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- 2025-12-23 23:22:37
- Policy
- AZ and Pfizer COVID-19 vaccines to arrive on Mar. 24
- by Kim, Jung-Ju Mar 19, 2021 06:27am
- The detailed arrival schedule for the COVID-19 vaccines to be supplied this month has been finalized. When the vaccines arrive to South Korea, they would be distributed to 22 inoculation centers around the country, where the vaccines would be used to inoculate elderly citizens aged over 75, and elderly care center occupants and workers from Apr. 1. On Mar. 17, the COVID-19 Vaccination Task Force Team, led by the Korea Disease Control and Prevention Agency (KDCA) Director Jeong Eun-kyeong, has announced the vaccines by AstraZeneca and Pfizer to be used from the second quarter would be dispatched soon from Europe. The 500,000 doses of Pfizer vaccines, the South Korean health authority directly negotiated for, would arrive on Mar. 24. The vaccine has already been approved by the Ministry of Food and Drug Safety (MFDS), and it would be used for inoculation immediately after the fast-track lot release inspection. The outstanding 500,000 doses would be supplied in the last week of March. KDCA official said the vaccines are expected to be supplied to the country in April through May, but more specified dates have not been confirmed. Regarding the batch of AstraZeneca vaccines purchased through COVAX, the UNICEF told the 690,000 doses and 1.41 million doses would be dispatched on Mar. 31 and Apr. 22, respectively, from the Netherlands. Considering the customs processing in Europe and shipping take at least two to three days, the first batch would arrive early April and the latter batch would arrive late April. The COVAX-AstraZeneca vaccines are manufactured at SK Bioscience plant in Andong, South Korea, which was listed for an emergency use drug list by the WHO on Feb. 15. To distribute them consistently, the vaccines would be sent to Europe and supplied back to South Korea. The AstraZeneca vaccine has been authorized MFDS as of last Feb. 10, and the batch arriving soon would be used on occupants of nursing facility aged 65 and over, and the facility workers. Director Jeong Eun-kyeong commented, “To initiate the second-quarter inoculation plan promptly and safely, the government would put utmost care in distribution, storing and preparation for the vaccines coming to South Korea.”
- Policy
- Pfizer vaccine is recommended for seniors 65 and older
- by Lee, Jeong-Hwan Mar 19, 2021 06:27am
- It is suggested that the elderly 65 years of age or older with underlying diseases should be vaccinated with Pfizer vaccine, not AstraZeneca vaccine. Due to the risk of blood clots, some foreign countries, including Europe, have stopped vaccinating AstraZeneca vaccine. The question is whether Korea should also recommend Pfizer vaccination to elderly people. On the 17th, Rep. Jeong-sook Seo of People Power Party made such an inquiry to the MOHW and the KCDA at the plenary meeting of the Health and Welfare Committee of the National Assembly. As of the 15th, some EU countries, such as Italy, Germany, and France, have temporarily suspended AstraZeneca vaccination until the announcement of the EMA due to side effects such as blood clots. In Korea, AstraZeneca vaccination began on the 26th of last month, and more than 570,000 people received the vaccination until the 16th. Among them, 71 cases of anaphylaxis were suspected, 8 cases of serious side effects, and 16 cases of death occurred. Based on this, Rep. Jeong-sook Seo argued that Pfizer vaccination should be recommended to citizens aged 65 or older, taking into account the anxiety of the elderly and those with underlying diseases. She said, "I propose to the government authorities, including Minister Kwon Deok-cheol and Commissioner Jeong Eun Kyeong. Plan to vaccinate Pfizer vaccinations for those over 65." She explained that “the public anxiety and the logic of the health authorities coexist, but death cannot be recovered.” Commissioner Jeong Eun Kyeong announced that she would review the necessity through discussions with domestic experts along with EMA’s result of the causal relationship between AZ vaccine and blood clots. She said, “The EMA announcement was scheduled on the 18th, and we are in real-time discussions with domestic vaccine experts. The causal relationship between the side effects of thrombosis and the vaccine was not confirmed. We will review the European announcement and domestic reality to make a decision.”
