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- 2025-12-23 12:44:13
- Policy
- Companies in a dilemma over who bears losartan recall cost
- by Lee, Tak-Sun Dec 03, 2021 05:55am
- Pharmaceutical companies are unsatisfied with the health authorities’ request for companies to fully bear the cost of exchanging ‘losartan’ products that were found to contain azido impurities. While many companies have submitted the ‘cost-bearing letter of commitment,’ the companies have been left with a bitter aftertaste, due to the ongoing litigations and uncertainties on how much the exchanges will cost. Some companies have not submitted the letter of commitment yet. The Ministry of Food and Drug Safety had gathered the manufacturers and sellers of losartan products on the 29th of last month to request a ‘letter of commitment on bearing the cost,’ a commitment by the companies to bear the cost of exchanging, re-prescribing, and re-dispensing drugs that arise from recalls, saying that the cost should be borne by the pharmaceutical companies. After receiving the request, over half of the companies have submitted their letter by the 30th, the deadline for submitting impurity test results. Companies that submitted their letter of commitment did so because they do not expect the cost burden to be large, and that they could not disregard the government's request. An official from a mid-grade pharma company said, “ We submitted the letter of commitment as requested because we expect the number of recalls to be small, the number of products exchanged or re-prescribed by consumers to be even smaller.” As only specific lot numbers in issue are subject to recalls this time without stopping reimbursement, the companies expect the number of consumer recalls to be smaller than that for valsartan or ranitidine. In fact, the number of antihypertensive drugs that were recalled by consumers in September due to AZBT impurities was only 4, giving some credibility to these companies’ expectations. However, as there were no re-prescriptions, re-dispensing, and no public promotion activities informing the people about the recalls then, other companies believe the larger amount of recalls would increase the cost incurred as well. Another industry official said, “It may not have been so if the recalls were conducted quietly, but if the recalls become politicized, the cost of exchanging the products may grow bigger. Most of the losartan products are prescribed for long-term use, for over a month, and may become a big burden for pharmaceutical companies.” Another issue is that the letter of commitment may affect the ongoing non-existence of a debt suit being conducted on valsartan products. The suit arose after the National Health Insurance Service filed claims to pharmaceutical companies to retrieve the cost incurred while exchanging valsartan products that were found to have impurities. Companies have asserted that the indemnity claims were excessive as the unexpected impurities were only found due to the development of science and were unavoidable as the drugs were manufactured due process. However, the first trial court ruled in favor of NHIS and judged that a total of 2.03 billion won should be paid in claims for indemnity by 69 companies in September. The companies appealed, and the lawsuit is now being tried in a second trial. In this context, if the companies submit the ‘letter of commitment on bearing the cost,’ this contradicts the claims the companies had made at court and acknowledges indemnity. This is highly like to negatively affect the outcome of the lawsuit. This is why some companies have not been able to decide on whether to submit the letter of commitment. Recently, the MFDS is known to have been urging pharmaceutical companies to promptly submit the letter of commitment. A pharmaceutical company official said, “As the underdog, it would be difficult for us to reject the MFDS’ request. However, it is an unjust procedure for the government to unilaterally decide on the bearer of the costs and notify and companies to submit a letter of commitment.” Meanwhile, the MFDS is expected to soon announce a list of high blood pressure losartan drugs that contain excess azido-based impurities and start recalls from pharmacies, distributors, and consumers.
- Policy
- MFDS reviews Pfizer COVID-19 vaccine used without dilution
- by Lee, Tak-Sun Dec 02, 2021 05:54am
- On the 30th, the Ministry of Food and Drug Safety had announced that it had started reviewing the approval of Pfizer’s COVID-19 vaccine that does not require dilution – ‘Comirnaty inj. 0.1㎎/㎖ (registered name)’ – after the company applied for the authorization of its import product license. The product contains the same active ingredient as the previously approved Pfizer vaccine, ‘Comirnaty inj,’ but is more user-friendly as it may be used directly without dilution. Its single dose is 30㎍, same as that of the already approved vaccine. The ‘Comirnaty inj. 0.1㎎/㎖’ vaccine that is applying for approval this time comes in a vial with a gray cap, which can be differentiated from the purple cap of the already approved vaccine. The product has already been authorized(approved) in Europe and the U.S. The EU approval came on November 3rd and the US emergency approval on November 19th. The MFDS stressed that it will continue to be committed to the rapid provision of safe and effective vaccines for the Korean people.
