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- 2026-05-14 05:31:33
- Policy
- COVID vaccine side effects proven by the Government
- by Kim, Jung-Ju Nov 24, 2022 05:50am
- In order to prevent new infectious diseases such as COVID-19, a revision to the related law will be promoted to allow the government to receive medical and nursing expenses first if it is damaged by side effects after being vaccinated. Chung Chun-sook, a member of the Democratic Party of Korea's Health and Welfare Committee, proposed today (22nd) a bill to partially revise the Infectious Disease Prevention and Management Act. The revision aims to prevent damage as most of the people voluntarily participated in vaccination for community safety when new infectious diseases such as COVID-19 are prevalent around the world, but some people suffer from diseases, disorders, or deaths due to abnormal reactions caused by vaccination. The application of this amendment is limited to cases where new infectious diseases are prevalent. It also includes special cases such as expanding the scope of compensation for existing vaccination damage, providing medical and nursing expenses first, and ensuring that the state is responsible for proving the causality with vaccination to compensate the public for damage caused by new infectious diseases. Lawmaker Chung's office explained, "The main purpose is to apply the revised law from the beginning of vaccination due to COVID-19 and to compensate the public as much as possible by applying it even when compensation for vaccination is set." Meanwhile, it included Kang Byung-won, Kang Hoon-sik, Kim Won-i, Kim Han-kyu, Yang Kyung-sook, In Jae-geun, Choi Hye-young, Huh Jong-sik, Kang Eun-mi of the Justice Party, and independent Kim Hong-gul.
- Policy
- The government are in full swing discussing support
- by Lee, Jeong-Hwan Nov 24, 2022 05:50am
- The ruling party and the government's move to expand access to patients with severe and rare diseases, which was President Yoon Suk Yeol's presidential pledge, is notable. On the 21st, the People's Power, the Ministry of Health and Welfare, and the Ministry of Strategy and Finance will hold a policy meeting at the National Assembly to prepare measures to support the treatment of severe and rare diseases. The move is aimed at collecting opinions from private experts on the establishment of nursing hospitals specializing in severe and rare diseases and supporting medical expenses for new drugs for rare diseases and reflecting them in related policies and budgets. The policy meeting will be attended by People's Power figures, including Sung Il-jong, chairman of the policy committee, Lee Chul-kyu, secretary of the Special Committee on Budget and Accounts, and Lee Jong-sung, a member of the Health and Welfare Committee. In the government, Park Min-soo, the second vice minister of welfare, Hwang Soon-kwan, the Ministry of Economy and Finance, and the director of chronic disease management at the Korea Centers for Disease Control and Prevention will attend. In the private sector, the co-CEO of the Seungil Hope Foundation, permanent directors, and chief-level officials will be present. Ahead of the review of the Special Committee on Budget and Accounts, the People's Power announced that it would set up a regional specialized institution to deal with rare diseases of children and adolescents, establish a nursing hospital for rare incurable diseases such as amyotrophic lateral sclerosis(ALS), and increase the budget by 34.5 billion won to support medical expenses for non-reimbursed new drugs. Analysts say that it is unusual for the ruling party's policy committee to directly mention medical expenses for new drugs for severe and rare diseases. It is interpreted as a move to fulfill President Yoon's presidential campaign pledge and meet the demand for access to new drugs for incurable diseases raised by the private sector. President Yoon has made a pledge to resolve policy blind spots on treatments for severe and rare diseases and inject finances where practical guarantees are needed.