- Policy
- Sovaldi's criteria for re-examination are relaxed
- by Lee, Tak-Sun Mar 18, 2021 08:26am
- Re-examination criteria of Sovaldi (Sofosbuvir) and Harvoni (Sofosbuvir-Ledipasvir) by Gilead Science Korea are relaxed. This is because the emergence of new drugs and the continuation of COVID-19 epidemic make it difficult to conduct sufficient usability surveys. Since the recently released hepatitis C treatment can be cured, the number of patients is decreasing. According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee held last month decided to reduce the number of cases in the post-marketing investigation plan of Sovaldi and Harvoni. Sovaldi and Harvoni received domestic permits in the second half of 2015, and re-examination ends in September and October of this year respectively. New drugs usually need to be investigated for a certain period of time in order to verify side effects after marketing. In the case of Sovaldi and Harvoni, conditions were imposed to conduct investigations of 3,000 patients each for 6 years. If this is violated, the marketing permission is finally canceled along with administrative disposition. The Central Pharmaceutical Affairs Review Committee concluded that it is reasonable to adjust the number of Sovaldi and Harvoni cases from 3000 to 1840 and 798. The reason is that although the number of patients has rapidly decreased due to the emergence of new drugs and the environment of COVID-19. In the minutes of the Central Pharmaceutical Affairs Review Committee meeting, a member said, "This drug is difficult to register for new subjects due to COVID-19 situation and the decrease in prescription itself as the use of other drugs increases and the number of subjects to be treated decreases.” He said, "The number of investigation cases is insufficient to confirm the incidence of abnormal cases according to the results of the investigation after overseas marketing, but it is judged that the plan revision is inevitable." He added, "We recommend that they submit a PSUR to maintain drug surveillance after the end of the post-marketing investigation." Most of the committee members concluded that it is reasonable to adjust the number of cases considering the environment of this drug. In fact, Sovaldi's market share in 2017 was 62% due to the decline in patients, and last year it was only 2%. Last year's outpatient prescription (UBIST) was only ₩900 million. Harvoni's outpatient prescription sales last year was ₩8.6 billion, down half from the initial launch. Sales of Mavyret are also declining. Mavyret's outpatient prescriptions last year were ₩32.6 billion, down 26.6% from the previous year. The Central Pharmaceutical Affairs Review Committee explained that although the use of Sovaldi and Harvoni has declined, it is still essential for the treatment of Hepatocirrhosis genotypes 2 and 3.
- Policy
- Alunbrig coverage granted for first-line lung cancer therapy
- by Lee, Hye-Kyung Mar 17, 2021 06:10am
- The South Korean health authority approved listing Takeda Pharmaceuticals’ Alunbrig (brigatinib) for treating anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) as first-line therapy, seven months after the indication expansion. The Health Insurance Review and Assessment Service (HIRA) recently published a revised notification of drug prescribed and administered to cancer patients, and it is accepting relevant public opinion until Mar. 25. Without much of objection, the revised notification would come in effect from Apr. 1. The revised version includes details of a NSCLC treatment Alunbrig and its new reimbursement, a combination therapy of Taxotere (docetaxel) for prostate cancer, selective reimbursement on Zytiga (abiraterone), and amended copayment rate in Cardioxane (dexrazoxane). ◆New coverage on first-line NSCLC treatment: First authorized for the South Korean market on Nov. 30, 20218, Alunbrig has been used to treat ALK-positive patients with advanced or metastatic NSCLC, who have been previously treated with crizotinib since April of 2019. And on Aug. 27 last year, South Korea’s Ministry of Food and Drug Safety (MFDS) granted expanded indication to treat ALK-positive patients with advanced or metastatic NSCLC as a first-line therapy, which was later listed for reimbursement. HIRA, reviewing relevant textbooks, has found the National Comprehensive Cancer Network (NCCN) guideline recommends Alunbrig as a Category 1 preferred regimen. And ultimately, HIRA approved of the first-line therapy reimbursement considering Alunbrig’s Phase III clinical trial confirming the clinical efficacy non-inferior to Alecensa (alectinib) and Zykadia (ceritinib), currently used with coverage. ◆A new combination therapy option for metastatic hormone-sensitive prostate cancer (mHSPC): So far, the Taxotere plus androgen deprivation therapy (ADT) combination therapy used