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- 2026-05-06 12:35:35
- Policy
- Rybrevant has been approved in Korea
- by Lee, Tak-Sun Feb 17, 2022 05:52am
- Janssen's Rybrevant, which is conducting a combined clinical trial with Leclaza, a new non-small cell lung cancer treatment drug developed by Yuhan Corporation, has been approved in Korea. The MFDS approved Janssen's Rybrevant on the 15th. This drug is used for "the treatment of patients with local progressive and metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in which the disease progressed during or after platinum-based chemotherapy." The recommended dosage also varies depending on the patient's weight with intravenous injections. The drug is drawing particular attention because it is conducting clinical trials in combination with Leclaza of Yuhan Corporation, a new domestic development drug, in the global market. Lazertinib exported technology worth 1.4 trillion won to Janssen in 2018. Since then, Janssen has been conducting clinical trials on non-small cell lung cancer patients using Lazertinib and its own developed Amivantamab. Two phase 3 clinical trials are underway in Korea. The phase 3 clinical plan was approved in September 2020 as the first treatment for patients with EGFR mutant local progressive and metastatic non-small cell lung cancer. In December of last year, EGFR-mutant, which failed Tagrisso treatment, entered phase 3 clinical trials for patients with local progressive and metastatic non-small cell lung cancer. Tagrisso is a third-generation treatment for EGFR mutated non-small cell lung cancer, and is a large drug with annual sales (based on IQVIA) exceeding 100 billion won in Korea. Leclaza and combination therapy of Leclaza-Amivantamab are expected to be competitive drugs for Tagrisso. Lazertinib expects conditional approval from the U.S. FDA this year as a second and third treatment for non-small cell lung cancer. In addition, combination therapy of Amivantamab-Lazertinib also challenges FDA approval. Rybrevant was approved by the MFDS as a GFR exon20 mutant non-small cell carcinoma treatment, but it was also approved by the U.S. FDA as a therapy that blocks epithelial cell growth factor (EGFR) and MET mutations at the same time.
- Policy
- Revised the method of Rx notes for health functional foods
- by Lee, Jeong-Hwan Feb 17, 2022 05:52am
- Regarding the regulation of "Note Prescription of Health Functional Foods," the MFDS expressed its position to push for legislation after watching the operation of the prohibited regulation that the health functional food industry voluntarily announced. The government plans to steadily monitor the operation of fair competition rules, draw up policies to support voluntary improvement in the health functional food industry, and review the need to revise health functional foods in earnest according to the results. This is the result of examining the prescription management plan for health functional food submitted by the MFDS to the National Assembly's Health and Welfare Committee on the 13th. Representative movements to pay attention to in order to improve the practice of prescribing health functional foods are the legislation of the National Assembly and the enactment of fair competition rules in the Fair Trade Commission and the Health Functional Food Industry. In the case of legislation, Rep. Kim Woni of the Democratic Party of Korea has proposed a revision to the medical law, and the Fair Competition Rules will take effect in April, discussed by the Fair Trade Commission and the KHSA. The revision to the Medical Service Act stipulated that doctors and medical institutions are not allowed to receive rebates such as money and entertainment provided by health functional food companies. The Fair Competition Rule is a method in which the health functional food industry voluntarily imposes penalties of less than 10 million won and heavy penalties of less than 100 million won when detecting rebates such as expedient health functional food note prescriptions. Some worry that the revision of the Health Functional Food Act should be promoted separately from the revision and enforcement of the Fair Competition Rules to regulate the prescription of health functional food, but the MFDS, which is in charge, is in a position to watch the operation of the Fair Competition Rules. Although the MOHW and the specialized committee of the Health and Welfare Committee expressed their position that the Health Functional Food Act needs to be revised prior to the revision of the Medical Service Act, the MFDS insisted that the need to revise the law be slowly considered. The MFDS argued that medicines and medical devices also implemented fair competition rules in the industry first and then revised related laws over a period of time. In the case of medicines, the Pharmaceutical Affairs Act was revised in 2010 after the enactment of the protocol in 1994, and the MFDS explained that the Medical Device Act was revised in 2013 after the enactment of the protocol in 2011. The health functional food-style note prescription does not directly affect health insurance finances, and unlike medicines and medical devices, the reality that health functional foods have open consumer options also affected the direction of the MFDS' policy operation. As a result, it is expected that the revision of the Health Functional Food Act will become a reality depending on the results of the enactment and enforcement of fair competition rules in the health functional food industry this year. The MFDS said, "We will continue to monitor the operation of fair competition rules while supporting voluntary improvement in the industry," and explained, "According to the results, we will review the need to revise the Health Functional Food Act." Health functional foods have a variety of sales channels such as the Internet, large discount stores, pharmacies, multi-level, door-to-door sales, and home shopping, so consumers can choose them, and medicine and medical devices have also been revised since the enactment of the rules, the MFDS added.
