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- 2025-12-23 19:19:17
- Policy
- The adverse drug reaction rate of Trulicity is 19%
- by Lee, Hye-Kyung Apr 11, 2022 05:58am
- As a result of a six-year post-marketing survey of Type 2 diabetes treatment Trulicity in Lilly Korea, 15 cases of serious adverse drug reactions that cannot be excluded from causal relationships were reported. The permit will be changed as 62 unexpected adverse drug reactions, which cannot exclude causal relationships, also occurred. The MFDS recently announced that it will pre-announce and reflect the order to change the permission according to the results of the re-examination of Trulicity 1.5 mg/0.5ml and Trulicity 0.75 mg/0.5ml disposable pens from July 6. Trulicity was developed as a disposable syringe formulation as a long-acting GLP-1 analog and obtained domestic permission in 2015. As a result of a post-marketing survey of 3,022 people for 6 years for re-examination in Korea, the incidence of abnormal cases was reported to be 19.49% (589/3,022 people, total 819 cases), regardless of causality. Significant adverse drug reactions were found to be 0.46% (14/3022 patients, 15 cases), with occasional blood sugar increases and rare dizziness, poorly controlled diabetes, diabetic gastritis, gastroesophageal reflux disease, acute kidney damage, and diabetic kidney disease. In the case of unexpected adverse drug reactions such as weight loss, weight gain, sensory degradation, and gastroenteritis, 1.99% (60/3,022 cases, 62 cases) occurred. Trulicity is administered as an adjuvant to dietary and exercise therapy to improve blood sugar control in adult type 2 diabetes patients. Among patients who have difficulty controlling sufficient blood sugar with Metformin and Sulfonylurea combination therapy, insurance benefit is being applied to the combination therapy of patients who cannot perform body mass index ≥25kg/㎡ or insulin therapy. Last year, it recorded 47 billion won in outpatient prescriptions based on UBIST, up 23% from 38.2 billion won in the previous year.
- Policy
- NHIS to study measures on improving the PVA system
- by Lee, Tak-Sun Apr 11, 2022 05:58am
- With a study on improving the price-volume agreement (PVA) system in plan, the possibility that the improvement may increase drugs subject to PVA is being raised. According to industry sources on the 8th, the National Health Insurance Service is preparing to conduct a research to ‘evaluate the performance of and improve the Price-Volume Agreement system’ and will post a bid for its research services soon. Its plan, as disclosed by the NHIS, indicates that the study will be conducted for 6 months from the period of its initiation and be completed at the end of the month. Through the study, the authorities plan to establish a mid-to-long-term roadmap for the PVA system and ensure the appropriateness of the drug expenditures to save excess resources and strengthen Korea’s NHI coverage. Feasibility reviews on alternatives that go beyond the existing agreement system and reference formulas will also be developed in the study. For example, the current system applies the rate of increased claims in the formula, but the study will review the application of a reference formula that considers the absolute claims amount and the amount of increase. In addition, the study will be used to prepare a reasonable plan that considers the fiscal impact of the selection/exclusion criteria that were already revised this month, and review diversifying the method used to make PVA. Based on the research results, NHIS also plans to hold public hearings with relevant institutions to improve the PVA system to prepare a system improvement plan that can enhance both acceptability and negotiation power, and propose a mid-to-long-term development direction for the PVA system based on legal and institutional review. NHIS announced its plan to research measures to improve the PVA system earlier this year. At a policy roundtable meeting on the ‘Rational improvement of the PVA system’ that was held by the National Assembly in January, Hyun-Deok Kim, Director-General of the Pharmaceutical Management Department, said, “We are aware of the issue caused by reviewing only the rate of increase without consideration of the absolute increase in claims amount. We agree that there is a need to conduct a comprehensive review on the PVA system and prepare improvements, and will be posting a bid for research services within the year.” As the main purpose of the study is to save NHI pharmaceutical expenses, friction with pharmaceutical companies seems inevitable in the process of its implementation. An industry official expressed regrets, "Contrary to the pharmaceutical industry’s opinion of reducing or deferring the PVA system, the government’s only plan seems to be to reduce its expenses. By the contents of the study alone, it seems that subject drugs and discount rate would only increase further."
