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- 2025-12-23 02:31:38
- Policy
- Companies receive mixed reimb results in urothelial cancer
- by Lee, Tak-Sun Jul 20, 2022 05:49am
- The changes made in the reimbursement standards for urothelial carcinoma brought joy or sadness to affected companies. A new reimbursement standard for urothelial carcinoma has been created for MSD’s ‘Keytruda inj (pembrolizumab),’ while the reimbursement standard for Roche’s ‘Tecentriq inj (atezolizumab)' has been removed from the list because it was unable to satisfy the conditional marketing approval requirements set by the Ministry of Food and Drug Safety. The Health Insurance Review and Assessment Service conducted an opinion inquiry on the “notice on the revision of the pharmaceuticals prescribed and administered to cancer patients” that contains the content above by the 18th. Under the revised notice, Keytruda monotherapy (second-line or higher, palliative therapy) will be newly added to the list as of August 1st, but the Tecentiq monotherapy (second-line or higher, palliative therapy) category will be deleted as of September 1st. In the case of Keytruda, results of the long-term follow-up on the open-label, randomized Phase III trial, KEYNOTE-045, that had been conducted on 542 urothelial carcinoma patients that failed platinum-based treatment showed that the Keytruda-administered group demonstrated clinical efficacy over the control group that received chemotherapy (docetaxel, paclitaxel, etc) with an ORR of 21.1% vs. 11.0%, and a median overall survival of 10.1 months vs. 7.3 months, which led to the new establishment of the reimbursement standards. Patients with locally advanced or metastatic urothelial carcinoma that failed treatment using platinum-based chemotherapy will be eligible to receive reimbursement for Keytruda. Patients who have relapsed during or within 12 months of receiving adjuvant and neoadjuvant platinum-based chemotherapy will also be eligible for reimbursement. However, the standard only applies to those who have not revived treatment with immune checkpoint inhibitors like PD-1 class treatments. However, Tecentriq, which has been reimbursed for the same indication, has been removed from the reimbursement standards. The removal was made upon the pharmaceutical company’s request, as the company was unable to satisfy the conditional marketing approval requirements set by the Ministry of Food and Drug Safety. In other words, the company was unable to demonstrate the efficacy of its drug for the indication. Roche had already voluntarily withdrawn the urothelial carcinoma indication abroad. In March last year, Roche announced it will be voluntarily withdrawing the indication for Tecentriq as a second-line treatment for urothelial carcinoma that received conditional marketing approval from the US FDA. While approving Tecentriq’s urothelial carcinoma indication, the US FDA had set the condition that Roche should demonstrate the efficacy of Tecentriq in urothelial carcinoma with the confirmatory clinical trial, IMvigor 211. However, no value result that can demonstrate the clinical efficacy of the drug was derived from the clinical trial, and Roche voluntarily withdrew the approved indication. As the company failed to satisfy the conditional marketing approval requirements in Korea as well, the reimbursement authorities had first waited until a reimbursement category is established in urothelial carcinoma for another immune checkpoint inhibitor, Keytruda, to support patient treatment. And upon Keytrua’s reimbursement, Tecentriq’s reimbursement has been removed. The urothelial carcinoma indication in itself may also likely be removed in Korea as well. However, patients who are receiving Tecentriq therapy will be able to administer the drug under the previous standards until treatment completion. Meanwhile, the revision also contained the establishment of a new category, combined use(first-line, palliative therapy) of Xtandi soft capsule 40mg (enzalutamide) and androgen deprivation therapy (ADT) to treat metastatic hormone-sensitive prostate cancer.
