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- 2025-12-24 19:51:36
- Policy
- Rapid support to develop COVID-19 vaccines & treatments
- by Kim, Jung-Ju Mar 29, 2020 11:19pm
- Taeho Yoon, director of Disinfection, the central disaster management headquartersThe government said it was moving rapidly to support R&D for the development of 'COVID-19' vaccine and exclusive treatment. Taeho Yoon, the director of Disinfection, the Central Disaster Management Headquarters (Public Health Policy Officer, the MOHW) today (25th) morning after the video conference about COVID-19/the central disaster and safety countermeasure headquarters made the announcement through a press briefing. Because COVID-19 does not have a dedicated treatment, the government has taken measures to make health insurance available and were preferentially made to be used for 7 types of treatment for other diseases such as AIDS treatment and malaria treatment based on expert recommendations such as the KSID. At the end of January, in the early stage of the influx, a budget of about ￦1.6 billion was urgently provided to assist domestic pharmaceutical companies to quickly begin research on the development of exclusive treatments. Director Taeho Yoon emphasized that we are working closely with domestic researchers and pharmaceutical companies to research treatment and vaccine development, such as adding an additional ￦6 billion, including a reserve of ￦1 billion and an additional ￦5 billion, and expediting approval of clinical plans.
- Policy
- Gangnam Severance to test chloroquine preventing COVID-19
- by Lee, Tak-Sun Mar 29, 2020 11:18pm
- Gangnam Severance HospitalGangnam Severance Hospital is to conduct a research-purpose clinical trial on malaria drug hydroxychloroquine to test its preventive effect, as it is currently used on patients with COVID-19. On Mar. 25, Korea’s Ministry of Food and Drug Safety (MFDS) approved the clinical trial protocol on a ‘Study on Hydroxychloroquine’s Post-exposure Prophylaxis against SARS-CoV-2,’ submitted by Gangnam Severance Hospital. Professor Song Younggoo at Infectious Disease Department would lead the study. Unlike other clinical trials on chloroquine, the researchers would test the medicine’s preventive effect and not the treatment effect. Accordingly, the study participants would not be the confirmed cases, but people who came in contact with a confirmed patient, regardless of showing symptoms. The participants would be eligible for the study only within 72 hours since their contact with confirmed patient. The protocol calls for total 2,486 participants. Lasting until March next year, the study would use Hanlim Pharm’s Haloxin as a trial drug. The investigators would confirm the infection conversion rate of COVID-19 by confirming the participants' negative infection test first before the administration of the drug and testing them again 14 days after the exposure. Both tests would use polymerase chain reaction (PCR) test. Prior to the latest approval, Asan Medical Center also received an approval for a hydroxychloroquine clinical trial. But Asan Medical Center is testing the medicine’s treatment effect in patients with COVID-19.
- Policy
- “Lowest A7 price for latecommer PE-exempted RSA drug”
- by Lee, Hye-Kyung Mar 29, 2020 11:18pm
- When a first-in-class drug is listed with risk sharing agreement (RSA), a follow-on pharmacoeconomic evaluation (PE)-exempted drug would be reviewed for reimbursement feasibility with price higher than the lowest A7-adjusted price. And the revised review criteria added a phrase, ‘only referring to drugs with public health insurance reimbursement in foreign countries or equivalent level of coverage,’ for reviewing international adjusted average price based on overseas reimbursement listing status. Korea’s Health Insurance Review and Assessment Service (HIRA) is accepting public opinion for 80 days until June 11 on the revised ‘Review Criteria on New Drug and Negotiating Drugs’ with the said changes. The review criteria has been set to provide basis for the Article 11-2 of Rules on National Health Insurance Reimbursement Standard, the Article 7 of Pharmaceutical Decision and Adjustment Standards and the Article 4 of Regulation on Pharmaceutical Reimbursement Listing Evaluation Standard and Procedure. The revised notice preannounced by Ministry of Health and Welfare (MOHW) includes details of applying RSA on follow-on drugs, which HIRA has specified by setting down ‘Evaluation Criteria on Drugs Applied with Manufacturer’s Compliance Terms (RSA).’ For RSA eligible drug groups, MOHW has included drugs exempted from PE data submission among drugs reviewed as cost-effective for reimbursement. HIRA defined drugs that fall under ‘the Article 6-2 of Regulation on Pharmaceutical Reimbursement Listing Evaluation Standard and Procedure’ are the RSA applicable subjects. These drugs could be subject to RSA when qualifying conditions with their main indications. But, even drugs qualifying with additional indication could be applicable as well, if the main indication has been verified as cost-effective. The standard of a ‘main’ indication depends on the patient size. One of the PE exemption conditions, ‘the committee evaluates the subject patient size is too limited for evidence development,’ is decided based on the reimbursement beneficiary patient size (within Korea) and projected patient size status. Regardless of the Article 6-2, a reimbursement-seeking follow-on drug with treatment level equivalent to first-in-class PE-exempted RSA drug would follow the evaluation criteria and post-management standards of the first-in-class drug. These drugs’ pricing would be decided based on the lowest of adjusted price from A7 countries (the U.S., the U.K., Germany, France, Italy, Switzerland and Japan). The labeled price for the refund type RSA would be decided considering the price offered by the pharmaceutical company, and the offered price should be higher than the lowest A7 adjusted price. But in case the estimated selling price (actual price) offered by the company is higher than the evaluation standard price, the company may offer unit cost of the applicant drug taking the lowest A7-adjusted price into account. A Korean-developed drug approved first time in the world in Korea, with reimbursement listing in three A7 countries, would be priced considering lowest A7-adjusted price of a same-class drug, and the ones with listing in less than three A7 countries would receive price decided by Drug Reimbursement Evaluation Committee (DREC) based on 10 percent premium on the highest price of alternative drug and external adjusted price of same-class drug. A phrase stating ‘only referring to drugs with public health insurance reimbursement in foreign countries or equivalent level of coverage’ has been added to the definition of foreign adjusted average price, as a part of overseas listing status evaluation criteria.
- Policy
- “NA should stop loosening new drug regulation”
- by Lee, Jeong-Hwan Mar 29, 2020 11:17pm
- Prior to the upcoming general election, health related civic groups are voicing out to the National Assembly (NA) about their disapproval on over-the-counter (OTC) drug sold outside of pharmacy and profit-making pharmacy. The groups urged the lawmakers to establish public pharmaceutical company, learning from COVID-19 outbreak, and stop alleviating pharmaceutical regulations, and also to reinforce public infrastructure of healthcare human resources by expanding the share of public healthcare institutes up to 30 percent. On Mar. 24, the Free Healthcare Campaign Center convened a press conference in front of the NA to demand public health expansion policies for the general election. The Campaign Center has reprehended the ruling and opposition parties for not setting forth policies regarding new infectious disease responding public health improvement and financial support to overcome life-threatening disaster when COVID-19 is spreading and April general election is approaching. The organization pointed out that most of political parties are neglecting the voters’ needs when the election is to be held amid the global catastrophe. Specifically, the organization demanded the NA to secure the share of public healthcare institute at least up to 30 percent to protect the lives of the people from highly detrimental infectious disease like COVID-19. The Campaign Center official stated, “As a start, the NA should open public healthcare clinics in Daejeon, Gwangju, Ulsan and Western Gyeongnam Provicne, buyout Cheongdo Dae Nam Hospital and Busan Wallace Memorial Baptist Hospital and make Daegu Dongsan Hospital public.” “Although a political party claims infectious disease specializing hospitals should be opened, the special hospital would eventually follow the footsteps of Ajou University Hospital Trauma and Acute Care Surgery Division,” the official added. The officials explained the government should hire doctors and nurses as public health infrastructure for the public healthcare institutes. And the organization appealed the necessity of mandatory service of medical professionals at public healthcare institutes by passing a bill on establishing public medical school. The Campaign Center demanded for a financial support, such as sickness benefit, and temporarily lessened medical expense in case of disaster. The organization argues Korea should also implement the sickness benefit policy as most of OECD member countries provide income security when treated from public health insurance. They explained it would provide more practical support if paid leaves are given institutionally and layoff is banned during COVID-19, like in other countries Moreover, the officials demanded the government to significantly reduce copayment rate to allow the people to use medical care sufficiently, despite economic recession and income cut. More specifically, the Campaign Center demanded for public pharmaceutical company. COVID-19 vaccine has unclear prospects in profit making and return on investment. And