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- 2026-05-04 12:09:25
- Policy
- The risk group for COVID-19 depression was 18.5%, down
- by Lee, Jeong-Hwan Jun 13, 2022 05:54am
- The COVID-19 depression risk group surveyed in the first quarter of this year was 18.5%, down from 22.8% in March last year. It is still high compared to 3.2% in 2019, before COVID-19, and the government plans to push for COVID-19 psychological support for daily recovery. On the 3rd, the MOHW made the announcement at a regular briefing on COVID-19. According to the COVID-19 National Mental Health Survey of 2,063 adults nationwide, the depression risk group is on the decline to 18.5%. Specifically, the risk group for depression in March 2020 is decreasing to 18.5% this year, compared to 17.5% in March 2020, 22.8% in March last year, and 18.9% in December last year. However, it is still higher than 3.2% in 2019, before COVID-19. By gender, 20.3% of women were higher than 16.7% of men. In addition, 22.7% of those whose income decreased were at higher risk of depression than 16.7% of those whose income increased or did not change. The suicide rate surveyed in March this year was 11.5%, which was also on the decline, but it was still higher than 4.6% in 2019, before COVID-19. Like the depression risk group, by age, those in their 30s (15.2%), those in their 40s (13.3%), and those in their 20s (11.9%) were high, and those in their 20s (15.2%) were high. By gender, men (12.2%) were higher than women (10.9%). Based on the results of a survey on COVID-19 depression, the MOHW prepares and promotes psychological support measures for daily recovery. According to the transition of the general medical system during daily recovery, psychological support for confirmed patients is converted from existing national and regional trauma centers to local mental health welfare centers to provide comprehensive mental health services in the local community. It also provides customized services for children, adolescents, young people, women, workers, and small business owners who are vulnerable to mental health. The MOHW said, "We will continue to promote psychological support so that government ministries and local governments can restore the people's daily lives in good health and actively support anyone who needs help."
- Policy
- Govt skeptical about using existing vaccines on monkeypox
- by Lee, Jeong-Hwan Jun 09, 2022 06:25am
- The government has said that the use of licensed human smallpox vaccines, antivirals, or vaccinia immune globulin intravenous (VIGIV) to prevent the domestic outbreak of monkeypox should be carefully considered in terms of efficacy and safety. In particular, the authorities explained there is a plan to study whether the 3rd generation smallpox vaccine that is being jointly developed with a Korean pharmaceutical company is effective in preventing monkeypox. The Korea Disease Control and Prevention Agency announced so in its measure to respond to monkeypox that it submitted to the National Assembly on the 8th. Cases of monkeypox are currently arising in western countries such as the United Kingdom, Portugal, Spain, Germany, the Netherlands, and the United States. However, due to the possibility of its influx the disease control and prevention authorities are working to introduce the monkeypox vaccine ‘Jynneos’ that received marketing authorization from the US Food and Drug Administration. Jynneos is a ‘third-generation smallpox vaccine,’ while other smallpox vaccines approved in Korea are classified as ‘second-generation smallpox vaccines.’ The government is skeptical about using the approved second-generation smallpox vaccines, antivirals, and VIGIVs on monkeypox. Although the second-generation smallpox vaccines are known to be 85% effective against monkeypox, KDCA explains that no proper efficacy and safety data exists and their method of administration is too complicated. Thus it is expected that the KDCA will not seriously review the use of approved second-generation smallpox vaccines and treatments until a monkeypox case arises in Korea. KDCA said, “We currently have no monkeypox treatments or vaccines in stock. The US CDC (Center for Disease Control) is guiding the use of smallpox vaccines, antivirals, and VIGIVs to control monkeypox, but recommends its use according to new drug clinical trials.” The KDCA added, “If monkeypox outbreaks in Korea, we plan to discuss the use of VIGIVs that we have in stock as treatment with experts. Also, we are monitoring the development and supply status of monkeypox antivirals in Korea and abroad for their use.” In particular, KDCA announced that a study is being planned to evaluate whether the approved second-generation smallpox vaccine and the third-generation smallpox vaccine that is being jointly developed with a domestic pharmaceutical company show effect in preventing monkeypox. The smallpox co-developer that KDCA mentioned seems to be HK Inno.N. HK Inno.N is the only Korean pharmaceutical company that manufactures a second-generation smallpox vaccine. HK Inno.N is conducting a clinical trial to confirm the preventive effect of its second-generation smallpox vaccine against monkeypox while working to develop a third-generation smallpox vaccine. Third-generation smallpox vaccines are attenuated live vaccines that are expected to improve safety and have reduced toxicity compared to second-generation smallpox vaccines. The KDCA said, “As of now, no vaccine is being developed for the prevention of monkeypox in Korea. However, there are plans to study whether the approved smallpox vaccines and the third-generation smallpox vaccine in joint development with a Korean company is effective against monkeypox.”
