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- 2026-05-04 15:38:43
- 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.
- Policy
- Reimb standards will be newly established for Coagadex
- by Kim, Jung-Ju Nov 22, 2022 06:04am
- Reimbursement standards for the hemophilia treatment Coagadex (Human coagulation factor X) that had been granted urgent introduction in Korea have been newly established. Also, oral eperisone hydrochloride as well as oral and ophthalmic solutions that include syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy will be applied new reimbursement standards according to their reevaluation results. The Ministry of Health and Welfare announced its partial amendment to the ‘Details on the standards and methods for application and method (pharmaceuticals)‘ and is opinion inquiry until the 24th. The new reimbursement standards are set to be applied on December 1st. First, the MOHW recognized the need for reimbursement for the hemophilia treatment Coagadex (Human coagulation factor X) in patients confirmed with hereditary Factor X deficiency and willy newly establish reimbursement standards. Patients with hereditary Factor X deficiency will be allowed the administration of Coagadex. In terms of a single administration (single dose), 40 IU/kg in patients aged less than 12 years, 25 IU/kg in patients aged 12 years or older will be allowed, with up to 4 courses recognized per visit. Under the doctor’s discretion, such as when the patient's condition is stable, up to 8 courses of administration will be reimbursable if a patient visits once every 4 weeks. If Coagadex is administered in the hospital, those administered in hospitals are also counted. However, if bleeding occurs in the patient even after administering 8 courses for 4 weeks, an additional 2 courses per visit may be covered, but the doctors’ medical opinion in the medical record needs to be attached. Also, oral eperisone hydrochloride, oral, and ophthalmic solutions including syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy this year will be applied new reimbursement standards according to their reevaluation results. Eperisone hydrochloride drugs including CHodang Pharm’s Mulex Tab will be reimbursed for painful muscle spasms associated with musculoskeletal disorders such as cervicobrachial syndrome, periarthritis, and lower back pain. Sodium alginate preparations including Taejoon Pharm’s Lamina-G solution etc will be granted reimbursement for improving subjective symptoms of reflux esophagitis. For ophthalmic solutions including syrup and oral suspension forms, a new reimbursement standard will be set under oral sodium alginate products according to the reimbursement reassessment results, and be deleted under general principles for ophthalmic solutions. The restrictions set on the number of administrations for Hanmi Pharmaceutical’s Maqaid Inj (triamcinolone acetonide) will be deleted based on approvals in Korea and abroad, textbooks, clinical practice guidelines, clinical literature, and opinion from related societies, but readministration will only be applied reimbursement when administered in intervals that exceed 3 months. Also, Hanmi Pharmaceutical’s Esomezol Cap 10mg (oral esomeprazole 10mg) will be newly listed next month and be added to the list of proton pump inhibitors. Reimbrusement standards for oral proton pump inhibitors include omeprazoles like Yuhan Losec Cap, lansoprazoles like Lanston Cap, pantoprazole like Pantoloc Tab, rabeprazoles like Pariet Tab, and esomeprazoles like Nexium Tab. However, as Esomezole DR Cap 10mg was not approved for the treatment of H.pylori infections, this indication is off-label and excluded from reimbursement. Reimbursement for Kyowa Kirin Korea’s Romiplate Inj 250μg (Romiplostim) will be extended to the treatment of refractory or relapsed aplastic anemia following immunosuppressive therapy based on approvals in Korea and abroad, textbook, clinical practice guidelines, and clinical literature. Reimbursement standards for vedolizumab injections that are applied to Takeda Pharmaceuticals Korea’s Kynteles Inj (vedolizumab) will newly include Kynteles refilled Pen Inj to account for its new listing. However, in consideration of the differences between existing formulations and the approvals (dose and usage), the evaluation method for ulcerative colitis will be changed and new standards for self-injection and long-term prescription will be set. According to the new details, considering how Kynteles Prefilled Pen Inj is a self-injection formulation, the patient should fill out a 'patient dosing diary' to monitor the administration period of the drug for the management of medical care institutions. Also, for long-term prescriptions of Kynteles Prefilled Pen Inj, a single prescription period shall be up to 2 weeks upon discharge from the hospital and up to 3 weeks for outpatient prescriptions and shall be prescribed in hospitals in principle. Patients who show no side effects and stable disease activity 24 weeks since initial administration.
