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- 2025-12-25 02:54:35
- Policy
- 13 drugs containing Nizatidine were banned for sale
- by Lee, Hye-Kyung Nov 26, 2019 07:15am
- 13 gastrointestinal drugs containing 'Nizatidine' which had been covered by health insurance, now are not available on the 22nd. The MFDS and the HIRA said that on the 22nd, they took action that Nizatidine medicines are not prescribed or dispensed by hospitals, clinics or pharmacies, from the midnight, prescriptions and dispensing were blocked through the DUR (Medical Insurance Information System) of the HIRA to prevent prescriptions from hospitals, clinics and pharmacies. The banned items are 13 items for discontinued benefits and 53 billing codes. When re-prescribing Nizatidine drugs in a hospital or clinic, the new prescription should be given only for the remaining days instead of changing the existing prescription. When re-prescribing, the specific description code 'MT059' should be entered. As the existing prescription is not changed, the date of re-prescription and re-dispensing at the time of patient visit comes to be the prescription (prescription) date. Although the patient's copayment is generated when preparing the bill for re-prescription and re-dispensing, there is no copayment for the re-prescription and re-prescription. Therefore, clinics, hospitals and pharmacies must claim the dispensing fee and prescription fee by writing the type code 'B / 01' for each medical service in 'MT059'. HS Codes and standard codes for 13 banned drugs containing Nizatidine
- Policy
- MOHW lukewarm about Epilepsy Patient Support Bill
- by Lee, Jeong-Hwan Nov 26, 2019 07:12am
- ‘Epilepsy Patient Support Bill’ is at stake due to a dispute over feasibility of a bill specifically accommodating a certain disease. The National Assembly lawmakers and the government are contemplating on passing an individual bill for a disease as it could trigger other patients to demand bills for their disease, and cause confusion in administrative regulation and fairness among diseases. Whereas, patients and neurology healthcare providers are urging for the epilepsy bill to be passed as soon as possible, because the disease significantly shortens patient’s life span and poor social awareness and unfair social stigma are discriminating against patients with epilepsy. The National Assembly Health and Welfare Committee convened a public hearing session on Nov. 22 about the ‘Epilepsy Management and Support Bill’ introduced by Lawmaker Kim Kim Se-Yeon. The point of dispute was on fairness of establishing an independent law solely dedicated a single disease. Epilepsy is a central nervous system disorder that causes abnormal events in brain cells, which leads to sudden and intense spasm and seizure lasting few minutes. Experts say the estimated number of patients with epilepsy in Korea is around 360,000, and the disorder notably lowers not only the patients, but also the patients’ families’ quality of life, along with the huge impact of financial and social burden. The submitted bill mainly aims to stipulate legal grounds of planning and executing epilepsy preventive measures, diagnosis, related research, as well as a patient support program to help the patients recover and become independent. A couple of key objectives of the bill are to establish a policy raising public awareness and discrimination prevention of epilepsy and patients with epilepsy. And also it would form National Epilepsy Patient Management Committee affiliated under Ministry of Health and Welfare (MOHW). Another objective is to set up and operate Central Epilepsy Support Center and regional centers, and to allocate budget for contracted agency and Epilepsy Specializing Clinic Center assigned to manage patients by regional government body. Lawmaker Kim Se-yeon suggested MOHW to lay the bill and urged Korea to stop neglecting patients with epilepsy any more. “Usually, I keep a reserved stance on legislation, but this bill is different. When a healthcare institute with a scale of Samsung Seoul Medical Center struggles with surgery on the disorder, it means the problem is quite serious”, Lawmaker Kim stated. “If the weight of an individual bill accommodating a single disorder is too much, then consider a vision of a comprehensive bill covering three major brain disorders in few decades. As I am not in the place to come back to the 21st National Assembly, I am desperately requesting the ministry to establish the bill”, Lawmaker Kim urged as he would be leaving the next election. On the other hand, Lawmaker Ki Dong-Min pointed out an individual law for epilepsy could bring administrative and legal confusion, like the Deaf-blind Bill or so-called Helen Keller Bill, and also that it could unintentionally promote other patients to demand individual laws for their conditions fairly. “Although we agree with the objective of the bill, the ministry seems to be shy of passing the bill. Please elaborate further on the reality of patients with the disorder and why the bill should be process right now”, commented Lawmaker Ki. Professor Kim Heung-dong of Severance