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- 2026-03-12 07:27:40
- Policy
- Reimb review for Pompe disease drug Nexviazyme underway
- by Lee, Tak-Sun Apr 10, 2023 05:53am
- Reimbursement review is underway in Korea for Nexviazyme Inj (avalglucosidase alfa-ngpt), Sanofi’s Pompe disease drug that had been approved by the Ministry of Food and Drug Safety on the 29th. Nexviazyme is the first biobetter among rare disease drugs to be approved in Korea. According to industry sources on the 7th, the Health Insurance Review and Assessment Service started the reimbursement review for Nexviazyme and requested the Ministry of Food and Drug Safety to confirm the drug’s Target Product Profile. Nexviazyme is regarded an upgraded version of the company's Myozyme. The MFDS has been approving products with improved safety, efficacy, and use over existing approved biodrugs or those that were recognized for their progressive technology, as biobetters. Nexviazyme is the first drug among rare disease drugs to obtain marketing authorization as a biobetter drug. Pompe’s disease is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA). When left untreated, it may lead to muscle damage, respiratory failure, movement disorders, and even premature death. The company has implemented innovative technology to increase the amount of mannose-6-phosphate (M6P), which plays a major role in the drug's cellular enzyme uptake, in Nexviazyme by 15 times compared with Myozyme. The company added, the increase in M6P also improves immunogenicity and provides safety benefits. Myozyme is currently reimbursed at KRW 653,000 per vial. In 2021, USD 7.7 million's worth of Myozyme was imported to Korea.
- Policy
- Only a few cold drugs will be subject to PVA negotiations
- by Lee, Tak-Sun Apr 10, 2023 05:52am
- The number of drugs subject to negotiations under the Price-Volume Agreement (PVA) system among cold medicines and antibiotics whose usage increased explosively with the rise in the number of confirmed COVID-19 patients, is expected to be small. When the National Health Insurance Service applied the correction plan it had devised after collecting industry opinion, results showed that little more than 10 items were subject to negotiations. Such results will be applied around the end of April when the government monitors PVA ‘Type C’ drugs. According to industry sources on the 8th, the NHIS corrected the use amount of about 2,600 cold medicines and antibiotics whose use had increased due to COVID-19 and simulated the number of items that will be subject to negotiations. Results showed that the subject drugs were reduced to around 10. The correction was made by comparing each drug’s use amount with the previous year after excluding their usage from a specific month when the number of COVID-19 cases increased explosively. When applying the correction, most of the drugs were not subject to receive negotiations. In other words, their amount of use was similar to the previous year, if not for the COVID-19 crisis. Drugs fall under Type C when claims of products in the same therapeutic class increase by over 60% from the claims amount filed in the previous year, or have increased by over 10% but the increased amount exceeds KRW 5 billion. Items that did not undergo NHIS negotiations on their expected claims amount fall under ‘Type C.' Most of the cold medicines and antibiotics that the correction plan will be applied to fall under PVA ‘Type C.' Therefore, the NHIS plans to apply the final correction plan when monitoring drugs for Type C PVA negotiations. As monitoring is expected to begin at the end of April, the industry expects the correction plan to soon be finalized.
