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- 2026-04-10 17:07:08
- 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."
- Company
- Generic for Godex development has come to an all-stop
- by Nho, Byung Chul Mar 31, 2023 06:09am
- As pharmaceutical companies preparing to release generics for Godex announced that they would give up development, Celltrion Pharm is expected to dominate. According to the industry, about three pharmaceutical companies have been identified that are preparing generics for Godex, but drug development has been suspended due to development difficulties/declining product margins. Reasons for stopping the release of generics can be roughly divided into difficulties in 'registering DMF' and 'securing bioequivalence', as well as rising costs following continued drug price cuts. In the meantime, the price of Godex is currently listed at 312 won after going through ten price cuts from 422 won at the time of permission in 2009. When a generic is released, the drug price will drop to W166, which could significantly lower margins to 144 won, the price of Nissel for a single Pharmaking BDD. Godex contains Biphenyl Dimethyl Dicarboxylate/BDD 25mg as the main ingredient, Carnitine Orotate 150mg, Adenine Hydrochloride 2.5mg, Antitoxic Liver Ext. 12.5mg, Cyanocobalamin 125μg, Pyridoxine Hydrochloride 25mg, and Riboflavin. In addition, it is observed that the biggest obstacle is the certification and confirmation of the drug substance registration (DMF) of Antitoxic Liver Ext., one of Godex. Except for some injections, DMF registration has been made mandatory for drug substances used in all medicines since 2017. In the case of Antitoxic Liver Ext., which is extracted from cow liver, DMF is not registered, so generic companies have to bear the burden of proving it by investing a huge amount of money. According to what is known, Celltrion Pharmaceuticals, the original developer, also has different laws and regulations at the time of product development and approval. If the lineup is expanded to tablets (pills) following existing capsules, DMF registration is required, making it difficult to launch new products with the same ingredients. the situation that might be possible. Meanwhile, BDD, the main component of Godex, is known to have been first developed by China's LIU in 1982. There is Pharmaking Nissel for BDD single drug and Pharmaking Pennel for a combination. The first company to launch a BDD single ingredient in Korea was Taerim Pharmaceutical, which changed its name to Pharmaking in 2005. Godex, which obtained permission in January 2000, is a blockbuster drug with 70 billion prescriptions as a 7-drug complex with 25mg of BDD as the main ingredient, the same as Nissel Pennel. BDD, the main component of Godex·Nissel·Pennel, rapidly lowers GPT, the level of liver inflammation, through antioxidant action, normalizes ALT level, and reduces the rebound phenomenon in which ALT rises again when medication is discontinued.
- 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.
- Company
- Jemperli starts reimbursement process in Korea
- by Eo, Yun-Ho Mar 31, 2023 06:08am
- Jemperli, a new cancer immunotherapy is attempting reimbursement listing in Korea. According to industry sources, GSK Korea has recently submitted an application to list its PD-1 inhibitor Jemperli (dostarlimab) for reimbursement in Korea. With the application, whether another treatment option may be released into the market remains to be seen. Unlike other immunotherapies, Jemperli was first approved as a treatment for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy regimen. Therefore, the company plans to first provide treatment opportunities to patients in need. For the benefit of these patients, GSK has been carrying out an Expanded Access Program (EAP) in 15 major medical institutions in Korea since earlier this year before filing for reimbursement. Endometrial cancer develops in the endometrium, the inner lining of the uterus, and accounts for the majority of cervical cancer. Roughly, 1 out of 4 endometrial cancer patients are diagnosed to be in the advanced stage or experience recurrence, and patients whose disease recurs after platinum-based chemotherapy have limited treatment options. Jemperli’s approval was based on the cohort A1 analysis results of Phase I multicohort GARNET trial that included a cohort of patients with relapsed or advanced dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. In particular, this study had the largest cohort among PD-1 inhibitor monotherapy studies for dMMR/MSI-H endometrial cancer patients among those that have been conducted so far. The major efficacy outcome measures of the study were Objective Response Rate (ORR) and Duration Of Response (DOR) as determined by a Blinded Independent Central Review (BICR) according to (Response Evaluation Criteria Solid Tumors) RECIST v 1.1. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% (95% CI, 34.0-53.4) and the median DOR was not yet reached. Disease Control Rate (DCR) was 55.6%, and the proportions of responses lasting 6 and 12 months were 97.9% and 90.9%, respectively. Jae-Weon Kim, Professor of Obstetrics and Gynecology at Seoul National University Hospital (President of the Korean Society of Gynecologic Oncology), said, “Most endometrial cancers are diagnosed early and have a relatively good prognosis, but 7-15% of these early-stage patients experience recurrences, and a limitation existed in that area due to lack of treatments available for use in case of recurrence after platinum-based chemotherapy.” Professor Kim added, “Tumors with confirmed dMMR/MSI-H respond well to treatment using PD-1 inhibitors, and Jemperli, with its significant treatment effect, safety profile, and treatment convenience, has offered a new possibility as second-line treatment for patients with recurrent or advanced dMMR/MSI-H endometrial cancer.”
- 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.
