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- 2025-12-23 19:19:50
- Policy
- Discussions on the benefits of migraine txs begin in earnest
- by Lee, Tak-Sun May 16, 2022 06:14am
- Emgality that passed the Drug Reimbursment Evaluation Committee on the 12thAs Lilly Korea's Emgality passed the HIRA's Drug Reimbursment Evaluation Committee, discussions on the benefit of the migraine txs are rapidly progressing. Following Emgality, Handok Teva's Ajovy, the same (CGRP) target treatment, is also seeking to enter the benefit. Reyvow of Ildong Pharmaceutical, which was approved in Korea on the 12th, is also speeding up the payment process through the approval-benefit evaluation linkage system. On the 12th, the Drug Reimbursment Evaluation Committee of the HIRA held the fifth meeting in 2022 and judged that Lilly's Emgality was eligible for the benefit. Accordingly, Emgality will enter the stage of drug price negotiations with the NHIS. Emgality is currently licensed for three products in Korea. In September 2019, Emgality 120 mg/ml PFS and Emgality 120 mg/ml PFS Pen, and Emgality 100 mg/ml PFS were licensed in May 2020. The product that passed the Reimbursment Evaluation Committee this time was Emgality 120mg/ml PFS, which was recognized as a migraine prevention drug in adults. Triptan-based painkillers are used as migraine treatments, but side effects such as vascular over-contraction are often pointed out. Recently, new drugs for migraine are attracting attention as their effects have improved as they overcome the side effects of existing drugs. A representative drug is an antibody new drug that directly targets CGRP receptors. Emgality and Teva's Ajovy are typical CGRP drugs. Emgality submitted in March last year and passed the Reimbursment Evaluation Committee more than a year ago. Ajovy also reportedly submitted in January. A new oral tx has also emerged. It is Reyvow, which acquired domestic copyrights by Ildong Pharmaceutical. It was originally confirmed to be introduced in Korea in 2013 when Ildong signed a development partnership and domestic sales license agreement with CoLucid Pharmaceuticals, a developer. Since then, Eli Lilly acquired CoLucid Pharmaceuticals in 2017, and in 2019, it has also obtained US FDA approval under the name Reyvow. Ildong then began testing bridges for domestic sales permits and submitted an application for permits immediately after the end of last year. Recently, the drug is known to be undergoing a review at the same time as permission. Accordingly, Emgality's benefit is expected to be the standard for other migraine new drugs. For now, Emgality is also expected to negotiate with the industrial complex. Teva is also expected to establish a benefit strategy while looking at the results of Emgality's negotiations. The domestic migraine treatment market is smaller than that of patients. The annual prescription amount of tryptan-based drugs remains at 15.5 billion won based on UBIST in 2020. However, the prevalence of migraine in Korea is not small at around 6%. According to the HIRA statistics in 2020, 550,000 patients visited the hospital for migraine and received treatment, but about 2 million patients have not visited hospitals. Therefore, pharmaceutical companies expect that the market size will be much larger than it is now if the migraine tx, which has been upgraded from the existing drug, is reimbursed.
- Policy
- Daewoong’s P-CAB drug Fexclu receives conditional approval
- by Lee, Tak-Sun May 16, 2022 06:14am
- Daewoong Pharmaceutical’s P-CAB class gastroesophageal reflux disease (GERD) treatment ‘Fexclu’ has received conditional approval from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee. The committee decided reimbursement was appropriate for the drugs if the company accepts a price below the appraised amount. Accordingly, their reimbursement will be determined in the drug price negotiations with NHIS that will follow. The NHIS announced that it held the 5th 2022 Drug Reimbursement Evaluation Committee (DREC) meeting on the 12th to deliberate on the adequacy of providing insurance benefits to 4 drugs including Fexclu. The 4 drugs that were deliberated were fexuprazan hydrochloride products including Fexclu Tab. 40mg, etc that Daewoong’s subsidiaries Daewoong Pharmaceutical, Daewoong Bio, Hanall Biopharma, iN Therapeutics received approval for. DREC determined that reimbursement was appropriate if the companies accept a price below the appraised amount for the treatment of erosive gastroesophageal reflux disease (GERD). In other words, the company needs to accept the appraised price to receive reimbursement. The decision will now depend on the NHIS negotiations that will follow. The reimbursement process will progress rapidly if Daewoong and the other pharmaceutical companies accept the appraised price, but be difficult otherwise. The Donerion/Donesive patch (donepezil) developed by Celltrion·Icure also received conditional approval from DREC. The drug is the first patch to be developed using donepezil, the ingredient most widely used for the treatment of Alzheimer's-type dementia. As in the case of fexuprazan, DREC determined that reimbursement for donepezil was appropriate if the companies accept a price below the appraised amount for the treatment of Alzheimer's-type dementia symptoms. On the other hand, new drugs developed by multinational pharmaceutical companies were determined appropriate for reimbursement without any condition, and their progress to reimbursement is expected to proceed more quickly. Novartis Korea’s SMA treatment ‘Zolgensma (onasemnogene abeparvovec-xioi)’ and Lilly Korea’s migraine prophylaxis drug ‘Emgality (galcanezumab)’ were recognized as appropriate for reimbursement. In the case of Zolgensma, the drug was approved appropriate for reimbursement in patients with SMA with a bi-allelic mutation in the SMN1 gene under the condition that the drug receives prior approval for medical care benefits and is applied the patient-unit performance-based RSA and an expenditure cap. Emgality was determined appropriate for reimbursement as a preventive treatment of migraine in adult patients.