- Policy
- Lee to pledge ‘incentives for homegrown new drugs'
- by Lee, Jeong-Hwan Feb 16, 2022 05:51am
- Presidential candidate Jae-Myung Lee of the Democratic Party of Korea is positively reviewing reinforcing incentives for new drugs that were developed by Korean pharmaceutical companies or conducted trials in Korea, establishing a megafund for the pharmaceutical industry, and introducing a pre-approval system for prescriptions of ultra-high priced drugs as pledges for the coming presidential election this year. Also, the candidate is preparing to set official pledges on establishing a public electronic prescription system, institutionalize government support for public late-night pharmacies and complete eradication of hospitals owned by non-medical personnel. The pledges above were those requested by the domestic pharmaceutical industry, pharmacists’ association, and medical field and gained consensus from the NA Health and Welfare Committee. Lee plans to disclose the details of the policy in line with the official electioneering period that starts on the 15th. Lee is known to be reviewing various specific healthcare policies that require expertise regarding non-face-to-face treatment, biopharmaceutical industry, and pharmacy industry, in addition to the public healthcare pledges that he repeatedly announced including the expansion of public hospitals and reinforcing public medical personnel. In particular, the candidate is known to have drawn a relatively detailed blueprint on the development of homegrown vaccines that have greatly increased in importance due to the prolonged COVID-19 pandemic, public manufacture of essential medicines, and national support for the pharmaceutical and bio-industry are being. More specifically, the candidate is likely to make pledges to increase the vaccine self-sufficiency rate of vaccines in the National Immunization Program and strengthen the financial and administrative support needed for the treatment of COVID-19 vaccine and treatments while building a public manufacturing system for essential drugs that are at risk of supply disruption due to low profitability. Also, the candidate is considering incentive systems and active state-driven investment in the pharmaceutical and bio-industry to make Korea a pharmaceutical and biopharmaceutical powerhouse. Lee’s plan is to establish create a public-private matching-fund type megafund to improve the support system for clinical trials and realign the compensation system for homegrown new drugs and clinical trials conducted in Korea. Also, enhancing patient access to new drugs and pre-approval system for prescriptions of ultra-high-risk or ultra-high-priced drugs are being considered as pledges. The pledges above were those that multinational pharmaceutical companies with subsidiaries in Korea had continuously requested to the National Assembly and the government. In particular, the policies requested by Korea Pharmaceutical Association and pharmacists around are also expected to be included in Lee’s pledge. Policies that establish a system for non-face-to-face healthcare that has been temporarily approved due to COVID-19 and promote a state-led public e-prescription system, and policies to expand accessibility and convenience to medication for patients with public late-night pharmacies. The state-led public electronic prescription transmission system has been a policy that KPA had requested for several years now. The public late-night pharmacies are being piloted this year after securing a budget the previous year. Lee’s aim is to expand this pilot project into a main project. In addition, to completely eradicate hospitals owned by non-medical personnel, pledges to allow judicial police power to the NHIS, voluntary reporting, immunity for whistleblowers, stronger report rewards, punishment for those who made illegal establishments, and stronger recovery of unlawful profits are also expected to be included in the manifesto. Also, Lee’s camp promised to fully include ‘small/clear happiness pledges’ Lee had made as health insurance reimbursement of hair loss treatments, contraception, and abortion, free vaccination of HPV vaccines in adolescents, and soft landing the legalization of CCTVs in the operating room. An official from Lee’s camp said, “The camp is busy making additional modifications and final touches to the manifesto. We are in the healthcare pledges are in the final stages, and review the general improvements required in healthcare from public Healthcare to pharmaceutical and bio-industry, to patient systems at hospitals and pharmacies in Korea. The official added, “due to the diverse and multifaceted range of pledges that are being discussed by Lee’s camp, some have been producing false news that Lee excluded the reimbursement pledge for hair loss drugs based on the draft prepared by the camp. The completed pledge manifesto will be disclosed on the 15th when the official election campaign begins."
