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- 2026-04-17 06:15:02
- Policy
- MFDS “All Korean and U.S. COVID-19 test kits use RT-PCR"
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- On Mar. 15, Korea’s Ministry of Food and Drug Safety (MFDS) has dismissed the news articles accusing Korea’s COVID-19 test kit is not even adequate for an emergency use, citing the U.S. Food and Drug Administration’s (FDA) review. According to earlier news reports by a number of Korean media, Rep. Mark Green has reportedly claimed during a congressional hearing that the test kit from Korea is unreliable by citing the U.S. FDA would not approve of using the kit in the U.S. Regarding the issue, MFDS confirmed the antibody test kit referred by the news article is not the kit the Korean health authority has cleared for emergency. The ministry official also elaborated the four emergency test kits approved by the U.S. FDA are also using the same reverse transcription polymerase chain reaction (RT-PCR) technique as the Korean kits. MFDS official stressed, “All five COVID-19 test kits approved for emergency in Korea use real-time RT-PCR technique that MFDS and Korea Centers for Disease Control and Prevention (KCDC) have verified. The Korean Society for Laboratory Medicine is continuously monitoring the accuracy of those kits, and we have not received any reports of an inaccurate diagnosis to this date.”
- Policy
- All traveler record accessible via DUR from Mar. 18
- by Lee, Hye-Kyung Mar 18, 2020 06:37am
- From 2 p.m., Mar. 18, information of all travelers entering Korea would be provided to healthcare providers via Drug Utilization Review (DUR) system and International Traveler Information System (ITS). Health Insurance Review and Assessment Service (HIRA) has been providing real-time information of travelers from China, Italy, Iran, Singapore, Japan, Thailand, Vietnam, Taiwan, Malaysia, France, Germany, Spain, the U.K., the Netherlands, Hong Kong, Macao, where COVID-19 has spread, and those who came in contact with confirmed cases through DUR system. However, as the outbreak has been spreading throughout the world, the Central Disaster and Safety Countermeasures Headquarters (CDSCH) has announced on Mar. 17, “Starting from Mar. 19, all travelers entering Korea from overseas would undergo special immigration procedure.” Accordingly, HIRA is also expanding its server to provide all inbound travelers’ information to healthcare providers using ITS. The traveler’s information would be disclosed on a real-time pop-up window in the DUR system, accessible to hospital, clinic, and pharmacy, as a part of the page with information regarding healthcare institute registration, medical counseling, and pharmaceutical prescription and dispense. To confirm the DUR system properly working and providing travelers’ information, a healthcare institute’s registration desk could type in test name and registration number on the National Health Insurance reimbursement billing software and check the pop-up window. Doctors can also access the information by inputting test name and registration number on the page for diagnosis and prescription, which would appear on a pop-up window when running DUR system. Pharmacists can input the test name and registration number on the dispensing software and check pop-up window when running the DUR system. Healthcare institutes, without an installed ITS, may download an update patch (‘Infectious Disease Related ITS version July 1, 2019’) available on HIRA Healthcare Institute Business Portal website (https://biz.hira.or.kr) under ‘Monitoring’ category.
- Company
- Pharmaceutical industry focuses on Kyung-Hae Lee from GSK
- by Eo, Yun-Ho Mar 18, 2020 06:35am
- Candidate Kyung-Hae LeePersonnel from executives of multinational pharmaceutical companies is on the list of proportional representative candidates for the United Future Party, attracting the attention of the industry. Kyung-Hae Lee(52) is the current vice president of BioGraphene and has been working in the Foreign Cooperation Department of GlaxoSmithKline (GSK) from 2011 to 2018. The Future Korea Party, the United Future Party’s satellite party, tentatively confirmed the list of candidates for the general election on April 15 and the order number on the 16th. This is the 13th which is rated as the right to win, among the 7 pharmacists who applied for a candidate for proportional representation. She graduated from the Department of Chemistry at Dongguk University and from Sungkyunkwan University School of Pharmacy. She has experience in teaching general chemistry and organic chemistry at the Department of Chemistry at Dongguk University. Prior to joining GSK, She also worked as a policy adviser to former National Assembly member, Eunhee Bae who is now deceased. When she worked for GSK, Kyung-Hae Lee was primarily responsible for expanding the benefits of premium vaccines such as the pneumococcal vaccine 'Synflorix' and the cervical cancer vaccine 'Cervarix'. All of these vaccines are currently included in the National Immunization Program (NIP). In addition, her husband, Won-dong Jeong (53), was the executive officer of Senior Secretary to the President for Political Affairs of Cheongwadae, and is currently a member of the Korea Exchange. Expert committee member Jeong is said to have played a strong role in helping Lee start the political campaign. An official from a multinational pharmaceutical company who worked at GSK said that he was cheering for the new starter by saying that Kyung-Hae Lee had been a good-natured and sincere person since she worked at a pharmaceutical company. Meanwhile, on the list of proportional representatives, Sang-Hyuk Bang (53), a full-time vice-chairman of the Korean Medical Association, was given the number 20 of the elections.
