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- 2025-12-24 07:47:23
- Policy
- Opdivo's benefit extends for kidney cancer & parietal cancer
- by Lee, Hye-Kyung Aug 25, 2021 05:57am
- As domestic No. 1 immuno-cancer drug "Opdivo (Nivolumb)" renewed its contract with RSA, the benefit standard has also been expanded. The HIRA will issue a "proposal to revise the announcement of drugs prescribed and dispensed to cancer patients" and will inquire about their opinions by the 25th. If there is no disagreement, the benefit will be applied from the 1st of next month after the Health Insurance Policy Review Committee's resolution this week. According to Opdivo-related standards, Yervoy (Ipilimumab) and combined therapy were recognized in the first stage of kidney cancer, and it was recognized in the second or more solo therapy for parietal cancer and the third or more Hodgkin lymphoma. Yervoy 50mg and Yervoy 200mg was licensed as a "medium- or high-risk, progressive neocarcinoma treatment with Optdivo and combined therapy," which has no previous treatment experience. As a result of the review of benefit criteria for Opdivo and Yervoy combination therapy, NCCN guidelines recommend preferred category 1 for primary treatment of moderate or high-risk transparent cell carcinoma, and 'I, A' for ESMO guidelines. The benefit standard was set by limiting the tissue type of kidney cancer to patients with moderate or high-risk IMDC risk classification to clear cell carcinoma. Based on Opdivo's criteria for treatment of parietal cell carcinoma, the NCCN guidelines recommend "second-line and subsequent therapy" as "category 1" for recurrent, non-abstructive or metastatic cancers during or after platinum-based chemotherapy. However, if the expression rate of PD-L1 is less than 1% in open-label clinical trials, the standard was set only when the expression rate of PD-L1 was 1% or higher considering the median value of the entire survival period (mOS 5.7 months vs. 5.8 months) similar to alternative therapy. HSCT is also recognized for typical Hodgkin lymphoma patients who have recurred or progressed with Brentuximab Vedotin. Children were also included in the list, considering the nature of Hodgkin's lymphoma disease and the addition of permission for children in excluded countries. According to the HIRA's review, premenopausal patients intentionally performed ovarian resection to induce menopause for use in line with the current benefit criteria, or the expected additional financial requirements were not significant.
- Policy
- Janssen’s acetaminophen tablets may replace Tylenol
- by Lee, Tak-Sun Aug 24, 2021 06:06am
- Janssen Korea, which locally manufactures and sells Tylenol in Korea, has received import authorization for its product. The company is presumed to be making the move to secure alternatives in advance before stopping the operation of its Hyangnam plan at the end of this year. On the 23rd, the Ministry of Food and Drug safety approved Janssen’s import of acetaminophen tablets that contain the antipyretic analgesic ingredient, ‘acetaminophen.’ The product is identical in ingredient, strength, and formulation to the Tylenol 500mg tablets that are locally made by Janssen. With the surge in demand for Tylenol 500mg as a means to relieve the side effects of COVID-19 vaccinations, the drug has made the highest sales performance among all OTC drugs. A large amount of the Tylenol tablets that are currently in the market are known to be stockpiled items that were produced in preparation for the shutdown of Janssen's Hyangnam plant. With the amount in the market being rapidly depleted, the amount left in stock after the shutdown of the Hyangnam plant may be less than expected. This was why a new product from a new manufacturing facility had to be secured in advance for import. Jannsen’s acetaminophen tablets that will be imported will be those that are manufactured in Indonesia and are expected to replace the Tylenol 500mg tablets that are being manufactured in the company’s Hyangnam facility. One thing to note is that the company did not use the brand name ‘Tylenol,’ but rather listed its generic name in the import authorization. This is noteworthy as pharmacies in Korea had trouble securing Tylenol after the Korean authorities had mentioned the specific brand name as a treatment for COVID-19 vaccine’s side effects. However, this may only be due to the fact that Janssen’s marketing authorization for the brand name in Korea is still in place. The industry expects that the company will consider changing the generic name authorization to the brand name after the company withdraws its license for the Hyangnam plant's Tylenol. The dominant opinion is that it will not be easy for the company to give up the name because of the high brand recognition. As such, Janssen has been preparing alternative products in preparation for the Hyangnam plant shutdown. Janssen’s ‘Ultracet Set Tab,’ which is a combination of acetaminophen and tramadol hydrochloride, has also been granted import authorization. Technology transfer for the extended-release formulation of the Ultracet brand has been made to a domestic pharmaceutical company, Handok. As there are many products in the Tylenol brand, these are also expected to undergo technology transfers or be switched to imports. Therefore, 'Tylenol' manufactured from Janssen's Hyangnam plant will not be seen in the market from next year. Established in 1983, Janssen’s Hyangnam plant was one of the few manufacturing bases established by multinational pharmaceutical companies. Hwanin Pharmaceutical acquired the facility in November last year at 46 billion won, and Janssen will be withdrawing its plant that had been in operation for 38 years.
