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- 2026-05-05 07:23:22
- Policy
- Based on PVA exclusion, the arithmetic average is 90%
- by Lee, Tak-Sun Apr 04, 2022 06:07am
- Drugs subject to PVA with an arithmetic average of less than 90% of the same product group are excluded. Previously, only drugs below the arithmetic average were excluded, but the target was further narrowed to less than 90%. Products with annual claims of less than 2 billion won are also excluded from PVA drugs. Previously, products worth less than 1.5 billion won were excluded, but the revision will expand the drugs subject to exclusion. The NHIS announced on the 28th that it will revise detailed operating guidelines for PVA negotiations to enhance the role of drug expenditure management and promote efficiency in operating the system. The NHIS explained that the PVA negotiation system is a system that adjusts drug prices as the usage increases after listing drugs, and plays a key role in the follow-up management of drug prices. The need to improve effectiveness has been steadily raised, and the guidelines have been revised this time. The revision of the guidelines focused on revising the drugs subject to negotiation (Article 6 of the Guidelines) for efficient operation of the system and financial management. First, in order to select the top drug of the amount of claims excluded due to reasons below the arithmetic average, the rule excluding "less than the arithmetic average" was revised to the "less than 90% arithmetic average" rule. As of 2020, the average claim for drugs subject to PVA negotiations in 2021 was 12.7 billion won, while those subject to exclusion below the arithmetic average were 22.3 billion won, much more than this. Most of the drugs subject to exclusion below the arithmetic mean were between 90% and 100% of the arithmetic mean. An official from the NHIS explained, "In the past, it was difficult to efficiently operate the system by excluding drugs below the arithmetic average price from the PVA negotiations." The revision will revise the existing regulations to less than 2 billion won in order to exclude small claims with low fiscal impact from negotiations. Among the subjects of the 2021 negotiations, drugs in the section between 1.5 billion won and 2 billion won in claims account for 35.6% of the total. Jeong Hae-min, head of the NHIS' Pharmaceutical Management Office, explained, "The revision of the detailed operation guidelines for PVA negotiations will strengthen the follow-up management of drugs that affect insurance finances by strengthening drug management." The revised detailed operation guidelines for PVA negotiations will be implemented from April 1, and they will also be applied to drugs undergoing PVA monitoring and negotiations at the time of implementation of the guidelines.
- Policy
- To commercialize innovative new drugs/supply essential drugs
- by Lee, Jeong-Hwan Apr 03, 2022 04:25pm
- The MFDS reports discuss ways to become a bio-health powerhouse The Presidential Acquisition Committee Yoon Seok-yeol and the MFDS agreed to systematically support the commercialization of high-tech and innovative medical products and establish a stable supply environment for rare essential drugs with low profitability. The transition committee plans to take the lead in the development of domestic treatments for COVID-19 to establish sovereignty over vaccines and treatments, a major pledge of Yoon Seok-yeol. On the 28th, Yoon Seok-yeol's transition committee's social welfare and culture division made the announcement after reporting to the MFDS. Lim Yi-ja, secretary-general of the MFDS, as well as standing expert committee members Kim Mi-ae and Seo Jung-sook of Ahn Sang-hoon, Baek Kyung-ran, and Kim Do-sik were present in the report. From the MFDS, deputy director Kim Jin-seok, evaluation director Seo Kyung-won, and directors attended. The development of domestic treatment for COVID-19 is a major pledge related to COVID-19 by President-elect Yoon Seok-yeol. Yoon promised to expand full national R&D support to establish sovereignty over vaccines and treatments and build a global vaccine hub. It will also come up with policies to open Yoon's pledge, and the MFDS emphasized the importance of ▲preemptive preparation of predictable screening criteria,▲ systematic commercialization support for advanced and innovative medical products, ▲ training of human resources with global level of regulatory response capabilities, and▲ the role of the MFDS to leap forward as a bio-health powerhouse, such as strengthening international cooperation to secure global competitiveness. Discussions on preparation for the outbreak of new infectious diseases were also held. The acquisition committee and the MFDS agreed that rare and essential medical products, which are difficult to supply to the market due to lack of profitability, should play their role in the country. The transition committee said, "We need to discuss with various experts and closely cooperate with related ministries in the stage of reviewing the safety and effectiveness of medical products." The transition committee said, "We should respond quickly with forward-looking judgments in crisis situations such as COVID-19. The MFDS should make efforts to ensure that domestic medical products have international competitiveness."