- Policy
- Did Mooncare truly reinforce coverage for rare diseases?
- by Eo, Yun-Ho Dec 01, 2021 05:57am
- The voice requesting expanded coverage for patients with rare diseases had been exceptionally high this year in the 4th year of Mooncare. Starting with NA discussions held to enhance coverage of innovative new drugs for rare genetic disorders in May by the NA Health and Welfare Committee member Sunwoo Kang, NA members Byungwon Kang, Woni Kim, Young Seok Seo, Hyunyoung Shin held a public hearing to discuss ways to resolve the medically unattended areas, continuing on the effort to foster a policy environment that in which patients with rare diseases are not marginalized. The main contents that were discussed included the need to apply special exemption of calculation to diseases that are not being covered due to non-designation as a rare disease, and the strong proposal on the need to expand patient access to new rare disease treatments. The discussion continued to the NA Audit, where the NA Health and Welfare Committee member Sunwoo Kang, and members of the ruling and parties including JaeKeun In and Jongseong Lee all unilaterally urged improvement. ◆100% reimbursement rate for rare disease treatments in 2020? However, the public hearing revealed the different views held by the Health Insurance Review and Assessment Service. At the public hearing in May, HIRA presented that the reimbursement rate for rare disease treatments was 85.3%(2016~2020) and 100% in 2020. The numbers indicate that patient access to rare disease treatments is perfect. But if this is the case, why is the voice to expand reimbursement for rare disease treatments continuing to rise? 출처: 희귀유전질환 혁신신약 접근성강화를 위한 국회 토론회The results announced by HIRA were the reimbursement rate of drugs that went through the review and assessment process, not the actual reimbursement rate among all rare disease drugs. In other words, HIRA’s result excluded various factors including rejected and voluntarily withdrawn items. Data studied by the Korean Research-based Pharma Industry Association and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association showed that only 50% of the pharmaceuticals that were designated orphan drugs over the past decade were listed on the reimbursement list. ◆Industry "Need to expand the pharmacoeconomic evaluation exemption system" The two associations joined forces to address the issue. Dailpharm found that KPBMA and KRPIA saw consensus on the need to expand accessibility to rare disease treatments and submitted a statement on the need to expand the pharmacoeconomic evaluation exemption system for rare disease treatments. In the statement, the two associations pointed out the existence of many rare diseases that greatly affect households with indirect medical costs and deteriorate the quality of life of patients but are not qualified for the ‘life-threatening (less than 2 years of life expectancy)’ condition that needs to be fulfilled to be able to utilize the current special exemption system (RSA and pharmacoeconomic evaluation exemption system) Therefore, the associations insisted that evaluating the ‘clinical need’ only with life expectancy does not take into account the characteristics of rare diseases, and diseases that do not meet the ‘less than 2-year life expectancy’ part of the clinical need requirement should also be allowed PE exemption if it is authorized through expedited approval processes abroad (US BTD, EU PRIME). The government had said that it would make efforts to improve access to rare disease treatments in the several public hearing and NA audits, but no specific plan or goal seems to be in place. An industry official said, “The government had recently adjusted the price evaluation criteria of PE exemption drugs by 20% from the lowest A7-adjusted price to improve the price transparency of PE exemption drugs. If the authorities decided to reduce the risk factors in price as such, they also should increase its scope of benefits.”