a public pharmaceutical company should take over the job as private companies are reluctant about the vaccine production. The officials also stressed again the government should stop alleviating pharmaceutical regulations, such as the Cutting-edge Regenerative Medicine Act. The official urged, “Even the distribution of over-the-counter and essential drugs would struggle as pharmaceutical exports are restricted due to the outbreak,” and “to stabilize production of essential drugs crucial to public health management, public pharmaceutical company is necessary.” “While incidents like fake drug Invossa is happening, the NA has passed the Cutting-edge Regenerative Medicine Act that loosens safety regulations on genetic treatment and stem cell treatments. It is a law that approves drugs so easily, regardless of clinical trial process. And OTC sales should not be allowed outside of pharmacy and legislating profit-making pharmacy should be dropped,” the official added.
- Policy
- Saxenda's misuse and abuse are discussed
- by Lee, Tak-Sun Mar 26, 2020 06:12am
- Self-injecting agent used for the purpose of weight loss The Ministry of Food and Drug Safety plans to release and disclose self-injection system safety management measures such as 'Saxenda', which has recently increased in sales volume as a weight management supplement. However, in the course of the discussion, there was still a large difference in opinion between doctors and pharmacists. Patients do not abuse, and agree to strengthen education to use properly, and disagreements have emerged among educational subjects.. The Ministry of Food and Drug Safety is unlikely to be a government agency that can determine the number of divisions or increases in the discussion process, so it is expected to draw a final focus on strengthening patient education. The Ministry of Food and Drug Safety (MFDA) plans to deliberate and write a consultation on the adequacy and validity of the measures to support the safe use of biopharmaceutical self-injection drugs from the 30th to April 3rd. Through this, the policy is to prepare a final draft. Previously, Minutes of the Central Pharmaceutical Affairs Council held in January were also released. Specialists representing representatives of doctors and pharmacists and experts from consumer organizations also attended the meeting. At the meeting, it was said that they agreed to the direction of measures to support the safe use of self-injection drugs. The main content is strengthening education such as directions. However, there was a disagreement between the representatives of physicians and pharmacists over the subject of education. A doctors' group official argued that the hospital should be the center of education, while a pharmacist's group said that the pharmacy should be the educational subject. As pharmacies strengthened their education, it was also suggested that fundamental problems, such as mandatory outpatient’s prescription of self-injection and increase in pharmaceutical charge, should also be considered. Another opinion is that patients should be trained in the hospital for initial treatment and in the pharmacy during continuous treatment. In the end, they all acknowledged the need to strengthen education so that patients could use self-injection. However, there is a slight disagreement over the subject of education because the self-injection system is an exception in the current system of separation of prescribing and dispensing drugs, 'Getting treatment to doctors, dispense to pharmacists'. Saxenda is an injection, but because it can be used by patients outside the hospital, it is also sold in hospitals and in pharmacies. Moreover, as it is used for cosmetic purposes such as weight loss, side effects caused by misuse have also been raised. In the last year's parliamentary assembly, the issue was raised, and there was also an opinion that self-injection prescriptions should be mandatory for outpatient’s prescription. Accordingly, the Ministry of Food and Drug Safety (MFDS) announced that it will prepare measures for abuse and correct use of patients. An official from the Ministry of Food and Drug Safety said, "We are looking for ways to focus on strengthening education within a framework that can be used correctly without abuse by the patient, and plan to make a final plan in the near future through expert opinion". The MFDS is expected to come up with a plan to strengthen video education and practice education with usage, expand public awareness of misuse, strengthen crackdown on illegal advertising violations, and check illegal distribution. However, It is clear that the mandatory outpatient prescription (separation of prescribing and dispensing drugs) and the increase in pharmaceutical charge are not included in the management of the MFDS. In the end, even if the Ministry of Food and Drug Affairs comes out, it is expected that the conflict between physicians and pharmacists will continue despite the subject of sales and guidance of self-injection.
