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- 2026-04-15 22:52:05
- Company
- 117 Organon-transferring MSD employees files for a remedy
- by Dec 08, 2020 03:55pm
- A photo of Chair Shim Sang-nam of MSD Korea Labor Union submitting an application for the remedies for unfair transfer to Seoul Regional Labor Relations Commissions 117 employees notified to transfer from MSD Korea to a new subsidiary Organon have requested a remedy for unfair transfer. Resisting against the transfer ordered without consent, the MSD Korea Labor Union filed a remedy for unfair transfer to the Seoul Regional Labor Relations Commission on Dec. 1. The application for the remedy was submitted as MSD Korea on Nov. 10 disclosed the list of employees to be transferred to Organon Korea. The list contained names of 222 employees to be housed by the new subsidiary. Total 117 employees requested the remedies, which is about a half of the 222, who have been notified to be transferred. Currently, the remedy application is processed only by the corporate labor union from two unions in the company (corporate and industrial). About 95 percent of 124 transferring employees, who are also part of the corporate union, are applying for the remedies. The union official stated, “Although the transfer requires individual employee’s consent, MSD Korea has unilaterally ordered the transfer to Organon Korea and ignored respective employee’s agreement. We are asking the commission to order MSD Korea to admit the unfair treatment, and immediately cancel the order.” Specifically, they are skeptical about the new subsidiary Organon offering a similar level of working environment as MSD Korea. Organon’s asset only consists of off-patent items and the R&D department, considered as the future driving force in a pharmaceutical company, is not transferring to the new company at all. And as the physical office space is located in a share office, which could be moved or sold at any time, the employees expect faltering working condition and unstable job security. The employees said, “For instance, Pfizer’s spin-off Pfizer Upjohn has merged with Mylan in just two months after the split and took a new name of ‘Viatris.’ The associated employees had to move twice from Pfizer Pharmaceutical Korea to Pfizer Upjohn Korea, and then to a brand new generic drug company Viatris. Moreover, they emphasized, “The Pfizer’s development unfolded quite different from the management’s original promise to keep the major changes in working environment to a minimum. Hence, there is no guarantee MSD Korea would not repeat the same scenario.” The union claimed, Organon Korea could start offering early retirement programs to the employees, except for the key jobs, or either sell off to a private equity firm or merge with other company for so-called business recovery.” After accepting the application for the remedy, the Seoul Regional Labor Relations Commission would have to make a decision within 60 days to either accept or deny the application through hearing and discussion. The union could file an appeal to the Central Labor Relations Committee, if unsatisfied with the decision.
- Policy
- Drug price negotiation agreement by NHIS is 97.9%
- by Lee, Hye-Kyung Dec 08, 2020 06:12am
- 285 items (97.9%) completed drug price negotiations. Dailypharm reviewed the current status of drug price negotiations on December 29, 2006, after the last health insurance registration method was switched to the positive list system as part of a plan to optimize drug costs. Negotiations were completed for 1,924 items out of a total of 1972 negotiations that were received from 2007 to the end of November this year. Of these, 1,786 items were agreed on a contract, and the average agreement rate was 92.8%. The Drug Price Negotiation Department, Drug Price Post Management Department, Drug Price System Improvement Department, and Generic Negotiation Management Department are in charge of negotiations for 7 items, including new drugs, risk-sharing drugs (RSA) renewal, expected billing amount, expansion of scope of use, usage-drug price linkage (PAV), generics, etc. The price of new drugs is registered in health insurance through negotiations between the NHIS and pharmaceutical companies and a resolution by the MOHW's Health Insurance Policy Deliberation Committee, and some incrementally modified drugs and generics are determined according to the calculation criteria without drug price negotiation. This year, there were drug price negotiations for 316 items, and negotiations for 285 items (97.9%) were completed. The remaining 6 items (2.1%) were broken. There are currently 16 drug price negotiations underway, and 9 items this year have not reached an agreement.
