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- 2026-05-18 13:21:20
- Policy
- No need to extend the benefit period of Keytruda
- by Lee, Jeong-Hwan Oct 14, 2021 05:38am
- The MOHW said there is little need to extend the benefit period of Keytruda, an immuno-cancer drug, for patients who are effective in secondary treatment of non-small cell lung cancer by more than two years. This is because the clinical period of Keytruda was designed to be two years, and related societies such as the Korean Association for Lung Cancer also submitted a position that the benefit period should be set based on medical grounds such as clinical trials. On the 13th, the MOHW's insurance drug department responded like this to a written inquiry from Democratic Party of Korea's Kang Sun-woo. Representative Kang asked patients who showed efficacy in the second treatment of small cell lung cancer if they needed to extend the Keytruda benefit period to more than two years. The MOHW replied that there is virtually no need to extend the benefit period. The MOHW's position is that Keytruda's clinical trial was designed for two years, and that the Korean Association for Lung Cancer also suggested that the benefit period should be set on medical grounds such as clinical trials. In particular, it was suggested as a basis that all four countries, including the UK, which refer to the benefit evaluation, have limited the administration period to two years. The MOHW replied that equity should also be considered with other carcinomas that are not covered by immuno-cancer drugs.
- Policy
- Poor ‘Benefit Adequacy Assessment' in controversy
- by Lee, Jeong-Hwan Oct 14, 2021 05:38am
- (Pic. by National Assembly Press Corps) A bill to specify the basic definition of the Insurance Benefit Adequacy Assessment and stipulate the submission period for its data for assessment is being promoted. On the 13th, the National Assembly member Jong-Sik Heo announced that he had presented a bill for the partial amendment of the National Health Insurance Act that contained the above measures. The insurance benefit adequacy assessment system evaluates whether all medical services provided with health insurance are medically and pharmaceutically reasonable and cost-effective, then provides the results to healthcare providers. The purpose of the system was to promote public health by inducing voluntary improvement in the quality of medical care and supporting the rational medical choice of the people using assessment results disclosed to the public. Heo pointed out that the current law only regards the insurance benefit adequacy assessment as one of the tasks performed by HIRA, and that the legal basis necessary to perform the assessment is insufficient because even the required basic definition for the assessment is not stipulated in the Act. In particular, Heo pointed to how the submission period for the data assessment, which is the basis for deriving assessment results and payment adjustment, is not clearly defined. The unclear period unnecessarily prolongs the assessment period to 1-2 years from data collection to its assessment result. Due to such delay, the medical reality is not adequately reflected in the assessment results, which then acts as a limitation by making it difficult for the authorities to provide reliable information for the public or induce healthcare providers’ voluntary improvement of their medical behavior. Thus, Heo proposed a bill to raise the predictability of the system by stipulating the purpose, target, and result of the insurance benefit adequacy assessment. The revised bill also clarified the data submission period so that the results could be derived in a timely manner. Heo explained, “The legal basis necessary to perform the assessment is insufficient and even the basic definition for the assessment is poorly defined. Also, the period of data submission is unclear, which acts as a barrier in inducing the healthcare providers’ voluntary improvement of their medical behavior. Ultimately, we aim to contribute to improving public health by guaranteeing our people their right of medical choice.”
