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- 2025-12-24 19:51:36
- Policy
- Korea takes further actions for now-pandemic COVID-19
- by Kim, Jung-Ju Mar 16, 2020 06:28am
- As the outbreak of 2019 novel coronavirus (COVID-19) is spreading worldwide, the Korean government has decided to reinforce prevention of transmission from external source and to take related steps. Besides, the government plans to promptly update ‘Mask App,’ a Smartphone app used for government-issued mask sold at pharmacies. Led by the Head Chung Sye-kyun (Prime Minister), the Central Disaster and Safety Countermeasures Headquarters (CDSCH) for COVID-19 gave a briefing on newest updates and talked about new steps for the outbreak with representatives from central government and 17 city and provincial leaders at Central Government Complex, Seoul. As the World Health Organization (WHO) has officially designated the outbreak as ‘pandemic’ on Mar. 11, Head Chung Sye-kyun urged the government to prevent overseas travelers infecting the local community by taking preemptive actions. He also stressed about paying more attention on preventing further community transmission. Moreover, he ordered CDSCH to improve the Mask App, started working from Mar. 10, to minimize the people’s inconvenience. According to pharmacy sources, the Mask App crashed shortly after it started working, and customers were complaining about how the mask stock status indicated on the app differed from actual stock. And CDSCH is tightening inbound traveler control to block out the virus coming into Korea as the outbreak has been spreading rapidly in other countries. To this date, the Korean government has been applying special immigration procedure for travelers from countries with vastly growing number of infected cases or with extensive community transmission. Subjects applicable for special immigration procedure would have their body temperature checked and fill in a special quarantine declaration with address in Korea and contact information. The government is also requiring the travelers to install government-developed ‘Self-diagnostic App’ on their mobile phones for them to submit self-diagnosis everyday for 14 days. In case the app user reports suspected symptoms for two days straight, the app would relay the information to public health center to decide if the use has to be tested.
- Policy
- COVID-19 impacts MOHW pharmaceutical divisions’ personnel
- by Kim, Jung-Ju Mar 16, 2020 06:27am
- Korea’s Ministry of Health and Welfare (MOHW) fighting against COVID-19 outbreak at the forefront, is suffering from manpower vacuum as their directors and senior deputy directors in pharmaceutical affairs have been temporarily transferred. The Pharmaceutical Benefits Division, in charge of pharmaceutical benefit listing, reimbursement standard and policies regarding pharmaceutical benefit enhancement initiatives, is experiencing difficulties in processing their work as the director position is vacant and newly appointed senior deputy director has been transferred to COVID-19 response team. Also the Pharmaceutical Policy Division handling policies on pharmacy and pharmaceutical distribution is missing a director as the former director has been dispatched to overseas. According to MOHW on Mar. 11, the human resource issues in both Pharmaceutical Benefits Division and Pharmaceutical Policy Division would last at least until end of this month. Former Director of Pharmaceutical Benefits Division, Kwak Myeong-Seop (left) and Senior Deputy Director Lee Seon-joo The Pharmaceutical Benefits Division is a key part of the ministry enhancing pharmaceutical coverage, accessibility, and pharmaceutical review, such as new drug and generic reimbursement listing, revising generic pricing system, and reducing price based on actual transaction price. Including pharmaceutical coverage enhancement and expenditure structure reform (pricing reduction) based on the National Health Insurance Comprehensive Plan, all crucial parts related to pharmaceutical and bio industry are concentrated in the division. As the Former Director of Pharmaceutical Benefits Division, Kwak Myeong-Seop has been dispatched to South Korea Consulate in Guangzhou, China, on Mar. 11, Director General Lee Ki-il of Health Insurance Policy has taken over the division’s work at the moment. Moreover, the division is missing both director and senior director, as Senior Deputy Director Lee Seon-joo, has been