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- 2025-12-23 06:55:48
- Policy
- It has been four years since Eucept was released
- by Lee, Hye-Kyung Nov 07, 2022 06:06am
- The permission of LG Chem's rheumatoid arthritis treatment Eucept (Etanercept) will be changed. The MFDS will prepare an order (proposal) to change the permission items based on the results of the re-examination of Eucept Prefilled Syringe and Eucept Auto Injector and inquire about opinions until the 17th. Eucept is LG Chem's first antibody-drug and was approved in Korea in March 2018 as a treatment for rheumatoid arthritis, psoriatic arthritis, axial spinal arthritis, and psoriasis. LG Chem started developing Eucept in 2010 and launched it in Japan and Korea, even before the biosimilar market was formed. Eucept was selected as a national project for the Daedeok Special Zone Strategic Industry R&D Project hosted by the Ministry of Science and ICT in 2010 and the Health and Medical Technology R&D Project hosted by the MOHW in 2015, and conducted a 52-week long-term clinical trial for 370 rheumatoid arthritis patients in Korea and Japan. In particular, the Auto Injector type was also released to make it more convenient for patients with rheumatoid arthritis who have difficulty with their hands due to the nature of the product that patients inject themselves. LG Chem has been approved for two products, Auto-Injector and PFS formulation, which are automatic injection methods for pen formulations. For re-examination in Korea, a post-marketing survey of 351 people has been conducted over the past four years. As a result, the expression rate of abnormal cases was reported as 35.33% (124/351 people, a total of 187 cases) regardless of the causal relationship. Significant drug adverse reactions that cannot exclude causality were 0.57% (2 patients/351 patients, 2 cases), showing bacterial pneumonia, increased eosinophils, and drug reactions accompanied by systemic symptoms. Unexpected drug abnormalities were 3.99% (14/351, 14 cases), with pus blisters, insomnia, breast inflammation, abnormal sensation in the eyes, palpitations, wet cough, liver lipoma, joint swelling, rheumatoid nodules, fever, and based on this, abnormal cases will be added in the precautions for use of the permit.
- Policy
- We will continue to strengthen cooperation with the HIRA
- by Kim, Jung-Ju Nov 07, 2022 06:05am
- The HIRA (Director Kim Sun-min) announced on the 4th that Rudi Eggers, director of the World Health Organization (WHO) Integrated Health Services (IHS), visited the HIRA to discuss international cooperation measures. Under the agreement with the WHO, the HIRA has been sending screening and evaluation experts to the WHO Integrated Health Service Bureau since 2016, and in December last year, it was designated as the WHO Cooperation Center in Strategic Purchasing and has strengthened practical cooperation such as holding joint training courses. The visit came within today from the 31st of last month when Director Rudy Eggs asked Director Kim Sun-min to discuss ways to cooperate with the two organizations. Director Rudi Eggers began discussing ways to cooperate by introducing the work of the healthcare system and the HIRA. He admired the HIRA's achievements in improving medical quality and efforts to collect and utilize health and medical big data, and suggested that "the WHO and the HIRA work together to expand health security in the international community and improve medical quality." Director Kim Sun-min said, "We will continue to expand the role of the HIRA in the international community to ensure universal medical care and strengthen the sustainable healthcare purchase system."