- Policy
- National Responsibility for the Side Effects of Vaccines
- by Lee, Jeong-Hwan Apr 11, 2022 05:58am
- Ahn Cheol Soo, the chairman of the presidential transition committee/the special chairman of the COVID-19 emergency response committee said they would provide wide support for adverse reactions to the COVID-19 vaccine while significantly easing the burden of public proof. On the 7th, Chairman Ahn held the 6th meeting of the COVID-19 Special Committee at the Transition Committee in Samcheong-dong, Jongno-gu, Seoul, and discussed ways to realize a national responsibility system for adverse vaccine reactions and secure treatments. Chairman Ahn said, "We have emphasized the importance of scientific quarantine and focused on policy implementation measures based on objective data such as the national antibody positive rate and vaccine abnormalities." "From next week, we plan to release related data one by one with the KDCA and the NHIS," he said. The COVID-19 Emergency Response Special Committee asked the government to come up with measures to compensate for damage from adverse reactions to vaccines, expand diseases subject to support, and ease the burden of public proof to provide quick and fair damage compensation. The KDCA promised to strengthen support by reflecting this request. Specifically, abnormal reactions registered by pharmaceutical departments in major overseas countries will be recognized as related diseases first, and the scope of causal recognition will be expanded if the COVID-19 Vaccine Safety Committee comprehensively analyzes the causalities of related diseases. A project to be supported will also be established, and if the disease is suspected after vaccination and is treated or tested, actual expenses will be provided for the cost. In order to ease the public's burden of submitting evidentiary documents, rapid compensation procedures will also be implemented, such as simplifying submission centered on necessary evidentiary documents in the case of related diseases. The number of objections will also be expanded from one to two. The transition committee said, "We decided to provide consolation money for sudden deaths within 30 days of vaccination, where the cause of death is unknown even as a result of the autopsy." In addition, he said, "There was no support if not diagnosed as a disease subject to vaccine abnormal response compensation and support, but in the future, if the disease is suspected and treated or tested, we plan to provide actual support for the cost."
- Policy
- CAR T-cell therapy has shown the disappearance of leukemia
- by Kim, Jung-Ju Apr 11, 2022 05:57am
- A research team of domestic CAR-T (Chimeric Antigen Receiver-T Cell) treatment confirmed the disappearance of leukemia cells in clinical trials of pediatric and adolescent leukemia patients. The government plans to positively evaluate the treatment of children and adolescents with leukemia through advanced regenerative medical clinical research and continue to provide related policy support. The MOHW (Minister Kwon Deok-cheol) announced on the 7th that the results of the disappearance of leukemia cells in children and adolescents through advanced regenerative medical clinical research research at Seoul National University Hospital (Director Kang Hyung-jin). CAR-T introduces a gene that combines the receptor site of an immune cell (T cell) and the characteristic antigen recognition site on the surface of a cancer cell into a patient's T cell and is a cell with a function of specifically recognizing and attacking the surface antigen of a cancer cell. This study is a high-risk clinical study, which was approved and approved as the first high-risk clinical study by the Advanced Regenerative Medical and Advanced Biopharmaceutical Review Committee and the MFDS in December. Seoul National University Hospital said it administered its own CAR-T treatment to an 18-year-old leukemia patient on February 28, and that a bone marrow test conducted on March 28 confirmed that leukemia cells completely disappeared. This project is to support research funds for clinical studies approved or approved by the Council and the MFDS. In addition to this clinical study at Seoul National University Hospital, it is also supporting clinical research conducted by Samsung Medical Center and Catholic University Industry-Academic Cooperation. Seoul National University Hospital receives 1.25 billion won in research funds from 2022 to 2023, Samsung Medical Center 1.83 billion won from March 2022 to December 2023, and Catholic University Industry-Academic Cooperation Group 1 billion won from 2022 to 2023. As of the end of March, a total of five clinical studies were finalized and approved by the Deliberation Committee and the MFDS, and one high-risk clinical study and one medium-risk clinical study will also apply for research funding to the Advanced Regenerative Clinical Research Support Group. The MOHW explained that the number of applications and applications for advanced regenerative medical clinical research has been on the rise since the Advanced Regenerative Bio Act took effect in August 2020 and the deliberation committee began to form and operate in January 2021. The deliberation committee is determining whether or not to make a decision on the suitability of clinical research in consideration of the validity and safety of the research plan, and the proportion of clinical research that has recently been approved is increasing. Among them, the number of suitable resolutions through the deliberation committee so far has been 10. Recently, the advanced regenerative medical field is attracting attention as a future food in the biohealth field, and as the number of advanced regenerative medical institutions capable of conducting clinical research continues to increase, advanced regenerative medical research is expected to be further activated. Accordingly, the government will strengthen legal essential education for clinical research personnel, R&D for virus production and human transplantation, and GMP support to promote joint research between hospitals and startups. "It is encouraging to provide treatment opportunities for pediatric leukemia patients through the first high-risk clinical study," said Kim Young-hak, head of the MOHW. "We will do our best to provide treatment opportunities to more patients through pan-ministerial regenerative medical technology development projects."
