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- 2025-12-24 13:20:48
- Policy
- Most clinics have 60,000 calling in prescriptions
- by Kim, Jung-Ju Apr 21, 2020 06:27am
- COVID-19 outbreak showed that the government has temporarily allowed some phone consultations and prescriptions, and until recently, Clinics claimed about 60,000 cases, most actively making phone calls. The total amount of medical treatment totaled ₩1.28 million, of which the total amount of clinics was ₩736.7 million. The MFDS has compiled and released claims for a month and a half from February 24 to the 12th of this month when infectious diseases were most prevalent for phone consultations and prescriptions for medical institutions that are in limited use to prevent the spread of COVID-19. This count is also interlocked with pharmacy drug proxy receipt, which was allowed at the same time as telephone consultations and prescriptions, so it is meaningful as an objective data for pharmacies to indirectly measure billing flow, location, and trends. First, the number of medical institutions that conducted phone consultations and prescriptions in the past month and a half was 3072, and a total of 103,998 cases were charged as related examination fees. In other words, 33.9 cases per agency that conducted telephone consultations and prescriptions during this period. The total amount of medical bills they charged was ₩1,288,127,000, which is about ₩419,000 per institution, which is a bill for phone in counseling and prescriptions. Looking at each type, both the number of claims and the size of medical expenses were by far the most overwhelmingly high in clinics. It is analyzed that phone in counseling and prescriptions are mainly focused on the elderly and chronic patients. During the month and a half, 2,231 clinics participated, claiming 59,944 cases, and the scale was about ₩736,792,000. Subsequently, 109 general hospitals claimed 2,522 phone in consultations and prescriptions for reimbursed cost of ₩274,707,000. It was found that 275 hospitals were implemented at a total of 1,493 cases and claimed at a scale of 1,673.4 million won. Subsequently, 14 senior hospitals participated and claimed 2,858 cases. The total amount was calculated as ₩43,551,000, which was similar to the nursing homes’ medical fee of ₩38,186,000. On the other hand, this count reflects only the data requested by the medical institution, and may differ from the actual number of cases due to the different billing time and consultation time. The Ministry of Health and Welfare explained that in the future, the number of medical institutions could change when they request additional examination fees.
- Policy
- Futhan, clinical trial of COVID-19 pneumonia treatment
- by Lee, Tak-Sun Apr 21, 2020 06:26am
- Futan (Nafamostat mesylate, SK Chemicals), which is used as an anticoagulant for hemodialysis patients and patients with acute pancreatitis, begins clinical trials in patients with COVID-19 pneumonia. The MFDS approved Sponsor-Investigator Trials on the treatment effect of Futhan's COVID-19 pneumonia patients submitted by Gyeongsang National University Hospital on the 17th. This clinical trial will be conducted at 84 patients with COVID-19 pneumonia at Gyeongsang National University Hospital, Kyungpook National University Hospital, Dankook University Cheonan Affiliated Hospital, Pusan National University Hospital, Seoul Medical Center, and Yangsan Pusan National University Hospital. This is a randomized, open trial for the analysis of treatment effects. Futan is a product obtained by SK Chemicals in June 2004, and currently has 15 items with the same ingredients.
