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- 2026-04-11 03:01:33
- 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.
- Company
- Reimb for Revlimid as maintenance therapy near after 4 yrs
- by Eo, Yun-Ho Dec 19, 2022 04:35am
- After 4 long years of await, Revlimid as maintenance therapy is nearing reimbursement listing in Korea. According to industry sources, the agenda of reimbursing Revlimid as maintenance therapy that has passed deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in June will be deliberated at this year’s final Health Insurance Policy Deliberation Committee meeting. If this last procedure progresses and is completed without issues, the drug’s reimbursement is expected to be expanded from 2023. The agenda of using Revlimid as maintenance therapy had undergone various twists and turns in Korea. Since 2019, BMS Korea had actively sought to list the drug for reimbursement, but made no progress. The agenda has also been listed for deliberation by the CDDC in September 2019, June 2020, then again in September last year at the CDDC meeting that gained attention due to its deliberation of the CAR-T therapy ‘Kymriah (tisagenlecleucel),’ but to no avail. “A drug that prevents or delays recurrence of cancer” This is an extraordinary concept. All cancer survivors would jump to take that option. Revlimid has presented such an option for the first time in the field of multiple myeloma, a type of blood cancer that has a recurrence rate of 70-80%. The National Comprehensive Cancer Network made a Category 1 recommendation for the Revlimid maintenance therapy as the only option allowed for in all patients, regardless of eligibility for transplant. The European Society for Medical Oncology guidelines also recommends Revlimid as the only maintenance therapy to be used after autologous stem-cell transplantation. The significance of Revlimid, which has settled as the global standard of care as a maintenance therapy, has been demonstrated through a meta-analysis of 3 clinical trials (CALGB 100104, IFM 2005-02, GIMEMA RV-MM-PI-209). In a median follow-up of 79.5 months on 1,209 patients, PFS (progression-free survival) of patients that used Revlimid maintenance as monotherapy was 52.8 months, which was a significant improvement from the 23.5 months observed in the control arm that did not use maintenance therapy. the study demonstrated Revlimid’s clinical efficacy with more than double extension in PFS. In the follow-up study that was conducted for 88.8 months, the OS (overall survival) of the control group that did not receive maintenance therapy was 86.9 months. On the other hand, the Revlimid maintenance therapy arm’s OS was 111 months, demonstrating a significant improvement. The study showed that maintenance therapy can be a solution to prevent recurrence and improve the quality of life in multiple myeloma patients that experience frequent recurrence. Since patients with multiple myeloma experience worse symptoms when their cancer recurs, it is most important to prevent or delay recurrence after transplantation. Ki-Hyun Kim, Professor of Hemato-oncology at the Samsung Medical Center (Chair of the Multiple Myeloma Research Committee of the Korean Society of Hematology), said, “The prognosis for multiple myeloma deteriorates significantly and the treatment options narrow greatly with every recurrence, therefore using good treatments at the start of treatment is important. It is a shame that we cannot actively recommend maintenance therapy to patients despite their proven clinical efficacy due to the realistic issue of ‘non-reimbursement’.” “If the maintenance therapy is also approved for reimbursement in addition to RVD therapy, it will greatly improve the long-term quality of life in patients in Korea.”
- 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."
- Company
- Severe asthma treatment Fasenra seeks reimb in KOR
- by Eo, Yun-Ho Dec 19, 2022 04:34am
- Another severe asthma treatment is attempting insurance reimbursement in Korea. According to industry sources, AstraZeneca is undergoing the reimbursement process for its monoclonal antibody for asthma, Fasenra (benralizumab). Other biological drugs including GSK’s ‘Nucala (mepolizumab),’ and Teva-Handok’s ‘Cinqair (reslizumab)’ have also been reattempting reimbursement in Korea as well. Fasenra was approved in Korea in 2019 as an add-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled with existing treatment options. The drug is administered once every 4 weeks for the first 3 months, then every 8 weeks thereafter. One of the main purposes of asthma management is to reduce the risk of asthma exacerbations. Fasenra directly binds to the alpha subunit of the interleukin-5 receptor (IL-5Rα) to induce apoptosis. The drug demonstrated efficacy in reducing asthma exacerbation and improving lung function. In the global SIROCCO trial that was conducted to evaluate the effect of Fasenra in treating asthma exacerbations in 1,205 asthma patients including 122 Korean patients, the annual rate of clinically significant asthma exacerbations was reduced by 45% in patients who were treated with Fasenra once every 4 weeks, and by 51% in patients who were treated with Fasenra once every 8 weeks. Also, in the CALIMA trial, Fasenra demonstrated a significant reduction in asthma exacerbations compared to the placebo. In the trial, the annual rate of asthma exacerbations was reduced by 36% in patients who were treated with Fasenra once every 4 weeks, and by 28% in patients who were treated with Fasenra once every 8 weeks compared with placebo. In both trials, a change from baseline in mean FEV1 (forced expiratory volume in 1 second) was observed using Fasenra, and a consistent improvement compared with placebo. The long-term efficacy and safety of Fasenra in severe eosinophilic asthma were evaluated through the BORA trial, a long-term extension trial on 1,926 patients that participated in the SIROCCO and CALIMA trials. In terms of safety, Fasenra showed no significant difference compared to the placebo, and 72% of the patients that were administered Fasenra did not experience asthma exacerbations and were able to maintain their FEV1. Surprisingly enough, asthma is associated with a high mortality rate. The mortality rate of hospitalized patients due to asthma exacerbation is nearly 1/3, and the expenses spent by patients that require emergency treatment or hospitalization due to asthma exacerbation account for more than 80% of the total asthma-related cost, representing a high burden of social cost. Eosinophilic inflammations are found in 50% of all asthma patients and may lead to reduced lung function or asthma exacerbations. In particular, eosinophilic asthma patients that show increased blood eosinophil levels despite appropriate ICS therapy are inadequately controlled with existing treatment therapy including ICS and LABA therapy. Therefore, the quality of life of these patients is threatened by the pain caused by the symptoms and the frequent exacerbation of the disease. Meanwhile, AstraZeneca sought to expand its indication to uncontrolled Fasenra to chronic rhinosinusitis with nasal polyp (CRSwNP), but FDA turned down the final approval and requested additional data.
