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- 2025-12-24 02:57:07
- Policy
- Will special imports be applied for vaccine introduction?
- by Lee, Tak-Sun Dec 15, 2020 06:04am
- Public opinion is growing as the number of COVID-19 confirmed cases is recording the highest every day, and the FDA also urgently approves Pfizer's mRNA-based COVID-19 vaccine following the first vaccination in the UK. Some criticized Korea for failing to preemptively secure a vaccine unlike other advanced countries. It takes some time to get official approval, so it is analyzed that it may be a special import like the last COVID-19 treatment Remdesivir. On the 14th, the Commissioner of KDCA, Jeong Eun-kyeong, at a briefing on the outbreak of COVID-19 in Korea, said, “We are continuing to introduce vaccines developed overseas. We are in consultation with pharmaceutical companies about the amount of additional supplies other than the already secured for 44 million people.” In addition, "At least two or more are currently reviewing and discussing the contract with the goal of completing the contract by the end of the year. It is expected that the supply will be the fastest since AstraZeneca vaccine is produced in Korea, and other vaccines are still negotiating with regard to delivery timing." The total amount of COVID-19 vaccines that the government said to have secured so far is for 44 million people. The COVAX Facility provided for 14 million people, AstraZeneca, Pfizer, and Modena provided for 10 million people, respectively, and Janssen provided for 4 million people. And, Kovax Facility and AstraZeneca have completed the contract. The government is planning to introduce COVID-19 vaccine with the aim of vaccinating next March as soon as possible. It takes too little time to get official approval in Korea. In the case of the AstraZeneca vaccine, which has been contracted with the government, the MFDS is undergoing an expedited review process, but the phase III clinical trial has not been completed. The MFDS plans to complete the approval within 40 days as soon as possible, but considering the release of the national lot, it must apply for a permit in January at the latest. Currently, it is not known when the clinical trials of the AstraZeneca vaccine will end. That is why the Korean government will find a way to use it before formal approval, which takes time, as the US and UK have urgently approved the vaccine. It means that we have no choice but to use the special import system. Special import is a system in which the head of the MFDS imports drugs that are not approved in Korea through importers in order to cope with a public health crisis situation such as an infectious disease pandemic. In June, COVID-19 treatment, Remdesivir was introduced in Korea through this system. At that time, the KCDC (currently The KDCA) requested special import from the MFDS according to the Clinical Committee for New Infectious Diseases proposal, and the MFDS received special import for Remdesivir after deliberation by the National Essential Medicines Stable Supply Council (Disease Management Subcommittee). Decided. It took only 4 days from the request of the KCDC to the decision. It is also the fastest way to introduce the COVID-19 vaccine in Korea. The MFDS can also relieve the burden of expedited screening if it is first introduced through special import and then a formal permit review is conducted. In the case of Remdesivir, it has been granted a conditional permission for Phase III within about 50 days after the decision of special import. The MFDS official also said, "The way to get emergency approval like the United States or the United Kingdom is to go through the special import procedure," he said. "But there must be a request from the KCDA." However, as the special import has not been officially reviewed, it is expected to refer to the approval of advanced overseas regulatory agencies. For example, the US FDA, European EMA, or WHO approval is likely to be the standard. The first AstraZeneca vaccine, which is likely to be introduced, can be referred to other developed countries or WHO approval, even if FDA approval is late. Vaccines by Pfizer and Moderna have not yet been contracted, and the supply timing is uncertain, so it is expected that it will be difficult to request special imports from Korea even if the UK or the US has approved them.