for mHSPC could have been used as an off-label treatment with restricted authorization by a health authority. Also the patients had to cover the entire cost of the treatment. But as academic society requested for reimbursement expansion on the indication last year, the Cancer Deliberation Committee reviewed the off-label anticancer therapy based on post-evaluation (literature review), and decided to grant the coverage for the clinically confirmed therapy. Zytiga, approved to treat in combination with ADT the patients newly diagnosed with mHSPC, also requested for the coverage expansion, but the health authority evaluated the combination therapy is more expensive than an alternative option regardless of the confirmed clinical efficacy. However, the health authority decided to apply selective reimbursement of 30 percent, considering the benefit of proactive administration, improvement in administration convenience with oral regimen, and high social demand. ◆50 percent selective reimbursement on Cardioxane: According to the healthcare coverage enhancement policy in effect, HIRA has reviewed approving reimbursement on administering Cardioxane for extravasation or for cardiotoxicity prevention purpose in pediatric patients, currently covered 100 percent by the patients. The health authority found a textbook mentioning of using Cardioxane for anthracycline extravasation, and reducing the cardiotoxicity in pediatric patients without impeding the anthracycline treatment effect. But HIRA decided to apply 50 percent of selective reimbursement as the indication has not been authorized, yet, and there is no amendment in a treatment guideline to be reflected on the reimbursement criteria.
- Policy
- PE guideline revised for the first time in 9 years
- by Lee, Hye-Kyung Mar 17, 2021 06:10am
- The pharmacoeconomic evaluation (PE) guideline revised by South Korea’s Health Insurance Review and Assessment Service (HIRA) for the first time in nine years has been in effect from last January. The amended 2021 version of the PE guideline reflects the latest evaluation methodology, and specifies the detailed evaluation criteria based on the accumulated experiences and environment of South Korea. On last Jan. 20, HIRA (President Kim Sun-min) official announced the PE guideline was revised republished. The PE guideline explains of the criteria for PE on better effective new drug, which was first introduced by the health authority in 2006 for the positive listing system, and it was revised in December 2011 based on the domestic environment changes. The key revisions are as follow; changes in analysis perspective and discount rate; specified analysis term, methodology, subject population group, designated reference subject, cost and modeling; newly set indirectly comparison, statistical analysis, and guideline on drugs accompanied by a testing kit; and removed financial impact analysis. The analysis perspective was shifted to a perspective from healthcare system, in which the indirect medical cost (transpiration, time and etc.) was excluded from the basic analysis to generally take in account of the decision makers’ interest and to minimize the uncertainty in cost outside of the healthcare system. The discount rate was lowered from 5 percent to 4.5 percent considering the market interest rate calculated during the preliminary feasibility evaluation and the declining economic growth tendency. Beside the observation period, the analysis period was changed to confirm and inspect the uncertainty found during the process of extrapolating the long-term effect and cost, and the revised version specified the cost-utility analysis CUA is preferred as an analysis methodology. The analysis subject population group was amended to newly set a guideline on the sub-group analysis. As for designating the reference subject, the revised guideline would consider using a comparison alternative used in a clinical trial, when it is supported by quality evidence, regardless of the existing principle. Regarding the utility and health related quality of life, the guideline improved the clarification of preferring indirect measure as one of various methodologies to predict the quality of life. Also, the detailed guideline was provided for case of using formula, direct measurement and referencing other literature. The financial impact evaluation initially included was removed, although it would be included in the pharmaceutical decision application submission. Other guidelines were added for effect projection methodology and supplementary screening drug. Director Kim Ae-Ryun of Pharmaceutical Management Department at HIRA elaborated, “During the process of revising the guideline, the agency is putting much effort to hear various opinions from stakeholders, and the guideline would be revisited and revised consistently in the future.”