Pediatric Hospital (left) and Professor Hong Seung Bong of Samsung Seoul Medical Center testifying at the public hearing session. Professor Hong Seung Bong of Neurology Department at Samsung Seoul Medical Center and Professor Kim Heung-dong at Severance Pediatric Hospital testified that epilepsy is not only about ‘life or death issue’, but also about its critical impact on patient’s day-to-day life. In particular, the two professors claimed Koreans have little understanding of epilepsy, which induces patient discrimination and hinders the patients to get proper treatment timing, often leaving them in hospital emergency rooms. Apparently, people run away or give an unnecessary CPR to patients having a seizure, and eventually end up with unfortunate accidents like collapsed rib cage, all due to the public’s lack of awareness. Moreover, the testifiers also explained there are only five healthcare institutes in Korea to conduct a proper epilepsy surgery in Korea. Professor Hong Seung Bong explained “As far as individual laws for single disease go, there are ‘Dementia Management Act’, ‘Cancer Disease Support Law’, and ‘Act on Guarantee of Rights of and Support for Persons with Developmental Disabilities’. Epilepsy has been designated as a most common but serious brain disorder by the World Health Organization (WHO). The patient size of epilepsy is about a half of the dementia patients’, but the severity is much graver and the patients’ families often go through posttraumatic stress disorder after experiencing social discrimination”. Professor Hong added, “Epilepsy is the second most severe disorder shortening a patient’s life span. The severity of the disease should be taken more seriously. In Korea, only five hospitals are capable of the disorder surgery. Hospital’s training on doctors and policies are also problematic. Korean people in general are quite ignorant about the disorder. For instance, Australia spends about AUD 20 million to raise public awareness of the disorder”. Professor Kim Heung-dong stated “At the moment, patients with epilepsy are mostly neglected from the existing law, and it is the classic case of “hidden disabilities”, where the patient would not speak up of the disorder. Many people tend to run away from a patient experiencing a seizure, because first, they do not know how to react, and second, the fear of possible death. These factors create intentional ignorance of the disorder”. “Out of goodwill, some people try to give a CRP on a patient having a seizure, but the patient breaks a rib or two and visits emergency room. By educating the people about epilepsy and common knowledge, the patients can finally have their place in the society. If the individual law is not the main issue, then the bill should be processed immediately”, Professor Kim strongly emphasized. MOHW official answered it understands the hardship that the patients go through, but as a government body, processing an individual law for all disease is a stretch, realistically speaking. The ministry also elaborated that epilepsy treatment technology and drugs are mostly covered by National Health Insurance, and other neglected parts are supplemented by existing laws on persons with disabilities and rare disease. The ministry insisted that existing laws are already reasonably managing the epilepsy and patients with the disorder. “Setting a standard for testing feasibility of individual bill on a single disease should be approached carefully. Every case of what patients undergo is extremely unfortunate. But having a loose standard would only create unfairness in treating respective disease as a government body. Soon, other patients would complain why there aren’t laws solely dedicated to chronic respiratory disorder or hepatic cirrhosis and so on”, MOHW official stated. The government official added, “If the patients and their family feel the government support is insufficient now, then they can apply to have the disease designated as an individual disease under the grounds of Public Health and Medical Services Act. The government believes that the epilepsy and patients’ issues should be handled not with an individual law, but with existing law”. Some of Health and Welfare Committee members urged an individual law is needed. Lawmaker Choi Do-ja argued “Excessive legislation of bills is problematic, but law should be amended and bills should be passed when the people are in need of help. That is the purpose of National Assembly. When the patients and their families get the news of what MOHW has said about not needing an individual law for epilepsy, they would be in a deep despair. Law should be made, if need be”. “Korea should change. An individual law dedicated for 360,000 patients with epilepsy should be established for their improved treatment opportunity. If hospitals are not equipped with neurologic diagnosis exam tools, then it should be purchased to treat the patients. Running a daycare center for 31 years and taking care of a child with epilepsy myself, I personally experienced the traumatizing event. This is where the government should step in”, Lawmaker Choi added.