temporarily transferred to COVID-19 response team immediately after the new appointment to the division was announced. When the outbreak subsides, Senior Deputy Director Lee Seon-joo would come back to the division and take over the role of leading reimbursed drug pricing system revision and reforming generic listing, which would affect the industry significantly. The Pharmaceutical Policy Division is also missing some key persons. The division generally covers all pharmaceutical affairs directly affecting pharmacy industry, such as pharmaceutical and medical device company expenditure report, pharmaceutical distribution, pharmacy on-site inspection, credit card fee at pharmacies and OTC drugs. The controversial issues about adding CSO as one of mandated subjects for filing expenditure report is also dealt by the division. Director Yoon Byung-chul of Pharmaceutical Policy Division Director Yoon Byung-chul of Pharmaceutical Policy Division has been dispatched to Central Disaster and Safety Countermeasure Headquarters (CDSCH) for COVID-19 in Osong as soon as the outbreaks started in Korea. Director Yoon is an expert in pharmaceutical affairs with three years of experience in the division. Technically he was supposed to be appointed to other division in past January, as he has served as the director of the division for the longest time in MOHW. Similar to the former Director Kwak, Director Yoon was initially decided to be assigned to an overseas position, but his personnel change has been postponed for the government to better confront the infectious disease issue. And the division is lacking sufficient manpower to tend practical affairs, because some assistant director positions are left open. Regarding the issue, MOHW official explained the ministry has been doing its best to prevent further spread of COVID-19 by borrowing specialists from all divisions, so the manpower shortage is unavoidable. However, the government plans to fill up the vacuum during the regular personnel season. The official commented, “All positions would be filled when the regular personnel changes are executed. The appointments would be unveiled from late March.”
- Policy
- Probe that detects COVID-19 was successfully made
- by Kim, Jung-Ju Mar 12, 2020 06:07am
- While global attention is focused on the development of 'COVID-19' therapeutics, government-level development research is also in full swing. The government has succeeded in producing specific proteins to detect these infectious antibodies. The National Institute of Health (President Jun-Wook Kwon) in the KCDC (Director Eun-Kyung Jung) announced on the 10th that it has succeeded in producing a protein for detecting COVID-19 antibodies, which is essential for developing antibody treatments for COVID-19 response research. This protein, called Probe, can detect and isolate COVID-19 antibodies. According to the researcher, the production of antibody-detecting protein enables specific detection of neutralizing antibody-producing cells (B cells) in the blood of recovering patients, enabling the production of COVID-19 antibodies. The National Institute of Health has established the immunofluorescence (IFA) method by collecting the blood of patients who have been cured in the meantime, and plans to purify various COVID-19 antigen proteins and establish a neutralization test to evaluate the efficacy of therapeutic agents. Currently, the National Institute of Health has conspired two times on 12 urgent issues for the treatment, vaccine, and diagnostic and clinical research of COVID- 19, and is promoting the development through cooperation research with academia and companies by laying the foundation for the development of therapeutic antibodies, discovery of vaccine candidates, clinical epidemiology and serological studies, expansion of drug use range, and rapid diagnosis. In addition, by securing this supplementary budget, the institute will develop animal models for vaccine research and treatment, and make efforts to develop blood system materials using plasma of recovery patients. Sung-soon Kim, director of Center for Infectious Diseases Research, said that research on the development of antibody therapeutics through the urgent issue and the development of blood system drugs through the supplementary budget will promote cooperation with external companies, academia, and the medical community to advance the development of COVID-19 treatments that can be clinically applied.
