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- 2026-05-07 06:41:57
- Policy
- OTC combination drug with APAP-IBU, not approved again
- by Lee, Tak-Sun Jun 11, 2021 05:53am
- Advil Dual Action in USOTC approval of APAP-IBU complex has failed again. Experts who participated in the review objected to the permission on the grounds that safety issues had not been resolved. According to the Central Pharmaceutical Affairs Review Committee minutes released on the 7th, seven out of 10 members opposed the OTC approval of Acetaminophen-Ibuprofen. The MFDS is also known to have opposed it, and finally, the complex failed to make its second attempt at licensing after 2017. Based on UK permit in 2017, this time it applied for permit based on US FDA. The complex requested in 2017 was a product that take one or two tablets of Acetaminophen 500mg-Ibuprofen, and it applied for permission to take two tablets of Acetaminophen 250mg-Ibuprofen 125mg. The U.S. FDA approved GSK's "Advil Dual Action" containing Acetaminophen 250 mg and Ibuprofen 125 mg as OTC. It was the first case in the United States that Acetaminophen-Ibuprofen complex was approved as OTC. At the Central Pharmaceutical Affairs Review Committee held on the 17th of last month, members of outside experts generally opposed. "There are already many single drugs, but the benefits of taking them as a complex seem to be in marketing rather than validity," a member said. "It is questionable whether consumers will keep the fact that they should take them within three days because they are feared to have side effects in the long term." Another member of the committee opposed, "We reviewed it as complex of the same ingredients in 2017, and it seems that there is no special accumulation of data on safety or efficacy of drugs. Clinically, elderly patients experience a lot of gastrointestinal bleeding after taking a lot of painkillers." Another committee member said, "I think it is important to the general consumer that the risk is greater than the benefit. Failure to comply with dosage can increase the risk of liver damage, and it is not appropriate to grant permission." A member of the Committee in favour of permitting the complex stressed that it was appropriate in terms of accessibility. "There are consumers who want to buy items that are very popular in the U.S. but are currently illegally using them in Korea. Pediatrics often use both for fever at the same time, and they already prescribe Acetaminophen as powder and Dexibuprofen as liquid." However, only three out of 10 members voted in favor of the permit, and the deliberation committee voted that the approval of OTC for Acetaminophen-Ibuprofen was not valid. Based on this, the MFDS also reportedly refused to grant permission. Kolmar's "Bufferin Lady," which was approved in 2008, also contains Acetaminophen (65 mg) and Ibuprofen (65 mg). However, it also includes Allylisopropylacetylurea and Caffeine Anhydrous.
- Policy
- 5 companies' developing vaccines have completed Phase I
- by Kim, Jung-Ju Jun 10, 2021 05:55am
- Minister Kwon Deok-cheol is briefing on the report at a special quarantine inspection meetingThe development products of five companies that are developing domestic COVID-19 vaccines have all been found to have completed phase 1 clinical trial and entered the next stage Depending on the product, some vaccines are aimed at entering phase 3 clinical trials as early as next month (July). The MOHW reported the status of vaccine development in Korea and future plans at the 3rd Special Quarantine Inspection Meeting on COVID-19 this afternoon (7th). Since May, the government has jointly operated the Pan-Government COVID-19 Vaccine Treatment Clinical Trial Support TF" to share the progress of each company and continue to check the preparation status of each department." First of all, it plans to provide all-out support for the rapid development of domestic vaccines. The government plans to introduce IRB to minimize unnecessary administrative waste and expedite clinical trials in line with the domestic vaccine phase 3 clinical plan. It will secure additional R&D budgets for Phase III clinical support to distribute risks and reduce corporate costs due to Phase III clinical progress, and actively purchase domestic vaccines in advance if development results are visible to some extent. Considering that most domestic development companies are planning to promote phase 3 clinical trials in controlled clinical trial, the government plans to make every effort to secure standard substances, establish standard test methods (SOPs) and secure vaccines so that controlled clinical trial can be carried out smoothly. Controlled clinical trials refer to the validation of a development vaccine by identifying a similar level of immunogenicity (such as antibodies) to a previously licensed vaccine. Looking at foreign cases, Valneva, France, is pursuing Phase III clinical trials with AstraZeneca vaccine and controlled clinical trials for the inactivated vaccine as of April 21. If clinical trials are completed, or if development is suspended or failed, vaccinations will be given first. At the briefing, Kwon Deok-cheol, Minister of Health and Welfare, said, "The government will 'support' until the development of domestic vaccines is completed, and we will continue to make pan-government efforts to ensure rapid performance."
