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- 2026-05-04 04:46:03
- Policy
- Pts with osteopenia need screening tx
- by Kim, Jung-Ju Aug 26, 2022 05:35am
- The National Evidence-based Healthcare Collaborating Agency (Director Han Kwang-hyeop, NECA) analyzed the drug effect in osteopenia patients and developed a fracture risk prediction model and published the results of the study on the 25th. As aging rapidly progresses worldwide, the prevalence of osteopenia and osteoporosis is rapidly increasing. In particular, osteopenia is estimated to be about half of the current elderly population, and the social and economic burden of this is rapidly increasing as the frequency of hip fractures gradually increases. NECA conducted a study on the necessity of preventive treatment for fractures in osteopenia patients so that fracture risk factors can be analyzed and preemptively treated in osteopenia patients and announced the results. As a result of analyzing the data of a 66-year-old woman who underwent a life-changing medical examination of the NHIS, the number of osteopenia patients has continued to increase since 2007, and in 2019, osteopenia patients accounted for half of 66-year-old women. As a result of analyzing the incidence of fractures according to the bone density level, the incidence of fractures in the patients with osteopenia and osteoporosis was higher than in the group with normal bone density. As a result of identifying fracture risk factors and establishing a predictive model in 66-year-old female patients with osteopenia among life-changing health examiners from 2008 to 2009, falls, diabetes, cerebrovascular disease, asthma, and past fracture risk factors were included. As a result of reviewing domestic and foreign literature on osteoporosis fracture incidence, NECA confirmed that osteoporosis drug treatment groups had a statistically significantly lower risk of fracture than those without drug treatment in osteopenia patients and significantly increased bone density. Therefore, even if the bone density is not as low as that of osteoporosis, it is necessary to select and treat patients at high risk of fracture. According to expert opinion surveys from the Korean Society for Bone and Mineral Research and The Korean Endocrin Society, all respondents said they needed to selectively administer drugs to patients with osteopenia, and that they needed to expand insurance benefits to make actual prescriptions more active. Kim Jung-hee, an associate professor of endocrinology and metabolism at Seoul National University Hospital, said, "We confirmed that osteopenia patients have a higher risk of fracture than normal bone density groups, and active treatment should be considered for osteopenia patients with high risk of fracture." Professor Kim said, "We hope that the fracture prediction model developed in this study will be used as a useful indicator for evaluating the risk of fracture in patients with osteopenia." Yoon Ji-eun, an associate researcher at NECA, who is in charge of joint research, said, "We expect it to be used as an important basis for clinical treatment guidelines that determine whether to administer osteoporosis drugs to patients with osteoporosis in the future."
- Policy
- MET mutant anticancer drug Tepmetko challenges
- by Lee, Tak-Sun Aug 25, 2022 05:52am
- Following the MET mutant anti-cancer drug Tabrecta, which landed in Korea last year, Tepmetko is also undergoing a review. MET mutations occur only in about 3-4% of non-small cell lung cancer patients, but the prognosis is poor, so there is a desperate need for treatments that are covered by benefits. According to an industry on the 24th, the HIRA is considering establishing a new benefit standard for Tepmetko 225mg. Tepmetko 225mg is an anticancer drug approved in Korea by Merck in November last year and is used to treat patients with local progressive or metastatic non-small cell lung cancer with MET Exxon 14 skipping confirmed. When MET Exxon 14 deficiency occurs, the MET pathway, which plays a necessary role in cell signal, proliferation, and survival, is said to be excessively stimulated and cause cancer cell proliferation. On the same day, Tepmetko of Novartis Korea was also approved, allowing MET mutant anticancer drugs to be used for the first time in Korea. The two drugs had a mechanism to block the MET phosphorylation reaction by binding to the phosphorylase region of the receptor in the cell. The two drugs appear to be undergoing a benefit process afterwards. Tepmetko was on the agenda of the Deliberation Committee for Severe Cancer Diseases on the 10th, but failed to set a benefit standard. Currently, the two drugs can be used as non-reimbursedment, but it is difficult for patients to access them easily in that the price is around 10 million won. They want to apply prompt benefit to related patients and medical sites. However, it takes a long time to apply the benefit, such as setting anti-cancer drug benefit standards. Since Tepmetko failed to pass the cancer disease review committee, Tepmetko cannot guarantee to pass the first stage of the benefit process. In particular, in the case of MET Exxon 14 defects, the use environment is not easy because the companion diagnosis method has not yet been developed. Attention is focusing on whether Tabrecta and Tepmetko, which were approved on the same day, will be able to successfully register their benefits.