- Policy
- Generics for Forxiga will be released simultaneously on the
- by Lee, Tak-Sun Apr 06, 2023 05:53am
- Chong Kun Dang, Hanmi, Donga ST, Jeil, Boryeong, Daewon, etc. new products launched As generics of the SGLT-2 diabetes treatment drug Forxiga (Dapagliflozin, AstraZeneca) were released simultaneously on the 8th, the related market is expected to intensify. Last year, outpatient prescription sales of Xigduo, a single drug combining Forxiga and Metformin, were 91.4 billion won (Forxiga's sales were 48.5 billion won, Xigduo's sales were 42.9 billion won), and a large market is forming. From the 8th, a total of 149 items (89 single drugs, 60 complex drugs) of Dapagliflozin will be covered by insurance, and fierce competition will unfold for the 90 billion won market. According to the industry on the 5th, the Ministry of Health and Welfare announced that 149 dapagliflozin diabetes treatment drugs would be added to the benefits list from the 8th. Including the two items of Dong-A ST Dapapro, which were on the existing list, a total of 151 Dapagliflozin active ingredient drugs are covered by health insurance. As the market size is large, generics include many large companies. Chong Kun Dang, Hanmi Pharm, Jeil Pharm, Boryung, and Daewon Pharm, which introduced salt-altering drugs, including Dong-A ST, which entered the market first through prodrugs last December, will enter the market. As Forxiga is the first original drug in the SGLT-2 series whose patent has expired, and Daewoong Pharmaceutical, which owns Envlo, is the only domestic company that owns SGLT-2, it is analyzed that large companies have also participated en masse in the generics market. The drugs entering the market this time include 5mg and 10mg of single active ingredients of Dapagliflozin, Metformin 1000mg + Dapagliflozin 10mg, Metformin 500mg + Dapagliflozin 10mg, Metformin 500mg + Dapagliflozin 5mg, and Metformin 1000mg + Dapagliflozin 5mg. Dapagliflozin 5mg is a drug for which the original drug is also registered for reimbursement. Therefore, it is expected that the effect of increasing the market size will be large with the introduction of generics. The upper limit is 262 to 342 won for Dapagliflozin 5mg and 334 to 514 won for 10mg. The highest price of Dapagliflozin 5mg is Dong-A ST Dapapro 5mg. The highest price of 10mg includes Dong-A ST Dapapro 10mg, Hanmi Pharmaceutical Dapalon 10mg, Boryung Trudapa 10mg, Kyungdong Pharmaceutical Dapazin 10mg, Sinil Foxigly 10mg, Han Wha Posilozin 10mg, KUKJE PHARM Focidi 10mg, Daewon Dapaone 10mg, etc. The most expensive drugs are prodrugs or salt-altering drugs, priced at 70% of the original upper limit. On April 8 next year, the additional price will end, and the drug prices will all be the same at 53.55% of the highest price. In the case of a single agent, 5mg is 262 won, and 10mg is 393 won. An official from the pharmaceutical industry explained, "As Forxiga accounts for a large portion of the diabetes treatment market, and since the combination of SGLT-2 drugs has been expanded since April, expectations for generics are also high."
- Policy
- Government's drug pricing policy
- by Lee, Jeong-Hwan Apr 05, 2023 05:48am
- The Ministry of Health and Welfare revealed its will to create a specific preferential drug price policy for innovative new drugs and essential drugs, and at the same time, it revealed a policy to use generic drugs by reducing drug prices, attracting attention. Recently, in the process of reviewing the amendment to the Special Act on the Promotion of the Pharmaceutical Industry, which was proposed by Rep. Jeong-sook Seo of the National Assembly’s Health and Welfare Committee, the 1st Bill Subcommittee of the National Assembly, 2nd Vice Minister of Welfare Park Min-soo revealed the direction of the operation of the drug price policy. The key to the bill proposed by Rep. Seo Jeong-sook is to convert the arbitrary regulations on preferential drug prices for drugs made by innovative pharmaceutical companies into mandatory regulations. The Ministry of Health and Welfare expressed difficulties with the provision and virtually opposes it while promising to make a specific provision that can give preferential treatment to innovative pharmaceutical companies through consultation with the pharmaceutical industry and discussions at the National Assembly. Rep. Seo Jung-sook and Democratic Party lawmaker Nam In-soon expressed doubts about the position of the Ministry of Health and Welfare but decided to believe it. Rep. Seo said, "If you look at the administrative flow of the Ministry of Health and Welfare if you say 'can do', will it be possible