- Policy
- There's plenty of COVID-19 PO medicine, Regkirona
- by Lee, Jeong-Hwan Feb 16, 2022 05:51am
- The quarantine authorities said they have secured sufficient supplies of COVID-19 oral treatments in Korea and will continue to consider additional purchases depending on the quarantine situation. The quarantine authorities also said they would consider using the budget for purchasing Regkirona as an oral drug as Regkirona, an antibody treatment for COVID-19, is known to be vulnerable to responding to Omikron mutations. On the 14th, the KDCA responded in writing to the National Assembly's Health and Welfare Committee's Seo Young-seok of the Democratic Party and Lee Jong-sung of the People's Power. Rep. Seo asked if it was possible to secure PO drugs such as Paxlovid and expand the number of additional prescriptions. He also inquired about plans to expand the pharmacy in charge. The KDCA replied that it has pushed for a purchase contract for 1,044,000 people in consideration of the spread of Omicron and the quarantine situation. The KDCA has signed a purchase contract Pfizer vaccine (for 762,000 people) and MSD vaccine (for 242,000 people). The KDCA also said it will continue to consider the need for purchase by comprehensively considering the quarantine situation, medical response, development status of domestic and foreign treatments, and clinical efficacy. The KDCA explained that it has been steadily expanding and operating prescription agencies and pharmacies in charge after bringing PO drugs into Korea on the 14th of last month, and that the criteria for those subject to administration have also been expanded. The KDCA replied, "We will continue to improve for a stable supply so that the treatment to be eaten can be administered quickly and safely to those who need it." Rep. Lee Jong-sung said that the budget set for the purchase of Regkirona, an antibody treatment, should be changed to the budget for additional purchase of oral drugs effective in omicron mutations.bThe KDCA agreed with Rep. Lee and replied that it would consider ways to use Regkirona's purchase cost for oral medicine. Specifically, the KDCA set aside 393.3 billion won in the main budget this year, and 3.4 billion won in the purchase of Regkirona. As a result of the Regkirona pharmacological test on mutants, it was evaluated that they were less likely to show activity in omicron mutations, so they should be careful when prescribing them. Accordingly, the KDCA plans to allow the purchase of Regkirona to be used as the purchase of PO drugs in response to Omikron. The KDCA said, "We have not yet signed a contract for Regkirona purchase cost of 3.4 billion won this year," and added, "We will consider securing PO treatments effective for Omicron mutations."