- Policy
- Voluntary withdrawal of benefit redemption excluding α-GPC
- by Lee, Hye-Kyung Mar 16, 2021 06:22am
- The redemption of benefits related to the drug-related 'Choline Alfoscerate', a brain function improvement agent, has been extended until April 12th. The NHIS has been negotiating benefits redemption of 230 items from 130 companies including Choline Alfoscerate in accordance with the order of the MOHW on December 14 last year. In addition to 227 Choline Alfoscerate, Alvogen Korea's Ateroid, Chodang's Mesocan 50mg, and Ajou's Aju Vesseldue-F were included in the benefit redemption negotiations. In the first round of negotiations, which took place from December 14, 2020 to February 10, 2021, about half of Choline Alfoscerate products, Ateroid, and Mesocan were decided to voluntarily withdraw. However, more than 60 Choline Alfoscerate products and Vesseldues were unable to negotiate with The NHIS, resulting in a second negotiation (~March 15). The NHIS negotiated the contents of the negotiation that was initially known in the process of the 2nd negotiation, if the clinical trial fails, pharmaceutical companies will return the entire NHIS contribution from the date of submission of the clinical plan to the date of deletion to the NHIS. They focused on finding consensus, such as making corrections. According to the pharmaceutical industry, the NHIS initially presented the redemption amount as the full amount of the NHIS charge (approximately 70% of the billed amount), and then reduced it to 50% of the final total billed amount. In the case of Vesseldue, voluntary withdrawal was decided on March 15, the date of the end of the negotiations, but in the case of the remaining 60 items of Choline Alfoscerate, negotiations for the redemption of benefits were not agreed. Therefore, the MOHW issued a third negotiation order until April 12th. In accordance with Article 11, Paragraph 7 of the Standards for Medical Care Benefits, when the NHIS chairman requests the Minister of Health and Welfare, for an additional 60 days, negotiations can be delayed or temporarily suspended.
- Policy
- Samsung Bioepis' biosimilar for Avastin was first approved
- by Lee, Tak-Sun Mar 16, 2021 06:21am
- Samsung Bioepis was the first in Korea to be licensed for the anticancer drug biosimilar for Avastin (Bevacizumab, Roche Korea). The MFDS licensed Samsung Bioepis' Onbevezy on the 11th. Onbevezy is a biosimilar for Avastin of Roche Korea. Onbevezy is the only approved biosimilar for Avastin in Korea. Like Avastin, Onbevezy is used for various cancers such as metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and cervical cancer. Last year, Avastin's domestic sales amounted to ₩118 billion based on IQVIA, ranking third. Domestic companies such as Celltrion are also developing biosimilar for Avastin.