to support innovative pharmaceutical companies to the extent of sending a message?" Rep. Nam, who introduced a bill with an arbitrary clause giving preferential treatment to innovative pharmaceutical companies four years ago, pointed out the administration of the Ministry of Health and Welfare, which had not enacted sub-statutes, and even checked whether the WTO complaint problem was resolved. Rep. Nam said, “Is there any problem with the WTO complaint that I was concerned about? Vice Minister Park Min-soo said that he actively sympathized with the legislation that converts the preferential drug price provisions for drugs made by innovative pharmaceutical companies from voluntary regulations to mandatory regulations, but appealed that even if the amendments to mandatory regulations are ineffective. Vice Minister Park’s position was that the Ministry of Health and Welfare would come up with a specific drug price preferential policy through communication with the pharmaceutical industry even if the law was not changed due to the enforcement of preferential drug prices. In addition, he said that the drug price preferential policy for innovative pharmaceuticals was announced several times and the pharmaceutical industry was already aware of it and that the drug price preferential policy reflecting this was being communicated with the pharmaceutical industry. Vice Minister Park said, "There are few legislative precedents that revise the law to make it mandatory by saying that drug prices should be given preferential treatment. As the Ministry of Health and Welfare has already expressed its willingness to policy, if you keep an eye on it, we will come up with a policy plan by materializing the presidential decree and improving the health insurance drug pricing system." “It is a burden to do it as a duty,” he added. Vice-Minister Park said, "Even if the law is revised as 'must', even if the current drug price preferential system is not changed even one person, the revised law will not be violated." "For effectiveness, the government's will and policy direction must be firmly established. I raised the price of the drug I was using to 89 won. The preferential price for innovative drugs is steadily preparing and I have a firm will.” Vice Minister Park said, "In terms of WTO issues, most of the (preferential) targets are likely to become global companies if they are innovative pharmaceutical companies. The government's idea is to foster the domestic industry, but there was a dilemma in going global." are doing," he said. Regarding generic drug prices, it was clear that the system would be revamped in the direction of cutting. He is determined to operate the system so that pharmaceutical companies will no longer be seen engrossed in generic marketing competition rather than innovation, such as new drug discovery and research and development. Vice Minister Park said, "There has been a preference for generics so far, and now generics are being cut down mechanically and step by step in the order they come in." We just put in our effort," he said. "It is the Ministry of Health and Welfare's idea that this behavior should disappear from the industry and we will take action,” he added.
- Policy
- Countdown to initial non-face-to-face treatment
- by Lee, Jeong-Hwan Apr 05, 2023 05:48am
- Member of People’s Power Kim Seong-won (Photo: Congressman Kim Seong-won’s office blog)The Power of the People Together with Rep. Kim Seong-won, Democratic Party Rep. Kang Hoon-sik co-represented the National Assembly's startup research group'Unicorn Farm', which plans to propose a bill to amend the Medical Act to allow non-face-to-face treatment from the first visit on the 3rd. The representative initiative of the bill is Kim Seong-won (Dongducheon-si, Gyeonggi-do, Yeoncheon), and Rep. Kang Hoon-shik is listed on the list of co-sponsors. Rep. Kim Seong-won is active in the Industry, Trade, and Energy Small and Medium Venture Business Committee of the National Assembly. Rep. Kang Hoon-shik is the secretary of the Democratic Party of the Health and Welfare Committee. The core of the bill is to allow non-face-to-face treatment for patients specified by the Ordinance of the Ministry of Health and Welfare, regardless of whether they are first or re-examinations if it is possible to improve medical accessibility without harming the patient's health. The bill stipulates the scope of non-face-to-face treatment as continuous observation of health and disease, diagnosis, consultation, hospital visit guidance, and prescription. On this day, an official from Unicorn Farm explained in a phone call with Daily