- Policy
- The effectiveness of NIP expansion policy?
- by Aug 24, 2021 06:05am
- Moon Jae-in president announced to expand under the age of 17 for vaccine against cervical cancer vaccination for free, while the few people seemed to be criticizing as 'show off'. President Moon said he would expand the vaccination target from the age of 12 to the age of 17 to mark the 4th anniversary of the petition. In the past, people aged 13 to 17 were eligible for free vaccination, and 70 to 80% had already been vaccinated. Some point out that it is a show off policy because the number of people actually receiving support is small. President Moon said in a video on the 19th, "We will allow all women and teenagers to receive free vaccination benefits," marking the 4th anniversary of the introduction of Cheongwadae's petition. Cervical cancer is the only cancer that can be prevented by vaccination, but many asked for more support due to the cost of ₩600,000. Recently, the price of inoculation has increased and the burden has increased, leading to a national petition. If the expansion plan is implemented, women aged 13 to 17 will also have a chance to receive a free vaccine. However, not many people are expected to receive actual benefits. The expanded number of female teenagers aged 13 to 17 was already eligible for free vaccination. The human papilloma virus (HPV) vaccine to prevent cervical cancer has been designated as NIP since 2016 and has been implemented for 12-year-old girls. People born in January 2003 and December 2004 were the first targets. These are the 17-year-olds, the highest-age group President Moon said he would expand. It is pointed out that it seems to include an age that was not previously applicable while targeting people who were vaccinated for free in the past. Even if the expansion plan is implemented immediately, only those of female teenagers aged 13 to 17 who missed the timing of vaccination in the past can receive support benefits. According to the KDCA, the primary vaccination rate in 2003 was 61.5% in the first year. The primary inoculation rate was 72.6% for those born in 2004. 87.2% of those born in 2005 have already been vaccinated. President Moon said, "For women aged 18 to 26, we will gradually expand the scope of vaccinations by allowing low-income people to receive free vaccinations." Also, there was no mention of men implemented by half of the 36 OECD countries, including advanced countries such as the United States, Canada and the United Kingdom. Kim Jae-yeon, chairman of the Korean Association of Obstetricians & Gynecologists, said, "It is an ineffective demonstration policy to expand the scope to female teenagers aged 13 to 17 who have already received free vaccinations." He pointed out that "in effect, the government should suggest ways to increase the vaccination rate and prevent cervical cancer."
- Policy
- Over 40mil COVID-19 vaccines cleared for release in 6 mos
- by Lee, Tak-Sun Aug 23, 2021 05:55am
- Ministry of Food and Drug Safety The number of COVID-19 vaccines granted National Lot Release in Korea has exceeded 40 million. The large-scale batches of Pfizer vaccines introduced in late July have accelerated the number of vaccines approved for lot release. According to the Ministry of Food and Drug Safety on the 22nd, 1.6 million doses (for 800 thousand people) Pfizer Korea’s ‘Cormirnaty inj. (tozinameran)’ were approved for National Lot Release on the 20th. The cumulative number of doses approved reached 41.263 million with the release, exceeding 40 million doses for the first time in 6 months since the first lot of COVID-19 vaccines were released on February 17th. The National Lot Release system is the final quality inspection system conducted by the MFDS before releasing appropriate products for marketing approval. Only COVID-19 vaccines that were officially approved are counted, and vaccines supplied by COVAX Facility or from other countries are not subject to the national lot release. With vaccinations now in full scale for people less than 50 years of age in Korea, most of the vaccines approved for lot release are Pfizer vaccines. Over 1 million doses of the Pfizer vaccine have been supplied since the end of July. 코로나19백신 국가출하승인 현황(식약처 자료 발췌) However, the amount approved for national lot release and the number of people vaccinated differ. The use of vaccines that did not go through the national lot release system and the use of the low dead space syringe has increased the number of those vaccinated. According to the Korea Disease and Prevention Agency, 25,866,970 people received their first vaccination, and 11,562,518 people completed vaccinations as of 22nd, 12:00 p.m. In other words, 50.4% of the population has received the first dose, and 22.5% of the population has been fully vaccinated. Among those that received the first dose of the COVID-19 vaccine, 10,836,390 received the AstraZeneca vaccine, 11,620,319 received the Pfizer vaccine, 2,280,477 received the Moderna vaccine, and 1,129,784 received the Janssen vaccine. Only 101,000 doses of the Janssen vaccine were approved through the National Lot Release, however, much more people were able to be vaccinated with Janssen vaccines that were provided by the U.S., which did not pass through the National Lot Release system. A total of 2,454,000 doses of the Moderna vaccine, which had seen a disruption in supply recently, were approved through the National Lot Release system. Currently, the Korean Ministry of Food and Drug Safety has approved 4 COVID-19 vaccines from AstraZeneca, Pfizer, Janssen, and Moderna.
