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- 2026-05-18 13:59:03
- 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.
- Company
- Tabrecta and Tepmetko are approved simultaneously for NSCLC
- by Nov 25, 2021 05:56am
- Two new anticancer drugs that target the MET gene to treat non-small cell lung cancer have entered the Korean market. The two drugs are Novartis’ ‘Tabrecta (capmatinib)’ and Merck’s ‘Tepmetko (tepotinib)’ The Ministry of Food and Drug Safety approved Tabrecta and Tepmetko together on the 23rd. Both are targeted therapies that target MET mutations and have the same indications. Tabrecta and Tepmetko may both be used to treat locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutations. Various mutations that induce cancer cell growth occur in NSCLC. Dysregulation in the proto-oncogene MET that is located in the long arm of chromosome 7 is also one of such many mutations. MET dysregulation can largely be divided into MET amplification or MET mutation. The MET exon 14 skipping mutation that is targeted by Tabrecta is one of the most commonly reported oncogenic MET mutations. MET exon 14 skipping mutation overstimulates the MET pathway that plays a key role in the signaling, proliferation, and survival of cells, resulting in the proliferation of cancer cells. MET exon 14 skipping (METex14) alterations are rare, occurring in only around 3% of all patients with metastatic NSCLC. However, its prognosis is poor due to its aggressive nature. In particular, retrospective analysis on patients with MET exon 14 skipping mutations showed that 37% of the patients had brain metastasis and 49% had bone metastasis at diagnosis. Tabrecta and Tepmetko are drugs that selectively inhibit the MET receptor tyrosine kinase. It blocks the MET phosphorylation response by binding to the intracellular kinase domain. In the US, Novartis’ Tabrecta was first approved and listed as the first MET targeted anticancer therapy. Tabrecta was approved in May last year, and Tepmetko in February of this year by the US FDA. In Korea, both were authorized simultaneously and are on an equal footing. At the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Tepmetko demonstrated a 43% ORR in patients regardless of treatment experience, and DoR was 10.8 months ORR in treatment-naïve patients and 11.1 months in previously treated patients Both companies are also actively studying the combined use of their respective drugs with EGFR-targeted therapies with the hope that it could address the issue of resistance that patients acquire after treatment with EGFR inhibitors. MET mutation or amplification are key mutations that cause EGFR-TKI resistance. In this context, the companies are studying the combination of Tabrecta with Iressa, Tagrisso, etc, and Tepmetko with Tagrisso.
- Company
- Shionogi's stock price is soaring
- by Eo, Yun-Ho Nov 25, 2021 05:56am
- Shares of Japan's Shionogi Pharmaceutical, which is developing a treatment for COVID-19 with Ildong Pharmaceutical, are on the rise day after day. According to related industries, Shionogi's stock price has steadily risen since August, breaking this year's highest price. As of the 24th, Shionogi Pharmaceutical's stock price is trading at around 8,100 yen, up nearly 40% from 5,950 yen on July 27, when it announced the launch of phase 1 clinical trial for COVID-19. This is analyzed due to expectations for the oral COVID-19 treatment S-217622, which is being developed by Shionogi. In particular, in the case of the 17th, it has been on the rise since the announcement that domestic pharmaceutical company Ildong Pharmaceutical has started joint development of S-217622. On the 17th, Ildong Pharmaceutical announced in a media report that it received IND approval from the Ministry of Food and Drug Safety for phase 2/3 clinical trials of S-217622 and that it would immediately begin clinical trials. S-217622 clinical trials will be conducted simultaneously in Japan, Korea, and Singapore, and its strategy is to shorten the development period and secure sufficient data through multinational clinical and joint development to prove the value of drugs. According to previous studies, S-217622 showed excellent safety and drug resistance, and it prevents virus proliferation by inhibiting protease (3CL-protase) present only in SARS-CoV-2, the source of infection that causes COVID-19. It was confirmed that alpha, beta, gamma, and delta corona-19 mutations all have similar levels of viral proliferation inhibition capabilities. Above all, the convenience of taking oral medicine once a day is drawing attention as a strength over the selective treatment. Meanwhile, if commercialization of S-217622 is successful, Ildong Pharmaceutical is expected to promote its own production and distribution.
