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- 2025-12-22 17:52:46
- Policy
- Roche’s Lunsumio receives 1st GIFT designation in Korea
- by Lee, Hye-Kyung Dec 01, 2022 05:46am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had designated Roche Korea’s ‘Lunsumio Inj (mosunetuzumab)’ as the first product subject to the Global Innovative product on Fast Track (GIFT) program it has been operating since September to support the development of innovative medical products in Korea. Lunsumio is used to treat adults with refractory or relapsed follicular lymphoma. With no other existing treatment options available for the disease, its urgent need for introduction had been recognized and designated as an item subject to the GIFT program. Drugs subject to GIFT receive various support for the rapid commercialization of its product including support for preparing approval data, rolling review support, and provided opportunities for close communication between the reviewer and developer, expert consulting on regulatory affairs, etc. The MFDS also newly established a page for GIFT on its webpage to ensure transparency in GIFT designations and allow easy access to related information in one place. The page provides information on GIFT and its main areas of support, eligibility for GIFT, the application process, submitted data, and the fast-track designation status of drugs, etc. As a result, information on Roche Korea’s Lunsumio Inj which received the first GIFT designation has also been disclosed on the GIFT information webpage. The information page can be accessed through www.mfds.go.kr → Public communication → active administration → GIFT The MFDS said, “We will continue to actively support the research and development of innovative new drugs and their rapid commercialization through the effective operation of the GIFT program.
- Policy
- The price of Donepezil 5mg fell below 500 won
- by Lee, Tak-Sun Dec 01, 2022 05:46am
- Dementia tx original AriceptDonepezil, which is most commonly used to treat dementia, fell to less than 500 won for 5mg due to the step-type drug price implemented in July 2020. The drug prices refer to 85% of the lowest price of the upper limit of the same product registered if more than 20 products are registered. According to industries on the 29th, Donepezil HCl applied by C.L.Pharm will be listed on the 1st of next month at 85% of the lowest price with step-type drug prices. Accordingly, C.L.Pharm's Bielpezil 5mg will be listed for 425 won and Bielpezil 10mg for 544 won. It has fallen to 85% from the previous lowest price product. In the case of 5mg of Donepezil HCl hydrate, 122 pharmaceutical products are listed. If newly registered, the upper limit will continue to fall depending on the price of the stepped drug. In the case of Donel 5m of i-World Pharm, the previous lowest price of 5mg of Donepezil, it was lowered from 1,223 won to 500 won in June through a voluntary cut. C.L.Pharm product is listed at 425 won, which is 85% of 500 won. price for Donepezil 5mg is 2,060 won, which is now about five times the difference. The industry analyzes that hospitals and clinics are receiving incentives under the drug-saving incentive system when they switch from high-priced drugs to low-priced drugs, so the lowest prices in Donepezil formulations are continuing.
- Policy
- Pediatric drugs eligible for PE exemptions from January
- by Kim, Jung-Ju Dec 01, 2022 05:46am
- Chang-Hyun Oh, Director of MOHW The government expects the ‘Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments’ that gained industry attention for increasing the scope of use of the pharmacoeconomic evaluation exemption system (PE exemption system) will be applied to drugs that apply for reimbursement in January. In other words, the government plans to confirm and apply final revisions in December. The revisions to the Health Insurance Review and Assessment Service’s guidelines are currently complete and are being reflected in the National Health Insurance Service’s detailed standards for negotiations (negotiation guidelines). After the process is complete, it will be possible to extend the application of the PE exemption system to pediatric new drugs that apply for reimbursement in January. In the case of the 200 set as the ‘small number of patients’ standard, the government reaffirmed its position that extending PE exemption to drugs for adults deviates from the purpose and priority of reimbursement while emphasizing the flexibility of the Drug Reimbursement Evaluation Committee review as it had responded at the last NA audit. Chang-Hyun Oh, Director of the Pharmaceutical Benefits Division replied so at the QA session on pending issues at a recent meeting with the multinational pharmaceutical company press on the 29th. Also, Oh drew the line and said that it was different from the government’s intentions regarding the market’s prediction that the measures will be immediately applied from November upon notice. The following is the QA script between the press corp and Director Oh. ▶After the administrative notice, HIRA has not yet publicly announced the expansion of the PE exemption system to pediatric drugs. Were there any problems in the implementation process? “We are currently changing the NHIS