- Policy
- Domestic drugs, access to the Chilean procurement market
- by Lee, Tak-Sun Mar 26, 2020 06:11am
- The KHIDI (Director Deok-cheol Kwon) announced that it has signed a Memorandum of Understanding (MOU) with Chile's Health Procurement Service (CENABAST, Valentin Diaz Gracia, Chief Executive Officer) and Korean companies to advance into public procurement of pharmaceuticals in Chile. The Chilean Health Procurement Authority (CENABAST) manages the public procurement of all medicines and medical devices in Chile and supplies them to public health institutions. Through the signing of this Memorandum of Understanding, the two sides agreed to ▲discover excellent Korean companies that meet procurement needs ▲sign an export contract with the Korean Corporate and CENABAST ▲actively support and cooperate with Korean companies to obtain approval from the Chilean Public Health Service( Instituto de Salud Pública, ISP). In particular, it is said that through this cooperation, products that have not been approved for marketing in Chile can participate in procurement through the preparation of required documents if they have a Korean marketing license. It is said that cooperation with the CENABAST has made it possible to enter the market more quickly. The signing of the Memorandum of Understanding was promoted on the basis of cooperation between the two countries' Ministry of Health (G2G), and the signing of the Memorandum of Understanding between the Ministry of Health and the Republic of Korea in 2015 became an important foundation, the KHIDI said. The Memorandum of Understanding between the Ministry of Health is based on information exchange and joint project cooperation to promote mutual cooperation in areas of common interest, such as health care policy, pharmaceutical and medical device cooperation, and aging. Meanwhile, the KHIDI signed a three-way agreement with the KPBMA (Chairman Hee-mok Won) and the Korea Pharmaceutical Traders Association (Chairman Jang-suk Oh), and plans to cooperate to find companies and derive results to expand the domestic pharmaceutical industry into the Chilean market. To cooperate. It is expected that the agreement will accelerate Korean companies' entry into Chile. Chile has a market of $4.2 billion in pharmaceuticals last year. In addition, the CENABAST's public procurement purchases amounted to $1 billion, of which pharmaceutical products accounted for 84.2%, the highest at $ 850 million. The government's medical spending is expected to continue to increase due to the increased incidence of chronic diseases in Chile, the aging population, and the expansion of access to healthcare services to improve health care. Chile's major importers of pharmaceuticals are the United States, Germany, France and India, and Korea ranks 28th in the total import market. Korean companies such as Daewoong, Korea United Pharm, Green Cross, Daewon Pharmaceutical, Samjin Pharm, Ildong Pharmaceutical, and Boryung have exported biosimilars, anti-cancer drugs, and pharmaceuticals to Chile.