- Policy
- The MFDS released a national lot release of Comirnaty
- by Lee, Hye-Kyung Mar 31, 2022 04:29pm
- The MFDS (Director Kim Kang-rip) announced on the 29th that it has released 299,000 doses of Pfizer's Comirnaty 0.1mg/mL (for 5-11 years old) in Korea. The MFDS conducted Comirnaty test and reviewed the manufacturing and test data of the manufacturer, and confirmed the effectiveness, safety, and quality, and decided to release the national lot according to the standards. Comirnaty 0.1mg/mL (for 5-11 years old) is an mRNA vaccine developed and produced by Pfizer of the United States for the purpose of preventing COVID-19 between the ages of 5 and 11. The previously approved Comirnaty, Comirnaty 0.1 mg/mL and Tozinameran were the same active ingredient, but the dose was reduced to 1/3 (10)) per inoculation. The MFDS expected this national lot release to help prevent children from getting worse due to COVID-19 and seriousness at a time when the number of confirmed children increases and family infections increase. COVID-19 vaccine national lot release information can also be found online on the MFDS' website, COVID-19 Vaccine and Treatment Information (www.mfds.go.kr). The national lot release is a system in which the state comprehensively evaluates the test results and manufacturing and test results for each manufacturing unit (lot numbers) before vaccines are distributed on the market.
- Policy
- Roche RET target anticancer drug Gavreto, approved in Korea
- by Lee, Hye-Kyung Mar 31, 2022 04:23pm
- Roche's non-small cell lung cancer treatment Gavreto (Pralsetinib)"has obtained an item license in Korea. The MFDS approved Gavreto 100mg on the 29th. The drug was recognized for its effectiveness in the treatment of ▲RET (RET) fusion-positive local progression or metastatic non-small cell lung cancer adult patients and ▲ systemic therapy required RET mutation local progression or metastatic thyroid medullary cancer for adult patients. The effectiveness is based on the reaction rate and reaction period, and there is no data proving the improvement of the survival period. According to 136 patients who have been administered platinum-based chemotherapy drugs and have been administered Gavreto, the total response rate was 58.8% and the average response duration of 22.3 months. The recommended dosage is 400 mg in adults, which is administered orally once a day. Gavreto obtained conditional approval from the EU Commission in November last year after receiving accelerated approval from the US FDA in September 2020. The FDA approved adult metastatic RET gene fusion-positive non-small cell lung cancer treatments and progressive RET mutation thyroid cancer treatments for children and adults over the age of 12, and the EU applied for permission as a treatment for RET mutated thyroid cancer. Competitive drugs are Lilly's Retevmo 40mg and Retevmo 80mg, and Retvmo was approved from the MFDS on March 11. Retvmo is the first FDA-approved RET inhibitor in May 2020. In Korea, it has indications such as metastatic RET fusion-positive non-small cell lung cancer, progressive or metastatic RET-variant thyroid medullary cancer requiring systemic therapy with previous treatment experience of Sorafenib and/or Lenvatinib. Among domestic pharmaceutical companies, HK inno.N introduced the RET target anticancer drug "VRN061782" from Voronoi in February last year and is conducting commercialization development.