- Policy
- Entry of HER2-low breast cancer Tx imminent in Korea
- by Lee, Hye-Kyung Aug 25, 2022 05:52am
- Daiichi Sankyo Korea and AstraZeneca Korea’s human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) “Enhertu Inj (trastuzumab deruxtecan)” is expected to be approved in Korea soon. This imminent entry of the first treatment for HER2-low breast cancer in Korea attracting much attention. According to industry sources on the 24th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Enhertu. With the completion of the safety and efficacy review, the industry analysis is that the drug will be soon approved if no other variables arise. Enhertu, which has indications for breast and gastric cancer, was first approved for the treatment of recurrent metastatic HER-positive breast cancer in the US in 2019. Since then, Enhertu was additionally approved in the US for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received prior standard treatment with “Herceptin(trastuzumab)” last year. In Korea, the drug has been under regulatory review after the MFDS granted Enhertu an Expedited Review Designation in June last year. If approved, patients who have difficulty using Herceptin or Perjeta due to low HER2 expression are expected to benefit from the marketing authorization of Enhertu in Korea. Although HER2 protein is generally expressed in breast cancer, it is also found in some other types of cancer. One out of five gastric cancer patients in the US is diagnosed with advanced HER2-positive gastric cancer. In October last year, the European Society for Medical Oncology Clinical Practice Guidelines were updated to recommend Enhertu for use as the preferred second-line therapy for patients with HER2 positive metastatic breast cancer following progression with a taxane and trastuzumab, based on the results of DESTINY-Breast03 trial. In July this year, the European Commission approved Enhertu as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
- Policy
- 3rd gen ALK NSCLC drug Lorviqua to be listed on next month
- by Lee, Tak-Sun Aug 25, 2022 05:52am
- Pfizer ALK Inhibitory Non-Small Cell Lung Cancer Treatment Pfizer's third-generation non-small cell lung cancer treatment, Lorviqua, will be listed next month (September). As this drug can be used for non-small cell lung cancer that does not respond to ALK-positive first- and second-generation drugs, patients' treatment opportunities are expected to expand with registration. The HIRA announced on the 22nd that it will establish a new Lorviqua (second or more, chronic therapy) for non-small cell lung cancer in September while conducting an inquiry on the revision (draft) of the announcement according to drugs prescribed and administered to cancer patients. Detailed administration targets are progressive or metastatic patients who have been treated with ALK-positive and have been treated with primary ALK inhibitors such as Selectinib or Ceritinib or Brigatinib. However, patients who have received Crizotinib as a primary ALK inhibitor can also be used when disease progression is confirmed after administration of Alectinib, Ceritinib, or Brigatinib as a secondary ALK inhibitor. Xalkori is the first ALK inhibitor, and Alecensa, Zykadia, and Alunbrig are the second drugs. The HIRA said that as a result of reviewing textbooks, guidelines, and clinical papers, the therapy is mentioned as an ALK-positive non-small cell lung cancer treatment in the textbook. According to a single-group, phase 2 clinical trial (study 1001) of ALK-positive non-small cell lung cancer patients who previously received one non-Crizotinib TKI or two TKIs treatment, the reason for the establishment of the pay standard was reported as 39.6% for ORR, 6.6 months for mPFS, and 20.7 months for MOS. This is in accordance with the permission at the time of domestic approval in July last year. It also added that patients who started treatment with Brigatinib were included in the benefit list in consideration of guidelines and academic opinions. Lorviqua has been negotiating drug prices with the NHIS since it was recognized for its benefit adequacy at the HIRA Drug Reimbursment Evaluation Committee in April. Initially, it was expected to be registered this month, but it was completed to be registered next month through additional negotiations.
- Policy
- Benefit for Sigmart 48mg will be newly established on Sept.