- Policy
- Gov’t to increase drug price reference countries
- by Lee, Tak-Sun Nov 23, 2022 06:04am
- The Health Insurance Review and Assessment Service made a preannouncement of a revision plan to expand the number of reference countries used to evaluate new drugs from 7 to 9 (US, UK, Germany, France, Italy, Switzerland, Japan, Canada, Australia·A9). After opinion inquiries, the revised plan will take effect in January next year. Although the reference countries are used to evaluate the adequacy of reimbursement of new drugs that are waived submission of pharmacoeconomic evaluation data, domestic pharmaceutical companies that own more generics than new drugs are also voicing opposition due to concerns over the next step HIRA will take afterward. According to industry sources on the 22nd, HIRA is also preparing reevaluations on listed drugs based on the revised plan to expand the number of price reference countries. Therefore, it is analyzed that reevaluations will be carried out sequentially from 2024 at the earliest after making preparations next year. The industry had expressed concerns about the very low price of generic drugs in Australia, which was added as a drug price reference country in the revision. Australia is known to introduce the cheapest drugs through competition. According to research, some generic drugs in Australia are set at one-fifth of the price in Korea. Therefore, using the drug price of 9 countries including Australia when conducting reevaluations on the adequacy of listed drugs will likely reduce the price of listed drugs in Korea. In other words, it will have the same effect as the unilateral price cut that had been made in 2012. Another industry concern is that such reevaluations are also being driven by policies after the ruling party pointed out that generic prices in Korea are high at the last NA audit. An industry official said, “If the expanded reference countries are used not only for pricing of new drugs but also reevaluations of all listed drugs, the price of generic drugs will inevitably be cut.” The reevaluation plan of listed drugs was also discussed with the expansion of pricing reference countries at the public-private working group meeting that had been held previously. Thus, HIRA is expected to start preparations after including the reevaluation plan for listed drugs in the 2nd Comprehensive Plan of National Health Insurance according to the expansion of reference countries. As a result, the industry believes that the criteria will be set next year and the drug price of listed drugs adjusted after sequentially receiving reevaluations from 2024.
- InterView
- The key to treating stroke tx is preventing the recurrence
- by Kim, Jin-Gu Nov 23, 2022 06:04am
- Stroke is a battle against time. Whether the blood vessels in the brain are blocked (brain infarction) or burst (brain hemorrhage), blood should be supplied to the brain normally within a short period of time. The medical community explains that the golden time of stroke is 4.5 hours. This means that the problem can be solved only when the symptoms occur and arrive at the hospital within 4 hours and 30 minutes. The importance of preventive treatment has been increasing. As the results of stroke treatment have improved compared to the past, drug treatment to prevent the recurrence of patients with stroke once has become more important. Park Jong-kyu, a professor of neurology at Cheonan Hospital affiliated with Soonchunhyang University, said, "The key to treating stroke drugs is to prevent a recurrence," adding, "Various drugs are used differently depending on the cause. Since the brain is a drug used in special areas, it should be used carefully in consideration of the side effects of bleeding, he said. ◆ Antiplatelet agents for vascular stroke and anticoagulants for embolic stroke There have been changes in the treatment of stroke over the past decade. In the past, even if a stroke occurred, it often came late. Many patients fell down holding the back of their necks and visited the emergency room. As such, the treatment period has been delayed. Major surgery was needed and the prognosis was not so good. As public awareness of stroke has been aroused, treatment performance has improved significantly recently. Unlike in the past, more and more patients visit the hospital due to initial symptoms, such as poor speech, narrow vision, and poor finger grip. Treatment methods are also changing. The importance of drug treatment is increasing as a secondary preventive treatment to prevent recurrence after treating an initial stroke. Professor Park Jong-kyu said, "Depending on the cause of stroke, drugs are used differently," adding, "In the doctor's opinion, if it is a vascular stroke caused by blood clots accumulating in the cerebral blood vessels, an anticoagulant is used." Professor Park emphasized, "In the case of anticoagulants, it may look better to prevent the recurrence of stroke in that it prevents blood itself from coagulating, but it should be used carefully because there is a high risk of side effects of bleeding." ◆"Anticoagulants have a high risk of bleeding side effects, so they should be used carefully for stroke" According to Professor Park, anticoagulants are mainly used for patients suffering from arrhythmia or heart valve disease at the same time. The problem is when heart disease is not clearly diagnosed. In this case, the doctor's judgment is involved. Professor Park explains, "Clinically, it seems that an embolized blood clot came from under the heart and blocked the cerebral blood vessels, but if there is not enough evidence." It is right to use antiplatelet drugs, but he explains that he uses anticoagulants on a limited basis because there is often a high risk of stroke recurrence. Multiple cerebral infarctions, in which several blood vessels in the brain are blocked