- Policy
- High-dose ‘pyridoxine’ to be classified as an Rx drug
- by Lee, Hye-Kyung Feb 14, 2022 05:54am
- The high-dose Vitamin B6 ‘Pyridoxine Hydrochloride 300mg’ is likely to be classified as a prescription drug. Although pyridoxine doses up to 250mg are classified as a health functional food abroad, experts reached a consensus that the 300mg dose of the same drug should be classified as a prescription drug in consideration of the side effects that arise from the long-term use of the higher dose, and similar cases where a low-dose formulation of an approved drug had been classified as an OTC and the high-dose formulation as an ETC. The Ministry of Food and Drug Safety disclosed the minutes of the meeting held by the drug classification subcommittee of the pharmaceutical policy committee under the Central Pharmaceutical Affairs Council that was held on January 17th. In Korea, pyridoxine may be taken up to 100mg as an OTC, up to 250mg under the Korean manufacturing standard for medicine, and up to 67mg as a health functional food. The product that was under review this time is a high-dose formulation that contains 300mg of pyridoxine. Other than in Japan which classified the 300mg high-dose formulation as a prescription drug, other countries have classified the same drug as a health functional food or OTC. However, the subcommittee members were skeptical about the classification of high-dose pyridoxine as an OTC due to concerns over its side effects and duration of use. In particular, the members reached a consensus that it is reasonable to classify the high-dose formulation as a prescription drug as the high-dose pyridoxine is used for conditions that require diagnosis, such as to prevent deficiencies arising from the administration of Vitamin B6 antagonists and the treatment of B6 dependence, in addition to well as the side effects that may arise. Also, some raised the opinion that the 300mg needs to be classified as an ETC for the safe use of the drugs in consideration of cases where the lower dose was approved as an OTC and the higher dose was approved as ETC. Regarding its efficacy and effect, some members pointed out that although the 300mg formulation is not expected to be sold as a nutritional supplement the standard between the health functional food and OTC was unclear as the same ingredient is approved as a health functional food up to 67mg/day, and as OTC up to 100mg/ day. To the question where dosages other than the 300mg high-dose formulation that is under review may be reviewed for classification as OTC/ETC, the MFDS responded that such cases would require a separate application for review. As a result, the MFDS voted to classify pyridoxine 300mg as a prescription drug with consensus from the committee members.
- Policy
- The selection of benefit revaluation is approaching
- by Lee, Hye-Kyung Feb 14, 2022 05:54am
- The pharmaceutical industry has suggested that it is difficult to review and predict the criteria for selecting evaluation targets as the targets for benefit revaluation were disclosed in the current year during the pilot project of Choline alfoscerate and Bilberry Fruit Dried Ext, Avocado-Soya, Ginkgo Leaf Ext, Silymarin, and Vitis Vinifera. In response, The HIRA held a meeting with the pharmaceutical industry on December 23 last year to set standards for the ingredients subject to re-evaluation after discussing the ingredients and standards required for evaluation through expert advisory meetings since September last year. Jang Yong-myung, executive director of HIRA Development, said at the Korea Special Press Association briefing held on the 8th, "We will conduct a deliberation to select a target for benefit revaluation at the Drug Reimbursement Evaluation Committee held on the 10th. We plan to disclose the results of the selection of ingredients subject to re-evaluation in February and conduct a re-evaluation of appropriateness such as a basis-based practical review and expert advisory meeting from March." Specifically, the HIRA will present agenda items for the 2022 and 2023 benefit revaluation necessary components and standards discussed so far as a deliberation list at the Drug Reimbursement Evaluation Committee to be held on the afternoon of the 10th. If members of the Drug Reimbursement Evaluation Committee oppose the disclosure of ingredients subject to two years' revaluation during the deliberation process, the results discussed so far may come to nothing. If all committee members accept the results discussed by the HIRA, experts, and the pharmaceutical industry for three months last year, unlike the pilot project and the first main project, the pharmaceutical industry will be able to first check the ingredients subject to two years' benefit revaluation. Kim Ae-ryeon, head of the drug management office, said, "The Drug Reimbursement Evaluation Committee will deliberate on this year's revaluation target and next year's target." She said, "There have been demands from the pharmaceutical industry to talk about the following ingredients and standards in advance, so we have put them on the agenda for deliberation." Director Kim explained, "For ingredients this year, if we pass the Drug Reimbursement Evaluation Committee like the pilot project and the main project procedure, we will proceed quickly through deliberation of the Health Insurance Policy Committee and inquiry of opinions from the pharmaceutical industry." She added, "The list will be released next year, but if it is released in advance, pharmaceutical companies will have enough time to prepare."