- Policy
- No budget set to compensate increasing Paxlovid AE reports
- by Lee, Jeong-Hwan Nov 07, 2022 06:05am
- It has been found that no government budget has been set to compensate for the adverse events that may occur after receiving COVID-19 treatments granted emergency use authorizations in Korea. Therefore, a claim has been raised that a supplementary budget needs to be set to review and provide damage relief from the use of EUA drugs that did not receive official approval like Paxlovid, Lagevrio, and Evusheld when patients apply for compensation to the government. In other words, a separate budget needs to be set to compensate for adverse drug reactions from EUA drugs as Korea’s current relief system for adverse drug reactions only applied to drugs that received official marketing authorization under the Pharmaceutical Affairs Act. Senior expert member SunHee Jin of the National Assembly’s Health and Welfare Committee made such a statement in the 4th in the review report for the Ministry of Food and Drug Safety's 2023 budget plan. In March 2021, the ‘Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis’ was enacted to respond to public health crises such as COVID-19. The Act allows manufacturers and importers to supply drugs that have not been granted marketing authorization or have been reported to respond to public health crises through EUA. Based on the Act, one item last year – Paxlovid, and 2 items this year – Lagevrio Cap and Evusheld, have been granted EUA in Korea. As of September of this year, 614 cases of dysgeusia, dizziness, and high blood pressure were reported and 3 cases of adverse event damage relief applications were submitted to the government from the use of EUA drugs. However, the problem is that it is unclear whether adverse events that arise from EUA drugs can be compensated through the existing relief system. The adverse drug reaction relief program, which is supported by the Korea Institute of Drug Safety & Risk Management, provides relief from adverse events of drugs approved under the Pharmaceutical Affairs Act. Therefore, the grounds are unclear as to whether it can provide compensation for adverse reactions from EUA drugs that were approved under the Public Health Crisis Response Act. The compensation for relief provided under the Pharmaceutical Affairs Act is not financed by the state but is financed by contributions paid by drug manufacturers, marketing authorization holders, and importers. Expert member Jin Seon-hee judged that adverse events from drugs that were approved under the Public Health Crisis Response Act cannot be provided compensation for damages under the Pharmaceutical Affairs Act. Therefore, Jin pointed out that such compensations for EUA drugs including Paxlovid should be made using national finances, however, this has not been reflected in the budget. Jin said, “A partial amendment to the Public Health Crisis Response Act has been presented to provide legal grounds to compensate for adverse events from EUA drugs with national finances. Rep. Hye-Young Choi and Miae Kim submitted the bill that is under review by the Health and Welfare committee, therefore, additional budget considerations are needed.”
- Policy
- Strepto formulations negotiated at a rate of 20%
- by Lee, Tak-Sun Nov 04, 2022 05:39am
- The pharmaceutical industry has low drug prices, so if the recovery rate is more than 20%, there is no margin left Based on the results of the clinical re-evaluation of the anti-inflammatory enzyme drugs Streptokinase and Streptodornase, the NHIS and pharmaceutical companies, which have started negotiations to recover their salaries, are reportedly showing differences in their positions over the recovery rate. While the NHIS requires more than 20% of the recovery rate, pharmaceutical companies say they can never agree on more than 20%. The return rate of 20% is the rate agreed upon in the negotiation for the return of the brain function improvement drug Choline alfoscerate. According to the industry on the 3rd, the NHIS began negotiations with pharmaceutical companies until the 14th as the HIRA decided to suspend the re-evaluation of benefit adequacy for one year only for items that agreed to be recovered according to the results of clinical re-evaluation. It is said that data has already come and gone along with face-to-face negotiations. The key to negotiations is the rate of return and the period of return. However, it is known that it is not easy to reach an agreement due to significant differences in the recovery rate. The NHIS is said to have offered a higher amount as a baseline for the 20% return rate agreed with Choline alfoscerate pharmaceutical companies in 2021. However, pharmaceutical companies say they can never accept more than 20%. An industry official said, "Streptokinase and Streptodornase have nothing left from the cost if the return rate exceeds 20% because the upper limit is cheap." The upper limit of Streptokinase and Streptodornase is 58 to 70 won, which is not comparable to the 500 won Choline Alfocerate. However, the NHIS is said to be unable to lower the recovery rate as the recovery period is expected to be short as the results of the clinical re-evaluation of the drug are scheduled for next year. In fact, the clinical re-evaluation of Choline alfoscerate was launched last year, and considerable time is left until 2025. In comparison, Streptokinase and Streptodornase are likely not to have a long recovery period like Choline alfoscerate as they have been confirmed to be submitted as a result of clinical re-evaluation next year. However, the recovery period may vary depending on how the NHIS and the pharmaceutical company agree on the timing of the recovery. It is unclear whether an agreement will be reached by the end of the negotiations on the 14th because the gap between the two sides is significant in the recovery rate. If the agreement fails, the Ministry of Health and Welfare is expected to consider whether to order renegotiation or reflect it in the results of salary adequacy. For now, the Ministry of Health and Welfare plans to reflect the results of the re-evaluation of benefit adequacy in the list.
