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- 2026-05-03 22:10:32
- Policy
- President Yoon said, block medical shopping
- by Kang, Shin-Kook Dec 20, 2022 06:05am
- As concerns arose that it might lead to a reduction in health insurance coverage, President Yoon Suk Yeol mentioned a second plan to reform health insurance. Regarding the direction of health insurance reform at the first state affairs inspection meeting at the Blue House guesthouse on the 15th, President Yoon said, "It means that we will eliminate it and re-define the insurance system because moral hazard hurts other good insurance subscribers." President Yoon said, "When I and my family have a serious disease that is really expensive, we will normalize the health insurance system to get proper treatment and recover health without worrying about the money (treatment cost)." "There is a person who goes to the hospital thousands of times a year because it is so-called medical shopping." In addition, there are cases where expensive MRI (Magnetic Resonance Imaging Device) is used indefinitely, he said. "We want insurance subscribers to receive fair support for serious diseases and essential medical care." President Yoon said, "I don't think it's desirable for us to set up a principle called the Medical Judgment Rule and treat it according to normal medical judgment. We'll design and operate a very effective objection procedure system for screening and evaluation." Health and Welfare Minister Cho Kyu-hong, who attended the National Policy Task Inspection Meeting, also stressed that the recent measures to improve the sustainability of health insurance do not reduce the role of health insurance. Minister Cho said, "What the government is trying to reorganize is to provide essential and severe medical care to the public as it is, not to reduce its role, but to improve sustainability," adding, "However, it is to prevent medical abuse or theft of qualifications." The Ministry of Health and Welfare held a public hearing on measures to improve health insurance sustainability and support essential medical care on the 8th and announced measures to recognize benefits only when medical needs are recognized in large-scale items such as paid brain and cerebrovascular MRI and ultrasound. When the Yoon Suk Yeoln government formalized health insurance reform that virtually abolished the so-called "Moon Jae In Care" (a policy to strengthen health insurance coverage), the opposition party strongly protested, saying that there was no case of reducing coverage in the conservative government.
- Policy
- ICER of general drugs KRW 15.97 mil for the past 15 yrs
- by Lee, Tak-Sun Dec 19, 2022 04:35am
- The median ICER (Incremental Cost-Effective Ratio) value of general drugs from 2007 to 2021 was KRW 15.97 million in Korea. The ICER value of anticancer drugs was KRW 45.16 million, and rare diseases KRW 15.97 million in the same period. This was the first time that the ICER results were disclosed, and the disclosed results are expected to be useful for pharmaceutical companies that seek to reimburse new drugs. On the 16th, the Health Insurance Review and Assessment Service announced that it had disclosed the cost-effectiveness evaluation results of drugs that are required to submit pharmacoeconomic evaluation data (ICER) for the past 15 years (2007-2021) since the positive-listing system was first introduced to Korea. ICER is a value used to evaluate the economic feasibility of a new drug that offers an improved effect and shows the additional cost required per unit of increased effect or efficacy of a new drug compared to its alternative. Accordingly, a new drug is interpreted as being cost-effective compared to its alternative if the ICER of a certain drug is lower than a certain threshold. However, instead of using an explicit threshold, Korea flexibly refers to the results of previous deliberations in consideration of the severity and social burden of the disease, its impact on quality of life, and innovativeness. The disclosure follows the deletion of the 'GDP per capita' standard and the addition of the ‘existing review results' standards in the revised regulations for the ICER threshold in the ‘Detailed Evaluation Standards for Drugs Subject to New Drugs, Etc.’ in September last year. HIRA explained that the revision specifies the use of the alternative reference value that is used in Korea, as Korea does not use an explicit threshold value. After the initial disclosure this year, HIRA plans to disclose the 5-year ICER data every December, but in consideration of the number of ingredients in each drug category each period to prevent specifying the evaluation results of individual drugs. In the case of the ICER