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- 2025-12-26 09:24:31
- 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).
- Policy
- The MFDS encourages production of KF80 masks
- by Lee, Tak-Sun Mar 16, 2020 06:29am
- In order to encourage the KF80 standard health mask to be produced, the MFDS decided to temporarily grant permission to change items that are currently approved under the KF94 standard to KF80. It is judged that the KF80 has less filter requirements than the KF94, which can lead to an increase in mask production. However, there is criticism that the MFDS recommended KF94 to block the virus in the early days of the COVID-19 epidemic, but as the demand for masks increased, KF80 and cotton masks could also be used, causing confusion in the mask supply and demand policy. The Ministry of Food and Drug Safety prepared a rapid approval plan for health masks according to the COVID-19 pandemic, and informed the first-line manufacturers (importers) on the 9th . The main contents of the rapid approval plan are ▲ temporary permission to change the new filter ▲ temporary permission to change the final mask for health ▲ rapid approval of the imported health mask. First, it is possible to change the filter standard of the health mask. Currently, the filter is a core ingredient of the health mask, and as a rule, it is permitted as a new item when the filter is changed. However, However, filters for air conditioners and air purifiers can be used for health masks temporarily. KF94 standard health masks are also permitted to change permission to KF80 temporarily. Currently, it is classified as KF80, KF94, and KF99 and is permitted as a separate item. Changing the KF94 mask that has already been approved to KF80 will have different efficacy effects, standards and test methods. The efficacy and effectiveness of KF94 is 'protecting the respiratory tract from particulate harmful substances such as yellow dust and fine dust and infectious agents', but if it is changed to KF80, there is no 'effectiveness and effectiveness' of 'protecting the respiratory system from infectious sources'. In addition, dust collection efficiency is changed from 94% to 80%. An industry insider said, "Change from KF94 to KF80 can reduce the filter requirement by 30%". Imported health masks are also quickly approved. It is a policy that permits prompt approval if imported mask raw materials and all product standards are equal to or higher than the Ministry of Food and Drug Safety's notice or guidelines. In the case of test reports, foreign test reports were also accepted. It is said that the US N95, the European FFP2, and the KN95 in China are more than the equivalent of the health mask standards in Korea. This measure will be temporarily operated until the effective date of emergency supplies and demands for masks and hand sanitizers. In the situation where the supply and demand of health masks is not smooth, it is interpreted as a way to increase production. When President Moon visited the mask maker on the 6th, Choi Kyu-bok, CEO of Yuhan-Kimberly, suggested that “the filter requirement for KF94 is 20-30% higher than that of KF80. If it is mainly produced in KF80, it will reduce the amount of filter shortage”. President Moon also said it was a "very good plan". However, there is a criticism that the countermeasure against this was that the Ministry of Food and Drug Safety recommended a health mask of KF94 or higher in the early days of the Corona 19 epidemic to prevent viruses, and recently changed to KF80 and cotton mask. The Ministry of Food and Drug Safety recommended in the end of January that "KF94" and "KF99" masks are recommended to prevent infections such as new coronavirus". However, on the 12th, if there were respiratory symptoms such as coughing, or if a healthy person cares for a suspicious person, a visitor to a medical institution and a worker in the occupational group at high risk of infection and transmission recommended a health mask of KF80 or higher. On the 3rd of this month, the use of cotton masks is also helpful when there is no high risk of infection or there is no health mask. According to the initial recommendations from the MFDS, manufacturers were more immersed in the production of KF94 masks in high demand, leading to a shortage of KF80 masks. Recently, it has been reported that a reversal phenomenon in which the price of the KF80 mask is more expensive than the KF94 mask is also occurring. Meanwhile, the KF80 mask can block more than 80% of fine particles with an average size of 0.6 μm, and the KF94 and KF99 masks can block more than 94% and 99% of particles with an average size of 0.4 μm, respectively. KF stands for Korea Filter, and the number after it means particle blocking performance.
- 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.