- Policy
- Cases for Pre-approval of Ultomiris exceeds 100
- by Lee, Tak-Sun Jun 09, 2022 06:25am
- Soliris (left) and UltomirisThe number of approved Ultomiris administered was 101 until April. Ultomiris, a treatment for paroxysmal nocturnal hemoglobinuria (PNH), has been shown to have completely replaced Soliris, the existing treatment since its benefits in June last year. Both are expensive rare drugs, and must be approved in advance by the Board of Review and Assessment before administration. According to the HIRA on the 8th, a total of 101 cases of Ultomiris were approved in advance by April for PNH patients after their benefits in June. Soliris did not have any prior approval applications for PNH patients at this time. Ultomiris has completely replaced Soliris, at least for new patients. The prospect that Ultomiris, which has improved convenience, would replace Soliris was predicted even before Ultomiris' benefits. This is because the number of Ultomiris injections is once every eight weeks, while Soliris is once every two weeks. The number of injections decreased, so the patient levy decreased compared to Soliris. Price for Ultomiris is 5,598,942 won per bottle and price for Soliris is 5,132,364 won, which is not much different. Considering the number of shots per year, Ultomiris administration is much more economical. Alexion Pharmaceuticals, the developer of the two drugs, succeeded in transforming Soliris' patent expiration crisis into an upgraded Ultomiris. Soliris' biosimilar is about to be released. The domestic vendors of Soliris and Ultomiris are Handok. The difference in the number of pre-approval cases is also reflected in the performance. Based on IQVIA, Ultomiris' sales in the first quarter of this year were 9.6 billion won, overwhelming Soliris, which recorded 2.8 billion won. PNH is a rare blood disease caused by the destruction of red blood cells by complement, which is part of the immune system. Urine color is red, and bruising or bleeding easily occurs. It is a fatal disease in which four out of ten people die within five years if not treated after diagnosis, and requires drug administration. There are about 200 patients in Korea.
- Policy
- Monkeypox becomes Class 2 infectious disease in Korea
- by Lee, Jeong-Hwan Jun 09, 2022 06:24am
- The viral zoonosis monkeypox will be designated and managed as a ‘Class 2 infectious disease’ by law starting today (8th). With its level raised, monkeypox will now be managed and considered to have the same level of risk as COVID-19, tuberculosis, and chickenpox. If a person is confirmed with a Class 2 infectious disease, this must be reported to the quarantine authorities within 24 hours, and the infected person is required to undergo mandatory quarantine. The Korea Disease Control and Prevention Agency said, “In consideration of the characteristics of monkeypox including its severity, monkeypox will be designated as a ‘Class 2 infectious disease that is designated through discussion between the KDCA commissioner and MOHW minister.’ Other notices that have been partially revised include the notification on the diagnostic criteria for infectious diseases and the notification of infectious diseases that the KCA commissioner deems in need of emergency quarantine measures. The main content of the revised notice is to classify monkeypox as a second-class infectious disease and give treatment and quarantine obligations to confirmed patients. Under the Infectious Disease Prevention Act, patients confirmed with statutory infectious diseases are obligated to report their infection. 22 diseases including COVID-19, tuberculosis, and chickenpox are designated as Class 2 Infectious Diseases that require isolation in consideration of the possibility of its transmission. The authorities have issued an “interest” alert for monkeypox after holding a risk assessment meeting on monkeypox with the Infectious Disease Risk Management Committee at the end of last month. Also, due to the increase of overseas visitors and infected cases abroad, the authorities had set up a separate task force to preemptively respond to the rising possibility of its influx to Korea. Previously, the KDCA had evaluated that there is an ‘intermediate’ risk of infection in high-risk groups that have contacted confirmed or symptomatic patients without appropriate personal protective equipment (sexual contact, cohabitant), and a ‘low’ risk of infection in the general public. Monkeypox is mainly transmitted through close physical contact and has a lower transmission rate than COVID-19. Monkeypox, originally an endemic that had previously been confined to Central and West African countries, was first reported in the UK early last month, followed by sporadic reports of the disease globally including in