results of rare disease drugs from 2007 to 2013, HIRA disclosed the minimum and maximum ICER values, but not the median value to prevent the evaluation results of individual drugs from being specified. The ingredients subject to disclosure are ingredients deemed cost-effective by the Drug Reimbursement Evaluation Committee and evaluated for reimbursement. Only for 2022, all data from 2007 to 2021 were disclosed at once. Also, the evaluation results from 2007 to 2013 and 2014 to 2021 were separately disclosed in consideration of the major policy changes that had been made in 2014, such as the ▲increased ICER limit to strengthen coverage for severe diseases (from November 2013) and the ▲ implementation of the risk-sharing system (from December 2013), etc. HIRA explained that the data disclosed are divided into three categories: general drugs, anticancer drugs, and rare disease drugs, and the number of ingredients and cost-effectiveness evaluation results for each category are disclosed. In the case of anticancer and rare disease drugs, the classification is made according to the classifications made during DREC evaluations, and all other drugs are included in the general drug category. The number of ingredients was calculated based on the results of the cost-effectiveness analysis and subject ingredients, and HIRA will be disclosing the median, minimum, and maximum values based on drug category. The ICER results of drugs that submitted data for economic evaluations showed that the median ICER of generic drugs from 2007 to 2021 was KRW 15.97 million. Also, the ICER value of anticancer drugs was KRW 45.16 million, and rare disease drugs KRW 32.32 million. The ICER results of drugs subject to PE data submissions can be found on HIRA’s webpage. Mi-Young Yoo, Deputy Minister of HIRA's Pharmaceutical Benefits Management Department, said, “The ICER results that were disclosed this time are meaningful as this is the first time the data had been disclosed since the introduction of the positive-listing system, and the annual regular disclosure of the data is expected to be used as an alternative reference value related to ICER.” Yoo added, “However, in evaluating the reimbursement adequacy of drugs, not only the ▲cost-effectiveness from PE evaluation results, but also the ▲clinical effectiveness, and ▲its impact on NHI finances, are comprehensively considered. Korea does not use an explicit ICER threshold value; it rather evaluates the value in consideration of the uncertainties based on the results of the sensitivity analysis in addition to the basic analysis results. Therefore, we ask people to play caution in interpreting the published cost-effectiveness evaluation results.”
- Policy
- Pfizer Cibinqo, re-applied to the HIRA
- by Lee, Tak-Sun Dec 19, 2022 04:35am
- Pfizer Cibinqo, which aims to pay for atopic dermatitis indications as a JAK inhibitor, is being paid later than expected. It was expected to be deliberated by the Drug Benefit Evaluation Committee within the year after passing the HIRA Drug Benefit Standards Subcommittee in August, but it is expected to take some time for the salary to be converted as it is known to have recently withdrawn and submitted a new application. According to the industry on the 15th, Pfizer Cibinqo recently withdrew its application for benefits decision and immediately resubmitted it. The screening is expected to be delayed further as the salary application has been withdrawn and resubmitted. Initially, Cibinqo applied for salary registration in April and passed a review by the Drug Benefit Standards Subcommittee in August. According to the procedure, it should have been reviewed by the Drug Benefit Evaluation Committee this month, but it was not. In the industry, Cibinqo was expected to proceed without difficulty as the same JAK inhibitors Oluminant and Rinvoq were previously applied not only to rheumatoid arthritis but also to adult atopic dermatitis since May. Pfizer is currently leading the related market with JAK inhibitor Xeljanz. However, compared to competing drugs, there is no atopic dermatitis indication, so we are counting on Cibinqo. Cibinqo has dropped the permit The reasons for reapplying are not known exactly. Although Cibinqo is struggling with salary, it has recently passed the Drug Commission (DC) of large hospitals such as Seoul National University Hospital one after another, laying the foundation for a prescription. If the salary is made, it is expected to settle in the market quickly. Cibinqo has the efficacy and effect of treating severe atopic dermatitis in moderate symptoms of adults and adolescents aged 12 or older who are subject to systemic therapy.
- Policy
- Green light for the reimb of Onureg, Rolontis, etc.