- Policy
- A transition of power? Xofluza landed in Korea
- by Lee, Tak-Sun Nov 26, 2019 07:12am
- Flu medicines, which have been greatly improved in convenience, have landed in Korea. It is Roche's Xofluza (Baloxavir marboxil). It is expected to see the effects of flu treatment with only a single dose. The oseltamivir formulations, represented by conventional Tamiflu, had to be taken for 5 days. With Tamiflu's patent expiration in 2017, the flu drug market has been restructured into a multi-competitive system. It is noteworthy whether Xofluza will regain Roche's glory. The Ministry of Food and Drug Safety approved the 20mg and 40mg of flu medicine, Xofluza by Roche, Korea. Xofluza is a single oral drug administered within 48 hours of symptom onset regardless of food intake. Conventional Roche's Tamiflu should be administered orally for 5 days regardless of adult or child. However, Xofluza can be taken only once after the onset of symptoms. Compared with Tamiflu, the time to symptom improvement was not significantly different, with 73 hours for Xofluza and 81 hours for Tamiflu. Currently, there is a single dose of flu treatment called Peramiflu by GC green cross, but it is intravenous injection type, different from oral preparations such as Tamiflu and Xofluza. However, it is unlikely to replace Tamiflu completely because it is not approved by children. Xofluza is used to treat influenza type A or B virus infections in adults and adolescents 12 years of age and older. The FDA approved the drug in last October and obtained a domestic license in one year.
- Policy
- How much does new drug's R&D Investment cost?
- by Lee, Hye-Kyung Nov 26, 2019 07:11am
- The Organization for Economic Cooperation and Development (OECD) has presented monitoring of project activities to countries as part of future projects. Recent data suggests that a successful R & D cost estimate ranges from at least $ millions to $ 2.6 billion. Dahee Lee, a senior researcher at the Health Insurance Review and Assessment Service, suggested improvement plan about calculating OECD’s drug and medical expenditure information through 'HIRA policy trends'. In Korea, employees of the HIRA are attending the OECD Drug and Medical Device Experts' Group meeting. Dahee Lee, a senior researcher has made an opinion on behalf of Korea at the second meeting held in May. At this meeting, the OECD has published a number of reports that provide estimates of the size of the pharmaceutical market and corporate profits, but it is difficult to assess reliability because the data sources and methodologies are not clear. In particular, as the controversy arises due to the lack of reliable data for the profitability of the pharmaceutical industry, the OECD Secretariat suggests that it is necessary to determine the source of data for a simple index list and to develop an analysis framework and select indicators. For the Performance-Based Managed Entry Agreements, which were discussed at the first group meeting of experts in March 2018, the OECD has carried out the survey of 11 countries including the United Kingdom, Australia, Belgium, Czech Republic, Estonia, Japan, Lithuania, the Netherlands, Norway, Sweden, and the United States. Comprehensive examples of MEAs in six countries responded and found that they are implementing MEA contracts for 24 drugs The OECD has discussed the related management and access to anticancer drugs with some member countries, and 6 key tasks were introduced: key issues including ▲up-front costs, ▲economics and financial sustainability, ▲uncertainties in clinical benefits, cost effectiveness and budgetary impacts, ▲ treatment location, ▲imbalance in access, and ▲patient expectations. At the meeting, the representative of WHO Geneva gave a presentation on the pricing of anticancer drugs, insisting that "drug selection should be directed towards increasing efficiency in drug expenditure and opening and adjusting mutual drug prices to promote transparency". The OECD will finalize its report on anticancer drug management and access by the end of this year. The senior researcher Lee said, "The OECD Secretariat introduced an overview of the challenges raised in access to anticancer drugs and shared procedures and future schedules for solving them" and the senior researcher added, “Anticancer drugs may cause inequality in access because coverage and accessibility vary depending on the level of country, region and institution”. Therefore, Korea needs to cooperate in the process of analyzing how the OECD's health system responds to the challenging task. Lee said, “OECD will carry out the investigation necessary to establish a policy regarding rational use of medicines this year.” The Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, and the Ministry of Food and Drug Safety are expected to actively participate in the policy to encourage the use of medicines and to investigate ways to reduce the prescription of multi-items for the elderly.