- Policy
- Reimbursement priorities in ultra-high-priced one-shot Txs
- by Lee, Tak-Sun Mar 31, 2022 05:57am
- With the reimbursement imminent for the ultra-high-priced one-shot treatment Kymriah, the National Health Insurance Service is preparing to conduct research on the performance evaluation of the risk-sharing agreement (RSA) and its mid-to-long-term development direction. The research will be exploring ways on the development direction of the RSA system through measures such as setting priorities in the reimbursement of ultra-high-priced one-shot treatments, etc. On the 28th, the NHS made an urgent announcement for a bid on research services for the ' Performance Evaluation of the Risk Sharing Agreement Scheme.’ The research is expected to be completed by November this year after signing a research service agreement in April. In the bid proposal document, NHIS stated, “8 years have passed since the introduction of the risk-sharing system in 2014 to improve access to drug treatment, with no objective evaluation of the effect of the introduction of the system. Also, concerns about the sustainability of insurance finances and the function of v are growing due to the rising demand for reimbursement of ultra-high-priced drugs (one-shot treatments) that can cure patients with a single administration,” indicating the need for research. The purpose of the research is to evaluate the performance of the RSA scheme from a social, economic, and industry aspect and conduct an interview with expert groups to analyze the payable price level for ultra-high-priced drugs, to seek direction on the development of the RSA scheme. To evaluate the performance of the RSA, the research will ▲evaluate the social effect of the RSA scheme (comparison of new drug listing rates pre-and post-implementation to evaluate its influence on patient accessibility, and speed of new drug introduction in Korea) ▲evaluate the economic effect of RSA (assessment of fiscal impact through analysis of RSA drug claims data, assessment of its impact in reducing patient burden, etc.) ▲evaluate the industrial effect of RSA (changes in industry activities in the pharmaceutical industry due to introduction or change of the system, etc.) ▲evaluate the effect of introducing the system from various aspects (including collecting opinions from stakeholders such as academia, patients, medical circles, industry, and government). In order to derive mid-to-long-term improvement plans for the development of the RSA scheme, the research will ▲analyze the pros and cons of the system through a performance evaluation and seek development plans ▲seek improvement plans by examining its operations in other countries ▲seek measures to relieve the administrative burden that increased due to RSA follow-up management such as refunds, etc. In addition, to set priorities for reimbursement and wet standards for the willingness to pay on ultra-high-priced drugs, the research will ▲analyze the reimbursement listing and claims status of ultra-high-priced drugs through an operational definition of the drugs ▲ conduct a focus-group interview (FGI) to survey the experts’ will to pay for ultra-high-priced drugs and seek advice on the considerations that should be made for their reimbursement to set priorities in reimbursement. The NHIS plans to use the research results as evidence for coverage reinforcement policies. In particular, when reviewing the reimbursement listing of ultra-high-priced one-shot drugs that have high social demand, the government will be reflecting the reimbursement priorities’, intention to pay, and other criteria derived from the research into their decision-making process. In addition, the goal is to establish a sustainable management system by preparing effective measures to reduce administrative burdens in the post-management of RSA drugs.
- Policy
- Multidrug-resistant ‘Zavicefta’ applies for approval
- by Lee, Hye-Kyung Mar 29, 2022 05:54am
- Pfizer Korea has applied for the approval of its important treatment for severe gram-negative bacterial infection, ‘Zavicefta.’ Zavicefta, which received marketing authorization in 2016. is a combination drug that contains the third-generation ceftazidime. According to industry officials on the 28th, Pfizer Korea recently submitted an application for the marketing authorization of Zavicefta to the Ministry of Food and Drug Safety. Zavicefta was developed to address the urgent need for new antibiotics in severe infections that cause serious problems such as multidrug-resistant pseudomonas aeruginosa or carbapenem-resistant gram-negative Enterobacteriaceae and extended-spectrum-lactamase (ESBL) producing intestinal bacteria. Zavicefta is used for the treatment of adult patients suffering from complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP); and the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. Zavicefta was developed by AstraZeneca. On August 24th, 2016, the company sold the global development and sales rights for its low molecular weight antibiotic business outside the United States to Pfizer.
- Policy
- Will the migraine tx Reyvow step on the same track
- by Lee, Tak-Sun Mar 29, 2022 05:54am
- IldongIldong Pharmaceutical's domestic copyrighted migraine drug Lasmiditan seems to be speeding up its benefit using the patent-approval linkage system. According to the industry on the 28th, the HIRA is recently listening to opinions on whether the migraine treatment Reyvow 50 & Reyvow100mg is eligible for medical care benefits through related conferences. Reyvow is known as the brand name of Lasmiditan, which Ildong Pharmaceutical secured domestic copyright in 2013. The group signed a development partnership and a domestic sales license agreement with CoLucid of the United States, the original developer of the drug. In 2017, CoLucid was acquired by global pharmaceutical company Eli Lilly also holds Lasmiditan's global rights. Reyvow was approved by the U.S. FDA in October 2019, and then Ildong started a bridging study for domestic permits. In January, the MFDS was found to have ended Reyvow's safety and effectiveness review. As a result, it is understood that the screening is underway using the patent-approval linkage system. It is a system that allows the MFDS to apply for a benefit decision before marketing approval based on this data when safety and validity screening are completed. Usually, it is applied after approval from the MFDS, but using the patent-approval linkage system can shorten the evaluation period by 30 to 60 days. Ildong plans to sell Reyvow domestically this year. Reyvow is the first migraine treatment to act on serotonin (5-HT) 1F receptors and has a mechanism to lower neuropeptide release and inhibit pain delivery pathways, including trigeminal nerves. It acts selectively on serotonin receptors and is characterized by no cardiovascular side effects due to vasoconstriction.
