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- Prosecution combs vaccine companies for alleged collusion
- by Kim, Jin-Gu Nov 16, 2019 06:29am
- The prosecution set out to investigate on a suspicion of pharmaceutical companies colluding together when supplying vaccine to government. According to pharmaceutical industry on Nov. 14, the prosecution combed ten alleged pharmaceutical companies and distributors on Nov. 13. Companies like GC Pharma, Kwangdong Pharmaceutical, Boryung Pharmaceutical and Korea Vaccine, and distributors like Wooin Meditech, and Pharm World were reportedly on the search and seizure list. Allegedly, the companies have fixed bidding prices of vaccine products submitted to Public Procurement Service when supplying the products to national healthcare institutes. The suspicion not only accuses them for price fixing, but also for supplying products without reporting vaccine’s adverse reaction. In fact, the authority apparently found documents related to vaccine bidding and supply as prosecutors and investigators were searching their offices in the afternoon of Nov. 13. Meanwhile, seven pharmaceutical companies, including Boryung Biopharma, SK Chemical and GC Pharma and CJ have been caught by Fair Trade Commission for colluding vaccine prices in 2005 to 2009. As a result, the companies were fined by the court’s decision.
- Company
- Novatis Korea, 5 Copyright arrangements including Exelon
- by An, Kyung-Jin Nov 16, 2019 06:28am
- Exelon Capsules Novartis Korea is working copyright control of some central nervous system (CNS) medicines such as Excelon. According to the industry on 14th Novartis Korea is considering selling the copyrights of some of the CNS products sold by the Rx medicine business division. The intention is to clean up less profitable items and focus sales marketing activities on the company's flagship products. The abolition of division in charge of CNS products such as dementia, epilepsy and Parkinson's disease drugs has already been phased out, leaving only official announcements. Novartis' original copyrighted products are sold to domestic pharmaceutical companies, and it is likely to return the original copyrighted products from other industry to the original developer. Novartis will continue to supply products while maintaining product licensing rights, but the overall sales activities, including product promotions and sales manpower, will be handed over to domestic pharmaceutical companies. The contract partner is not yet confirmed. The products sold by the CNS department are five drugs, including anti-intermittent drugs named 'Trileptal' and 'Tegretol', Parkinson's drugs named 'Stalevo' and 'Comtan' and Alzheimer's dementia drugs named 'Exelon'. Parkinson's drugs named Stalevo and Comtan, are two products that Novartis does not own the original copyright and are likely to return to the original developer without re-signing. Drugs under the copyright sale has been a record a sharp decrease in sales after the rebate suspension According to UBIST Data Bank, outpatient prescriptions sales for ‘Excelon’ in 2018 were ₩1.8 billion, 86.7% less than in 2016, before the suspension of reimbursement was imposed. The total sales of five products in the CNS department, including Exelon, dropped 57.3% from ₩51.5 billion in 2013 to ₩21.6 billion in 2018. In this regard, Novartis Korea was found to provide medical workers with illegal rebates and was suspended from the MOHW for six months (Aug 24 2017 ~ Feb 23 2018) for nine items in 2017. At the time, the sales loss was big due to the inclusion of four different doses of Execlon capsules and three different doses of Execlon patches. The company’s stance is that it is just to optimize the CNS portfolio, not related to the rebate case. A Novartis official said, “In the process of optimizing our product portfolio strategy, we are reducing the activity of some older products and increasing the concentration of new drugs. Reducing the domestic sales marketing of some items does not mean we withdraw our business division. "
- Policy
- Doctors consider 'efficacy' over cost on anticancer Rx
- by Lee, Hye-Kyung Nov 15, 2019 06:29am