- by Kim, Jung-Ju Aug 25, 2022 05:52am
- Including Sigmart 48mg, JW Pharmaceutical's angina treatment, Nitroglycerin such as Nicorandil's drug, Elyson's Perlinganit 0.1% injection, which is used as a blood pressure control before and after surgery, and Verapamil HCl, Sanofi-Aventis Korea's Adenosine, are expected to be reimbursed next month. The benefits of Mycophenolate mofetil injections such as Roche's Cellcept, which is used to prevent rapid growth rejection of patients with kidney, heart, and liver transplants, and Ustekinumab injections such as Stella PFS 45mg, which treat psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, will be expanded. The Ministry of Health and Welfare decided to push for a partial revision notice of details on the criteria and methods of applying medical care benefits" and recently made an administrative notice. First of all, as of the 1st of next month, four drugs related to angina will be included in the benefit. The target drugs are JW Pharmaceutical's Sigmart 48mg, Elyson Perlinganit 0.1% injection, ILSUNG Isoptin, and Sanofi-Aventis Korea Adenocor. Sigmart 48mg is considered to induce maximum congestion during intra-coronary pressure measurement when no-reflow occurs during PCI, and Perlinganit 0.1% injection is recognized for spasm relief, coronary angiography, and intervention in patients with dysplasia. ILSUNG Isoptin is provided to prevent vasoconstriction during carotid coronary angiography and intervention, and Adenocor is provided to induce maximum congestion during no-reflow during PCI and intra-coronary pressure measurement. Mycophenolate-based drugs such as Roche's Cellcept will be expanded to patients confirmed to be in the WHO classification stage of lupus nephritis. Ustekinumab injections, such as Janssen Korea's psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis treatment Stelara PFS 45mg, do not show an appropriate response to a universal therapeutic agent or are not resistant to mediocre ulcerative colitis patients.
- Policy
- All domestic restrictions on PVA cut are agreed
- by Lee, Tak-Sun Aug 24, 2022 05:56am
- 정해민 건보공단 약제관리실장이 23일 전문기자협의회와 브리핑을 하고 있다.Jeong Hae-min, head of the NHIS Pharmaceutical Management Office, is briefing with the Korea Special Press Association on the 23rd. In the PVA negotiations that reflect this year's revised guidelines, all domestic pharmaceutical companies agreed with the NHIS. Initially, negotiations with some domestic pharmaceutical companies were expected to be difficult due to opposition to the retroactive application of the revised guidelines, but they reached an agreement within the target deadline. The agreed items will be reviewed by the Health Insurance Policy Review Committee this week and announced on September 1. Jeong Hae-min, head of the NHIS Pharmaceutical Management Office, explained in a briefing with the Korea Special Press Association on the 23rd that 173 out of 175 items subject to negotiation were agreed. Type A negotiations are subject to an increase of more than 30% of the expected claims negotiated with the NHIS, and a product which cap has been adjusted by type price negotiations has increased by more than 60% or 10% from the previous year and increased by more than 5 billion won. This year's type C negotiations drew attention as the revised guidelines were reflected in April. The revised guidelines exclude less than 90% of the arithmetic average of the same main ingredient code and less than 2 billion won in annual claims from the negotiations. Previously, less than 100% of the arithmetic average and less than 1.5 billion won in annual claims were excluded. As a result, products from small and medium-sized pharmaceutical companies with an annual billing amount of less than 2 billion won will be excluded, but drugs with an arithmetic average of less than 90% will be included in the list, increasing the possibility of a drug price cut. In response, some pharmaceutical companies and the KPBMA have suggested that the guidelines should not be applied retroactively as of the previous year. However, regarding the retroactive application, the NHIS expressed its intention to reject it and began negotiations with individual pharmaceutical companies, saying that it shared it through meetings such as public-private consultative bodies. Jeong said, "We completed negotiations with individual pharmaceutical companies through sufficient consultation with pharmaceutical companies when negotiating with each company." As a result of the negotiations, an agreement was reached on 173 items in 52 product lines out of 175 items in 53 same product lines from 37 companies. Two items of one product line will be renegotiated, and the product is known to be two items of Xigduo XR of AstraZeneca Korea. Chief Jeong said, "The average cut rate of items that have been negotiated has decreased from last year, but the amount of fiscal savings has increased from last year." According to the revised guidelines, the average claim for drugs added due to the adjustment of the arithmetic average price was about 16.23 billion won, and the average claim for drugs excluded due to the upward revision of the claim was about 1.7 billion won. Director Jeong added, "As with the goal of revising the guidelines, we can see the reduction in administrative costs due to the exclusion of negotiations on drugs with small claims and the expansion of follow-up management of drugs with a large impact on insurance finances."