- Policy
- 200 million tablets of Acetaminophen are available
- by Kim, Jung-Ju Jun 09, 2021 06:07am
- The government has stressed that Acetaminophen is well stocked before more people are vaccinated. Pre-dosing before inoculation does not fit medical information and does not require purchasing only certain brands (ex:Tylenol). COVID-19 Central Disaster and Safety Counters Headquaters (CDSCHQ) told in a regular briefing this afternoon that they discussed plans to supply Acetaminophen. Son Young-rae, head of CDSCHQ's social strategy team, said, "People who recently booked a COVID-19 vaccine are looking for Acetaminophen fever painkillers." He spoke about the MFDS' current supply and demand of Acetaminophen and a smooth supply plan. "The pharmaceutical company currently has about 200 million tablets of Acetaminophen in stock. Even if 10 tablets are taken per people, 20 million people can use it, and considering 8 million people scheduled to be inoculated in June, it is enough. "In particular, there is no reason to insist on certain products because about 70 generics are currently distributed in Korea." Moon Eun-hee, head of the Drug Policy Division , also explained that the supply is sufficient even if unproduced items are excluded from the 70 licensed generics. "Of 70 Acetaminophen products approved by the MFDS, there are also products that are not produced. However, since pharmaceutical companies have about 200 million stocks so far, it is enough for those who will be inoculated in June. Moon then said, "We will consider and promote support measures with pharmaceutical companies to expand production so that more inventory can be produced in consideration of the expansion of vaccinations."
- Policy
- PVA is a variable in the negotiation of α-GPC recovery
- by Lee, Hye-Kyung Jun 08, 2021 06:01am
- Re-negotiation on benefit recovery and PVA negotiation related to pharmaceuticals with the brain functional improvement agent "Choline alfoscerate" have emerged as variables. On the 3rd, the MOHW ordered the NHIS to conduct negotiations on 123 items of Choline alfoscerate for 40 days from June 4 to July 13. Choline alfoscerate recovery negotiations, which began on December 14 last year, have been under way four times so far, and 123 items from 58 final companies have not been agreed on. The pharmaceutical industry is questioning the effectiveness of the fourth round of negotiations that will be held again after failing to reach an agreement over the past six months. The NHIS considered the fourth round of negotiations to be the final stage, and says it will ask the MOHW to remove the benefit in the event of a final breakdown. If the NHIS' drug price management department (excluding the generic negotiation department) has been involved in the Choline alfoscerate negotiations due to lack of work and manpower, this time the drug price planning department will be in charge of negotiations. The Pharmaceutical Price System Planning Department is a department led by Lee Young-hee, who was in charge of major negotiations in the past, including high-priced anticancer drugs such as "Keytruda," "Opdivo" and "Spinraza." Based on her experience in negotiating various new drugs, She plans to conclude negotiations on the recovery of Choline alfoscerate. In particular, the inclusion of Choline alfoscerate from a large pharmaceutical company, which is suing the MOHW and the NHIS for suspension of execution, emerged as a variable in the recovery negotiations. Last year, Arlico, Hana, and Kyungbo were lowered as PVA 'Da' type (the amount of drug claims in 2019 increased by more than 60% or increased by more than 10% from 2018 and increased by 5 billion won). The pharmaceutical companies agreed on a contract clause that states that "if permission is revoked as a result of revaluation, the pharmaceutical company must return the full amount of the claim from the date of the MFDS' clinical trial to the NHIS." In the case of PVA negotiations, it is necessary to sign an agreement to return the full amount of the NHIS claim if there are problems with safety and validity such as clinical revaluation as well as drug price reduction. Attention is focusing on what choice pharmaceutical companies with PVA negotiated items will make at a time when the NHIS lowered the recovery rate by up to 50% of health insurance claims in the last third round of negotiations.