- Policy
- Chinese companies are set to debut in the domestic market
- by Lee, Tak-Sun Apr 11, 2022 05:57am
- Chinese pharmaceutical companies' new anti-cancer drugs, which were approved in Korea last year, are more likely to be listed on the Korean health insurance. Expectations for benefits are growing as BeiGene's Bruxinsa passed the HIRA's Cancer Disease Review Committee as a sole treatment for WM adult patients the previous day. Another Chinese pharmaceutical company, Antengene's Xpovio, will also continue to challenge the domestic market. On the 6th, the deliberation committee set a benefit standard for BeiGene's Brukinsa, which applied for a new benefit, for VM that have received more than one treatment before. If the HIRA's Drug Benefit Evaluation Committee recognizes the appropriateness of the benefit and if the drug price negotiation is concluded with the NHIS, it will be on the domestic health insurance benefit list so that patients can easily receive medication. This is expected to be the first case in which a new anti-cancer drug developed by a Chinese pharmaceutical company enters the domestic benefit market. Brukinsa is a target anticancer drug that inhibits the survival and spread of malignant B cells by blocking Bruton kinase protein, a signaling molecule that affects the survival and development of B cells as a Brutons Tyrosine kinase inhibitor. It was first approved as an MCL treatment by the U.S. FDA in November 2019, and was also approved as a WM treatment in September last year. To be approved as a WM treatment, Bruxinsa conducted a comparative clinical trial with Janssen's Imbruvica, the same BTK inhibitor. American businessman John V. Oyler and biochemist Xiaodong Wang, Ph.D co-founded BeiGene in 2010. As the name of BeiGene suggests, it is headquartered in Beijing, China. Brukinsa is currently in 23 countries with approval from around the world. It has established a branch office early in October 2019 and has been preparing to enter the market. Brukinsa, which was approved by the MFDS on February 25, passed the WM indication committee in less than two months, raising expectations for a high-speed listing. The Chinese pharmaceutical company's new anti-cancer drug approved prior to Brukinsa is Antengene's Xpovio. Xpovio received approval from the MFDS in July last year. This drug is a new mechanism that selectively inhibits XPO1, a nuclear export protein. In January, it was submitted to the cancer screening and discussed setting benefit standards, but failed. In recurrent or refractory polymyeloma, it applied for benefits as a combination therapy with Dexamethasone, and treatment for recurrent or refractory diffuse B-cell lymphoma, but failed to pass. Antengene is expected to continue to challenge the domestic benefit market while watching the situation of overseas registration. Xpovio has already passed the so-called Big 5 DCs such as Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, and Seoul Asan Hospital and is being used as non-reimbursement. Founded in 2017, Antengene is a major developer of anticancer drugs invested by global pharmaceutical company BMS and is headquartered in Shanghai, China. In March last year, a local corporation was established.