- by Lee, Tak-Sun Dec 19, 2022 04:35am
- A green light has been lit for the reimbursement of BMS Korea’s leukemia treatment ‘Onureg tab,’ with its agenda passing deliberations for setting reimbursement standards. Also, reimbursement standards have been prepared for 5 neutropenia treatment products including Hanmi Pharmaceutical’s Rolontis. The Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee (CDDC) held its 10th meeting on the 14th and made the deliberations above. First, Onureg tab (azacitidine, BMS Korea), which is attempting to establish a new reimbursement category, succeeded in establishing reimbursement standards as ‘maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT). On the other hand, Novartis Korea failed to receive reimbursement standards for Scemblix tab (asciminib, Novartis Korea) as a treatment for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs). Also, the CDDC did not approve the establishment of reimbursement standards for Inrebic cap (fedratinib hydrochloride, BMS Korea) as a treatment for enlarged spleen or other symptoms related to primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythaemia myelofibrosis in adult patients that have been previously treated with ruxolitinib. In addition, Nerlynx tab (neratinib maleate, Bixink) failed to receive reimbursement for use as monotherapy as extended adjuvant treatment for patients with early-stage HER2-positive breast cancer in those who have received adjuvant trastuzumab-based therapy within a year. 10th CDDC deliberation results On the other hand, the green light has been lit for neutropenia treatment products that are in use in Korea. The products are: Neulasta prefilled syringe inj (pegfilgrastim, Kyowa Kirin Korea), Neulapeg (pegteograstim, GC Corp), Dulastin prefilled syringe (tripegfilgrastim, Dong-A ST), Lonquex prefilled inj (lipegfilgrastim), and Rolontis prefilled syringe ing (eflapegrastim, Hanmi Pharmaceutical). The products succeeded in establishing reimbursement standards on reducing the incidence and period of febrile neutropenia in patients undergoing cytotoxic chemotherapy for malignant tumors, and on reducing the period of severe neutropenia in patients undergoing cytotoxic chemotherapy for solid tumor and malignant lymphoma.
- Policy
- HIRA, established a management system for high-priced drugs
- by Lee, Tak-Sun Dec 19, 2022 04:34am
- Medical institutions submit administrative information and response evaluation results to the Board of Audit and Inspection. The HIRA (Director Kim Sun-min) announced that it has been operating a "high-priced drug management system" since the 12th to increase the work efficiency of analyzing the results of response evaluations for patients receiving high-priced drugs and to facilitate data submission. It is explained that the high-priced drug management system was promoted to analyze and monitor the entire administration process from administration information of ultra-high-priced drug administration patients such as Kymriah and Zolgensma to response evaluation of drugs. Medical institutions that claim expensive drugs log in to the "care institution work portal" and fill out and submit "administration information and response evaluation results" according to the drug-specific evaluation form, and the application will be completed after inspection by the evaluation agency. Looking at the evaluation period by drug, Kymriah submits it for one year every six months and Zolgensma for five years every six months. Medical institutions that administer ultra-high-priced drugs such as Kymriah and Zolgensma, which were registered this year, were cumbersome and uncomfortable by submitting patient-specific administration information by e-mail, but it was improved by directly entering or uploading data according to the system. It is explained that the administrative convenience of medical institutions' submission of data has been increased, and the HIRA has improved work efficiency as accurate data can be collected through real-time data checks. Recently, as social demands for expensive new drugs with high treatment effects are increasing, there is a need to strengthen patient access and secure the sustainability of health insurance through proper management of expensive drugs. In response, the HIRA Pharmaceutical Management Office established a salary management roadmap for the proper management of high-priced drugs in July and formed a dedicated organization to prepare a driving force for the post-management of high-priced drugs. In the future, it will lay the legal foundation for the stable promotion of high-priced drug performance management by specifically defining the targets for high-priced drug management, follow-up management period, and billing method. "The establishment of a high-priced drug management system is the first step to establish a performance-based follow-up system for ultra-high-priced new drugs," Yoo Mi-young, head of the drug management office, said. "The performance evaluation results will be used as data to calculate the NHIS's drug refunds and contribute to securing health insurance sustainability."
