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- 2025-12-25 17:28:52
- Policy
- NA urges for more COVID-19 vaccine, MOHW to take a survey
- by Lee, Jeong-Hwan Nov 27, 2020 06:29am
- The National Assembly Health and Welfare Committee pressured the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) to focus their capacity to seek access to investigational COVID-19 vaccines around the world. Also they ordered the South Korean government to extinguish the people’s concerns about the vaccines by proactively disclosing the corporate collaboration and contract information with a developer. MOHW then answered the ministry would put more efforts to get access to COVID-19 vaccine, while it would survey the people’s perception on the immunization. On Nov. 26, the National Assembly Health and Welfare Committee convened a general meeting and deliberated the bills the first and second Bill Examination Committees reviewed with questions to the government officials. People Power Party Lawmaker Kang Giyun pointed out the MOHW’s next year budget plan does not include the COVID-19 vaccine procuring cost. The lawmaker also reprimanded the ruling party’s responsibility as the Budget and Accounting Evaluation Subcommittee allocated 965 billion won for procuring the vaccines, but the Health and Welfare Committee did not pass it. Moreover, Lawmaker Kang raised an issue on the government signing the contract with AstraZeneca with 70-percent effective vaccine, when Pfizer and Moderna are developing 94.5-percent and 90.0-percent effective vaccines, respectively. Also he criticized the government for neglecting to proactively announce the detail. Lawmaker Kang said he cannot agree with the MOHW’s policy to generate herd immunity by procuring 30 million doses, which would cover 60 percent of the people nationwide, and advised the Ministries to focus on getting access to over 50 million doses for the people. Lawmaker Kang urged, “I cannot comprehend the reason why the government would sign a deal with AstraZeneca, when its vaccine is less effective than Pfizer’s and Moderna’s. The news of locally manufacturing the vaccine should have come from a ministry’s official channel, and not from a news media. Inexpensive price is important, but the vaccine quality and efficacy are more crucial. And I do not believe securing the vaccines for only 60 percent of the population would get us to reach herd immunity. Please get access to enough vaccines.” MOHW agreed with the lawmaker’s criticism about the government should put more effort, and answered it would seek access to vaccines with the efficacy and safety as much as possible. But also the ministry said it would soon conduct a nationwide survey to grasp the people’s perception on the COIVD-19 immunization and to fathom the reasonable doses of vaccines to procure. Minister Park Neung-hoo of Health and Welfare explained, “We have contacted all companies actually capable of manufacturing COVID-19 vaccine, and we are currently negotiating terms and conditions with more than five companies. The deal would be sealed by the end of this year or early next year. The 70 percent effectiveness of AstraZeneca’s vaccine is an average from two testing groups, and as far as I understand the company is manufacturing the 90-percent effective vaccine.” The minister added, “AstraZeneca had an advantage in talking about the procurement contract, as the company manufactures significant amount in South Korea. We would also get access to stable amount of vaccines from Pfizer and Moderna. Stocking too many doses of vaccine causes an issue of disposing unused ones. Although we plan to take the responsibility until the end, we also plan to conduct a thorough survey on the national immunization.” With the third wave of COVID-19 cases in South Korea, with over 500 testing positive in a day, the lawmakers urged the government to approve of using a COVID-19 self-testing kit for the people to test the infection in the comfort of their home. The government officials pleaded for the lawmakers’ understanding by explaining the current legal complications within the medical scene, where either a doctor or nurse has to take the sample for the testing. People Power Party Lawmaker Kim Miae demanded the government officials to answer “why South Korea cannot use the self testing kit, when they can be used in the U.S. with approval by the Food and Drug Administration (FDA).” Democratic Party Lawmaker Shin Hyunyoung also ordered, “Raising the quarantine level higher due to the third wave of COVID-19 frustrates the people. It would be difficult to provide it for all the people, but the government should consider expanding the use of rapid antigen testing kit in places with high risk of community infection, such as hospitals and army bases.” Minister Park answered, “In South Korea, the regulation on rapid testing kit defines the sampling of testing specimen as a medical practice. Any healthcare institute with a doctor or nurse can test a subject, but self-testing by an individual is difficult at the moment.” The minister added, “Even in the U.S., children aged younger than 14 are regulated to must have a healthcare provider to sample the test specimen. In Korea, the regulation allows the primary healthcare institutes to test COVID-19 infection, swiftly.” Minister Kim Gang-lip also elaborated, “The two testing kits with the market approval are all for medical professionals only. The antigen testing kits require the testing specimen to be collected from deep inside of a nasal cavity with a tool. Also the antibody testing kit requires blood to be drawn. So providing access to self-testing kit would be unlikely.” The minister noted, “When a convenient self-testing kit product applies for the market approval, the ministry would review it based on safety and usability. The FDA-approved self-testing kit also needs a doctor’s prescription. Basically, only the specimen sampling can be done at home, after the doctor prescribes the testing kit.”