- Policy
- MOHW to consider HIPDC meeting after stabilizing outbreak
- by Kim, Jung-Ju Apr 21, 2020 06:26am
- Yoon Tae-ho, Overall Officer of Disinfection (Director of Public Health Policy Bureau at MOHW) at Central Disaster Management Headquarters, is giving a regular online COVID-19 briefing at the Government Complex. The Korean government has announced major vis-à-vis meetings like Health Insurance Policy Deliberation Committee (HIPDC) would be scheduled after the COVID-19 outbreak is better contained. Although international experts view the COVID-19 curve in Korea has been bent, the government has not halted its effort to control the outbreak in fear of seasonal variables. Yoon Tae-ho, Overall Officer of Disinfection (Director of Public Health Policy Bureau at Ministry of Health and Welfare (MOHW)) at Central Disaster Management Headquarters, answered media’s questions after convening a video conference for the COVID-19 Central Disaster and Safety Countermeasures Headquarters (CDSCH) on Apr. 17. Officer Yoon said, “The government is prioritizing the order of healthcare policy execution as simultaneous execution is unfeasible at the moment,” and he explained the biggest reason is the ministry’s human resources preoccupied by the infectious disease control. According to the health ministry official, approximately 40 percent of the ministry officers are responding against COVID-19 outbreak. And with the officers working from home, normalizing policy execution was impossible for months. Sources predict the rescheduling of HIPDC meeting would be considered after the government makes an official announcement of stabilized COVID-19 outbreak state and alleviating social distancing. Officer Yoon supported the prediction by stating “The vis-à-vis HIPDC meeting would be rescheduled only after the situation is considered contained.” Regarding the prioritized order of policies, the officer explained “The ministry would prioritize policies closely related to healthcare institute operation and the people’s daily life as operating MOHW, human resource and the Central Disaster Management Headquarters would center on social distancing.” However, the officer also stressed COVID-19 policies does not only respond against the outbreak, but also affect the safe use of healthcare institute for general patients, because they are naturally related to safe medical practice policies, such as healthcare institute policy and support plan, emergency room support and designation of tertiary hospital.
- Policy
- Pan-government working group for COVID-19 was established
- by Kim, Jung-Ju Apr 21, 2020 06:26am
- Pan-government working group for the development of treatments and vaccines for COVID-19, a public-private joint government presided over by the President, was established. In the future, the Working Group plans to serve not only for R&D, but also for full-time support such as production, national stockpiling, and the use of a quarantine site. On the 17th, the government announced that it had formed a joint public-private joint government support group to provide rapid results by intensively supporting the development of COVID-19 treatments and vaccines through a joint meeting of industry, academia, research, and hospitals presided over by the president on the 9th. The support group is co-directed by the Minister of Health and Welfare and the Minister of Science, ICT and Future Planning, and Deputy Minister of related ministries, the Head of the KCDC, the Director of the MFDS, and the private experts participate. The Pan-Government Working Group analyzes the situation throughout the entire cycle and identifies issues in the field, including COVID-19 treatments, vaccines, R&D, production, national stockpiling, and use of quarantine sites, and prepare a support plan. The Working Group is co-chaired by the Director of the Korea National Institute of Health & Head of R & D Policy of the Science, ICT and Future Planning. In addition, a general subdivision consisting of each division head and the heads of related ministries is operated. The Working Group will hold the first meeting at 8 am today (17th) at the Korea Press Center (Maehwa Hall) as the co-host of the Director of the Korea National Institute of Health and Head of R&D Policy of the Science, ICT and Future Planning. The current status of domestic and foreign COVID-19 treatment, vaccine research and development, and the supply and demand of quarantine products and devices will be reviewed, and the role of the working group to quickly discuss ways to resolve difficulties in the field and plans to support related ministries will be discussed. In particular, the government will prepare a roadmap for the development of COVID-19 treatments and vaccines that contains the government's R&D investment in promising items for COVID-19 treatments and vaccines in Korea, supporting periodic R&D from basic research to commercialization, and plans to improve regulations on licensing and commercialization. According to the Ministry of Health and Welfare, it is planning to discover detailed agendas through regular and intensive discussions on a weekly basis by three divisions (therapeutics, vaccines, quarantine products and devices) under the Working Group. In addition, it is planning to provide professional consulting to quickly resolve the difficulties of domestic therapeutic and vaccine development companies in connection with the 'Company Grievance Relief Support Center (the Korea Health Industry Development Institute)' to be installed under the government support group. In addition, the Ministry of Health and Welfare explained that it will cooperate with each other in the search for solutions to scientific and technological difficulties through the “research and development support council” consisting of government-funded research institutes, universities, and so on. The Joint Promotion Director said that in order to completely overcome Corona 19, early development of therapeutic drugs and vaccines, and proper distribution of quarantine products and devices are essential. He also said that the Working Group would support the pan-government support group and play an active role in identifying and implementing practical improvement measures and solutions based on major issues.
- Policy
- The NHIS agreed the drug price negotiation rate to 95.5%.
