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- 2025-12-22 02:51:37
- Policy
- Enhertu's referral to the National Petition Welfare Committe
- by Lee, Jeong-Hwan Feb 09, 2023 05:49am
- It was referred to the National Assembly's Health and Welfare Committee as the number of people's consent to the application of breast cancer treatment Enhertu's health insurance reached 50,000. Enhertu is an antibody-drug conjugate that obtained a domestic marketing license last year due to the petition of the National Assembly. The petition for the approval of Enhertu Health Insurance rose on the 30th of last month, and 50,000 people agreed on the 3rd of this month, five days later. The petitioner pointed out that Enhertu is a high-priced drug that costs 5 million won per injection, and expressed the need to strengthen the accessibility of breast cancer patients. In June and August last year, Enhertu also filed a petition calling for approval of health insurance. In particular, Enhertu was designated as a subject of rapid permission in June 2021, but it was not approved for more than a year, so it was approved due to the influence of the national petition. Both Enhertu developers Daiichi Sankyo Korea and AstraZeneca Korea completed submitting a salary application for the approved indication in November last year and are currently waiting for the HIRA to review it. The public is paying keen attention to whether the government will respond quickly. The petition review subcommittee of the Welfare Committee is expected to review the petition calling for Enhertu health insurance approval according to the procedure.
- Policy
- Legislation of health functional foods
- by Lee, Jeong-Hwan Feb 08, 2023 05:53am
- A bill to make drug preferential treatment for drugs developed by innovative pharmaceutical companies mandatory by law and a bill to institutionalize customized health functional foods will be presented to the plenary session of the National Assembly's Health and Welfare Committee on the 9th. A bill to strengthen regulations on specialized human drugs distributed from pharmacies to animal hospitals and a bill to allow the application of "e-labels" to government-designated specialty drugs were also listed on the agenda. On the 7th, the Health and Welfare Committee confirmed the list of the plenary session on 146 laws under its jurisdiction. Looking at the major bills, a bill to change the name of the Pharmaceutical Industry Promotion and Support Committee to the Pharmaceutical Bio-Industrial Innovation Committee and raise its status to an organization under the Prime Minister will be held at the plenary session. It is a revision to the Special Act on the Promotion and Support of the Pharmaceutical Industry, which was proposed by Rep. Seo Jung-sook of the People's Power. The bill included a provision to revise provisions such as drug preferential treatment for drugs made by innovative pharmaceutical companies into mandatory regulations. A revision to the Health Functional Food Act, which provides a legal basis for the pilot project of "Sales of Personalized Health Functional Food," which is currently temporarily operated as a regulatory sandbox, will also be proposed at a plenary session. The bill, proposed by Kang Ki-yoon, a lawmaker of the People's Power, introduces the concept of customized health-functional foods, establishes customized health-functional food sales, and subscribes to liability insurance to relieve consumer damage. It also included regulations that prohibit the introduction of customized health functional food managers and the sale of non-report customized health functional foods. A bill that mandates pharmacists to report sales details to the General Center for Drug Management when distributing and selling Rx drugs to animal hospitals was also on the agenda. Seo Young-seok of the Democratic Party of Korea proposed a bill to make the Rx drug distribution network used in animal hospitals transparent. A bill to allow Rx e-labeling, which was proposed by Rep. Seo Young-seok and Baek Jong-heon's power, will also be proposed. The content allows electronic information such as barcodes and QR codes, not paper manuals or text messages, to be provided to Rx drug containers and packaging designated by the Minister of Food and Drug Safety. Six amendments to the medical law to be held at the plenary session were decided, including the Democratic Party of Korea lawmaker Han Jung-ae's bill, which provided the basis for considering ESG management indicators in the designation of advanced general hospitals and certification of medical institutions. A revision to the Medical Law to strengthen punishment for drug offenders of medical personnel is also proposed. The bill, proposed by Jang Dong-hyuk, the people's power, calls for medical personnel to cancel their licenses for five years if they are addicted to drugs and reduce the ratio of internal doctors on the license issuance review committee. The eight amendments to the National Health Insurance Act included in the agenda included a bill that would fund the national health insurance finances so that they would be subject to the National Finance Act and subject to parliamentary review.