- Policy
- 30 new drug items reimbursed or extended coverage this year
- by Kim, Jung-Ju Nov 30, 2021 05:52am
- 30 new drugs were newly listed on the reimbursement list or extended reimbursement standards from January this year to this month. Among these, 25 were newly listed new drugs, and 5 were already-listed new drugs that have extended their scope of reimbursement and increased coverage. The reinforced coverage of new drugs this year benefited only 107,000 patients in Korea until last month, but the new listing of Bronpass Tab had increased the number of beneficiaries sevenfold to record 781,725. First, 30 drugs (based on representative dosages) were enhanced coverage being newly listed on the reimbursement list or extended reimbursement standards from January to November. Drugs that were newly listed as of the 1st this month are the severe neutropenia treatment Rolontis Prefilled Syringe inj and acute bronchitis treatment Bronpass Tab. No drugs were extended reimbursement standards this month. The two drugs that were newly listed differ greatly in the expected number of patients in Korea and annual financial requirements. Reimbursement for Rolontis Prefilled Syringe inj is expected to be applied to 4,000 people, costing ₩10 billion. On the other hand, Bronpass Tab is reimbursed for 670,000 people and will be applied to the most amount of patients among all newly listed drugs this year, however, its annual fiscal spending is relatively small, by ₩2.9 billion. This is interpreted as a result of comprehensively reflecting to flexibly expand coverage even for expensive drugs required for a small number of rare diseases and the social maturity to accommodate them. The number of beneficiaries greatly varies due to policies that now allow flexible expansion of NHI coverage to high-price drugs that are used for a small number of rare diseases, that were established based on the increased social maturity that can now accept such policies. The government and payer expect the new listing and extended reimbursement standards to cost ₩256.4 billion and grant access to 781,725 people.
- Policy
- Review period & material improved for COVID-19 Txs, etc.
- by Lee, Jeong-Hwan Nov 29, 2021 05:58am
- The government will lead the improvement of administrative effectiveness and predictability by preparing specific standards on the review period and scope of materials submitted for the marketing approval of pharmaceuticals. The measure was made as means for the government to preemptively respond to the expedited approval of new drugs, anticancer drugs, orphan drugs, and infectious disease treatments such as COVID-19 drugs. On the 25th, Prime Minister Boo-Kyum Kim held the 137th State Affairs Inspection and Coordination Conference and announced “the 8th measure for regulatory innovation to address difficulties in the new industry” The regulatory innovation that will directly affect the pharmaceutical industry is the measures made for the bio-health industry. In line with the Ministry of Food and Drug Safety, the Office for Government Policy Coordination had agreed on the need to improve the priority review system for pharmaceuticals. Currently, the MFDS has an expedited review process in place during marketing authorization for the prompt introduction of new drugs such as new drugs, anticancer drugs, orphan drugs, and infectious disease treatments. However, unlike the US FDA, the system does not specify the review period or the scope of materials submitted in detail, which undermines the administrative effectiveness and predictability of the system. On this, the Ministry of Food and Drug Safety decided to prepare specific standards on the review period and scope of submitted materials by revising the Pharmaceutical Affairs Act & Regulation on Safety of Drugs, Etc. The pre-announcement of legislation was issued on October 19th, and the revised Regulation on Safety of Drugs will be in full effect from January 21st next year. The scope of submitted materials will be specified to define the evidence data, development process, manufacturing method, dosage/administration, efficacy/effect of drugs subject to priority review. The MFDS expects the regulatory innovation to preemptively respond to the need for pharmaceuticals and promote the protection of national health. The regulations on chemical materials used for pharmaceutical manufacturing and quality inspections will also be alleviated. The MFDS exempts import requirements for raw materials that are essential for drug manufacturing when importing chemicals for drug manufacturing or quality inspection. The problem is, the MFDS reviews the cases case-by-case, only after the importer inquires to the ministry whether its chemical material is applied the exemption of import requirements. Due to this, criticism arose that the lack of criteria within the system is causing inconvenience for the importers. Accordingly, the MFDS decided to provide detailed criteria for determining substances subject to the exemption of import requirements and provide detailed case examples to aid better understanding among civilians and improve administrative processes for its employees. More specifically, the ministry plans to revise the ‘Tacts for recommending pharmaceuticals among those subject to import requirement confirmation exemption’ guidelines for business conduct in the coming December.