- Policy
- Phase 3 of Fitusiran, an all-around tx for hemophilia
- by Lee, Hye-Kyung Nov 22, 2022 06:04am
- Phase 3 clinical trials of Fitusiran, a treatment candidate substance that is effective for both hemophilia A and B, are also being conducted in Korea. The Ministry of Food and Drug Safety approved a phase 3 clinical trial of Sanofi-Aventis Korea on the 18th. This clinical trial is a phase 3, single group, multi-organ, multinational clinical trial to investigate the efficacy and safety of Fitusiran prevention therapy in male severe type A or type B test subjects over the age of 12 with or without inhibitory antibodies to coagulation factor VIII or IX. In phase 3 of multinational clinical trials targeting 75 male hemophilia patients around the world, Korea has been approved for clinical trials in five patients. Clinical trials are conducted at Kangdong Kyung Hee University Hospital, Severance Hospital, and Inha University Hospital. The Fitusiran global clinical trial was voluntarily suspended by Sanofi in October 2020 after non-fatal symptoms of thrombosis were found in phase 3 clinical trial participants. Sanofi also stopped all studies in September 2017 when one patient died of thromboembolism in the brain during phase 2 clinical trials. Hemophilia is a congenital hemorrhagic disease caused by a lack of blood clotting factors, and the incidence rate is estimated to be around one per 10,000 people. Depending on the type of insufficient coagulation factors, it is divided into two types: hemophilia A and hemophilia B, with type A accounting for 80% of the total and type B accounting for the remaining 20%. Fitusiran is a small interference RNA (siRNA) treatment that targets antithrombin, which is a treatment for hemophilia type A and type B patients and promotes thrombin production by lowering the level of antithrombin to prevent hemophilia's hemostasis and bleeding. Currently, Hemlibra, which is used for hemophilia type A, ranks first in the hemophilia treatment market, and Sanofi and Novonordisk's Concizumab are the development treatments used for both hemophilia type A and type B patients.
- Policy
- Gov't declines preferential pricing for innovative drugs
- by Lee, Jeong-Hwan Nov 21, 2022 05:56am
- Complaints are rising in various areas of the pharmaceutical industry with the Ministry of Health and Welfare maintaining its position that preferential pricing for new drugs manufactured by Korea Innovative Pharmaceutical Companies cannot be introduced in practicality due to issues including trade conflict, NHI finances, etc. The industry is complaining that the Ministry of Health and Welfare taking too much of a protective stance rather than focusing on preparing preferential pricing measures based on the fact that not only domestic pharmaceutical companies but US and UK companies are accredited as Korea Innovative Pharmaceutical Companies. On the 20th, MOHW reiterated its position that authorities must play caution in providing preferential pricing measures for Korea Innovative Pharmaceutical Companies and drugs that use domestically manufactured APIs, etc, virtually reaffirming its plan on the non-introduction of such policies. Although a clause for providing preferential pricing to Korea Innovative Pharmaceutical Companies had been prepared as of December 11th, 2018 under the Special Act On Fostering and Support of Pharmaceutical Industry, the government had also expressed practical difficulties in its implementation as providing pricing support for specific pharmaceutical companies, despite its legal basis, can lead to trade conflict. Regarding the enactment of subordinate statutes, the MOHW said it agrees with their necessity, but would need to consider whether it conforms to the international trade order. The ‘Premium drug pricing system for global innovative new drugs,’ which had been announced on July 7th, 2016 to provide preferential treatment for drugs developed by such companies, had been deleted in December 2018 as a discriminatory factor as a result of negotiations on amendments and modifications of the US-Korea (KORUS FTA). However, the domestic pharmaceutical industry stressed the need to promptly introduce a preferential pricing policy for innovative new drugs based on the fact that the criteria for accrediting innovative pharmaceutical companies are not limited to domestic companies. Also, the demand for preferential pricing of innovative new drugs by domestic pharmaceutical companies has been increasing further as MOHW Minister Kyu-Hong Cho stated that “further phased price cuts are deemed necessary as the price of generics are more expensive in Korea than overseas” regarding price cuts for generic drugs that are considered the basis of Korea’s pharmaceutical industry at the NA audit this year. The main