- Domestic oncologists have considered more efficacy and safety than the medicne expense when they prescribe anticancer drugs It implies that health authorities need to mix the ratio of anticancer efficacy and toxicity when applying the valuation tools of the European Society for Medical Oncology(ESMO) and the American Society of Clinical Oncology(ASCO). Korean Cancer Study Group (KCSG) has been conducting researches on 'Analysis of valuation tools for foreign cancer drugs and their application in Korea' as a service project of the HIRA (Health Insurance Review & Assessment Service) since June. KCSG conducted perception survey of 17 oncologists (1st), 165 stakeholders(2nd), and 20 specialists in hematology and oncology(3rd) in order to explore Wertform model of Korean anticancer drugs to evaluate the value of high-priced anticancer drugs using ESMO and ASCO. Prof. Ryu, Min-hee Prof Ryu, Min-hee, trustee of KCSG director presented the results of the 1st, 2nd and 3rd perceptions at the public hearing on Oct 23, and many respondents responded positively to using the value evaluation tool as an anticancer health insurance benefit or afterlife assessment criteria. In the first survey of 17 oncologists, efficacy was considered ranked first when prescribing general anticancer drugs and immune chemotherapy, 94.1% and 75%, respectively. Only 1 (5.9%) responded that the MD considered costs for generic anticancer drugs, while 3 (18.75%) answered that they considered costs for immune chemotherapy. Anticancer drug evaluation items of ASCO and ESMO consists of efficacy and toxicity. When asked about the appropriate ratio in Korea, 58.8% of respondents answered that 70% efficacy and 30% toxicity. The other 23.5% said 60% efficacy and 40% toxicity, and the remaining 17.6% said 80% efficacy and 20% toxicity. The ASCO anti-cancer drug value evaluation reflects additional scores in improving the quality of life (QoL) besides efficacy and toxicities. If the sum of the importance of anticancer efficacy and toxicity is 100, 47.4% answered 20% of the appropriate quality of life ratio. the remaining 37.5% chose 10%, and 6.3% over 30%. As a result of asking the oncologist about the cost of drugs that are not included in the two valuation tools, 43.8% of the respondents consider it to be 60% to 80%. Domestic clinicians are also considering the burden of drug costs. When the Korean anti-cancer drug value evaluation tool developed by the government is developed, 50% of respondents said 'use it as evaluation standard when applying health insurance', and 31.3% said 'use it for evaluating the efficacy of anti-cancer drug after marketing' and the rest ‘ used by MD to decide on patient treatments.'' The second perception survey was conducted by oncologists, nurses, and pharmacists at the ASCO in Busan in last August. Occupation rate was 49.4% of doctors, 35.5% of nurses, and 11.4% of the pharmaceutical industry. The rest chose a duplicate with the others. In the survey of stakeholders, more than half of the respondents said that more than half of the respondents chose to choose generic anticancer drugs or immunocancer drugs with the most importance of efficacy. In addition, 97.6% of the respondents said that it is necessary to develop an anti-cancer drug clinical evaluation tool for the Korean situation. In particular, the majority of opinions that the valuation tool should be used as a standard of health insurance benefits or afterlife assessment. 90.4% of respondents said that value evaluation tools that reflect clinical effects, toxicity, and quality of life should be used as criteria for determining health insurance benefits. 93.4% of respondents said they needed to use a value evaluation tool as a post-registration evaluation tool for conditionally listed anticancer drugs. The third recognition survey was conducted with 20 hematological oncologists from MM working party. More than 90% of the respondents consider the effects of selecting general anticancer drugs and immunocancer drugs. The drug costs were 5% and 10%, respectively. Respectively 80%, 90% of the respondents commented on the need to use a value evaluation tool as a basis for reimbursement decision and afterlife assessment. Prof. Ryu said, "The results showed that they takes count of the efficacy the most when prescribing general anticancer drugs and immunocancer drugs. Education and seminars were needed to utilize and apply the research tools." The response was positive for being used as reimbursement standards or fterlife assessment standards” Prof. Ryu said, "New Bio drugs such as anticancer drugs are shifting the paradigm of disease treatment with new treatment mechanisms and improved effects. However, some high-cost anticancer drugs raise questions about the uncertainty of cost effectiveness compared to the therapeutic effect." "We need to consider introducing an objective and standardized drug valuation tool for fiscal integrity and sustainability."