- Policy
- A new pre-approval system for Ultomiris was established
- by Lee, Hye-Kyung Nov 29, 2021 05:58am
- The pre-approval application system for Ultomiris, a treatment for night hemoglobin (PNH) in Handok, has just been established. The HIRA recently established a new Ultomiris pre-approval application system in the nursing institution business portal. The application for pre-approval of Ultomiris is in the same position as Soliris, which is previously prescribed in the benefit certificate. Nursing institutions that want pre-approval of Ultomiris and Soliris can register their applications after selecting the drug name from the pre-approval of medical standards management → Eculizumab and Ravulizumab on the nursing institution portal. Monitoring application data can also be submitted through the same menu. Monitoring data should be submitted for each subject every six months after treatment begins. In accordance with Article 6 of the Method and Procedure for Pre-Approval, etc., approval application and monitoring data related to pre-approval, such as Ultomiris and Soliris, shall be submitted from the 1st to the 10th of the even month in accordance with the subject's deliberation period. Meanwhile, Ultomiris was listed at KRW 5,598,942 per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris is an insurance cap of 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price alone reaches 400 million won per year. Both Ultomiris and Soliris were expensive new drugs, and pre-approval and monitoring were essential for registration. Since the registration of Ultomiris in June, pre-approval has been steadily made since July, and in August, one Soliris and four Ultomiris were approved for new PNH patients during the deliberation of the HIRA Medical Review and Assessment Committee.
- Policy
- Winner of pricing suits will be compensated for damages
- by Kim, Jung-Ju Nov 26, 2021 05:54am
- The countless litigations between government and companies regarding reimbursements such as drug price cuts or reduced scope of reimbursement are causing wasteful losses to both parties. On this, the government and the National Assembly have been proposing various solutions to prevent excessive stay of executions. The NA has proposed an amendment to the National Health Insurance Act which allows government authorities to recover the reflective profits the companies accrued during the suspension of execution period if it wins the main lawsuit, and refund them to companies when vice versa after a pharmaceutical company applies for administrative litigation and suspension of execution in opposition to the disposition of drug price cuts. The bill passed the plenary session after passing the Health and Welfare Committee's bill review subcommittee. The biggest contributor to the implementation of this refund system was the stay of execution the companies filed with their drug pricing lawsuits. The stay of execution is filed by a pharmaceutical company to suspend execution of the government’s drug price cut disposition based on the presumption of innocence. In general, the court cites or accepts the stay of execution request because of ‘irrecoverable damages’ that may occur from the company’s aspect. Since 2018, 36 out of 38 stays of executions were accepted, with the other two suits withdrawn. Most of the litigations have resulted in favor of the government. The problem is that the company’s only option during the suit to defend its drug price is to use the stay of execution and minimize damage or maximize profits during the litigation period. In this case, any cost that arises from the non-change in the drug price during the trial period results in a loss in health insurance finances. The government estimates that the financial loss caused by the suspension of drug price cuts since 2018 amounts to nearly ₩400 billion. Broadly applied to price cuts, reimbursement suspensions, selective reimbursement, etc. Will include added interest… price-cut drugs may choose either a lump-sum payment or price raise The refund system will be used to reduce such side effects. The system will be applied when a stay of execution filed by the pharmaceutical company is dismissed at the administrative ruling or litigation, but accepted in the original suit. In other words, the system will be applied when the government loses and the pharmaceutical company wins the suit. The compensation for damages will be applied to all pharmaceutical dispositions that are directly related to pharmaceutical sales, such as pricing adjustments, reimbursement suspensions or exclusions, reduced scope of reimbursement, selective reimbursement (changed copayment rate), etc. If these requirements are met, the NHIS needs to pay the pharmaceutical companies for the losses as a “binding act,” meaning that the government must compensate for losses. The government has decided to announce the standard rules and amendments to the medical insurance benefit criteria next month. Considering the administrative procedures such as legislative notice, regulatory review, legislative review, and public announcement, the amendment is expected to be implemented within the first half of next year.