- Policy
- MOHW holds a launching meeting of the pharmaceutical team
- by Kim, Jung-Ju May 13, 2022 05:46am
- The MOHW (Minister Kwon Deok-cheol) announced at 3 p.m. on the 12th that it will hold a launching meeting of the mid- to long-term strategic planning team for the pharmaceutical industry to establish the "third comprehensive plan for fostering and supporting the pharmaceutical industry." The government shall prepare a five-year comprehensive plan to promote the creation of a foundation for the development of the pharmaceutical industry and strengthening international competitiveness. The comprehensive plan to be established this time is the third plan since the implementation of the system in 2012, and will present a mid- to long-term vision of the pharmaceutical and bio industry promotion policy for the next five years from 2023 to 2027. The MOHW formed a strategic planning team including industry and academic experts (Lee Hyung-hoon, director of health and industry policy at the MOHW, and Lee Byung-gun, chairman of the Korea Sponsor Board of the International Vaccine Research Institute). The strategic planning team will be appointed as a sub-division of each industry (4) and strategy (4) to discuss the basic direction (vision, goal, strategy) of the comprehensive plan and comprehensively review the detailed implementation tasks discussed in each department. At the launching meeting, the results of the second comprehensive plan (2018-2022) were shared, and the strategic planning team and the division's operation plan were discussed. The main achievements of the second comprehensive plan were the expansion of R&D investments by the government and the private sector to promote new drug development, including the Ministry of Health, Science and Technology, Information and Communication, and Trade. To establish the third comprehensive plan, the strategic planning team will hold a meeting at least once a month, and it plans to first operate the industry division in May to June to find tasks for each field, and then prepare detailed action plans in each strategy division. The government plans to operate a strategic planning team (including the division) by the end of this year and announce the third comprehensive plan around December this year after deliberation by the Pharmaceutical Industry Promotion and Support Committee (Chairman, Minister of Health and Welfare). Lee Hyung-hoon, director of the Health and Industry Policy Bureau, said, "The year 2022 when the third comprehensive plan is established is an appropriate time to create a bio-health innovation ecosystem beyond the turning point of COVID-19 and to discuss mid- to long-term directions for Korea to become a pharmaceutical and bio powerhouse." He said, "As this comprehensive plan has been open to various opinions from academia and industry since the beginning of its establishment, industries and research circles will actively participate to express their outlook and opinions, and the planning team will prepare policy tasks and deliberate by the committee."
- Policy
- Vaccine consultative body launched
- by Kim, Jung-Ju May 13, 2022 05:45am
- Representative vaccine companies in Korea will launch a "Vaccine consultative body" to establish vaccine sovereignty and enhance international competitiveness, and actively cooperate with the aim of strengthening R&D capabilities in the industry and promoting vaccine commercialization. The MOHW (Minister Kwon Deok-cheol) and the Vaccine Practicalization Technology Development Project Group (Director Sung Baek-rin, professor of Yonsei University Medical School) held the launch ceremony of the Vaccine Practicalization Council at COEX at 3 p.m. today (12th). This reflects the need to secure vaccine sovereignty triggered by COVID-19, and companies have agreed to achieve self-sufficiency of essential vaccination vaccines as well as responding to the global pandemic (pandemic) of future infectious diseases. The consultative body will participate in 14 representative vaccine companies participating in research and development projects supported by the vaccine commercialization technology development project group, and support the overall operation as an executive agency. Participating companies are GC Pharma, LG Chem, SK Bioscience, EyeGene, Boryung Biopharma,HK inno.N, EuBiologics, InThera, Genexine, GeneMatrix, Geneone, Cha Vaccine Research Institute, QuadMedicine, and Quratis. The council is divided into two vaccine divisions: self-sufficiency of essential vaccinations, future response, and unresolved, and plans to seek alternatives and promote vaccine commercialization through follow-up research and discovery of new research needs. At the launch ceremony, the participating companies adopted a joint cooperation declaration to the effect of "cooperation to protect public health, establish vaccine sovereignty, and enhance international competitiveness as Korea's representative vaccine companies." Companies declared that they would strengthen their R&D capabilities, promote the commercialization of domestic vaccines, and actively cooperate with the government to come up with countermeasures in the event of an infectious disease-related national health crisis. Sung Baek-rin, head of the Vaccine Practicalization Technology Development Project, said in his opening speech, "The Vaccine Practicalization Technology Development Project is a large project involving domestic industry, academia, research, and disease experts, and it will be an opportunity to develop their research capabilities and draw collective intelligence." Park Geum-ryul, a leading medical support officer at the MOHW, said in a congratulatory speech, "We strongly sympathize with the purpose of the launch of the consultative body, and we hope that active exchanges and discussions will take place as it is launched with the full support and participation of representative companies in the future."