Farm, “There have been complaints from non-face-to-face treatment platform companies such as the Telemedicine Industry Council (hereinafter referred to as Wonsanhyup), and we will propose a bill for non-face-to-face treatment for first-time patients soon.” The official explains that the first-time non-face-to-face treatment bill is being legislated at the level of Unicorn Farm, a startup research group. Rep. Kim Seong-won, a member of the ruling party and a co-representative of Unicorn Farm, said that he agreed with the complaints regarding the non-face-to-face treatment regulation of Wonsanhyup, a member of which includes Dr. Rep. Kang Hoon-sik, a member of the opposition party, is also known to be in the position that, as a co-representative of Unicorn Farm, it is necessary to discuss and review the bill for first-time non-face-to-face treatment in the National Assembly. However, Rep. Kang Hoon-sik, secretary of the opposition party of the Welfare Committee, is fully aware of the fact that first-time non-face-to-face treatment is strongly opposed by the healthcare community, so he plans to put it on the discussion table to collect and deliberate various opinions from doctors, pharmacists, platform companies, and patients. Previously, Congressman Kang proposed a unicorn farm-level bill as a representative on the 13th of last month. The medical advertisement platform proposal, such as Gangnam Unni, was the starting point, and the amendment to the Medical Act that allows the Ministry of Health and Welfare to intervene in the review standards of the Medical Advertisement Deliberation Committee, which is composed of functional groups such as doctors, oriental doctors, and dentists, is that. This time, following Rep. Kang, Rep. Kim Seong-won accepted the proposal of a non-face-to-face treatment platform such as Wonsanhyup and introduced a bill to allow first-time non-face-to-face treatment. The first non-face-to-face treatment bill, which Congressman Kim is about to propose, allows non-face-to-face treatment from the first visit, except in cases where there are special restrictions. It is a legislative measure to address concerns that platform companies will go bankrupt if non-face-to-face treatment is allowed only for returning patients, and the scope of non-face-to-face treatment is specified in a negative regulatory manner rather than a positive regulation. When Kim's bill is proposed, for the first time, the National Assembly will review a first-time non-face-to-face treatment bill. All four non-face-to-face treatment bills proposed so far are bills centered on returning patients that do not allow first visits. Democratic Party lawmakers Kang Byung-won, Choi Hye-young, and Shin Hyun-young and People’s Power Congressman Lee Jong-seong have each proposed a representative initiative. An official from Unicorn Farm said, "It is a bill that allows non-face-to-face treatment for patients specified by the Ordinance of the Ministry of Health and Welfare if it can increase medical access without harming the patient's health." The scope of non-face-to-face treatment includes continuous observation of disease, diagnosis, consultation, hospital visit guidance, and prescription.” Meanwhile, the research purpose of Unicorn Farm, a research group of the National Assembly, is regulation rationalization, policy development, and related legislative measures to support the growth of startups and venture companies.
- Policy
- The severity level of COVID-19 lowered from May
- by Lee, Jeong-Hwan Mar 31, 2023 06:09am
- 한덕수 총리 The government announced plans to lower the severity level of COVID-19 to the alert from May and switch to a medium-level capital system. When the serious stage is lifted, the current 'temporary non-face-to-face treatment' by the current Infectious Disease Control Act is expected to end automatically. Today (29th), Prime Minister Han Deok-soo held a 'COVID-19 meeting' at the Seoul Government Complex and made this announcement. Prime Minister Han Deok-soo said, "Recently, the decline in the global COVID-19 epidemic is clear. The domestic quarantine situation is also being stably managed." We will finalize the action," he said. Prime Minister Han said, "We plan to change the obligation to quarantine and the obligation to wear masks, which remain, to a 'full recommendation'." We will maintain the protection system for the vulnerable,” he added. "The long fight against COVID-19, which has been going on for more than three years, is coming to an end," he said. "The government will do its best to protect the lives and safety of the people until COVID-19 is completely over."