- Policy
- Study for effects of Truvada and Kaletra will continue
- by Lee, Jeong-Hwan Mar 12, 2020 06:06am
- The government plans to continue research on the effectiveness of COVID-19 therapeutic substances and patient administration through various methods such as clinical trials. Following the clinical approval of Remdesivir, It will continue to study the necessity of administering drugs that are expected to be effective in treating corona, such as antiviral drugs Truvada and Kaletra. Sung-soon Kim, director of Center for Infectious Diseases Research, said on the 10th in the COVID-19 related meeting of the National Assembly, said, “There are many opinions that antiviral drugs such as Truvada and Kaletra should be used for COVID-19 therapy and plan to promote it as a research project”. In addition, Yoon Il-kyu, a member of Democratic Party Party pointed out that in order to reduce the deaths caused by COVID-19, preparations for treatments such as Remdesivir, Chloroquine, and Kaletra should be thoroughly prepared. Representative Yoon said, "Remdesivir, ebola treatment, is expected to be put into treatment in the US soon. I wonder if Korea is preparing for it". Representative Yoon said that COVID-19 doesn't have a vaccine anyway, so the treatment is important. Also added he, “there are especially lack of chloroquine in Korea, and there is still insufficient data that Hydrochloroquine has the same effect as chloroquine. Government measures related to therapeutics are needed". Sung-soon Kim, director of Center for Infectious Diseases Research instead of Vice Minister Kang-lip Kim answered, “Remdesivir is being used in Korea for the treatment of COVID-19”. Chloroquine's domestic volume, etc., was reported after confirming the situation. Sung-soon Kim, director of Center for Infectious Diseases Research said, "Remdesivir is approved by the MFDS and is being administered at three hospitals in Korea". Kim said, “Chloroquine is not nationwide, but I heard some of them are taking medication when visiting the field in Busan”. Also, he added that there are many opinions that clinicians want to use antiviral drugs such as Truvada and Kaletra in COVID-19, and am willing to carry out the reserch project.
- Policy
- Court suspends execution of Forsteo price reduction
- by Kim, Jung-Ju Mar 12, 2020 06:03am
- Price reduction of Lilly Korea’s osteoporosis treatment Forsteo (teriparatide) is temporarily deferred, although it was notified earlier to be executed this month. The company has reportedly filed a lawsuit to cancel the government-authorized price reduction. On Feb. 28, Seoul Administrative Court has granted suspension of execution on the revised List of Reimbursed Drugs and Maximum Reimbursed Price (Notice number 2020-38) due to the litigation filed by the pharmaceutical company against Ministry of Health and Welfare (MOHW). The medication received reimbursement for treating osteoporosis in post-menopausal women and men with high risk of fracture. Initially, MOHW has decided to authorize pricing reduction of the drug by revising the List of Reimbursed Drugs and Maximum Reimbursed Price as of March. The ministry applies ‘Half-priced Drug’ system on generics receiving reimbursement, which lists the first generic at 53.55 percent of the original’s price but grants weighted pricing of 70 percent of the original for one year. However, if the number of companies manufacturing the same generic is three or less, the weighted pricing benefit is sustained until the fourth company lists the generic, despite a year has elapsed. The multinational pharmaceutical company filed litigation against MOHW as Forsteo was included in the government-authorized drug pricing reduction list. The osteoporosis drug was originally listed at 326,358 won per injection, but the government revised the price down to 228,451 won. As the legal proceeding has started, the court has decided to suspend the execution of pricing reduction until it makes a final decision. In other words, the original price of 326,358 won would be temporarily sustained. The suspension of the execution is to last until Aug. 24. MOHW would withhold the pricing reduction until the date, and notify any further changes made.