- Company
- Korea Otsuka Pharma’s Hyangnam Plant rises as a global hub
- by Nho, Byung Chul Oct 14, 2021 05:38am
- Pic. of Korea Otsuka Pharmaceutical Korea Otsuka Pharmaceutical, which is soon to face its 40th anniversary in Korea, is receiving attention with its Hyangnam Plant rising as a forward base for global exports and production. Korea Otsuka Pharmaceutical is a global total healthcare enterprise that covers a wide range of businesses from clinical research, R&D, manufacturing, and export of pharmaceuticals. The company will celebrate its 40th anniversary in Korea in 2022. It is one of the rare multinational pharmaceutical companies in Korea that owns and operates a large-scale production facility locally in the Hyangnam Pharmaceutical Industrial Complex in Gyeonggi-do. 99% of the company’s pharmaceutical products released in Korea are supplied through the local Hyangnam plant, and Korea Otsuka Pharmaceutical has continuously invested in the manufacturing facility to expand the facility's role as Otsuka’s global hub. Established in 1989, Korea Otsuka Pharmaceutical’s Hyangnam Plant obtained KGMP approval in December 1990, and BGMP approval in December 1999. By obtaining approval from the US FDA as an API manufacturing facility in July 2000, the plant had grown into a production facility that covers the entire process of drug production from raw material synthesis to the finished product. Ever since its establishment, the company has been continuously investing in the production facility, gradually transforming the plant into a world-class production facility that can produce pharmaceuticals that meet global quality standards. In 2018, the plant was also selected as the first-ever Digital Medicine (DM) manufacturing site, raising expectations of expanding exports to North America after obtaining cGMP approval from the US FDA as well as contributing to further progressing the domestic pharmaceutical industry's production capability. Since the company started to reexport its products to Japan in 1991, Korea Otsuka Pharmaceutical has expanded exports to 13 countries in Asia including China, the Philippines, and Indonesia. In 2014, the company’s facility obtained EU-GMP approval and expanded its exports to 44 countries including those in Europe, raising over 40 billion won in annual exports. Based on the growing export sales, the company had been awarded the ‘$10 million export Tower’ in 1998, ‘$20 million export Tower’ in 2009, and ‘$30 million export Tower’ in 2015 for its outstanding export performance, contributing to the development of Korea's pharmaceutical industry through continuous job creation and the development of the domestic economy. Also, through continuous R&D investment and its independent R&D activity, the company has obtained new indications and developed new formulations, demonstrating the superior development capability of domestic researchers while increasing exports and expanding global approvals. In April this year, Korea Otsuka Pharmaceutical had succeeded in developing a global product- ‘Mucosta SR Tab.’ - for the treatment of gastric mucosal lesions using only domestic infrastructure through open innovation development with a domestic venture company, IMD Pharm, and Aju University Industry-Academic cooperation foundation. Such R&D investment activities are not irrelevant to the virtualization of its Hyangnam plant. The development of various new items with new indications and formulations led to expanded approvals in Korea and nearby countries, based on which the company has expanded exports of pharmaceuticals produced at its Hyangnam plant in Asia, Arab, and Europe regions. With the increased exports, the Hyangnam plant has been exerting its influence as a well-established production base of Otsuka Pharmaceutical. Meanwhile, Korea Otsuka Pharmaceutical has been the only multinational pharmaceutical company to be nominated as an ‘innovative pharmaceutical company’ for 4 consecutive years in recognition of its continuous investment in production facilities and activation of the domestic pharmaceutical industry.
- Policy
- # of COVID-19 confirmed medical staff doubled in 3 months
- by Lee, Jeong-Hwan Oct 14, 2021 05:37am
- Rep. Choi Yeon-sook (Photo by Korea Special Press Association)Among domestic medical personnel, the cumulative number of confirmed cases of COVID-19 has more than doubled compared to three months ago. Out of a total of 321,352 COVID-19 confirmed patients as of 0 o'clock on the 5th, 5,444 were medical personnel or medical institution workers. On the 12th, Choi Yeon-sook of the People Party made this announcement through data submitted by Central Disease Control Headquarters. According to the data, the cumulative number of confirmed patients of medical personnel (doctors, nurses, dentists, and oriental medicine doctors) increased from 977 as of 0 o'clock on July 6 to 1,861 as of 0 o'clock on July 5, up 884 (90.5%). About half (47.5%) of the confirmed medical personnel who have occurred in about a year and nine months since the first confirmed case came out in Korea in January last year have been confirmed in the past three months. The fourth pandemic of COVID-19 since July seems to have affected the confirmation of medical staff. Dentists and oriental doctors with relatively little contact with COVID-19 confirmed patients increased slightly compared to three months ago (13% for dentists and 12% for oriental doctors), but the cumulative number of confirmed patients more than doubled (158%) from 213 to 550. The number of nurses also increased 78.4% from 685 to 1,222 during the same period. As of 0 o'clock on the 5th, out of a total of 321,352 COVID-19 confirmed patients, a total of 5,444 medical personnel or medical institution workers were counted. This is the status of COVID-19 confirmed patients reported to the KDCA Corona Information Management System. According to the status of COVID-19 infection by medical personnel, 550 doctors, 61 dentists, 28 oriental doctors, 1,222 nurses, 894 nursing assistants, 423 nursing care workers, 85 clinical pathologists, and 2,181 others were confirmed. Others included physical therapists, radiologists, pharmacists, emergency medical technicians, medical recorders, and dental hygienists.