- Policy
- Pipeltro/Delstrigo will be reimbursed if the amount offered
- by Lee, Hye-Kyung Jun 08, 2021 06:00am
- Pipeltro (Doravirine) and Delstrigo (Doravirine, Lamivudine, Tenofovir), the HIV treatment by MSD, are the two major human immunodeficiency virus. And, were declared "Conditional Coverage" at the first step of the reimbursement if it was accepted below the appraised amount. On the 3rd, the HIRA held the 5th Pharmaceutical Benefits Advisory Committee in 2021, and conducted a review of benefit adequacy for new drugs related to HIV and asthma. Pipeltro, a combination of other anti-retroviral drugs for HIV-1 treatment, and Delstrigo for adult patients were proposed, but MSD's submission to the HIRA was higher than that of the Pharmaceutical Benefits Advisory Committee. Both Pipeltro and Delstrigo have received indications for HIV-1 treatment in adult patients who have no previous experience in antiretroviral treatment. Gilead, GSK, MSD, Janssen, AbbVie, and BMS are competing in the HIV sector in the domestic market, with Gilead and GSK accounting for about 90% of the market. Novartis Korea'sAttectura Inhalation Cap. (150/80μg, 150/160μg, 150/320μg) and Enerzair Breezhaler (150/50/80μg,150/50/160μg) will also be accepted below the evaluation amount. The Board of Review and Assessment assesses the appropriateness of drugs after deliberation by the Pharmaceutical Benefits Advisory Committee in accordance with Article 11-2 of the National Health Insurance Care Benefit Standards. The results of the Pharmaceutical Benefits Advisory Committee assessment are subject to changes in the scope of the drug's detailed benefit and other criteria items, changes in the authorization of the item applied for and revocation of the permit.
- Policy
- Ultomiris can be reimbursed with prior approval
- by Lee, Hye-Kyung Jun 07, 2021 06:06am
- Ultomiris (Ravulizumab), Handok's paroxysmal nocturnal hemoglobinuria (PNH) treatment, will be listed at ₩5,598,942 per bottle starting today (7th). The upper limit price for Soliris (30ml) is ₩5,132,364, so if 3 vials are administered every other week, about ₩400 million won is needed for a year. Ultomiris, on the other hand, can be administered at a maintenance dose every eight weeks from two weeks after the initial dose, which is expected to lower the annual dose per patient compared to Soliris. However, like Soliris, the pre-approval system is introduced, and health authorities check from before to after the administration. The HIRA recently conducted a "Guidance on Establishment and Announcement of Details on Pre-Approval of Ultomiris" and asked the head of the HIRA to apply for approval for use before administration. Medical institutions equipped with personnel, facilities and equipment prescribed by the criteria for madical benefits for hematopoietic stem cell transplantation may apply for prior approval of Ultomiris for patients with paroxysmal nocturnal hemoglobinuria (PNH). The pre-approval review will take place on Thursday the last week of the even month at the Ultomiris Subcommittee, which will be set up within the Medical Review and Assessment Committee. In the event that the Ultomiris subcommittee approves the reimbursed administration, it must be administered within 60 days from the date the medical institution is notified of the results of the deliberation. It must be reapplied if administered after 60 days. Ultomiris was approved by the U.S. Food and Drug Administration (FDA) in December 2018 and the European Medicines Agency (EMA) in July 2018 and obtained an item license on May 21, 2020. Handok applied for insurance registration as of August 31 after the permit, and the HIRA submitted it to the Pharmaceutical Benefits Advisory Committee as of March 4 this year to determine that it would be appropriate to accept it below the weighted average price of alternative drugs. The Pharmaceutical Benefits Advisory Committee considered clinical usefulness to be inferior to Soliris, an alternative drug based on clinical trial results, but found it cost effective if Soliris' weighted average of ₩5,598,942 or less per bottle. As the company accepted it, it has agreed to ₩33 billion through negotiations with the NHIS on expected claims.
- Policy
- SK Bio regains license for 'SKYPneumo'
- by Lee, Tak-Sun Jun 07, 2021 06:06am
- SK Bioscience regained its license for its ‘SKYPneumo,’ the first-ever pneumococcal vaccine developed in Korea. This approval comes in less than a year since the company had withdrawn its license in October last year in the aftermath of losing a patent suit. On the 4th, the Korean Ministry of Food and Drug Safety (MFDS) approved SK Bioscience’s 13-valent pneumococcal vaccine, ‘SKYPneumo prefilled syringe inj..' The vaccine is used for infants six weeks to 6 months old and adults over 50 years of age to prevent pneumococcal disease. It was approved by demonstrating its non-inferiority to the existing vaccines in clinical trials. The MFDS designated the vaccine's re-examination period to June 3rd, 2025. SKYPneumo had been previously approved in July 2016. However, the drug was unable to enter the market after losing a patent suit to Pfizer’s Prevnar 13 which had been dominating the pneumococcal vaccine market. Prevnar 13 is also a vaccine to prevent pneumococcal diseases. SK Bioscience filed a suit claiming the invalidity of the composition and formulation patent of Prevnar 13. However, the Supreme Court rejected the claim in December 2018. Due to this ruling, the company was not allowed to sell SKYPneumo until 2026, when the patent for Prevnar 13 expires. Unable to meet the post-marketing surveillance and other requirements, the company had voluntarily withdrawn its license for SKYPneumo last October. It will be difficult for SK Bioscience to market SKYPnuemo as approved until March 2026, when the patent for Prevnar 13 expires. Therefore, the eyes are on whether SK Bioscience will succeed in avoiding the patent rights with a new strategy and be released in the market. Meanwhile, according to IQVIA, Pfizer’s Prevnar 13 sold 81.3 billion won in sales just last year.