- Policy
- The benefit adequacy of Lorviqua was recognized
- by Lee, Tak-Sun Apr 08, 2022 06:08am
- Pfizer Pharmaceutical's Lorviqua has taken a step closer to insurance benefits in recognition of benefit adequacy as a treatment for non-small cell lung cancer. If negotiations with the NHIS are smoothly concluded in the future, the final benefit will be successful. The HIRA announced on the 7th that it held the 4th Drug Reimbursement Evaluation Committee in 2022 and recognized the benefit adequacy of Pfizer Pharmaceutical. The target products were Lorviqua 25 mg and Lorviqua 100 mg, and the Drug Reimbursment Evaluation Committee judged that there was benefit adequacy as a treatment for adult patients with ALK positive progressive non-small cell lung cancer (NSCLC). Results of deliberation by the 4th Drug Reimbursement Evaluation Committee in 2022 Lorviqua was approved in Korea in July last year to use Alecensa Cap or Zykadia Cap as a sole therapy for adult patients with ALK-positive progressive non-small cell lung cancer or as treated with Xalkori and at least one other ALK inhibitor. The Drug Reimbursement Evaluation Committee judged that Sonazoid and Duchembio's Dopa check at GE Healthcare's Korean branch had benefits when accepting less than the evaluation amount. It is subject to acceptance conditions below the evaluation amount. Sonazoid applied for benefits when used for liver gastric tumor lesion ultrasonography in adult patients, and Dopa check applied for use in positron emission tomography (PET).
- Policy
- Bavencio by Merck passed the Cancer Drugs Benefit Committee
- by Lee, Tak-Sun Apr 08, 2022 06:08am
- Bavencio by Merck Immuno-cancer drug Merck Bavencio passed the Cancer Drugs Benefit Appraisal Committee as an indication for urinary tract epithelial cell cancer. The HIRA's Cancer Drugs Benefit Appraisal Committee held the 4th meeting in 2022 on the 6th and announced that Bavencio's standards for urinary epithelial cell cancer have been set. Cancer Drugs Benefit Appraisal Committee also set standards only for WM in the case of BeiGene's Brukinsa, which applied for benefits on the same day. It is expected to be used as a monotherapy in adult WM patients who have previously received more than one treatment. However, Brukinsa failed to set the standard for "single therapy in adult patients with osmotic cell lymphoma (MCL) who have previously received more than one treatment." Lynparza of AstraZeneca, Korea, known as an ovarian cancer treatment, also started to expand the standard, but it was bittersweet. The standards were set for the treatment of adult patients with BRCA mutagenic castration resistant prostate cancer, who had previously experienced disease progression after treatment with new hormone treatments, but the remaining three indications were not set. Combination maintenance therapy in adult patients with highly epithelial ovarian cancer, ovarian cancer, or primary peritoneal cancer, which is HRD-positive (defined as BRCA mutation or dielectric instability) in response to primary platinum-based chemotherapy and Bevacizumab combination therapy, did not pass the Cancer Drugs Benefit Application Committee. The treatment of gBRCA mutant HER2-negative metastatic breast cancer adult patients with previous chemotherapy experience and maintenance therapy of gBRCA mutant metastatic pancreatic cancer adult patients who did not undergo primary platinum-based chemotherapy for at least 16 weeks were not recognized.
- Policy
- Phase 3 of Voclosporin has been approved in Korea
- by Lee, Hye-Kyung Apr 07, 2022 06:10am
- Phase 3 clinical trials of Voclosporin, the first oral treatment for lupus nephritis, will be conducted in Korea. On the 6th, the MFDS approved a clinical trial of Voclosporin, an LN treatment of Aurinia Pharmaceuticals, a subsidiary of Iljin SNT. Phase 3 clinical trials will be conducted at Seoul National University Hospital and Kyungpook National University Hospital as a double blindfold, placebo-controlled, and dose-increasing test to evaluate the efficacy, safety, and pharmacokinetics of Voclosporin for adolescents with lupus nephritis. Voclosporin was approved by the FDA in January last year for the treatment of adult patients with active lupus nephritis. Voclosporin, a calcineurin inhibitor, blocks interleukin (IL)-2 expression and T cell-mediated immune response and stabilizes podocytes in the kidney. According to the results of a study released by Aurinia Pharmaceuticals in November last year, Voclosporin showed continuous safety and weakness compared to placebo in the interim analysis of phase 3 clinical continuous research. Patients in the Voclosporin group maintained a significant decrease in proteinuria. From the baseline prior to treatment of AURORA 1 to 30 months of AURORA 2, UPCR was found to be -3.32 mg/mg for the Voclosporin group and –2.55 mg/mg for the control group (n=90). The eGFR, an important measure of renal function, remained stable until 30 months, and there were no unexpected new side effects reported in the Voclosporin group compared to the control group. Treatments for lupus nephritis include Cyclophosphamide, Cellcept, and Prednisone.