- Policy
- A second survey of expenditure reports was initiated
- by Lee, chang-jin Nov 27, 2020 06:26am
- A second survey of expenditure reports was initiated that documented the economic benefits that health authorities legally provided to medical personnel. The related industry is straining as meticulous inspections are expected to be carried out in order to strengthen the management of expenditure reports such as indirect rebates pointed out in the state audit. According to the results of the Medical Times interview on the 27th, it was confirmed that the MOHW recently sent an official letter to pharmaceutical companies and medical device companies to submit expenditure reports. The MOHW was initially scheduled to conduct a second survey in the first half of this year, but has delayed the timing of the survey to reflect the industry difficulties arising from COVID-19 incident. The subjects of this survey are pharmaceutical companies and medical device companies, excluding companies that submitted data in the first survey at the end of last year. The first and second survey target companies total 37 domestic and multinational companies. The submission period is about one month, and the company that received the official letter must submit a one-year expenditure report from January to December 2019 to the MOHW in November. Expenditure reports include providing samples, support for academic conferences, support for clinical trials, medical instituitons product presentations, post-marketing investigations, cost discounts (pharmacy), and other economic benefits, and CSO (sales agency) and CRO (clinical trials entrusted by the company) Institutions) Expenditures are included. The list of related medical professionals, pharmacists, conferences, medical instituitons, etc. who received economic benefits from the company should also be specified. The MOHW is known to receive expenditure reports from large companies such as Yuhan, Daewoong Bio, Korea Abbott, and Chong Kun Dang in the first survey and are in the process of checking. The MOHW is pursuing follow-up measures such as the expenditure report management plan pointed out at this year's national audit. Young-in Ko, a member of Democratic Party of Korea based on Abbott's expenditure reports, raised suspicion of indirect rebates, such as excessive academic support from certain academic societies, at the state audit, and Minister Park Neung-hoo promised strict management of expenditure reports. The MOHW said in a written response, "The MOWH agrees with the point that the expenditure reporting system should be operated according to the purpose of introduction to eradicate illegal rebates." Also the MOWH replied, "We will review measures for improvement such as strengthening sanctions when the expenditure report is not prepared so as to increase the effectiveness of the system" The MOHW also said, "We don't think it will be easy to eradicate new rebates as they are done in a more secret and subtle way. We will closely grasp the status of the pharmaceutical field and prepare a plan for improving the expense report system and managing the sales agency (CSO) by collecting expert opinions." The pharmaceutical and medical device industries are paying close attention to the situation in which the expenditure reporting system introduced to promote transparent economic benefits may turn into an illegal rebate crime schedule.