- Company
- Viatrice Korea appoints Bill Schuster as new CEO
- by Jung, Sae-Im Mar 30, 2023 05:42am
- Viatris Korea announced on the 28th that it would appoint Bill Schuster as its new CEO. New CEO Bill Schuster is an expert with more than 30 years of diverse business experience in the healthcare and pharmaceutical industries. Based on his career as a senior leader in Asia, the Americas, and Europe, he is highly regarded for his understanding of the diverse healthcare systems and cultural backgrounds of each region. Since the launch of Viatrice in 2020, Bill Schuster, the new CEO, has led the growth of the diverse product portfolio as Head of the Beatrice Brand Division in Japan. He also contributed to Beatrice Japan's strong growth by playing a pivotal role in Japanese digital channel innovation as well. Bill Schuster, the new CEO, was born in Ireland and received a Bachelor of Science and Ph.D. from Dublin University and an MBA from INSEAD Business School in France. He held key positions in marketing and business strategy at Shionogi Pharmaceutical, Takeda Pharmaceutical International, and Mylan Japan. He has worked as a marketing manager in charge of Japan and Korea at Boehringer Ingelheim and Novo Nordisk Pharmaceuticals in Japan. New CEO Bill Schuster said, "I am very pleased to serve as CEO of Viatrice Korea, one of the leading companies in the pharmaceutical industry in Korea." We will further solidify our position in the Korean market and continue to contribute to Korean society by realizing the company's mission of supporting.
- Policy
- New Pompe disease drug Nexviazyme is approved in Korea
- by Lee, Hye-Kyung Mar 30, 2023 05:41am
- The long-term enzyme replacement therapy for Pompe disease, Nexviazyme Inj (avalglucosidase alfa-ngpt), has received marketing authorization in Korea. On the 29th, the Ministry of Food and Drug Safety (Minister Yu-Kyung Oh) announced that it had approved Sanofi-Aventis Korea’s Nexviazyme, a treatment for a rare condition called Pompe disease. Nexviazyme is a recombinant enzyme used as a long-term enzyme replacement therapy in patients confirmed with Pompe disease, which is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA). Pompe disease is a rare genetic disorder that causes progressive weakness in the heart and skeletal muscle, leading to respiratory failure and cardiomyopathy. It is a rare condition reported in 1 in 40,000 around the globe and affects about 1,300 people in Korea. The disease presents in two main forms: infantile-onset Pompe disease (IOPD) which presents during infancy, and late-onset Pompe disease (LOPD) which is characterized by onset at all ages and progressively weakens the patients’ muscles. The muscle damage also leads to heart failure, respiratory failure, movement disorders, and sleep disorders. In particular, as Pompe disease is caused by a disorder in the GAA gene, a drug that targets the mannose-6-phosphate (M6P) receptor that allows the transportation of GAA enzymes into the lysosome is administered for its treatment. The drug is a biobetter that has improved dosage and administration over the company’s previous Pompe disease treatment, ‘Myozyme (alglucosidase alfa).’ The company had changed the sugar structure of Myozyme to improve cell absorption of Nexviazyme's active pharmaceutical ingredient. Patients who did not see an effect with Myozyme may use Nexviazyme Inj and see an effect. The MFDS said, “We will continue to make efforts to allow the prompt provision of treatments with confirmed safety and efficacy based on regulatory science."
- Opinion
- [Reporter’s View] Accepting drugs used by very few patients
- by Eo, Yun-Ho Mar 30, 2023 05:41am
- It's the same 'cancer', but different. So how should we regard these new anticancer drugs that target only a very few among all patients that have the same type of cancer? The cancer types that we commonly refer to, such as liver cancer, stomach cancer, and lung cancer are just major categories used, and the specific condition of each patient is classified in more detail. According to the specific class of cancer, the difficulty of treatment may vary even for tumors that originate from the same organ and affect a varying number of patients. The development of precision medicine is already heralding a shift in the prescription standards from organs to genes. In other words, the era of personalized healthcare has now arrived but is still regarded as an unfamiliar concept by many. Korea is still having difficulty accepting cutting-edge targeted anticancer therapies that show an effect regardless of cancer type according to each patient’s identified gene mutation. In this sense, targeted anticancer therapies and cancer immunotherapies that have previously been listed are experiencing considerable difficulties in the process of extending their reimbursement. This is due not only to the high price of the drugs but also because the drugs need to undergo value assessments again and reestimate their amount of use. This is the key framework that sustains Korea's national health insurance system. However, one of the characteristics of the recently developed new drugs is that the number of subject patients, that is, the number of patients confirmed with the specific genetic mutations that allow the use of such new drugs is very small. In other words, there are not many people who are eligible to use the new drugs. Less than 1% of all solid cancer patients have a rare type of solid cancer, and in terms of diagnosis, around 200 are diagnosed with such rare conditions in Korea. The typical standard-of-care therapies (existing drugs) do not work well in these patients. This was why industry voices have been on the need to redefine rare diseases. In other words, the number of patients corresponding to each treatment option should be reflected rather than the number of patients that are affected by the same disease. Of course, such redefinition would require systematic and detailed discussions. However, the time has now come for Korea to consider how to reimburse the new targeted anticancer drugs whose use has increased and targets reduced. Korea's current system is not the issue. Korea just need to consider how to solve the problem regarding the increasing number of anticancer drugs difficult to reimburse through the current system.