- Product
- 7 out of 10 doctors exposed to patient violence
- by Kang, Shin-Kook Nov 15, 2019 06:29am
- Apparently, seven out of ten doctors have faced verbal abuse or physical violence against them by a patient or their family. On Nov. 13, Korean Medical Association (KMA, President Choi Dae-zip) published a result of an urgent survey conducted on 2,034 member doctors of the organization. The survey result found among 1,455 doctors (71.5 percent), who have experienced verbal abuse or physical violence against them committed by a patient or their family in exam room in last three years, about 15 percent of them have been physically assaulted, and 10.4 percent ended up with a physical damage. KMA President Choi Dae-zip And more than a half of the surveyed doctors said they have experienced verbal abuse and physical violence against them about once or twice a year. 9.2 percent answered they have been in such situation at least once a month. Most of such aggression was fired up by medical exam results, and some other cases were sparked from complaints of long waiting time and expensive medical service charges. Moreover, 61 percent of the doctors answered a patient or their family came back to the abused doctor later for medical service. 1,254 doctors (61.7 percent) among them have also been forcefully demanded by a visitor to forge a medical report or falsely edit already issued medical record. “The association aims to protect member doctors by introducing a new bill that stipulates punishment on visitors demanding doctors to forge medical record. KMA is committed to have the lawmakers to promptly legislate bills to protect doctors in vulnerable position. The association has been constantly urging the law turning down an indictment for committed assault in healthcare institute when a victim drops the charges should be abolished, and also doctor’s rights to refuse patients should be legally justified. The latest survey has provided us enough concerning evidences,” said KMA official. Moreover, KMA officials pointed out “The survey result says only 6.9 percent of the doctors at the moment have a protected space or facility to avoid verbal abuse and physical violence in an exam room. It means most of the doctors are vulnerably exposed to the harmful threats. The government should pay more attention on creating a safer environment for healthcare institutes”.
- Policy
- 4200 items subject to ATP-based price reduction by 1%
- by Lee, Hye-Kyung Nov 15, 2019 06:28am
- Korean regulators have decided to reduce drug prices of about 4,200 items based on actual transaction price (ATP) from Jan. 1 next year. Until Nov. 11, Health Insurance Review and Assessment Service (HIRA) informed details of price reduction to pharmaceutical companies with already-listed drugs subject to the reduction, and allowed them to visit and confirm the result. HIRA plans to accept their appeals until the end of the month, and to start re-evaluating the items from Nov. 30. The updated lists of reimbursed drugs and their upper limit price are to be in effect from Jan. 1, 2020. At a correspondent’s workshop held on Nov. 14, Director of Pharmaceutical Management Department at HIRA, Kim San stated, “Except for the exempted 4,398 items, weighted average price of 17,702 items, out of 21,732 reimbursement listed drugs, has been calculated. According to the first result, average reduction rate is about 1.3 percent, and it would be modified down to around 1 percent after the appeal review”. “Last year’s overall drug expenditure reached about 17.8 trillion won, and the figure would be decreased by around 90 billion to 100 billion won with price reduction rate around 1 percent. To provide reduced drug price from the beginning of next year, the span of National Health Insurance (NHI) benefit claim bill collection was shortened from three months to two months,” Director Kim added. This year’s ATP survey delved into NHI benefit claim made from July 1 of 2018 to June 30 of 2019, but 3,773 public healthcare institutes, four special veteran hospitals, and 40 military hospitals were excluded from 94,183 subject healthcare institutes. Price reduction subject drugs are to determine weighted average price based on healthcare institutes’ NHI reimbursement claim made on 17,702 listed drugs to HIRA during the surveyed period. Total of 4,398 items are exceptions to the upper limit price adjustment, which consists of 1,167 low-priced drugs, 638 shortage prevention drugs, 394 narcotics and orphan drugs, and 1,837 drugs newly listed during the survey period. Last year, overall 3,619 items had their prices lowered by average rate of 1.3 percent due to ATP-based price reduction, which apparently saved 80.8 billion won of drug coverage expenditure.