- Policy
- Cold drugs subject to PVA will be adjusted
- by Lee, Tak-Sun Mar 31, 2023 06:08am
- The government is paying close attention to the correction plan for the price volume agreement (PVA) system that will be applied to respiratory drugs such as cold medicines whose usage has increased due to COVID-19. Therefore, the schedule the authorities had set to start PVA monitoring in April after finalizing the correction plan within the month is expected to be somewhat delayed. The health insurance authorities plan to make a final decision after calculating the number of products subject to PVA through simulation when it applies the correction plan. According to industry sources on the 30th, the National Health Insurance Service collected the opinion of the pharmaceutical industry and tentatively confirmed a correction plan. In the plan, the NHIS has been known to have widely reflected the opinions it had collected from the pharmaceutical industry. The correction plan will compare each drug’s use volume with the previous year after excluding their usage in specific months when the number of COVID-19 cases increased explosively. About 2,600 items are subject to corrections, including cold medicine and antibiotics that the Ministry of Food and Drug Safety encouraged the production of during the COVID-19 crisis. On the 7th, Sang-il Lee, Executive Director for Benefit at NHIS explained that the NHIS will complete discussions with the industry within the month, finalize the corrective measure, and then start monitoring drugs for PVA negotiations from April. However, it seems that it will take more than this month for the government to decide upon the final measure because of the government's cautious stance. The NHIS plans to apply its tentative correction plan to subject items and simulate how many products will be subject to mock negotiations, and then decide upon on a final draft with the Ministry of Health and Welfare mid-April. The government is focusing on minimizing the number of negotiation subjects in consideration of the opposition that will be raised by the pharmaceutical industry. An industry official said, “Since there is still time left until the government monitors PVA ‘Type C’ drugs, the government is cautiously preparing the correction plan. The government seems to be carefully considering the measure, taking into account the opposition that may arise in the pharmaceutical industry.”
- Policy
- Overseas clinical trial drugs for therapeutic purposes
- by Lee, Hye-Kyung Mar 31, 2023 06:08am
- An amendment to the Pharmaceutical Affairs Act passed the plenary session of the National Assembly on the 30th, including permitting the use of investigational drugs overseas for therapeutic purposes, establishing a basis for prompt action against online illegal activities of drugs, and strengthening education and publicity on the labeling of drugs for consumers. This amendment will be transferred from the National Assembly to the government and promulgated and will come into effect six months after the date of promulgation. The Ministry of Food and Drug Safety will expand the scope of investigational drugs that can be approved for use for treatment purposes not only domestically under clinical trials but also overseas clinical trials in the future so that patients with life-threatening serious diseases or alternative treatment is said to expand treatment opportunities for emergency patients without means. Allowing the use of overseas clinical trial drugs for therapeutic purposes is task number 22 of the 100 tasks for food and drug regulatory innovation announced by the Ministry of Food and Drug Safety in August of last year to support industrial development while putting public health and safety first. Although the legal grounds for immediate action against illegal acts such as online drug sales and advertisements were insufficient, the Ministry of Food and Drug Safety will in the future strengthen consumer safety by requiring information and communication service providers to take measures to notify consumers that they are advertisements for illegal sales. The Ministry of Food and Drug Safety can provide education and publicity on the sales, purchase, labeling, and advertising of pharmaceuticals to help consumers use medicines safely, conduct research and development to investigate the current status of illegal online drug sales, and prepare effective monitoring technologies and methods. be able to support "We will continue to do our best to improve related systems to protect the public by realizing the safety of warm food and medicine with social values, putting public safety first," said Minister Oh Yoo-gyeong of the Ministry of Food and Drug Safety. did. Major amendments to the Pharmaceutical Affairs Act can be found at http://mfds.go.kr or the National Assembly Security Information System.
