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- 2026-05-03 10:13:35
- Policy
- MenQuadfi has entered the licensing process
- by Lee, Hye-Kyung Feb 10, 2023 05:53am
- MenQuadfi, Sanofi Pasteur's tetravalent meningococcal vaccine, is expected to be released soon. According to the pharmaceutical industry on the 7th, Sanofi Pasteur completed receiving product licenses from the Ministry of Food and Drug Safety, including clinical trials of MenQuadfi, a vaccine for meningococcal (A, C, Y, W) to prevent invasive meningococcal infections in children and adults over the age of 2. MenQuadfi is designed to induce high immune responses for four serum groups across a wide range of ages from 2 to 56 and was FDA-approved as the first and only tetravalent meningococcal vaccine in the United States using tetanus toxoid as a protein carrier in April 2020. FDA approval was based on clinical data from five double-blind, random, multi-organ, phase 2, and phase 3 trials conducted on 5,000 children and adults over the age of 2. Tests have shown that MenQuadfi-induced immune responses are inferior to other approved tetravalent meningococcal vaccines. Four clinical trials were conducted on those who have not been vaccinated against the meningococcal vaccine and one on those who have been vaccinated against the meningococcal vaccine. In a study of those who have not been vaccinated against the meningococcal vaccine, most (55.4-97.2%) were confirmed to have an immune response after 30 days of vaccination.
- Policy
- Rosuvastatin 2.5mg/Ezetimibe, Hanmi from Daewoong,& Yuhan
- by Lee, Tak-Sun Feb 10, 2023 05:53am
- Rosuzet 10/2.5 mg (left) and Daewoong Crezet 10/2.5 mg (right)The combination market, which combines low-dose (2.5 mg) Rosuvastatin + Ezetimibe, is fluctuating with the addition of large pharmaceutical companies. Yuhan Corporation will also join the market, which Hanmi Pharmaceutical first entered at the end of 2021, following Daewoong Pharmaceutical. As the market size is not expected to be small, competition between the three pharmaceutical companies is expected to intensify. According to the industry on the 9th, Yuhan received a license for Rosuvastatin 2.5mg + Ezetimibe complex developed by its affiliate Addpharma and received a license for Rosuvamibe 10/2.5mg on the 7th. Earlier, the original developer Addpharma has also licensed for Addrose 10/2.5mg in December last year. However, it is said that this product has not yet been applied. Rosuvastatin + Ezetimibe complex has become a trend in the treatment market for dyslipidemia. It is characterized by the combination of statins and Ezetimibe to increase the therapeutic effect. However, there has been a steady demand for low capacity due to the burden of existing statins. The Rosuvastatin 2.5 mg + Ezetimibe complex has the advantage of reducing side effects of high-dose statins such as diabetes-induced and muscular dystrophy while having a similar effect to a single drug, high-dose Rosuvastatin. Accordingly, it is becoming a new prescription option for patients with low and moderate-risk groups and elderly patients. Hanmi Pharmaceutical pioneered the market by launching Rosuzet 10/2.5 for the first time in Korea in December 2021. This product is known to have shown a blockbuster aspect as its monthly prescription (based on Ubist) has recently risen to about 1.4 billion won. Daewoong Pharmaceutical then joined the market by releasing Crezet 10/2.5mg in November last year. There is little difference in the drug prices of the two products. Rosuzet 10/2.5 mg is 751 won and Crezet 10/2.5 mg is 750 won. It's only a one-won difference. Yuhan is expected to be on the payroll list in May with permission this time. As the three pharmaceutical companies have a high market share in the Rosuvastatin+Ezetimibe combination market, market reactions are expected to be high. Last year, Rosuzet recorded 140.3 billion won, Crezet 25.8 billion won, and Rosuvamibe 66.8 billion won in outpatient prescriptions. They are expected to implement a strategy to maximize sales through the Rosuvastatin+Ezetimibe. Meanwhile, in addition to these three companies, other pharmaceutical companies such as NVP Healthcare are also said to have jumped into the development of Rosuvastatin 2.5mg + Ezetimibe complex. It is also leading to the development of Atorvastatin low-dose + Ezetimibe complex.