- Policy
- Bill to stop reimbursement of drugs upon disposition
- by Lee, Jeong-Hwan Feb 11, 2022 05:55am
- A bill to immediately stop prescriptions of pharmaceuticals that have received sales suspension dispositions due to expedient acts such as rebates at hospitals and clinics is being pushed for legislation. If enacted, the bill will immediately suspend reimbursement of pharmaceuticals that will receive administrative dispositions and stop hospitals and clinics from prescribing such pharmaceuticals. On the 10th, NA member Byung-Won Kang of the Democratic Party of Korea submitted a bill for the partial amendment of the Medical Service Act that contains the changes above. Kang pointed out the issue of continued prescriptions from hospitals and clinics for drugs that receive manufacturing and sales suspension dispositions. In such cases, the drugs that are suspended from sales continue to be prescribed at hospitals and clinics, resulting in shortages in the supply of such drugs during the disposition period. Kang claims that this issue needs to be promptly addressed. Due to continued prescriptions of such drugs, frontline pharmacies need to work to preemptively secure inventory of the drugs when an administrative disposition or sales suspension is imminent, which leads to a sales increase for the pharmaceutical company while the inconvenience and confusion caused by the disposition are passed on to pharmacies and patients. This is why the pharmacists’ community has been voicing that an actual sanction must be imposed on companies that receive administrative dispositions to maximize the prevention of recurrent acts. To address this need, Kang submitted the bill to immediately suspend reimbursement of pharmaceuticals that are confirmed to receive administrative dispositions and stop hospitals and clinics from prescribing such pharmaceuticals during the disposition period. Kang said, “The bill will suspend reimbursement of drugs and allow doctors and dentists to check if the drugs are suspended from sales if they receive administrative dispositions due to rebates to stop prescriptions. The bill will improve the unreasonable structure where the sales of drugs that have received administrative dispositions surge in a short term and minimize the damage borne by pharmacies and patients."
- Policy
- “Will provide systemic support for homegrown mRNA vaccines"
- by Lee, Hye-Kyung Feb 11, 2022 05:55am
- The Ministry of Food and Drug Safety promised to spare no effort in providing institutional support so that domestic companies can foster mRNA vaccine manufacturing and development capabilities. On the 9th, Food and Drug Safety Minister Gang-lip Kim held a roundtable meeting with vaccine R&D developers and experts that are participating in the ‘mRNA Bio-venture consortium’ at Quratis’ production facility (Osong, North Chungcheong Province) to discuss measures to support the development of homegrown mRNA vaccines. Members from the Vaccine Center for Assisting Safety & Technology, Korea biomedicine Industry Association, Eyegene, Geneone Life Science, Quratis, Boryung Biopharma participated in the meeting. mRNA(messenger RNA) platform has been receiving much attention as an innovative platform for pharmaceutical development, as the technology may significantly reduce the time and cost required for manufacturing pharmaceuticals and can be applied to treat various diseases including cancer in addition to vaccines. The roundtable meeting was prepared for the government to listen to the needs in the field and discuss measures for support, as the MFDS plans to actively support the system and infrastructure necessary for developing the mRNA platform technology in Korea. At the meeting, vaccine developers and experts agreed that although securing the source technology is important for developing homegrown vaccines using mRNA technology, fostering professionals and implementing advanced regulatory science are most important for the commercialization of the vaccines. In other words, the industry asked for the MFDS’ continued efforts in advancing relevant regulations and fostering related personnel for the development of the biopharmaceutical industry. Minister Kim said, “Development homegrown mRNA vaccines is a must not only to overcome the current COVID-19 pandemic but to prepare for new epidemics and ensure public safety. We will spare no effort in providing institutional support so that domestic companies can foster mRNA vaccine manufacturing as well as development capabilities. Kim added, “We are committed to improving public health and will continue to conduct approval reviews based on expertise and regulatory science while fostering experts in the area. I ask you for your best efforts in developing domestic vaccines to protect the health and safety of our people.”
