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- 2026-05-04 04:46:04
- Policy
- There is no concern about the disposal of COVID-19 PO tx
- by Lee, Jeong-Hwan Aug 23, 2022 06:03am
- Regarding the criticism that many of the COVID-19 PO treatments held by the quarantine authorities are likely to be discarded due to the expiration date early next year, it expressed that there is no problem in proper inventory management. As the use of PO drugs is increasing due to the re-proliferation of COVID-19 and an active prescription environment has been established, the current reserves can be used until November, so the introduction of additional supplies should be coordinated, not discarded. On the 18th, the KDCA made this announcement at a regular briefing for COVID-19. Some media reported that based on a report by the National Assembly's Budget Office, 700,000 of the 960,000 PO drugs brought in so far, will have to be discarded after the expiration date in February next year. In the briefing, a question was also asked about the criticism that many of the treatments will be discarded in February next year. The KDCA explained that in order to minimize damage to high-risk groups, it expanded hospital prescription institutions, increased pharmacies in charge, and encouraged medical staff to actively prescribe oral drugs. It also said that the current amount of oral drugs is doses for 690,000 people, which can be responded to by November this year, considering the recent weekly usage. The move is aimed at exhausting all of the current holdings before the disposal time in February next year. An official from the KDCA said, "We plan to flexibly adjust the additional introduction of the COVID-19 oral drug as it currently has a quantity that can be responded to by November rather than concerns about disposal." "We are also discussing with related agencies about extending the expiration date of Paxlovid and Lagevrio," he said. The official said, "We will push for proper inventory management without disposal for Paxlovid, which is scheduled to expire in February next year."
- Policy
- “Bio-vaccine fund will be created within the year”
- by Lee, Jeong-Hwan Aug 22, 2022 05:53am
- President Yoon Suk-Yeol reconfirmed his new government’s plan to raise and create a K-Bio·Vaccine Fund that focuses investments on Phase III trials within the year. The government will induce investments with pan-ministerial support and also accumulate data on 1 million people to develop next-generation treatments such as advanced biopharmaceuticals and precision medicine. Also, a public policy-based fee system will be implemented to reinforce essential healthcare such as less-favored areas such as craniotomy for cerebral aneurysms and areas with reduced demand, such as pediatrics and childbirth. On the 19th, the Ministry of Health and Welfare reported the new government’s operation plan that contained the abovementioned plans to the president. ◆Making the leap to become a global biohealth hub=The MOHW announced plans for Korea to make the leap and become a global biohealth hub. It plans to strengthen pan-ministerial support to attract investment from companies in Korea and abroad and raise and create a K-Bio·Vaccine Fund that focuses on Phase III trial investments within the year to attract private investments. Also, the ministry will provide regulatory relief by reorganizing the innovative medical device designation system within and announcing step-by-step implementation plans to innovate the biohealth regulations within the year. In addition, a ‘National Integrated Bio Big Data’ system will be established to develop next-generation treatments such as advanced biopharmaceuticals and precision medicine. With the goal of accumulating data on 1 million people, the government will apply for a preliminary feasibility study within the year. Also, a ‘Health Information Expressway’ will be created to safely manage and relay personal health and medical data for customized use by HCPs. R&D investments to establish health security and resolve national challenges will also be expanded, with the goal of reaching ₩1 trillion in 2025. In particular, the investment will be concentrated on securing core technologies such as mRNA (messenger ribonucleic acid) platforms, antiviral drugs, and universal vaccines. ◆Advancing capabilities for infectious disease response= The government’s 3rd-year COVID-19 countermeasures were also presented in the report. The plan is to promote precise, targeted quarantine in infection-vulnerable areas while maintaining daily life. Therefore, targeted distancing measures such as restricting visits and prohibiting outdoor visits or stays will be implemented in vulnerable facilities that have a high frequency of confirmed COVID-19 cases. In order to prevent group infection and progression to severe disease in such infection-vulnerable facilities, preemptive tests for workers will be expanded, and confirmed patients will be promptly treated to prevent further infection or disease progression. Also, access to testing will be reinforced by extending weekend and nighttime operation hours of screening centers (602 centers) and temporary screening centers (6 centers). Also, progression to severe disease in high-risk groups such as the elderly will be prevented by utilizing one-stop medical institutions (currently 12 locations) that can test, treat, and prescribe COVID-19 treatments within one day. As of 00:00, the proportion of COVID-19 patients aged 60 years or older among patients with severe·critical disease and deaths were 86.8% (427 patients) and 91.6% (76 patients), respectively. Also, outpatient prescriptions of COVID-19 treatments will be made possible at the patient's regular hospitals with the allowance of outpatient prescriptions in such hospitals and an increased number of pharmacies that handle COVID-19 treatments. A system for intensive treatment of severely ill patients and rapid response to emergency patients will also be prepared. Communication will also be strengthened. Ki-Seok Jeong, Chairman of the National Infectious Disease Crisis Response Advisory Committee, will be appointed Director-General of Special Response Central Disaster and Safety Countermeasure Headquarters, and will be running and explaining COVID-19-related news to the public in easy terms through the YouTube channel, ‘COVID-19 TV.’ Also, communication with the medical community will be strengthened by operating a city-regional medical consultative body with doctors’ associations in cities and provinces. ◆Expanding essential healthcare through introduction of public policy-based fee system, etc. =Also, the government will work to expand essential healthcare through the introduction of a public policy-based fee system and reform of the national health insurance expenditures to prevent the recurrence of tragedies such as the recent death of the nurse at Asan Medical Center. Essential healthcare refers to services that pose a serious threat to the lives of the people if not urgently provided, or are inadequately provide due to reduced medical demand. A public policy-based fee system will be implemented to strengthen the grounds for essential healthcare, in less-favored areas such as craniotomy for cerebral aneurysms and areas with reduced demand such as pediatrics and childbirth. Compensation for high-risk high-difficulty operations and emergency operations that are less frequent but high-risk such as aortic dissection, heart, and brain surgery that are shunned will be strengthened by increasing the policy-based premium fee. Also, support for the recovery of infrastructure on childbirth will be reinforced through measures such as raising fees and support for vulnerable regions. Also, compensation will be reinforced and infrastructure expanded after evaluating essential healthcare to identify areas in deficit such as children's hospitals. The plan also contained measures to increase the listing of essential healthcare and high-priced drugs through a thorough re-evaluation of existing reimbursed items that cause excessive use such as ultrasound and MRI, the improvement of standards for foreign dependents, and preventing theft of health insurance qualifications.
- Policy
- The PVA exception to COVID-19 cold drug is actively applied
- by Lee, Tak-Sun Aug 22, 2022 05:52am
- Pharmaceutical Industry Says "Response After Gathering Internal Opinions" The Ministry of Health and Welfare said it would actively apply the correction method to the pharmaceutical industry's request to exclude cold drugs used in COVID-19 from PVA. Although it is not excluded from the negotiation, the policy is to actively apply exception rules to prevent damage to drug price cuts. First, the pharmaceutical industry plans to collect opinions on the proposal and respond through a public-private consultative body. However, as the Ministry of Health and Welfare's official position has been reported, the pharmaceutical industry is also expected to consider using the correction method in a more advantageous way. According to the industry on the 18th, the Ministry of Health and Welfare sent an official letter to pharmaceutical organizations such as KPBMA, saying that if the COVID-19 drug is selected for negotiations, it will be actively applied. The KPBMA suggested that COVID-19 drugs be excluded from PVA to actively support the production of COVID-19 symptom treatments. Prime Minister Han Duck-soo said at a meeting of the COVID-19 Central Disaster and Safety Countermeasures Headquarters on the 12th, "As the number of COVID-19 confirmed patients increases, we will encourage and support the expansion of supply and demand of cold medicines such as antipyretics. He said, "We will ease PVA, which cuts prices when the use of drugs increases, so that manufacturers can increase production." The pharmaceutical industry also had some expectations for Prime Minister Han's remarks. The plan proposed by the Ministry of Health and Welfare is interpreted as an extension. The Ministry of Health and Welfare and the NHIS also conveyed their intention to correct the COVID-19 cold medicine in accordance with related regulations through a public-private consultative body, so not all demands from the pharmaceutical industry to be excluded from the negotiation were accepted this time. According to the provisions of Article 10 (2) of the PVA Negotiation Detailed Operation Guidelines, exceptions are made when applying PVA in the case of drugs used to support the treatment of infectious diseases. The Ministry of Health and Welfare explained that if the cold medicine that the Ministry of Food and Drug Safety encourages production for the treatment of COVID-19 is selected as a PVA target, the relevant regulations will be actively applied. When calculating the negotiation reference price, the amount of use prescribed for COVID-19 treatment is excluded, or the amount of use at a specific time (e.g., February to August) is excluded. However, the correction method will be decided after sufficient discussion with related associations through a public-private consultative body. The pharmaceutical industry plans to seek countermeasures after internal discussions. An official from the Pharmaceutical Association said, "We would like to hear the opinions of pharmaceutical companies on the proposal of the Ministry of Health and Welfare and communicate with the government through a public-private consultative body at the end of the month." As the government's policy has become official, the industry is expected to discuss countermeasures accordingly. This is because the demand to continue to be excluded from the negotiation target may work against the discussion process.