- Company
- XOSPATA , AML Medicine landing soon in Korea
- by Eo, Yun-Ho Nov 15, 2019 06:28am
- It is anticipated that new AML (acute myeloid leukemia) drugs which are lack of the treatment will be approved . According to the related industry on the 15th, Astellas Pharmaceuticals is in the process of approving from MFDS for 'Acute myeloid leukemia (AML) drug named Xospata (Gilteritinib). The drug is already approved in 2018 in the US and Japan and received European EMA approval last month. The efficacy of Xospata has been demonstrated in phase 3 clinical ADMIRAL studies. XOSPATA delivered superior survival with a median OS(Overall Survival) of 9.3 months vs 5.6 months with salvage chemotherapy during the ADMIRAL trial. XOSPATA more than doubled the 1-year survival rate compared with salvage chemotherapy. The one-year survival rate was 17% with salvage chemotherapy and 37% with XOSPATA. Adverse reactions occurred in more than 10% of patients receiving XOSPATA for 30days were anemia, increased ALT and AST, febrile neutropenia, thrombocytopenia, constipation, fever, and fatigue. AML is the most common form of leukemia, accounting for about 65% of adult acute leukemia. As you get older, the incidence increases. AML is first treated with a combination of two or three drugs such as Anthracycline. The problem is that even after the first chemotherapy, the leukemia cells fall to less than 5% and the degree of complete perception reaches 50-70%, but up to 50% of these relapse. As a result, many big Pharmacuticals are eager to develop new drugs. An official of the Korean Society of Hematology said, "AML is important to reduce cancer cell numbers in the beginning. We look forward to the appearance of options for prescribing older patients and patients who are unable to apply induction therapy." Meanwhile, Janssen's Decitabine named Dacogen has been prescribed as a primary treatment for older AML patients.
- Policy
- Pharmaceutical spending structure needs to be reorganized
- by Lee, Jeong-Hwan Nov 14, 2019 05:40pm
- We need to increase the expenditure of new drugs in drug costs far more than now. Patent expiration drugs must be left out of the market and replaced by generics for health insurance to be kept. However, since the structure could not be broken, the reform of the generic drug price system, which is a transitional measure, has started. It is solved only by redrawing the spending structure itself. There is often a conflict between estimating drug pricing and increasing reimbursement reflecting the social value of expensive innovative new drugs and the rational expenditure and management of limited health insurance financing. The government is trying to come up with a variety of tools to evaluate the value of innovative new drugs, but it is not easy to close the gap between regulators and profit-generating companies. Eventually, it was the government and experts' view that a massive restructuring of the financial spending structure in health insurance would be necessary to resolve this conflicting agenda. At the National Assembly Library on Nov 7, experts from the government, industry, and patients organization gathered in an open policy debate to solve the difficult task of balancing new drug?s social values and health finances. A panel discussion was held after the presentation of JiHong Bu, senior vice president of IQVIA Korea, which aims to increase the supply of new drugs by regulating the excessive use of chronic disease drugs. The discussion was attended by Myungseop Kwak, Director of insurance and pharmaceutical affairs at MOHW, Jinok Byun, director of the Center for Institutional Finance Research, Korea Institute for Health Insurance Policy, Prof.Lee, Wonbok, Graduate School of Law, Ewha Womans University, Sungjoo Kim, a member of Lee & Ko, and Representative Kijong Ahn , Korea alliance of patients organization ▲ Professor Wonbok Lee (left), Director of Jinok Byun he discussion was based on whether it would be reasonable to create a health budget for new drug benefits by regulating the use of mild and chronic disease drugs, and how to improve the expenditure structure of drugs cost. Prof. Lee, Wonbok, school of law of Ewha Womans University pointed to the lack of statistical or objective evidence that reducing the use of mild and chronic diseases and increasing new drug benefits would contribute to health and financial health. In particular, he introduced