- Policy
- Botulinum Toxin is poorly managed
- by Lee, Jeong-Hwan Jun 07, 2021 06:05am
- Poor management of some domestic botulinum strains has been detected. Illegal circumstances have also been detected, including analysis of strains' sources and characteristics, security management of fungus handlers, illegal acquisition of strains, and suspected cases of false separation reports. Authorities are planning to jointly come up with measures to strengthen safety management of bio pathogens, including botulinum bacteria. On the 3rd, the KDCA announced the results of an all-in-one survey of 24 botulinum-bearing institutions, including Botox producers' acquisition of botulinum strains and illegal transactions. The KDCA conducted a written survey of 24 institutions from December 2 to 11 last year and conducted an on-site survey of 11 institutions from February 3 to March 4 this year. As a result of the investigation, insufficient management was confirmed, including analysis of the source and characteristics of strains, security management of bacteria handlers, illegal acquisition of strains, and suspected cases of false separation reports. Inspection items included permission to possess germs, separation and movement of germs, violations of the Biochemical Weapons Act, detailed copies of experimental notes, interviews with fungal separators, and results of the agency's security system. Botulinum toxins are highly likely to use bioterrorism, which requires strict management, but it has been revealed that there is a lack of human security management system to prevent illegal transactions and exploitation. Suspicions of strains exploitation have been raised through the transfer of some handlers, but problems have also been identified without legal grounds to identify the list of handlers and the status of transfers. There was no regulation on the reasons for disqualification, such as the definition and scope of handlers and criminal experience, so there was even a blind spot for management. In addition, there was no mandatory regulation for record preparation and management, including research notes that record the entire process of research and development, and genetic information on pathogens such as the entire sequence was excluded from the management list. Of the seven institutions that conducted on-site surveys to check whether bacteria were separated, five institutions were not prepared experimental notes by date and experimental process, and two institutions were confirmed to lack experimental notes. It has been confirmed that strains of some institutions reported to be separated in Korea are very similar to those of the United States. Specifically, the problematic strains had a genetic sequence consistency of 99.99% or more with the U.S. strains. While trying to determine the source of botulinum, there were also suspected violations of genetically modified organism and methods for prevention of infectious diseases related to safety management of pathogens. A total of four violations of the law, including two suspected violations of mobile reporting, one violation of genetically modified organism development and approval of experiments, and one suspected false separation report. In consultation with related ministries and the National Assembly, the KDCA plans to revise related laws, including the mandatory submission of strains to test records of bio-terrorism infectious disease pathogens, handler management, and bio-terrorism pathogen data (DB). It will also push for mandatory recording and management, such as preparing research notes and diaries for experiments and production processes related to bacterial handling. The government plans to investigate and analyze overseas cases so that it can check the criminal history and mental history of handlers and introduce the disqualification of handlers in accordance with domestic conditions. The goal is to prevent false reports and illegal transactions by making it mandatory to submit strains if they have bioterrorism pathogens such as botulinum bacteria. It will also quickly respond to bioterrorism by establishing an analysis of the entire sequence of bioterrorism pathogens, genetic diversity analysis, and molecular epidemiological in the event of bioterrorism. In addition, the government will prepare methods and procedures necessary for establishing and implementing security measures for fungal handling agencies to prevent exploitation, outflow, and deviant behavior of strains. "Botulinum, which produce neurotoxins that are fatal to humans, can pose a serious risk to people's health in the event of bioterrorism and accidents," Jeong Eun Kyeong, commissioner of the Korea Disease Control and Prevention Agency (KDCA) said. "We will compensate for the deficiencies in the bioterrorism pathogen management system confirmed by the investigation and strengthen safety management," she said.