- Policy
- Manufacturing for development allowed during suspensions
- by Lee, Hye-Kyung Aug 19, 2022 05:53am
- An interpretation that manufacturing activities for the purpose of product development, not for commercial sale, is possible during the manufacturing business suspension disposition period. According to industry sources on the 18th, the Ministry of Food and Safety announced that not-for-sale manufacturing activities, such as those for product development or to prepare data for approval changes, are allowed during the manufacturing suspension period. This interpretation was provided after a number of queries on 'whether manufacturing for the purpose of product development is allowed during the suspension of manufacturing business period, and whether such manufactured units can be sold,’ were submitted on the national e-petition website, e-People. According to Article 76 of the Pharmaceutical Affairs Act, if a manufacturer of drugs or its importer violates the Pharmaceutical Affairs Act or any order issued under the Pharmaceutical Affairs Act, the Minister of Food and Drug Safety may revoke permission, approval, or registration held by the manufacturer of drugs, issue an order to prohibit manufacturing or importing products, or issue an order to fully or partially suspend his or her business for a period of up to one year. Also, according to Article 95, Annex 8-10 of the ‘Regulation on Safety of Medicinal Products,’ if companies perform the suspended business during the suspended period, their license or registration may be revoked. Regarding the provisions, the industry posted an inquiry on the e-People website on whether companies subject to manufacturing suspension dispositions may conduct manufacturing activities for the purpose of preparing submission data for the product’s approval change (change of consignee) or product development (and if allowed, whether the manufactured lot may be sold). After review, the MFDS said, “acts of manufacturing for non-sale, product development purposes (to prepare data for approval changes, etc.) are allowed during the manufacturing suspension period. However, the sale of the lot manufactured for approval changes, etc. or product development during the manufacturing suspension period is not allowed."
- Policy
- We need to increase the rate of PO tx for COVID-19 crisis
- by Lee, Jeong-Hwan Aug 19, 2022 05:53am
- In order to respond to the increase in the number of patients with COVID-19, it was pointed out that the prescription rate of treatments such as Paxlovid should be raised more than now, while continuing to maintain an environment where prescriptions are quickly prescribed. It was also suggested that the fast track of the COVID-19 high-risk oral drug prescription currently prepared by the government should be repeatedly checked, and the fast track system should not be predicted to continue to be sustainable. On the 17th, Jeong Ki-seok, chairman of the National Advisory Committee on Infectious Disease Crisis Response, made this announcement at a regular briefing on COVID-19. Chairman Chung Ki-seok positively assessed that the prescription rate of oral treatments, which stood at only 4% earlier this year, has now risen to 20%. Chung's assessment is that the prescription rate of PO drugs must rise steadily to be effective in responding to critical patients. He stressed that it is very important to secure a system that can prescribe PO drugs quickly and continue to check. Chairman Chung said, "The government is preparing a lot of PO drugs, but the medicine does not solve it." He said, "The system that can be prescribed the fastest in the right time is important. This is why experts strongly recommended fast-track operation to the government," he explained. Chairman Chung added, "We are operating a fast track, but the government should check for other system that allows high-risk groups to receive treatment first and receive treatment first," adding, "We should not predict that this will continue to be sustainable just because we have it in place." The Ministry of Health and Welfare announced that it will do its best to secure additional medical institutions and pharmacies handling oral drugs. Currently, there are only 274 places that prescribe treatments taken at or above the general hospital level and only 7 upper-level general hospitals. Park Hyang, head of the central disaster management headquarters, said, "There are about 10,000 one-stop hospitals, but it is true that the number of high-level general hospitals or general hospitals that can be opened at night is small." There will be more medication in the future," she said. "I heard opinions on why the drug progress is slow at the medical field, and there were problems with pharmacy issues and outpatient prescriptions," Park Hyang said. "In the case of Paxlovid, it seems still difficult to combine them." "Although 2,000 pharmacies have been previously secured, we are preparing to designate additional pharmacies at any time if there is an additional on-site request," she said. She added, "We will continue to listen to opinions from the medical field and supplement them."