- Policy
- MFDS prepares a list of pre-requisite data for inspections
- by Lee, Hye-Kyung Feb 07, 2023 05:47am
- The Ministry of Food and Drug Safety has prepared a list of pre-requisite data for local inspections of overseas pharmaceutical manufacturing plants. A total of seven data submission lists, including the list of drug manufacturing over the past three years, have been prepared to enhance the predictability and consistency of administration during field inspections of overseas manufacturing plants. This list of data is one of the suggestions submitted by the pharmaceutical industry through the first meeting of the regulatory innovation industry in the pharmaceutical sector held in July last year. At the time, the pharmaceutical industry requested that data should be prepared at the site of due diligence and submitted and reviewed during the due diligence process instead of submitting data in advance of the on-site inspection of overseas manufacturing plants. The on-site inspection of overseas manufacturing plants is conducted in accordance with Article 695 of the Pharmaceutical Affairs Act, and specific procedures and methods are stipulated through the Prime Minister's Decree, but a detailed list of pre-requisite data has never been released. In response, the Ministry of Food and Drug Safety decided to disclose a list of pre-required data by reflecting some of the pharmaceutical industry's suggestions instead of not submitting prior data. According to the list of required data, ▲ List of pharmaceutical products (including manufacturing date, manufacturing number, shipment status, export volume, etc.), ▲ List of document management regulations and standards (including approval date and revision number), ▲ Comprehensive Process Validation Plan and Report (badge filling test, filter validation included), ▲ Quality Assessment Report (P) ▲ Manufacturing Material Report (Recent) For the last three years, the list except for the manufacturing list of medicines and the manufacturer's general list must be submitted only for items subject to field inspection. The Ministry of Food and Drug Safety plans to finalize the list of pre-requisite data for overseas manufacturing plants in the future by collecting opinions from the pharmaceutical industry on the list.
- Policy
- Further proposals made for reimb of diabetes combos
- by Lee, Tak-Sun Feb 07, 2023 05:47am
- SGLT-2 inhibitor class diabetes drugs (from the left: Forxiga, Jardiance, Xigduo, Jardiance Duo) The health insurance authorities have once again started analysis on the fiscal impact of reimbursing diabetes combination drugs. In the latest financial impact analysis, a red light was turned on in reimbursing the combined use of diabetes drugs as the reimbursement amount exceeded the government’s range of expectations. Whether the newly submitted price cut proposals will satisfy the government's expectations and finally allow reimbursement to be made for diabetes combinations is gaining attention. According to industry sources on the 6th, the Ministry of Health and Welfare collected the voluntary price cut rates submitted by 11 pharmaceutical companies related to the reimbursement of combination drugs for diabetes until last Friday (3rd) and began analyzing their fiscal impact. Discussions on the reimbursement of combination drugs for diabetes had previously come to a halt after the MOHW determined the fiscal impact of the drugs that submitted voluntary discount rates in November last year exceed the expected range. Accordingly, the MOHW held another meeting on the 11th of last month with related pharmaceutical companies and requested the companies to submit the voluntary discount rates again within two weeks. If the fiscal impact falls within the expected range with the voluntary reduction rate that was submitted this time, discussions on the reimbursement of diabetes drug combos will gain momentum. The combinations being discussed are triple therapy combinations such as metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and the combination of some SGLT-2 drugs+sulfonylurea or insulin. The Korean Diabetes Association has been requesting reimbursement of the combined use of diabetes drugs since 2016. However, due to their large impact on finances, discussions on their reimbursement have only been made in earnest since 2021 and were sluggish before then. In the market, companies have also released fixed-dose combinations that were designed to increase treatment efficacy through the combined use of diabetes drugs. However, if the government turns down the reimbursement listing, these new drugs are likely to be abandoned without proper use. It is said that the government is determined to make the decision quickly as discussions on the reimbursement of the combined use of diabetes drugs had been ongoing for a long time. The key will be the discount rate submitted by companies that own large drugs such as Forxiga. An official from a related company said, “What discount rate the companies such as AstraZeneca that owns Forxiga submitted will greatly affect the reimbursement listing of combination drugs. If the additional proposal cuts the drug price by only a small amount from the previous proposal, the discussion itself will likely be discontinued. Therefore, this is virtually the last chance."