- by Lee, Hye-Kyung Apr 20, 2020 06:30am
- The NHIS last year negotiated drug prices on 176 items, including new drugs. Of these, 96.5%, 168 items, completed the drug price negotiations, and 8 items had to be broken. Looking at the current status of the NHIS, which Dailypharm confirmed on the 7th, has negotiated the drug price in the past 6 years, a total of 870 drug price negotiations have been introduced since 2014. Among them, 840 items were negotiated, and 30 items were broken. In the NHIS' reimbursement strategy division, the Drug Price Negotiation Department, the Drug Price Post-Management Department, and the Drug Price Department are in charge of negotiating six items such as new drugs, risk-sharing (RSA) contracts, expected claims, expanded scope of use, and Price-Volume Agreement (PVA). The price of the new drug is negotiated between the NHIS and the pharmaceutical companies and it is listed after the Health Insurance Policy Deliberative Committee. Some IMDs and generic drugs omit drug price negotiations and are decided based on calculation standards. On December 29, 2006, as part of the plan to optimize drug costs, the health insurance listing method of medicines was changed to a positive method, and the NHIS is negotiating drug prices. In the case of last year's drug price negotiations, 56 items increased compared to 2018, which was analyzed because the price of eye drops was reduced due to PVA (Price-Volume Agreement).
- Policy
- Strong sanctions, to expel drugs through re-evaluation
- by Lee, Hye-Kyung Apr 17, 2020 06:22am
- It was suggested that strong sanctions to ban prescriptions as a way to expel drugs that have not been proven safe and effective through re-evaluation of benefits. It is necessary to take effective administrative measures beyond the preparation of a plan for drug withdrawal by the Minister of Health and Welfare, based on the National Health Insurance Act. This opinion was presented through the 'Research plan to improve the re-evaluation of preliminary benefits (Researcher Kwon Yong-jin, Seoul National University Public Health and Medical Center)', which was conducted as an external research service for the Health Insurance Review and Assessment Service. Currently, the withdrawal of drugs is possible through the disposition of the Minister of Health and Welfare's reimbursed list deletion based on Article 13 of the Rules on National Health Insurance Benefits Standards. However, the research team pointed out that, in the case of reimbursed list deletion, it is not a strong sanction means because the medical institution can arbitrarily delete the benefit of the benefit to the patient as non-reimbursement. As a result, it was said that for effective administrative measures, it could be considered to indirectly impose prohibition obligations through disposition of unfair profit or disposition of business suspension to medical institutions that is acting as an evacuation plan. However, according to Article 12 of the Medical Act, the implementation of medical technology by medical personnel cannot be interfered with unless there is a restriction by law. He added that there should be clear regulations as a law to impose prohibition obligations on medical personnel or medical institutions while devising plan after reevaluating benefits. Meanwhile, this study was conducted to prepare a plan to improve laws related to the preliminary benefit policy included in the health insurance coverage expansion policy (Moon Jae-in Care) announced by the government in August 2017. The Positive list system is a policy that aims to put the targets that appear to be close to non-payment rather than cost-effectively into the framework of the reimbursement first, if the provisions are to be differentiated before the change of wages for a specific item. In the case of the screening benefit, the ratio of copayment is 50%, 80%, but in the preliminary benefit, the ratio is further subdivided into 50%, 80%, and 90%, and drugs are included. In the case of drugs, clinical usefulness (therapeutic effectiveness), cost effectiveness, replaceability, and social needs were comprehensively evaluated to determine the application rate and self-pay rate. The research team said, "The basic purpose of re-evaluating Preliminary Reimbursement is to determine whether the reimbursement standards are met or not satisfied, and to determine the maintenance of reimbursement, preliminary reimbursement, and the suspension of benefits. And it can be used as a basis for price renegotiation to minimize the impact on insurance finance."