reason for complaints raised by domestic pharmaceutical companies is that the Korean government is passive in preparing preferential treatment for innovative new drugs while concentrating on reducing the generic drug price. Also, the industry pointed out that as multinational pharmaceutical companies are also selected as Korea Innovative Pharmaceutical Companies in addition to domestic pharmaceutical companies, the policy should not be considered as being favorable for domestic pharmaceutical companies. Three multinational pharmaceutical companies – AstraZeneca Korea, Janssen Korea, and Korea Otsuka Pharmaceutical - have been accredited as Korea Innovative Pharmaceutical Companies. In other words, if the MOHW continues to solely pursue the plan to lower generic drug prices without specific preferential treatment or preservation measures, the concern of domestic pharmaceutical companies is likely to continue to deepen. A domestic pharmaceutical company official pointed out, “In every NA audit, the government had repeatedly promised policies to support drive new drug development, but no mechanism for preferential treatment for new drugs has been established as of now. The MOHW seems to have no plans to provide preferential treatment for drug prices and only have plans to lower generic drug prices." The official said, “If preferential pricing for Korea Innovative Pharmaceutical Companies may cause a trade dispute, the government should also separately contemplate measures to resolve the issue as well. Foreign pharmaceutical companies are also accredited as Korea Innovative Pharmaceutical Companies in addition to Korean companies.” Another official from a different pharmaceutical company in Korea also said, “The answer that the government would provide preferential treatment for new drugs after reviewing the international trade order and its financial impact on health insurance finances seems to mean that it will provide no preferential treatment. If this measure cannot be implemented, other measures to provide measures to preserve the drug price. The government has always been opposed to the request to preserve drug prices as well.” The official added, “If the government only formalizes the price cut of generic drugs and provides no response to the request for preferential treatment, reevaluation, or exceptions for the other drugs, domestic pharmaceutical companies will inevitably become more dissatisfied. The current response that no preservation or preferential treatment can be provided to domestic drugs because of NHI finances is quite irresponsible.” Meanwhile, members of the National Assembly's Health and Welfare Committee have also been demanding a drug price preservation policy every year, but it seems difficult for the NA to make further requests with the government continuing to repeat its principled answer. Following last year, members of the NA Health and Welfare Committee Rep. In-Soon Nam, Min-Seok Kim of the Democratic Party of Korea, and Rep. Jong-Seong Lee, Jong-Hean Baek, called for measures to provide preferential treatment for new drugs to foster Korea’s domestic pharmaceutical industry at this year’s NA audit.
- Policy
- Label for rosuvastatin to change following ticagrelor
- by Lee, Hye-Kyung Nov 21, 2022 05:56am
- The drug-drug interaction label for rosuvastatin drugs that are used to treat hyperlipidemia including AstraZeneca’s ‘Crestor’ will be changed. The drugs that affect rosuvastatin are ticagrelor drugs including AstraZeneca’s antiplatelet drug ‘Brilinta.’ The labeling change for ticagrelor has been preannounced by the Ministry of Food and Drug Safety in August and is set to be made on December 2nd. The labeling changes for rosuvastatin in line with the changes made for ticagrelor will also be applied after collecting opinions until December 2nd. According to the planned changes that will be made, the phrase ‘Ticagrelor can cause renal insufficiency and may affect renal excretion of rosuvastatin, increasing the risk for rosuvastatin accumulation’ will be newly added in the drug-drug interaction label of both the monotherapy and combination therapies of rosuvastatin. In some cases, co-administered ticagrelor and rosuvastatin led to a renal function decrease, increased CPK level, and rhabdomyolysis. Therefore, renal function and CPK control are recommended while using ticagrelor and rosuvastatin concomitantly. The MFDS prepared the label change based on European Medicines Agency’s safety review results on rosuvastatin. Items approved in Korea that contain rosuvastatin include 974 items including Crestor, Kuhnil Biopharm’s ‘Rosucande Tab,’ Kims Pharmaceutical’s ‘Rosuvac Tab,’ Ahngook New Pharm’s ‘Newsuvatin Tab,’ HK Inno.N’s ‘Vivacor Tab,’ Novartis Korea’s ‘Rosuco Tab,’ and Abbott Korea’s ‘Lypsta Tab.’