- Policy
- Contracts with modified indications are not terminated
- by Lee, Hye-Kyung Nov 26, 2020 08:58am
- The NHIS said that in the case of drugs that benefit from the RSA drug price negotiations, it cannot unilaterally terminate the existing contract to change the main indication. Based on the provisions of the NHIS on October 8th, the 'Detailed Operation Guidelines for Risk-Sharing Drug Price Negotiations', the contract cannot be terminated if the HIRA recognizes cost effectiveness when the benefits are expanded in the pharmaceutical industry. Nam-seon Choi is explaining the revision of the risk-sharing drug price negotiation guidelines The NHIS held ‘RSA drug price negotiation system and follow-up management online briefing' for more than 100 pharmaceutical companies from 2pm on the 25th. According to the revised guidelines, after the evaluation of the Pharmaceutical Benefits Advisory Committee, the NHIS and the company negotiate the contents of the risk-sharing contract (excluding the risk-sharing contract period) such as the upper limit amount, refund rate, and cap of the drug. In this regard, an official of Pharmaceutical Company A said, "If a drug that has been exempted from Profitability Evaluation with an Expenditure Cap passes the Pharmaceutical Benefits Advisory Committee after proving the cost-effectiveness of an indication other than the existing indication in the process of expanding benefits in the future, will the existing contract be terminated?" For example, the question is whether the existing contract should be maintained even if the scope of benefits expands due to a different area or age change, etc., in which indications and additional indications are exempted from Profitability Evaluation. Nam-seon Choi, head of the NHIS' drug price negotiations, said, "The part where the scope of benefits is expanded by proving cost effectiveness is a form of resetting the cap within the existing contract period, so the existing contract cannot be canceled." Choi said,"At the end of the Expenditure Cap contract, the Pharmaceutical Benefits Advisory Committee evaluation determines whether to maintain or terminate the contract." He added, "There was no real case like this, but if it comes out, we will review it in the negotiations, but we are not thinking about the termination of the existing contract when the scope of benefits is expanded."
- Policy
- RSA's collateral period was reduced by 3 months
- by Lee, Hye-Kyung Nov 26, 2020 08:38am
- The amount of collateral that pharmaceutical companies have to pay when signing an RSA drug is expected to decrease by 25%. According to the 'Detailed Operation Guidelines for Drug Price Negotiation of the Risk Sharing Agreement' revised by The NHIS on October 8, the period of collateral has been changed from 12 months to 9 months. This is because if the actual formula is substituted, the amount of collateral will decrease. The NHIS held a 'RSA drug price negotiation system and follow-up management online briefing' for about 100 pharmaceutical companies from 2 pm on the 25th. "Pharmaceutical companies have made a lot of requests to reduce the amount of collateral that is collectively entered at first," said Oh Se-rim, a team leader in the NHIS Drug Price Negotiation Department, who was in charge of announcing the revised matters. Following that, Team leader Oh said, "It has been shown that the amount of collateral is arithmetically reduced by 25% by reducing the amount of collateral by three months from 12 months to 9 months." In the case of the Refund type, as the amount of collateral is reduced, it becomes 'estimated billing amount (maximum) x refund rate x 130%' to 'estimated billing amount (actual) x refund rate/1-refund rate x 9/12 x 130%'. The reason that the estimated billing amount has changed from the upper limit (indicated price) to the actual price is that, while revising the guidelines, the 'actual fiscal impact criterion' was set in consideration of the refund of the estimated billing amount. Based on the revised guidelines, if the amount of the collateral is calculated assuming a drug with a labeling price of ₩10,000, an actual price of ₩80,000, a refund rate of 20%, and an estimated billing volume of 1 million vials, it was previously '10 billion won (maximum amount) × 20% (refund rate) × It had to pay ₩2.6 billion as '130%', but '₩8 billion (actual) x 20%/(1-20%) (1-refund rate) x 9/12 x 130%' is applied as a change between collateral. If so, it will reduce ₩650 million to ₩1.95 billion. Team leader Oh explained, "The initial guideline was released and there was no change in the formula that was not in the refund rate part, but it was corrected by changing it to the actual price minus the refund rate. There was a reduction in the amount of about 25%." Since its introduction in 2014, RSA has signed a total of 48 drugs and 85 items as of October 30. By type, there are 13 Refund types (26 items), 18 Expenditure Cap types (29 items), 1 Refund type for initial treatment (2 