the United States, Spain, Germany, France, Morocco, and Israel. According to the WHO, 780 cases of the disease in 27 countries have been confirmed in non-endemic areas as of the 5th of this month. The authorities are also in the process of introducing a ‘third-generation’ vaccine that has proven efficacy against monkeypox. Bavarian Nordic’s ‘Jynneos’ is being considered a likely candidate. The KDCA already owns 35 million courses of a second-generation smallpox vaccine in preparation for a public health crisis but is not considering using the stockpile for public vaccination. The authorities plan to treat confirmed patients in isolation wards as soon as a case of monkeypox occurs in Korea. Whether to impose quarantine on those in close contact is still being discussed. The authorities have asked those who visit countries where monkeypox occurred to practice good personal hygiene and contact the KDCA call center (1339) if suspicious symptoms occur within three weeks after returning to Korea.
- Policy
- Evusheld is expected to be introduced this month
- by Lee, Jeong-Hwan Jun 09, 2022 06:24am
- The government is expected to introduce Evusheld, a COVID-19 antibody treatment that is administered to patients who do not form antibodies well even with vaccinations, to Korea this month. Lee Ki-il, the first general coordinator of the Central Disaster and Safety Countermeasures Headquarters, presided over a meeting at the Sejong Government Complex on the 8th and said, "We will complete the EUA procedure of the Evusheld within June and guide local governments and the medical community." Lee Ki-il, the first general coordinator, explained, "It is a preventive antibody treatment for those who are difficult to form antibodies through vaccines because they are receiving immunosuppressants such as blood cancer patients and organ transplant patients." He added, "As the additional budget was confirmed last week, we will quickly push for the supply of Evusheld in Korea." From that day on, all overseas immigrants will be exempted from quarantine regardless of whether they have completed vaccination or their nationality. All restrictions on flights at Incheon International Airport will also be lifted. However, pre- and post-entry inspections are maintained to manage the inflow of new mutations. All entrants must submit PCR test results conducted within 48 hours before entering the country or rapid antigen test results conducted within 24 hours, and submit PCR test results within 3 days after entering the country. Recently, the COVID-19 situation has been managed stably. The number of weekly confirmed patients decreased for 11 consecutive weeks, and the number of critically ill patients and deaths last week also decreased by 29.5% and 56.5% compared to the previous week, respectively. As of the 8th, the operation rate of inpatient bed was also reduced to within 10%, including 8.8% for severe beds, 9.4% for semi-critical patients, and 6.8% for moderate beds, stressing that there is enough room for medical response. The infectious reproduction index was 0.74, which has remained less than 1 for 10 consecutive weeks. The first general coordinator said, "Experts continue to warn of the possibility of a COVID-19 pandemic in the summer. There are still many risks of re-pandemic, including local festivals and vacations in summer and the use of indoor air conditioners in an enclosed environment," he said.
- Policy
- Bringing 3rd gen monkeypox vaccine to Korea in discussion
- by Lee, Jeong-Hwan Jun 08, 2022 05:56am
- The government announced on the 7th that it has started discussions on the quantity and schedule for bringing a ‘3rd generation monkeypod vaccine’ to Korea with its manufacturer. The authorities decided to accelerate the introduction of this third-generation vaccine with proven efficacy as the number of confirmed cases of monkeypox continues to increase worldwide and the possibility of its inflow to Korea rises. The Danish company Bavarian Nordic’s ‘Jynneos’ is the only monkeypox vaccine that received marketing authorization in the world. Jynneos is currently available for vaccination in the US and Canada after receiving FDA approval in 2019. Jynneos is an attenuated, live, non-replicating smallpox and monkeypox vaccine used for the prevention of smallpox or monkeypox in adults over 18 years of age that is known to provide 85% protection against monkeypox. Geun-Young Kwon, head of the vaccination management team of the Vaccination Response Promotion Bureau of the Korea Disease Control and Prevention Agency (KDCA), said, “We are currently discussing the introduction of a third-generation smallpox vaccine to Korea with its manufacturer. We will provide information on its quantity and schedule as soon the discussions are complete.”