- Policy
- Non-face-to-face treatment included as key policy task
- by Kang, Shin-Kook Feb 07, 2023 05:47am
- The Korean government is expected to make systemic improvements in the field of healthcare this year, with non-face-to-face treatment included as a key social policy. The Ministry of Education (Deputy Prime Minister and Education Minister Ju-Ho Lee) held the first Ministerial Conference on Social Relations at the Government Complex-Seoul on the 6th to deliberate and decide on a plan for implementing key social policies in 2023. The 2023 Key Social Policy Implementation Plan that was jointly established by 15 social government ministries contained the vision, goals, and major policy tasks for social policies and areas that the ministries will focus and collaborate on this year. Key social policy tasks for 2023 During discussions, the institutionalization of non-face-to-face treatment was included as a healthcare policy task. The policy is aimed at introducing non-face-to-face treatment mainly in primary medical institutions for the health management of patients residing in islands and isolated areas, overseas residents, infectious disease patients, and chronic disease patients. Also, the plans also include measures to expand emergency medical centers and expand healthcare in public health centers. Measures to expand essential healthcare and improve accessibility were also included as social policy measures. The plan is the same as the one announced by the Ministry of Health and Welfare, which aims to expand essential medical services, especially for severe emergencies, childbirth, and pediatric care, and to improve and strengthen public medical infrastructure Major social policy tasks for 2023 Also, the development of manufacturing and quality control technology to localize essential national medicines and the establishment of a national supply chain for medical devices that are rare or require urgent introduction were included as key tasks. Ju-Ho Lee, Deputy Prime Minister and Minister of Education said, “We have prepared the Key Social Policy Implementation Plan this year to bring hope of making a Korea that realizes the value of freedom through solidarity. We have established a pan-ministerial cooperation system to promote this.” Prime Minister Lee added, “The plan consists of 9 major tasks and 27 detailed policy tasks to achieve the social policy goals of ▲leaping towards the future, ▲ solidarity together, and ▲ensuring safe daily life.”
- Policy
- The price of AbbVie Skyrizi is likely to be adjusted
- by Lee, Tak-Sun Feb 06, 2023 05:51am
- AbbVie's moderate-severe psoriasis treatment Skyrizi PFS has agreed to a PVA negotiation, which is expected to reduce the upper limit. The drug was registered in June 2020, and it is analyzed that it exceeded the expected claim agreed in advance with the NHIS from 2021. According to the industry on the 3rd, the NHIS has completed PVA negotiations with AbbVie which will be reflected in the list as of March 1. Skyrizi was also a PVA-monitoring drug in the third quarter of last year. As type A, this is the first upper limit under PVA negotiations. In patients with moderate to severe psoriasis lasting more than 6 months, if ▲Plaque psoriasis is more than 10% of the total skin area, ▲PASI 10 or higher, ▲ MTX or Cyclosporin is administered for more than 3 months, or if treatment cannot be continued due to side effects, ▲PUVA or UVB treatment. Psoriasis is an immune-mediated disease caused by abnormalities in the body's immune function, and redness and white dead skin cells occur throughout the body. Skyrizi has the convenience of taking it once every 12 weeks. It is evaluated to be excellent in terms of effectiveness, with skin improvement maintained even in the first year of administration in clinical trials. It was approved by the Ministry of Food and Drug Safety in December 2019, applied for benefits immediately, passed the Pharmaceutical Review Committee in March 2020, and was listed on the final list in June after the NHIS negotiations until May of that year. The annual financial requirement was expected to be 5.9 billion won, and the upper limit of insurance was set at 1,247,790 won per government office. According to IQVIA, Skyrizi sold only 1.5 billion won in its first year, but its performance jumped to 8.4 billion won in 2021. It is believed that the upper limit amount has been adjusted through PVA negotiations with the NHIS this time while exceeding the expected amount of claims.