items), and 3 Utilization Cap/Fixed Cost per Patient type (6 items), other type (1 item), and a combination of 12 items (21 items). Expenditure Cap Change = According to the guidelines changed by The NHIS, the Expenditure Cap was changed from 130% to 100% of the estimated billing amount when negotiating the Article 6 risk sharing proposal. At the time this guideline was published, the pharmaceutical industry was most opposed to it. The team leader said, "The omission of Profitability Evaluation changed the total amount based on financial impact." The team leader said, "There is a lot of worries in the pharmaceutical industry. As a result of analyzing Expenditure Cap-type drugs, most of them have reached the 100% standard. It will not have a big impact as expected." In addition, the standard of the estimated billing amount was changed from the upper limit to the actual price. Depending on the nature of the drug, it is possible to set the estimated billing amount based on the upper limit amount, and when monitoring the Price-Volume (PV), they can specify whether the refund amount is included in the agreement. Nam-seon Choi, Director of Drug Price Negotiations, said, "If we assume that an estimated billing amount of ₩20 billion and a refund of ₩5 billion, whether for initial treatment Refund or Utilization Cap/Fixed Cost per Patient, we will set ₩15 billion as the estimated billing amount." "Pharmaceutical companies can decide whether to set it based on the actual fiscal impact excluding the amount of refund or the details of the claim.“ Nam-seon Choi is explaining the amendment to the RSA drug price negotiation guidelines However, in principle, it is only stated in the guidelines that it is based on the actual price. "In the past, only one type was applied," said Choi, "a part that changed as the guidelines were revised and various types were mixed and the standard for the total amount was set together." He explained, "The principle is based on the actual price, but if the actual price cannot be made according to various types, it can be discussed in the negotiation and entered in the agreement." Expenditure Cap contract obligation for phase III conditionally licensed drugs = As risk-sharing targets expanded in this guideline, conditional drugs in phase III clinical trial were also included. This drug will sign an Expenditure Cap contract, and team leader Oh interpreted, "For these drugs, it is not easy to submit profitability evaluation data, but the possibility of benefit registration may have increased" However, the definition of conditional drugs in phase III was specified in accordance with the 'Examination Regulations for Declaration of Product Permission for Drugs', and limited to drugs that were approved by submission of data for phase II and approved under the conditions of clinical data for phase III. Team leader Oh said, "The drugs that have only partially submitted data on conditional drugs in clinical III or whose overall survival rate (OS) is released after approval are not considered conditional, but only drugs according to the review regulations." Expiration of contract term = One of the biggest changes from the revision of this guideline in The NHIS is the treatment method after the RSA contract term expires. In the past, before the expiration of the RSA contract period (4+1 years), the NHIS requested the evaluation of the risk-sharing system of existing RSA drugs in the Pharmaceutical Benefits Advisory Committee of the HIRA However, only the changed guidelines do not allow the Pharmaceutical Benefits Advisory Committee to determine whether or not to be eligible for a risk-sharing system. The clinical usefulness and cost-effectiveness of drugs near the expiration of the RSA contract will be evaluated. And the NHIS will be able to re-contract or terminate the contract by negotiating risk-sharing plans such as the upper limit amount of the drug, the estimated billing amount and the refund rate, and the cap based on the result. The NHIS, the parties to the contract, will have the overall risk-sharing contract. “In the past, the Pharmaceutical Benefits Advisory Committee evaluated whether or not to be eligible for RSA, and the contract was terminated because it was difficult to evaluate most of the risk-sharing when alternative drugs came in.” He added, "In the future, we will see the clinical utility and cost-effectiveness of RSA drugs, rather than evaluating whether the HIRA is subject to risk sharing." It means that if an alternative drug comes in or other issues arise, it will decide whether to continue the contract based on the cost-effective aspect. Team Leader Oh said, “The Leader decides whether to re-contract or negotiate based on the evaluation results of the HIRA, and continues the contract considering the upper limit amount, estimated billing amount, and refund rate in consideration of changes in the clinical environment over the past 4 to 5 years. We will discuss whether or not with a pharmaceutical company."