- Policy
- MOHW opposes legislating premium pricing for KIPC drugs
- by Lee, Jeong-Hwan Feb 10, 2023 05:53am
- The Ministry of Health and Welfare virtually opposed the bill that legislates preferential treatment for drugs manufactured by accredited Korea Innovative Pharmaceutical Companies. The MOHW’s position is that drugs manufactured by Korea Innovative Pharmaceutical Companies already receive preferential treatment, such as premiums provided on insurance price ceilings as well as other support such as additional points for R&D, levy discounts, etc.” On the 9th, the MOHW submitted the opinion above regarding the bill for the ‘Partial Amendment of the Special Act to Foster and Support for the Pharmaceutical Industry’ that was submitted by NA Rep. Jung-sook Suh of the People Power Party. Suh’s bill contains a clause that changes the official name of the Pharmaceutical-Bio Industry Innovation Committee and upgrades its status, as well as a clause that obligates the provision of preferential treatment on drugs manufactured by Korea Innovative Pharmaceutical Companies. Pharmaceutical companies have shown interest in the bill as the bill seeks to obligate the existing arbitrary regulation on preferential treatments for drugs manufactured by Korea Innovative Pharmaceutical Companies, including those that provide premiums on price ceilings set for reimbursement, etc. The industry is also in favor of upgrading the status of the Pharmaceutical-Bio Industry Innovation Committee to an agency directly operated by the Prime Minister. However, the MOHW expressed caution in reviewing the two provisions. Although the ministry agreed on the need to systematically support and foster the pharmaceutical and bio-industry, it opposed the provision of preferential drug pricing. The MOHW said, “Drugs manufactured by Korea Innovative Pharmaceutical Companies are already receiving preferential treatment with premiums provided on the reimbursed price ceilings of their drugs. Also, additional points for R&D, and payment discounts are also provided as support." Regarding upgrading the status of the committee, the MOHW explained, “The government plans to discuss the establishment of a pan-ministerial governance body that not only covers the pharmaceutical industry but also medical devices and digital healthcare. During legislative discussions for that agenda, it will be necessary to review the scope of jurisdiction of each committee, as well as their function, system, and operation method.” However, the Health and Welfare Expert Committee deemed it necessary to revise the mandatory regulations on preferential drug prices for Korea Innovative Pharmaceutical Companies. Article 17-2 of the current Act that stipulates preferential treatment such as providing a premium to the ceiling price of reimbursed drugs was newly established in December 2018 and is an arbitrary rule that provides preferential treatment for drugs manufactured by Korea Innovative Pharmaceutical Companies. However, due to the lack of follow-up legislation, it has been criticized that no preferential treatment other than the price ceiling is being provided under the clause. In other words, the committee believes the optional regulation alone is not enough for the preferential system to be properly applied to drugs manufactured by Korea Innovative Pharmaceutical Companies. The Health and Welfare Expert Committee said, “Effective support measures for drugs manufactured by Korea Innovative Pharmaceutical Companies are needed to increase incentives to attract investment into R&D in the pharmaceutical industry. Therefore measure to provide preferential treatment to benefiting companies and drugs should be specified and stipulated as legislations through discussion with the public-private consultative body.”
- Policy
- Drugs subject to 2nd evaluations may submit data by Oct
- by Lee, Tak-Sun Feb 09, 2023 05:50am
- Drugs that were to receive the 2nd series of reevaluations by HIRA and were required to submit data by July will also be deemed to have met their requirements even if they exceed their submission deadline and submit the Ministry of Food and Drug Safety review completion notice by the end of the objection period. This will allow companies an additional 3 months of time, until October, to submit data. The measure has been made in consideration of the unavoidable circumstances, just as the first series of drugs that were subject to receive evaluations this year. According to the Health Insurance Review and Assessment Service on the 7th, oral and sterile preparations that were subject to receive evaluations in the second review were required to submit data by July 31 will be deemed to have satisfied their requirements if they submit their MFDS review completion notice within the objection period in consideration of the delay in MFDS review. A total of 5,905 oral and sterile preparations that were expanded and designated to conduct bioequivalence tests were set to receive the second set of evaluations. Some of the items have not even started bioequivalence tests , being unable to designate reference drugs. The authorities had previously announced that it will register priority review requests from drugs subject to receive the first set of evaluations and need to submit their data by February, and deem those companies that submit MFDS review completion notice within the objection period to have satisfied standard requirements. Therefore, relevant companies will first submit review requests to the MFDS by February, then submit their review completion notice by May. The data submission deadline had been extended in consideration of the COVID-19 situation, and HIRA explained that the same consideration will be provided to drugs subject to the second series of evaluations. Therefore, drugs subject to receive the second series of evaluations will be allowed to first submit review requests by July and submit the review completion notice by October to satisfy the standard requirements. HIRA believes that the 3-month addition to the deadline of the drugs subject to receive the second series of evaluations will allow drugs whose bioequivalence tests have been delayed due to reasons including non-announcement of reference drugs or difference in the sorbitol additive with its reference drug, to fully conduct reevaluations. A HIRA official explained, “Although discussions will still need to be made with the MFDS, we believe most drugs will be able to submit data within the evaluation period." Meanwhile, HIRA will hold a briefing session on its reevaluation of standard requirements on reimbursed ceiling price of listed drugs at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association office from 3:30 p.m. on the 10th and provide guidance on frequently asked questions in a Q&A format. Afterward, after collecting the opinions of the pharmaceutical industry on the series of evaluation subjects that will follow, the final list of drugs subject to evaluation will be released on HIRA’s webpage once again.
- 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.