- Policy
- Cost bearer in debate ahead recall of some losartan products
- by Lee, Tak-Sun Nov 26, 2021 05:53am
- The MFDS has mentioned ‘re-prescribing or re-dispensing' some items at meetings with medical, pharmacist, and pharmaceutical associations while discussing measures to recall some of the antihypertensive ‘losartan’ products that were found to contain azido impurities during inspections. The re-prescribing or re-dispensing measures are prepared for cases when patients cannot exchange their drugs at pharmacies, and all lot numbers of some losartan items are highly likely to be recalled. In other words, some items will be subject to full recalls. Previously, the valsartan and ranitidine products that were fully recalled due to impurities had also been re-prescribed or re-dispensed. At the time, the patients’ out-of-pocket cost was borne by medical care institutions for valsartan, and by the National Health Insurance Service for ranitidine. The NHIS had later filed a suit to claim the re-prescribing and re-dispensing cost borne to the pharmaceutical companies. However, as medical and pharmaceutical associations believe the patients’ out-of-pocket cost should be borne by pharmaceutical companies, the issue is expected to raise much controversy this time. According to the industry on the 25th, the MFDS had held a series of meetings with doctors, pharmacists, and pharmaceutical associations on the 24th. At the meetings, the MFDS had mentioned the possibility of re-prescribing and re-dispensing some losartan items, upon which the associations expressed the position that pharmaceutical companies should bear the patients’ out-of-pocket costs that arises from prescribing and re-dispensing while minimizing product recalls. In summary, it seems that full recall of some losartan items will be inevitable. If re-prescribing or re-dispensing measures take place, conflict may arise over who pays for the patients’ out-of-pocket cost and NHIS cost. The government, as well as the medical and pharmaceutical groups, believe that pharmaceutical companies should bear the cost, whereas the pharmaceutical industry is reluctant to bear the cost as this is an unintentional impurity event. However, the analysis is that the companies may accept bearing the out-of-pocket cost of patients. If only a few products are subject to exchange or re-prescriptions, there is the possibility that the recall will proceed without much confusion like in the case of the last AZBT losartan recalls. Therefore, the attention is focused on how many items will be recalled, and what proportion of the products will be re-prescribed at the official announcement made by the MFDS. The MFDS announcement is highly likely to come in early December after the MFDS receives and aggregates pharmaceutical companies’ product impurity test results at the end of this month. The MFDS also plans to hold a meeting soon with pharmaceutical companies that possess products subject to recalls.
- Policy
- All agreed to the legislation of the CSO reporting system
- by Lee, Jeong-Hwan Nov 26, 2021 05:53am
- The MOHW, as well as KPBMA, KRPIA, and Korean Pharmaceutical Association, approved the mandatory government and local government reporting bill by CSO. Except for the opinion that the regulations related to the CSO reporting system should be tightened compared to the legislation pending in the National Assembly, no organizations opposed it. Depending on the results of this month's subcommittee's review, the legislation is expected to be completed within this year and implemented as early as early as next year due to the government's fear. This is the result of confirming the review data of the National Assembly's Health and Welfare Committee's bill 1 subcommittee on the revision of the Pharmaceutical Affairs Act and Medical Device Act on the introduction of the CSO reporting system for medicines and medical devices on the 23rd. The bill, proposed by Rep. Kim Sung-joo of the Democratic Party of Korea, requires CSOs to report to the heads of cities, counties, and districts as prescribed by Ordinance of the MOHW. Pharmaceutical companies, which are pharmaceutical suppliers, can entrust drug promotion work only to CSOs who have been reported. Consignment of drug promotion work to unreported CSOs was sentenced to up to three years in prison or fined up to 30 million won, and CSOs were prohibited from re-consigning drug promotion work. Violation of this will result in imprisonment for up to three years or a fine of up to 30 million won. In addition, CSO representatives, executives, and workers were obligated to complete the drug sales order training. Violations will be fined up to 1 million won. All KPBMA, KRPIA, and Korean Pharmaceutical Association agreed Both organizations representing the domestic and foreign pharmaceutical industries and pharmacist organizations, including the government, approved the bill. Rather, it submitted an opinion to further specify the CSO reporting method or raise the level of