- Policy
- Will Ho-Young Chung be able to enter Cabinet?
- by Lee, Jeong-Hwan May 12, 2022 06:07am
- With the inauguration of the new administration on the 10th, whether the Health and Welfare Minister nominee Ho-Young Chung will be able to enter President Yoon’s Cabinet is now at a crossroads. Industry experts expect that the nominee will be appointed today (12th) after the Minister of Economy and Finance Choo Kyung-ho starts his role as Deputy Prime Minister. If President Suk-Yeol Yoon does not remove the nominee from the list of appointments, then Chung is expected to ascend to the ministerial position regardless of the NA’s personnel hearing report. However, there remains a possibility that he will be excluded from the list of appointments due to continued opinion on Chung’s inappropriacy within the People Power Party, the Democratic Party’s voluntary resignation request and they plan to press charges. The industry expects the appointment results to come out on the 12th because Prime Minister Bu-kyum Kim’s term ended at midnight on the 11th, after which Deputy Prime Minister Choo is given the authority to recommend appointments. Minister nominees are appointed upon the recommendation of appointment by the Prime Minister, therefore, the term of the Deputy Prime Minister Choo needs to first start sequentially appointing the Cabinet members that the opposition party criticized to be incompetent. President Yoon needs Chung’s appointment to meet the quorum of 15 Ministers required to hold the first cabinet meeting and deal with the supplementary budget bill for COVID-19. Therefore, the president is expected to fill out the quorum with the 7 Ministers that he appointed beforehand, additional appointments made immediately before the Cabinet meeting, and Ministers from the previous administration. Pushing Chung’s appointment ahead will intensify the conflict between the ruling and opposition party, as the personnel hearing report for Chung was not accepted due to the collective exit of Democratic Party members during the personnel hearing. The Democratic Party of Korea plans to file a complaint against Chung on allegations of his two children's transfer to Kyungpook Medical University and his son's military service exemption decision. The Democratic Party of Korea has been urging the president to drop Chung’s appointment, referring to Chung as an ‘evader and breaker of laws.’ An official from the NA Health and Welfare Committee who is a member of the Democratic Party of Korea, said, “Chung should be the first candidate to be dropped. If the president pushes ahead with the appointment despite the disruption shown at the hearing without adopting the personnel hearing report, the government will not be able to avoid conflict with the National Assembly for a while. I understand that there is strong opposition to appointing nominee Chung even within the People Power Party. Even if he enters the Cabinet, it is questionable whether he will be able to properly serve as the Minister of Health and Welfare.”