- Policy
- Ranexa by Menarini was approved in Korea
- by Lee, Tak-Sun Mar 18, 2020 06:35am
- 'Ranexa', a new treatment for cardiovascular disease, has approved Ranexa is a Ranolazine-based drug that was approved by the US FDA in January 2006. The MFDS approved Menarini Korea's 'Ranexa' (Ranolazine) as a new drug to treat angina. Ranexa is a drug developed by CV Therapeutics, which was acquired by Gilead, and Menarini owns domestic rights. Ranexa attracted attention as an angina pectoris drug that was released over 20 years after the US FDA approval in January 2006. The mechanism of action of Ranolazine, the main component of the drug, is known to exhibit antianginal effects through inhibition of late sodium influx from heart cells. Currently, the primary treatment for angina pectoris is a beta-blocker or calcium antagonist (CCB), which is also used as a drug for hypertension. Ranexa is licensed as a combination therapy for symptomatic treatment of stable angina patients who are not adequately controlled or intolerant to primary angina treatment. In clinical trials, it was confirmed that the combination effect was high. In the core trial CARISA, Ranexa was added to the treatment of Atenolol 50 mg once a day, Amlodipine 5 mg once a day, or Diltiazem 180 mg once a day. 823 patients (23% of women) were randomized to receive Ranexa 750 mg twice a day, Ranexa 1000 mg twice a day, or placebo for 12 weeks. As a result, when the drug was used as an additional therapy, it was proved that it showed excellent efficacy in terms of prolonging exercise time after 12 weeks at both doses of Ranexa (Ranolazine) compared to placebo. Compared to placebo, the number of angina attacks per week and the amount of fast-acting Nitroglycerin was significantly reduced for one week. The ERICA test (565 subjects) added to Amlodipine 10mg once daily treatment also significantly reduced the number of angina attacks and fast-acting Nitroglycerin use for one week compared to placebo. Angina is acute pain or pain during exercise or activity. Atherosclerosis or atherosclerotic lesions are the causes. In Korea, there are data on the NHIS which has 645,000 patients as of 2017. The total medical expenditure spent on angina treatment was also very low at ￦771 billion in 2017. As a result, it is expected that it will be booming as new drugs have appeared in the domestic market after a long time. As of 2018, Ranexa's worldwide sales amounted to $ 760 million (about ￦915 billion).
- Policy
- Avigan is not imported for COVID-19
- by Lee, Tak-Sun Mar 18, 2020 06:35am
- AviganIt was found that the health authorities decided not to import special cases of 'Avigan' (Favipiravir), a new H1N1 flu treatment used in Japan as a treatment for COVID-19. This is because there is not enough clinical evidence to use COVID-19 as a treatment. It is said that the KCDC did not make any special requests to the MFDS to decide on special import through the emergency introduction system. According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee on Avigan's import exceptions concluded that Avigan'streatment efficacy base for COVID-19 is insufficient. Avigan is a drug developed by Fujifilm Toyama Chemicals, a subsidiary of Fujifilm in Japan, and is an antiviral agent with a mechanism to suppress RNA virus proliferation. In Japan, it has been approved for use when Tamiflu is not effective against influenza viruses. However, it has not yet received an item license in Korea. Lee Eui-kyung, the Minister of Food and Drug Safety, has been spotlighted on the 25th of last month by saying she was considering a special plan for imports from Avigan. In Japan, it is currently recommended for worsening symptoms in mild patients for COVID-19. However, the World Health Organization (WHO) is not raising Avigan as a candidate for clinical trials of COVID-19. It is known that the Central Pharmaceutical Affairs Review Committee also concluded that the efficacy data for COVID-19 patients is insufficient, and that it is negative for domestic patients because of the risk of side effects such as fetal toxicity. Officials from the MFDS said that drugs that have not obtained domestic permission can be imported through the emergency introduction system, but to use the emergency introduction system, the KCDC must make a request through Central Pharmaceutical Affairs Review Committee. However, there was no such request from the KCDC. He said, "Even if Avigan is not imported, the stock of domestic COVID-19 treatment is sufficient." Currently, in Korea, patients with COVID-19 are using HIV treatment, Kaletra (Lopinavir/Ritonavir), and an anti-malarial drug, Hydroxychloroquine, In addition, clinical trials of Gilead's antiviral drug 'Remdesivir' have been approved, and it has also begun to be administered to domestic patients.