- Policy
- The negotiation period for patent expired drugs ,shortened
- by Lee, Jeong-Hwan Apr 07, 2022 06:10am
- The Regulatory Reform Committee passed a regulation that would shorten the negotiation period for lowering the drug price of the original patented drug from 60 days to 20 days, effectively confirming its implementation. According to the results of the drug price reduction dispute, the revision of the law, in which the government refunds damages to pharmaceutical companies, was judged unregulated and was not reviewed by the Regulatory Reform Committee. The MOHW announced on the 4th that it received the results of a preliminary review of the Rules Amendment to the Standards of National Health Insurance Care Benefits" from the Regulatory Reform Committee. According to the MOHW, the Regulatory Reform Committee judged that among the contents of the regulations, a regulation strengthening plan to shorten the negotiation period for the reduction of drug prices from the current 60 days to 20 days is a "non-important regulation." The Regulatory Reform Committee also agreed with the MOHW's decision that the deadline for negotiations on ex officio adjustment is not needed until 60 days if the original drug price is lowered due to the registration of first generics. Regulations, which have been judged as non-critical in the preliminary review of the Regulatory Reform Committee, can be introduced immediately after going through the procedures of the Ministry of Legislation in the future. The system to shorten the original price reduction negotiation period to 20 days is expected to be implemented as scheduled, and the refund system for the price reduction lawsuit will be implemented based on the results of internal discussions by the MOHW. The timing of implementation is still difficult to estimate. This is because the MOHW must finalize the revision of the medical care benefit rule and set the effective date through all remaining administrative procedures. An official from the MOHW said, "The regulation to reduce the negotiation period for the original ex officio adjustment to 20 days has passed the Regulatory Reform Committee. The system was not reviewed by the Regulatory Reform Committee because it was judged unregulated. "We are discussing internally the revision of the rules for medical care benefits, including the two systems."
- Policy
- 76 generics for DM tx Jardiance Duo have been approved
- by Lee, Hye-Kyung Apr 06, 2022 06:06am
- Generics for Jardiance Duo, a diabetes treatment complex affiliated with SGLT-2 inhibition of Beringer Ingelheim, have been approved. On the 4th and 5th, the MFDS approved 76 items of Empagliflozin/Metformin HCl from 26 pharmaceutical companies. Generics for Jardiance Duo are commissioned by Dongkoo Bio. Empagliflozin/ Metformin for the original Jardiance Duo, which expired on March 11, 2025, but Chong Kun Dang succeeded in avoiding the patent by challenging the crystalline patent of Jardiance and Jardiance Duo, which ends on December 14, 2026. In January 2018, it was the first Korean company to request a passive judgment on the scope of rights, and the decision to establish some of them was confirmed in June 2019. Later in November last year, unlike Jardiance Duo, it was first licensed as CKD Empagliflozin Metformin, which combines Empagliflozin, Metformin HCl with L-Proline, a type of amino acid, and obtained generic for exclusivity. However, Chong Kun Dang's exclusive sale period is from August to December this year, and competition in the diabetes complex market is expected to intensify as 76 items that have been approved have also obtained generic for exclusivity. According to the drug market research firm UBIST, sales of Jardiance was 40.8 billion won last year, up 10% from 36.9 billion won in 2020, and Jardiance Duo also recorded 24.4 billion won, up 47% from 16.6 billion won a year earlier. The pharmaceutical companies that have been approved for Jardiance Duo's generics are Kookje, Hutecs , Shin Poong, Daehan Nupharm, Korea Medica, Guju, Theragen Etex, Aju, Samsung, Daewon, Dongkoo Bio, Jin Yang, SCD Pharm, Samik, Dongkwang, PharmGen Science, Myungmoon Pharm, Withus Pharmaceutical, Il Yang, Young Poong, Hana, JW Shinyak, Daewoong Bio, Dae Hwa, Daewoo, and Ahn-Gook.