- Policy
- HIRA, "price transparency of RSA was reduced"
- by Lee, Hye-Kyung Nov 25, 2019 06:23pm
- The National Health Insurance Service (NHIS) plans to make reasonable efforts to implement the risk sharing agreement (RSA) in consideration of patient treatment access and insurance finance. The NHIS responded to Insoon Nam, a member of the National Assembly at a national audit about the plan to rationalize pharmaceutical expenditures, including high-priced drugs. According to a written response on the 23rd, the National Health Insurance Service said, “It is true that there is concern RSA will reduce price transparency and increase administrative burden”. Although it has helped to increase access to treatments such as expensive anticancer drugs and reduce the burden on patients, there are also concerns. The NHIS said, "The government continues to make improvements to the RSA, but there is a demand for improvement in the scope of application or operation method." Regarding the introduction of a Fixed Budgeting Policy for Pharmaceuticals , which is raised only when the pharmaceutical expenditure-efficiency story comes out, the NHIS said, "we haven't specifically reviewed it.“ In the past, during the Park Geun-hye administration, the NHIS was suspected of introducing a Fixed Budgeting Policy for Pharmaceuticals to reduce the share of drug costs to the OECD level. The NHIS conducted the research service, but did not examine the introduction of the system in detail. When the system is introduced, we will fully share the results of the research service with stakeholders such as the pharmaceutical industry and collect opinions and consult with MOHW. For the management of ultra-high-priced drugs such as immunocancer treatments, only the drugs that have proven effective treatment and cost-effectiveness are covered by careful consideration of the expansion of reimbursement and financial management. The NHIS in consultation with related agencies such as the MOHW, is preparing a follow-up management plan to verify the treatment effect and cost-effectiveness after registration. The NHIS said, “We are preparing a cost-effectiveness evaluation plan, and will review post evaluation targets, methodologies, and institutional roles”. In order to improve price-volume agreement(PVA) negotiation system, some respondents said that they would consult with experts and the Ministry of Welfare to expand the targets in the future by improving the selection and exclusion criteria maintenance. The NHIS said, "The target of PVA negotiation is lower than the usage monitoring, so the selection rate of the negotiation target is only 0.2%, and the improvement of the system by selecting targets and improving exclusion criteria is needed". On the other hand, regarding 'Korea Passing', which has been an issue since last year, they said they would consider both insurance finance and patient access when negotiating drug prices so that the treatment access of medicines needed for future medical care is not reduced. The NHIS said, "Our country is showing a high proportion of drug costs for various reasons, such as the rapid increase in the elderly population, changes in disease structure, the emergence of high-priced drugs such as immunocancer drugs and biological drugs, the frequency of use of medical services, and cultural characteristics related to prescriptions. “by designing the reasonable expense structure, we will lower the share of pharmaceitical expenditure to the OECD level”.
