- Reviewing the removal of outdoor masks
- by Lee, Jeong-Hwan Apr 28, 2022 06:06am
- Photojournalists of the Presidential Transition CommitteeThe presidential transition committee announced its position to examine the COVID-19 situation in late May, a month after the launch of the new government, and then decide to release the outdoor mask. The new government plans to promote quarantine policies based on scientific evidence and prepare governance to respond to infectious diseases centered on experts' opinions and on-site judgment. Ahn Cheol Soo, the chairman of the transition committee made the remarks at a briefing on the announcement of comprehensive measures by the Health and Medical Division of the COVID-19 Emergency Response Committee at a joint press conference in Tongui-dong, Jongno-gu, Seoul on the morning of the 27th. Chairman Ahn announced four key tasks, including ▲strengthening compensation due to side effects of vaccines, ▲ scientific quarantine using big data, ▲reorganization of the medical system, including the establishment of hospitals specializing in infectious diseases, and▲ preparation of measures to protect the elderly and medical staff. Chairman Ahn has defined the government's quarantine as "non-scientific political quarantine." He emphasized that it is "scientific quarantine" to automatically calculate the severity and quickly process bed allocation by establishing a platform that collects data on infectious diseases. Chairman Ahn also came up with a plan to reform the medical system that responds to infectious diseases at all times. He said he would secure 7,700 beds in advance and establish a method of treating patients centered on general hospitals. Protection for high-risk groups and vulnerable groups of COVID-19 will be strengthened. The transition committee said that hospitals and facilities have been vulnerable to infection, but it will significantly improve the ventilation structure in the future and convert them into safe facilities for infection through infection education for workers. In the case of high-risk groups, a medical response fast-track policy is prepared to enable rapid testing and rapid treatment. The transition committee said it will secure enough treatments to relieve public anxiety and increase its responsiveness to infectious diseases. The new government will secure a total of 2.071 million people by introducing an additional 1,009,000 treatments and expand the scope of administration to those with underlying diseases aged 12 or older so that they can receive prompt treatment. It will also expand compensation and support for adverse vaccine reactions. Support for medical expenses will be increased from 30 million won to 50 million won, and death compensation will be increased from 50 million won to 100 million won. Support will be provided after basic reviews such as reducing the burden on the public and the causal agenda for the responsibility to prove abnormal reactions. It also plans to shorten the processing period to 120 days. Chairman Ahn said, "People must be most curious about when they take off their masks outdoors, but they are trying to judge by looking at the situation in late May." He explained, "Now, the number of confirmed cases in Korea is still the largest worldwide, making it difficult to compare directly with other countries that can take off masks outdoors." Chairman Ahn said, "We will make a decision around late May on whether to make it mandatory to take off the mask outdoors but wear an indoor mask when entering the building." He said, "The mandatory indoor masks will continue for the time being. If raking off a mask indoors, it will be evidence that our daily life will almost completely recover, he said.
- Policy
- The transition team operates biohealth regulatory sandboxes
- by Kang, Shin-Kook Apr 27, 2022 06:03am
- The presidential transition committee established the Pharmaceutical Bio Innovation Committee, which was the pledge of Yoon Seok-yeol, and presented deregulation through biohealth regulatory sandboxes as a policy task. Baek Kyung-ran, a member of the transition team's social welfare division, said on the 25th that he will recognize the biohealth sector as a future food industry and open the 'BioHealth Korea Era' through a briefing on vaccine development and state affairs. Member Baek said, "This morning, elected Yoon visited the headquarters of SK Bioscience, which is developing the COVID-19 vaccine," adding, "The purpose of the on-site visit is to encourage everyone who has participated in the development of the COVID-19 vaccine. It was to express our willingness to actively support the bio-health sector." "Yoon said that there is enormous national potential, food, economy, and health security in the vaccine treatment lab," Baek said. "In the future, the government will provide all support to companies that develop vaccines and treatments to respond to pandemics." He said, "The Yoon Seok-yeol government recognizes the bio-health sector as an axis of the future food industry and establishes national tasks with the aim of opening the 'Bio-Health Korea Era' by making it a field that takes a step ahead and leads other countries." "First of all, we will create an environment where our bio-health companies can leap into the world, we will establish a pharmaceutical bio innovation committee to strengthen biohealth governance so that basic research, hospitals and companies can cooperate together and related ministries can gather wisdom together." In addition, he said, "We will create a global mega fund that supports our pharmaceutical industry to develop innovative new drugs by our own strength beyond the limitations of technology exports." "We plan to actively train key personnel such as medical scientists and AI professionals and operate biohealth-specific regulatory sandboxes to improve regulations in the biohealth sector at all times," Baek said. It also unveiled measures to foster the digital healthcare industry. "To strengthen the industrial competitiveness of digital healthcare products such as electronic drugs, digital treatment devices, and AI diagnostic assistance, we will strengthen R&D," she said. "We will build a medical MyData platform that allows medical institutions, pharmacies, and insurance companies to flow." "We will also strengthen the legal basis so that new technologies and data platforms can be safely used without concerns over personal information infringement," Baek said. "We will establish a system that enables discriminatory support for areas directly related to health and security like infectious diseases. The U.S. invested about $10 billion immediately after the outbreak of COVID-19 to make its first vaccine in 350 days." Even after COVID-19, a new type of new infectious disease can occur again at any time. We also need a system that supports in a different and innovative way than ever before," she said. "We will fundamentally reorganize the R&D system by establishing a dedicated organization to minimize administrative regulations such as preliminary feasibility systems and provide rapid support," Baek said. "Biohealth is not only a promising field of our economy, but also a key area to improve the health and quality of life of the people. We will try to lead the growth and job creation of our economy by converging industry, science and technology, and medical care around the people and becoming a "second semiconductor," he stressed.
- Policy
- Betamethasone's permission change is expected
- by Lee, Hye-Kyung Apr 27, 2022 06:03am
- As a result of reviewing safety information on drugs containing the skin disease treatment Betamethasone, precautions for use such as Pheochromocytoma are expected to be added. The MFDS' Pharmaceutical Safety Evaluation Division prepared a change (draft) of permission based on the results of the European Medicines Agency's review of safety information on drugs containing "Betamethasone." This change includes both Betamethasone PO and Betamethasone Inj. "Pheochromocytoma, which could be fatal, were reported after administration of systemic corticosteroids. Patients suspected or confirmed to have Pheochromocytoma should be administered only after evaluating the appropriate risk and benefit of Corticosteroids.' For injections, general precautions include oral medications, while the terms of administration for pregnant women and lactating women added, "The study showed an increase in the risk of neonatal hypoglycemia after short-term treatment of Betamethasone before childbirth." The MFDS will receive an opinion inquiry by the 6th of next month regarding the establishment of such precautions. Betamethasone-containing PO products include Sinil Betamethasone, Ceretasone, Dexmin, Dongkoo Bio's Betamethason, Betaramin (for export), Cebita, Cerestar (for export), Almetamine (for export), Didstarsone, Benoramin, Arlico Betathro, Betomin, Young IL BETALOMIN, Gestar, and Betaclon. Betamethason-containing Inj. products include Betamethone Sodium Phosphate Injection Medica, Betamethasone Injection Jeil, Globetamethasone Injection, Betamethasone Sodium Injection Huons, Betamethasone, Tamezon, Betamethasone Sodium Injection Tab. Daewon, Betasone Injection Dongkwang and Hanall Betamethasone Inj.