- Product
- Organon aims to resume Cozaar XQ supply from 2022 Q1
- by Nov 25, 2021 05:56am
- 'Cozaar XQ,' an antihypertensive combination drug that contains losartan, may be resupplied to pharmacies within the first quarter of next year, at the earliest. The company had made preparations to change the API source of Cozaar XQ to be the same as the one for Cozaar, which uses a losartan API from a different overseas manufacturer (France), and explained that it will start manufacturing in December next month to supply the market in the first quarter of 2022. The company had stopped the shipment of Cozaar XQ after impurities that exceed the standard level were detected in the API of Cozaar XQ during the company’s independent inspections. Currently, the supply of Cozaar XQ 5/50mg, 5/100mg, 10/50mg has been temporarily suspended. Organon recently announced through medical and pharmaceutical associations that “Cozaar tab., Cozaar 100mg tab., Cozaar Plus tab, Cozaar Plus Pro tab, and Cozaar Plus F tab are imported after being manufactured using a losartan API from an overseas manufacturer. After an internal review that included an assessment of the overseas manufacturer’s API manufacturing process, impurity impact, and the European regulatory agency's laboratory results, we have submitted the review results to the MFDS. Also, we are in the process of developing a testing method according to MFDS instructions." Also, the company explained that it is preparing to change the API manufacturing source of Cozaar XQ to be the same as for its Cozaar products and plans to start supply in the first quarter of next year. Organon said, “We will actively follow MFDS instructions to enable the smooth supply of our products without inconveniencing the patients and HCPs.” Meanwhile, prescriptions of Cozaar XQ had recorded 7.2 billion won.
- 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.
- Product
- α-GPC can't be replaced with other drugs in the field
- by Kim, Jin-Gu Nov 25, 2021 05:55am
- Apart from the steady increase in the number of patients over the past 20 years, there has been no significant change in dementia treatments used in Clinic sites. However, two major changes have been predicted in the past two years. One is the controversy over the preparation of Choline alfoscerate in Korea, and the other is the controversy surrounding Aducanumab, a new dementia treatment drug that has been released for more than 20 years. The controversy is whether the drug is effective enough. The solution to the controversy is quite similar. Regulators in South Korea and the U.S. have instructed the controversy surrounding the two drugs to properly verify their validity through "clinical re-evaluation." What do the front-line prescription sites think about these controversies? Regarding the controversy over Choline alfoscerate, Ha Sang-wook, head of On Hospital, said, "It seems to help clinically improve cognitive function in early dementia," adding, "There will be positive results that re-verify the effectiveness of clinical re-evaluation." ◆ The prescription amount is similar to the previous one in reducing the benefit of Choline alfoscerate The core of the controversy is the effectiveness of Choline alfoscerate. This is because drugs were recognized as medicines in Italy, where drugs were developed, while in other countries they were sometimes used as health functional foods. In the end, the Ministry of Food and Drug Safety ordered a "clinical re-evaluation" last year to re-evaluate the safety and effectiveness of Choline alfoscerate on its own. 57 companies, including Daewoong Bio and Chong Kun Dang, have begun clinical re-evaluation. The Ministry of Health and Welfare has reduced the benefit of the Choline alfoscerate. Since August last year, when patients who have not been diagnosed with dementia use Choline alfoscerate, the drug price rate has risen from 30% to 80%. Pharmaceutical companies have actively taken legal action. Currently, a lawsuit for revocation of administrative disposition is underway. Regarding the controversy over the effectiveness of Choline alfoscerate, manager Ha Sang-wook explained, "There are many studies that improve cognitive function when dementia or dementia drugs are not activated in the early stages." He said, "Clinically, when replaced with Choline alfoscerate from other drugs, it is observed that it leads to cognitive improvement." For this reason, he explained that despite the reduced benefit, the prescription amount is almost the same as before. Manager Ha Sang-wook said, "First of all, it is a drug that patients are very satisfied with. Even if the prescription is changed to another drug, it is often prescribed again as Choline alfoscerate, he said. "I understand that it is prescribed steadily not only in our hospital but also in other places." He said there was no suitable drug to replace Choline alfoscerate. He said, "Except for Choline alfoscerate, there is virtually no drug to prescribe to patients." He said, "In particular, in the case of vascular dementia, Donepezil is not applied, so it cannot be used. Choline alfoscerate is the drug to be used, and if this drug is not allowed to be used, it is quite difficult for patients and doctors to use it, he said. He was also optimistic about the results of clinical re-evaluation. Manager Ha Sang-wook