- Policy
- Perjeta's price was down 10% to ₩2,214,600
- by Kim, Jung-Ju Aug 23, 2021 05:55am
- Five drugs that succeeded in insurance benefits in Korea due to Risk Sharing Agreement (RSA) have been re-contracted by lowering drug prices to the expiration of the contract. According to the industry, the MOHW is recently pushing to revise the list of drug benefits aimed at the 1st of next month for a total of five successful drugs negotiated by the NHIS and the pharmaceutical companies. The drugs are Roche Korea's Perjeta (Pertuzumab) and Novartis' Meqsel (Trametinib Dimethyl Sulfoxide) , which will reduce existing drug prices by at least 0.5% and at most 10%. Perjeta's prices were down 10% from ₩2,465,60 to ₩2,214,600. The price of Meqsel will be reduced from ₩128,344 to ₩127,639, and Meqsel 0.5mg will be lowered from ₩32,086 to ₩31,910, respectively.
- Policy
- AstraZeneca vaccine has been approved in 121 countries
- by Lee, Tak-Sun Aug 23, 2021 05:55am
- The most widely approved coronavirus vaccine in countries around the world was AZD1222, co-developed by AstraZeneca and Oxford University. AZ vaccine was the first approved COVID vaccine in Korea in February. According to the MFDS, the KOBIA, abd the national vaccine safety technology support center, AZ vaccine was approved in 121 countries around the world, with the largest number of licensed countries among COVID-19 vaccines. AZ vaccine has been tested in the largest number of countries, with 35 clinical trials in 19 countries. Developed by Pfizer and BioNTech, BNT162b2 has been licensed in 97 countries around the world. It was also granted the second COVID-19 vaccine in Korea following AZ in March. Pfizer vaccine was found to have carried out 31 clinical trials in 17 countries. The third most licensed vaccine was Sputnik V, developed by Russia's The Gamaleya Research Institute of Epidemiology and Microbiology, which was licensed in 70 countries. It is a product that has not yet been licensed in Korea, and Huons, which produces the vaccine on consignment, applied for a preliminary review before applying for permission in April. Unlike AZ and Pfizer vaccines, Sputnik V did not receive WHO's Emergency Use Authorization. The fourth most licensed vaccine is Moderna's mRNA-1273 vaccine, which has been approved for use in 65 countries. Moderna vaccine was approved in May in Korea. It was approved in the order of Ad26.COV2.S (59 countries), Sinopharm's BBIBP-CorV (53 countries), India's Serum Institute's Covishield (45 countries) and Sinovac's CoronaVac' (32 countries). In Korea, a total of four types of vaccines, including AZ, Pfizer, Modena and Janssen, have been granted, and vaccinations are underway. The WHO's EUA includes seven vaccines: Moderna, Pfizer, Janssen, AZ, Serum Research Institute, Sinopharm and Sinovac. The WHO's Emergency Use Authorized vaccines can be used by reference to countries that have difficulty in screening drugs alone.