at the same time, are a typical example. If the left blood vessel of the brain is observed to be blocked when the blood vessel of the brain is photographed, the cerebral infarction area should also be on the left side of the brain. However, there are patients who often have cerebral infarction on the right side of the brain. At this time, the location where the blood clot occurred is presumed to be below the heart, not the brain. At this time, if the patient has no history of heart disease, the anticoagulant is used under the judgment of a doctor that the patient lacks the basis for anticoagulant treatment, but the risk of recurrence is high. If multiple cerebral infarctions are not the first time, or if cerebral infarction occurs during recurrence prevention treatment with antiplatelet drugs, anticoagulants are used. Professor Park said, "Most of the patient's risk factors and mechanisms for cerebral infarction are identified and drug treatment is carried out accordingly to prevent a recurrence." ◆ Stroke is the fourth leading cause of death in Korea, and the number of young patients is increasing recently Severe or acute stroke is still treated surgically. Patients with blocked large blood vessels in the brain or blocked heavy blood vessels and poor symptoms are the targets. The key is to treat it as soon as possible. Generally, patients should visit the hospital within 4.5 hours. Professor Park said, "Finding and operating blood vessels is only possible when large blood vessels are blocked. In the case of heavy blood vessels and small blood vessels, surgery is attempted only when the symptoms are severe. He said, "Because there is a risk to the treatment itself, we solve it with thrombolysis through veins instead of surgery." Professor Park explained, "It can be rather harmful to perform surgery after golden time." He added, "This is because the bleeding occurs in weak areas in the process of penetrating blood vessels and supplying blood again, which can be dangerous for patients." Stroke is the fourth most fatal disease in Korea. According to the HIRA, 590,000 patients were diagnosed with stroke as of 2020. The perception of stroke has changed and the number of patients is increasing faster as the population ages rapidly. This is due to the increase in patients with hypertension and hyperlipidemia, which are the underlying diseases of stroke. The medical community estimates that the incidence rate doubles every 10 years after the age of 55. Professor Park explained, "As you get older, the risk factors you have are more likely to cause problems, so it will affect the increase in stroke." He said, "Recently, the number of young stroke patients under the age of 45 is increasing rapidly increasing. "There are concerns as risk factors for stroke, such as sleep apnea, are diversifying," he said.
- Policy
- MFDS recruits companies to develop 6 National Essential Drug
- by Lee, Hye-Kyung Nov 23, 2022 06:04am
- The government is busy recruiting institutions to develop domestic manufacturing technology for items that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines. The Ministry of Food and Drug Safety had recently selected 11 products, including 5 raw materials and 6 finished products, as candidates for Stage 1 development after deliberation by the Product Selection Committee, and posted an open recruitment for developers on the webpages of research institutions including Korea Orphan & Essential Drug Center and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The government will additionally recruit developers for items only a single company had applied for, which include 2 finished products (‘Amiodarone Inj,’ ‘stiripentol Cap’) and 4 APIs (‘amiodarone (amiodarone tablet, injection),’ ‘ibuprofen (ibuprofen injection 5mg/ml),’ ‘ketoconazole (ketoconazole tablet),’ ‘benserazide (levodopa, benserazide tablets)’). Although there is no limit to the number of development projects each institution may apply for, if the same applicant applies to develop the APIs that are candidates for a stable supply of national essential drugs and use them for the development and production of the finished drugs, the items will be recognized as two separate items and be supported separate R&D expenses. The MFDS selected drugs that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines and has been carrying out the ‘Research Project for Managing Stable Supply of National Essential Drugs’ from this year until 2026. Despite the need to maintain a stable supply of national essential drugs at all times, there recently has been a shortage of raw materials as well as finished drugs internationally due to the COVID-19 outbreak. In particular, Korea is heavily dependent on imported drugs, therefore criticism had been raised on the need to prepare a supply chain for essential drugs in case of the rise of public health crises in the future. in The MFDS will invest a total of KRW 5 billion for 5 years - KRW 1 billion each year- to build a stable supply system for national essential drugs that have supply concerns and will aim to develop raw materials and finished drug production technology for domestic production. In the first stage (first-second year) of the project, the development targets will be selected and over 40% of the technology for the target drugs will be developed. In the second stage (third-fifth year), the remaining technology will be developed and be subject to comprehensive assessments. The MFDS said, "In addition to developing the technology for the localization and self-sufficiency of API manufacturing, we will also expand the recognition of multiple specifications of APIs when adding API manufacturers to diversify the supply chain for APIs. Also, if a disruption in supply is expected, we will promptly handle related complaints including adding drug substance manufacturers, etc."