- Policy
- Evusheld will be included in Govnt's supplementary budget
- by Lee, Jeong-Hwan May 12, 2022 06:06am
- The government is setting out to secure a supplementary budget for the introduction of ‘Evusheld (tixagevimab, cilgavimab),’ an antibody combination treatment used to prevent COVID-19 infection in the immunocompromised that see a low effect from vaccinations. With the National Assembly also agreeing on the need to introduce Evusheld, its introduction will gain momentum as soon as the supplementary budget submitted by the government passes the National Assembly. The government plans to hold a Cabinet Meeting on the afternoon of the 12th to pass the supplementary budget. In the proposed supplementary budget, attention is focused on the budget managed by the Korea Disease Control and Prevention Agency which includes the proposal to introduce Evusheld, an antibody treatment for the immunocompromised. Evusheld is administered to people who show inadequate response to COVID-19 vaccines such as cancer patients and dialysis patients to increase their prevention against COVID-19 infections. The drug was approved in December last year by the US FDA, and in the UK by NHRA in March this year. France, Australia, and Singapore also signed advance purchase agreements for Evusheld as preventive therapy for COVID-19. On the other hand, The Korean government had received criticism for being late in its response because Korea only announced that it will review the introduction of the drug and did not specify when. Accordingly, the government plans to include about ₩40 billion to purchase 20,000 courses of preventive antibody treatments needed for the prevention of infection and serious COVID-19 in the supplementary budget for the immunocompromised. Severe immunocompromised patients, such as organ transplant patients receiving immunosuppressive treatment and blood cancer patients, are eligible for support. If approved, Evusheld’s distribution is not expected to be difficult as Samsung Biologics is currently manufacturing the whole amount. Samsung Biologics has been supplying Evusheld to the global market under the long-term strategic manufacturing partnership signed with AstraZeneca in September 2020. The companies further expanded the size of the contract in December last year to strengthen the strategic partnership
- Policy
- “Dualized RWD collection for Kymriah is inefficient”
- by Lee, Tak-Sun May 11, 2022 05:55am
- With the registration of the ultra-expensive one-shot treatment Kymriah, the opinion was raised that a plan should be prepared to ensure the efficiency of the system by standardizing the dualized real clinical data (RWD) collection required by different institutions. That the separate collection of data by the Ministry of Food and Drug Safety and the Health Insurance Review and Assessment Service is a burden on the medical staff. Ji-Hye Byun, Assistant Research Fellow of the Evidence-based Research Division at HIRA claimed so in the 22nd issue of ‘HIRA’ that was recently published. Kymirah is the world’s first chimeric antigen receptor T-cell (CAR-T) therapy that was developed by Novartis Korea. The drug was approved as the first advanced biopharmaceutical under the ‘Advance Regenerative Bio Act’ in March of last year. The drug injects genetic information that can recognize specific antigens of cancer cells to the surface of an immune cell (T cell) collected from the patient and is indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Its listing had raised much attention, being a ‘one shot’ treatment that can bring an effect with a single administration and is an ultra-high-priced drug that costs 500 million won per shot. The government listed the drug for insurance benefit at 360 million won per shot in April and decided to cover the drug price with the National Health Insurance. However, the issue is that each organization requested RWD as a condition in the approval and listing process. The MFDS designated Kymirah as an advanced biopharmaceutical and ordered the company to conduct a 15-year long-term follow-up study on the drug. Also, the company needs to submit a post-management form to HIRA at the time of administration, 6 months after administration, and 12 months after administration. The global registry, EU’s EBMT will also be collecting treatment information on domestic patients, Byun said, “As a result, the HCPs will have to bear the burden of inputting and submitting RWD of similar content to three institutions - the MFDS, HIRA and EU EBMT- after patient treatment. We need to improve the domestic RWD collection system to become more efficient.” Byun explained that in Europe, the authorities are working to understand the differences in the RWD collection environment of each country and establish governance for RWD utilization among all patients. EU’s EBMT was also established as a single registry to serve the multi-purpose of post-marketing safety research, reimbursement management, and clinical research. Byun added that HIRA already owns the infrastructure to manage such information, and argued that it is necessary to use this infrastructure to separate the additional information necessary as RWD and devise a way to link it with the hospital's electronic medical record system.
- Policy
- Reblozyl was approved after 1 yr of designation of rare drug
- by Lee, Hye-Kyung May 11, 2022 05:55am
- Reblozyl 25mg, a treatment for patients with beta-Mediterranean anemia, was officially approved for items a year after designation as a rare drug. The MFDS approved Reblozyl applied by BSM Pharmaceutical Korea. Reblozyl is equipped with▲ the treatment of adult beta-Mediterranean anemia patients who need red blood cell transfusion as an indication, and ▲MDS-RS with minimum, low, and moderate risk of ring ferrous hematopoietic stem cell or low, moderate risk of ring ferrous hematopoietic and thrombocytopenia with increased myelogenesis/myeloproliferative tumor (MDS/NMP-T) Reblozyl was designated as a rare drug on April 1 last year. Beta-Mediterranean anemia, also called Cooley's anemia, is a blood disorder genetic disease that reduces the production of hemoglobin, an iron-containing protein of red blood cells, and delivers oxygen to cells in the body. Although iron treatment through red blood cell transfusion and chronic blood transfusion therapy for survival are used to treat patients, the risk of thrombosis increases to an abnormal level. Reblozyl obtained FDA marketing approval in 2019 based on clinical results of placebo administration of 112 out of 336 patients with beta-Mediterranean anemia. At the time of FDA approval, 21% of patients administered with Reblozyl had a 33% higher blood transfusion reduction rate than 4.5% of patients administered with placebo. Common side effects of Reblozyl include headache, bone pain, joint pain, fatigue, cough, abdominal pain, diarrhea, and dizziness, and high blood pressure may occur within the dose period. Thrombotic monitoring should also be accompanied when administered. It should be prohibited if a pregnant or breastfeeding woman takes Reblozyl because it can harm the fetus or newborn.