- 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."
- Company
- Asthma treatment Cinqair attempts reimb again in Korea
- by Eo, Yun-Ho Dec 15, 2022 05:55am
- The asthma treatment Cinqair for asthma is again attempting reimbursement listing in Korea. According to industry sources, Teva-Handok has recently submitted an application for the reimbursement listing of its interleukin-5 antagonist monoclonal antibody Cinqair (reslizumab). Following Cinqair’s steps, other biological drugs for asthma including GSK Korea’s ‘Nucala (mepolizumab) are also moving to start their reimbursement listing processes as well. As an interleukin-5 antagonist, Cinqair reduces levels of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. The drug had first been first approved in Korea in 2017 as an add-on maintenance treatment for adult patients with an eosinophilic phenotype of asthma (those who have a blood eosinophil count of at least 400/㎕ before treatment) that were not adequately controlled with existing treatments. The company had applied for its reimbursement being launched without reimbursement in 2018 but failed. Teva-Handok has been jointly marketing Cinqair with Handok Pharmaceutical since its release. Meanwhile, Cinqair’s efficacy had been demonstrated through five placebo-controlled clinical studies that evaluated the safety and efficacy of Cinqair 3mg/kg in 1,028 adult and adolescent asthma patients that were uncontrolled with currently available therapies. In three Phase III clinical trial programs that were conducted on asthma patients with high blood eosinophil counts, Cinqair reduced the frequency of asthma exacerbations by up to 59% and significantly improved lung function, symptoms, and the asthma-related quality of life. Also, Cinqair received attention for releasing the post-hoc analysis results of asthma patients that require Step 4 and Step 5 treatment among all patients that participated in the Phase III trials. Cinqair reduced the clinical degree of asthma exacerbations in patients classified as Step 4 or 5 under the Global Initiative for Asthma guidelines by 53% and 72%, respectively, and increased the level FEV1 (forced expiratory volume in 1 second) by 103ml in Step 4 patients and by 237ml in Step 5 patients, demonstrating that the benefit was found to be greater in Step 5 patients.
- Company
- Verzenio expects to address the unmet demand
- by Eo, Yun-Ho Dec 15, 2022 05:55am
- Professor Son Joo-hyuk Expectations are high for securing early breast cancer indications for Verzenio, a breast cancer treatment with CDK4/600 inhibition mechanism. Lilly Korea held a press conference on the 14th to commemorate the expansion of permission for early breast cancer indications at high risk of recurrence of the anticancer drug Verzenio. Verzenio obtained approval from the Ministry of Food and Drug Safety on the 18th of last month as a treatment used in combination with hormone receptor-positive, human epithelial cell growth factor 2 negative (HR+/HER2-), early breast cancer adult patients at high risk of recurrence of lymph node-positive, and endocrine therapy. Verzenio's approval is meaningful in that the first CDK 4&6 inhibitor for early breast cancer patients at high risk of HR+/HER2-lymph node-positive recurrence was introduced in Korea. Sohn Joo-hyuk, a professor of oncology at Severance Hospital, shared the medical unfulfilled needs of HR+/HER2-lymph node-positive recurrence early breast cancer patients and the clinical value of Verzenio confirmed through the monarch clinical study, which was the background of approval of MFDS. In the first topic of the presentation, "HR+/HER2-High-Risk Early Breast Cancer Patients' Medical Unfulfilled Demand," Professor Sohn said, "Most of the female cancers in Korea are diagnosed early due to screening activation, especially in the standard treatment of HR+/HER2- patients, to prevent recurrence after surgery. He added, "The prognosis of HR+/HER2-early breast cancer is generally known to be good, but high-risk patients are highly likely to recur, making it difficult to expect long-term survival." According to domestic statistics, the survival rate of general early breast cancer patients is more than 90%, which is higher than that of other diseases. However, patients with recurrence risk factors such as lymph node-positive, high tumor grade, large tumor size, and fast cell proliferation are known to have a higher risk of remote recurrence and death than general patients. Studies have shown that if the tumor size exceeds 5cm, the 5-year survival rate of breast cancer patients decreases from 57% (without lymph node metastasis) to 21% (with lymph node metastasis). Professor Son said, "The recurrence of early breast cancer patients after the first treatment is usually one to two years, and more effective postoperative auxiliary treatment is needed to reduce the risk of recurrence and death." However, since the introduction of aromatase inhibitors in the early 2000s, the absence of new treatment options for HR+/HER2-early breast cancer patients has led to a medical non-fulfillment demand." Verzenio's monarch clinical trial is the only study that has confirmed successful results in about 20 years as a combination of endocrine therapy as an adjunct treatment for HR+/HER2-early breast cancer. In monarch cohort 1, which served as the basis for this indication expansion permit, Verzenio+ endocrine therapy confirmed remote recurrence risk reduction results through Distance Relapse-Free Survival (DRF) indicators as well as Invisible Disease-Free Survival (IDFS) indicators compared to endocrine therapy alone.