- Company
- Emerging Chinese company BeiGene readies for Korean market
- by Eo, Yun-Ho Dec 08, 2020 06:12am
- A China-based emerging pharmaceutical company, BeiGene is readying for the South Korean market. The pharmaceutical industry sources reported the Chinese company has opened a South Korean subsidiary recently. The company has already recruited Head of Medical Affairs Kim Jiyoon, previously worked in medical affairs at Sanofi Genzyme, and they plan to hire more staffs for the Regulatory Affairs and Market Access. A global pharmaceutical company Amgen owns a stake in BeiGene, as it acquired 20 percent of the share for USD 2.7 billion (approximately 3.1 trillion) last year. The company supplies three new drugs by Amgen, such as multiple myeloma treatment Kyprolis (carfilzomib) and acute leukemia treatment Blincyto (blinatumomab), for the Chinese market. BeiGene has licensed out PD-1 inhibiting candidate immunotherapy, like Keytruda (pembrolizumab) to Celgene, now acquired by Bristol Myers Squibb (BMS). And the U.S. Food and Drug Administration (FDA) also cleared the company’s BRK inhibiting mantle cell lymphoma (MCL) treatment Brukinsa (zanubrutinib).
- Company
- Coverage expansion this year 70% less than last year
- by Eo, Yun-Ho Dec 08, 2020 06:11am
- Apparently, the number of new drug reimbursement expansion has gone down significantly this year. Daily Pharm surveyed the pharmaceutical reimbursement status from 2019 to 2020 and found the number of reimbursement expansion dropped 70 percent and 75 percent by indication compared to last year. The statistic data includes reimbursement expansion for off-label use. In last year, total 107 items expanded their coverage, but as of Dec. 7, only 33 items have expanded. While 104 indications obtained expanded reimbursement last year, only 30 indications have obtained new coverage this year. The number is low, even if it includes the number of drugs currently in process of negotiating their pricings with the National Health Insurance Service (NHIS), as there is only about a month left in the year. Although the number of reimbursement expansion applications cannot be fathomed accurately, the industry claims the number of application has not been so different from last year. The biggest cause of the situation seems to be COVID-19. In fact, committee meetings essential to reimbursement listing and expansion, such as Cancer Deliberation Committee and the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC), have been delayed multiple times this year. To improve the situation, the government decided to alleviate the relevant regulations and conducted on-paper reviews from September. However, the pharmaceutical industry argues, besides COVID-19, the barrier in reimbursement expansion has gotten more strenuous to overcome than before. Especially the anticancer treatments, the current drug pricing system puts more financial burden on both the government and the pharmaceutical company to settle on an agreement. For instance, except for an immunotherapy Tecentriq, all anticancer treatments have failed to convince the health authority to grant expanded coverage. The progress on adding more reimbursement standards on targeted therapies like poly (ADP-ribose) polymerase (PARP) inhibitors Lynparza and Zejula has been also sluggish. A market access staff in a multinational pharmaceutical company said, “Compared to before, even overcoming the first threshold of Cancer Deliberation Committee has gotten tougher. HIRA used to evaluate the reimbursement expansion and NHIS to negotiate then after, but now the overall schedule is delayed as the Cancer Deliberation Committee evaluates the financial impact as well.” From January through November this year, total 16 new drug items have been listed for the pharmaceutical reimbursement. The number only counts one dose of each item.