- Policy
- COVID-19 vaccine vaccination rate has exceeded 64%
- by Kim, Jung-Ju Mar 15, 2021 08:24am
- COVID-19 vaccine vaccination rate has exceeded 60%. As the AstraZeneca vaccine is recommended for those over 65 years of age, the quarantine authorities decided to introduce an additional 7 million doses (for 3.5 million people) from the end of May. Joon-wook Kwon, the 2nd vice-president of Central Disease Control Headquarters, explained this trend through a regular briefing of COVID-19 Central Disease Control Headquarters during the day (11th). According to him, as of today's 0 o'clock, an additional 51,100 new people were vaccinated, and the first dose of COVID-19 vaccine was completed for 500,635 people, and the inoculation rate reached 64%. By vaccination institution and target audience, 175,454 people (85.9%) in nursing hospitals, 75,690 people (69.7%) in nursing facilities, 27,226 people (36%) in the first responder, and 209,334 (62.3%) in medical institutions and above, and 12,931 (22.7%) people were vaccinated in COVID-19 patient treatment hospital. Looking at the current status of COVID-19 treatment administration, the treatment 'Veklury (Remdesivir)' was administered to 4,975 patients in 122 hospitals as of 0 o'clock on the 10th. COVID-19 antibody treatment 'Regkirona (Regdanvimab)' was administered to 381 patients in 44 hospitals based on the same criteria. The vaccination promotion team announced that it will introduce 7 million doses (for 3.5 million people) of AstraZeneca vaccine from the last week of May to the end of June. This is the amount of individual contracts that will be introduced as the second, following 1.57 million doses of this product, which was first introduced from February 24th to 27th. The quarantine authorities are continuing to negotiate with pharmaceutical companies to secure quantities of Moderna and Janssen products that will be used for vaccination starting in the second quarter. He said that in medical institutions such as nursing homes and hospitals, there were cases in which the vaccine could not be used due to an accidental deviation in the temperature of the vaccine due to problems such as negligence during the storage of the vaccine. He said, “Due to a breakdown in the refrigerator, an abnormal thermometer, and carelessness of the person in charge of vaccine management, 770 doses of vaccines have been suspended at 7 medical institutions so far. We will continue to strengthen the supervision of consignment medical institutions in cooperation with local governments and the Ministry of the Interior and Safety.” He added, “Please keep and manage the vaccine thoroughly so that it does not happen that the vaccine is discarded due to minor carelessness even at the consignment medical institution.”
- Policy
- Cases of Vivozon & Binex need ‘1+3 Regulation Act’
- by Lee, Jeong-Hwan Mar 15, 2021 06:29am
- Following Binex, Vivozon illegally manufactured medicines in violation of the Pharmaceutical Affairs Act. As a result, the '1+3 Regulation Act' legislation that directly limits the number of drug became valid. The reason was the domestic licensing system and regulatory environment in which too many generics could obtain marketing licenses. Vivozon's incident made ‘1+3 Regulation Act’ even more necessary. According to the National Assembly and pharmaceutical industry officials on the 12th, Binex and Vivozon incidents further necessitated a legislative 1+3 Regulation Act for generics and data submission drugs. 1+3 Regulation Act was proposed by Rep. Yeong-Seok Seo (Democratic Party of Korea) and Rep. Jeong-sook Seo (People Power Party)'s ‘Drugs for data-based re-evaluation 1+3 restriction' amendment to the Pharmaceutical Affairs Act is pending in the National Assembly. Drugs for data-based re-evaluation 1+3 restrictions were opposed by some pharmaceutical companies and the MFDS' opinion was cautious, but the generic 1+3 Regulation Act was approved by many pharmaceutical companies and the MFDS. It is expected to pass if only the opportunity for examination is obtained at the temporary National Assembly in March. If the generic 1+3 Regulation Act is passed, the data submission drug (IMD) 1+3 regulation, which will be discussed, will be also valid. Binex and Vivozon incidents are accelerating the legislation of Drugs for data-based re-evaluation 1+3 restriction. Rep. Seo Young-seok appealed to the necessity of expediting the passage of the 1+3 Regulation Act immediately after Binex crisis. An MA (Market Access) manager at a top domestic pharmaceutical company said, "In fact, many pharmaceutical companies and the KPBMA have been consensus for a long time in the joint bioequivalence 1+3 regulation to resolve the generic mess." "Only some small pharmaceutical companies that are difficult to test for their own bioequivalence were opposed," he said. "But, as the government's regulatory policy on generic drug prices, generics without bioequivalence testing will no longer be sold on the market." He said, "The passing of the generic 1+3 Regulation Act (by Seo Young Seok) due to the Binex and Vivozon incidents is a pre-determined fact. The ruling party, the opposition party, and the government have the same opinions, so it is highly likely to pass." He added, “The quality manipulation situation has further increased the validity of the regulatory bill. It is pointed out that too many drugs have been released in the market, and the regulatory authorities are also not able to manage quality.” An official from the National Assembly's Health and Welfare Committee said, "The generic 1+3 Regulation Act was a bill that had a great influence on the domestic pharmaceutical industry, front-line medical institutions, and pharmacies, but it was a bill that was not well understood by the public." "If public opinion raises a strong issue in the case of low-quality drug distribution or quality-manipulated pharmaceutical companies, the National Assembly will inevitably have a legislative law reflecting public opinion." He said, "It is not because of the public opinion that the examination of the bill changes, but the speed of examination and promotion of the bill will be faster. In addition, the interest of the National Assembly members will also increase. The results of the internal investigation by the MFDS will also affect the validity of the 1+3 bill."
