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- 2026-05-09 18:06:56
- 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.
- Policy
- Dupixent, reimbursement in next January upon settlement
- by Lee, Hye-Kyung Nov 20, 2019 06:33am
- Treatment for severe atopic dermatitis, Dupixent are under drug price negociations. NHIS(National Health Insurance Services) recently released this fact on its website. NHIS concluded pre-negotiation with Sanofia aventis before entering into drug price negotiations. Drug negotiations will last up to 60 days. If the drug price negotiations between the NHIS and pharmaceutical companies proceed smoothly, the reimbursement is expected to be secured in next January. Dupixent passed the HIRA's Pharmaceutical Evaluation Committee on October 11th. After negotiating a drug price agreement with the HIRA, it is necessary to put a name on the final list of reimbursement after deliberation by the MOHW Insurance Policy Review Committee. Dupixent will follow the RSA process as a treatment for serious diseases through ‘the detailed evaluation criteria of new drugs’ in August. Once the price negotiations are concluded, they will be the first beneficiaries of the expansion of RSA. The existing RSA system was only applicable to drugs for cancer and rare patients. However, due to its high price, Dupixent was also a target of RSA in that there were some broken cases when there is too much finance.
- Policy
- All prescription drugs to hand in bioequivalence test result
- by Lee, Tak-Sun Nov 20, 2019 06:33am
- Subject for bioequivalence test is to expand out to all prescription drugs. Also, drug specification with test criteria and procedure would be required, as well as Good Manufacturing Practice (GMP) evaluation result from external contract manufacturing companies. Korean Ministry of Food and Drug Safety (MFDS) announced on Nov. 18 its plan to enact partially revised ‘Regulation on Pharmaceutical Safety’, as a follow-up to the excessive commercialization of generics and last year’s valsartan incident with carcinogen contamination. The ministry is to accept public opinion on the matter until Jan. 20, 2020. For Korean pharmaceutical industry that bases most of business off of generic products, the revised regulation is the most detrimental level of regulation to hinder the industry. Some of regulations were previously alleviated on a moderate level, but they are now tightened back again. ◆ Bioequivalence test for all prescription drugs: First, all prescription drugs are to be gradually obligated to hand in bioequivalence test data. Currently only prescribed tablet, capsule, suppository and other specific drugs designated to provide bioequivalence test result were required to submit the material. About 60 percent of prescription drugs are included in the said subject group. But from now on, the applicable drug regimen types would expand out to all kinds. The administration method types required to provide bioequivalence test material would expand on oral in 2020, aseptic techniques including injection in 2021, and all the other types in 2022. Based on its cost-benefit analysis, MFDS projects affected pharmaceutical companies would spend about 164.4 billion won according to the revised regulation. The analysis estimated a single case of bioequivalence test would cost about 220 million won. ◆ Specification submission exemption removed: All prescription drugs would be obligated to hand in specification material. Specification, containing pharmaceutical test procedures and acceptance criteria for new drug, is to provide information on the drug’s manufacturing and test methodology and criteria for quality control, which also includes evidence and test performance data. Except for biopharmaceuticals, currently a drug listed on an official compendium, such as Korean Pharmacopoeia, was exempted from the material submission. Some officially recognized compendium include Korean Pharmacopoeia, Korean Herbal Pharmacopoeia, Good Manufacturing Practice criteria, and other official compendium or pharmacopoeia acknowledged by Minister of Food and Drug Safety (i.e. U.S. Pharmacopeia, Japanese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, German Pharmacopoeia, and French Pharmacopoeia). However, there would be no exception from now on. As of 2017, 51 percent of prescription drugs applying for approval were listed on the official compendium. MFDS suspects additional cost would be spent on evaluation service fee, as companies would already have documented specification related materials. The industry is expected to spend about 3.2 billion won, due to the revised regulation. ◆ CMOs to hand in GMP evaluation results: Besides the bioequivalence test, MFDS is also requiring contract manufacturing organizations (CMOs) to submit GMP status report and evaluation results. At the moment, the submission is exempted for drugs wholly manufactured in contracted manufacturer. GMP status report and evaluation result should include manufacturing plant floor plan, plant facility and environment management information, GMP-dedicated organization chart and related documentation rules, product specification related to applicant item, record of product and quality control, and copy of validation result. MFDS analyzed that annually 738 items are manufactured by CMOs. The ministry deduced the average number based on approved CMO products from 2012 to 2017, assuming items sharing joint bioequivalence test result are entirely manufactured in external facility. The health authority estimated the revised regulation would have companies to spend about total of 3.7 billion won. MFDS also clarified no additional documentation on GMP evaluation is required other than the materials filed by the client company, but explained additional cost would be probably spent on human resources and evaluation service fee.
