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- 2025-12-23 12:52:12
- Policy
- Introduction of CDF for Zolgensma was proposed
- by Lee, Hye-Kyung Oct 18, 2021 05:54am
- When the National Assembly proposed the introduction of the Cancer Drugs Fund (CDF) for Zolgensma, the NHIS accepted the beginning of the discussion. Rep. Kim Sung-joo of the Democratic Party of Korea said in a parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, "There was a story of a new drug worth 2.5 billion won per time, but patients are losing valuable time because of pharmaceutical companies and the government trying to cut drug prices." "An alternative approach is needed to this issue," he said. Rep. Kim said, "I think a new fund is needed if there is no agreement between the parties." He said, "I want to propose an anticancer drug fund like the UK. I also know that a bill has been proposed for pharmaceutical companies, the government, and private foundations to pay for treatments that have been proven cost-effective in health insurance. "I want to ask what the chairman thinks," he asked. In this regard, Chairman Kim Yong-ik said, "CDF seems to be an important proposal," adding, "As of now, there is no discussion, so there is nothing good or bad about it." "I will say that we should open the beginning of the discussion," he said.
- Policy
- The HIRA also decided to disclose the results of Kymriah
- by Lee, Hye-Kyung Oct 15, 2021 05:58am
- The HIRA has decided to disclose the results of the drug benefit assessment. Although the entire evaluation process required by citizens, patient organizations, and the pharmaceutical industry is not disclosed in detail, it has decided to clearly disclose the establishment of benefit standards and appropriateness of benefits. The HIRA released the "7th Severe Cancer Drugs Benefit Appraisal Committee's deliberation results" at 6:23 p.m. on the 13th, and distributed a press reference to Kymriah deliberated at the Cancer Drugs Benefit Appraisal Committee at 10:46 p.m. The results of the Cancer Drugs Benefit Appraisal Committee deliberation include the items applied for the medical care benefit decision, pharmaceutical companies, efficacy and effect, deliberation results and expanded benefit standards. It is similar to the scope of disclosure of the results of the Drug Reimbursement Evaluation Committee review, which has been released since June 2017. Following the Drug Reimbursement Evaluation Committee, the HIRA decided to distribute the results of the Cancer Drugs Benefit Appraisal Committee deliberation on the media and website in the form of press references after the end of each month's meeting. Kim Ae-ryeon, head of the drug management office, said, "There have been demands for disclosure of the results of the Severe Cancer Drugs Benefit Appraisal Committee, and some unwanted pharmaceutical companies have been curious about expensive drugs and discussed with the Cancer Drugs Benefit Appraisal Committee." Regarding the press reference related to Kymriah, she said, "In addition to setting the benefit standard, Kymriah's reference data were exceptionally released." She said, "It was also dealt with in this parliamentary audit, and there were several issues. It won't come out continuously." The HIRA is considering the timing of distribution of press reference materials. Like the Drug Reimbursement Evaluation Committee, it was also scheduled to distribute press references the morning after the meeting. However, due to the issue drugs such as Kymriah, it announced that it would be distributed after 6 p.m. on the 13th, shortly after the end of the meeting, and distributed to reporters immediately after the monthly meeting. In this regard, Director Kim said, "We will need to consider the timing of distributing the press reference materials of the Drug Reimbursement Evaluation Committee and the Cancer Drugs Benefit Appraisal Committee," and added, "We will review the timing after the parliamentary audit and finalize it."
- Policy
- Requests for confirmation of medical expenses, disclosed
- by Lee, Hye-Kyung Oct 15, 2021 05:57am
- After Avastin receiving the indication of macular degeneration, a patient who paid at his own expense requested confirmation of medical expenses, but the non-reimubrsed cases was justified. The HIRA released a case of requesting confirmation of non-reimbursed medical expenses in the third quarter. Patients can check the details of medical expenses on the HIRA's website and request confirmation of medical expenses if they pay for the benefits as non-reimbursement. In the case of Avastin, as a result of the HIRA confirmation, it was confirmed that the medical institution applied for approval for non-reimbursement use after IRB deliberation. When prescribed and administered to patients beyond the scope of the MFDS' permission, non-reimbursement can be used after IRB deliberation. In the case of Leuplin, it was decided that there was no refund for calculating the full amount of patient copayment. According to the MOHW's notice, medical benefits are recognized when ▲ girls are 9 years old (8 years and 365 days), and boys are 10 years old (9 years and 365 days), ▲ secondary puberty stage 2 or higher and bone age increases from that age, and ▲ the maximum concentration is 5 IU/L or more as the sulfur-forming hormone (LH) increases 2-3 times the basal value in the stimulation test of GnRH (renewal gland stimulation hormone). However, in the case of patients who received a request for confirmation of medical expenses, it was decided that pt would pay the full amount beyond the benefit standard because she was a 10-year-old girl. A refund decision was made on antibody tests to confirm antibody production after COVID-19 vaccination. The COVID-19 antibody test conducted for health examination purposes was paid as non-reimbursement to confirm medical expenses, because the COVID-19 antibody test conducted without an application for a new medical technology decision cannot be collected as non-reimbursement cannot be applied. Request was made to confirm medical expenses for emergency medical management fees, sedation endoscopy patient management fees, human tube locks, synthetic gauze dressing, ultrasonography, MRI, breast surgery, and liposuction.