- Policy
- Women under the age of 17 will be given Gardasil 9 for free
- by Lee, Jeong-Hwan Aug 23, 2021 05:55am
- President Moon Jae-in is answering directly to celebrate the 4th anniversary of the petition. He promised the government will expand the scope of free cervical cancer vaccinations from women under the current age of 12 to under the age of 17 so that all women and teenagers can receive free vaccination benefits. He said he would also make efforts to expand the workforce and improve the working environment and treatment of nurses at health centers who are responding to COVID outbreak. On the 19th, President Moon directly responded to the public to mark the 4th anniversary of the petition. President Moon has declared more support for cervical cancer vaccinations. This is the answer to 18,817 people's petition to oppose the increase in the amount of the cervical cancer vaccine Gardasil 9 and to apply insurance premiums. There are a total of 48 requests for cervical cancer vaccine support. The standard is to respond when more than 200,000 people agree, but President Moon said, "A small number of agreements does not mean less important." President Moon said, "Cervical cervical cancer is the only cancer that can be prevented by vaccination, but it is often not vaccinated due to the cost of up to ₩600,000." He said, "We will expand the scope of free vaccination for cervical cancer from women under 12 to under 17 years of age and receive free benefits for all female teenagers." President Moon said, "We will allow low-income women aged 18 to 26 to receive free vaccinations and gradually expand the scope." It also mentioned hiring nurses and improving treatment at health centers, which are essential workers in response to COVID-19. 65,385 people have joined the petition to prevent nurses at health centers from collapsing. "We have hired 1,273 nurses in the first half of this year, and we are hiring 2,353 more people to respond to infectious diseases this month," President Moon said. "We will continue to expand the number of nurses and improve the working environment and treatment." In addition, President Moon promised to expand medical support for the infertility and strengthen support for vacation, preferential vaccination of COVID to caregivers and delivery call centers and visiting service workers. Furthermore, President Moon announced his plan to introduce a system that will allow government agencies such as the National Assembly, courts, Constitutional Court and the National Elections Commission to file petitions online at the end of next year.
- Policy
- Lyrica CR generics begin development...PMS expires next July
- by Lee, Tak-Sun Aug 20, 2021 05:56am
- Development for generics of Pfizer’s pain reliever ‘Lyrica CR,’ whose post-market surveillance (PMS) period expires in July next year, has begun. Unlike Lyrica, which is taken twice a day, Lyrica CR is a once-daily formulation and is used for peripheral neuropathic pain in adults. With more than 80 pharmaceutical companies participating in the development of Lyrica generic, attention is focused on whether such avid interest will be shown for Lyrica CR as well. On the 17th, the Ministry of Food and Drug Safety approved the bioequivalence study protocol for Dasan Pharmaceutical’s DSP2102. The study will assess the bioequivalence of Dasan Pharmaceutical’s ‘DSP2102’ and Pfizer Pharmaceuticals Korea’s ‘Lyrica CR 300mg’ on 34 healthy adult participants. Dasan’s study will be the first to compare a drug with Lyrica CR. The PMS period for Lyrica CR, which was approved in July 2018, will expire in July next year. The move to conduct bioequivalence tests for the development of generics has begun as approval for generics is possible upon expiry of the PMS period. Lyrica is a leading product in the domestic pain reliever market. Lyrica sold 52.9 billion won according to IQVIA last year. However, Lyrica CR’s performance is not as significant as Lyrica’s as it has been released relatively recently, has a limited indication, and has viable competitors. In the same period, Lyrica CR only made 700 million won in sales. However, when considering that around 80 generic companies entered the market after Lyrica’s substance patent expired in 2012, the possibility remains that latecomers in the field will show an interest in the more convenient, less frequently taken Lyrica CR. However, with market competitors already existing in the market and new regulations in place for development, the number of companies jumping in to develop Lyrika CR generics is expected to be less than that for Lyrica. Six other companies including Yuhan Corp. own once-daily drugs containing the same ingredient as Lyrica CR. The products entered the market only a few months after the original, and the companies have been enjoying the first-mover advantage. Also, due to the restriction limiting each consigner to share its bioequivalence tests with only three consignees, the burden of companies needing to develop generic drugs themselves will have an effect in reducing the number of products seeking market entry. The use of Lyrica CR is limited compared to Lyrica, as it can only be used to treat peripheral neuropathic pain in adults. On the other hand, Lyrica is additionally indicated for epilepsy (as adjunctive therapy for partial-onset seizures with or without secondary generalization) and fibromyalgia.