- Policy
- Discard Moon Care Policy
- by Lee, Jeong-Hwan Dec 19, 2022 04:34am
- President of Yoon Suk YeolPresident Yoon Suk Yeol announced a normalization policy, emphasizing the necessity and urgency of reforming the health insurance system. Analysts say that it has virtually formalized the abolition of the policy to strengthen health insurance coverage, which is the core of the so-called "Moon Jae-in Care" promoted by the previous government. "We urgently need to normalize health insurance, the last bastion of protecting public health," President Yoon Suk Yeol said in a statement at a Cabinet meeting held at the presidential office in Yongsan this morning (13th). "Health insurance reform is not an option, but a necessity," he said. President Yoon criticized, "We have spent more than 20 trillion won on strengthening coverage over the past five years, but the government has neglected medical abuse and free riding of health insurance," adding, "The burden is being passed on to the majority of the people." This is a criticism of the Moon Jae In government's policy to strengthen coverage, and the Ministry of Health and Welfare has recently decided to review whether to apply benefits to MRI and ultrasound tests suspected of abuse among salary items covered by health insurance. President Yoon said, "Popular populism that wastes taxpayers' money is supposed to destroy finances, harm the foundation of the health insurance system, and eventually force the public to make great sacrifices," and stressed, "We need to strengthen health insurance benefits and qualification standards and prevent waste and leakage of health insurance." "We will strongly support those suffering in medical blind spots with reduced funds," he said. "The key to the health insurance system is to ensure that essential medical care that is expensive like serious diseases but must be included."
- Policy
- MFDS approves Jemperil, the third PD-1 inhibitor in Korea
- by Lee, Hye-Kyung Dec 15, 2022 05:55am
- The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) approved GlaxoSmithKline's new drug endometrial cancer treatment Jemperil on the 14th. Jemperil will be the third PD-1 inhibitor to be licensed in Korea after Opdivo of Ono and BMS and Keytgruda of MSD. Jemperil is a monoclonal antibody targeting cell predetermined history 1 (PD-1), an immune gateway receptor for immune cells (T cells). PD-1 is an inhibitory immune checkpoint receptor belonging to the CD28 family and is expressed in activated T cells, B cells, NK cells, and bone marrow cells, and plays a pivotal role in immune regulation. The drug has been approved as an indication for the treatment of adult patients with recurrent or progressive inconsistency recovery defects (dMMR)/high-frequency microsatellite instability (MSI-H) endometrial cancer, which has been treated or progressed after treatment. It uses PD-1 expressed on the surface of immune cells (T cells) to block the survival mechanism of cancer cells avoiding immune cell attacks, and helping immune cells remove cancer cells. The Ministry of Food and Drug Safety said, "We will continue to do our best to quickly supply treatments that have been sufficiently confirmed for safety and effectiveness based on regulatory science."
- Policy
- MFDS “Increasing AAP manufacturing well in progress”
- by Lee, Hye-Kyung Dec 14, 2022 05:57am
- To the issue that had been raised on how the supply shortage is continuing in the field even after increasing the price of acetaminophen, the Ministry of Food and Drug Safety replied that it has reviewed the monthly production schedule and the increase in production is progressing according to plan. Also, the MFDS added that the acetaminophen stock shortages found in some online malls may not be an actual lack of stock, and that it would be necessary to check with the distributors. In other words, some online malls may be leaving the category as out of stock to prevent the large pharmacies to preoccupy the whole stock in online malls at once and allow small pharmacies the purchasing opportunity. Eun-hee Moon, Director of the Pharmaceutical Policy Division Eun-hee Moon, Director of the Pharmaceutical Policy Division at MFDS, said so at a briefing with the medical trade journal correspondents on the 13th. Director Moon said, “Even at the increased price, it is said that the companies cannot manufacture more because they are already at their maximum capacity, and some pharmacies are saying there isn’t enough supply. However, when checking with the manufacturers and reviewing their monthly production schedule, no company has yet said they are having difficulty matching the demand.” The Ministry of Health and Welfare raised the ceiling price of 18 products that contain acetaminophen 650mg to at least KRW 70 to a maximum of KRW 90 as of December 1st. The different ceiling prices have been set according to the manufactured amount. After holding drug pricing negotiations