- Policy
- The price gap between Memantine products is more than 2.5x
- by Lee, Tak-Sun Jun 07, 2022 06:04am
- Original for Memantine HCl The price difference between Memantine producst was more than 2.5 times. This is because if there are more than 20 generics depending on the price calculation formula, new products are listed at 85% of the lowest price. Memantine preparations have originally had a large price gap between products, but the gap is widening according to this price calculation formula. According to the industry on the 6th, Ibixa (Memantine HCl) of I-World Pharmaceutical was listed at 334 won on the 1st, which is 85% of the lowest price of the listed same product, as more than 20 products are listed. Before Ibixa's registration, 64 Memantine HCl 10mg preparations were registered, and the lowest price was 393 won for Dongkook Pharmaceutical's Mmentine 10mg. Accordingly, Ibixa was registered at 334, which is 85% of 393 won. Since there are more than 20 generics, the drug price will fall again to 85% of the lowest price if the next product is listed. With the registration of Ibixa, the gap between the highest and lowest prices of Memantine products is more than 2.5 times. The highest price is 845 won. The original for Memantine, Ebixa, costs 803 won. In particular, the price difference between the same drugs is widening in dementia treatments. Donepezil tablet 5mg has quadrupled the price difference between the same drugs. It is analyzed that this is due to the specificity of the dementia treatment market. This is because the market size is large and competition is fierce, but it is not easy to enter customers. Regardless of the price difference, this market has high confidence in patients and medical staff for the original. In addition, because the prescription rate of nursing hospitals that are difficult to access (CSO) is high, the lowest-priced products targeting this are also emerging. An official from the pharmaceutical industry said, "The price strategy of dementia treatments takes into account the specificity of Rx." He explained, "In the case of low-priced drugs, there are preferred medical staff because they are not burdensome to use with other drugs, and it seems that they were aiming for the demand to purchase high-priced drugs at low prices and receive incentives." Analysts say that the price difference does not have a significant impact on patients because patient copy of dementia patients is small. However, the industry reports that such a price difference occurs because the preferences of doctors are different.
- Policy
- Price Negotiation for One-shot Treatment Zolgensma
- by Lee, Tak-Sun Jun 07, 2022 06:04am
- Zolgensma of Novartis, which passed the Drug Reimbursment Evaluation Committee of the HIRA on the 12th of last month, began negotiations on drug prices to register health insurance benefits. Given that Kymriah of the same company, which has attracted attention as a once-in-a-lifetime drug, succeeded in being reimbursed two months after passing the Drug Reimbursment Evaluation Committee, attention is being paid to whether Kymriah will be able to proceed quickly. According to the industry on the 3rd, the NHIS and Korea Novartis will start negotiations on the drug price for the SMA treatment Zolgensma on the 25th of last month and proceed for two months until the 25th of next month. Earlier on the 12th of last month, Zolgensma was recognized as a condition for pre-approval of medical care benefits and application of RSA and caps based on patient performance at the Drug Reimbursement Evaluation Committee. Zolgensma is an ultra-high-priced drug sold in the U.S. for about 2.5 billion won, and it is urgent to register health insurance benefits for patients to relieve their economic burden and receive medication. There are many opinions asking for registration in that most of the patients with SMA, a rare disease, are children. The political community has welcomed the passage of the Drug Reimbursment Evaluation Committee. Choi Hye-young, a member of the Democratic Party of Korea, posted an SNS post titled "We are happy that it passed the Drug Reimbursment Evaluation Committee for SMA treatment," and Lee Jong-sung also said, "The adequacy of health insurance benefits for Zolgensma was recognized at the first review of the Yoon Seok-yeol government." "It is a decision that fits the policy philosophy of the Yoon Seok-yeol government to further protect the people in need," he welcomed. Zolgensma is compared to Kymriah, which previously succeeded in reimbursement for it, in that it is administered once in a lifetime and sold by Novartis. With the registration of Kymriah health insurance, it can be administered at up to 5.98 million won. As political circles and patient groups are paying keen attention, attention is being reimbursed to whether Zolgensma will succeed in making reimbursement as fast as Kymriah. If the drug price is settled within the negotiation period, health insurance benefits will also be available from August 1. As ultra-high-priced drugs appear one after another, health insurance finances are expected to be burdened by rising drug costs. Therefore, it is highly likely to affect the pharmaceutical industry depending on what position the Yoon Seok-yeol administration, which has just started, takes on the issue of drug cost management. Some analysts say that there is a possibility that generic drugs may be considered to be lowered due to the influence of the ultra-high-priced new drug registration.