- Policy
- Government-Pharmaceutical Consultation on Acetaminophen
- by Lee, Jeong-Hwan Nov 04, 2022 05:39am
- Second Vice Minister Park Min-sooThe Ministry of Health and Welfare met with domestic and foreign pharmaceutical companies to cooperate to increase production and facilitate distribution of cold medicine Acetaminophen 650 mg, and actively promote necessary institutional support such as raising the price of drugs. Park Min-soo, the second vice minister of the Ministry of Health and Welfare, held a meeting with officials from six major pharmaceutical companies that produce cold medicine (acetaminophen ingredients for preparation) at 2 p.m. on the 3rd at Seoul City Tower (based in Jung-gu, Seoul). Chong Kun Dang, Korea Johnson & Johnson, Kolon Pharmaceutical, Hanmi Pharmaceutical, Bukwang Pharmaceutical, Genuonescience officials, and Jang Byung-won, vice chairman of the Korea Pharmaceutical Bio Association, attended the meeting. Second Vice Minister Park Min-soo thanked the pharmaceutical bio industry for its efforts and cooperation in producing and developing medicines, including cold medicines, in the process of responding to COVID-19. In addition, considering the recent increase in COVID-19-confirmed patients and flu patients, we listened to the current status and difficulties of cold medicine and collected opinions on the ongoing process of adjusting health insurance drug prices at the request of pharmaceutical companies. The Ministry of Health and Welfare and the pharmaceutical industry decided to cooperate to increase production and facilitate distribution in order to ensure that people do not suffer inconvenience due to a lack of cold medicine in winter. It decided to actively promote necessary institutional support such as raising drug prices for this purpose. Second Vice Minister Park Min-soo said, "The government and the pharmaceutical industry's efforts are important to prevent disruptions in the production and supply of medicines needed for people's lives and health," adding, "We will continue to listen to the opinions of the field and actively promote practical and diverse support." Meanwhile, along with Vice Minister Park, Oh Chang-hyun, director of insurance and pharmaceutical affairs, Jeong Hae-min, director of the NHIS, and Yoo Mi-young, director of the HIRA's drug management office, also attended.
- Policy
- Reimb standards set for first RET-targeted Retevmo
- by Lee, Tak-Sun Nov 04, 2022 05:39am
- Reimbursement listing for Lilly’s ‘Retevmo cap(selpercatinib),’ the first RET-targeted anticancer therapy in Korea, is gaining speed after successfully setting reimbursement standards. As the drug is eligible for expedited listing in Korea as a treatment used for life-threatening conditions, its time to reimbursement listing is expected to be further shortened. The Health Insurance Review and Assessment Service announced that it had held the 9th Cancer Disease Deliberation Committee meeting and made the decision on the 2nd. At the meeting, CDDC set new reimbursement standards for Retevmo Cap as a treatment for ‘advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy’ and ‘advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy with prior sorafenib and/or lenvatinib treatment history.’ In addition, the CDDC further set reimbursement standards for Retevmo in non-small-cell lung cancer as well. RET is a kinase that can cause cancer. When mutated or bound with other genes, RET is known to promote cancer cell proliferation. Retevmo targets this RET gene mutation. In Korea, Retevmo is the first drug in its class to receive approval and set reimbursement standards. At the last NA Audit, HIRA mentioned that the reimbursement period for Retevmo can be reduced as it is a treatment used for a life-threatening condition. HIRA and NHIS are currently working to reduce the reimbursement listing period by 30 days for the applicable drugs. The plan is to shorten the listing period by negotiating with HIRA 30 days prior to the commencement of the Drug Reimbursement Evaluation Committee (DREC) meeting. As Retevmo’s reimbursement passed CDDC review and will be deliberated by DREC soon, the company may benefit from the government’s implementation of the expedited listing measure. Meanwhile, reimbursement standards failed to be set for TS-1 Cap+Eloxatin inj combination therapy and Kyprolis Inj+Darzalex Inj+Dexamethasone combination therapy that had been deliberated with Retevmo at the CDDC meeting.