- Policy
- Gov't “will reinvestigate overused reimbursed items”
- by Lee, Jeong-Hwan Aug 24, 2022 05:55am
- The government will begin discussions on fiscal reform of the National Health Insurance areviewreivew the overused healthcare items ng on already-listed reimbursed items to expand essential healthcare and ensure the sustainability of NHI finances. On the 23rd, the Ministry of Health and Welfare launched and held the first meeting of the NHI Fiscal Reform Promotion Team that was established to strengthen essential healthcare and create a sustainable health insurance system. Relevant institutions, including the Ministry of Health and Welfare, National Health Insurance Service, and Health Insurance Review and Assessment Service will jointly participate in the Promotion Team to discover and promote projects for NHI fiscal reform. The NHI system has been improving access to medical care for the public, achieving a universal health insurance system in a short period of time since its implementation in 1977. As a result, Korea was able to achieve high levels of health outcomes in key indicators such as life expectancy and cancer mortality, etc. while spending less on medical expenses compared to the average spent by other OECD countries. However, in the process of reimbursing non-reimbursed items and reducing the burden borne by patients, an unexpected side effect where usage of some items have surged to a greater extent than expected arose. The government plans to operate the Promotion Team to review whether reimbursed items are being used in excess and prepare a measure for its management. In addition, the government plans to reinforce essential healthcare services that are necessary for the public by preparing a measure for the structural reform of medical expenditures and inducing reasonable and appropriate use of healthcare by examining whether any financial leaks in NHI fiances arose from ▲excessive medical use ▲the increase in the amount of non-reimbursed and reimbursed healthcare usage and their relationship with indemnity insurance ▲theft of health insurance qualifications ▲inappropriate use of the foreign dependent system, etc. For this, the Promotion Team plans to intensively discuss and announce plans to restore essential healthcare until October and prepare detailed implementation plans for each task. Ki-il Lee, second vice minister of MOHW said, “The Promotion Team will work to reinforce the management of reimbursed items and excessive medical use while maintaining the health insurance benefits received by the public. We will do our best to ensure a trusted and sustainable NHI system that covers essential areas of healthcare such as emergency, high-risk operations, childbirth, etc.”
- Policy
- Na Kyung-won is considering being the Minister of Health
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- The opposition party is immediately criticizing the new government as Yoon Seok-yeol's office is reportedly considering Na Kyung-won, a former lawmaker with four-term experience, as a candidate for the next health and welfare minister. According to political circles of the ruling and opposition parties on the 22nd, President Yoon Seok-yeol put former lawmaker Na on the list of candidates for the welfare minister, which was compressed three times. She is said to have experience in related fields by working at the National Assembly's Health and Welfare Committee in the past and has experience and expertise in the field of health and welfare, including an honorary doctorate in social welfare at Soonchunhyang University in July. Having political power, such as serving as the floor leader of the Liberty Korea Party, the predecessor of the people's power, is also cited as the reason why former lawmaker Na is considered as the minister of welfare. Former lawmaker Na herself shows a cautious position or denies it. Regarding the appointment of the minister, former lawmaker Na is repeatedly answering in media interviews, saying, "There was no such thing at all," "There was no communication with the president's office," and "I didn't hear it." In response to this situation, politicians are speculating that it is a roundabout way of expressing their position to challenge the leadership of the people. She was recently mentioned as a strong candidate for the next party leader and said she was considering whether to challenge for the party's leadership. Na has recently been leading in several polls related to party leadership of the party. Lee Soo-jin, floor spokesman of the Democratic Party of Korea, said, "The appointment of Yoon Seok-yeol should signal a personnel reshuffle, not an extension of the personnel disaster," adding, "President Yoon is reportedly considering former lawmaker Na Kyung-won as a candidate for the welfare minister." "It is disastrous to consider a person who ran as a candidate for Seoul mayor in the 2011 local elections and was criticized for bathing teenagers in front of reporters as welfare minister," she pointed out. "President Yoon said at a 100-day press conference that the most important thing in the management of state affairs is the will of the people first and second," spokesman Lee Soo-jin said. "All policies, people, and attitudes should be changed." It is the will of the people to reform personnel and completely change the stance of state administration," she said.