- Policy
- Suspicions of preferential tx for SK Bioscience & Celltrion
- by Lee, Tak-Sun Oct 14, 2021 05:37am
- The appearance of the parliamentary audit of the National AssemblySuspicions have been raised during a parliamentary audit, led by opposition lawmakers, that the MFDS may have provided preferential treatment to the company for domestic COVID-19 drugs. Kim Kang-rip, head of the MFDS, dismissed the suspicion, saying he approved it based on evidence. Fentanyl Patch, a drug pain reliever, is being used by teenagers and requested to eradicate drug abuse. There was also an opinion that a doctor who prescribed drug abuse needs to temporarily suspend his license. It was found that opinions between the ruling party and the opposition party were divided on drugs to suspend pregnancy. The MFDS plans to carefully examine the product. Various issues such as COVID-19 treatment and vaccine screening were raised at the National Assembly Health and Welfare Committee's parliamentary audit held on the 8th. Opposition lawmakers pointed out that SK Bioscience's approval of phase 3 clinical trials of the COVID-19 vaccine and Celltrion's conditional approval of Regkirona, an antibody treatment, had inflated K-Bio's performance. "Isn't the government giving preferential treatment to domestic COVID-19 pharmaceutical companies?" Rep. Lee Jong-sung of the People Power Party pointed out, "In the process of approving the phase 3 clinical trial of the SK Bio COVID vaccine, the MFDS did not comply with the 10% domestic regulations and approved the phase 3 clinical trial even though the phase 2 clinical trial was not completed." Rep. Lee Jong-sung said, "It is very unusual to approve phase 3 before the results of phase 2 confirming the proper dosage and use of the SK vaccine are released."He said, "There is a reasonable suspicion that the MFDS was over-enthusiastic to make Moon Jae In government results rather than drug safety, or that Cheongwadae put pressure on K-Bio performance ahead of next year's election." He also claimed, "Celltrion's COVID-19 treatment Regkirona is suspected of giving preferential treatment to the MFDS even though the virus-negative conversion rate, which was the primary evaluation variable in clinical trials, failed to prove statistical significance." Kim Kang-rip, head of the Ministry of Food and Drug Safety (left), and Seo Kyung-won, president of the National Institute of Food and Drug Safety Evaluation (right) (Photo = provided by the National Assembly Korea Special Press Association) In response, Director Kim Kang-rip replied, "This is the result of expert advice that it will not be a problem at all if statistically significant patients are recruited to verify the validity of Koreans," adding, "We also confirmed more than five times the standard serum price in phase 2 and approved phase 3 with scientific judgment." Kang Ki-yoon, a member of the People Power Party, urged, "Samsung Biologics' GMP review of Moderna vaccine consignment production should be approved as soon as possible." Heo Jong-sik, a member of the Democratic Party of Korea, also said, "The Korean people can be vaccinated only with the production of COVID-19 vaccines at domestic production bases such as Samsung Biologics and SK Bioscience," adding, "This requires approval for use." Ko Min-jung, a member of the Democratic Party of Korea (photo by the National Assembly Korea Special Press Association) Samsung Biologics' GMP survey was conducted on September 25. Director Kim said, "We have completed an on-site investigation of production facilities and requested Samsung Biologics to supplement the GMP review," and explained, "The review will be completed within this month." Mifegymiso, ruling party and opposition party are also divided. Kang Ki-yoon, a member