- Policy
- The self-sufficiency of national essential drugs has begun
- by Lee, Hye-Kyung Nov 04, 2022 05:38am
- The selection of 11 candidate medicines that require the development of domestic manufacturing and quality evaluation technologies has been completed. The Ministry of Food and Drug Safety recently selected a total of 11 items (5 raw materials & 6 finished products) as the first stage of development candidates after deliberation by the Product Selection Committee and is announcing the recruitment of developers through the website of research institutes such as the Korea Rare Essential Drug Center and the KPBMA. The Ministry of Food and Drug Safety has selected items that are highly dependent on imports and unstable supply and demand to the self-sufficiency of national essential drugs and is promoting the "National Essential Drug Stabilization Management Research Project" from this year to 2026. The project aims to establish a stable supply system for products that are feared to be unstable in supply and demand among the national essential drugs used in public health crises, and aims to develop raw material and finished drug production technologies for domestic production. A total of 5 billion won will be spent on development for 5 years, with more than 40% of the drugs selected and targeted for development in the first stage, and the rest of the drug technology development and comprehensive evaluation in the second stage (year 3 to 5). There are six drugs that have completed support for the stable supply of the first phase of the project, including the candidate group, Amiodarone inj., Melphalan, Stiripentol Cap, Dantrolene inj., Amiodarone HCl, and Bromcriptine. The raw material drugs are five items: Amiodarone, 2% Lidocaine, Ibuprofen, Ketoconazole, and Benserazide. According to the opinion of the advisory committee, two items of complete pharmaceutical and two items of raw material will be selected in consideration of priorities, and additional items can be selected within the scope of the first-stage project research cost. The Ministry of Food and Drug Safety said, "We will expand the recognition of multiple standards of raw materials to diversify the supply chain as well as develop technologies to localize raw materials and realize self-sufficiency." The issue of self-sufficiency in medicines was also one of the points pointed out by this year's parliamentary audit. As the national crisis caused by the global supply chain, such as the Ukraine-Russia war and the Urea solution crisis, as well as COVID-19, has become a reality, it has been pointed out that the domestic drug supply situation cannot be relieved. Of the 567 finished drugs reported to have been suspended from production, import, and supply from 2017 to June 2022, 31 were suspended due to the supply and demand of raw materials, and 17 of them were found to be national essential drugs. The self-sufficiency rate of finished drugs, which was 77.6% in 2017, gradually decreased to 60.1% in 2021.
- Policy
- Akynzeo is licensed domestically
- by Kim, Jung-Ju Nov 03, 2022 05:54am
- The Ministry of Food and Drug Safety has landed in Korea with new drug imported by HK inno.N. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) approved Akynzeo, an imported new drug of HKinno.N, on the 31st, which prevents nausea and vomiting caused by the administration of chemotherapy drugs. This is a drug for preventing acute and delayed nausea and vomiting caused by initial nausea and vomiting prevention or repeated treatment among adults receiving moderate or higher vomiting-induced chemotherapy. The mechanism of action of Palonosetron and Netupitant, the active ingredients, inhibits the neural pathways involved in inducing nausea and vomiting, and both ingredients have a long half-life in plasma, which is effective as an antiseptic, according to the Ministry of Food and Drug Safety. Akynzeo is expected to contribute to improving the quality of life of patients by helping to prevent nausea and vomiting in patients who are difficult to take the existing oral formulation Akynzeo capsule with intravenous injections. The Ministry of Food and Drug Safety said, "We will continue to do our best to expand the treatment opportunities of patients in the future so that treatments that have been sufficiently confirmed in safety and effectiveness are quickly supplied based on regulatory science expertise."
- Policy
- NHI big data was used to evaluate safety of JAK inhibitors
- by Lee, Tak-Sun Nov 02, 2022 05:36am
- Soon-Ae Shin, Deputy Minister of the NHIS Big Data Headquarters held a press conference with its press corp on the 1st to explain the HQ’s main projects and plans. Big data from the National Health Insurance was found to have been used to evaluate the safety of JAK inhibitors, based on which its use has been restricted in high-risk patients in Korea. This is the first time that NHI big data had been used for safety evaluation of pharmaceuticals in Korea. The National Health Insurance Service’s Big Data Strategy Headquarters held a press conference with the press corp on the 1st at its Wonju headquarters to deliver this news. Soon-Ae Shin, Deputy Minister of the NHIS Big Data Headquarters, said, “We established a consultative body with the Ministry of Food and Drug Safety to conduct joint research on information related to the real use of pharmaceuticals and conducted a safety evaluation on JAK inhibitors used for rheumatoid arthritis, etc with the consultative body for the first time this year.” The NHIS performed a comparative analysis on the incidence of major cardiovascular diseases and mortality rate of TNF blockers and JAK inhibitors using NHI big data. In June, based on the results derived using