- Policy
- Surprise order by MFDS for all substance impurity risk test
- by Lee, Tak-Sun Nov 25, 2019 06:21am
- The Korean pharmaceutical industry is shook up as Ministry of Food and Drug Safety ordered companies to conduct tests on impurity contamination in all synthetic active pharmaceutical agents. Other foreign health authorities like European Medicines Agency (EMA) has released a new templates of carcinogen risk evaluation and confirmatory testing for pharmaceutical manufacturers fill in. But the Korean regulator caught Korean pharmaceutical companies by surprise. At the moment, unprepared companies are in a hurry to find a testing lab. After the decision has been made to ban sales on 13 nizatidine products found with cancer-causing compound N-Nitrosodimethylamine (NDMA), MFDS ordered Korean pharmaceutical company on Nov. 22 to conduct an impurity risk test on all of their active ingredients to reinforce drug substance safety control. Accordingly, active pharmaceutical ingredient manufacturing and importing companies, and complete product manufacturing and importing companies are to evaluate and test for impurity risk in active ingredients. The risk evaluation result should be reported to MFDS by May 2020, and complete test result by May 2021. Impurity risk evaluation comprehensively analyzes and evaluates possible risk of impurity contamination in active agents based on effect of substance manufacturing procedure, self-decomposition and complete product storage conditions. The tests should follow test procedure verified by a Korean Good Manufacturing Practice (GMP) certified manufacturer, MFDS designated quality test institute, or city and provincial-managed environment research lab, according to test methodology officially disclosed by either Korean or international regulators. And also companies with at least three product serial numbers in the market are required to take the tests. MFDS stated Korean whole drug manufacturer may substitute required test result with data from active agent manufacturing and importing companies, but the ministry pressured that the ultimate liability would be on the companies. The pharmaceutical industry clearly seemed perplexed with the news. A mid-sized pharmaceutical company frustrated with the government order and complained, “The ministry unilaterally released the news on the media without a proper notice. So we are at a loss. They say there is an impurity risk evaluation program, but we are not sure if it could actually test all active ingredients.” Many also complain about overall cost and required time for the test are unknown. A top pharmaceutical company insider commented, “If the required materials can be substitute with active ingredient manufacturer’s data, then more than a half of products are off the hook. But for smaller-scale substance manufacturing companies may not have evaluation material, so probably complete product manufacturing companies would have to take the bullet”. But testing for agents with risk of impurity contamination definitely puts a strain on the industry. MFDS has reportedly disseminated an official notice demanding companies to hand in nizatidine product test results by next year. “Apparently, there are only a handful of laboratories able to test drug substances. As many pharmaceutical companies would rush to get the test done, our company is also promptly looking for a testing facility”, an executive from a mid-sized company explained. Companies are concerned that testing price skyrocket from a normal rate of one million won per a case to few millions per a case. “Regulators in EU and Switzerland have recently decided to reinforce safety management by requiring companies to submit impurity risk evaluation and test results of synthetic drug agents. MFDS plans to continue tightening regulation for active pharmaceutical ingredient safety control”, said MFDS official.
- Policy
- NHIS, HIRA and NECA on joint reevaluation for listed drugs
- by Lee, Hye-Kyung Nov 24, 2019 09:58pm
- Drug Reimbursement Evaluation Committee (DREC) affiliated under Health Insurance Review and Assessment Service (HIRA) is to conduct reevaluation on already-listed high-cost drug items. When forming the seventh DREC, HIRA also established a ‘Post-marketing Drug Evaluation Subcommittee’ to be in charge of selecting insurance listed drug items or classes that need reevaluation. Initially, the subcommittee was to consist of four DREC members, two government officials and two experts, but HIRA finalized on three government officials, one clinical expert, two consumer and patient group representatives, and one external expert from DREC human resource pool. As a result, a chief of Pharmaceutical Management Department at HIRA Park Young-mi, a chief of Health Benefit Strategy Office at National Health Insurance Service (NHIS) Park Jong Heon, and a chief of Economic Evaluation Research Office at National Evidence-based Healthcare Collaborating Agency (NECA) Shin Sang Jin are to represent government bodies. The three government agencies have been running various researches related to post-management of already-listed drug items since last year. Professor Lee Dae-ho at Seoul Asan Medical Center, as recommended by Korean Academy of Medical Sciences, president of Korea Health Personnel Licensing Examination Institute Lee Yoon-seong and an executive director of Korea Alliance of Patients Organization Lee Eun-young, as recommended by consumer and patient groups, are selected to serve as members of the subcommittee. At the latest annual audit by National Assembly Health and Welfare Committee, HIRA answered Lawmaker Kim Myung-yeon’s question on ‘monitoring reimbursement feasibility of drugs with significant financial impact on National Health Insurance’, and stated “HIRA plans to have DREC to deliberate and compile a list of reevaluation subject items, and conduct reimbursement feasibility reevaluation on them”. After the Ministry of Health and Welfare (MOHW) unveiled the first National Health Insurance Comprehensive Plan, HIRA has been compiling reimbursement feasibility monitoring plan for drugs granted with the insurance reimbursement. “The subcommittee would consider clinical efficacy, financial impact, and external reimbursement listing reference of the reimbursed items. HIRA would consult with other government agencies and report reevaluation plan for more efficient management of National Health Insurance expenditure in the future”, HIRA official commented.