negotiation guidelines. The Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments does not only include expanding PE exemptions to pediatric drugs. It also includes the expedited listing of severe disease treatments and expanding the scope of reference countries to A9 which is set for December 11. These revisions have to be made collectively (none of them have been publicly announced yet). We will be able to confirm and revise the plan in December. ▶The pharma and bio industry expected the measures to be implemented immediately upon notice this month (in November) and awaited HIRA’s public notification. But at the current pace, the system will be applied next year at the earliest. Is this a delay or a deferment? “Since other revisions that need to be implemented also need to be reviewed and unilaterally implemented, the measure will be applicable to drugs that apply for reimbursement from January. Since the government had not announced that it will be implemented from November, it is not a delay." ▶The industry is still strongly voicing the need to extend the PE exemptions to drugs used in adults.” “A clause ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee’ has been added to HIRA’s guidelines. At the same time, ‘when the drug’s main indication is for pediatric patients’ condition has been added to NHIS’s reimbursement standard procedure improvement plan. As these two are being applied together, reimbursement will be extended to drugs whose main indication is for ‘pediatric’ patients among drugs used for both children and adults. Therefore, the extension will be applied to pediatric patients. There have been many requests for expanding the reimbursement benefit to drugs that affect adult patients. We can review it, but our current priority is in benefiting pediatric patients rather than adults.” ▶The NA and others have pointed out how the extension had rather raised the threshold for PE exemptions and reimbursement. What is the government’s opinion on this? "I have already explained the reason why the ‘small number of patients’ clause had been included at the past NA audit. The restriction was set to clarify that PE exemptions are applied when the drugs have difficulty producing evidence. DREC had answered to the National Assembly that it will deliberate reimbursements in consideration of the severity of the disease for drugs that affect a small number of patients. The same is true for the 200 range that had been set. Considering the severity of the disease, even if the number of patients exceeds 200, the drug can be considered and reviewed as a drug that affects a small number of patients. I believe DREC will make a reasonable decision."
- Policy
- First Forxiga follow-on Dapapro listed at KRW 684
- by Lee, Tak-Sun Nov 29, 2022 05:54am
- The first follow-on of the antidiabetic SGLT-2 inhibitor ‘Forxiga Tab (dapagliflozin, AstraZeneca)’ will be listed at ‘Dapapro Tab’ with reimbursement at KRW 684 on December 1. The price has been set at 90% of the original due to premium pricing as a data submission drug due to salt modification, etc. Dapapro Tab succeeded in avoiding the duration of the substance patent as a prodrug that has a different chemical structure from the original. According to industry sources on the 28th, Dapapro Tab will be listed for reimbursement at KRW 684 on December 1. This is 10% lower than the KRW 760 set for Forxiga. In general, generics are listed at 53.55% of the original’s ceiling price, but as a data submission drug, the price was set at 90% of the original. Dapapro's ceiling price will be maintained as is until another generic with the same ingredient is listed. Until February, the release of Dapapro had been unclear until before the substance patent expiry. Dong-A ST had filed a claim to confirm the scope of rights for Forxiga’s substance patent, claiming that its drug does not impede the scope of rights of Forxiga’s substance patent, but the Patent Court of Korea reversed the decision of the Intellectual Property Trial and Appeal Board that had admitted the company’s claim. Nevertheless, Dong-A ST newly challenged the patent again and received an admission in the trial to confirm the scope of rights on the 2nd. In other words, the court accepted the claim that the 917 days added to the patent term for Forxiga’s substance patent does not apply to Dong-A ST’s product. Based on this, Dong-A ST started its reimbursement process and succeeded in listing its drug with reimbursement on the 1st of the following month. Forxiga’s substance patent will expire in April next year, and if Dapapro is released with reimbursement, it will be marketed before the expiry of the substance patent. With Dong-A ST planning to release Dapapro by February next year, the product is expected to be the first drug sold among Forxiga follow-on drugs. Also, it will be the first SGLT-2 class follow-on to be released into the market as well. Also, Dong-A ST owns its new antidiabetic drug ‘Suganon.’ The addition of the SGLT-2 antidiabetic Dapapro to its portfolio is expected to expand the company’s share in the domestic diabetic drug market. In particular, with Dapapro being released earlier than the generic versions of Forxiga, it is expected to further occupy the follow-on drug market.