- Policy
- BMS acute myeloid leukemia tx Onureg was approved
- by Lee, Hye-Kyung Mar 29, 2022 05:54am
- Onureg 200mg and Onureg 300mg, the first PO drugs were approved. Currently, Azacitidine-based AML treatments, which are approved in Korea, are injections with Celgene's Vidaza100mg, Boryung Pharmaceutical's Vizadakin and Samyang Holdings' Azalid 100mg and Azalid 150mg, and Onureg has become the first oral treatment. The MFDS (Director Kim Kang-rip) recently approved BMS' AML treatment Onureg (Azacitidine). Onureg is an oral drug with a pink oval film coating and has the advantage of being administered regardless of meals. Indications can be used to achieve CR or CRi with incomplete hematological recovery after induction therapy, regardless of whether or not publicly announced therapy is performed, and to maintain therapy in adult patients with acute myeloid leukemia who are not suitable for HSCT. To administer Onureg, it must be initiated and monitored by a physician who has experience in chemotherapy, and should not be used interchangeably with injectable Azacitidine due to different exposure, dose, and administration schedules. Meanwhile, Onureg has been in the process of licensing items in Korea since the U.S. FDA approved in 2020.
- Policy
- Will the separation of the Ministry of Health be promoted?
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- Yoon Seok-yeol's presidential transition committee seems to be discussing the necessity of separating the Ministry of Health and integrating and absorbing the MFDS in the process of discussing the reorganization of the government after the inauguration of the next government. As the pandemic era became commonplace due to COVID-19, the role of the health sector grew, and the medical community strongly urged the independence of the Ministry of Health and even academia insisted on the necessity of the Ministry of Health. According to Yoon Seok-yeol's transition committee and related academia on the 27th, various discussions are taking place over the next government organization, including the reorganization of the MOHW. Yoon's transition committee receives reports from each government department until the 29th, while keeping in mind the need for independence of the Ministry of Health along with the abolition of the Ministry of Gender Equality and Family. Some say that if the Ministry of Health becomes independent, the MFDS will also inevitably change its organization. With the independence of the Ministry of Health, there is a possibility that the MFDS will be integrated and absorbed as it was an organization under the MOHW in the past. If the Ministry of Health becomes independent from the MOHW, the number of personnel is about 400, and the MFDS should be integrated to strengthen and exist the ministry functions. In addition, the Ministry of Health may divide areas other than the food sector within the MFDS after independence from the Ministry of Health as there is a need to transfer food sector work within the MFDS. The medical community strongly agrees with the independence of the Ministry of Health. The Ministry of Health should be separated to respond to the public health crisis caused by the outbreak of infectious diseases and foster the health care sector. The KMA proposed several government reorganization plans to establish the Ministry of Health and manage the KDCA, the MFDS, and public health centers since Yoon was a presidential candidate. Independence of the Ministry of Health is also emphasizing the necessity of related academia. Kim Eun-joo, a professor of social science at Hansung University, appealed the need for independence from the Ministry of Health at a seminar hosted by the KAOS and the KAPAR21 on the 25th. Professor Kim Eun-joo said, "The MOHW should separate health functions and deploy the KDCA as a member of the Ministry of Health to strengthen the health and safety system based on expertise in the health sector." She said, "We need to establish an effective response system to infectious diseases such as COVID-19. The MFDS should also strengthen its health risk factor management function," she argued. Professor Kim argues that the MOHW should be divided into the Ministry of Health and that KDCA, the ministry in charge of quarantine, should be assigned as a member of the Ministry of Health. Kim Yoon-kwon, a senior researcher at KIPA, also mentioned the establishment of the new Ministry of Health, saying, "We need to redesign welfare and health functions to secure function completeness based on our expertise." The transition committee plans to collect expert opinions on independence of the Ministry of Health, reorganization of the KDCA, and integration of the MFDS. The plan to reorganize the government is expected to be outlined only after the transition committee's business report is completed and before the next government is launched.