many cases where the cost-effectiveness of treatment for severe rare diseases was low and mentioned the risk of unconditional expansion of new drug benefits. Prof. Lee said, "Because the high-income countries except Japan and Korea are spending aggressively on new drugs, there is no justification for the expansion of new drug benefits." Prof. Lee said, "It must be accompanied by practical evidence. We need to provide quantitative indicators of what will help us in terms of health finance and public health." In particular, if the new cap expenditures are unconditionally increased due to the fiscal cap, there is a need for a solution to the backlash against the decrease in stakes in other sectors. � Jinok Byun, head of the Korea Institute for Health Policy Research, said people should not misunderstand that the government will not save or use health finances. Health insurance finances, after all, exist in order to be well spent, explaining that they are doing their best to meet the characteristics of medicines. In particular, the initial drug pricing negotiation of the original new drug is important in terms of financial financing. "The chronic leukemia drug Gleevec was the first targeted drug, called magic bullet because of its superior effect. When it was first introduced, the number of patients was 500," she said. "We have tens of thousands of patients a year and the Gleevec market is still active.� "This is the hallmark of the innovative new drug market. It is the case that Gleevec?s reimbursement was not stopped even after the Novatis?s rebate is caught." "If the new drug lie Gleevec is not managed by the government, it becomes a problem. It is the decision or adjustment process on drugs to agree on a reasonable basis for price in terms of overall price management." ▲ Sungjoo Kim (left) and Myungseop Kwak Sung-Joo Kim, Expert in Lee & Ko , said that the level of drug prices in Korea is not high compared to overseas, and that the application of innovative new drugs should be expanded quickly. "I agree with the significant improvement in the new drug registration rate, but the reimbursement approval is still limited. Cancer immunotherapy is a good example of this, we need to increase reimbursement level and expand the reimbursement drugs" said Kim. Mr. Kim said, ?In particular, we have to worry about creating surplus in financial fields other than pharmaceutical expenses. According to the analysis of the Health Insurance Review & Assessment Service bill data, The number of visits by the most visited clinics in Korea for one year was 300 times. It means that the patient went to clinics more than once per day, so we need to improve the efficiency of health finance. " Myungseop Kwak, the ministry's director of welfare, said that the drug expenditure structure should be redesigned for the social value of new drugs and sustainable health finance. The purpose of this study is to analyze the current spending structure and to rationalize as soon as possible to spend more on new drugs and to reduce the amount of money spent on patent expiration drugs and generics to secure sustainability of health and financial finance. However, since it is virtually impossible to break the spending structure at once, it is implementing measures that can be reformed, such as the reform of the generic drug system, which is a transitional stage. He said, ?Patients and the industry do not require reimubursement for patent expiring drugs. We pay only for new drugs.??We have established a rationalization plan and started research on expenditure structure analysis. We initiated expenditure structure analysis research, results will be released in the first half of next year.� He also said, "If you don't change the expenditure structure in the end, the answer will be microscopic. It's difficult to solve it without drawing a new macroscopic cost chart and digging into the details one by one." Sustainability can only be achieved if the patent expiry is released from the market and generics are replaced. " ?We started with the reorganization of the generic drug pricing system, which is a transitional measure because it is difficult to realize in the five-year health insurance guarantee plan. We plan to use the resources obtained through the reevaluation of patent expired drugs and non-payment drugs for high-cost anticancer drugs, rare incurable diseases treatments, and serious treatments."