- Policy
- The age group for SKYCovione was expanded
- by Lee, Jeong-Hwan Jul 20, 2022 05:49am
- SK Bioscience has expanded the conditions for clinical trials for cross-administration of booster shots (additional inoculations) of the nation's first COVID-19 vaccine SKYCovione (GBP510) to those aged 50 or older. This is due to the recent diversification of mutations and the re-proliferation of COVID-19. As a result, the company is expected to provide a clinical basis for being used as a booster shot for the elderly who have previously been vaccinated with mRNA vaccines. According to the pharmaceutical industry on the 18th, all adults aged 19 and older can participate in SK Bioscience's heterogeneous booster shot (additional vaccination with other vaccines), which was originally conducted for adults aged 19 to 50. This clinical trial is a test to confirm the safety and immunogenicity of adults who have completed basic vaccinations with other COVID-19 vaccines previously approved in Korea when SKYCovione is additionally inoculated. Nine domestic institutions, including Korea University Guro Hospital, are participating as clinical researchers led by the Korea Centers for Disease Control and Prevention. SK Bioscience was approved by the Ministry of Food and Drug Safety in December last year and has been recruiting participants for those aged 19 to 50. However, as the need for vaccination increased due to mutations this year, the conditions of clinical subjects were expanded and changed to the elderly. Through this clinical expansion, the government plans to provide a basis for significantly expanding the scope of vaccinations in the future by checking the effect of additional vaccinations by crossing SKYCovione in elderly people who have previously been vaccinated with other COVID-19 vaccines such as Pfizer and Moderna. With the recent spread of COVID-19 around the world, quarantine authorities are recommending the fourth round of COVID-19 vaccination for the elderly aged 50 or older. The use of mRNA vaccines such as Pfizer and Moderna is recommended first for the fourth vaccination, and if people do not want the mRNA vaccine, they may receive Novavax vaccine. SKYCovione is also recombinant protein vaccine technology. In addition to clinical trials for additional inoculations of different species, SK Bioscience is also conducting clinical trials for additional inoculations of the same kind that complete basic inoculations and additional inoculations with SKYCovione.
- Policy
- Lipilouzet, which is more expensive than Atozet
- by Lee, Tak-Sun Jul 20, 2022 05:49am
- Chong Kun Dang is establishing a clear position in the market for the hyperlipidemia complex Atorvastatin-Ezetimibe complex. This is because MSD's Atozet, the original drug, has been jointly sold since 2016, and there is even a certain insurance called Lipilouzet. Lipilouzet has a higher upper limit than Atozet. According to an industry on the 18th, Lipilouzet has been selling since it was listed as the highest price in April last year. Lipilouzet is the only item that started at the same price as Atozet, which was the highest price at the time of listing. The same-active ingredients listed on the same day are consignment items produced by Chong Kun Dang, and the drug price is lower than that of Lipilouzet according to the standard requirements. Since then, in October last year, Lipilouzet has become the highest-cap item in the same system as the original Atozet has been reduced in accordance with PVA negotiations. Lipilouzet 10/10mg is priced at 1,037 won, higher than Atozet 10/10mg 1005 won. In addition, Lipilouzet 10/20mg is 1,315 won, the highest in the same content, followed by Atozet 10/20mg 1,276 won. Lipilouzet 10/40mg is priced at 1,415 won, surpassing Atozet 10/40mg 1,373 won and listed at the highest price. Since Chong Kun Dang is overwhelming the Atorvastatin-Ezetimibe combination market through strong sales power, the high upper limit is advantageous for improving performance. Since Chong Kun Dang is overwhelming the Atorvastatin-Ezetimibe market through strong sales power, the high upper limit is advantageous for improving performance. However, Chong Kun Dang is still more eager to sell Atozet than Lipilouzet. In February, it signed an extension contract with Organon Korea for joint sales of Atozet. Organon is a spin-off company from MSD and owns Atozet. Atozet raised 86.8 billion won in outpatient prescriptions based on UBIST last year. For Chong Kun Dang, even if the joint sale of Atozet is terminated, the risk can be minimized because there is Lipilouzet, which has a higher upper limit than Atozet. It is an insurance that guarantees performance. Organon is likely to continue to maintain Atozet joint sales. Chong Kun Dang is also making consignment profits by supplying products with the same ingredients to other companies through the development of Lipilouzet, so both production and sales were possible at the same time.