explained, "The key will be how many patients with hidden cognitive impairment are discovered." He said, "I think more patients with cognitive impairment will get good enough results if they participate in clinical trials. The Dementia Association is also formed in a positive direction". ◆"Patients' interest in Aducanumab is increasing rapidly Expectations were high for the new dementia treatment "Aducanumab" recently approved in the United States. In June this year, the U.S. Food and Drug Administration (FDA) approved Aducanumab, co-developed by Biogen and Eisai, as a treatment for Alzheimer's dementia. It has been about 20 years since Allergan's Namenda in 2003. However, controversy over the validity of this drug has continued since the approval process. Conflicting results were found in two clinical trials conducted by Biogen. For this reason, the FDA Advisory Committee issued a non-approval recommendation in November last year. The FDA did not accept the advisory committee's opinion. However, in consideration of the controversy over its validity, the condition of "reevaluation after clinical trials" was attached. Biogen should reevaluate Aducanumab through post-marketing clinical trials. If the efficacy of Aducanumab is not proven in the re-evaluation, the approval will be revoked. In terms of controversy alone, it is almost similar to the case of Choline alfoscerate in Korea. Many patients ask a lot about this drug, he said. "The success of Aducanumab will significantly change the direction of dementia treatment itself. If proven effective, dementia will turn into a conquerable disease. On the contrary, if clinical trials fail, follow-up drugs of the same mechanism are likely to fail, he said. Since the approval of Aducanumab, several pharmaceutical companies have been developing drugs with beta-amyloid blocking mechanisms. In June this year, Eli Lilly's "Donanemab" and "Lecanemab," co-developed by Eisai and Biogen, were designated by the FDA for breakthrough therapy designation one after another. Both drugs are undergoing phase 3 global clinical trials.
- Company
- Opdivo combo in review for esophageal cancer indication
- by Eo, Yun-Ho Nov 24, 2021 05:53am
- The cancer immunotherapy ‘Opdivo’ is attempting to add another esophageal cancer indication as a combination therapy in Korea. According to industry sources, the Ministry of Food and Drug Safety is reviewing expanding the indication for Ono·BMS’s PD-1 inhibitor Opdivo (nivolumab) in combination with Yervoy (ipilimumab) or chemotherapy as first-line treatment for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. The combinations are under review by the EU EMA for the same esophageal cancer indication. The efficacy of the Opdivo-based combination therapy as first-line treatment in esophageal cancer was demonstrated through the Phase III CheckMate-648 trial. In the trial, the two Opdivo-based treatment combinations (Opdivo+chemotherapy and Opdivo+Yervoy) demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression ≥1%, as well as in the all-randomized population. The CheckMate-648 trial was the first global Phase III trial that evaluated the immunotherapy and chemotherapy combination and a dual immunotherapy combination in advanced esophageal squamous cell carcinoma. Also, the Opdivo+Yervoy combination was the first dual immunotherapy combination to demonstrate a superior survival benefit compared to chemotherapy in this setting. The primary endpoints of the trial, overall survival (median OS) in patients whose tumors expressed PD-L1 was 15.4 months for the Opdivo+chemotherapy group and 9.1 months for the chemotherapy group. The secondary endpoint, median OS in the all-randomized patient population, was 13.2 months and 10.7 months respectively. The Opdivo+chemotherapy combination also demonstrated a statistically significant PFS improvement in patients whose tumors expressed PD-L1. The median PFS by blinded independent central review (BICR) was 6.9 months in the Opdivo+chemotherapy group, which was longer than the 4.4 months in the chemotherapy alone group. The primary endpoint, median OS of patients whose tumors expressed PD-L1 was 13.7 months for the Opdivo+Yervoy group compared to the 9.1 months in the chemotherapy alone group. The secondary endpoint, median OS in the all-randomized patient population, was 12.8 months vs. 10.7 months, respectively. The Opdivo-Yervoy combination did not meet its other primary endpoint of PFS by BICR, recording 4.0 months and 4.4 months, respectively. The median duration of response (DoR) per BICR was 8.4 months for Opdivo+chemotherapy, 11.8 months for Opdivo+Yervoy, and 5.7 months for chemotherapy alone in patients whose tumors expressed PD-L1, and 8.2 months, 11.1 months, and 7.1 months, respectively, in the all-randomized population. Opdivo+chemotherapy also showed a clinically meaningful increase in objective response rate (ORR). The ORR per BICR was 53% for Opdivo+chemotherapy, 35% for Opdivo+Yervoy, and 20% for chemotherapy alone in patients whose tumors express PD-L1 and 47%, 28% and 27%, respectively, in the all-randomized population. Meanwhile, Opdivo as monotherapy was approved in April 2020 for patients with unresectable advanced or recurrent esophageal squamous cell carcinoma that were refractory or intolerant to fluoropyrimidine and platinum-based chemotherapy.