- Policy
- MOHW “Not to worry vaccine shortage, delay and safety”
- by Lee, Jeong-Hwan Dec 15, 2020 06:03am
- The South Korea’s Ministry of Health and Welfare (MOHW) official says the concerns about the shortage or delay in COVID-19 vaccine distribution or AstraZeneca vaccine’s safety issue would be unnecessary. The official claimed the government has already secured vaccine doses for total 44 million people through COVAX Facility and private partnership, which would mean no problem in nationwide vaccination with additional vaccine dose procurement and pre-order deals with Pfizer and Moderna’s vaccines. The ministry official also said the detailed vaccination schedule would be decided flexibly after the introduction of the vaccines in February through March next year, considering the overseas vaccination update, adverse reaction report and demand by the people. MOHW provided the said explanation for the recent news coverage on delayed vaccine distribution and vaccination, and the safety issues. The ministry also refuted the news articles reporting the government has only signed contract with AstraZeneca for the vaccine, and elaborated the terms of purchase and the supply confirmation letter have legal binding as effective as a purchase contract. The South Korean government has only inked the contract with AstraZeneca, but they also confirmed with other pharmaceutical companies to supply their vaccine to the country, which apparently hold liability as much as an official contract. And the government plans to sufficiently secure vaccine doses for everyone in South Korea by pre-ordering doses for 44 million people through COVAX Facility and private partnership, and then seeking more doses for the rest of the population according to the situation. On the news coverage claiming ‘the vaccine supply falling short’ and ‘Pfizer and Moderna depleted vaccine doses leaving nothing for South Korea,’ MOHW official assured the AstraZeneca vaccine manufactured by a South Korea-based SK Bioscience would be released gradually. The official added the vaccine distribution plan by the pharmaceutical companies with the pre-order deals is still unchanged. Also they commented on the public’s concern about the vaccination initiating only around the second half of next year and said the vaccination in South Korea would begin gradually from February through March and further schedule would be decided flexibly. The government aims to adjust the vaccination timing depending on the COVID-19 cases in the country, vaccination update around the world and the public demand. Regarding the U.S. Food and Drug Administration (FDA) skeptical about AstraZeneca vaccine and related safety issues, the ministry explained no approval by the U.S. FDA does not necessarily mean no approval in South Korea. The use of the vaccine in South Korea would be green lit when the Ministry of Food and Drug Safety (MFDS) reviews efficacy and safety and approves of it. MOHW official stated, “MFDS has already started the preliminary review on the vaccine efficacy and safety from October. Safe and effective vaccine would be provided after the thorough review.”
- Policy
- The vaccination fee for COVID-19 will be free
- by Kang, Shin-Kook Dec 14, 2020 05:57am
- Sohn Young-rae, Head of the planning teamThe vaccination fee is free in principle, and the elderly and medical staff will be given priority. IT starts from February to March next year as early as possible. The inoculation rate of 60-70% for the nation to become immune is expected to reach the second half of next year. Young-Rae Son, Central Disaster Management Headquarters' planning team (spokesperson of the MOHW) explained the vaccine supply plan on CBS radio’s Kim Hyun-jung's NEWS SHOW on the 9th. Vaccine prices vary by pharmaceutical company. Pfizer vaccine costs ₩43,000 per 2 doses, Modena vaccine costs ₩80,000, AstraZeneca vaccine costs ₩8,700, and Janssen vaccine costs ₩19,000. In response, he said, "the government is considering a plan to provide the vaccine itself for free. The total price of vaccination is the price of the vaccine itself and the cost of inoculation at medical institutions." He said, "Currently, the vaccine priorities that other countries are taking, or the priorities that experts say are roughly the health workers, starting with the elderly, with the highest fatality rate of COVID-19." He made it clear that the government will be responsible for any side effects of the vaccine. He said, "Because COVID-19 vaccination is part of national policy, the government will also compensate for side effects."