- Policy
- Background of reimbursement standards enhancement of Avodart
- by Lee, Hye-Kyung Nov 24, 2019 09:57pm
- Starting this month, the 5α-reductase inhibitors (5ARI), reimburesement standards of Pinagren tablets 5mg (Finasteride) and Avodart 0.5mg (Dutasteride), which are used to treat prostate enlargement and hair loss, will be strengthened. The Ministry of Health and Welfare has decided to reimbursement benefits when it is administered to 'positive prostate hyperplasia' among the permission of Pinagren and Avodart if both conditions are met. The conditions are as follows: ▲ more than 8 points of IPSS (International Prostate Symptom Score) ▲ Prostate size more than 30ml by ultrasound test or, if the rectal balance test showed moderate or more benign prostatic hyperplasia or serum seroprostate-specific antigen (PSA) levels exceeded 1.4ng/ml. In this regard, the Health Insurance Review and Assessment Service released a question and answer on the establishment of 5ARI reimbursement standards on the 5th and explained the background of strengthening the reimbursement standards of the two drugs. HIRA concluded that there is room to interfere with the correct interpretation of serum PSA level when serum PSA levels were decreased and used for early diagnosis of prostate cancer through taking 5ARI in the process of reviewing textbooks, clinical guidelines, and related opinions from the Korean Academy of Societies. The clinical literature also showed an increased probability of detecting high-risk prostate cancer in the 5ARI-treated patients, and HIRA said it has established a 5ARI reimbursement standards in consultation with relevant societies and associations to encourage the safe use of 5ARI. In addition, HIRA expected that problems such as decreased serum PSA levels and early diagnosis of prostate cancer related to 5ARI administration would be the same when administered for the purpose of treating male hair loss. HIRA explained that it is desirable to consult in a medical association or society considering that these male hair loss medicines are non reimbursement. The new reimbursement criterion 'must meet both conditions' means the condition at the start of 5ARI administration to benign prostatic hyperplasia. This condition was set in consideration of the clinical guidelines for benign prostatic hyperplasia published by a large group of experts (EAU, AUA, NICE, and Korean Urology Association). Excluded country guidelines suggest that the target of 5ARI administration are patients with a prostate size of 30-40ml or more. The related society suggested that 'more than 25-30 g of large prostate size' could be defined as 'more than moderate benign prostatic hyperplasia' There was also a description of the reimbursement condition that, during the administration of Pinagren and Avodart with both of the conditions, the PSA test should be performed at least once every 12 months to evaluate and record the value. HIRA said, "Because benign prostatic hyperplasia is common in men over 40 years old, When diagnosed with benign prostatic hyperplasia at this age, the experts’ opionion that regular assessment of the patient's condition through PSA testing is essential for early diagnosis of prostate cancer was reflected. However, the purpose of 5ARI treatment is to reduce prostate size and lower urinary tract symptom. Decreased serum PSA levels do not serve the purpose of treating benign prostatic hyperplasia, and sustained administration of 5ARI is possible even if PSA levels decrease during 5ARI administration. HIRA said, “In order to respect the autonomy of medical care, the inspection was made as a recommendation, not as a mandatory recommendation.” Patients who were diagnosed with benign prostatic hyperplasia prior to the establishment of the reimbursement standard and who received 5ARI may continue to receive the reimbursement even if they do not meet the two conditions. In the guidelines related to benign prostatic hyperplasia, Pinagren and Avodart are classified as 5ARI without classification according to the ingredients, and the same contents are mentioned. Both ingredients are considered reimbursement if they meet the conditions at the beginning of the administration under the reimbursement standard and alternative administration is possible.