big data and expert deliberations, the MFDS revised the approved label for JAK inhibitors so that patients 65 years of age or older, patients at high cardiovascular risk, and patients at risk of malignancies could only use JAK inhibitors if they see inadequate treatment effect from existing treatment options. Since last September, reimbursement standards have also been revised accordingly and applied to prescriptions. Jong-Hun Park, Deputy Minister of NHIS’s Big Data Strategy HQ, said, “We conducted big data research for two to three months per MFDS's request. Although the decision was made after expert deliberations by the Central Pharmaceutical Affairs Council, our study has also contributed to the policy decision-making process.” The NHIS is also known to be conducting safety evaluations on other pharmaceuticals using big data. The MFDS evaluated JAK inhibitors after acquiring safety information from overseas sources including the US FDA in September last year. The US FDA had restricted the use of JAK inhibitors to specific patients that do not respond or show intolerance to TNF blockers, as it can increase the risk of severe heart-related events including heart attacks. Europe has also first limited the use of tofacitinib, a JAK class inhibitor, to high-risk groups who have suitable treatment alternatives, and is reviewing the need for applying additional measures on other JAK inhibitors. Until now, the MFDS had used data on adverse reactions that had been collected separately for drug safety evaluations. The added reflection of NHI big data in drug safety evaluations is expected to allow customized measures to be made in Korea that reflects the domestic environment. Deputy Minister Shin said, “ We expect our research to verify drug safety and efficacy based on NHI big data to expand further around the consultative body.” NHIS also plans to support the research and development of real-world evidence (RWE) on pharmaceuticals ㅕusing big data. In other words, it aims to organically link NHI big data for use from the drug development stage to post-marketing research. In the preclinical development stage, big data is expected to be used to analyze the characteristic of the target disease and patient group, analyze existing treatment (drug prescription, etc.) patterns, explore combinations for drug development, drug repositioning, etc. In the clinical trial stage, it is expected to be used for clinical trial design support, estimation of a number of clinical trial subjects, support of the control group to ultimatley reduce the clinical trial period and improve the efficiency of clinical trials. Also, the NHIS added that big data can be used in various areas in the post-marketing stage as well, including for comparative evaluation between competitors, feasibility study of research topics, and post-marketing monitoring of drugs subject to re-examinations.
- Policy
- "Synthetic Biology" that Moderna used
- by Kang, Shin-Kook Nov 02, 2022 05:36am
- Deputy Prime Minister Choo Kyung-hoThe Act on Research Promotion and Support for Synthetic Biology' proposed legislation in the first half of next year. Support measures will be prepared for Synthetic Biology, which is evaluated to double the efficiency of research and development of innovative new drugs and materials. Deputy Prime Minister for Economic Affairs and Minister of Strategy and Finance Choo Kyung-ho presided over an emergency economic ministers' meeting at the Seoul Government Complex on the 1st and discussed plans to secure new growth engines such as bio. Considering the characteristics of Synthetic Biology, which is accompanied by innovation and risk, the government will propose a new law in the first half of next year to promote technology development and manage transparency at the national level. The name of the bill is the 'Act on the Promotion and Support of Synthetic Biology Research'. The government has decided to prepare a "National Synthetic Biology Initiative" this month to create a bio-innovation ecosystem based on Synthetic Biology and to respond strategically to global technology hegemony competition. This will include a comprehensive policy direction from a long-term perspective that encompasses R&D, infrastructure construction, industrial use, and ecosystem creation to secure core technologies. The government will establish 'Biofoundry', a key infrastructure to accelerate innovation in Synthetic Biology technology and strengthen domestic bio-manufacturing competitiveness. Biofoundry will be invested 300 billion won over five years from 2024 to 2028, and will be organized by the Ministry of Science and Technology. In addition, the government decided to revitalize the "Korea Synthetic Biology Development Council" to create a private-centered Synthetic Biology development ecosystem and gather domestic industry, academia, and research capabilities. Currently, 58 organizations, including 20 companies, 26 universities, and 12 contributing associations, are participating in the council. The government will hold a joint Korea-U.S. Synthetic Biology conference in December to lay the foundation for research cooperation with the U.S., a leading technology player in Synthetic Biology, and promote cooperation among major research institutes. Synthetic Biology means creating a life system by synthesizing genes. Synthetic Biology technology is evaluated as a key technology that can change the flow and landscape of all fields of the red, green, and white bio industries, and has also been designated as one of the top 10 core technologies in the U.S. Innovation Competition Act. In fact, Moderna shortened the development period by using Synthetic Biology in the process of developing the COVID-19 mRNA vaccine.