- Policy
- Avastin biosimilar will be reimbursed starting next month
- by Lee, Tak-Sun Nov 29, 2022 05:53am
- Celltrion VegzelmaCelltrion's Avastin biosimilar Vegzelma will be listed on the 1st of next month. As a result, Roche, which owns the original Avastin, has joined Alvogen Korea, a biosimilar company, Samsung Bioepis, and Celltrion, making the market competition a four-way race. According to industries on the 25th, Celltrion Vegzelma's 0.1g and 0.4g will be listed at 208,144 won and 677,471 won, respectively, on the 1st of next month. The price is the same as Samsung Bioepis' Onbevezy and Alvogen's Arimcis. Bevacizumab formulations are anticancer drugs used in various carcinomas, with the domestic market reaching about 100 billion won. The original Avastin recorded 38.1 billion won in the first half of last year based on IQVIA. In September last year, Samsung Bioepis Onbevezy received a salary and was released for the first time in Korea as a biosimilar. This product is currently being sold by Boryung Pharmaceutical. Onbevezy's one-year monopoly in the biosimilar market was broken when Albogen Korea released Arimcis last month. Arimcis is sold by Daewoong Pharmaceutical. Competition for Bevacizumab formulations is expected to begin in earnest as Celltrion joins in December. Although biosimilars are less popular in the domestic market, Celltrion is also looking forward to Bevacizumab as it is only Remsima that performs as well as the original. Since the drug price difference between the original and biosimilars is not significant, the performance difference is expected to appear depending on marketing and distribution capabilities. However, the fact that Alvogen Arimcis is limited in use in relation to ovarian cancer due to patent problems is considered a weakness in the indication. Although Samsung Bio and Celltrion are raising their stock prices with biosimilars overseas, it is true that they have been negligent in marketing in the domestic market, which is small in size. However, the Avastin biosimilar is expected to be active in investing in domestic sales due to its large domestic market size. Attention is focused on who will win the four-way race for biosimilars.
- Policy
- Actilyse's price to rise 15% from next month
- by Kim, Jung-Ju Nov 28, 2022 05:50am
- The price of Boehringer Ingelheim’s acute myocardial infarction treatment Actilyse Inj. (alteplase) will rise 15% from next month after applying for drug pricing adjustments. Aju Pharm’s acute back pain reliever (aceclofenac, eperisone hydrochloride) will newly receive a 10% premium for 1 year. Also, the 30.4% premium pricing for Hanmi Pharmacueetical’s allergic rhinitis treatment Potastine OD Tab (bepotastine calcium dihydrate) will be maintained due to the small number of companies producing the same product, and Kyowa Kirin Korea voluntarily opted for a 1.5% reduction in the price of its Romiplate 250μg (romiplostim). According to industry sources, the Ministry of Health and Welfare is working to amend the ‘drug reimbursement list and reimbursement ceiling price table’ to implement the changes above for implementation on December 1st. First, Aju Pharm’s Afexon Tab has been newly listed with premium pricing for 1 year. The premium pricing rate will be wet at 10%. For incrementally modified combined new drugs, the government applies a 59.5% premium for first generics for one year from listing. For drugs from innovative pharmaceutical companies, the premium is set at 68% of the original drug price in the first year, then subsequently lowered to 53.55% after the term is terminated. The premium pricing for Hanmi Pharmaceutical’s Potastine OD Tab will be maintained for the time being due to the small number of companies manufacturing the same item. The premium rate of the drug is set at 30.4%. The government applies premium pricing to drugs when there are 1 or less companies that produce a drug with the same route of administration, ingredient, and formulation as the first-listed incrementally modified new drug. However, if no other companies produce the same product even after the 5-year premium pricing period, the premium pricing is maintained until the number of companies becomes 2 or more. On the other hand, some companies have opted for strategic price reductions for marketing, etc. Kyowa Kirin Korea applied for drug pricing adjustments to reduce the price of its Romiplate 250μg by 1.5%, and the reduction will be applied from the next month. Boehringer Ingelheim Korea applied for a price increase for its Actilyse Inj. (alteplase), and after undergoing negotiations, the price of Actilyse will be raised by 15% for each strength from next month. The application to adjust the ceiling price for price increases can be submitted when the drug is ▲essential to the treatment of patients, ▲has no alternatives, ▲is supplied by one company and its administration is cheaper than its alternatives. After the drug passes deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Review and Assessment Service and undergoes drug pricing negotiations with the National Health Insurance Service.