of the People Power Party (Photo provided by the National Assembly Korea Special Press Association) Lee Sang-joon, CEO of Hyundai Pharmaceutical, was the only pharmaceutical company to be summoned as a witness during the parliamentary audit. This is to inquire about The objective media Mifegymiso. Mifegymiso is currently being reviewed by the MFDS. However, the pros and cons are mixed over the Bridging Study for Koreans. While civil society and women's organizations omit the Bridging Study and urge rapid approval, the obstetrics and gynecology society say it should be carefully introduced through the Bridging Study. The arguments of women and opposition parties are also mixed. In response, the head of the MFDS said, "We will review the submitted clinical data and refer to WHO guidelines and real data from 76 countries. The Central Pharmaceutical Review Committee said it could review the Bridging Study exemption, but we will comprehensively consider safety such as how to take it." Lee Sang-joon, CEO of Hyundai Pharmaceutical, who is sworn as a witness (photo = provided by the National Assembly CEO Lee Sang-joon, who served as a witness, said, "Hyundai has the ability to proceed with Bridging Study." Asked by Rep. Seo Jung-sook whether she predicts an increase in annual sales due to the introduction of Mifegymiso, CEO Lee replied, "The total number of abortions is reported in Korea, but it is difficult to predict Mifegymiso's market information, which can only be used within the first nine weeks."
- Company
- Tabrecta/ Rybrevant are expected to enter the market
- by Eo, Yun-Ho Oct 13, 2021 05:47am
- Two types of anticancer drugs targeting MET gene mutations are expected to enter the domestic market. According to related industries, Novartis Korea and Janssen Korea submitted applications to the MFDS for approval of the new anticancer drugs Tabrecta (Capmatinib) and Rybrevant (Amivantamab), respectively, and are currently undergoing screening. MET mutations are rare types that account for about 3% to 4% of metastatic non-small cell lung cancer, and interest in these new drugs is increasing as there have been no treatments. The two drugs have something in common that they target hepatocellular growth factor receptors (c-Met), but the indications are somewhat different. Tabrecta was first approved in the United States in May last year as a treatment for MET Exon14 mutated non-small cell lung cancer (NSCLC). In the case of Rybrevant, it obtained US approval in May, blocking epithelial cell growth factor (EGFR) and MET mutation at the same time. The first indication of this drug is non-small cell lung cancer with EGFR Exon20 mutation. Tabrecta and Rybrevant are spurring research for future combination therapy. In particular, it is expected to be able to solve the resistance problem of EGFR TKI in lung cancer. In fact, Tabrecta is conducting a clinical trial in combination with AstraZeneca's third-generation EGFR TKI Tabrecta (Osimertinib), while Rybrevant is conducting a study in combination with Yuhan's 'Leclaza(Lazertinib), a domestic new drug. Meanwhile, Tabrecta confirmed its validity through a phase 2 GEOMETRY mono-1 study of 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among the patients who took Tabrecta, DoR of previously untreated patients was 12.6 months and the patients treated were 9.7 months. Leclaza proved its efficacy through CHRYSALIS, a phase 1 clinical trial. According to the study, the objective response rate (ORR) was 40% when 81 patients with non-small cell lung cancer with 20 mutations of EGFR Exon were administered with Rybrevant. There were three patients with complete response (CR) with complete tumor disappearance, and 29 patients reached partial response (PR) with tumor size decreasing by more than 30%.