- InterView
- I know CRA grievances better than anyone else
- by Lee, Tak-Sun Nov 14, 2019 09:59am
- For CRA(Clinical Research Associate), it is very hard to communicate with many professional people. It's even harder if you don't have expertise. I wish my juniors would work with proud. I would like to have the pride of being an expert that communicates effectively with clinical expertise, monitors clinical practice, and leads clinical practice overall. Kyungsun Kong(52 years old), CEO of dreamCIS knows CRA grievances better than anyone else. The core of the CRO(Clinical Research Organization) is often called CRA. However, CRAs have a lot of work and are irregular, so they often move over. when working as a clinical monitoring agent, you may get hurt by professional experts, such as doctors and nurses. However, the power of the CRA may gaurantee clinical trial quality. It's no wonder that pharmaceutical companies are rushing to many CROs with competent CRAs. CEO Kong was also one of the most competent CRAs. In 1995, she began to work clinical trials as a clinical nurse (CRC) at SMC. The CRC is responsible for coordinating communication between subjects and researchers. In 2003, she conducted clinical trials for 25 years, including Wyeth, Parexel and YUHAN. She worked as a PM managing CRA at Parexel, and she took care of the clinical trial of Lasertinib, a lung cancer drug as a clinical development team leader at Yuhan. CEO Kong is probably the only one who started as a CRC and experienced various duties in the clinical field and became the head of the domestic CRO. This is because most domestic CROs maintain owner representative system. About the reason why she joined dreamCIS last April,“I wanted to try new experience and challenge, CEO Gong said. dreamCIS is an important global CRO since it was acquired by Tigermed in China in 2015. It was the first domestic CRO to undergo preliminary screening. By the end of this month, it will be decided. CEO Gong said, "The goal is to stably grow dreamCIS as a global CRO and It is very symbolic to have listed stocks as a leading company in the industry. It is expected in many ways.“ In recent years, dreamCIS has been gradually increasing global challenges in cooperation with Tigermed. 20-25% of current projects are global. Most of them carry out clinical tasks in China and Korea. CEO Gong said, “Chinese pharmaceutical companies are also growing so much that there is an increasing demand to conduct simultaneously clinical trials in Korea and Japan because the data is mutual recognition.” She said, "Since the merger of Taigermed, the progress of global tasks has been increasing considerably, and there are many opportunities for domestic companies to enter China." I want to contribute to the successful entry of Korean companies to China. ” CEO Gong plans to carry out his management philosophy with a focus on improving clinical quality. She said, “The important thing is clinical quality and I pay much attention to education and talent Recruitment.” Speaking as CRO, It is the key to have good talented CRA. Especially good CRAs control clinical quality. More than 50% of the 200 employees are CRAs in the company, and 80% of them are women. CEO Gong plans to devote herself to building a good company for women to work.“There are many benefits according to the number of women, and many of our employees are working from home and flexible, and I will continue to encourage them.” "I have experienced various companies as a female representative and also as a working mom, but I think that the diverse and flexible culture and system of dreamCIS provide more opportunities for competent working moms and young women focusing on their work creatively", she added. While working as a CRA, she had a lot of hard work, but much experience brought her here with pride. She advised, "To work with professionals such as nurses, pharmacists, doctors or nurses, you need expertise in the clinical field you are in charge of, and you need to communicate based on that knowledge. I wish our staff, as well as juniors working in the clinical industry, would be proud to work with them. ” “Global CROs are starting from the CRA and going up to the country head as they build up their careers, and I also have come to this position as I build up my career from the CRAs." I think it will be a good model for new emloyees and juniors to work” she said. CEO Gong concluded that she is planning a multi-faceted business after the IPO and plans to focus on a business based on the CRO.