- Policy
- Forxiga Prodrug will be reimbursed for five months
- by Lee, Tak-Sun Nov 23, 2022 06:04am
- ForxigaProdrug of Forxiga, an SGLT-2 diabetes treatment drug that Dong-A ST succeeded in avoiding patents through the development of drugs, will be listed on the 1st of next month. It is five months before the expiration of the patent. Earlier this month, it was possible because it succeeded in avoiding the duration of the material patent, which ends in April next year. The Ministry of Health and Welfare recently disclosed this fact through an administrative notice of the revision of some details on the criteria and methods for applying for medical care benefits. Dong-A ST's "Dapapro 10mg" will be newly registered on the 1st of next month and added to the standard for diabetes treatment. Dapapro was granted permission on 23 August. At that time, it was unclear whether Dapapro would be released before the expiration of its patent. This is because Dong-A lost the second trial of a patent suit against AstraZeneca, a patent holder of Forxiga, in February. Dong-A challenged the patent that Dapapro, a prodrug with a different chemical structure from the original, was not within the scope of Forxiga's material patent rights, but it was blocked in the second trial. The Korean Intellectual Property Tribunal, which is the first trial, decided that it was not within the scope of rights as requested by Dong-A. The ruling could have put Dong-A ST's early launch efforts in vain. This is because there is not much time left until the patent expires. However, Dong-A succeeded in avoiding patents on the 2nd of this month through a new patent lawsuit. This time, it was argued that Dong-A ST products were not included in the rights on the 917th day of the duration added to a material patent for Forxiga. For now, Dong-A ST is reportedly coordinating internally with the goal of releasing it before February next year if it is paid on the 1st of next month. Currently, the Ministry of Food and Drug Safety has approved 225 products containing Dapagliflozin. However, among them, only seven items from AstraZeneca, the original company, are on the market. It is virtually difficult to sell the remaining items until the patent expires in April next year. Dong-A ST is launching early alone. It is the first SGLT-2 generics in Korea. However, there is a possibility that the direction of patent litigation will emerge as a variable. It is not known whether AstraZeneca, who lost the patent tribunal, will appeal. If AstraZeneca expresses her intention to appeal, it will have to fight again in the patent court. If the ruling is overturned in the patent court, the sale of the product must be stopped. If there is a record of selling before then, AstraZeneca can also file a compensation suit based on this. It is highly expected that Dong-A ST will not miss this opportunity to dominate the market. Although it actively responds to patent lawsuits, it is expected to focus its efforts on marketing to preoccupy the market regardless of the outcome. It is reported that Dong-A ST believes that the patent issue has been resolved and judges the early release before the expiration of the patent.