- Policy
- The aftermath of the COVID-19 Pandemic
- by Lee, Hye-Kyung Feb 03, 2023 05:54am
- There is a need to convert COVID-19 vaccines and treatments, which had been designated for rapid screening, to general screening to cope with the COVID-19 pandemic situation. This is because it is argued that screening personnel should not be wasted due to rapid screening of COVID-19 vaccines and treatments in a situation where the world is concerned about COVID-19. In addition, there are voices that COVID-19 vaccines and treatments should be excluded from the rapid screening in order to focus on the Global Innovation Product Rapid Review Support System (GIFT) prepared by the Ministry of Food and Drug Safety last year. In this regard, an official from the Ministry of Food and Drug Safety said, "The Ministry of Food and Drug Safety is keeping an eye on the COVID-19 pandemic discussion. As it has been taken based on laws to cope with the COVID-19 public health crisis, we will take measures related to the rapid screening process for COVID-19 vaccines and treatments. Since August 31, 2020, the Ministry of Food and Drug Safety has established a rapid screening department and is conducting rapid screening only for innovative products such as life-threatening diseases or treatments for rare and incurable diseases and drugs that respond to public health crises. From September 2020 to July 2022, 23 items were designated for rapid examination of medicines, and 17 items were designated and subject to rapid approval review. According to the items that have been approved, COVID-19 vaccines accounted for the largest number of items with 10, followed by five chemicals, one biopharmaceutical, and one biopharmaceutical. The rapid screening period aims to shorten the general screening period to 75% of the general screening period, and the number of working days required for the rapid screening of the COVID-19 vaccine was short, averaging 26 days. This is because the screening period was shortened by using preliminary reviews in consideration of urgency, and 5 out of 10 COVID-19 vaccines that were approved were pre-reviewed and frequently reviewed in areas such as clinical, non-clinical, and quality. However, while the workload has increased, some say that the structure of drug screening personnel's work should be reorganized due to the rapid screening system of COVID-19 vaccines and treatments in order to properly utilize the GIFT system in the future. An official from the pharmaceutical industry said, "The seriousness of COVID-19 has decreased to the extent that even the obligation to wear indoor masks is lifted," adding, "The Ministry of Food and Drug Safety should also consider ending the rapid screening system for COVID-19 vaccines and treatments." Some say that all permits and screening personnel have been put into a rapid screening of COVID-19 vaccines and treatments, and other tasks have been pushed back by nearly a year, he said. "To solve the problem, we need to think about completing the system that was applied to a crisis." The United States recently declared that it would end the COVID-19 public health emergency from May to November. Subsequently, there is an opinion that Korea will be able to completely lift its obligation to wear a mask in May.
- Policy
- CDDC sets reimb standards for Inrebic Capsule
- by Lee, Tak-Sun Feb 03, 2023 05:54am
- A green light has been turned on for the reimbursement of the myelofibrosis treatment Inrebic Cap. (fedratinib, BMS Pharmaceutical Korea) with the Cancer Disease Deliberation Committee setting reimbursement standards for the drug. Also, the reimbursement standards for the ovarian cancer treatment Zejula Cap (niraparib, Takeda Pharmaceutical) have been extended. The drugs will be approved and listed for reimbursement after passing review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee and drug pricing negotiations with the National Health Insurance Service. HIRA announced that it had held the 1st Cancer Disease Deliberation Committee (CDDC) meeting in 2023 on the 1st and announced it had deliberated as such. Inrebic is indicated as a treatment for enlarged spleen or other symptoms related to ▲ primary myelofibrosis ▲ post-polycythemia vera myelofibrosis, and ▲ post-essential thrombocythaemia myelofibrosis in adult patients that have been previously treated with ruxolitinib. The CDDC determined that setting the salary standard in line with the indication was appropriate. The 1st CDDC deliberation results in 2023 Also, the CDDC determined it appropriate to extend reimbursement and set additional reimbursement standards for Zejula Cap as ‘maintenance monotherapy in adult patients with HRD-positive ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have shown response to first-line platinum-based chemotherapy (partial or complete response).’ On the other hand, no reimbursement standard had been set for the MET exon 14 skipping mutation treatments Tabrecta and Tepmetko. At the same meeting, the CDDC declined Kyowa Kirin Korea’s application to set reimbursement standards for ‘Poteligeo Inj’ to treat adult patients with mycosis fungoides (MF) or Sézary syndrome (SS).