- Policy
- To halve the death rate from COVID-19
- by Lee, Jeong-Hwan Jul 18, 2022 06:06am
- Veru homepageAs the domestic quarantine authorities announced their plan to review and promote the purchase of Sabizabulin, a new oral treatment for severe patients in preparation for the COVID-19 re-pandemic, attention is being paid to the treatment. Sabizabulin, developed by U.S. pharmaceutical company Veru, is the first serious oral treatment for COVID-19, and is known to significantly reduce the relative risk of death compared to placebo to 55%. On the 17th, the Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention reaffirmed to the National Assembly the need to introduce new oral drugs such as Paxlovid (Pfizer) and Largevrio (MSD). Sabizabulin is still a candidate drug for oral severe COVID-19. Developer Veru submitted an application for emergency use approval for Sabizabulin to the U.S. Food and Drug Administration (FDA) early last month. Developers are expected to be commercialized from August. Paxlovid and Lagevrio are for mild COVID patients. The difference is that the two oral drugs can be effective only when taken immediately after confirmation, while Sabizabulin has shown efficacy when used in severe patients who have already deteriorated due to confirmation. Sabizabulin is known to reduce the mortality rate by half (55%) when taken, and is evaluated as a new weapon to fight the COVID-19 pandemic. According to the results of a phase 3 clinical study published in the international journal New England Journal of Medicine (NEJM), Sabizabulin and standard treatments were administered to 150 severe COVID-19 patients, and the standard treatment group died 45.1% after 60 days, compared to 20.2% in Sabizabulin. As a result, the relative risk of death of Sabizabulin compared to placebo was significantly reduced to 55.2%. In addition, the period of hospitalization in the intensive care unit and the period of use of the ventilator were reduced by 14 days, respectively, compared to the placebo group. Sabizabulin was originally developed as an anticancer drug. Cancer cells grow on microtubules that move between cells in the body, blocking them from growing. Researchers at the University of Tennessee in the U.S., who developed the drug in the early days of the study, began further research, believing that when the coronavirus outbreak broke out in 2020, they could block the microtubule in cells to suppress the growth of the coronavirus. In the case of existing antibody treatments, the treatment effect may decrease depending on the virus mutation, but Sabizabulin is known to have no difference in the treatment effect due to the mutation. This is because it acts in a way that directly interferes with the microtubule in cells necessary for virus proliferation, not the virus itself. Developer Veru said, "If FDA approval is completed in July, we will be able to supply 57,000 people in July and 100,000 people in August." Veru introduces itself as a bio-cancer drug pharmaceutical company targeting bladder cancer and breast cancer.
- Policy
- Abbott has filed a suspension of execution with the court
- by Kim, Jung-Ju Jul 18, 2022 06:06am
- Abbott Korea, which has been in a dispute with the Ministry of Health and Welfare, immediately filed an appeal against the administrative court ruling by raising the issue of lowering the additional revaluation of the Rytmonorm SR series. Leo Pharma, which raised the issue together last year, decided to avoid legal confrontation with the government and abandoned the appeal. As a result, the drug price of Leo Pharma's seven items has been lowered as planned by the government from the 15th, and the drug price of Abbott's three items will be temporarily maintained due to the suspension of execution. Abbott appealed to the High Court for a total of three products containing Rytmonorm SR 225mg, 325mg and 425mg, and applied for a suspension of execution of the government's drug reduction plan (Notice No. 202-223), which the court accepted. Earlier in September 2021, the MOHW decided to conduct an additional revaluation by extensively overhauling the additional system that adds to the drugs listed on the list and conducting the first drug reduction according to the results. Products from these companies were included in the target. The lawsuit began as companies that were hit by the weak cut immediately protested. However, as the Seoul Administrative Court recently ruled in favor of the government, the first lawsuit ended, and at the same time, the suspension of execution, which temporarily maintained the price until the ruling, ended. But Abbott immediately appealed. Accordingly, the High Court decided to maintain the original price until the ruling, citing the suspension of execution applied by the company. Once the suspension of execution is maintained from the 15th to the 29th of this month, it is highly likely that the extension will be repeated again if the lawsuit is prolonged. Leo Pharma chose to give up the appeal and the drug price was immediately lowered. "We have decided not to proceed with the appeal process by persuading the Danish headquarters about the ongoing revaluation lawsuit," said Leo Pharma. The company added, "There is no way to recover from the decline in sales, but we decided to give up the appeal to do our best to meet social responsibility as a pharmaceutical company." Meanwhile, the ministry plans to guide further changes during the lawsuit.