- Policy
- Zejula max reimbursed price 76,400 won from Dec. 1
- by Kim, Jung-Ju Nov 14, 2019 09:08am
- From December, Takeda Pharmaceutical Korea’s ovarian cancer treatment, Zejula 100mg capsule (niraparib) would be on the insured drug list at a price of 76,400 won. Although it is more cost-effective than the alternative option Lynparza, Zejula received the same price cap because Lynparza was listed via pharmaceoeonomics (PE)-exempted risk sharing agreement (RSA). Zopista would also be listed from next month at a price of 108 won per 1mg tablet. Health Insurance Policy Deliberation Committee (HIPDC) convened a meeting on Oct. 30, and decided to revise the list of reimbursed drug and upper limit reimbursement rates. Ministry of Health and Welfare (MOHW) explained the reimbursement listing schedule reflects the actual supply schedule of each listed drug, for instance, Zopista from Nov. 1, Zejula from Dec. 1 and Velphoro chewable tablets (sucroferric oxyhydroxide) from Jan. 1, 2020. ◆ Zejula 100mg capsule: Zejula 100mg capsule was approved as an oral maintenance therapy for platinum-sensitive adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Reaching an agreement with National Health Insurance Service (NHIS) on drug pricing negotiation, Zejula’s reimbursed price was set at 76,400 won per capsule. The drug was passed with expenditure cap as its alternative drug Lynparza was passed with a case of PE-exempted expenditure cap type RSA. Takeda released Zejula in Korean market after Ministry of Food and Drug Safety (MFDS) approved it on Mar. 22. On Mar. 25, the company submitted an insurance reimbursement listing application. The application was deliberated by Severe and Cancer Disease Deliberation Committee and Drug Reimbursement Evaluation Committee on June 12 and July 25, respectively, and the drug’s price was negotiated from Aug. 13 to Oct. 10. MOHW official explained patient’s burden on the drug is expected to be lowered significantly as the drug’s daily cost for patient reimbursement the cost is now at 7,640 won, whereas without reimbursement was at 152,800 won before. ◆ Velphoro chewable tablet: Velphoro is a new drug used to control serum phosphorus levels in patients with chronic kidney disease on dialysis, and HIPDC passed the drug at a reimbursed price of 1,697 won per tablet. The tablet was approved by MFDS on Mar. 20 last year, and it applied for reimbursement on Oct. 24 the same year. DREC deliberated and passed the drug on Apr. 25 this year, and NHIS conducted a pricing negotiation from May 22 to July 19. ◆Zopista tablet: An insomnia treatment, Zopista was approved by MFDS on last May 3, and it applied for reimbursement on May 31. The treatment was passed by DREC on Aug. 29 and reached an agreement with NHIS on pricing negotiation from Sept. 24 to Oct. 21. The tablet’s reimbursed cap price was set to 108 won, 162 won and 203 won for 1mg, 2mg and 3mg tablets, respectively. Director Kwak Myeong-Seop of Pharmaceutical Benefits Division stated “The updated reimbursed drug list has expanded insurance coverage on recurrent ovarian cancer treatment, and accordingly enhanced treatment access but lessened patient’s financial burden. The updated list would be officially in effect from Dec. 1, providing National Health Insurance reimbursement on newly added Zejula, Velphoro and Zopista”.
- Policy
- 62 DI including Belviq® and CONTRAVE®,added to DUR
- by Lee, Tak-Sun Nov 14, 2019 09:07am
- The MFDA(Ministry of Food and Drug Safety) has announced additional contraindicated DI(Drug Interaction) medicines that will be updated in the DUR (Drug Utilization Review). Especially, one of the antiobesity medicines, Contrave®(Bupropion-Naltrexone) is contraindicated with Belviq® (Locaserine HCl), and , Cough®, one of expectorants was added Category X which means highly unsafe in pregnant woman. MFDA announced on Nov 11 the partial amendment proposal of 'Regulations on Designation of Contamination of etc.'. This amendment will be implemented immediately after the opinion submission period and will be reflected in the DUR. The revised contents includes 62 DI medicines including Bupropion & Naltrexone-Locaserin, which are considered necessary for contraindication DI. The Bupropion / Naltrexone preparations are generic for Contrave® recently approved. It was added to DUR not to take with Belviq®. Also Belviq® is anti-obesity medicine. 42 contraindicated drugs for pregnany women including Dihydrocodein tartrate was added to DUR, too. Cough® and Codaewon-Forte® are the main medicines including Dihydrocodein tartrate. Remarks have been changed and added to Fentanyl and other ingredient, which are designated as category X. Fosfomycin, on the other hand, was lifted from category X. 10 contraindicated drugs for certain age criteria like Atomoxetine added age-specific contraindications and dosage forms. In addition, the age criteria for 4 ingredients including Bicalutamide were changed. The ingredient name and dosage forms for 4 components including Mesalazine were changed. MFDA officer said, “This amendment will be implemented after the opinion submission period and will be reflected in the DUR immediately” and added “ The amendment was based on the information in the drug insert".