- Policy
- HIRA green lit coverage on 14 out of 26 new drugs
- by Lee, Hye-Kyung Dec 10, 2020 06:11am
- 14 out of 26 new drugs deliberated by the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) were listed for the healthcare reimbursement. To this date, the DREC has listing rate of 53.8%, but it could get higher as there are new drugs, cleared by DREC during the 10th meeting convened in October, that are currently either negotiating the pricing with NHIS or waiting for it. On Dec. 9, Daily Pharm analyzed new drugs deliberated and decided by DREC in its 12 meeting held in 2020. The analysis found total 13 out of 26 new drugs that passed the reimbursement feasibility review were listed for reimbursement. Only two drugs—Kowa Company’s Granatec Eye drops 0.4% (ripasudil hydrochloride hydrate) and Daewoong Pharmaceutical’s Fiblast spray (trafermin)—could not pass through the DREC’s threshold, as they were labeled ‘non-reimbursements.’ An item is decided as a non-reimbursement, when clinical efficacy and cost-effectiveness are relatively ambiguous. The non-reimbursement can reapply for the reimbursement and wait for DREC to deliberate the item after the evaluation on newly submitted cost-effectiveness evidence. And other 11 drugs would be listed if the company accepts pricing lower than the evaluated price as they would cost more than their alternative options, regardless of the clinically proven efficacy. When a pharmaceutical company accepts to take the pricing lower than DREC-evaluated adequate reimbursed pricing, the applicant drug can receive the reimbursement. Until a few years ago, such case was labeled as ‘conditional non-reimbursement’ or coverage with evidence development. Four drugs that accepted HIRA’s evaluated pricing and received the reimbursement include Merk’s Maven Clad Tablet (cladribine), Ferring Pharmaceuticals Korea’s Rekovelle Prefilled Pen (follitropin delta), SK Chemicals’ Ongentis Capsule 50 mg (opicapone) and Novartis Korea’s Kisqali tablet 200 mg (ribociclib). Dae Hwa Pharmaceutical’s Liporaxel and Bukwang Pharmaceutical’s Navelbine capsule (vinorelbine tartrate) were not listed as they refused to accept HIRA’s evaluated pricing. Eisai Korea’s Equfina Film Coated Tablet (safinamide mesilate) and JW Pharmaceutical’s Ferrinject (Ferric hydroxide carboxymaltose complex) DREC passed in October, and Takeda Pharmaceuticals Korea’s Ninlaro capsule (ixazomib citrate) green lit in November would be listed for pharmaceutical reimbursement next year if they reach agreement with the National Health Insurance Service (NHIS) in drug pricing negotiation within 60 days. From October through December, DREC granted coverage with evidence development on Santen Pharmaceutical Korea’s Eybelis Eye drops 0.002% (omidenepag isopropyl), Roche Korea’s Xofluza tablet 40 mg (baloxavir marboxil), Novartis Korea’s Beovu Injection and Pre-filled Syringe (brolucizumab), Novo Nordisk Pharma Korea’s Xultophy FlexTouch Injection (insulin degludec/ liraglutide) and CSL Behring Korea’s Afstyla injection (lonoctocog alfa). When these companies accept the pricing lower than the HIRA-evaluated pricing, they can initiate the negotiation on the projected reimbursement claim with NHIS.
- Policy
- Secured COVID-19 vaccines for 44 million people
- by Lee, Tak-Sun Dec 10, 2020 06:09am
- The government announced that it has secured up to COVID-19 vaccines for 44 million people AstraZeneca, a global pharmaceutical company, has already signed a contract to supply 10 million vaccines (20 million doses), and Pfizer and Modena announced that they have signed a binding purchase agreement with 10 million doses (20 million doses) respectively. The remaining doses will be filled with COVAX Facility (about 10 million people) and 4 million Janssen vaccines. The government announced that it had deliberated and decided on a plan to secure a vaccine developed overseas for COVID-19 and discussed vaccination plans at a cabinet meeting presided over by the Prime Minister on Tuesday. Through the meeting, the government announced that it will pre-purchase overseas vaccines for up to 44 million people through COVAX Facility (for about 10 million people) and global vaccine companies (for about 34 million people). With the goal of equally supplying vaccines up to 20% of the population by the end of 2021, COVAX Facility is focused on the World Health Organization (WHO), Coalition for Epidemic Preparedness Innovations (CEPI, vaccine development), and Global Vaccine Alliance (GAVI, vaccine supply). It is a multinational coalition that is being promoted. At a meeting of experts in introducing vaccines, it was recommended to secure AZ, Pfizer, Modena, and Janssen vaccines