- Policy
- Sanofi’s new laxative line-up DulcoSoft approved in Korea
- by Lee, Tak-Sun Mar 26, 2020 06:11am
- The world’s top-selling constipation treating drug brand ‘Dulcolax’ The world’s leading constipation relief Dulcolax maker Sanofi is expanding the brand line-up. The global company means to consolidate the leadership in the competitive Korean laxative market with new oral solution. On Mar. 23, Sanofi-Aventis Korea has received Ministry of Food and Drug Safety’s (MFDS) approval on DulcoSoft powder (macrogol 4000). In the market, there are two other products with macrogol 400. The non-absorbable osmotic laxative medicine improves defecation by increasing the volume of intestinal fluids to the stools. Macrogol 4000 is widely used in over-the-counter laxative for chronic constipation. Currently Ahn-gook Pharmaceutical’s Forlax powder and Ipsen Korea’s Ipsen Macrogol 4000 powder are two other macrogol 4000 medications approved in Korea. DulcoSoft was actually released once in Korea as an offshoot of Dulcolax brand. Before Sanofi acquired Dulcolax from Boehringer Ingelheim, it was launched in Korean market in 2009. Since Sanofi took over Dulcolax in 2016, Dulcolax-S enteric coating tablet (docusate sodium, bisacodyl) and Dulcolax suppositories (bisacodyl) are available in Korea at the moment. Dulcolax is the world’s top-selling chronic constipation treatment. According to global healthcare consulting firm Nicholas Hall, Dulcolax was the most sold laxative in 2018. Since the release in 1953, Dulcolax has been sold in over hundred countries. The laxative was introduced to the Korean market in 1976, and it has been leading the market for over 17 years. Sanofi says 5.2 packages were sold per minute in 2018. Pharmaceutical market research firm IQVIA found Dulcolax has generated over 13.1 billion won in Korea last year. It topped the market easily putting aside other competitors like Mayqueen-Q by Myung In Pharmaceutical (5.2 billion won), Bicogreen S by Kolon Pharma (2.5 billion won) and Alaxyl by Bukwang Pharm (1.9 billion won). However, the industry experts see that well-known brand name is not enough to defend the title as many laxative makers are aggressively marketing their products. Sanofi’s intention is to add a new line-up to secure the market share. DulcoSoft is recommended to adults and children aged eight years and over. It can be taken one or two sachets dissolved in a liquid to take once-daily, but for children, one sachet in two days is recommended depending on symptoms. The benefits occur within one or two days. However, children should not take the medication for more than three months.
- Policy
- Researchers from Korea start verifying COVID-19 treatments
- by Lee, Tak-Sun Mar 25, 2020 09:57am
- Treatments such as Hydroxychloroquine, used in COVID-19 infected patients, have entered clinical trials in earnest. Large hospitals, such as the AMC, have tried to verify safety and effectiveness through sponsor-investigator trials. Other hospitals besides the AMC have also been reported to apply for a clinical trial for Hydroxychloroquine and are waiting for approval. Jin-Young Yang, deputy director of the MFDS, said on the 24th that five cases of COVID-19 treatment were applied for clinical trials and are currently being reviewed. The cases include 'Panaphix' of Kormipharm, which has already announced the application for clinical trial through public announcement and drugs of some bio companies. In particular, it is said that there is also a clinical trial of researchers on 'Chloroquine' which recently became the topic of discussion that US President Trump recently announced as a treatment for COVID-19 The AMC sponsor-investigator trial has been approved for Hydroxychloroquine as well as Kaletra on the 20th. The AMC plans to conduct a study by March 2025 on 150 mild patients with COVID-19 over 18 years of age. It is planned to take Hydroxychloroquine 400mg once a day for 7 to 10 days, and verify the efficacy through virus levels. Kaletra is also planned to be taken twice a day for 7 to 10 days to verify efficacy in the same way. Kaletra and Hydroxychloroquine are currently being used in Korea as a primary treatment for COVID-19 infection. Kaletra (Ritonavir-Lopinavir) is a product of AbbVie and is an antiviral agent used to treat HIV-1 (human immunodeficiency virus) infection in combination with other antiretroviral agents. Hydroxychloroquine is used for the treatment and prevention of rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin disease and malaria. In Korea, there are Duroc by PMG Pharm, Aruquin by Unimed, Oxiquine by Telcon-pharm, Oxiklorin by Elyson, Chlorquine by Myung In Pharm, Polanil by LegoChem Pharma, Halrochrosin by koruspham, Haloxin by Hanlim, Hyroquin by BCworld Pharm. In a recent overseas study, the efficacy of COVID-19 treatments such as Hydroxychloroquine and Kaletra is insufficient. It is noteworthy what domestic researchers will conclude through clinical trials..