- Policy
- Domestic vaccine for COVID-19 developed within 2 years
- by Kim, Jung-Ju Apr 17, 2020 06:21am
- Taeho Yoon, the head of the quarantine, the Central Emergency Government Headquarters of the Ministry of Health and Welfare is conducting a regular briefing of COVID-19 at the government building as an online live broadcastThe government will immediately implement measures to support for the development of COVID-19 treatment and vaccines. The goal is to release antibody drugs as early as next year, blood plasma treatment within 2-3 months, and vaccines within 2 years. Tae-ho Yoon, the head of the quarantine, the Central Emergency Government Headquarters of the Ministry of Health and Welfare, today, on the morning of the 14th, said through a press after the video conference of COVID-19 Central Disaster Safety Countermeasures Headquarters. At this meeting, the progress of COVID-19 treatment and vaccine development and future plans were discussed. The government said that it was preparing a government support system to develop anti-corrosive drugs and vaccines to overcome COVID-19. In the case of therapeutic drugs, the government is ▲rapidly supporting drug re-creation clinical trials by expanding the range of use of existing drugs to develop drugs that can be treated within the year, and ▲is pursuing the development of antibody drugs and blood device drugs using confirmed patient’s blood. Antibody drugs are being jointly researched by the Korea National Institute of Health & Celltrion, and are expected to be available as early as next year with the goal of entering clinical trials this year. Blood plasma treatment is also under joint research with a domestic company, and if a large amount of blood is secured, the Central Disaster Safety Countermeasures Headquarters expects to develop a therapeutic agent within 2-3 months. In the field of vaccine development, there is a development gap of about 6 months with the United States, but various platform vaccine researches are under way to develop domestic vaccines in the second half of 2021 or 2022 through public-private cooperation and international cooperation research. Vaccines are synthetic antigen vaccines, nucleic acid (DNA) vaccines, and virus delivery (mRNA) vaccines. The government will continue to ▲streamline the provision of blood for cured people, ▲rationalize the application of regulations such as exemption from institutional IRB ▲expand investment in infectious diseases R&D to discover promising tasks, and study the possibility of virus mutations against resurgence ▲build a platform to discover candidates for AI-based treatment ▲the Public Vaccine Development Center ( Completion of this October), expansion of research infrastructure such as the vaccine commercialization project team ▲support for strengthening international cooperation in infectious disease research. Along with this, the government has a support system for the development of COVID-19 treatment and vaccine development system and is operating immediately. Taeho Yoon, the head of the quarantine said that as mentioned by the President, therapeutic drugs and vaccines are a must to overcome in order to completely overcome COVID-19, and plans to establish the government support system so that treatment and vaccine development can succeed early, and provide policy and institutional intensive support. The Minister of Health and Welfare and the Minister of Science and ICT are co-directors, and the 'Corporate Support Group' for COVID-19 treatment and vaccine development is established. ▲Domestic COVID-19 treatment and vaccine development status is checked and ▲Support measures are identified by identifying difficulties in the field. "The government will quickly establish a working group with related ministries and industry, academia, research institutes and hospitals to support the pan-government support group," said Yoon, the head of the quarantine.
- Policy
- Exemption of some in vivo tests when developing COVID-19
- by Lee, Tak-Sun Apr 14, 2020 06:12am
- The MFDS decided to exempt in vivo tests on some of the formulations for rapid clinical entry of COVID-19 treatments. In order to enter the clinical trial, in vitro and in vivo studies should be completed and reviewed, but in some formulations, such as antiviral drugs, in vivo studies can be replaced with existing test results. According to the industry on the 12th, the MFDS recently released a guideline on Considerations in Developing COVID-19 treatment. The MFDS provided the current position of the MFDS based on discussions conducted over the past two months to minimize trial and error by developers. and it is expected that the entry of clinical trials will provide opportunities for new drugs to work. According to the main contents of the guideline, in vivo testing is conducted in an animal model infected with COVID-19, but considering that the mechanism of action of the drug to be developed is applicable to various viruses, if it is determined that it can be applied to various viruses, In vivo test data using a viral infection animal model is accepted. For example, in the case of a drug that has already been approved and used as an antiviral agent, it is possible to enter the COVID-19 clinical trial based on in vivo test data, clinical trial data, and post-marketing experience submitted at the time of approval. However, in the case of drugs that have not been demonstrated for antiviral activity, in vivo test data using a virus-infected animal model should be secured. The Ministry of Food and Drug Safety presented examples of non-clinical trials of Remdesivir, which is conducting commercial clinical trials of COVID-19 for reference. In the case of anti-inflammatory drugs, data from animal models of virus infections other than COVID-19 are allowed, although it does not limit the type of virus, it is explained that the test results of similar viruses (influenza virus causing respiratory infection, respiratory syncytial virus (RSV), etc.) when the target organ is infected may be considered. The MFDS added that double-blind, randomized, placebo-controlled, and parallel-group trials should be considered as considerations when designing a clinical trial. This is because the current clinical trial of COVID-19 is the first dose of clinical trial drug to the patient, and the nature of the exploratory clinical trial is strong. The Ministry of Food and Drug Safety said that it would reflect relevant information if necessary after hearing opinions from various fields on the guidelines. As the Ministry of Food and Drugs exempts some data, opportunities will increase for companies seeking clinical entry as a COVID-19 treatment.