- Company
- Roche Xofluza to be prescribed for flu prevention in Korea
- by Eo, Yun-Ho Dec 08, 2020 06:11am
- The prescription of a next-generation influenza new drug Xofluza is to get accessible in South Korea for prevention purpose. According to the pharmaceutical industry sources, Roche Korea applied for approval on Xofluza to the Ministry of Food and Drug Safety (MFDS) after the drug’s new indication to prevent influenza was cleared by the U.S. Food and Drug Administration (FDA) in November. The ministry is currently reviewing the application and the final decision would be made from the beginning of 2021. Endo-nuclease inhibiting Xofluza is a new influenza treatment, approved two decades after the launch of ‘Tamiflu (oseltamivir),’ and it treats flu patients with a single dose (Tamiflu requires five-day administration). The flu prevention efficacy was confirmed in Phase III BLOCKSTONE study, where Xofluza lowered the risk of influenza infection by 86 percent compared to a placebo. The primary endpoint of the study was to evaluate the proportion of participants who tested positive for the influenza virus, and the secondary endpoints was the proportion of patients, who tested positive through a reverse transcription polymerase chain reaction (RT-PCR) test with no apparent symptom like fever, and patients, who tested positive through RT-PCR test with severe influenza symptoms or fever higher than 37 degrees Celsius. The primary endpoint found 1.9 percent of Xofluza-treated subject group was tested positive, compared to 13.6 percent of the control group. And the protective effect was even more highlighted during the subgroup analysis targeting non-vaccinated, high-risk and children and adolescent groups. Moreover, the Xofluza group and placebo group did not show significant difference in adverse reaction with 22.2 percent and 20.5 percent, respectively. Xofluza is currently in process of receiving the National Health Insurance (NHI) reimbursement in South Korea. When listed, the industry expects the drug would be quickly prescribed widely. Targeting to expand the influenza drug market share, Roche has inked the co-promotion deal for Xofluza with Chong Kun Dang in last March.
- Policy
- Xultophy Flex Touch pen·Afstyla can be reimbursed
- by Lee, Hye-Kyung Dec 08, 2020 06:11am
- Novo Nordisk's Xultophy Flex Touch pen (Insulin Degludec and Liraglutide) and CSL Behring's Afstyla (Antihemophilic Factor) were set higher in the amount applied by pharmaceutical companies compared to the adequacy evaluation of Benefits. The HIRA (President Kim Sun-min) released the results of the deliberation on the adequacy of medical treatment benefits for the drugs applied for decision deliberated by the 12th Pharmaceutical Benefits Advisory Committee in 2020. Two items, Xultophy Flex Touch pen, a treatment for improving blood sugar control in adults with type 2 diabetes, and Afstyla, a treatment for preventing and preventing bleeding in adults and children with hemophilia A, were proposed in the Pharmaceutical Benefits Advisory Committee. As a result of the evaluation of the Pharmaceutical Benefits Advisory Committee, the reimbursement was appropriate, but the amount submitted by the pharmaceutical company was determined to be expensive. These drugs are reimbursed if they receive less than the evaluation amount suggested by the HIRA. Meanwhile, the HIRA is evaluating the adequacy of reimbursement of drugs after deliberation by the Pharmaceutical Benefits Advisory Committee in accordance with Article 11-2 of the National Health Insurance Standards for Medical Care Benefits. In the event of changes in the detailed coverage range and standard items of the deliberation drug, changes in the permission details of the item requested for decision, and withdrawal of permission (cancellation), the final evaluation result may be changed.