- Company
- FDA clears Celltrion’s 2nd HIV drug manufacturing plant
- by An, Kyung-Jin Mar 18, 2020 06:34am
- On Mar. 16, Celltrion announced its HIV treatment CT-G07-manufactuing Cheongju facility has passed the U.S. Food and Drug Administration’s (FDA) on-site inspection with no violation. Prior to CT-G07’s global launch, the on-site inspection was carried out to confirm the plant’s manufacturing facility and quality control system. In January, the inspection focused on the plant’s capacity to manufacturing double-layer tablet, which was not included in the Current Good Manufacturing Practice (cGMP). As a part of ‘Global Chemical Project,’ Celltrion has developed CT-G07, an incrementally modified drug (IMD) for HIV treatment. The pharmaceutical industry suspects the new IMD would have a better marketability than Temixys, commercialized earlier in the U.S., as the drug is a triple combination drug consisting of three agents that currently popular in the global HIV treatment market. Celltrion has applied for FDA approval and World Health Organization’s (WHO) prequalification (PQ) in last May and September, respectively. The company evaluates the ‘flawless’ grade given by the FDA would leverage the company to leap for the global chemical market. The company has publicly announced the plan to commercialize and manufacture CT-G07 from April at earliest. According to Clinton Health Access Initiative (CHAI), the HIV treatment market volume has reached around 1.2 trillion won last year. The company expects to easily take over 10 percent of the market share from early on. Ultimately, it aims to surpass the market share of 20 percent. Celltrion official said, “Celltrion Pharm’s Cheongju plant is the key chemical product manufacturing facility of the group. The plant manufactures and supplies high quality drug meeting global standards and demands. With the latest FDA review, we were able to reaffirm the facility’s global level chemical product manufacturing facility and quality control capacity.”
- Policy
- Would HIRA disclose DREC review result to drug industry?
- by Lee, Hye-Kyung Mar 18, 2020 06:34am
- Health Insurance Review and Assessment Service (HIRA) is contemplating on expanding the scope of disclosure regarding the Drug Reimbursement Evaluation Committee (DREC) deliberation. The contemplation would focus on whether or not to extend details of the deliberation to pharmaceutical companies after sufficiently reflecting their opinion as a stakeholder. And the government agency would ponder on including pharmacoeconomic evaluation result and the time taken from application submission to DREC deliberation within the disclosed information. In 2017, HIRA decided to disclose the DREC deliberation result to a selected news media, but now the agency disseminates a press release to news media first, and posts the information on its website. However, the industry has been criticizing the provided information as it has been limited to reviewed item’s name, company, benefit and effect, and final review outcome. HIRA official said, “The government agency would reflect various stakeholders’ opinions on the scope of provided information of DREC deliberation. We would set down a number of proposals.” On June 9, 2017, HIRA unveiled the DREC review outcomes to news media for the first time. A day after the new drug reimbursement feasibility was reviewed in the sixth DREC meeting of the year on June 8, 2017, HIRA distributed the result fast to news media that requested the information. A decade after forming DREC, the agency broke the non-disclosure principle of DREC review. DREC was established under HIRA a year after the positive listing system was implemented in December 2006. The committee evaluates new drugs’ adequacy of insurance reimbursement based on clinical efficacy, cost-efficiency, listing status in foreign country, necessity in treatment, reimbursed drug and financial status of National Health Insurance. The latest DREC deliberation result disclosed on HIRA website as press release on Mar. 6. The provided information only includes the name of reviewed item and pharmaceutical company, the drug’s effect and reimbursement feasibility review result. After moving the headquarters to Wonju, HIRA has been convening DREC meeting on first Thursday of every month. The government agency reports the meeting’s result to the president of HIRA, and the agency disseminates press release on the day after. When the committee’s deliberation result was unveiled for the first time, the same criticism on the insufficient scope of provided information was raised. The current reimbursement listing procedure requires HIRA’s Pharmacoeconomic Evaluation Subcommittee and DREC reimbursement feasibility review first, and Health Insurance Policy Deliberation Committee’s (HIPDC) final decision followed by National Health Insurance Service’ (NHIS) pricing negotiation. HIRA would likely to ponder on the issue considerably as it would pressure NHIS if a DREC-reviewed item with detailed information disclosed fails to pass the pricing negotiation stage.