- Policy
- Zerbaxa passed evaluation committee after 4 yrs of challenge
- by Lee, Tak-Sun Jun 03, 2022 06:36am
- MSD Korea's antibiotic drug Zerbaxa has been recognized for its benefit adequacy by the HIRA Drug Reimbursment Evaluation Committee. As a result, it is likely to be listed on health insurance benefits through NHIS negotiations. The HIRA released the results of the 6th Drug Reimbursment Evaluation Committee review on the 2nd, and determined that Zerbaxa was appropriate for complex intra-abdominal infection, complex urinary tract infection, and hospital infection pneumonia. Zerbaxa is a super antibiotic approved in Korea in 2017, and is evaluated as a drug that can overcome antibiotic resistance. Dr. Low, who has challenged since 2018, succeeded in passing the Drug Reimbursment Evaluation Committee for the first time in four years. In 2019, the Drug Reimbursement Evaluation Committee recognized the clinical necessity but non-reimbursed because it was difficult to see that the clinical treatment rate was inferior. As the MOHW expanded the anti-bacterial system for treating symptomatic infections to PE in 2020, Zerbaxa also seems to have benefited.
- Policy
- Lioresal was newly listed
- by Kim, Jung-Ju Jun 02, 2022 05:59am
- With the new registration of 10mg/5mL of the skeletal muscle relaxant, the standard was newly established this month. Jakabi 5mg, which belongs to an anti-malignant tumor drug, has been clearly set in accordance with the change in permission from the MFDS. The MOHW announced that it partially revised the "details on the criteria and methods for benefits" as of the 1st. Looking at the change table, 10mg/5mL of Lioresal was newly registered, and the standard for this ingredient was newly established by applying the permission of the MFDS. According to the MFDS' recognition, this drug is used to treat severe, chronically increased muscle tension that has not been treated with standard drugs for progressive neurological diseases in the brain and spinal cord accompanied by physical and mental symptoms. The scope of benefit has been clarified as the MFDS' permission for Jakabi 5mg has been changed. The added indication is a non-antibiotic therapy. Benefits are expanded in the general principle of oral chronic hepatitis B treatment. The MOHW and the Korea Appraisal Board deleted the taboo and expanded the benefit, considering that the permission for "administration of patients with mild, moderate, and severe" of the drug was changed and that Besifovir was recommended as an initial treatment if there was a decrease in renal function. The MOHW and the HIRA made the decision in consideration of domestic and foreign permits, textbooks, clinical medical guidelines, clinical research documents, opinions of related academic societies, and approval for the use of non-reimbursement exceeding the permission of the MFDS. Looking at the newly established contents in detail, Voriconazole injections that exceed the permission can be recognized if they are administered according to the standard. Subject patients are only adult patients diagnosed with Fungal Endophthalmitis who are confirmed to have fungal infection in the blood or eyeball, and are recognized when administered in the anterior injection (50 μg/0.1ml) and in the vitreous cavity (50 μg/0.1ml~100 μg/0.1ml). Anti-inhibitor coagulant complex injection Faiva is paid more. The MOHW and the HIRA have a need for preventive therapy because antibody patients themselves have a very high tendency to bleed, and other hemophilia drugs have recently recognized preventive therapy for antibody hemophilia patients, so they decided to expand their benefits. Specifically, it is recognized up to six times per visit, and a total of 12 times per four weeks. However, if bleeding occurs after administering 12 doses every 4 weeks and visits the hospital, it can be recognized up to 2 times per visit, and a doctor's note must be attached. In the case of in-house administration, the in-house administration is included when calculating the number of administrations.