- Policy
- KDCA opposes use of Paxlovid in healthy 50s
- by Lee, Jeong-Hwan Aug 18, 2022 05:48am
- The disease control and prevention authorities have expressed opposition to the plan to lower the prescription age for Pfizer’s oral COVID-19 treatment, Paxlovid, to those in their 50s, on grounds of domestic Emergency Use Authorization standards. The decision was influenced by the fact that eligibility for Paxlovid had already been extended to those over the age of 50 with underlying diseases and that no efficacy evaluation results exist for its use in healthy adults in their 50s. On the 16th, the Korea Disease Control and Prevention Agency said, “Paxlovid can be prescribed to patients aged 12 years or older including those in their 50s that have risk factors such as underlying diseases.” NA Health and Welfare Committee member Jong-Seong Lee of the People Power Party had pointed out the need to review lowering the prescription age for Paxlovid to those in their 50s. Paxlovid is currently granted emergency use without an official marketing authorization in Korea. Under the EUA, patients who are confirmed with mild-to-moderate COVID-19 and are at high risk for progression to severe disease must satisfy additional standards to receive Paxlovid. The patient must additionally satisfy one or more of the following standards: 60 years or older who are immunocompromised, or 40 years or older with underlying diseases (diabetes, cardiovascular diseases, chronic kidney diseases, chronic lung disease, BMI over 30kg/㎡) The KDCA, which made the decision to expand Paxlovid’s eligibility to those in their 50s with underlying diseases in February (effective from February 7th), expressed skepticism on increasing the scope to those in their 50s who do not have underlying diseases. The KDCA said, “The subjects eligible for Paxlovid's use were set based on the efficacy evaluations results within the Emergency Use Authorization granted by the Ministry of Food and Drug Safety, in patients with risk for progression to severe disease because Paxlovid was found effective in the set target group.” The KDCA added, “Also, if a patient has risk factors such as underlying diseases, etc.. patients not only over the age of 50 but those who are 12 years or older may be prescribed Paxlovid.”
- Policy
- Why is price different btw patent-expired original/generic
- by Lee, Tak-Sun Aug 18, 2022 05:47am
- The drug price will be lowered to 53.55% of the existing upper limit from the 22nd after losing an administrative lawsuit against the drug price lowered by the anticoagulant Xarelto with the government. As a result, it will be the same as the highest price of generics registered last year. However, the drug price of Xarelto 10mg is expected to be about 20 won higher than the original. What is the reason? First, Xarelto 10mg immediately before generic registration was higher in drug price than Xarelto 15mg or Xarelto 20mg. The original three dosages were the same at 2,626 won at the time of initial registration, but just before the generic registration in July last year, the price of Xarelto 10mg was 2,487 won for Xarelto 15mg and Xarelto 20mg was 2,450. This seems to be a strategy to increase the main capacity of 10mg more. However, as the original low dosage exceeded the high-capacity drug price, the generic drug price needed to be adjusted. This is because the upper limit of low-doset products is calculated to be below the upper limit of high-content products if products with the same company, administration path, ingredients, and formulations are already listed. For this reason, the highest price of Xarelto's generic 10mg was registered at 1,312 won which is the same as Xarelto's generic 15mg and 20mg. The original Xarelto is reduced to 53.55% by calculation formula, making 15mg and 20mg the same as the generic high at 1,312 won, while 10mg becomes Xarelto 1,332 won. In 2012, the principle of patent expiration original-generic identification collapsed due to changes in drug price policy. Since the price difference between the original and generic is not large, the impact on the market is expected to be insignificant. In addition, if a generic that meets the standard requirements and registers only 10mg of Xarelto alone is released, the original upper limit is expected to be the same.
- Policy
- KDCA will announce its plan to inoculate bivalent vaccine
- by Lee, Jeong-Hwan Aug 17, 2022 05:52am
- The domestic quarantine authorities plan to announce vaccination plans at the end of this month, including the subject and use of Moderna's bivalent vaccine for COVID-19 omicron. Moderna bivalent vaccine is still in the pre-application stage, and the intention is to make a plan for use in consideration of the effectiveness and safety of vaccines as well as the quarantine situation and the amount introduced in Korea. Baek Kyung-ran, head of the Korea Centers for Disease Control and Prevention, answered reporters' questions at a regular briefing on COVID-19 on the 16th. Moderna's bivalent vaccine "Moderna COVID-19 Spikevax," called the Omicron vaccine, has been officially approved by British health authorities for the first time in the world on the 15th (local time). Specifically, MHRA conditionally approved the use of Moderna bivalent vaccine for additional inoculations (booster shots) for adults. This is the first time that the Omicron variant COVID-19 vaccine has been officially approved by a government agency. The vaccine is effective in preventing both the early round virus that caused the COVID-19 pandemic. Korea is conducting a preliminary evaluation of Moderna bivalent vaccine, and plans to announce a domestic vaccination plan as soon as the official approval review is conducted. Director Baek Kyung-ran said, "We are currently conducting a preliminary evaluation at the request of Moderna regarding Moderna bivalent vaccine. We haven't started any formal deliberations yet," she said. As soon as the review application proceeds, we will announce the use plan at the end of August, considering the effectiveness and safety of the improved vaccine, as well as the quarantine situation, introduction schedule, and quantity.