with pharmaceutical companies, the National Health Insurance Service and the companies agreed to increase the monthly average manufacture amount by 50% more for 13 months until September of next year. Also, in consideration of the increased demand and exhaustion of market inventory in the winter and in-between seasons, the period from this month to April next year will be set as an intensive management period, and the monthly target manufacture amount set by 60% more during that period. The average monthly supply will rise the previous 45 million tablets per month to 67.6 million per month for the 13 months, and to 72 million tablets per month during the intensive management period. Also, the MFDS issued an ‘Emergency management and import order for medical products,’ ordering companies that supply prescription acetaminophen 650mg to report their manufacture and import plans, expected monthly manufacture and import and manufacture and import results from December 1, 2022, to April 30, 2023. Director Moon said, “The monthly manufacture amount submitted by the pharmaceutical companies has been set by adjusting the manufactured volume of other drugs. It was not vaguely made." For companies that consign productions, the companies agreed on the price increase after making the production plans for all of its products and confirming their production schedule with their factories. Director Moon emphasized, “Hanmi Pharmaceutical and Chong Kun Dang switched their consigned acetaminophen products to self-manufacturing and submitted their specific manufacture schedules before signing the price increase agreement. The companies are working hard to achieve the goal of expanding production by 50% and 60% more from the previous period according to the plans set by the government.” The MFDS believes that the supply shortages raised in the field will not occur as the contracts that were signed mandate companies to refund the drug price if the production volume does not reach the target amount. Director Moon said, “The MFDS’ manufacture and import order was issued to address the concern that not enough acetaminophen will be supplied in the file even after the NHIS signed agreements with companies that link the production and supply amount to the drug price. As the MFDS and NHIS are managing the issue together, I believe the production of acetaminophen will be carried out as planned." Moon added, “Companies that cannot fulfill the manufacture/import orders were directed to consult with the MFDS, but there has been no talk of companies being unable to meet the volume yet. I have reviewed the production volume until early December, and more acetaminophen is being supplied compared to November." However, as the specific production volumes of acetaminophen in November and December need to be compared, the actual difference can only be found at the end of the year. The MFDS is also preparing a plan to prepare for the supply shortage of raw materials for cold medicine that may arise due to China’s recent lifting of COVID-19 restrictions. Director Moon said, “When checking the raw material suppliers, most were from the US, China, and India, and we think we can use Indian suppliers if there is a disruption in the supply of raw materials in China. While receiving plans for increased production of acetaminophen from companies, we are also checking the current status of raw material supply” The exemptions from the mandatory small-package packaging of prescription cold medicine also continue to be in effect. Moon explained, "We had originally decided to apply the small packaging exemption for the period when we monitor the supply and demand, which is conducted once every two weeks."
- Policy
- $25.5 billion in exports to the health industry
- by Kim, Jung-Ju Dec 14, 2022 05:56am
- Exports of health medicine-related industries this year amounted to $25.5 billion, similar to last year, but the export of medicines such as biosimilars and vaccines was notable. The pharmaceutical sector is expected to surpass $10 billion for the first time next year based on a single item, raising expectations as a next-generation "good son export sector." The Health Industry Promotion Agency (Acting Director Kim Young-ok) announced the "2022 Major Export Performance and 2023 Export Forecast" this afternoon (7th). Although it recorded the highest performance in the first half of the year* thanks to increased demand for COVID-19 vaccines, treatments, and diagnostic products, the decline in quarantine goods (vaccines and diagnostic products) was noticeable due to full-scale enddemicization in the second half. Looking at export trends in the first half of 2022, it grew by 8.5% to a total of $13.35 billion, of which pharmaceuticals increased by 45% to $4.35 billion. Medical devices grew 5.2% to $4.93 billion, and cosmetics fell 11.9% to $4.06 billion. In particular, exports of medicines are expected to increase by 23.9% year-on-year