- Policy
- Bill for 'state compensation for Paxlovid's side effects'
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- A bill proposing the government's compensation for damages arising from the administration of COVID-19 treatments that were granted Emergency Use Authorization (EUA) such as Paxlovid or Lagevrio etc. has been filed. On the 22nd, People Power Party member Mi-Ae Kim proposed a bill as representative for the partial revision of the “Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis” which contained the abovementioned contents. Currently, side effects arising from COVID-19 vaccines are compensated based on the ‘Infectious Disease Control and Prevention Act,’ and the side effects arising after administration of drugs that are granted marketing authorization are compensated based on the “Pharmaceutical Affairs Act’ under respective side effect damage relief systems. However, under current laws, no clear grounds existed to provide compensation for side effects arising from the use of oral COVID-19 treatments that were granted EUA. To address this, People Power Party member, lawmaker Miae Kim submitted a bill that allows for the state to compensate for damages occurring due to the use of drugs approved for emergency use and the standards, scope, and procedure for compensation and investigation and appraisal for compensation payment to be applied the Pharmaceutical Affairs Act. As of the 22nd, the Ministry of Food and Drug Safety has granted EUA for 5 COVID-19 treatments – Evusheld inj., Lagevrio cap., Actemra inj., Vekury Powder For Concentrate For Solution For Infusion, and Paxlovid. If the National Assembly passes Kim’s bill, a safety net will be established for the state’s compensation for side effects that arise from the treatments that were granted EUA. In addition, the bill contained a provision to add separate subcommittees for each area of the Public Health Crisis Response Medical Product Safety Management and Supply Committee. It also provided a basis to entrust the maintenance and management of the crisis response medical product information system to the President of the Korea Institute of Drug Safety & Risk Management. Kim said, “We need to protect the lives and safety of our people from the damages and side effects caused by the use of EUA treatments."
- Policy
- When will the CSO reporting system be legislated?
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- In consensus, the government and pharmaceutical industry are voicing the need to legislate the pharmaceutical contract sales organization (CSO) reporting system and urging the National Assembly to review the bill. Both the government and pharmaceutical industry share the position that a bill needs to be passed by the National Assembly to accurately identify CSOs that perform drug sales and promotion activities for pharmaceutical companies, such as one-person CSOs, to abolish indirect illegal rebates. On the 21st, the Ministry of Health and Welfare and the pharmaceutical industry were found to be busy closely following the National Assembly’s review and passage of the bill for the establishment of the CSO reporting system. Both the MOHW and industry believe that identifying the status of CSOs that are acting on behalf of domestic pharmaceutical sales is difficult because of the delay in the timely review of the CSO reporting system. In particular, the MOHW is closely eyeing the legislative timeline because the ministry can only publicly announce the standards and guidelines on the eligibility of the CSO reporting system after the bill is passed by the National Assembly. The CSO reporting system is a bill to regulate the CSO's drug promotion activities conducted on behalf of pharmaceutical companies that have not been reported to the government and local governments as illegal. The bill, if legislated, is expected to have a significant impact on the domestic pharmaceutical business environment. The MOHW plans to discuss and finalize the details of the system, such as the subject for the CSO report and the reporting system, with related ministries such as the Ministry of the Interior and Safety as soon as the bill passes NA review and is finalized. The industry has also long been awaiting the legislation of the CSO reporting system. Relevant laws have already been revised and CSOs are subject to filing and submitting expenditure reports. However, as the bill for the CSO reporting system is yet to be passed, the specific size of the CSOs industry is difficult to identify. This is why the criticism that a legal loophole has been created as the subjects for filing and submitting expenditure reports had been expanded, but those subject to the system are not identifiable, leaving open the risk for the rise of illegal indirect rebates. In addition, the bill to legislate the CSO reporting system needs to be passed for the pharmaceutical sales order education to be legislated, and the obligation to write and manage consignment reports be introduced for further reinforcement of the drug distribution order. Also, the passage of the bill will abolish the rebate attempts where some companies pay excessive promotion fees to CSOs for indirect rebates. An official from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association said, “CSOs are being imposed the same level of obligations as pharmaceutical companies in filling out and submitting economic profit expenditure reports but without the passage of the CSO reporting system, which companies will be applied the system, including one-person CSOs cannot be clearly identified. The CSO system will allow the government to clearly identify and distinguish CSOs and assign the duty to prepare and manage consignment reports and prevent indirect rebates.” An official from a pharmaceutical company said, “Also, the system needs to be introduced to solidly establish a distribution order through pharmaceutical sale order education, etc. Currently, there is a widespread perception that CSOs are used as a window for rebates after being paid excessive promotional fees. The legislation is expected to have the effect of preventing excessive competition by allowing the pharmaceutical companies to pay appropriate fees to their CSOs while strengthening the government’s management and supervision function." Meanwhile, the MOHW plans to publicly disclose the expenditure report content submitted by pharmaceutical companies and medical device companies from January 2024 on its webpage and through other public systems. The MOHW and the pharmaceutical industry believe the CSO reporting system needs to be implemented in a timely manner in line with the public disclosure system for the expenditure report.