- Policy
- Discussions began on the scope of Mifegymiso license
- by Lee, Tak-Sun Nov 24, 2021 05:53am
- Moon Eun-hee, head of the pharmaceutical policy division at the MFDSAn expert meeting was held on the 24th, and the review was conducted regardless of the revision of the criminal law. The MFDS, which is reviewing the product license of Mifegymiso, a drug for abortion, has begun a discussion process on the specific scope of use rights. It is a policy to decide through collecting opinions from all walks of life. Moon Eun-hee, head of the pharmaceutical policy division, said on the 23rd, "We are scheduled to hold a meeting with experts on Mifegymiso screening measures on the 24th. We are thinking about whether to limit prescription authority to obstetrics and gynecology and what capabilities we will describe." She added that Mifegymiso will basically be classified as Rx drug and compare preparation and administration cases in various countries to discuss whether it will be inpatient Rx or outpatient Rx. However, she mentioned that an agreement with all walks of life is needed. She stressed that she does not conduct a permit review on the premise of revising the criminal law related to abortion, but that she hopes the law will be revised as soon as possible so that licensed products can be used. It is found to be contrary to the opinion that Mifegymiso's approval review should be delayed due to the lack of criminal law by Seo Jung-sook and others. The abortion crime was abolished in 2018 when the Constitutional Court ruled against the Constitution. At that time, the Constitutional Court recommended that supplementary legislation be completed by the end of 2020, and five bills, including related criminal laws, were submitted to the National Assembly, but have not been processed. The criminal law contains specific conditions and regulations that allow abortion. The MFDS expects that abortion drugs will not violate the revised law and plans to examine them according to scientific procedures and methods. She explained, "I don't think that the termination of pregnancy in efficacy will apply to the revised Pharmaceutical Affairs Act related to the expression of abortion suggestion." She said, "Even in the revised criminal law, drugs, including drugs, are not considered to be applied to abortion conditions and grounds, but it seems that (related drug permission) is not desirable because it varies depending on interpretation." However, as collecting opinions from all walks of life is important, she plans to continue to discuss drug use. "I don't think it will be concluded by a single meeting on the 24th," she said adding, "There has been a process of collecting opinions from all walks of life, but we will continue to receive opinions if necessary." The plan is to determine whether the method of collecting opinions will be a consultative body of experts or a larger scale such as public hearings depending on the situation. For now, it is known that expert organizations such as Korean Association of Obstructors & Gynecologists, Korean Society of Obstetrics and Technology, and Korea Society of Health System Pharmacists will attend the meeting on the 24th. Regarding Mifegymiso's Bridging Study, the Central Pharmaceutical Review Committee also had a number of opinions on the exemption of Bridging Study, but it was not finally confirmed. Currently, the Mifegymiso review has been requested to supplement the data, but the data has not been submitted yet.