- Policy
- ₩965 billion for COVID-19 vaccine should be reflected
- by Lee, Jeong-Hwan Nov 26, 2020 06:03am
- People Power Party Rep. Kang Ki-yoon, urged the Democratic Party of Korea and the government to reflect the cost of COVID-19 vaccine in next year's budget so that the nation can get COVID-19 vaccine. Earlier, a bill containing COVID-19 vaccine budget of ₩965 billion was voted in the Budget Adjustment Subcommittee of the Health and Welfare Committee, but the Democratic Party of Korea rejected the opinion by opposing the reduction in the cost of establishing a public medical school by ₩230 million, and the government draft proposed a special committee for budget settlement. It is a demand for follow-up measures. On the 24th, Kang Ki-yoon, a member of People Power Party said, "The Budget Adjustment Subcommittee of the Health and Welfare Committee, which includes COVID-19 national vaccination budget of ₩965 billion, which is not included in the government proposal, was canceled due to a reduction of ₩230 million in the cost for public medical schools in Namwon, Jeollabuk-do." He criticized that the Democratic Party of Korea and the government only insisted on reflecting the budget of the public medical school, so that the cost of purchasing COVID-19 vaccine was omitted. He argues that the government should not secure COVID-19 vaccine for 30 million people, which is 60% of the nation, but buy 51 million people. He said, "The Welfare Committee has agreed to reflect the national vaccination fee, but it is a pity that we cannot pass the general meeting of the Welfare Committee due to the controversy on the reduction of design cost for public medical schools." Also he said, "I urge the Democratic Party and the government to proactively cooperate and take action so that next year's government budget can be a budget to save people's health and lives by increasing the national vaccination fee again, even in the Special Committee on Budget & Accounts."
- Policy
- NSCLC treatment Vizimpro coverage effective from December
- by Lee, Hye-Kyung Nov 25, 2020 06:26am
- The healthcare reimbursement on Pfizer’s non-small cell lung cancer (NSCLC) treatment Vizimpro (dacomitinib) would be granted from Dec. 1. But the drug has to pass the Ministry of Health and Welfare (MOHW) Health Insurance Policy Deliberation Committee (HIPDC) on Nov. 27 to be fully approved. Prior to the HIPDC deliberation, the Health Insurance Review and Assessment Service (HIRA) is to accept the public opinion on the revised ‘Notice on Drugs Prescribed and Administered to Cancer Patients’ that contains the detail of establishing the reimbursement standard for Vizimpro. In last February, Vizimpro was approved for the South Korean market as a first-line treatment for patients with locally advanced or metastatic NSCLCL with epidermal growth factor receptor (EGFR) exon 19 deletion or L858R substitution on exon 21. After reviewing textbooks, guidelines and clinical literatures to set reimbursement standard on the initial administration for NSCLCL, HIRA found a textbook mentioning Vizimpro as a new drug categorized as second generation Tyrosine kinase inhibitor (TKI). And the National Comprehensive Cancer Network (NCCN) guideline recommends the drug as 'category 1’ for treatment patients with sensitizing EGFR-positive advanced, metastatic NSCLC, when the European Society for Medical Oncology (ESMO) recommends it as I and B, and the Pan-Asian ESMO guideline as I and A. Apparently, a randomized, open-label, Phase III clinical trial compared Vizimpro and Iressa (gefitinib) head-to-head with a group of patients with newly diagnosed stage IIIB/IV NSCLC along with exon 19 deletion or L858R substitution on exon 21. The trial found the each drug marked median overall survival (mOS) of 34.1 months vs. 26.8 months, median progression-free survival (mPFS) of 14.7 months vs. 9.2 months, and objective response rate (ORR) of 75 percent and 72 percent, respectively. HIRA official said, “The guideline currently recommends the applicant drug to the patient group with the EGFR-activating mutation, and other EGFR-TKI clinical trial did not find many of patients without 19 deletion or L858R substitution. The reimbursement standard was set considering the limited size of patients, who have an off-label EGFR-activating mutation.” Vizimpro has completed the pricing negotiation with the National Health Insurance Service (NHIS), after the Drug Reimbursement Evaluation Committee (DREC) green lit the reimbursement on Nov. 12.