- Policy
- Public policy fee for severely ill children is implemented
- by Kim, Jung-Ju Nov 21, 2022 05:56am
- The government will push for a pilot project for a new payment system for the sustainability of treatment for severely ill children and adolescents. The Ministry of Health and Welfare (Minister Cho Kyu-hong) announced that it will recruit participating institutions for about four weeks from today (17th) to December 15th, which will take effect in January next year. Participating institutions are Seoul National University Hospital, Asan Medical Center, Yonsei Severance Hospital, Samsung Medical Center, Chonbuk National University Hospital, Chonnam National University Hospital, Chungnam National University Hospital, Chilgok Kyungpook National University Hospital, Yangsan Pusan National University Hospital, and Kangwon National University Hospital. The Ministry of Health and Welfare explains that this is a pilot project to prevent the collapse of medical infrastructure with groundbreaking support for severe childhood diseases, which are weakening due to a decrease in the child population. The pilot project is the first step in implementing the public policy fee presented as a national task. The government introduces a new payment system called a package follow-up method rather than an additional method for individual medical services to strengthen support for pediatric specialized care infrastructure. The Ministry of Health and Welfare explained that it aims to lay the foundation for pediatric patients and guardians to receive sufficient professional treatment even close by supporting the maintenance of essential medical infrastructure by region through pilot projects. The Ministry of Health and Welfare plans to operate the pilot project by adopting a new support method to operate a stable treatment system for severely ill children by region. The selected medical institution will expand essential manpower such as pediatricians and nurses to provide high-quality children's medical services and carry out key projects suitable for each center's characteristics such as short-term hospitalization and home medical services. The pilot project will be conducted for three years from January 2023 to December 2025, and the target of the application is an institution designated as a children's public medical center that wishes to participate. The participating institution will be selected by comprehensively evaluating the level of securing pediatric professionals and the quality of pediatric treatment. Minister of Health and Welfare Cho Kyu-hong said, "This pilot project is part of the public policy fee to strengthen the public role of health insurance," adding, "We hope that an environment will be provided for all children to grow safely and healthily."
- Policy
- The budget for Paxlovid's SE relief will be prepared
- by Lee, Jeong-Hwan Nov 18, 2022 06:04am
- The Welfare Committee approved a budget of 1.7 billion won. Payment can be made next year if the plenary session is passed. The budget for relieving abnormal cases and side effects of drugs being administered in Korea through the EUA system, which is not approved based on the current Pharmaceutical Act, is smoothly being secured. This is because the National Assembly's Health and Welfare Committee recently voted 1.79 billion won for next year's budget to relieve damage to EUA drugs such as COVID-19 treatments, and attention is focused on the results of the special committee on budget settlement. Given that the EUA drug damage relief budget is recognized by multiple lawmakers and professional committee members of the Welfare Committee, and the government is also actively encouraging the administration for COVID-19 prevention, calls for a side effect damage compensation budget are gaining momentum. As of November this year, a total of six drugs including Paxlovid, Remdesivir, Actemra, Lagevrio, Evusheld, and Comirnaty 2 are being administered in Korea as EUA drugs by the Ministry of Food and Drug Safety. There is no way to relieve the damage even if serious side effects such as abnormal reactions, deaths, and diseases are developed in patients who have taken six drugs approved for emergency use. This is because the drug and vaccine damage relief system is operated only for drugs and vaccines that are officially approved based on the Pharmaceutical Affairs Act. Choi Hye-young of the Democratic Party of Korea and Kim Mi-ae of the People's Power, who are members of the Welfare Committee, have proposed a bill to relieve the state from side effects caused by EUA drugs. Prior to the legislation, the Welfare Committee voted to increase the budget of 1.79 billion won to compensate for damages to EUA drugs during next year's budget review. If the budget bill passes through the Special Committee on Budget and Accounts and passes the plenary session, it will be able to compensate for side effects caused by the administration of EUA drugs such as Paxlovid from next year. Currently, the quarantine authorities are actively encouraging the use of EUA drugs such as oral COVID-19 treatments to prevent and treat severe COVID-19 and death, so there is a high expectation that the budget for damage relief will also pass the committee. There have been cases in which applications for relief from abnormal cases that occurred after taking Paxlovid have been received, and compensation for the cases will be possible only when the budget for next year is prepared. The Welfare Committee voted 271 million won, the same as this year, for the budget for the "relief from side effects of drugs" project.