- Policy
- Benefit redemption of α-GPC will be promoted soon
- by Lee, Hye-Kyung Dec 07, 2020 06:06am
- As the clinical re-evaluation of Choline alfoscerate is imminent, the NHIS' benefit redemption contract is expected to be pursued sooner or later. The consortium of Daewoong and Chong Kun Dang On the 1st of the month, an online briefing session for clinical reevaluation was held, and it was announced that it would recruit pharmaceutical companies to participate in the joint clinical trial of Choline alfoscerate by the 9th. The consortiums divided into degenerative and vascular in the case of mild cognitive impairment, and each investing a clinical cost of ₩9.5 billion for 54 months. It has a plan to invest about ₩10 billion in 60 months by adopting a method. Korea United Pharm recruited pharmaceutical companies to participate in the joint clinical trial of mild cognitive impairment until the 4th. As pharmaceutical companies participating in the clinical re-evaluation of Daewoong Bio and Chong Kun Dang's consortium group and United Group are confirmed within this week, the MOHW is also expected to proceed with the redemption of benefits according to the results of clinical re-evaluation. The MOHW has been reviewing a generic negotiation plan that states,'If the clinical trial fails, the entire health insurance prescription amount from the date the MFDS to conduct the clinical trial will be returned to the NHIS'. According to the Rules on the Standards for medical Benefits by the NHIS, If the Minister of Health and Welfare acknowledges that it is necessary for the stable supply of drugs that have already been notified of medical care benefits and the upper limit, it applies to the chairman of the NHIS. Negotiations may be ordered with drug manufacturers, consignment manufacturers, and importers on matters referred to in Article 11-2 (7) 4. In this case, the procedures in Article 11 (7) to (9) shall be applied mutatis mutandis. In the case of Choline alfoscerate, it is highly likely that the MOHW will issue a collective negotiation order to the NHIS during this week as the clinical usefulness re-evaluation can be included in the'etc.' in the phrase'stable supply, etc.' If the MOHW issues a negotiation order within this week, the NHIS will be able to proceed with a generic medical care benefit contract that includes reimbursement of benefits for pharmaceutical companies that have submitted a clinical re-evaluation plan as early as next week. In preparation for the failure of a clinical trial, if the approval is canceled after reevaluation or the criteria for benefits are changed, the contract will contain details such as the full refund of the benefits or the recovery of the benefits of the deleted indication. If a pharmaceutical company participating in clinical reevaluation does not comply with the NHIS' contract, it will take the procedure to delete benefits. It is stated that the procedures in Article 11, Paragraph 7 to Paragraph 9 of the Medical Benefit Standards are applied mutatis mutandis to items subject to clinical re-evaluation such as Choline alfoscerate, and thus there is a possibility of the deletion of benefits if the Minister of Welfare does not comply with the negotiation order. The NHIS predicts that if it signs a contract related to reimbursement of benefits along with clinical reevaluation of Choline alfoscerate, it can protect health insurance finances of more than ₩300 billion per year.
- Company
- Daewoong succeeded in evading patent for Belkyra
- by Kim, Jin-Gu Dec 07, 2020 06:06am
- Daewoong has passed the final gateway for the early release of a generic for Belkyra (Deoxycholic acid), an injection for improving submandibular fat. The original company Allergan succeeded in avoiding the remaining one of the two divisional patents. According to the pharmaceutical industry on the 3rd, the Intellectual Property Trial and Appeal Board recently decided on 'Establishing a Claim' in a trial to confirm the passive scope of rights that Daewoong recently filed for formulation patent for Belkyra. Daewoong succeeded in evading Belkyra’s patent. Daewoong successfully avoided Belkyra's formulation patent on June 19 and November 20. It was Belkyra's last patent. Daewoong's patent challenge for Belkyra began in January 2018. Daewoong filed a judgment on formulation patent for Belkyra to confirm the scope of the passive rights. Daewoong won the patent trial. In June, the Intellectual Property Trial and Appeal Board filed a trial decision for the settlement of the claim, and it was confirmed on July 23, when Allergan abandoned the appeal. However, there were two more obstacles that Daewoong had to overcome. In January and April this year, when Daewoong and Allergan were in the midst of a fight, Allergan registered two more new Belkyra patents. Allergan removed and registered only some of the existing patents. It was part of the 'evergreening strategy' that continues its duration through divisional applications. In the end, Daewoong had to challenge the two split patents. In March of this year, Daewoong filed a trial for a passive confirmation of the scope of rights to the newly registered formulation patent for Belkyra. With this trial decision, Daewoong succeeded in targeting all three patents. In the case of a trial decision made earlier in June, Allergan accepted the result without appealing to the Patent Court of Korea and was confirmed. The two trial decisions are also likely to be confirmed. Daewoong is developing its own injection for improving submandibular fat under the name DWJ211. Since March of last year, it has entered phase III clinical trial for 150 patients at Konkuk University Hospital and Chung-Ang University Hospital. The indication for DWJ211 is improvement of moderate and severe submandibular fat, which is the same as that of Belkyra. When the development is complete, Daewoong may be sued for patent infringement from Allergan. The trial decision is expected to be appropriately used for defense purposes.