- Policy
- Novavax vaccine approved for use for 12+ years in Korea
- by Lee, Hye-Kyung Aug 17, 2022 05:52am
- The age eligibility of Novavax’s COVID-19 vaccine will be extended. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the Post Approval Change Application for the COVID-19 vaccine ‘Nuvaxovid Prefilled Syringe,’ developed by Novavax and manufactured by SK Bioscience, to change the vaccination age from the previous 18 years older to 12 years or older. Nuvaxovid in teens aged 12 to 17 years will be administered as two 0.5ml doses three weeks apart, the same as the dosage and administration approved for those aged 18 years and older. The MFDS determined it was appropriate to extend the allowed age of administration for Nuvaxovid based on clinical data from a trial conducted on adolescents aged 12 through 17 years. Trial results showed that adverse events observed in those aged 12-17 after receiving Nuvaxovid were generally similar to those in people aged 18 years and older, and were well-tolerated. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, malaise, nausea, arthralgia, etc. The symptoms were mostly mild or moderate and disappeared within a few days after vaccination. Nuvaxovid showed a 79.5% preventive effect on 1799 subjects (1,205 in the vaccine group, 594 in the placebo group), 6 of which in the vaccine group and 14 in the placebo group were confirmed with COVID-19, 7 days after the second vaccination. Also, the neutralizing antibody titer in 400 subjects who were not infected with COVID-19 two weeks after the second vaccination showed that the neutralizing antibody titer of those aged 12 to 17 (390 people) was 1.46 times that of those aged 18-25 (416 people), meeting the required standard. The MFDS said, “We will continue making our best efforts to provide safe and effective vaccines to our people.”
- Policy
- Generic exclusivity of Ticagrelor terminated but no benefits
- by Lee, Tak-Sun Aug 16, 2022 05:47am
- Brilinta, original for Ticagrelor Anti-thrombotic Ticagrelor have disappeared, but no news of generic benefit has been heard. Since the expiration of material patents in November last year, six pharmaceutical companies, including Chong Kun Dang, have registered their benefits, but pharmaceutical companies that have obtained generic exclusivity or later approved have been hesitant to register their benefits. This is because manufacturing costs are high and marketability is insufficient. According to the industry on the 13th, the general exclusivity period of Ticagrelor's generic will end on the 20th.No pharmaceutical company has applied for benefits on the premise of sales since that day. Ticagrelor's original drug is Brilinta of AstraZeneca. The drug expired its material patent on November 20 last year, allowing generics to enter the market after succeeding in subsequent patent challenges. Contrary to expectations, only six pharmaceutical companies registered their benefits at the time. They include Chong Kun Dang, Genuonescience, Samjin, Hana, Alvogen, and Hutecs. Like them, there were 18 more pharmaceutical companies that succeeded in subsequent patent challenges and obtained generic for exclusivity, but they did not register their benefits. This is because raw material prices are expensive and marketability is insufficient. They were also excluded from the generic for exclusivity list. An industry official said, "It is analyzed that the growth potential is not high as existing anti-thrombotic drugs competing with Ticagrelor are in good shape." "There are many companies that are worried about the balance of payments due to the high cost of raw materials," he said. Last year, the original Brilinta recorded 9.7 billion won in outpatient prescriptions based on UBIST. Pharmaceutical companies that failed to acquire generic for exclusivity have also received permission, but there is no movement to register their benefits. Even after the generic for exclusivity period is over, products can be sold only when the original drug patent challenge is successful, but few companies are active. Currently, 41 Ticagrelor generic companies are licensed, but none of them are seen in pharmaceutical companies that are considering entering the market except Chong Kun Dang, which is licensed for salt change drugs. Even Hanmi Pharmaceutical, Yooyoung and Korea Prime dropped their licenses this year. Some companies are said to have applied for and withdrawn their benefits.
