- LOGIN
- MemberShip
- 2025-12-23 15:45:15
- Policy
- Negotiations for Pfizer Lorviqua have not been completed
- by Lee, Tak-Sun Jul 22, 2022 05:52am
- Pfizer It was found that Lorviqua' a third-generation non-small cell lung cancer treatment that inhibits ALK (anaplastic lymphoma kinase), failed just before being listed. The HIRA announced the establishment of a standard next month, but the NHIS negotiations were not completed, leading to the deletion again. According to the industry on the 19th, Lorviqua passed the HIRA Pharmaceutical Benefit Evaluation Committee in April and has since been negotiating drug prices with the NHIS. As the committee judged that there is an appropriate benefit for the treatment of adult patients with ALK-positive progressive non-small cell lung cancer, the industry believes that it would not be unreasonable to pass if the pharmaceutical company and the NHIS derive an appropriate drug price. As a result, some predicted that the benefit would be registered as early as the 1st of next month. However, the negotiations have not yet been completed, so it is expected that it will not be registered until September at the earliest. This fact is known as the announcement of the establishment of an anticancer drug benefit standard by the HIRA. Initially, the HIRA conducted an opinion inquiry on the revision of the announcement according to drugs prescribed and administered to cancer patients on the 18th, signaling the establishment of a new benefit for Lorviqua in August, but it was immediately deleted. This was because drug price negotiations with the NHIS have not yet been completed. Lorviqua is a third-generation drug that can be used if ALK-positive non-small cell carcinoma patients use first-generation Xalkori, second-generation Zykadia, and Alecensa, but it is not effective. In other words, it is a new alternative for patients who have used second-generation drugs but become resistant. Patients are also expected to be registered quickly. However, it will be possible only after one more month.
- Policy
- “Pharma companies cannot conduct online product briefings"
- by Kim, Jung-Ju Jul 21, 2022 06:04am
- “Online product briefing sessions by pharmaceutical companies are clearly illegal, but we cannot directly warn the pharmaceutical industry by pressing charges or requesting investigations at the moment." With the prohibition temporarily lifted on the pharmaceutical and medical device companies’ support of online academic conferences, the government made it clear that the online product briefing sessions should be straightened out in a relatively mild manner, such as by status surveys or advance notices. Director Tae Gil Ha and Deputy Director Jung Hyun Yeo of the Division of Pharmaceutical Policy at MOHW responded so during the QA session on the present state of affairs that was held with the MOHW correspondent council. The following is a QA on the present state of affairs discussed at the session. (From the left) Deputy Director Jung Hyun Yeo, Director Tae Gil Ha of the Division of Pharmaceutical Policy at MOHW ▶The government has temporarily extended the allowance of advertisements and sponsorships on online and ‘hybrid (on+offline)’ academic conferences due to the COVID-19 situation. Do you have any plans to institutionalize this in the future? “The regulation on online academic conferences, if amended, falls under the Fair Competition Code of the Korea Fair Trade Commission. Therefore, to systemize this, changes should be made to the Fair Competition Code. We discussed this while meeting with the FTC to temporarily extend the allowance of online academic conferences. The FTC’s position is that the current form of online academic conferences is not fit for temporary extensions and would need to be institutionalized in the future. Lifting the temporary period limitation can be done by revising the Fair Competition Code. Of course, this discussion would be made next year (after the temporary extension ends), but the direction that they will take is to institutionalize online academic conferences through code revision. ▶The training education by individual medical institutions that were allowed for the past one year is now impermissible. Why has this changed? “This is an exception made from the previously allowed acts against the Fair Competition Code. It is MOHW’s role to compromise the opinions between the industry and the medical community. As the online training was exceptionally allowed due to the nation’s social distancing measures, the MOHW worked to coordinate and combine the opinions and derive a compromised option. The “no expense support for long-term care institution-level academic conferences” was not decided by MOHW. The decision reflects the opinion of member companies of industry associations such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the Korea Medical Devices Industry Association, and the Korea Research-based Pharma Industry Association. They say that online events are less effective in terms of advertisement than face-to-face events. There are grounds for allowing events at the long-term care institution level regardless of size. This means that the member companies regarded this burdensome with little advertisement effect. Some may ask whether we disallowed it against evidence, but in the relationship aspect, its allowance would have tilted the scale to one side. This was why we decided to reflect industry opinions.” ▶What plans do you have in place for regulating “digital marketing," the online product briefing sessions? “Under the current law, holding an online product briefing session in itself is allowed, but the company may not provide economic benefits to medical professionals attending the event. Some in the pharmaceutical industry believe this should be deregulated somewhat. However, others in the industry have pointed out that if this is allowed, it may become means to provide detour rebates online. We have listened to the industry’s opinion on this recently, but the discussion is still ongoing as a consensus has not been made yet. In conclusion, it is illegal to hold an online product briefing session and provide economic benefits to attending medical personnel under the current law. We are currently discussing the need to improve the system." ▶Then as the discussions are still ongoing, don’t you think you should inform the companies that are currently providing such benefits of the possibility of punishment to clarify the signal? “We need to first understand the current situation rather than press charges or requesting investigations. We need to see which companies are providing benefits. It means that we should meet with the companies and listen to their story rather than press charges right away.” ▶The pharmaceutical industry would want the government to clarify and organize the situation in advance before cracking down on the industry as it had done in the past for offline rebates. "We will not be requesting prosecutions immediately. It is realistically impossible for MOHW to find all companies and file charges. We should first provide guidance or advance notice.”
- 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.