- Policy
- The NHIS recalculates ￦2 billion refund for pharmaceuticals
- by Lee, Hye-Kyung Mar 17, 2020 06:29am
- The NHIS has taken corrective action to settle the refund amount of the refund-type risk sharing agreement (RSA) through an internal audit. In the case of RSA drugs that have a 'double drug price' that differs from the drug price and the actual selling price, the NHIS notifies the pharmaceutical company of the payment of the medical institution's claims. If RSA drugs are administered within the scope of the reimbursed standard, the patient pays only 5%(co-payment), and the pharmaceuticals must return the drug cost corresponding to the refund rate to the NHIS. If RSA drugs are administered outside the scope of the reimbursed standard, the patient pays the full amount of the drug first, and the pharmaceutical company refunds cash directly to the patient based on the data from the NHIS. In the process, it was revealed that the amount of the difference of about ￦2 billion was generated by the NHIS overestimating or underestimating some RSA drug refunds from January 1 to December 31 of last year. According to the 'Annual Audit Report for 2019' released by the NHIS recently to Alio, corrective action was taken by not properly managing the drug cost after management, such as neglecting notice of drug refunds to pharmaceutical companies through internal audits. In particular, fiscal dispositions such as the settlement of over ￦2 billion was refunded by companies that had been excessively and under-reimbursed. Meanwhile, the Audit Office of the NHIS conducted a total of 134 times, including comprehensive and planned audits, to request ￦21.6 billion of financial measures, including 2588 administrative and identification measures such as improvement, recommendation, and notification, and post-management of other collection deficit management (recovery).
- Company
- 2nd anti-CGRP migraine drug Ajovy seeks approval in Korea
- by Eo, Yun-Ho Mar 17, 2020 06:28am
- A second anti-calcitonin gene-related peptide (CGRP) treatment for migraine is preparing for the Korean market. According to pharmaceutical industry sources, Handok Teva has submitted approval application on CGRP targeted migraine treatment Ajovy (fremanezumab) aiming for the Ministry of Food and Drug Safety’s nod by late June. Ajovy’s migraine prevention effect has been evaluated in two Phase 3 clinical trials on patients with unbearable migraine pain affecting their daily lives. The results proved Ajovy reduces more number of days with migraine than the placebo group. When it receives the Korean government’s approval, Ajovy would compete against Lilly’s Emgality (galcanezumab) in both reimbursed and non-reimbursed drug markets. The two drugs are humanized monoclonal antibody (mAb) that binds to CGRP ligand playing a crucial role of causing migraine, and blocks its binding to the receptor. Ajovy has improved its drug compliance by offering both monthly and quarterly injection options. After winning the U.S. Food and Drug Administration’s (FDA) approval in September 2018, it also gained European Commission’s (EC) approval in just six months. Emgality has been released in the Korean market as non-reimbursed drug in last December. As none of the drug in the class has been listed for reimbursement, the competition between two drugs over the listing would get fierce. CGRP mAbs are relatively expensive drugs so the first listing standard would be limited to at least third-line treatment. However, considering patients suffering from migraine have such a low quality of life and have limited treatment options, the non-reimbursed use of the drugs would be as popular as well. Professor Chu Min Kyung of Neurology Department at Severance Hospital explained, “The pain from migraine is beyond imaginable and it significantly harms patients’ quality of life. Patients experiencing headache more than four to five days a month could expect to improve quality of life by preventive treatment. Because the condition uses hypertension and epilepsy treatments as preventive treatment at the moment, CGRP mAb would be a preferred option in the future.”