- Policy
- Ibrance & Besivo were added to the price-volume agreement
- by Lee, Hye-Kyung Mar 10, 2020 01:43pm
- Ildong’s Besivo (Besifovir dipivoxil maleate) & Pfizer Korea’s Ibrance (Palbociclib)75mg/100mg/125mg were added to the price-volume agreement negotiation monitoring of the first quarter of this year. Novartis Korea's Entresto (Sacubitril/Valsartan Sod Hydrate) 50mg/100mg/200mg & Myung In Pharm's Q pam (Levitiracetam) 500mg are also being monitored. The NHIS recently released its first-half 2020 price-volume agreement negotiation (type A and type B) drugs to be monitored. The price-volume agreement negotiation system divides the risks of health insurance finances by the NHIS and the pharmaceutical company. In the case of drugs whose usage has surged, the drug price is lowered through negotiations with the NHIS. The first quarter’s monitoring targets are 194 items in 105 pharmaceutical groups. Drugs monitored for consumption from January to March of this year are Merck’s Gonal F pen (Follitropin alfa) 20IU/45IU/75IU/90IU, Pfizer Korea’s Vyndaqel (Tafamidis meglumine) 20mg, Gilead’s Vemlidy (Tenofovir alafenamide) and Hanmi’s Olita (Olmutinib). Celgene's Revlimid (Lenalidomide), Ahn-gook pharm's Rupafin (Rupatadine fumarate), and Takeda’s Edarbi (Azilsartan medoxomI) are also subject of the price-volume agreement negotiation. The price-volume agreement negotiation type A is the case when the same product group claim with agreed billing amount increased by more than 30% from the estimated bill amount by negotiation with the NHIS, negotiation of estimated bill amount, negotiation of adjustment of drug price increase, negotiation of expansion of scope of use, etc. Type B is the case which is negotiated by type A or is for the same product group four years after the initial listing date without Type A negotiations, where the previous type A is at least 60% more than the previous year's charge or at least 10% & more than ₩5 billion every year from the day following the end of the analysis period. Meanwhile, drugs with an annual billing amount of less than ₩1.5 billion, drugs with lower upper limits than the arithmetic mean of the same ingredient, low-cost drugs, and shortage prevention drugs are excluded from the price-volume agreement negotiation system.
- Policy
- CSL Behring steps into hemophilia treatment market in Korea
- by Lee, Tak-Sun Mar 10, 2020 06:29am
- CSL Behring, a subsidiary of Australian-based global pharmaceutical company CSL, is to join the hemophilia treatment competition in Korea. The company acquired approval on hemophilia B treatment Idelbion injection on Mar. 5, after receiving a marketing license on Afstyla infection, a hemophilia A treatment developed based on SK Chemicals’ license-out pipeline, in last January. The approval process has handled by Zanovex Korea, an offshoot of Zuellig Pharma. CSL Behring is a global pharmaceutical company with line-ups of genetic recombinant technology-based hemophilia and rare disease treatments. As a subsidiary of Australian-based parent company CSL Limited, the global biopharmaceutical company has offices in 60 countries around the globe. Its headquarter is housed in Pennsylvania, U.S. Although the company has been active in China and Japan, it had not stepped into Korean market until its Korean office opened January last year in Gangnam Finance Center, Seoul. The Korean office is led by General Manager Sohn Ji-young, a seasoned global pharmaceutical industry expert. Graduated from Ewha Womans University College of Pharmacy, the general manager served in Pfizer Korea’s Marketing Management and Strategic Planning Unit and Roche Korea’s Oncology Business Unit after earning MBA from Korea University. The name of CSL Behring grabbed the Korean pharmaceutical industry’s attention since the deal signed with SK Chemicals. The Australian biopharmaceutical company licensed in hemophilia A treatment Afstyla, developed by the Korean company, in 2009. After winning the U.S. Food and Drug Administration’s (FDA) nod in May 2015, Afstyla was also cleared in EU in January 2017. Korea’s Ministry of Food and Drug (MFDS) also approved the treatment on Jan. 20. Hemophilia causes prolonged bleeding due to blood clotting process slowed by mutation in gene on X chromosome. Approximately one out 10,000 suffer from the condition, which is divided into either hemophilia A or B depending on the deficient blood clotting factor. Among all hemophilia patients, 80 percent is diagnosed with hemophilia A and 20 percent with hemophilia B. Sources report there about 2,000 hemophilia patients in Korea. The treatment market volume is at around 180 billion won, and the hemophilia A treatment market is led by Shire Pharma’s Advate and GC Pharma’s Greengene F. On the other hand, over 90 percent of the hemophilia B treatment market is taken up by Pfizer’s Benefix. Considering the strong competitors in the market, CSL Behring’s challenge would not be the easiest ride. However, their two items have advantage of effect lasting longer than other existing options providing improved administration convenience. Doubling the existing option’s acting time, patients could benefit from administering Afstyla by only administering two or three times a week. Most of the currently available treatments are administered three to four times a week. Advate, for instance, has to be administered three to four times a week to prevent bleeding. Administered once-weekly, Idelbion has a longer half-life than Benefix that prevents bleeding by administering once in three to four days. However, CSL Behring would have to overcome the increasing intensifying competition between long-acting hemophilia treatments with new competitors emerging to the market. Meanwhile, the original developer of the hemophilia treatment, SK Chemicals’ blood product subsidiary SK Plasma would be in charge of the marketing and sales of Afstyla in Korea.