- Policy
- Govn’t to introduce 460,000 courses of oral COVID-19 drugs
- by Kim, Jung-Ju Mar 28, 2022 06:10am
- Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters The government will be introducing 460,000 courses of oral COVID-19 treatments by the end of next month. In principle, Paxlovid will be prescribed first, and Lagevrio, which has recently been approved for emergency use, should be used for patients who are restricted from using Paxlovid, such as users of contraindicated drugs. On the 25th, COVID-19 Central Disaster and Safety Countermeasures Headquarters (Head, Prime Minister Boo-kyum Kim) presided over a meeting in the videoconference room at the Sejong Government Complex with the central government departments, 17 metropolitan governments, and 18 cities and provinces on their COVID-19 vaccine/treatment development status and measures for support. According to Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters who spoke at a briefing by the disease control and management authorities, the government has procured a total of 1,400,000 courses oral COVID-19 treatments and is in the process of introducing them sequentially. As of the 24th, 163,000 courses of Paxlovid (from Pfizer) have been introduced to Korea, 114,000 courses of which have been used on patients in Korea. On the criticism that Paxlovid is not being actively prescribed by managing medical institutions even if symptoms appear unless older adults in their 60s directly ask for prescriptions themselves, the authorities said they will check on it. Ki-il Lee said, “We will do our best to make sure that institutions that conduct rapid antigen testings can immediately prescribe the drugs to those aged 60 years or older and the immunocompromised. We have requested this from the presidents of 16 doctors’ associations in 16 cities and provinces. W We will do our best to allow prescriptions to be made as soon as possible." Also, the government is continuing negotiations to rapidly introduce oral COVID-19 treatments. Including the 20,000 courses introduced yesterday, the government is pushing for the early introduction of 460,000 courses of oral COVID-19 treatments by the end of April. On the 24th, the first 20,000 courses of Lagevrio were introduced in advance for use from tomorrow (26th). Lagevrio was granted Emergency Use Approval on the 23rd by the Ministry of Food and Drug Safety after conducting safety/efficacy reviews and expert consultations. In consideration of its EUA indication, the drug will be used ▲within 5 days of symptom onset, ▲on patients over the age of 60 or age of 40 with underlying diseases or immunocompromised ▲who have difficulty using existing treatments. The authorities will allow use of Lagevrio in patients who have difficulty using other treatments due to the use of contraindicating medications, etc., although Paxlovid will be first prescribed in principle. Patients with severe hepatic or renal impairment or patients taking drugs of specific ingredients (28 types (23 types that are approved in Korea)) are restricted from the use of Lagevrio. In addition, pregnant women and patients under the age of 18 are excluded from eligible subjects in consideration of the EUA condition set by the MFDS. The government said it is making every effort to ensure that the new oral COVID-19 treatment, Lagevrio, can be safely used in the field. In order to prevent prescriptions from being made to pregnant women, children, and adolescents and its safe use, the drug was registered in the DUR (Drug Utilization Review) system, and relevant systemic improvement measures were completed, such as adding drug information to the patient management information system. Also, the 'Treatment Use Guide (6th edition)' has been distributed to medical institutions to guide Lagevrio prescriptions in institutions, and pharmacies will be distributing detailed medication guides to those patients who have been prescribed Lagevrio. Meanwhile, the government announced that it would monitor the introduction and use of oral COVID-19 drugs, and will continue to compensate for serious adverse events that arise by applying the drug’s side effect damage relief procedures. The current side effects damage relief measures include a lump-sum death compensation (114 million won), funeral expenses (9.8 million won), disability lump-sum compensation (29 million won to 114 million won), and hospitalization & treatment expenses (up to 20 million won). Medical institutions, pharmacies, patients, etc. can report side effects that occur after the use of drugs to the Korea Institute of Drug Safety and Risk Management (report online at www.drugsafe.or.kr) or receive related consultations.