- Policy
- Samsung reigns over Avastin biosimilar market in Korea
- by Lee, Tak-Sun Jul 14, 2022 05:54am
- No new biosimilars of ‘Avastin (Roche, bevacizumab)' are being introduced to the market after Samsung Bioepis’s biosimilar. The Avastin biosimilar market is estimated to have a ₩120 billion market in Korea. In terms of approvals, Pfizer Korea and Alvogen Korea had also received approval for their biosimilars after Samsung Bioepis, but only Samsung Bioepis received reimbursement approval for its biosimilar in September last year. The industry analysis is that the supply amount and results of patent challenges have risen as a variable, delaying reimbursement and release of the other biosimilars. According to industry sources on the 13th, Alvogen Korea withdrew its reimbursement application for ‘Alymsis inj’ that was approved in January this year. With the withdrawal, Alymsis’s reimbursed release in Korea is expected to be further delayed. The industry had previously expected Alymsis to be released with reimbursement in September this year. Alymsys is an Avastin biosimilar developed by the Spanish pharmaceutical company mAbxience that received US FDA approval in April through Amneal Pharmaceuticals. In Korea, the drug will be supplied by Alvogen Korea and marketed by Daewoong Pharmaceutical. The two companies signed an agreement in October last year under which Daewoong Pharmaceutical owns the rights to exclusively distribute and sell Alymsis in Korea. However, a variable - the patent challenge - arose with only reimbursement approval left for its release. Two of Alvogen’s three patent invalidation trials filed by the company were accepted by the court, but one was rejected. The rejected patent is known to be a combined therapy use patent set to expire in 2033. The industry believes that patent challenge results may have affected Alvogen’s reimbursement application withdrawal. However, no news on the reimbursement of Pfizer’s ‘Zirabev inj,’ which was approved before Alymsis, is arising either. Zirabev was approved in May last year. Therefore, speculations are rising that the release date of Zirabev is not being set due to insufficient domestic supply. With the release dates of Alvogen and Pfizer’s Avastin biosimilar unclear, the market preoccupation effect of Samsung Bioepis’s ‘Onbevzi inj,’ the first biosimilar that was released in September last year, has doubled. Onbevzi, which is sold in Korea through Boryung Pharmaceutical, has already passed the review of drug committees at 58 hospitals in Korea. This includes the ‘Big 4’ hospitals in Korea - Samsung Medical Center, Seoul Asan Medical Center, Seoul National University Hospital, and Sinchon Severance Hospital. Based on IQVIA, Onbevzi accounted for 9% of the market in the first quarter of this year. Onbevzi 0.1g/4mL is listed at ₩208,144 in Korea. This is slightly cheaper than Avastin 0.1g/4mL, which costs ₩218.782. Samsung Bioepis has also been emphasizing the economical price of its drug. A company official said, “We will continue to make efforts to provide more treatment options for patients with Onbevzi while contributing to the NHI fiscal-saving effort made by the health authorities in Korea.” Meanwhile, Celltrion had also applied for the approval of its Avastin biosimilar 'CT-P16' in September last year but had not received marketing authorization yet.
- Policy
- No social distancing obligations are introduced
- by Lee, Jeong-Hwan Jul 14, 2022 05:54am
- People in their 50s and 18s and older are also vaccinated with underlying diseases. In order to respond to the COVID-19 pandemic, the government has decided to expand the scope of the fourth vaccination to those in their 50s and 18 years of age or older. The mandatory quarantine period shall be maintained for seven days, but distancing shall not be implemented for the time being. Prime Minister Han Duck-soo presided over a meeting of the COVID-19 Central Disaster and Safety Headquarters on the 13th and announced measures to respond to the COVID-19 re-pandemic. It has decided to expand the target of 4th vaccination. The 4th vaccination target currently being conducted for people aged 60 or older and immunocompromised includes those in their 50s and 18s or older. It will also secure beds for the treatment of severely hospitalized patients. The government believes that it can afford as the operation rate of intensive care units is currently maintained at 10%. It is pointed out that thorough countermeasures are needed as the number of COVID-19 confirmed patients has doubled on a weekly basis recently. As a result, the government plans to prepare for hospitalization treatment with the possibility of up to 200,000 patients in mind. 10,000 "one-stop medical institutions" will be secured earlier by the end of this month so that confirmed patients who are not hospitalized and receive home treatment can receive tests, treatment and prescriptions at nearby hospitals and clinics at once. It will not implement measures to make it mandatory to keep distance immediately. It plans to consider introducing selective and phased distancing at a time when the COVID-19 re-pandemic situation is expected to become serious. Prime Minister Han asked, "Please thoroughly follow the basic quarantine rules such as wearing a mask, washing hands, vaccination, and periodic ventilation, which are the most reliable means of quarantine."