- Policy
- A new drug preferential law will be promoted
- by Lee, Jeong-Hwan Oct 15, 2021 05:57am
- The MOHW announced that it will start enacting subordinate laws to substantially implement and secure the effectiveness of the "clause for preferential treatment of new domestic drugs" developed by innovative pharmaceutical companies under the Special Act on the Pharmaceutical Industry. The "upper limit price preferential treatment of drugs" stipulated in Article 17-2 of the Special Act on the Pharmaceutical Industry was newly established on December 11, 2018, but criticism has been raised as the Presidential Decree and enforcement regulations have not been created for nearly three years. On the 12th, the MOHW responded to individual written inquiries from Rep. Nam In-soon of the Democratic Party of Korea, a member of the National Assembly's Health and Welfare Committee. Rep. Nam asked why, background, and cause sub-laws related to the preferential provisions for new drugs developed in Korea, including Article 17-2 of the Pharmaceutical Industry Act, have not been made for years. The pharmaceutical preferential provisions in the Pharmaceutical Industry Act are of great interest not only in the National Assembly but also in the domestic pharmaceutical industry. Domestic pharmaceutical companies say that they need a system that recognizes drug prices higher when pharmaceutical companies selected as innovative pharmaceutical companies make new drugs in Korea to promote their willingness to develop new drugs in Korea. Domestic companies are calling for the MOHW to show some preferential treatment in terms of follow-up management of drug prices if it fails to create subordinate laws due to concerns over trade friction with foreign countries such as the United States. The intention is that the introduction of measures such as delaying the start of PVA negotiations or limiting the number of times will provide an environment that actually favors the price of new domestic drugs without having to think about ordinary problems. An official from pharmaceutical company A, which owns a new domestic drug, said, "The drug price depends on the first registration after development and post-marketing follow-up management.""If it is difficult to give preferential treatment to drugs when registering as a normal problem, if we give preferential treatment to new domestic drugs during follow-up management such as PVA, the system will be effective without any problems," he said. An official from Company A added, "If the start of follow-up management such as PVA is delayed further, the follow-up price will be applied after the new domestic drug has sufficiently established itself in the Korean market. I think it is one of the ways to realize the system's goals without ordinary friction. Rep. Nam In-soon, who sympathized with the domestic pharmaceutical industry's position, also pointed out the responsibility for the situation to the MOHW and urged for improvement. In particular, Rep. Nam presented an example in which foreign countries provide drug preferential treatment for locally approved new drugs. According to data submitted by the MOHW to Rep. Nam, in Japan, 10-20% is applied to new drugs that were first approved prior to other countries. In addition, in Japan, 5-20% of new drugs that explicitly contain dosages for children are subject to additional calculation. However, if there is no clinical result that includes Japanese children in the country, the relevant addition is excluded. Taiwan is applying an additional 10% to new drugs that have conducted clinical trials on a certain scale or larger that have proven their effectiveness in the country. The MOHW plans to consult with related agencies such as the KPBMA regarding the absence of subordinate laws and regulations under the Pharmaceutical Industry Act. Regarding the reason for not enacting subordinate laws for more than two years, the MOHW explained that it had no choice but to be cautious because it could lead to trade disputes with foreign countries. In addition, the MOHW says that some preferential measures are already being implemented for generics and biosimilars made by innovative pharmaceutical companies.The MOHW adds the first one-year drug price to innovative pharmaceutical companies when applying insurance after developing generic products based on "drug decision and adjustment standards." An additional rate of 68% for innovative pharmaceutical companies and 59.5% for other pharmaceutical companies were set. The MOHW said, "On December 11, 2018, a provision for preferential drug treatment for innovative pharmaceutical companies was prepared under the Special Act on the Pharmaceutical Industry." It said, "However, drug treatment for certain companies can lead to trade disputes with foreign countries, so careful review is necessary." It said, "The global innovative drug preferential system, which favored drug prices developed by innovative pharmaceutical companies, has been excluded from the FTA revision negotiations between Korea and the U.S.," adding, "There are no sub-laws for domestic new drugs, but some preferential treatment such as generic and biosimilars are being implemented." The MOHW then promised, "We will consult with related agencies to review drug support measures, including the enactment of subordinate laws, so that innovative pharmaceutical companies can be supported while avoiding trade friction in the future."
- 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.”
- 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."
- 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).