- Policy
- The current health insurance premium increase rate is 2.91%
- by Lee, Hye-Kyung Aug 20, 2021 05:56am
- Health authorities have refuted allegations that health insurance premiums have been raised for the success of health insurance policies. The MOHW and the NHIS recently released a statement by the Korea Enterprises Federation (KEF) explaining that "reorganization, including a cap on health insurance premiums, is a reasonable and fair result of social consensus." The KEF said in a report that Japan and Taiwan, which have similar systems to Korea, have a higher upper limit on domestic health insurance premiums than other countries, with a gap of about 24 times and 12 times, respectively. The NHIS explained, "Health insurance is based on the principle of social solidarity, a social insurance system in which subscribers premiums, and anyone, regardless of income level, receives medical benefits as needed." The NHIS explained, "In Korea, as a single national health insurance, the insurance upper limit is institutionalized as income redistribution and social solidarity are emphasized, and the insurance upper limit is the result of social consensus that reflects the history of the national system and people's perception." In France, the health insurance premium rate reaches 13% (full copayment of patient), but the higher the wage level due to the lack of an upper limit, the greater the user's health insurance premium. The upper limit of insurance premiums is part of a reform of the health insurance premium system, and discussions have begun to cope with the heavy burden on low-income local subscribers. "It is based on years of social discussion and the agreement between the ruling and opposition parties to increase the equity of insurance premiums," the NHIS said. "It is planned to reorganize the imposition system of Step 1 in July 2018 and revise the effect of Step 1 in July 2022. In the process of promoting Moon Jae-In Care, the health insurance premium rate is 2.91%, which is lower than the average of 3.20% over the past decade (2007-2016), and the NHIS said, "As of 2021, the health insurance premium rate is 6.86%, France (13%), Germany (14.6%), and Japan (9.21-10.0%)." The NHIS said, "The health insurance premium rate for next year has not been determined, and it will be decided through social consensus after sufficient discussion by the Health Insurance Policy Committee, which includes all members, suppliers, and public interest members."
- Policy
- Seven companies are supplying flu vaccines this year
- by Lee, Tak-Sun Aug 20, 2021 05:55am
- SK Bioscience will focus on COVID vaccine after consulting with the KDCA. The market share of the GC Pharma is likely to increase. Two imported vaccines including Sanofi and GSK Flu vaccines, which will be distributed and sold in Korea this year, are nine items from seven companies, down three from the previous year. SK Bioscience, which had the highest sales performance of flu vaccines last year, will not supply them this year due to the production of COVID-19 vaccine, and Dong-A ST and LG Chem have also been excluded from the market. According to the MFDS on the 17th, domestic manufacturers that distribute flu vaccines this year are Boryung Bio (2 items), Boryung, GC Pharma (2 items), Il Yang (2 items), and the importers are Sanofi Pasteur and GlaxoSmithKline. Compared to last year, SK Bioscience, Dong-A ST, and LG Chem were excluded. SK Bioscience has been unable to distribute flu vaccines in Korea this year due to the production of COVID vaccine. SK Bioscience is commissioning and producing AZ and Novavax vaccine and is also developing its own products. A company official said, "The existing production line of the flu vaccine at Andong plant is producing COVID vaccines, in consultation with the KDCA, we decided not to supply flu vaccines this year." SK Bioscience recorded the highest performance in Korea last year, with production of only 4-valent flu vaccine worth ₩164.7 billion. As SK Bioscience is out this year, only two companies that produce raw material to finished products in Korea will remain: GC Pharma and Il Yang. The share of GC Pharma, which recorded the second highest production performance of ₩82.9 billion after SK Bioscience last year, is expected to increase significantly. In the case of Dong-A ST, the company received the original amount from Sanofi and manufactured and supplied the finished product, but due to the expiration of the contract, Vaxiflu Tetra Injection Solution Prefilled Syringe was revoked in January. LG Chem, which receives products from GC Pharma, is not selling flu vaccines this year. Like last year, Sanofi Pasteur and Glaxosmithkline distribute imported vaccines. However, Sanofi Pasteur participates in NIP for children and pregnant women under the age of 13. It is explained that the mandatory vaccination for national procurement aged 65 or older was not available because it was difficult to meet the supply schedule suggested by the KDCA. It is known that importers such as GSK do not actively participate due to the same low cost of the national mandatory vaccination project as last year. The MFDS predicts that about 28.8 million flu vaccines will be distributed this year. Among them, 14.6 million people were involved in the NIP project. Last year, National lot releases for 29 million people were distributed. As of the 13th, the national lot release for 3.66 million people was received.