- Policy
- Companies are worried about the result of Godex revaluation
- by Lee, Tak-Sun Jul 13, 2022 06:04am
- CelltrionThe result of the revaluation of Celltrion Pharmaceutical's Godex raised concerns for some pharmaceutical companies. This is because the re-evaluation results came out around the time the development of generics began in earnest. According to an industry on the 8th, some pharmaceutical companies are developing generic drugs for Godex. Godex contains seven ingredients, including ▲Biphenyl dimethyl dicarboxylate, ▲antitoxic silver ext., ▲Adenine HCl, ▲Pyridoxin HCl, ▲Riboflavin, and ▲Cyanocobalamin. Since it is a product that generates 70 billion won in annual performance, it was a product that had a strong desire to develop generic drugs. In particular, small and medium-sized companies have steadily challenged. It is known that some companies solved all raw material problems and completed development right before commercialization test. Other pharmaceutical companies also paid attention to the results of Godex's revaluation. The HIRA Pharmaceutical Benefit Evaluation Committee decided on the 7th that Godex was not eligible for benefits. It is a big deal for companies preparing generic drugs. Some companies have also been interested in developing tablets for Godex, a capsule formulation. This is because Celltrion Pharmaceutical was expected to defend generic drugs through tablet development. However, there is no news of permission for Godex, which has been approved in phase 3 clinical trials. Except for Godex's benefit, the HIRA's development of tablets is also likely to be disrupted. This is because, regardless of the formulation, products with the same ingredient have been determined to be non-reimbursement. Therefore, generic drugs also make it difficult to be reimbursed. An official from a company said, "I understand that some pharmaceutical companies have been seeking to develop generica for Godex for a long time." He expressed regret, saying, "I would have identified and planned the original defense strategy, but if the HIRA takes measures to delete the final benefit, all of this will be ruined." The crisis of Godex's deletion of benefit was not only a problem for Celltrion Pharmaceutical.
- Policy
- Hanall Biopharma's Glucofree OR is back
- by Lee, Tak-Sun Jul 12, 2022 05:53am
- Metformin OR products, which had been suspended due to the detection of excess NDMA of carcinogenic substances, are returning. Hanall Biopharma products have also returned to the reimbursed market with their names changed. With the emergence of them, competition is expected to intensify as the imbalance in supply and demand of Metformin OR is resolved. According to an industry on the 11th, Metformin OR products of Hanall Biopharma and Daewoong Bio have recently been lifted. The items are Hanall Biopharmas Glucofree OR 500mg, Glucofree OR 750mg, and Daewoong Bio's Diaformin XR 500mg and Diaformin XR 750mg. Hanall Biopharma's Glucofree OR is the name changed from Glucodown OR. Glucodown OR was the second highest-selling product in the Metformin single-product market after the original Diabex (Daewoong Pharmaceutical). In May 2020, manufacturing and sales of NDMA, a substance that is feared to cause cancer, were suspended because it exceeded the provisional management standards. Hanall Biopharma has been able to lift its manufacturing and sales suspension by changing it to an impurity-free product for about two years. Daewoong Bio's product, which was manufactured at the same factory and stopped manufacturing and selling together, has also returned. With the re-launch of the two products, worries about supply and demand can be eased, especially in the Metformin OR 750mg market. As the two products disappeared, Metformin OR 750mg was the only Metformin OR 750mg of Yuhan. Since the suspension of sales in 2020, the demand for Metformin OR 750mg has increased rapidly, making it difficult to supply it. 45 items in the Metformin OR 500mg market receive benefits. Hanall Biopharma and Daewoong Bio are also working to lift the suspension for 1000mg OR products. Before the suspension in 2020, Hanall Biopharma was the only competitive drug for imported Glucophage XR 1000mg and Diabex XR 100mg for domestic brands. Now, the number of competitive domestic drugs has increased as Dalim Biotech and Yuhan Corporation have newly entered. Hanall Biopharma and Daewoong Bio are members of Daewoong Pharmaceutical Group. Although Daewoong Pharmaceutical continues to rank No. 1 in the Metformin single-product market with its marketing import Diabex, its own production items of Hanall Biopharma and Daewoong Bio are also strategically important. This is because it is necessary to maintain the overwhelming market share of Daewoong Pharmaceutical Group while being a domestically produced product that can check imported items. Metformin preparation is the primary essential drug for patients with secondary diabetes. As a result, it is expected that Yuhan and Dalim will compete fiercely with Hanall Biopharma and Daewoong Bio for the first place as they are growing high in the single market of Metformin after the suspension of sales.