- Company
- Amid COVID-19 industry conflicted with working from home
- by Kim, Jin-Gu Mar 17, 2020 06:28am
- The pharmaceutical industry is in a dilemma of working from home. Pharmaceutical companies that have given an order to work from home to a part or all of the office are conflicted whether to continue or to stop working from home. Depending on companies, some of them have already been working remotely for over a month. But they complain it is impossible to keep working from home, because their work efficiency has plummeted. In fact, some of them have given up working from home. And if only making the decision to have salespeople resume external marketing activity was as easy. The companies still have to calculate the possible loss they would face when a confirmed case is found within. The simplest and the most certain answer to all is ‘an early end to the COVID-19 outbreak,’ but it is now a hopeful thinking as a mass infection has occurred again centering Guro-gu, Seoul. Increasing number of pharmaceutical companies are contemplating on coming back to workplace considering the number of new confirmed cases has been lowered to 110, as of 12:00 a.m., Mar. 13. ◆Switching from remote work to shortened hours or dispersed hours According the pharmaceutical industry sources on Mar. 13, the companies are setting out different tactics switch out of remote working. First, Dong-A ST and GC Pharma, where everyone works from home, have turned back into regular working hours from Mar. 9 for the in-office workers and researchers, except for the sales. But Chong Kun Dang, which also ordered all employees to work from home, has decided to extend the remote working status until this week. Companies that initially ordered the sales to work from home are also deeply conflicted by the situation. Many of them are returning to the normal working status. For instance, a Korean company that decided to have everyone work from home is considering on sending out the salespeople back to the field, except for ones assigned to Daegu, North Gyeongsang Province and Guro-gu, Seoul. And another Korean company is considering on shifting towards shortened working hours or dispersed hours, despite their earlier decision to have all sales work from home. On the other hand, most of global pharmaceutical companies have reportedly decided to continue working from home, until the outbreak subsides. An insider from a Korean company commented, “Until the early last week, the company was positively considering on stop working from home as the number of confirmed cases in Daegu and North Gyeongsang Province has been descending. But as the fear of community infection has gone up again with the surge of cases in Guro-gu, we have decided to continue work from home.” “Sales is the basics of a pharmaceutical company. Indefinitely working from home does not make sense in the business. But also, we cannot order the sales to resume visiting their accounts,” the insider added. An associate from a global company explained, “Actually, the headquarters have urged for precautions as, unlike Korea, the outbreak in Europe and the U.S. has intensified and the World Health Organization has designated the outbreak as a pandemic. The remote working would be sustained for a while.” Severance Hospital’s notice banning outside visitors. With hospitals requesting salespeople to refrain from visiting, working from home became unavoidable. ◆Why the workers cannot wait to go back to their workplaces Besides the companies’ dilemma and decision, employees working from home complain that they want to rather go back to the workplace. Their reasons vary vastly. Some say their working efficiency has plunged and some say they cannot help it with the boss’ pressure on sales performance. And some even say they are extremely fatigued by the company’s excessive workload. A salesperson from a Korean company explained, “The company is assigning almost impossible tasks as we have been working from home for a long time. Many of my colleagues say going back to work would be much better.” “Monitoring and interfering through KakaoTalk or other messenger apps have worsened over the time. What’s worse is when the supervisor thinks I’m not doing anything, when the actual workload has gotten heavier,” the salesperson added. Another Korean company’s salesperson said, “The company officially advised the sales to work from home from the get-go. But quite the opposite is happening in the field. The company may be advising working from home, but their pressure on sales performance is intense.” An in-office worker from a Korean company complained, “As we have switch to remote working without a proper preparation, most of the colleagues are frustrated. Video conference always has glitches and work reporting via email is slow on feedback. It would be much better to just go back to the office.” Another in-office working from a global company noted, “We’ve been working from home for over a month now. The working efficiency has dropped noticeably. We are holding on to it somewhat, but I have a ton of work I cannot do at home.”