- Policy
- Introduction of online electronic sign-off from February
- by Lee, Tak-Sun Feb 02, 2023 05:48am
- NHIS Pharmaceutical Price Negotiation Introduces Online Electronic Signing from February Simplify operations to shorten the end of negotiations. The online electronic signing method will be introduced in next month's drug price negotiations. It is expected to simplify work and shorten the negotiation period by compensating for the shortcomings of the existing written agreement. The NHIS plans to introduce drugs subject to calculation and adjustment first, and next year, it plans to introduce an electronic signing method to negotiate new drugs and usage. NHIS (Chairman Kang Kyung-tae, hereinafter referred to as the Public Corporation) announced on the 30th that it will sign online electronic contracts for drugs subject to calculation and adjustment starting with drugs ordered by the Ministry of Health and Welfare. Since the electronic signing method is a method of signing in the form of an electronic (PDF file) through an authentication service company, it is evaluated that it has compensated for the shortcomings of the existing written agreement. The NHIS expects that related tasks will be greatly simplified, such as issuing and submitting seal certificates and eliminating the process of sending seal seals and mail in written agreements, which have been repeated every negotiation, and the end of the negotiations will be shortened by at least six days. In order to consider the preparation period of pharmaceutical companies and prevent confusion, the company will first apply it to the existing written agreement method and actively promote it by sending detailed notices to individual pharmaceutical companies and pharmaceutical associations and holding online briefing sessions for pharmaceutical companies. An NHIS official said, "We plan to expand the electronic contract method to new drug and usage negotiations next year and unify the agreement method to electronic signing method in the second half of this year. NHIS will continue to contribute to stabilizing the supply and quality of medicines and protecting public health by actively communicating and cooperating with pharmaceutical companies."
- Policy
- A year after Abilify 1mg was released,
- by Lee, Tak-Sun Feb 02, 2023 05:48am
- Competition is expected to intensify as generic companies gradually for Aripiprazole 1mg used for childhood autism hypersensitivity. The original product of this preparation is Otsuka's Aripiprazole 1mg. The drug was approved on December 3, 2021, and even generics appeared in more than a year. According to the industry on the 31st, 1mg of Aripiprazole from Whanin will be listed at 170 won per tab from the 1st of next month. This is the third time as an Aripiprazole 1 mg preparation. As for generic companies, Repizole was the first to register 1mg of Aripiprazole The first drug listed was the original Aripiprazole 1mg, which was listed at 595 won per tab in March last year. Myungin Repizole 1mg was then listed in November last year, becoming the first generic to enter the market. The upper limit of Myungin and Whanin is the same at 170 per tablet. It is about 71% cheaper than the original. Aripiprazole, which is used for schizophrenia and depression, had various doses such as 2 mg, 5 mg, 10 mg, and 15 mg, but there was no use for 1 mg until the 1 mg product was approved. The demand for 1mg was not small while prescribing first doses or combinations. However, as the 1mg product was approved, a new indication was created. 1 mg was recommended with 2 mg as the recommended initial dose of hypersensitivity related to autism disorder in children (6-17 years old). Previously, Otsuka was also licensed in Japan for 1 mg as an initial dose of childhood autism disorder hypersensitivity. As new products came out like this, generic companies responded quickly. Eight months after the original's salary was registered, a master entered the market, and Hwanin also joined the ranks this time. The two pharmaceutical companies also succeeded in paying 30mg of Aripiprazole, which is not even in the original. Last year, the original Aripiprazole was 31.9 billion won in outpatient prescriptions. Myungin Repizole and Whanin Aripizole are 400 million won and 1.2 billion won, respectively, which are wide apart from the original, but latecomers are expected to gradually increase their market share as they are strengthening sales and marketing activities. Accordingly, the movement of the two CNS-specialized pharmaceutical companies, including Myungin and Whanin which have received the 1mg market, is also expected to become active.