- Policy
- Remdesivir, clinical trial at the SNUH
- by Lee, Tak-Sun Mar 10, 2020 06:29am
- Gilead's COVID-19 drug candidate, Remdesivir is conducting a clinical trial at Seoul National University Hospital. The trial is a multinational researcher-led clinical trial led by the National Institutes of Health (NIH) under the auspices of the World Health Organization. The MFDS approved Remdesivir’s multinational phase II clinical trial plan, led by Seoul National University Hospital. The trial is a multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of Remdesivir in patients with COVID-19. It is held at SNU Boramae Medical Center, Seoul National University Bundang Hospital and Seoul National University Hospital. The number of domestic subjects is known to be 100. The trial is an NIH-led researcher's clinical trial. In the United States, clinical trials are being conducted at the University of Nebraska Medical Center, and 50 countries are reported to participate in the administration of 394 patients worldwide. Meanwhile, a large commercialized clinical trial led by Gilead was approved on the 2nd in Korea. 195 patients with severe and severe COVID-19 were included. Commercialized clinical trials are conducted at Kyungpook National University Hospital, National Medical Center, and Seoul Medical Center. An official from the MFDS said, "As a matter of urgency, this trial is likely to be administered immediately after the first patient enrollment." In general, other clinical trials have been reported to take up to a week after the first patient enrollment report with MFDS.
- Policy
- ‘Korea Passing’ Xolair returns for second attempt on DREC
- by Lee, Hye-Kyung Mar 10, 2020 06:29am
- Although it abruptly dropped out from pricing negotiation in Korea for a better reimbursement listing in China, Novartis’ asthma treatment Xolair (omalizumab) has crossed the first threshold of reimbursement listing in Korea. Daehwa Pharmaceutical’s Liporaxel would proceed to negotiate pricing with National Health Insurance Service (NHIS) if it accepts the weighted average pricing proposed by Health Insurance Review and Assessment Service (HIRA). HIRA (President Kim Seung-taek) has unveiled the result of pharmaceutical reimbursement feasibility review during the third Drug Reimbursement Evaluation Committee (DREC) session of 2020. Novartis’ allergic asthma treatment Xolair injection and Xolair prefilled syringe, AbbVie Korea’s treatment for moderate to severe psoriasis Skyrizi prefilled syringe (risankizumab), Lilly Korea’s breast cancer treatment Verzenio tablet (abemaciclib), and Daehwa Pharmaceutical’s stomach cancer treatment Liporaxel solution (paclitaxel) were on the committee’s agenda. DREC acknowledged the feasibility of reimbursement for Xolair, Skyrizi and Verzenio. The respective companies would be negotiating their pricing with NHIS for 60 days, when Ministry of Health and Welfare (MOHW) gives an order for the negotiation with NHIS. As for Xolair, it received DREC’s nod in 2018 and started negotiation with NHIS immediately, but it withdrew the listing process amid the negotiation on Dec. 20 of the year. The global company has given up on reimbursement listing in Korea back then, as the Chinese health authority has decided to refer to drug pricing in Korea right when the negotiation with NHIS initiated. The incident was branded as the first ‘Korea Passing’ phenomenon. After receiving reimbursement on Xolair in China last year, Novartis has been working on pharmacoeconomic analysis for the second attempt at reimbursement listing in Korea. Started the reimbursement listing procedure from 2018, Liporaxel would earn the rights to initiate drug pricing negotiation with NHIS if it accepts the HIRA’s evaluated pricing (weighted average pricing). The treatment would remain non-reimbursed, unless Daehwa Pharmaceutical takes the proposed pricing. The outcomes of DREC deliberation could be altered depending on changes in detailed reimbursement scope and standard item, and also changes in approved item’s label and license termination. Due to the COVID-19 outbreak, the DREC meeting sessions from Mar. 3 to 4 were substituted to on-paper review.