- Policy
- Saxenda's upgraded injection (once a week) will be imminent
- by Lee, Tak-Sun Apr 14, 2020 06:11am
- Saxenda by NovonordiskSaxenda's upgraded version of the drug, which is causing a sensation in the domestic obesity treatment market, is predicting clinical trials in Korea, attracting attention. It was Ozempic (Semaglutide), which improved the convenience of administration by injection once a week. The MFDS approved IND for Semaglutide applied by Novonordisk on the 8th. The clinical trial is conducted to evaluate the efficacy and safety of Semaglutide 2.4 mg once weekly for weight management in overweight or obese subjects. This is a Phase IIIa, multinational clinical trial. Semaglutide has already been approved for clinical trials in Korea in 2018 as an indication for obesity. At the time, it was conducted on subjects in East Asia who were overweight or obese, and 40 of the 400 subjects were known to be domestic patients. The approved clinical trial seems to be proceeding with an increased dose compared to the previous clinical trial. Ozempic 0.4 mg showed a reduction effect of 13.8% in phase II clinical trials for 52 weeks, suggesting a possibility as a treatment for obesity. Ozempic, which received FDA approval for diabetes treatment in 2017, has not yet been approved for marketing in Korea. Currently, GLP-1 analogue, Saxenda (Liraglutide) are creating a sensation in the domestic obesity treatment market, raising expectations for Ozempic in domestic market. Released in March 2018, Saxenda recorded sales of ₩42.6 billion (IQVIA) last year, creating a sensation of the domestic obesity treatment market. The GLP-1 analogue drug has a mechanism of regulating appetite by reducing hunger and increasing satiety by passing the hormone GLP-1 secreted by the body into the hypothalamus of the brain upon food intake. Saxenda is a once-a-day self-injection, but Ozempic is evaluated as a convenience upgrade once a week.
- Policy
- The government, cuts health insurance premiums by 50%
- by Kim, Jung-Ju Apr 14, 2020 06:11am
- The government has decided to temporarily cut down some health insurance premiums to alleviate the economic damage of low-income and small business owners. The Ministry of Health and Welfare (Minister Park Neung-hoo) announced on the 10th that from March to May, it would reduce (30-50%) the health insurance premiums of the bottom 50% in special disaster areas and the bottom 40% in all other nationwide areas. This was in response to the announcement of the 3rd emergency economic conference announced on the 30th of the same month, with revised supplementary budget of ₩265.6 billion to support the health insurance premiums for vulnerable groups such as low-income and small business owners who suffer severe economic damage due to the recent COVID-19. On the 9th, the government revised and issued the 'Notice of Eligible Persons to Reduce Health Insurance Premiums'. Subject to the revised notice, the subjects will be reduced health insurance premiums from March to May this year, and the reductions in health insurance premiums already paid in March will be retroactively supported in April. The bottom 50% in the special disaster area is reduced by 50% of the health insurance premium, the bottom 20% in all other areas are reduced by 50% of the health insurance premium , and from the excess of the bottom 20% to 40% are reduced 30% of the health insurance premium. Through this support, the government provided a total of ₩91,559 health insurance premiums per person per month over 3 months, including 700,000 people in special disaster areas (400,000 in workplaces, 330,000 in regions), and 10.89 million in other regions (6.6 million in workplaces and 4.24 million in regions). Subjects are selected by the NHIS based on the health insurance premiums of the month without any separate application process. The MOHW and the Health and the NHIS will send a notice to the targeted people from the 13th to the 17th, so that the public can know if they are eligible, and will send out the 22nd and 25th of the April health insurance bill with a retroactive reduction in March.