- Company
- Kadcyla can be prescribed after registering benefit
- by Eo, Yun-Ho Nov 23, 2022 06:04am
- According to related industries, anticancer drugs such as ADC and Antibody-drug conjugate Kadcyla and CDK4/600 inhibitor Verzenio are entering the early breast cancer area in Korea. Kadcyla was already listed on the insurance benefit list in July, and the actual prescription began. The drug, which was used for the second or more treatment of HER2-positive metastatic breast cancer, has expanded access to postoperative adjunct therapy in HER2-positive early breast cancer patients with invasive residual lesions after receiving prior chemotherapy, including Taxane and Trastuzumab. The effectiveness of Kadcyla's early breast cancer was confirmed through an open-label study in phase 3 (KATHERINE). KATHERINE is a study comparing the efficacy and safety of the Kadcyla-only and Trastuzumab-based preoperative adjuvant group in 1,486 HER2-positive early breast cancer patients who were confirmed to have invasive residual lesions in the surgical site or armpit lymph nodes even after undergoing taxane and Trastuzumab-based preoperative adjuvant therapy. As a result of the study, the 3-year invasive disease-free survival (iDFS) of the Kadcyla solo administration group was 88.3%, an 11.3% improvement over the Trastuzumab solo administration group (77.0%), and a 50% reduction in the risk of disease recurrence or death. Verzenio succeeded in securing HER2-negative early breast cancer indication. This drug obtained additional approval from the Ministry of Food and Drug Safety on the 19th for HR+/HER2-, high-risk early breast cancer with lymph node-positive recurrence. The enlargement of the indication was based on the results of the Phase III clinical study cohort 1 of Verzenio's monarchE in 5,637 adult women and men at high risk of lymph node-positive type HR+/HER2- who underwent resection. As a result of the monarchE study, both IDFS (Invisible Disaster-Free Survival) and DRFS (Distant Relapse-Free Survival) at the time of follow-up 3 years showed significant improvement compared to the control group in the Verzenio administration group. The Verzenio administration group showed a 30% reduction in risk of recurrence and death within 3 years compared to the control group (88.8% of the 3-year IDFS ratio with Verzenio+endocrine therapy, 83.4% of the endocrine therapy alone), and a 31% decrease in risk of remote recurrence and death. The proportion of early breast cancer patients, which is between 0 and 1, accounts for more than half of the total breast cancer patients (as of 2018), emphasizing the importance of reducing recurrence rates through optimal treatment.
- Company
- Imjudo is expected to be introduced in Korea
- by Eo, Yun-Ho Nov 23, 2022 06:03am
- Another immuno-cancer drug with CTLA-4 inhibitory mechanism is expected to be introduced in Korea. According to related industries, AstraZeneca Korea has submitted an application for domestic permission for CTLA-4 inhibitor Imjudo, a partner in combination therapy for PD-L1 inhibitor Impinzi. The combination therapy of Impinzi and Imjudo was approved by the U.S. FDA last month as an irreversible hepatocellular carcinoma treatment. Combination therapy is the only dual immuno-cancer therapy allowed to date for the first round of liver cancer. Combination therapy is a STRIDE (Single Tremelimumab Regular Interval Durvalumab) strategy in which Impinzi is additionally administered at regular intervals every 4 weeks after one dose of Impinzi 1500 mg and Imjudo 300 mg. This combination therapy demonstrated OS benefits in phase 3 clinical HIMALAYA study, lowering the risk of death by 22% compared to the control Nexavar monotherapy. The overall survival rate in the third year was 31% in the Impinzi and Imjudo combination therapy group and 20% in the Sorafenib monotherapy group. Imjudo combination therapy recently added a lung cancer indication in the United States. In phase 3 clinical POSEIDON study on which the permit was based, the patient group receiving a combination of Impinzi, Imjudo, and platinum-based chemotherapy showed a 23% lower risk of death compared to various chemotherapy controls. The overall survival rate in the second year was 33% in the combined group and 22% in the control group. Meanwhile, Imjudo is conducting a phase 3 study of combination therapy with Impinzi in several types of cancers, including local liver cancer (EMERALD-3 study), small cell lung cancer (ADRIATIC study), and bladder cancer (VOLGA and NILE study).