- Policy
- Quick diagnosis is essential for Hepatitis C
- by Nov 18, 2022 06:03am
- Pharmaceutical companies such as BMS, Gilead, and Abbvie introduced direct anti-virus (DAA) treatments, and hepatitis C opened the era of complete recovery. Re-treatment options for a small number of patients who failed to treat also appeared this year. The goal of hepatitis C is to find "hidden patients" who have not yet been diagnosed. Experts stress that national checkups should include hepatitis C. Bruce Kreter, general manager of Global Medical, who was in charge of the development of hepatitis C treatment at Gilead, and Ahn Sang-hoon, a professor of gastroenterology at Yonsei University Severance Hospital, asked about the current status of hepatitis C screening at home and abroad. ◆ Government-led hepatitis C screening test vs. repeated discussions for years The World Health Organization (WHO) declared the fight against hepatitis C by 2030 and urged international efforts. As the treatment is completed, it can be managed by simply finding hepatitis C carriers. The domestic prevalence rate is estimated to be around 1%, and it is considered an important strategy to quickly find and treat patients who can be the source of infection because there is no separate vaccine. Unlike the United States, which conducted a government-led hepatitis C screening test under the WHO's declaration, Korea has been only discussing whether to include hepatitis C tests in national checkups for years. The paradigm of hepatitis C treatment completely changed after the introduction of DAA preparations. With a treatment success rate of nearly 100%, complete recovery can be expected, treatment can be performed regardless of genotype, and the treatment period, which was up to one year, has been greatly reduced to two to three months. Even this year, a re-treatment system has been created that can be used by a small number of patients who have failed to treat due to resistance. The success rate of re-treatment is also close to 100%. It is evaluated that treatment is close to completion among the two factors for eradicating disease, "prevention" and "treatment." The problem is prevention. Hepatitis C does not have a vaccine, so a quick diagnosis is the best. Professor Ahn pointed out that it is meant to treat only patients without prevention. In particular, it is analyzed that Korea has never been tested for hepatitis C and does not even know that it is a carrier. Professor Ahn said, "More than 70% of hepatitis C patients in Korea were asymptomatic patients who did not know that they were hepatitis C, and more than 60% had never been tested for hepatitis C in their lives," and stressed, "There are more recent situations such as drugs and tattoos, so we need to quickly detect and treat the source of infection." In 2020, the United States began recommending screening tests for hepatitis C under the leadership of the CDC. This is a change to keep pace with the WHO's announced goal of eradicating hepatitis C. The United States recommends that all adults undergo at least one hepatitis C screening test. Countries with national examination programs such as Taiwan, Japan, and Egypt included hepatitis C tests in the category. " Hepatitis C is asymptomatic and the patient cannot be recognized as a carrier unless diagnosed through a test. However, these patients may have been in poor condition for a long time, but they feel that their quality of life is improved through treatment. At the national level, medical costs can be lowered by lowering the probability of liver cirrhosis or hepatocellular carcinoma when hepatitis C is completely cured, he explained. In Korea, discussions have also been made since late 2015 to include hepatitis C tests in the national health examination category, but no conclusion has been reached even seven years later. It is not that the utility value that can be included in national projects has not been proven. Although the Korean Association for the study of the Liver has consistently proven cost-effectiveness through feasibility studies and pilot projects, there is still no progress. The Korean Association for the study of the Liver is conducting additional research to analyze the government's financial impact assessment. Professor Ahn said, "The Korean Association for the study of the Liver confirmed the cost-effectiveness of national hepatitis C screening through an early detection pilot project for hepatitis C for 105,000 people aged 55 in 2020. "When comparing the costs of treatment with screening tests and neglecting liver cirrhosis, it was much more effective to conduct screening tests for high-risk groups," he explained. He said, "In addition, research to verify whether the government's financial consumption of national checkups is possible through the government's fiscal impact assessment will be announced within this year as it is almost the final stage."