- Policy
- SB16 has been approved for phase III clinical trial
- by Lee, Tak-Sun Dec 07, 2020 06:06am
- Samsung Bioepis headquartersSamsung Bioepis is the first in Korea to enter Phase III clinical trial of Prolia's biosimilar, an osteoporosis treatment. The MFDS approved the Phase III clinical trial protocol for a biosimilar candidate for Prolia, SB16, which Samsung Bioepis applied on the 1st. Prolia developed by Amgen was approved in Korea in September 2014. It is the first biological agent to appear as a treatment for osteoporosis and is jointly sold by Chong Kun Dang in Korea. Based on IQVIA, sales in the first half of this year alone reached ₩34.9 billion, an increase of 102.7% from the same period last year. Samsung Bioepis started Phase I clinical trial of Prolia's biosimilar in France in October. Multinational clinical trials were conducted for global sales. Domestic development is expected to be faster than overseas with the approval of the phase III clinical trial of the MFDS.
- Product
- COVID-19 vaccine almost there, how about cost-effectiveness?
- by Choi,sun Dec 07, 2020 06:05am
- The anticipation for the COVID-19 vaccines in development is soaring as a number of global pharmaceutical companies have announced successful clinical trial results. The health authority and the public would closely follow the vaccines’ further development to confirm their effect, safety and reasonable pricing. ▲The COVID-19 vaccine candidates currently in Phase III trial Total 11 candidate vaccines have initiate their Phase III clinical trials globally, categorized in three major types of mRNA, virus vector and inactivated vaccine. BNT162, in development by Pfizer and BioNTech, and mRNA-1273 by Moderna are mRNA vaccines. Instead of an attenuated vaccine that reduces virulence for the injection, mRNA vaccine uses mRNA strand from a virus to manufacture the vaccines fast. On the contrary, AstraZeneca, Janssen, Gamaleya (Russia) and CanSino Biologics (China) are developing viral vector vaccines. The type of vaccine injects viral vector to transport the viral gene. AstraZeneca’s candidate vaccine uses chimpanzee adenovirus-based vector to combine the spike-like protrusions on COVID-19 virus. Moderna has also applied for the use approval on Nov. 30 in the U.S. and EU for its 100-percent effective vaccine proven through Phase III trial findings. The U.S. Food and Drug Administration (FDA) scheduled the vaccine approval review on Dec. 11 and 17 for Pfizer and Moderna, respectively. ▲Clinical results for each vaccine disclosed but AstraZeneca leaves questionable findings On Nov. 23, AstraZeneca presented the results of Phase II/III on its developing vaccine AZD1222. The clinical protocol was to confirm the COVID-19 prevention effect shown two weeks after two doses of vaccine administered in one-month interval on 10,000 volunteer subjects aged 18 and over. The trial found the vaccine was 90 percent effective in 2,741 subjects who were administered with a half-dose, whereas it was 62 percent effective in 8,895 subjects who had a full-dose. Total 131 subjects were reportedly infected with the virus. AstraZeneca claimed the vaccine is average 70 percent effective by combining the two trial findings from 11,636 volunteers. Apparently, the company had no reports of severe adverse reaction. The medical experts are clashing over the AstraZeneca’s vaccine; they are conflicted over the facts that the half-dose was more effective and the company insisting on the average efficacy deducted from using two different doses. Also the experts are suspecting the use of half-dose could have been an unintentional error in the trial. An insider from the Korean Society of Infectious Diseases (KSID) commented, “It is odd to calculate average by adding the results from two different dose groups, but also we are questioning the credibility in the efficacy data extracted from only 2,741 people. FDA requires data analysis from at least 30,000 people.” Regarding the skepticism, Dr. Kim Woo-joo at Korea University Guro Hospital Department of Infectious