- Policy
- What is the difference between Remdesivir & VSF
- by Lee, Tak-Sun Mar 09, 2020 07:59am
- There are two investigational drugs approved by the MFDS for COVID-19 patients as of the 5th. The first is the antiviral drug 'Remdesivir' of the US global pharmaceutical company Gilead Science, and the other is the antiviral candidate called 'VSF' of Korean bioventure Immunemd. However, the reasons for authorizing the administration of the two candidates to the patient are somewhat different. If Remdesivir is a commercial trial for commercial purposes, VSF is an emergency treatment. 'Remdesivir' is the first candidate for COVID-19 treatment for clinical trial Gilead is the best pharmaceutical company to make nucleotide analogue antiviral agents. So this Remdesivir is attracting more attention as a treatment for COVID-19.Gilead is the best pharmaceutical company to make nucleotide analogue antiviral agents. So this Remdesivir is attracting more attention as a treatment for COVID-19. Remdesivir was approved by the MFDS on the Phase III trial of COVID- 19 patients. The plan is to conduct 120 domestic and 75 severe patients at Seoul Medical Center, the NMC, and Kyungpook National University Hospital. The trial is a global clinical trial (total 1,000 patients worldwide), the first COVID-19 clinical trial conducted by a pharmaceutical company. The Remdesivir trial, which is conducted in 761 patients in Wuhan, China, is a clinical trial led by a researcher. In addition, a recent clinical trial launched in the United States is a clinical trial led by the National Institutes of Health. To be recognized as a formal treatment, Remdesivir must be validated in commercialized clinical trials. Once the trial has been completed, it is difficult to be approved as a formal treatment in the first half of this year. However, because COVID-19 occurred suddenly, it cannot be identified as a pandemic. Even if it is not approved as a formal treatment, it is meaningful to be used only for patients who are currently occurring for therapeutic purposes. Gilead Science Korea also said the trial is more humane for patient care opportunities than for immediate approval. However, if clear efficacy data are available in this clinical trial, the license can be applied as a formal treatment. Remdesivir is one of the nucleotide analogues that has had antiviral effects. Nucleotide analogs act as nucleic acid analogs in the synthesis of viral DNA to inhibit the growth of the virus. Gilead has a nucleotide-like blockbuster product that acts on antivirals, such as hepatitis B and HIV, including Viread and Stribild. Immunemd’s VSF approved for treatment for one patient on a humane basis On the other hand, Immunemd’s VSF, which is approved for therapeutic purposes, cannot be applied as a formal treatment with this data, even if it is effective after patient administration. This is because it is temporarily approved for therapeutic purposes and not for commercialized clinical trials. The MFDS has made an exception for the purpose of granting treatment opportunities to patients who do not have other treatment and have life-threatening diseases. The condition is to treat a patient with a serious life-threatening condition, such as terminal cancer or AIDS or to treat an emergency patient prescribed by the prime minister's order, such as life-threatening or no alternative treatment. VSF mechanism of action (provided by Immunemd) Immunemd’s VSF has been conducting Phase I clinical trials with antiviral drugs since 2018 at Seoul National University Hospital. Then, was approved on February 21 for treatment of COVID-19 confirmed patient who had no treatment, The company plans to administer a total of four (Day1/Day3/Day7/Day14) doses, and officials from Seoul National University Hospital, the MFDS, and Immunemd are conducting joint monitoring of drug effects and side effects after dosing. Immunemd added that it applied to the Food and Drug Administration on 4th last month to approve the use of a provider (Immunemd) for therapeutic purposes, which can be administered for up to 25 people, separately from those currently available only to individual patients. VSF binds to cells infected with viruses and regulates DNA damaging agents and tumor necrosis factors, thereby preventing infected cells from proliferating or inhibiting inflammation. Immunemd teamed up with Lonza, a British company, to develop a humanized version of VSF (hzVSF), which Lonza produces for clinical trials.