regulation. The MOHW predicted that the CSO reporting system will clarify those subject to CSO for medicines and medical devices and incorporate them into the legal system so that administrative authorities can manage and supervise them. The MOHW agrees with Rep. Kim Sung-joo's proposal to eventually strengthen the management of the distribution order of medicines and medical devices by blocking indirect illegal rebates through CSO by establishing the obligation to prohibit rebates. KPBMA also approved the bill. However, it urged pharmaceutical companies to clarify the purpose of the law by adding content that imposes management obligations for CSOs. KRPIA demanded stricter regulations against the bill, asking pharmaceutical companies to specify legal grounds for CSO to request information such as whether to report under the Pharmaceutical Affairs Act and whether representatives, executives, and employees complete rebate prohibition training. The Korean Pharmaceutical Association also said the bill could contribute to preventing illegal rebates by identifying the current status of CSO and ensuring transparent distribution networks. The Korean Pharmaceutical Association further proposed the introduction of a punitive fine in consideration of the reality that it is difficult to eradicate illegal rebates. Only the provisions for re-consignment of CSO in the validity of the bill are changed. Hong Hyung-sun, an expert at the National Assembly's welfare committee, also agreed with the purpose of the bill to make the distribution order of medicines and medical devices correct. It did not prohibit re-consignment between CSOs, but expressed an opinion on changing the provisions so that the consignment route could be identified. In order for the CSO to re-consign drug promotion work to another CSO, it is to stipulate that the original drug provider is informed of the facts as prescribed by the MOHW. In addition, pharmaceutical companies and CSOs presented revised opinions on the contents of the promotion work consignment and the clause requiring the other party to prepare a "consignment report" within one month from the contract date and keep it for five years with evidence. Violation of this would result in imprisonment for up to one year or a fine of up to KRW 10 million, and the CSO definition would include cases where drug promotion work was re-consigned. In addition to preparing grounds for cancellation of designation by CSO educational institutions, Hong also proposed an incidental amendment to establish a hearing procedure in case of cancellation of designation.
- Policy
- Losartan, which has a high proportion of consignment
- by Lee, Tak-Sun Nov 25, 2021 05:55am
- Concerns are growing as the proportion of consignment production is high in HBP treatment "Losartan" formulation, which is known to have excess Azido-based impurities. If it appears as an impurity problem at the raw material stage, there is a possibility that many pharmaceutical companies tied up with consignment will start collecting products. According to the Ministry of Food and Drug Safety on the 22nd, in the case ofLosartan 50mg, 16 companies in Korea manufacture it, but the number of licensed products is 88. 72 pharmaceutical companies are entrusting manufacturing to other companies. The factory that manufactures the most items is Withus Pharmaceutical's Anseong Plant 1, which produces a total of 21 items, and Youngil Pharmaceutical's Jincheon Plant 1 is followed by 18 items. Withus Pharmaceutical Anseong Plant 1 and Youngil Pharmaceutical's Jincheon Plant 1 also manufacture the largest number of items in combination of HCTZ+Losartan potassium (12.5 mg/50 mg) . Withus Pharmaceutical Anseong Plant 1 produces 15 items, and Youngil Pharmaceutical Jincheon Plant 1 produces 20 items. If there is a problem with the consignment factory product, it is highly likely that the consignment item will be the same problem. In particular, if the same raw material is used, there is a high risk of recovery at the same time. In the industry, this interpretation is possible as companies have recently temporarily suspended product shipments due to raw material problems. Withus Pharmaceutical, which produces the most items of Losartan potasium 50mg, has decided to voluntarily recover its Withus 50mg (2 lots) as of the 16th. Dasan Pharmaceutical's "New Cosar 50mg" (2 lots) produced in the same factory also decided to voluntarily recover as of the 15th. Currently, only two recovered items announced by the Ministry of Food and Drug Safety as Azido-based impurities are Withers Pharmaceutical and Dasan Pharmaceutical, but it is analyzed that there is a possibility of further increase in the future. In fact, the industry believes that more items have stopped selling or voluntarily took measures to recover them. Analysts say that if the Ministry of Food and Drug Safety collects the results of the investigation and turns out to be a raw material problem, it is likely to lead to a large-scale recovery.