- Company
- Attention focused on whether Luxturna will be reimb in Korea
- by Eo, Yun-Ho Nov 22, 2022 06:04am
- Discussions on expanding coverage of the one-shot gene therapy ‘Luxturna’ is not making much progress. Therefore, the industry’s eyes are on whether Novartis Korea’s Inherited Retinal Dystrophy (IRD) treatment Luxturna (voretigene neparvovec) will be presented as an agenda for deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee within this year. Novartis Korea applied for reimbursement of the drug in September last year, but no news has been heard on its passage of the Drug Reimbursement Standard Subcommittee until now. However, based on the speed of progress, the drug can still be listed in the first half of next year at the earliest. By replacing the defective or defective RPE65 gene - one of the causes of IRD - with a normal gene, Luxturna restores the visual function of an IRD patient with a single administration. In other words, the drug provides a fundamental cure for IRD. After being granted a Breakthrough Therapy Designation by the FDA in 2014, the drug was approved as an orphan drug in 2016, then granted priority review and a fast-track designation in 2017. IRD is a rare disease in which vision loss occurs due to mutations in genes responsible for the structure and function of retinal photoreceptors. In addition to over 20 ophthalmologic diseases, IRD leads to vision loss and may cause complete blindness in certain patients. There are currently over 300 genes that have been identified as being associated with IRD. IRD, which is caused by the mutation in RPE65 gene, causes abnormalities in the visual cycle of the retina that converts visual information into a neural signal and delivers it to the brain. The mutation in the RPE65 gene reduces the RPE65 protein essential to the visual cycle and destroys the retinal cell, gradually narrowing the field of vision to eventually result in blindness. Meanwhile, the efficacy of Luxturna was established in a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, which was 1.6 points higher than the 0.2 points in the control group.
- Opinion
- [Reporter's view] Poor COVID-19 vaccine inducement
- by Nov 22, 2022 06:04am
- "Did you get the COVID-19 vaccine in winter? Mom and dad are the ones who should be vaccinated" The mother answered in a casual manner. "It's okay. I'm in my 60s, so I don't have to get it." "What are you talking about? You have hyperlipidemia. Get it right quickly." "It's okay. I think it'll pass lightly even if I get COVID-19." But will parents listen to the government's recommendations when she doesn't listen to their daughter easily? The government is trying to increase the vaccination rate for COVID-19. Understandably, a crisis is detected in recent COVID-19 statistics. As of the 21st, the number of critically ill patients hospitalized for COVID-19 was 465, up 14 from 451 the previous day. It is the highest level in two months since September 21 (494 people). The cumulative death toll from COVID-19 exceeded 30,000. As the number of deaths increased, the fatality rate also rose to 0.11%. As the number of confirmed cases increased due to the 7th re-pandemic, the average number of new confirmed cases per day over the past 7 days reached 52,002. In the end, it is necessary to protect the vulnerable group of COVID-19 with a vaccine, but the vaccination rates for booster shots in winter for the elderly aged 60 or older or those related to vulnerable facilities are only 17.3% and 17.6%, respectively. Eight out of 10 elderly people did not receive a divalent vaccine. The quarantine authorities set an additional vaccination period for winter from this week to the 18th of next month and started to encourage vaccinations centered on the elderly and vulnerable facilities. The goal is to complete the divalent vaccination of more than half of the elderly aged 60 or older within this period and achieve a 60% vaccination rate for vulnerable facilities. In contrast to these big goals, the incentives are fairly poor. Incentives given to individuals include temple stay discounts, cultural experience benefits such as free admission to palaces and Neungwon, and discounts when using local governments' facilities. From a child's point of view, it is unlikely that my parents will get a vaccine to go to Temple Stay or Palace. Even the old palaces and ridges are already open for free to those over 65. The public perception of COVID-19 has already changed too much. Even if you get COVID-19, you don't think it's a big deal, and rather, you're scared of the side effects of vaccines. They are not vaccinated for prevention but vaccinated for necessity. There are cases where you need to go on a trip, but you need booster shot certification, or if you don't get a vaccine, there are disadvantages. In this situation, it is hard to understand to offer incentives such as free admission to Temple Stay, which only worked last year. More effective incentives are needed. It is also necessary to promote in various ways so that the public can voluntarily seek vaccines for prevention. It is not useful to simply emphasize the justification of "vaccination." If the government's power is not enough, it can borrow the hands of pharmaceutical companies. As public advertisements are allowed for vaccines, COVID-19 vaccine developers can promote their own vaccines to increase the overall vaccination rate. The government encourages vaccination at daily briefings. It is time for an in-depth strategy to persuade the public not to end up with a cry in the air.