- Policy
- MFDS will quickly & thoroughly verify Merck's COVID-19 tx
- by Lee, Tak-Sun Oct 13, 2021 05:46am
- Minister KIM Ganglip It was pointed out that Merck's oral treatment, which is considered a COVID-19 game changer, should be quickly introduced in Korea. Kang Ki-yoon, a member of the People Power Party, said in a parliamentary audit of the MFDS held at the National Assembly on the 8th, "Oral treatments are needed during the With Corona," stressing, "Not only domestic pharmaceutical companies but also overseas development products applied to the FDA should be introduced late." Minister KIM Ganglip explained, "The drug is currently in phase 3 overseas," adding, "We understand that it has applied for emergency use approval." Rep. Kang said, "The KDCA purchased 18,000 and plans to purchase 20,000 more." "We need to prepare for approval as soon as possible," he stressed. Minister KIM said, "We will do our best to quickly and thoroughly verify safety and effectiveness of oral treatments."
- Policy
- ‘Skilarence’ may be reimbursed if it accepts PBAC's price
- by Lee, Hye-Kyung Oct 13, 2021 05:46am
- Kolon Pharma’s plaque psoriasis treatment 'Skilarence Enteric Coated Tab. (Dimethyl fumarate)' will be reimbursed if the company accepts a price lower than the price assessed by the Pharmaceutical Benefit Assessment Committee. On the 8th, the National Health Insurance Service (President Sun-min Kim) disclosed the deliberation results on the adequacy of medical care benefit for pharmaceuticals that applied for decisions at the ‘2021 9th PBAC meeting.’ Skilarence is a treatment for adult patients with moderate-to-severe plaque psoriasis in adults subject to systemic or light therapy. The drug received marketing authorization on May 14th. Developed by Almirall, a Spanish pharmaceutical company, Skilarence achieved PASI 75 response after 16 weeks of treatment in a clinical trial conducted on 671 patients in Europe. Kolon Pharma had applied for its reimbursement with the aim to release Skilarence in October this year. Meanwhile, PBAC deliberation results on Boehringer Ingelheim’s ‘Ofev soft cap. (nintedanib esylate),’ was to not provide benefit for the new orphan drug. Ofev is approved in Korea to treat people with idiopathic pulmonary fibrosis (IPF) or to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD), or to treat chronic interstitial lung disease. Under Article 11-2 of the ‘Regulation on Criteria for Providing Medical Care Benefit,’ NHIS has been assessing the appropriateness of granting medical care benefits to pharmaceuticals through deliberation by PBAC. However, the assessment results may change with alternations in the detailed range of reimbursement and base items or with changes in the indication of the drug that applied for such decision, or in the case of license revocation (cancellation).
- Policy
- Drug prices are the key to easing the PAH benefit standard
- by Choi-sun Oct 13, 2021 05:46am
- There is a possibility that PAH tx benefit standard, which has been criticized by strict standards, will be eased. As the HIRA mentioned that it has prepared an amendment that fully reflects the opinions of the society on the application indicators of combination therapy and the initial three-drug combination pointed out as a problem, the public has passed over to the MOHW. On the 15th, the Korean guideline for diagnosis and treatment of treatment and the Korean Pulmonary Hypertension Association held a National Assembly debate with Heo Jong-sik, a member of the National Assembly's Health and Welfare Committee, to establish measures to improve the survival rate of patients with PAH. In Korea, the three-year average survival rate of patients with PAH is only 54.3%, ranking the lowest among OECD countries, and very low compared to 82.9% in Japan and 73% in the United States. The main reason for this is that unlike global treatment guidelines, which are recommended to use combination therapy from the beginning, combination therapy is only possible in high-risk groups in Korea. As a result of The Korean Society of Cardiology and the Korea Lung Arterial Hypertension Patients Association filing complaints about the revision of standards, the HIRA held an expert advisory committee with related societies in July to discuss the validity of the revision. Pulmonary hypertension, a rare disease, improves the prognosis if diagnosed quickly and treated appropriately. As the mortality rate varies significantly depending on the active use of drugs in the early stages, the association