- Policy
- Crysvita, referred to the welfare committee
- by Lee, Jeong-Hwan Nov 28, 2022 05:50am
- A petition for national consent calling for quick approval of the rapid use of "Crysvita," a treatment for hypophosphatemia, a rare disease, was recently referred to the National Assembly's Health and Welfare Committee with 50,000 consent. Crysvita is a treatment for XLH hypophosphatemia rickets and osteomalacia supplied by Kyowa Kirin Korea in Korea. XLH (X-Linked Hypophosphatemia, X chromosome dominant hypophosphatemia) is a genetic disease and has a characteristic of severely bending legs. The prevalence of XLH is about one person per 20,000 to 60,000 people, and most of them are found after the disease has progressed considerably due to signs around the age of two. Early detection of XLH is essential for future treatment and management of patients. If you miss the timing of treatment, you may suffer from side effects such as limb deformity, growth delay, reduced height, increased risk of fracture, kidney calcification, and elevated parathyroid levels. In severe cases, you may not be able to walk. Kyowa Kirin Korea's Crysvita was approved by the Ministry of Food and Drug Safety in September 2020 as a treatment for XLH and osteomalacia. However, it has not been eligible for salary for two years since the permission. The petitioner, who introduced himself as the patient's mother, explained, "XLH chromosome-dominant hypophosphatemia is a disease that requires living in pain for the rest of your life because early detection is essential for the patient's future treatment and management. She appealed, "In Korea, it is excluded from the standard of fewer than two years of survival threat or life expectancy, so treatment cannot be used even before the eyes." The petitioner appealed, saying, "The mother of a patient who is having a hard time every day because health insurance is not covered even before the treatment for hypophosphatemia rickets, which has been waiting for more than 20 years." She said, "Since health insurance is not covered, individuals have to pay hundreds of millions of won in treatment costs." Crysvita was approved by the FDA in April 2018, is used as a treatment for adults and children over 6 months, and has been approved for sale in major countries such as Europe, the United States, and Japan.
- Policy
- IVI-Biovac has signed an agreement to develop an OCV
- by Lee, Hye-Kyung Nov 28, 2022 05:49am
- The International Vaccine Research Institute (IVI) announced on the 24th that it has signed a license and technology transfer agreement with Biovac, located in South Africa, for the local manufacture of IVI's OCV. This agreement is meaningful in securing the manufacturing capacity of raw materials, that is, the ability to produce antigens/raw materials necessary to actually manufacture vaccines, through the project. The agreement comes at a time when recent outbreaks of cholera have been triggered by climate change, armed conflict, and forced migration in countries such as Pakistan, Nigeria, and Malawi, seriously hurting already vulnerable health systems. This situation is already causing additional demand for the supply of cholera vaccines, which are in short supply worldwide. In recent years, the area of cholera outbreak has expanded further amid growing supply-demand imbalances caused by a lack of supply of cholera vaccines. The purpose of the agreement signed by IVI and Biovac is to permit and transfer vaccine manufacturing technologies, and ultimately to solve the shortage of vaccines by increasing vaccine production worldwide to prevent cholera. In addition, this technology transfer is expected to be an opportunity to establish and demonstrate the full capacity of GMP expansion, local manufacturing of clinical trial products, and production of vaccines available in Africa and around the world. The agreement is expected to be an important step in enabling vaccine production on the African continent decades later. In the African market, locally produced vaccine production is currently less than 1%, and infectious diseases are still one of the main causes of death, especially for children under the age of five. African leaders have expressed their commitment to creating a local vaccine industry, aiming to raise the proportion of vaccines manufactured in Africa from 1% in 2021 to 60% in 2040 The agreement is the first step in the project's launch and will receive $6.9 million in donations from the Wellcome Trust Foundation and the Bill and Melinda Gates Foundation. Through this agreement, Biovac will be able to expand its capabilities from vaccine vial filling and packaging to all areas of vaccine product development and raw material drug manufacturing. The technology transfer process begins in January 2023, and the first batch of vaccine prototypes for clinical trials is expected to be produced in 2024. The South African National Regulatory Authority (SAHPRA) approval for product use and the WHO Pre-Qualification Certification (PQ), which will take place immediately after approval, is scheduled to be completed in 2026.
- Policy
- SGLT2+DPP4 standards expanded, will it be over again?