- Policy
- Budget increase for drugs and vaccines under NA review
- by Lee, Jeong-Hwan Nov 17, 2022 05:54am
- The proposal to set a new budget worth KRW 14.4 billion to support the patients’ medical expenses of ultra-high-priced new drugs for rare diseases will be reviewed by the Adjustment Subcommittee of the National Assembly’s Special Committee on Budget and Accounts. A plan to increase the budget for the K-global vaccine fund project by KRW 40 billion or KRW 20 billion from the KRW 10 billion that was originally submitted by the government, will also be discussed at the Adjustment Subcommittee of the Special Committee on Budget and Accounts. The Adjustment Subcommittee of the Special Committee on Budget and Accounts will be reviewing the agendas above on the 16th. The budget to support the medical expense for non-reimbursed new orphan drugs is a new budget that had not been reflected in both the government’s original proposal or the resolution bill of NA’s Health and Welfare Committee The agenda became subject to review after Rep. Cheol-Gyu Lee and Dong-Hyuk Jang, Hee-Young of the Special Committee on Budget and Accounts raised the need for a new budget. The plan is to increase the budget by KRW 14.4 billion to support medical expenses for non-reimbursed drugs before they are applied insurance coverage. If the budget plan is reflected, rare disease patients that use ultra-high-priced drugs that are yet to be reimbursed may receive benefits. Also, for the ‘K-Global Vaccine Fund Project’ that had been passed by the NA Health and Welfare Committee, two budget increase proposals – one to increase the budget by KRW 40 billion requested by Rep. Hyun-Young Shin and Hye-Young Choi, and the other to increase the budget by KRW 20 billion requested by Rep. Dae-Sik Kang, Sun-Woo Kang, Jin-Gyo Bae, Hyun-Jin Bae, Jung-Sook Suh, Yong-Ho Lee, Hye-Sook Jun, Su-Jin Cho will be reviewed by the special subcommittee. In other words, plans to increase the budget for the fund to support the development of local homegrown vaccines and new drugs to KRW 50 billion and KRW 30 billion are set to be reviewed side by side. The pharmaceutical and bio-industry is of the opinion that it is necessary to secure as much government budget as possible to actively support companies that develop homegrown vaccines and new drugs who are preparing to conduct Phase II or III trials. All the plans are for budget increases, and the subcommittee review of the agendas is scheduled for next week.
- Policy
- Use of Evusheld extended to the severely immunocompromised
- by Kim, Jung-Ju Nov 16, 2022 06:10am
- The COVID-19 Vaccination Response Promotion Team (Head: KDCA Commissioner Kyung-Ran Baek) announced that it had expanded the eligibility of Evusheld as of the 14th to protect the severely immunocompromised from the next wave of COVID-19 outbreak that may arise in the winter season. With the expansion, blood cancer patients, transplant recipients, and people with congenital immunodeficiency who are severely immunocompromised; those with solid cancer, HIV, or rheumatism following deliberation by the Infectious Disease Control Committee; and patients who are receiving serious immunosuppressive treatment such as chemotherapy or B-cell depletion treatment regardless of disease are eligible for Evusheld. Also, the treatment period for patients to apply for the treatment has been extended from the previous 2-4 months to 6-12 months. The dose, which had previously been 300mg, was also increased to 600mg based on MFDS’ Emergency Use Authorization which allows ‘patents to recieve 600mg in the event variants arise,’ cases in the US where the authorities granted increasing the dosage to 600mg to respond to the Omicron variant, and committee deliberation, etc. Those who already received the 300 mg dose within 3 months may receive an additional dose of 300mg, and those who received Evusheld over 3 months ago may receive an additional dose of 600mg. The COVID-19 Vaccination Response Promotion Team said, “As we have expanded the target and increased the administered dose of Evusheld in preparation for the next wave of COVID-19 that may arise in the winter season, we ask the severely immunocompromised that receive serious immunosuppressive treatments to receive Evusheld for further protection. Healthcare professionals at medical institutions that administer Evusheld should actively explain the changes to eligible patients and encourage prompt administration and apply for Evusheld.”