- Policy
- The duration of administration of Maviret was reduced
- by Kim, Jung-Ju Nov 25, 2020 06:24am
- A plan to reduce the dosing period of Maviret (Glecaprevir/Pibrentasvir), a chronic hepatitis C virus treatment in Korea, from 12 weeks to 8 weeks in patients with chronic hepatitis 3 C infection in adults with targeted cirrhosis. Is promoted. Sumatriptan succinate, such as Myungin's migraine treatment Sumatran, doubles the daily reimbursed dose. The MOHW announced an administrative notice on the 23rd with the aim of implementing a partial amendment notice of the'Pharmaceutical Reimbursement Listing Standard and Method' on December 1st. First, the duration of some administration of AbbVie's Maviret is shortened. The government and the HIRA will change the dosing period of targeted liver cirrhosis from 12 weeks to 8 weeks among adult chronic hepatitis 3 hepatitis C patients who have no previous treatment experience, referring to clinical practice guidelines and expert opinions regarding the change of food and drug approval. The daily dose of Sumatriptan succinate oral medications such as Myungin's Sumatran, among migraines treatment, is doubled from 100 mg to 200 mg. The benefit of off-label use of Janssen Korea's adult Crohn's disease treatment Remicade (Infliximab), which has recognized the benefit even with off-label use, is not recognized. The MOHW is scheduled to register'Remsima PFS', which is licensed for Crohn's disease, ankylosing spondylitis, ulcerative colitis, and rheumatoid arthritis, for adults only. Benefits are recognized when administered internally, but will be excluded from benefits that recognize off-label use. Valsartan, Atorvastatin calcium hydrate, and Anlodipine Besylate combined oral drugs, Daehan New Pharm, for hypertension are scheduled to be listed and added to the subject of the compound oral notification. In addition, Rivaroxaban formulations such as Bayer Korea's stroke treatment Xarelto 2.5mg will be revised to clearly show the description of multivascular coronary artery disease. In addition, the government decided to expand the benefits of administering related drugs to Rifampin-resistant/multi-drug-resistant tuberculosis patients in accordance with the recommendations of the WHO guidelines and the principles of drug composition, reflecting the revisions of the WHO guidelines for tuberculosis treatment last year. Zyvox (Linezolid) tablet type, 2 mg/ml injection type, Augmentin (Amoxicillin/Potassium clavulanate), Tienam injection (Cilastatin Sodium/ Imipenem Monohydrate), Meropen inj (Meropenem Hydrate), Finibax (Doripenem monohydrate) are the targets. In addition, the government reflected the revisions of the WHO guidelines last year regarding tuberculosis treatment, and exceeded the scope of the approval of Bedaquiline fumarate such as Sirturo100mg and Delamanid such as Deltyba. · We plan to expand the benefit if it is approved by the Korea Disease Control and Prevention Agency in advance for continuous administration. The MOHW will receive group or individual opinions by the 25th, and if there are no specific matters, the MOHW will be implemented as the original plan. The effective date is December 1st.