- Policy
- Advanced payment for COVID-19, expanded
- by Lee, Hye-Kyung Mar 25, 2020 06:02am
- care benefits, which were currently applied only to medical institutions in Daegu and Gyeongbuk. However, the support organizations are dedicated to the prevention of COVID-19 spread and treatment of patients and are limited to medical institutions, excluding pharmacies, The NHIS is expanding the nation's special cases of advance payment for medical and health institutions. With regard to the exclusion of pharmacies, an official from the NHIS said, “The special payment for medical care benefit is a measure to alleviate the financial difficulties of medical institutions dedicated to treatment related to the spread of COVID-19”. "The existing medical institutions located in Daegu and Gyeongbuk will expand the exemption of advance payments nationwide,and applications and submissions are accepted from the headquarters of the Corporation and the regional headquarters starting today (23rd)", the NHIS said in a press release on the 23rd. In the case of Daegu and Gyeongbuk areas that have already been accepted, additional support may be received in May, like other areas that are expanding. The amount of support will be paid from the end of March as the average monthly amount of medical care benefit expenses paid for three months from March to May 2019. Institutions with direct influence, such as medical institutions in Daegu and Gyeongbuk regions, infectious disease management institutions, and outbreak patients and treatment institutions, pay 100% of the average monthly reimbursement for March~May of the previous year and 90% for other medical institutions. The standard of payment is the same as that of MERS outbreak, and the monthly reimbursed costs are first subtracted from the applied amount, and if there is an additional claim within the month after the advance payment, the balance is paid after the first offset from the advance payment settlement. This will be offset equally from the cost of medical reimbursement to be paid from July to December (six months). It is explained in detail in the news of the newsletter of the NHIS and the information category of the medical institutions.
- Policy
- Eligibility standards on RSA change for better accessibility
- by Kim, Jung-Ju Mar 25, 2020 06:02am
- The risk sharing agreement (RSA) system implemented to enhance reimbursement access on an expensive drug would be amended and applied on follow-on drugs as well. To this date, multinational pharmaceutical companies and related industry have been strongly demanding for the change. They are now anticipating the change to resolve issues in high-cost new drug accessibility and fairness in pharmaceutical coverage. Korea’s Ministry of Health and Welfare (MOHW) has preannounced the revised ‘Pharmaceutical Decision and Adjustment Standard’ with the said changes on Mar. 23. Accordingly, the ministry is accepting related public opinion until June 11. The main objective of the revision is to reflect changes made from the revised ‘Regulation on National Health Insurance Reimbursement Standard,’ and to improve RSA system to apply the terms on follow-on drugs as well. The revision has expanded RSA-eligible subject scope to include follow on drugs, more specifically cost-effective drugs at a treatment level on par with RSA-covered first-in-class drug. At the moment, RSA is limited to first-in-class drug. However, the RSA subject scope has been constantly criticized as its subject drugs are mostly expensive anticancer or rare disease treatments, and the public has raised issues of fairness in the RSA eligibility. Trying to keep RSA as limited as possible to protect the positive listing system, the government had not expanded RSA eligibility onto follow-on drugs. But as the focus of reimbursement listing system has shifted towards patient-centered accessibility, the government has decided to make the change. Along with the eligibility expansion, the government has established a legal basis to apply RSA on pharmacoeconomic evaluation-exempted drug and drugs approved on condition to conduct Phase III clinical trial that meet the cost-effectiveness assessment criteria. And also, complicated combination formulation with two or more agents would be eligible for RSA. The pharmaceutical adjustment standard would be newly added for drugs with expanded indication as well. The maximum price of a drug, with change in indication, would be adjusted based on the Minister of Health and Welfare’s assessment on the adequacy of the maximum price. The maximum price adjustment would be recalculated based on ‘Pharmaceutical Decision and Adjustment Standard.’ However, depending on an assessment by the Drug Reimbursement Evaluation Committee (DREC), the adjustment could be based on the drug’s history of reimbursement listing and unique quality. After accepting the public opinion, the government is planning to enforce the changes from the day the revision notice is issued.