- Policy
- It's hard to handle free national support for self-diagnosis
- by Lee, Jeong-Hwan Feb 11, 2022 05:55am
- Prime Minister Kim Bu-Gyeom expressed disapproval of the ruling party's proposed "free support for self-diagnosis kits for the whole country." This is because the production of diagnostic kits is currently insufficient to cover free distribution across the country. On the 8th, Prime Minister Kim responded to a question from Rep. Shin Hyun-young of Democratic party of Korea in a comprehensive policy inquiry by the National Assembly's Special Committee on Budget and Settlement. On the same day, Rep. Shin asked, "The ruling party has argued that free supply to the whole country is needed." In fact, when the National Assembly's Health and Welfare Committee decided on the supplementary budget review on the 7th, the unit opinion said, "The government is considering supplying self-inspection kits to the entire nation." Demand for self-diagnosis kits has increased significantly recently as the government has implemented a quarantine policy that allows PCR tests only when positive results are obtained in rapid antigen tests. Prime Minister Kim said, "The production itself is difficult to cover the nation's free distribution of self-kits," explaining, "We made about 200 million kits a year, of which 100 million kits have to be exported, so there is a limit to production to free support with the rest." Regarding criticism that the government should adjust its own kit consumer sales price to less than 2,000 to 3,000 won, Prime Minister Kim replied, "The distribution process will also cost appropriate supply," adding, "We will decide with the MFDS and organize it quickly so that there will be no confusion." Meanwhile, according to the government, the current public sector procurement unit price per kit is about 2,350 won, and the market price is between 7,000 won and 8,000 won.
- Policy
- Following Kymriah, Zolgensma is also about to be reviewed
- by Lee, Tak-Sun Feb 09, 2022 06:09am
- Jang Yong-myung, executive director of HIRA development, briefing with reporters at Korea Special Press Association on the 8th So-called "one-shot treatments" that treat specific rare diseases with one administration are speeding up the reimbursement. Following Kymriah, which treats blood cancer such as leukemia and lymphoma, Zolgensma (Onasemnogene Abeparvovec), which treats a rare disease called SMA, is also set to be reviewed by HIRA's Drug Reimbursement Evaluation Committee. These drugs were difficult for patients to access because of their high price instead of high therapeutic effects, but if they are reimbursed, the burden of drug prices is expected to be relieved. Jang Yong-myung, executive director of HIRA Development, said at the Korea Special Press Association meeting on the 8th that Zolgensma will deliberate on the Drug Reimbursement Evaluation Committee to evaluate the adequacy of medical care benefits. Zolgensma is a drug that can treat spinal muscular dystrophy with a single dose. Spinal muscular dystrophy is a fatal rare genetic disease in which muscles are gradually contracted due to deficiency or mutation of normal SMN1 genes, and if not treated, 90% of SMA type 1 dies before the age of 2 or requires permanent respiratory aids. More than 30% of SMA type 2 patients can also die before the age of 25, requiring lifelong treatment. Zolgensma replaces genes that can prevent SMA progression, so it is expected to improve the quality of life of patients and their families as it can be fundamentally treated only once in a lifetime with intravenous administration. It is an ultra-high-priced new drug worth about 2 billion won, and it is too expensive for patients to handle, so being paid is the only hope for patients and their families. Accordingly, the solution found by the insurance authorities allows pharmaceutical companies to refund the amount paid to patients who was not effective. Executive Director Jang said, "Kymriah and Zolgensma are one-shot treatments that expect therapeutic effects from single administration, but there is a limit to proving cost effectiveness through existing evaluation methods due to high price and long-term uncertainty." "In the case of Kymriah, all patients who have been administered will be obligated to collect patient conditions for a certain period of time, and according to the results of the patient-level performance evaluation, pharmaceutical companies will refund a certain amount of money after administration," he explained. He also said, "If we claim more than a certain amount, we will pay on the condition of a contract that returns all excess amounts," adding, "We will be subject to risk-sharing revaluation after the fourth year of registration." Kymriah passed the Reimbursement Evaluation Committee on the 13th of last month under these conditions. As the adequacy of benefit has been recognized, it will now be possible if negotiations between the NHIS and pharmaceutical companies proceed smoothly. The HIRA plans to evaluate the adequacy of benefit in the same way as Kymriah or Zolgensma. Novartis applied for a decision on medical care benefits for Zolgensma in May last year and is currently being reviewed by the HIRA. It has been collecting opinions from the society since July last year, and at the end of last year, an expert advisory meeting was held to discuss clinical usefulness. At the end of January, the Drug Benefit Standards Subcommittee also reportedly set the benefit criteria. Executive Director Jang said, "Zolgensma is also considering a therapeutic performance-based refund mechanism to overcome the limitations of proving uncertainty and cost-effectiveness about long-term effects, just like Kymriah, as a drug that is effective with one administration."