- Policy
- President Yoon said he was grateful to the people
- by Lee, Jeong-Hwan May 11, 2022 05:55am
- President Yoon Seok-yeol said on the 10th, "I am deeply grateful to the medical staff for their respect and dedication to the people who have endured great pain in the process of overcoming the COVID-19 pandemic over the past two years." At the inauguration ceremony of the 20th president held in front of the main building of the National Assembly, President Yoon said, "We will rebuild the country as a country where the people are the true owners based on liberal democracy and market economy." In Yoon's inaugural address, "freedom" said a total of 35 times. President Yoon's ambition is to ensure the value of freedom as much as possible to make it a country where the people are the true owners and fulfill their responsibilities and roles in the international community. President Yoon insisted that the universal value of freedom should be shared as something to be done to resolve excessive collective conflicts between countries and within countries and to overcome the democratic crisis. "We must properly and accurately recognize the value of freedom," Yoon said. "We must rediscover the value of freedom. Looking back on human history, the place where free political rights and free markets were breathing has always been prosperous," he said. "If any individual's freedom is violated, even the freedom of all members of the community is threatened," he said. President Yoon said, "Freedom is by no means a winner-take-all. To be a citizen with freedom , a certain level of economic fundamentals and opportunities for fair education and access to culture must be guaranteed," he said, adding that he cannot be called a free citizen without such a thing. If someone's freedom is violated or fails to meet the conditions necessary to become a free citizen, all free citizens should help in solidarity," he stressed. "Science, technology and innovation will protect our liberal democracy, expand freedom, and sustain a dignified life," President Yoon said. "We should cooperate and unite with many countries that have achieved technological progress and innovation by respecting freedom and creativity." "We are in the 10th largest economy group in the world. Therefore, we should take an attitude as a global leader in actively supporting and defending universal international norms based on freedom and human rights values," he said. He added, "I will make sure to create a country where the people are the true masters, a country that is responsible and respected in the international community based on the values of freedom, human rights, fairness and solidarity."
- Policy
- Only 40% of asthma pts undergo Pulmonary function testing
- by Lee, Tak-Sun May 06, 2022 05:46am
- Although it is recommended to take pulmonary function test at least once a year to manage diseases in asthma patients, only less than half of all patients are tested. The HIRA announced on the 3rd that it will analyze and disclose the results of the 2020 (8th) asthma adequacy evaluation to mark World Asthma Day. As a result of the evaluation, the rate of Pulmonary function test was steadily increasing, but only 42.4% of the patients subject to evaluation were tested, which was still low. For early detection of asthma exacerbation and management of diseases such as drug control, Pulmonary function tests should be performed at least once a year. (Guidelines for Asthma Treatment, Korean Academy of Tuberculosis and Respiratory Diseases 2020) By age, the pulmonary function test rate in their 70s was the highest at 48.5%, and those in their 90s and older were the lowest at 27.6%. By gender, 40.9% of women and 44.2% of men showed a lower rate of pulmonary function tests for women of all ages than men. The ratio of ICS prescription patients was also low at 55.9%, showing low results for both tests and prescription indicators. Inhalation steroids are the most effective preventive drugs for maintaining asthma control and should be used in all possible asthma patients. (Guidelines for Asthma Care, Korean Academy of Tuberculosis and Respiratory Diseases 2020) Institutions with pulmonary function test equipment showed better results in all evaluation indicators than institutions without. Asthma is a chronic respiratory disease that can prevent the deterioration of the disease and hospitalization if it is treated effectively in an outpatient clinic. In 2019, the prevalence of asthma over the age of 19 in Korea was 3.2% and 5.0% over the age of 65, and the asthma hospitalization rate was 65 per 100,000 people, higher than the OECD average of 34.4. Since the number of patients receiving treatment is less than the prevalence of asthma estimated by the national health statistics, it is more important to conduct lung function tests for early diagnosis of asthma. Kim Yang-joong, a member of the HIRA, said, "There are some types of respiratory tests that can be easily taken," and explained, "Not only suspected asthma patients but also patients undergoing treatment are encouraged to take respiratory tests at least once a year." The HIRA is unveiling a hospital with good results in the adequacy evaluation of asthma so that it can be continuously managed at a nearby local hospital.