- Policy
- Full listed drug reevaluation subjects to be revealed soon
- by Kim, Jung-Ju Nov 24, 2020 09:04am
- The government plans to finalize and announce the list of second listed drug reimbursement feasibility evaluation (clinical reevaluation) and the first full-fledged reevaluation in next month. However, conducting the reevaluation using international reference pricing (IRP) would be physically impossible in a mean time, because of clashing opinions and standard and principle establishment requiring extra time to establish. As for the immunotherapy Keytruda, the Cancer Deliberation Committee is expected to talk about the drug this week as the Reimbursement Standard Expansion Council has failed to reach an agreement. On Nov. 18, the Ministry of Health and Welfare (MOHW) presented a series of insured drug policy plans centering pharmaceutical reimbursements, such as the progress on the pilot and full clinical reevaluation and the immunotherapy reimbursement expansion. First, the list of the first full reevaluation subject substances and drugs, following the pilot reevaluation on the cognitive function enhancer choline alfoscerate would be unveiled in December. While MOHW is currently reviewing the list of subjects, the ministry said the Post-marketing Evaluation Subcommittee and Drug Reimbursement Evaluation Committee would select and announce the final list of subjects for the full reevaluation. The full reevaluation would follow a guideline constructed based on the pilot reevaluation on choline alfoscerate. However, the government is likely to set different standards and principles on reevaluation with IRP as the stakeholders are deeply conflicted with the approach. Expecting the government to take more time on the reevaluation type, the IRP reevaluation would be unlikely to be included in the first list of full reevaluation. Moreover, the government official stated it could not reach a final decision on the cost sharing plan submitted by MSD Korea, although the ministry convened a meeting with the Reimbursement Standard Expansion Council on Nov. 17 to discuss about immunotherapy Keytruda. As the council demanded additional review, so the government would have to report the discussion progress to the Cancer Deliberation Committee at a meeting scheduled on Nov. 25. The government disclosed the weighted drug pricing benefit reevaluation standard and plan (for reevaluated drugs), compiled based on the ‘Standard and Regulation on the National Health Insurance Reimbursement’ and the’ Standard of Drug Decision and Adjustment.’ And regarding the plan, the government would hold a meeting with the pharmaceutical industry organization in the last week of the month to survey their opinions. The key part is the condition to extend the weighted pricing benefit, because MOHW plans to have the Drug Reimbursement Evaluation Committee to use the new conditions reflecting the collected opinions.
- Policy
- Why Daewoong Bio tests Gliatirin as a comparator
- by Lee, Tak-Sun Nov 24, 2020 09:03am
- Gliatamin (Daewoong Bio), the No. 1 sales item in the brain function improvement drug Choline alfoscerate, which is drawing attention as a re-evaluation issue, was newly approved for a bioequivalence test. This bioequivalence test, which is conducted on products with improved formulations, is attracting more attention due to the recent reevaluation and the case of a dispute over Chong Kun Dang's comparator in the past. The MFDS approved Daewoong Bio's bioequivalence test protocol for Gliatamin on the 18th. This bioequivalence test is a test for healthy adults to evaluate the bioequivalence of Gliatamin and Chongkundang Gliatirin. This bioequivalence test is interpreted as a procedure for Daewoong Bio to improve Gliatamin and obtain a permit. Gliatamin is an item directly manufactured by Daewoong Bio and is already on the list of approved bioequivalence tests. This is not a recent bioequivalence test for drug price maintenance. However, the reason why the approval of this bioequivalence test has received attention is that Choline alfoscerate has recently been attracting attention through reevaluation. In the first half of this year, benefits were re-evaluated only for use of dementia patients, and manufacturers/sellers and the MOHW are currently in lawsuits over the measures. In addition, the clinical re-evaluation has been decided and the clinical plan must be submitted by the 23rd of next month. Gliatamine is the product with the highest sales among Choline alfoscerate formulations. With a cumulative sales of ₩73.8 billion in the last three quarters based on UBIST, Chongkundang Gliatirin (₩63 billion billion) was beaten by about ₩10 billion, and ranked first. Because of the large sales of Gliatamine, which accounts for Daewoong Bio, the company is focusing very much on this re-evaluation. It is also a hot topic that Daewoong has been approved for a bioequivalence test using Chongkundang Gliatirin, which was not previously recognized as a comparator. Chongkundang Gliatirin is a product introduced by Italian pharmaceutical company Italfarmaco. In 2016, a domestic copyright company changed from Daewoong to Chong Kun Dang. At the time, Daewoong also conducted an administrative lawsuit with the MFDS, taking into question Chongkundang Gliatirin's qualification as a Comparator. Daewoong insisted that Gliatamin, the first-selling product, is a comparator. However, as Chongkundang Gliatirin was recognized as a comparator, the controversy ended. The bioequivalence test is drawing attention from the industry as Gliatamin uses Chongkundang Gliatirin as the first comparator. In the past, the two companies were hostile due to copyright issues, but recently, Choline alfoscerate's reevaluation has led to a crisis, showing that they are working together. It is known that the clinical reevaluation will also be conducted as a team.