The government has formed Vaccine Introduction Special Team (TF) composed of relevant ministries and private experts from the end of June to secure vaccines quickly, and from July to global companies leading vaccine development such as Pfizer and AstraZeneca. On September 15th, it was decided to first secure a vaccine that can inoculate 60% of the people (about 30 million people) through participation in COVAX Facility and negotiations with individual companies as a first step through a state council meeting. It is explained that the government has been reviewing the supply conditions, safety and effectiveness of each company with private experts, and has carefully negotiated to secure a vaccine with good safety, effectiveness and high probability of success. The government decided to pre-purchase more vaccines than vaccines that can be inoculated by 60% of the population, taking into account the possibility of failure of the developed vaccine after discussing experts in the field of vaccines, and proceeding with the procedure for signing a contract for pre-purchase with global companies. The committee recommended securing all vaccines from four companies: AstraZeneca, Pfizer, Modena, and Janssen. Accordingly, the government first purchases up to 64 million doses (for 32 million people) of vaccine through global pharmaceutical companies. The government pre-purchases 20 million AstraZeneca batches, 20 million Pfizer batches, 4 million Janssen batches, and 20 million batches by pharmaceutical companies. The government announced that AstraZeneca had already signed a pre-purchase contract, and the rest of the companies also signed binding terms and conditions, and confirmed purchase quantities, and the remaining contract procedures will be expedited. It explained that the pre-purchased vaccine will be introduced in stages from the first quarter of 2021 (February and March), and it will closely monitor the development trend of subsequent vaccine development in the future, and will actively secure additional quantities required. The government explained that it has secured a budget of about ₩1.3 trillion, including ₩172.3 billion for transfer and exclusive use of the 2020 budget for advance payment of vaccines and purchase of vaccines, for the fourth additional ₩183.9 billion, and ₩900 billion for reserves in 2021. ₩85 billion of ₩172.3 billion is previously executed as an advance payment for joining the COVAX Facility. Establishment of COVID-19 Vaccination Response Promotion Team, Comprehensive consideration of vaccination timing The government said that it will prepare COVID-19 vaccination system quickly and without disruption. It was expected that there would be difficulties in the vaccination preparation process due to the storage conditions of the vaccine (Pfizer -70℃±10℃, etc.), short shelf life, two doses and various types. Regardless of the timing of vaccinations, the government plans to pursue preparations in earnest. The KDCA is promoting the establishment of a separate organization (COVID-19 Vaccination Response Promotion Team) for vaccine introduction and vaccination. Vaccine development has not yet been completed with respect to the vaccination timing, and there are still concerns about the safety and effectiveness, so it will be flexibly decided in consideration of ▲COVID-19 domestic situation ▲foreign vaccination trends and side effects ▲national demand. The government is reviewing the recommended targets for vaccination (approximately 36 million people) for the elderly, the elderly, living in group facilities, chronic diseases, etc. And it will be reviewed with relevant ministries. However, the evidence of safety and efficacy for children and adolescents is still insufficient, but the future vaccination strategy will be reviewed through continuous monitoring of clinical trial results. Minister of Health and Welfare Park Neung-hoo said, “As the vaccine is still in the pre-development stage, and there are still uncertainties about success such as side effects during the vaccination process, we will pre-purchase more than the 30 million people announced by the government for public health and safety.” He said, “As it is expected that the domestic treatment currently being developed will be commercially available as early as next year, a more robust quarantine system can be established with prevention (COVID-19 vaccine)-rapid discovery and diagnosis-early treatment.” He stressed, "As it takes a considerable amount of time to complete the vaccination against the COVID-19 vaccine, the people need to strictly follow the quarantine guidelines, such as distancing in daily life, wearing masks, and refraining from going out."