- Policy
- AZ vaccination recommended for age 65 or older
- by Kim, Jung-Ju Mar 15, 2021 06:28am
- The Vaccination Specialist Committee recommended AstraZeneca COVID-19 vaccination for people 65 years of age or older. Accordingly, the quarantine authorities decided not only to immunize them, but also to immunize patients and workers in nursing hospitals and facilities during this month. The COVID-19 Vaccination Promotion Team (Director Eun-kyung Jung) announced on the 11th that it has decided in this way following the deliberation of the '6th Vaccination Specialized Committee in 2021' on the 10th. The committee reviewed the results of studies in the UK and Scotland and recommended the use of the AstraZeneca vaccine in hospitalization and severe prevention in the evaluation of the elderly. Previously, the UK said that Pfizer and AstraZeneca vaccines prevented similar levels of disease (about 70%) and confirmed the effect of preventing hospitalization among the elderly in their 70s or older. In Scotland, Pfizer and AstraZeneca vaccines showed up to 85% and 94% of hospitalization prevention effects, respectively. The COVID-19 Vaccination Promotion Team plans to immunize approximately 376,000 people aged 65 or older and workers in nursing hospitals and nursing facilities in accordance with the deliberation result of the Vaccination Committee. In addition, the Vaccination Committee deliberated on detailed implementation standards for the second vaccination for those who were confirmed as COVID-19 after the first vaccination and those who responded to anaphylaxis. As a result, the committee decided that if COVID-19 was confirmed among the first inoculations, the second inoculation should be performed, and that it is possible after the quarantine is lifted. For the timing of vaccination, if the confirmed person received passive antibody treatment, vaccination should be performed after at least 90 days, and otherwise, it was recommended to complete the vaccination according to the recommended vaccination interval for each vaccine. The recommended vaccination interval is 21 days for Pfizer vaccine and 8 to 12 weeks for AstraZeneca vaccine. Among the primary inoculations, the vaccination subjects with anaphylaxis reactions were decided not to perform the second vaccination because there is insufficient evidence for cross vaccination with another platform, Pfizer's mRNA platform, and AstraZeneca vaccine's viral vector platform vaccine. In addition, considering the current supply status of AstraZeneca vaccine and clinical trial results that the longer the vaccination interval, the longer the vaccination interval was applied, the 2nd vaccination schedule was decided to change to 10 weeks when the vaccination interval was applied. In fact, on the 10th of last month, WHO SAGE recommended that the vaccination interval of AstraZeneca vaccine is 8-12 weeks, considering that the longer the vaccination interval between the 1st and the 2nd vaccination increases, the more effective it is. The Vaccination Specialist Committee included in the 2nd quarter vaccination target group to block the outflow of mutant viruses for flight attendants who are subject to the exception of self-isolation, although they often come and go abroad due to their occupational characteristics. About 20,000 people, including crew members of international airliners belonging to Korean airlines, are covered. The COVID-19 Vaccination Promotion Team plans to establish a second quarter vaccination plan according to the deliberation result of the Vaccination Expert Committee and announce it next week.