- Policy
- The Health and Welfare Committee, postponed to 26th
- by Lee, Jeong-Hwan Nov 24, 2020 09:01am
- The Health and Welfare Committee of the National Assembly suffered a lapse of resolution of the budget for 2021 by the relevant government ministries on the afternoon of the 19th, and the subcommittee for legal review, which had been operating from this morning, also decided to suspend it without reopening. Ki-yoon Kang, a member of People Power Party, who served as chairman of subcommittee of the Health and Welfare Committee, decided to resume the bill review schedule at 9:30 am on the 26th. As planned, the subcommittee should have completed the review of a total of 35 major health bills, including the Medical Act, Pharmacist Act, and the Public Health Crisis Response Medical Products Special Act. As the review schedule of the subcommittee on legislation was postponed, only 8 of the 35 bills under jurisdiction were reviewed. The 27 bills that suddenly lost their chances of judging included a number of bold agendas. Four cases of special laws for medical products responding to new infectious diseases such as COVID-19 and public health crisis (Dong-min Ki, Han Jeong-ae, Paik Jong-heon, and Lee Jong-seong) are representative. The bill was scheduled to be admitted to the Health and Welfare Committee's legal review board for the first time on this day. The goal of the legislation is to prove safety and promote the approval of drugs that show breakthrough efficacy. The amendment to the Pharmaceutical Affairs Act (Young-Seok Seo) of the generic joint biological equivalence test 1+3 regulation is also a major bill that will bring considerable transformation to the pharmaceutical industry. Two amendments to the Pharmaceutical Affairs Act (Choi Hye-young and Kim Ye-ji) that require braille marking on safety-prepared drugs, and a revised bill of the Pharmaceutical Affairs Act to reinforce impurity regulations by making it mandatory to specify imported raw material drugs such as NDMA, which are suspected of carcinogenicity, Reinforcement of regulations on biopharmaceuticals with false approvals such as Invossa·Medytox, etc. The revised bill of the Pharmacist Act (Clinician Bill of Kang Byungwon ) was disrupted by the suspension of the subcommittee on the bill. In addition, six amendments to the Medical Law (Kim Won-i, Kwon Chil-Seung, Kang Byungwon, Park Ju-min, Kang Seon-woo) and the medical institution's operating room CCTV installation revised medical law reinforced regulations such as sexual and violent crimes, etc. Two cases (Kim Nam-guk and Ahn Kyu-baek's bill) were also postponed. In particular, in a five-minute free speech at the plenary session of the National Assembly immediately after the decision to suspend or postpone the Act Subcommittee's emergency suspension, the Democratic Party of Korea unilaterally overturned the resolution of the Subcommittee for Budget Cuts in Public Medical Schools, and poured out criticism against the ruling party. It is speculated that the schedule of the 1st bill, which had been judged for marathon of 35 bills, was suspended or postponed. Kang said, "The ruling party's overturning the result of the budget cuts for public medical schools is to ignore the rule of law and to unilaterally break the agreement between the people and the pledge." He criticized, "Abandoning justice and breaking public promises causes problems in the qualifications of members of the National Assembly. Look back on the meaning of the rule of law and be self-reliant."