- Policy
- Clinical data for COVID-19 vaccine will be submitted soon
- by Lee, Tak-Sun Dec 09, 2020 05:56am
- Park Neung-hoo, Minister of Health and Welfare Minister of Health and Welfare Park Neung-hoo said that AstraZeneca will soon submit clinical trial data for COVID-19 vaccine to the MFDS. On the morning of the 8th, the government announced that it has signed a purchase contract with AstraZeneca for 10 million COVID-19 vaccines. In a press briefing after the announcement, Minister Park said, "I think that the final clinical results will be submitted to the MFDS in the near future, in the next week or so." "It was mentioned in recent consultations with the government and the delegation of AstraZeneca," he said. Yang Jin-young, deputy head of the MFDS, said, "COVID-19 vaccince by AstraZeneca has been pre-screened since last October and is currently undergoing non-clinical screening." He said that companies other than AstraZeneca have not yet requested a preliminary review. Contrary to some concerns, it was also said that the side effects of AstraZeneca's vaccine were not significant. Professor Nam Jae-hwan of Catholic University said, "Not only the AstraZeneca vaccine is particularly dangerous, all vaccines have side effects, and it turned out that the side effects from AstraZeneca in particular were not so serious side effects." Prof. Nam added, "I personally think that purchasing the AstraZeneca vaccine first from the government was a very good strategic decision." COVID-19 vaccine developed by AstraZeneca is commissioned and produced by SK Bioscience, a domestic pharmaceutical company. The government explained that the domestic production of AstraZeneca vaccine, which will be introduced in stages in the first quarter of next year. The expert advisory committee also announced that it has selected AstraZeneca vaccine first in consideration of the advantages and safety of domestic production. However, the government-purchased COVID-19 vaccine manufacturers are claiming an exemption that they will not be held liable for side effects, thus raising concerns about unfair contracts. In response, Minister Park said, " It is a common phenomenon worldwide although there is an unfair contract, so it is a little difficult to avoid or reject only us." He said, "We will ensure safety through sufficient validation tests even if such a contract is signed and a vaccine is introduced."
- Policy
- Drug price negotiation agreement by NHIS is 97.9%
- by Lee, Hye-Kyung Dec 08, 2020 06:12am
- 285 items (97.9%) completed drug price negotiations. Dailypharm reviewed the current status of drug price negotiations on December 29, 2006, after the last health insurance registration method was switched to the positive list system as part of a plan to optimize drug costs. Negotiations were completed for 1,924 items out of a total of 1972 negotiations that were received from 2007 to the end of November this year. Of these, 1,786 items were agreed on a contract, and the average agreement rate was 92.8%. The Drug Price Negotiation Department, Drug Price Post Management Department, Drug Price System Improvement Department, and Generic Negotiation Management Department are in charge of negotiations for 7 items, including new drugs, risk-sharing drugs (RSA) renewal, expected billing amount, expansion of scope of use, usage-drug price linkage (PAV), generics, etc. The price of new drugs is registered in health insurance through negotiations between the NHIS and pharmaceutical companies and a resolution by the MOHW's Health Insurance Policy Deliberation Committee, and some incrementally modified drugs and generics are determined according to the calculation criteria without drug price negotiation. This year, there were drug price negotiations for 316 items, and negotiations for 285 items (97.9%) were completed. The remaining 6 items (2.1%) were broken. There are currently 16 drug price negotiations underway, and 9 items this year have not reached an agreement.
- Policy
- Xultophy Flex Touch pen·Afstyla can be reimbursed
- by Lee, Hye-Kyung Dec 08, 2020 06:11am
- Novo Nordisk's Xultophy Flex Touch pen (Insulin Degludec and Liraglutide) and CSL Behring's Afstyla (Antihemophilic Factor) were set higher in the amount applied by pharmaceutical companies compared to the adequacy evaluation of Benefits. The HIRA (President Kim Sun-min) released the results of the deliberation on the adequacy of medical treatment benefits for the drugs applied for decision deliberated by the 12th Pharmaceutical Benefits Advisory Committee in 2020. Two items, Xultophy Flex Touch pen, a treatment for improving blood sugar control in adults with type 2 diabetes, and Afstyla, a treatment for preventing and preventing bleeding in adults and children with hemophilia A, were proposed in the Pharmaceutical Benefits Advisory Committee. As a result of the evaluation of the Pharmaceutical Benefits Advisory Committee, the reimbursement was appropriate, but the amount submitted by the pharmaceutical company was determined to be expensive. These drugs are reimbursed if they receive less than the evaluation amount suggested by the HIRA. Meanwhile, the HIRA is evaluating the adequacy of reimbursement of drugs after deliberation by the Pharmaceutical Benefits Advisory Committee in accordance with Article 11-2 of the National Health Insurance Standards for Medical Care Benefits. In the event of changes in the detailed coverage range and standard items of the deliberation drug, changes in the permission details of the item requested for decision, and withdrawal of permission (cancellation), the final evaluation result may be changed.