due to biopharmaceuticals (biosimilars) and vaccines, but exports of medical devices and cosmetics are expected to decrease by 7.3% and 10.1% due to the full-fledged COVID-19 endemic and worsening external conditions. This year, the average monthly export of the health industry was $20.8 billion, continuing positive growth for 33 months since September 2019, and turning to negative growth since June this year. By industry, pharmaceutical exports are expected to rise 15.5% year-on-year to $10.1 billion, cosmetics are expected to rise 6.7% to $8.8 billion, and medical devices are expected to fall 6.2%, to $8 billion. Exports by region are expected to grow 5.8 percent to $13.6 billion, Europe to $6.8 billion, and North America to $4.2 billion, with Asia/Pacific exports expected to account for more than half. Diagnostic products, which had increased exports due to the global pandemic, are expected to continue to decline in exports, and exports of anti-pathogenic biological drugs such as biosimilars and toxins will continue to increase, accounting for 23.8% of the market share (based on division). Among them, pharmaceutical exports are expected to surpass $10 billion next year, up 15.5% from this year, based on the first single item ever. Exports of vaccines and treatments, which have soared since the end of last year, are expected to gradually decrease, and overall exports of medicines are expected to grow steadily due to continued demand for biosimilars. In the case of medical devices, exports are expected to fall 6.2% from this year to $8 billion next year. Existing major items such as ultrasound imaging devices, implants, and radiographic devices are expected to exceed exports in 2019, before COVID-19, thanks to a rapid recovery. On the other hand, exports of reagents for diagnosis in Korea are expected to gradually decrease as demand for COVID-19-related products decreases worldwide. Han Dong-woo, head of the Health Industry Innovation Planning Division at the Promotion Agency, said, "In 2023, health industry exports are expected to increase 5.4 percent year-on-year to $26.9 billion as cosmetics exports turn positive along with steady exports of medicines." "Since COVID-19, our health industry has proven its growth potential due to rapid increases in exports, but it may be more sensitive to external shocks such as weak economic conditions, global supply chain instability, high export dependence on the U.S. and China, and policies to strengthen protectionism," Han said. Meanwhile, the agency explained that it is working to support the industry and support government policies by providing information on exports and imports in the health industry, investigating overseas perceptions of the health industry, analyzing the impact of supply chain reorganization, and collecting opinions from the industry.
- Policy
- Reimb of Samil·Kukje's rebamipide eye drops adequate
- by Lee, Tak-Sun Dec 13, 2022 06:07am
- Samil Pharmaceutical and Kukje Pharma’s rebamipide eye drop solutions that were developed as a treatment for dry eye were deemed adequate for reimbursement by Korea’s Health Insurance Review and Assessment Service. This is the first achievement made for the drug in 4 months since its approval in June. With the reimbursement adequacy recognized for the drug, its reimbursement listing is expected to come sooner after negotiations with NHIS. HIRA’s Drug Reimbursement Evaluation Committee (DREC) held its 12th annual meeting on the 8th and announced such results. The DREC determined that the reimbursement of Kukje Pharma’s ‘Reba-eye Eye Drops’ and Samil Pharmaceutical’s ‘Reva-K Eye Drops’ are adequate for the treatment of tear functions and ocular surface status in adult patients with dry eye symptoms. Kukje and Samil’s two drugs were approved as incrementally modified drugs by the Ministry of Food and Drug Safety in June. Rebamipide has been previously approved as a treatment for gastric ulcers and gastritis in Korea. However, after its mechanism of action that increases goblet cell density and mucus in the eye were found, Samil Pharmaceutical and Kukje Pharma developed the drug as an eye drop for affected patients. Their drug demonstrated superior efficacy over placebo in a domestic clinical trial in Koreans. Based on such evidence, the MFDS approved them as incrementally modified new drugs, recognizing their improved safety and efficacy. After receiving acknowledgment for its safety and efficacy from the MFDS, HIRA’s DREC acknowledged the adequacy of the drug’s reimbursement during its first deliberation of the drugs. If the agenda passes the drug pricing negotiation step with the NHIS, they will be listed for reimbursement. On the same day, DREC also granted conditional approval for the reimbursement of Janssen Korea’s Erleada Tab (apalutamide).' Erleada's reimbursement adequacy will be accepted if the company accepts the conditions proposed by DREC for the reimbursement.