requested to ease the indicator criteria for combination therapy and increase the choice of combination therapy drugs from the beginning. Park Jae-hyung, a cardiology professor at Chungnam National University Hospital, said, "The problem with the treatment of pulmonary hypertension in Korea is that the treatment is delayed because the conditions for starting the combination therapy are high," adding, "Please lower the standard and lift the restrictions on the choice of combination therapy." In this regard, the HIRA also said it reflected the opinions of academia and patient associations as much as possible. Ha Sung-hee, head of the drug standard department at the HIRA Drug Management Office, said, "There are not many diseases in which domestic treatment guidelines are made, but it is quite encouraging that domestic treatment guidelines have been established for rare diseases such as PAH." She said, "Based on this, we had a meeting with experts from the society in July to prepare an amendment to the benefit standards, and we organized the contents and reported them to the MOHW." In the debate, questions flooded about the exact timing of improvement in the standard because the survival rate within three years was only half. "We need to take a close look at various financial capabilities," Ha said adding, "We know that many people are waiting because there are follow-up procedures such as administrative notices to announce, but please understand that it takes time." The MOHW also suggested the possibility of expanding the salary standard through drug price negotiations with pharmaceutical companies. Yang Yoon-seok, head of the insurance drug division at the MOHW, said, "As the association has created medical guidelines, it seems desirable to meet health insurance benefits as much as possible." He said, "We are looking at the revision that came up after a meeting of the expert advisory committee in July." He said, "We will review from the patient's point of view how those suffering from the disease can be properly treated." He explained, "We are reviewing whether to expand benefits based on cost effectiveness, and we think PAH needs measures not only in drugs but also in the areas of diagnosis and follow-up management."
- Company
- ‘Rinvoq’ tries AD reimbursement following ‘Olumiant’
- by Eo, Yun-Ho Oct 12, 2021 05:50am
- Companies have been actively seeking insurance benefits for their JAK inhibitors in atopic dermatitis. According to industry sources, Abbvie Korea has also applied for the reimbursement of its ‘Rinvoq (upadacitinib)’ in atopic dermatitis after its indication expansion, following Lilly Korea’s reimbursement application for ‘Olumiant (baricitinib) in May. Rinvoq had been additionally approved for atopic dermatitis, ankylosing spondylitis, and psoriatic arthritis on October 5th. Also, with the application for Pfizer Korea’s ‘Cibinqo (abrocitinib)’ in process in addition to the two drugs, whether a viable new treatment option will be introduced to the field of atopic dermatitis following Sanofi-Aventis Korea’s ‘Dupixent (dupilumab),’ is receiving attention. For Dupixent, discussions are ongoing with the health insurance authorities on whether the drug’s reimbursement should be extended to cover pediatric·adolescent patients with atopic dermatitis. Rinvoq became the second JAK inhibitor following Olumiant to be approved to treat atopic dermatitis, a field that had few treatment options. Unlike Olumiant, which can only be used in adults, Rinvoq can also be used in adolescents 12 years or older. Rinvoq’s efficacy was verified through the Heads Up study, a head-to-head trial between Rinvoq and Dupixent. Study results showed that 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group. More recently, the patients’ eczema area was divided into 4 (head and neck, body, arm, leg) to assess the rate of EASI 75 response at Week 16 in the areas. EASI 75 rates at Week 1 in all 4 areas were higher for Rinvoq and continued until Week 16. In other words, the study indicated that Rinvoq can relieve symptoms faster than Dupixent, regardless of the affected area. However, the safety issue of JAK inhibitors as a whole is on the board. Based on the post-marketing safety study of Xeljanz, the US FDA had issued a Dear HCP letter warning of the risk of heart attacks in JAK inhibitors such as Xeljanz, Olumiant, and Abbvie's 'Rinvoq (upadacitinib).’ Whether this issue can be resolved and the drugs can settle as a treatment option in the field of atopic dermatitis remains to be seen.