- Policy
- Benefit redemption of α-GPC will be promoted soon
- by Lee, Hye-Kyung Dec 07, 2020 06:06am
- As the clinical re-evaluation of Choline alfoscerate is imminent, the NHIS' benefit redemption contract is expected to be pursued sooner or later. The consortium of Daewoong and Chong Kun Dang On the 1st of the month, an online briefing session for clinical reevaluation was held, and it was announced that it would recruit pharmaceutical companies to participate in the joint clinical trial of Choline alfoscerate by the 9th. The consortiums divided into degenerative and vascular in the case of mild cognitive impairment, and each investing a clinical cost of ₩9.5 billion for 54 months. It has a plan to invest about ₩10 billion in 60 months by adopting a method. Korea United Pharm recruited pharmaceutical companies to participate in the joint clinical trial of mild cognitive impairment until the 4th. As pharmaceutical companies participating in the clinical re-evaluation of Daewoong Bio and Chong Kun Dang's consortium group and United Group are confirmed within this week, the MOHW is also expected to proceed with the redemption of benefits according to the results of clinical re-evaluation. The MOHW has been reviewing a generic negotiation plan that states,'If the clinical trial fails, the entire health insurance prescription amount from the date the MFDS to conduct the clinical trial will be returned to the NHIS'. According to the Rules on the Standards for medical Benefits by the NHIS, If the Minister of Health and Welfare acknowledges that it is necessary for the stable supply of drugs that have already been notified of medical care benefits and the upper limit, it applies to the chairman of the NHIS. Negotiations may be ordered with drug manufacturers, consignment manufacturers, and importers on matters referred to in Article 11-2 (7) 4. In this case, the procedures in Article 11 (7) to (9) shall be applied mutatis mutandis. In the case of Choline alfoscerate, it is highly likely that the MOHW will issue a collective negotiation order to the NHIS during this week as the clinical usefulness re-evaluation can be included in the'etc.' in the phrase'stable supply, etc.' If the MOHW issues a negotiation order within this week, the NHIS will be able to proceed with a generic medical care benefit contract that includes reimbursement of benefits for pharmaceutical companies that have submitted a clinical re-evaluation plan as early as next week. In preparation for the failure of a clinical trial, if the approval is canceled after reevaluation or the criteria for benefits are changed, the contract will contain details such as the full refund of the benefits or the recovery of the benefits of the deleted indication. If a pharmaceutical company participating in clinical reevaluation does not comply with the NHIS' contract, it will take the procedure to delete benefits. It is stated that the procedures in Article 11, Paragraph 7 to Paragraph 9 of the Medical Benefit Standards are applied mutatis mutandis to items subject to clinical re-evaluation such as Choline alfoscerate, and thus there is a possibility of the deletion of benefits if the Minister of Welfare does not comply with the negotiation order. The NHIS predicts that if it signs a contract related to reimbursement of benefits along with clinical reevaluation of Choline alfoscerate, it can protect health insurance finances of more than ₩300 billion per year.
- Policy
- SB16 has been approved for phase III clinical trial
- by Lee, Tak-Sun Dec 07, 2020 06:06am
- Samsung Bioepis headquartersSamsung Bioepis is the first in Korea to enter Phase III clinical trial of Prolia's biosimilar, an osteoporosis treatment. The MFDS approved the Phase III clinical trial protocol for a biosimilar candidate for Prolia, SB16, which Samsung Bioepis applied on the 1st. Prolia developed by Amgen was approved in Korea in September 2014. It is the first biological agent to appear as a treatment for osteoporosis and is jointly sold by Chong Kun Dang in Korea. Based on IQVIA, sales in the first half of this year alone reached ₩34.9 billion, an increase of 102.7% from the same period last year. Samsung Bioepis started Phase I clinical trial of Prolia's biosimilar in France in October. Multinational clinical trials were conducted for global sales. Domestic development is expected to be faster than overseas with the approval of the phase III clinical trial of the MFDS.