Disease said, “A half-dose vaccination showing higher efficacy is an exceptional result. A lot of news media is reporting it as an error, but a clinical trial cannot possibly have such error.” ▲mRNA vaccine competition, Moderna 94.5% vs. Pfizer 95% An interim analysis of Moderna’s COVID-19 vaccine Phase III COVE study was announced on Nov. 16. The protocol targeted 30,000 people administering two doses in four-week interval to confirm the COVID-19 infection after two weeks. In the first interim analysis, total 95 people were infected, including 90 people receiving placebo and five people receiving the mRNA vaccine. The vaccine was 94.5 percent effective. The reports on the adverse reactions were of mild cases, such as pain around the injected area and fatigue. The second endpoint was the number of COVID-19-infected people after using the vaccine. The placebo group had a total of 11 severe cases, but none of the mRNA vaccine group reported a severe case. Based on the findings, Moderna claims their vaccine is 100-percent effective against severe case of COVID-19. Pfizer administered two doses of their vaccines on 43,661 people in 21-day interval. Total 10 cases were confirmed with the virus, where nine were from the placebo group and one was from the vaccine group. Analyzing the result, the company states the vaccine is 95-percent effective. The vaccine had no reports of adverse reaction so far. Dr. Kim Woo-joo mentioned, “In regards to the efficacy, Moderna and Pfizer’s vaccine demonstrating 94.5 percent and 95 percent efficacy is outstanding. Now the problem is distribution of these vaccines.” ▲Taking account of cost-effectiveness, which could be accessible from South Korea? The experts say all three vaccines are over 90-percent effective, if they were to directly quote AstraZeneca with their 90-percent effective vaccine trial result. However, the three vaccines have widely contrasting distribution methods and pricing. First, Pfizer’s vaccine requires to be stored at minus 70 degrees Celsius. The vaccine is priced at USD 19.50 (approximately 21,600 won) per dose (requires two-dose administration). And as the vaccine distribution would need a cold chain to maintain the minus 70 degrees Celsius, the actual administration cost would be much higher. Considering South Korean flu vaccine distribution struggled to maintain 2 to 8 degrees Celsius, distributing Pfizer’s vaccine soon may be out of question. The Ministry of Food and Drug Safety (MFDS) official commented, “Pfizer’s COVID-19 vaccine requires an ultra-cold chain to deliver them at minus 70 degrees Celsius. It is questionable a company in South Korea would be able to handle mass distribution of Pfizer vaccine in such challenging environment.” Moderna vaccine, on the other hand, has to be stored at minus 20 degrees Celsius. As normal refrigerated distribution is kept at around minus 20 degrees Celsius, the vaccine distribution would be more manageable by private companies. But the issue is its pricing. Moderna says it would be priced at 32 to 37 dollars, or approximately 35,500 won to 41,000 won. For the two-dose administration, it would cost more or less 80,000 won. Meanwhile, AstraZeneca’s vaccine can be distributed at around 2 to 8 degrees Celsius and is priced at around 4 dollars per dose (approximately 4,400 won). The experts argue the vaccine would be most preferred with the cost of about 10,000 won for two-dose administration. Regardless of the emergency approval given to the vaccine in other countries, the company would be able to start the distribution in the first quarter next year at earliest as it would need to wait for the MFDS approval, vaccine procurement contracting and manufacturing. MFDS official added, “We would have to wait and see first if the actual vaccination result would match its clinical finding, as it started its emergency use approval application procedure in other countries. If AstraZeneca can prove the low-dose vaccine efficacy through additional clinical trials, their vaccine would be most adequate to be used in South Korea.”