- Policy
- Improvements to exempted calculation of psoriasis are urged
- by Kim, Jung-Ju Jun 07, 2021 06:05am
- #iThe registration for exempted calculation of severe psoriasis is just a year away. Patients have pointed out the difficulties and problems of the system. The point is that there are many unequal and unreasonable conditions, so the system should be improved to ensure quality before re-registration. The Korea Organization For Patient Group issued a press release today (3rd) calling for new and re-registration of special cases for severe psoriasis and improvement of the system. Psoriasis has been included in this list since June 2017. However, the government is applying exempted calculation only for "severe injuries" rather than all psoriasis. At the time, the NHIS estimated that out of a total of 1.5 million psoriasis patients, about 22,000 had severe psoriasis. Four years after the application of the special calculation case, only about 4,500 patients have been registered, and patient groups have called for improvement. The Korea Organization For Patient Group pointed out that compared to other immune diseases such as spondylarthritis ankylopoietica, Crohn's disease, and rheumatoid arthritis, the new registration period and baseline conditions for severe psoriasis are strict, which is equivalent to about 17,500 severe psoriasis patients. They also pointed out, "The fact that the existing treatment, which has been effective in treatment at the time of the five-year re-registration standard for calculation, has been set as a condition for re-registration adds to the difficult situation of psoriasis patients." This organization urged to apply the same special system for exempted calculation of severe psoriasis as ▲spondylarthritis ankylopoietica, Crohn's disease, and rheumatoid arthritis, and,▲it also urged the withdrawal of unreasonable criteria for discontinuing drugs under treatment when re-registration of special cases of calculation after 5 years. The Korea Organization For Patient Group emphasized, "These standard issues have lost equity compared to other diseases, and the pain and difficult situation of patients with severe psoriasis have not been properly identified, so they must be withdrawn."
- Policy
- NA prepares bill to prevent 'price cut lawsuit' gimmicks
- by Lee, Jeong-Hwan Jun 04, 2021 06:06am
- A bill to prevent pharmaceutical companies from filing administrative suits for the purpose of evading or delaying drug price cut dispositions made by the government is expected to be introduced at the National Assembly. The bill will prevent the recurrence of cases similar to the suspended execution of drug price cuts ruling for the brain function enhancer choline alfoscerate, which has been a hot issue since last year’s NA audit. An official from Woni Kim’s office of the NA Health and Welfare Committee explained, “The avoidance of drug price cuts and reimbursement suspensions by companies is an issue that every Health and Welfare Committee member should pay attention to. We are preparing to amend relevant laws.” Woni Kim’s office is not the only place preparing a bill. The bill will aim to recover the reimbursed benefits paid to drugs during the period that the price cuts were avoided using the suspension of execution when the pharmaceutical company that filed the administrative lawsuit in objection to the government’s price cut disposition loses the suit. The key is to impose a penalty and exercise the right to indemnity when a pharmaceutical company deliberately pursues a lawsuit to cancel or delay the government’s justifiable drug price cut disposition. Of course, the bill will also include a provision that compensates for the damage suffered by pharmaceutical companies during the litigation period if the government's unjustifiable drug price cut is proven in court after a pharmaceutical company wins the lawsuit. Also, retroactive application of the bill is also being reviewed in consideration of the fact that many drugs including choline alfoscerate are in litigation to cancel their price cuts. The issue of health insurance finances wasted due to objections to price cut dispositions has been an agenda discussed for many years including at last year’s audit. At the NA audit last year, NA Health and Welfare Committee members Insoon Nam and Jaekeun In of the Democratic Party of Korea had appealed the need to amend the laws, criticizing the cancelation and injunction suit filed by choline alfoscerate makers whose reimbursement reduction and price cuts were set. They pointed out that the administrative suits or suspension of execution filed for the drug price adjustment disposition are being used as a means to preserve or make profit for pharmaceutical companies, or that it is causing unreasonable loss of health insurance finances. In had said that an estimate of 150 billion won of health insurance finances was lost in three years from 2018 to 2020 due to the abuse of drug price reduction cancellation lawsuits by pharmaceutical companies. An official from a member’s office of the NA Health and Welfare Committee said, “Several ruling party members in the committee agree to the validity of such a bill and are coordinating the bill with the Ministry of Health and Welfare. Legislation of this bill requires careful examination in retrospective application, enforcement date, and the supplementary provisions, as the issue on choline alfoscerate is still ongoing.” The official added, “Some have criticized that the drug price reduction cancellation lawsuit and injunctions are being abused as marketing tools by pharmaceutical companies to minimize damage from such price reductions. The Ministry of Health and Welfare and the National Health Insurance Service also agree on the need for the bill, so we expect that a bill will be proposed soon.”