- by Lee, Tak-Sun Nov 24, 2022 05:51am
- from left to left, Forxiga, Jardiance, Xigduo XR, Jardiance Duo The expanded application of salary standards for the combination of diabetes treatment SGLT-2 inhibitor-based drugs and DPP-4 inhibitor-based drugs is expected to pass another year. Since the Korean Diabetes Association requested expansion in 2016, there have been expectations for application within this year as full-scale discussions have been underway, but in fact, it is unlikely to be applied this year. According to the industry on the 23rd, the Ministry of Health and Welfare is expected to receive a voluntary cut rate from related companies by this week and conduct a financial impact analysis based on it. If the expected financial scope is satisfied by the weak reduction, it will be reflected in the salary through a report by the Health Insurance Policy Review Committee. Analysts say that it is difficult to apply this year because each company has a different position and the constitutional review was held on the 23rd to reflect benefits in December. The Ministry of Health and Welfare held a meeting with pharmaceutical companies last week regarding the expansion of the benefit standards for diabetes treatments and asked each company to suggest ways to voluntarily cut them. As a result, pharmaceutical companies are expected to submit data on how to cut the upper limit through their own analysis to the Ministry of Health and Welfare by this week. The Ministry of Health and Welfare's mention of the option of voluntary cuts is interpreted as a move to quickly conclude that the expansion of salary standards has a greater impact on finances than expected. In June, the HIRA announced that it is currently analyzing the financial direction while reviewing the salary standards for three drugs such as Metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and some items of SGLT-2+sulfonylurea or insulin combination. It was necessary to complete the change in standards and drug price evaluation after completing the financial impact and deliberation by the Drug Benefit Evaluation Committee. The drug price is determined by the standard according to the increase in the expected amount of claims. Drug prices will be lowered by a maximum of 5%. However, the Ministry of Health and Welfare encouraged pharmaceutical companies to voluntarily cut the price before deliberation by the committee. This is because the voluntary reduction drug to expand the scope of use can be applied through the report of the Health Policy Review Committee immediately after skipping the committee's deliberation. Analysts say that this is because even if the upper limit is cut by up to 5% according to the set procedure, it far exceeds the expected fiscal range. Accordingly, it is known that the government plans to reduce the level of fiscal input as much as possible by inducing a larger range of voluntary cuts. In particular, the Ministry of Health and Welfare reportedly ordered pharmaceutical companies with SGLT-2 drugs, which are expected to see a high rise in claims, to make a large cut. The pharmaceutical companies that accepted the proposal are in different positions. It is said that some pharmaceutical companies with low-claimed items have already voluntarily replied that they will not cut drug prices. On the other hand, pharmaceutical companies with large claims are expected to accept voluntary weak cuts and present a cut rate to the Ministry of Health and Welfare. Some analysts say that if the voluntary cut rate falls short of expectations through financial impact analysis, it may be difficult to expand the combined salary. On the other hand, if the cut-rate meets expectations, the pace of salary application is expected to accelerate. The overall atmosphere is that it will be difficult to apply this year. In addition, it is unknown at the moment whether to apply expansion to items that have not chosen voluntary cuts. The HIRA official said, "We know that we will receive voluntary cuts from each company and then examine whether it is appropriate to expand benefits through financial impact analysis." He said, "I understand that nothing has been decided yet about the subsequent procedure."
- Policy
- COVID vaccine side effects proven by the Government
- by Kim, Jung-Ju Nov 24, 2022 05:50am
- In order to prevent new infectious diseases such as COVID-19, a revision to the related law will be promoted to allow the government to receive medical and nursing expenses first if it is damaged by side effects after being vaccinated. Chung Chun-sook, a member of the Democratic Party of Korea's Health and Welfare Committee, proposed today (22nd) a bill to partially revise the Infectious Disease Prevention and Management Act. The revision aims to prevent damage as most of the people voluntarily participated in vaccination for community safety when new infectious diseases such as COVID-19 are prevalent around the world, but some people suffer from diseases, disorders, or deaths due to abnormal reactions caused by vaccination. The application of this amendment is limited to cases where new infectious diseases are prevalent. It also includes special cases such as expanding the scope of compensation for existing vaccination damage, providing medical and nursing expenses first, and ensuring that the state is responsible for proving the causality with vaccination to compensate the public for damage caused by new infectious diseases. Lawmaker Chung's office explained, "The main purpose is to apply the revised law from the beginning of vaccination due to COVID-19 and to compensate the public as much as possible by applying it even when compensation for vaccination is set." Meanwhile, it included Kang Byung-won, Kang Hoon-sik, Kim Won-i, Kim Han-kyu, Yang Kyung-sook, In Jae-geun, Choi Hye-young, Huh Jong-sik, Kang Eun-mi of the Justice Party, and independent Kim Hong-gul.