- Policy
- Started a demand survey for drugs participating in the pilot
- by Lee, Tak-Sun Mar 31, 2023 06:08am
- Due to the burden of simultaneous data submission, there are likely to be fewer participating drugs. The government started a demand survey for drugs to participate in the parallel trial project of 'Permission Evaluation Negotiation', which is being pursued rapid reimbursement. The project was planned to drastically shorten the registration period by simultaneously proceeding with benefit evaluation and negotiations from the MFDS approval application stage. According to the industry on the 30th, the Ministry of Health and Welfare is conducting a drug demand survey to participate in a parallel pilot project in 2023, including application for permission, evaluation of benefits, and negotiation of drug prices, as part of a plan to improve access to treatment for expensive severe diseases and strengthen reimbursement management. Candidate drugs are scheduled to apply for approval from the Ministry of Food and Drug Safety in 2023 and are drugs aimed at treating diseases that threaten survival (life expectancy is less than one year) or rare diseases. If there is no existing treatment or if there is a clinically significant improvement in efficacy, etc. compared to existing treatment, participation is possible. The data to be submitted are related to approval: ▲the expected date of application for domestic approval, ▲effectiveness and effect among items of application for domestic approval (scheduled) , ▲countries approved in foreign countries and items permitted, ▲consistency between items approved in foreign countries and items scheduled for application for domestic approval. Regarding disease information of approved indications, ▲ disease severity, life expectancy, survival rate, progress, etc. ▲ existing treatment methods, and treatment performance data for the disease. Regarding clinical usefulness, ▲a clinical trial summary of the therapeutic confirmatory trial (or related evidence source), ▲the expected number of patients, ▲A8 listing status and listing price, ▲benefits evaluation result in excluding countries, ▲cost when applying for decision Effectiveness application track expected data (PE, medication cost comparison, etc.) can be submitted. The data will be used as basic data for selecting drugs for pilot projects. Applications must be submitted to KPBMA by April 4th. The government plans to promote the pilot project in earnest from the second half of the year. On the 28th, Yoo Mi-young, head of the Pharmaceutical Management Office of the HIRA, said at a meeting with the Korea Special Press Association, “We are currently discussing the target selection and related procedures with the relevant departments of the Ministry of Food and Drug Safety to promote the pilot project.” Explained. It is expected that there will be not many drugs to participate in the pilot project. Since the evaluation methods and conditions of the three agencies - MFDS, HIRA, and NHIS - are different, related pharmaceutical companies are also burdened with preparing data at the same time. It is interpreted that the first step was to investigate demand before starting the pilot project in earnest in the second half of the year.
- Policy
- About 180 clinics without IRB used diagnostic drugs
- by Park,Yang-myeong Mar 30, 2023 05:42am
- Avastin and Decapeptyl, are drugs that allow the use of drugs beyond the scope of approval without the IRB. How much is it used in front-line medical institutions? About 230 macular degeneration treatment drugs Avastin and precocious puberty drug Decapeptyl injection were found to be using these drugs without IRB at 180 hospitals and clinics. The Pharmaceutical Management Office of the Health Insurance Review and Assessment Service disclosed the current status at a meeting with the Special Press Association held on the 28th. In 2019, the relevant notice was changed so that drugs exceeding the permitted scope could be used without reimbursement even without an IRB, but it was only last year that the system was actively applied to the field. The first drug approved by an institution not implemented by the IRB is Avastin, which is used for ophthalmic diseases. Avastin, as a targeted anticancer drug, has been used for various cancers, including colorectal cancer, breast cancer, non-small cell lung cancer, renal cell cancer, ovarian cancer, peritoneal cancer, and cervical cancer. In February 2020, the Korean Academy of Ophthalmology applied for the use of Avastin over the permitted scope to the ophthalmologist, and the HIRA prepared guidelines after discussing infection control measures. The guidelines include measures to prevent infection during the dispensing process. The HIRA received applications for use from non-IRB organizations since February of last year, and until last year, about 230 places used Avastin for ophthalmologic diseases. The second approved drug is Decapeptyl 0.1mg, which is used to diagnose precocious puberty. Decapeptyl is a prescription drug approved for hormone-dependent prostate cancer, endometriosis, uterine fibroids, and central premature onset of puberty in girls under 9 years old and boys under 10 years old. It was not approved as a diagnostic reagent for precocious puberty, but as the supply of the only diagnostic reagent was stopped, medical institutions are continuing to apply for approval for excessive use. It was applied by the Korean Hospital Association in October 2021, and it was confirmed that about 180 hospitals and clinics without an IRB applied for use between July last year and just five months. On the other hand, for the use of drugs over the scope of permission by institutions that have not implemented the IRB, the Korean Medical Association, the Korean Hospital Association, the Korean Dental Association, and related academic societies for each specialty apply for use over permission, and the HIRA reviews for approval. ▲ More than one-third of approved drugs compared to all drug clinical trial institutions for the same case, ▲approval of more than 3,000 drugs for the same case based on the previous year, ▲ Need for expansion Approval can be made if it meets at least one standard, such as medicines for rare diseases and pediatric diseases that are recognized.