- Policy
- Reimbursement of new migraine drugs gain momentum
- by Lee, Tak-Sun Jul 11, 2022 06:04am
- New migraine drug Reyvow receives conditional approval from the DREC on the 7th New migraine drug Reyvow receives conditional approval from the DREC on the 7th New migraine drugs are competitively pushing to receive reimbursement listing in Korea. Following Lilly’s ‘Emgality (galcanezumab)’ in May, Ildong Pharmamceutical’s ‘'Reyvow (lasmiditan)’ has also passed deliberations by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC) on the 7th. With Emgality already in pricing negotiations with the National Health Insurance Service, Il Dong is also working to speed up the listing process for Reyvow. Also, Teva-Handok’s new migraine drug ‘Ajovy’ is being reviewed for reimbursement adequacy. The industry analysis is that all 3 new migraine drugs may be reimbursed within the year. Reyvow passed DREC review in only 2 months after it received approval in May through the approval-assessment linkage system. This is evidence that its importer and seller, Ildong Pharmaceuticals, is making efforts to speed up Reyvow’s reimbursement process. Therefore, if the price level presented by DREC close to the company’s estimate, the two parties may immediately begin pricing negotiations. Reyvow selectively inhibits serotonin 5-HT 1F receptor. Triptan-class drugs, which are most commonly used for migraines also work on serotonin but may constrict the blood vessels and cause cardiovascular diseases such as myocardial infarction, strokes, etc. On the other hand, Reyvow, a selective inhibitor, has the advantage of causing fewer cardiovascular side effects. If a patient has difficulty receiving triptans due to side effects, Reyvow would rise as a viable option. Also, both the triptans and Reyvow come in tablet formulations. The other two, Emgality and Ajovy, are injection-type formulations. Both are humanized monoclonal antibody drugs that bind to the CGRP ligand that plays a key role in inducing migraine symptoms to inhibit its binding to its receptor. Therefore, the drugs are known to cost millions of won per year, much more expensive than the existing drugs. This is why the listing price of Emgality and Ajovy is also the focus of attention. Existing triptan class drugs are listed at 3,000 to 4,000 won per tablet, but the price of Emgality and Ajovy will have to be much higher than triptans as they use a different mechanism of action to improve treatment effect. Their formulation, as injection-type drugs, also differs from triptans. However, like triptans, Reyvow is a tablet formulation that acts on serotonin, therefore the price of the listed triptan class drugs may be used as a reference in Reyvow’s pricing. With Emgality at the forefront of the listing process, Teva and Ildong will first be keenly eyeing what price will be set for Emgality. As Teva has applied to hold a briefing session on Ajovy for HIRA reviewers, its reimbursement is also expected to be deliberated by DREC soon. The Korean migraine treatment market has remained small compared to its patient size. Accoring to UBIST in 2020, annual prescriptions of triptan-class drugs were at a 15.5 billion won range. However, the prevalence rate of migraines in Korea is 6%. According to HIRA's statistics, 550,000 patients received medical treatment for migraines, but around 2 million patients are estimated to have not visited hospitals or clinics for their condition in 2020. Therefore, the release of new drugs in the field is expected to further increase the market size.