- Policy
- IMD of Januvia approved, launching scheduled for Sep 2023
- by Lee, Tak-Sun Nov 22, 2019 06:32am
- The salt-modifying drug of Janivia (Sitagliptin Phosphate Hydrate, MSD Korea), which has a high share in the diabetes treatment market as a DPP-4 inhibitor was approved for the first time. This is Januritin alpha 100mg in Daewon pharmaceuticals. MFDS approved the marketing of Januritin alpha on the 19th as drug requiring the safety/efficacy review data submission. Januvia is a big drug with an outpatient prescription of ₩43.3 billion last year. In addition, Janumet, which combines Sitagliptin phosphate hydrate and Metformin hydrochloride, was the best out of diabetic medicine last year, with ₩ 69.4 billion in outpatient prescription sales. Of course, domestic latecomers are highly interested in entering the market. As a result of the development of late-release drugs, 149 cases of Sitagliptin drugs in domestic pharmaceutical companies were approved. The patent challenge also eliminated the patent for salts and hydrates in Januvia. At this time, 55 items that succeeded in patent challenge and first applied for permission obtained exclusivity for generics from Sep 2 2023 until June 1 2024, when the substance patent was terminated 'Januritin tablet 100mg', generic for Januvia and 'Januricombi', generic for Janumet in Daewon Pharmaceutical were also approved in Aug 2015, but did not obtain exclusivity for generics. However, with the initial approval of IMD, the company laid the foundation to enter the market even during the ban on exclusivity of generics. Januritin alpha in Daewon Pharmaceuticals is the first component of Sitagliptin hydrochloride in Korea. It is IMD(incrementally modified drug) synthesized from Januvia phosphate to hydrochloride. As long as there is no same ingredient, it is expected to be available for sale after Sept 2 2023, when the Zanubia material patent is terminated. Existing licensed products are 'Sitagliptin hydrochloride monohydrate with the same ingredients as Januvia or Sitagliptin hydrochloride '' without hydrates. A total of 55 items were approved for Sitagliptin hydrochloride. Attempts have been made to avoid material patents in Januvia. But in last September, patent tribunal dismissed the claim of a domestic pharmaceutical company. Domestic pharmaceutical companies tried to neutralize about 1 year extension to the substance patent as a salt-modified or hydrate-modified drug, but patent tribunal did not accept it. In last January, the Supreme Court ruled that the salt-changing drug also falls within the scope of the extended patent for substance. If the material patent challenge was successful, the launch of the late drug could be after July 5 2022. Currently, however, the patent is blocked, so the late-release drug of Januvia will have to wait another four years. It is the woe of a late comer.
- Policy
- NHIS collected 440 million won for valsartan indemnity
- by Lee, Hye-Kyung Nov 21, 2019 11:40pm
- Only 21.5 percent of pharmaceutical companies have paid the charged indemnity on valsartan damage. Report on ‘Valsartan related Indemnity Claim and Collection Status’ provided by National Health Insurance Service (NHIS) to Democratic Party Lawmaker Nam In-Soon stated the government agency has charged 69 pharmaceutical companies 2.03 billion won as indemnity for additional National Health Insurance expenditure made. However, only 26 out of 69 of them, or 21.5 percent, have paid 436 million won to the government. NHIS announced it spent about 2.03 billion won the agency was not liable for, due to the drug exchange order on already dispensed valsartan medicines last year. The amount consists of 964 million won for diagnosing 109,967 patients, and 1.07 billion won for dispensing other option of treatment to 133,947 patients. Accordingly, the agency charged indemnity for the additional expenditure against 69 pharmaceutical companies on Sept. 25. The first payment deadline was on Oct. 10, but the initial collection rate reached about 4.8 percent. After the second deadline on Oct. 31, total of 26 pharmaceutical companies paid 21.5 percent of the charged indemnity. “Based on external legal consulting, pharmaceutical manufacturers had a fault in safety of manufactured products. On the grounds of product defect as stated in the Product Liability Act, the government claiming for damages was confirmed legitimate. The agency is considering on filing a litigation case worth 1.59 billion won against 43 companies for the unpaid indemnity payment”, NHIS official explained. Meanwhile, pharmaceutical companies with the unpaid due are reportedly considering on taking a joint legal action or litigation to prove absence of legal liability, when NHIS files for damage suit.