- Product
- AstraZeneca vaccination is expected to end as of this year
- by Nov 24, 2021 05:53am
- The first inoculation will end at the end of November, and for the second inoculation, all inoculations will end on the 31st of next month. Medical institutions that have AstraZeneca vaccines should provide primary vaccinations with vaccines they have, and inform the inoculated that secondary vaccinations should be cross-vaccinated with Pfizer vaccines. However, if the vaccinated person want to have AZ shot, the AstraZeneca vaccine can also be vaccinated until December 31 of this year. The KDCA recently guided medical institutions entrusted with COVID-19 vaccination on the end of the AstraZeneca vaccination. Those who have already been scheduled for the second vaccination with AstraZeneca vaccine will be vaccinated according to their reservation details, but if they wish, cross-vaccination is also possible through the health center. However, those who are scheduled for the second vaccination with AstraZeneca vaccine in 2022 will be changed to cross-vaccination. The KDCA urged consigned medical institutions to cooperate to ensure safe vaccination by familiarizing themselves with the expiration date of the vaccine they have and how to inoculate them. The COVID-19 vaccination response promotion team explained, "There are no plans to introduce additional AstraZeneca vaccines, and the validity period of the previously introduced inventory is imminent, so it is necessary to review the inoculation plan considering the amount available."
- Policy
- Betmiga PR prices fluctuated 3 times Between 15 days
- by Kim, Jung-Ju Nov 24, 2021 05:53am
- It is a drug with a lot of stories. Betmiga PR (Mirabegron) of Astellas Pharmaceutical of Korea, which is in a lawsuit with the government to cancel the drug price drop, is a drug with a lot of price fluctuations. The drug has repeatedly filed lawsuits against the government's drug price cut, returning, cutting and raising drug prices as the results of the Price-Volume Agreement and additional calculations are added, with at least three drug price changes expected this month alone. In the aftermath, continued settlement and fluctuations in pharmacies and distributors are expected to follow, signaling chaos. According to the Ministry of Health and Welfare, the price of two Betmiga PR (Mirabegron) items, whose suspension of drug prices was lifted on the 14th, will rise slightly as of the 22nd as the price hike was adjusted this time. The increased price is KRW 314 for Betmiga PR and KRW 471 for 50mg of Betmiga PR. Up to two additional changes from the new generic registration to the new suspension of execution It is now common for drug price changes to occur frequently due to drug price lawsuits against the government. However, Betmiga PR is experiencing price hikes and cuts due to additional criteria, application and cancellation of the Price-Volume Agreement results, and price changes due to further litigation. Since the drug was lowered on the 14th due to the previous ruling of the administrative court (2021a 10434), the government has considered the additional application of the drug. This drug is subject to additional application. Therefore, it was raised to the 22nd by applying an additional calculation as of the standard from the 14th application at the time. In addition, the cancellation of the Price-Volume Agreement conducted earlier this year was reflected, making it different from the drug price (price before 14 days) at the time of the administrative court suit. The company is filing an appeal with the High Court. At the same time, the company raised a suspension to the effect of maintaining the actual initial price, but on the 12th, the High Court did not accept it unusually. However, since the suspension of execution can be carried out separately from the lawsuit on the merits of our law, the company immediately applied for a separate suspension of execution to the Supreme Court, and the results have not yet been released. If the Supreme Court results are decided to cite suspension of execution, the price will change again if the price changes to its original state Price fluctuations do not stop here. As Mirabegron's generic is scheduled to be additionally registered on December 1, the drug price change, which was expected to be adjusted to December 22, will change again in December. In other words, since there are three companies based on registered companies and the number of new generics exceeds three companies, the additional mechanism applied by the government will be lifted and the price will fall again. This is a change in drug prices that has progressed or is scheduled for only 15 days since the application of the administrative court results on the 14th, and the number of times alone is as many as three or up to four times. Confused by frequent fluctuations in drug prices and wholesale and retail prices of pharmacies and distribution prices As a result, the return and settlement of distributors and pharmacies, which are wholesale and retail branches of drugs, and confusion in face-to-face patients are inevitable. First of all, pharmacies should pay attention to discrepancies in claims if they miss the update of drug prices. In addition, it should be notified when facing the patient. In the case of distributors, they must make predictable plans for returns and settlements to check the volume with trading pharmacies and customers. Due to the nature of wholesale and retail dealing with tens of thousands of drugs, such confusion is expected to continue unless the system and law improve. In order to solve such a legal battle, the ruling party is currently pushing for a revision of the law aimed at banning and recovering corporate lawsuits, and the government and insurance authorities are also closely watching it. The MOHW said, "The part to be raised and adjusted as of the 22nd will end on December 1st," adding, "Astellas is appealing to the Supreme Court (related to suspension of execution), so if there is any change, additional information will be provided immediately."
