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- 2026-05-18 18:57:47
- Policy
- A review of Hemlibra's benefit without ITI is under way
- by Lee, Hye-Kyung Aug 12, 2021 06:05am
- The HIRA is reviewing the benefit criteria for JW Pharma's hemophiliac injection Hemlibra (Emicizumab). Currently, patients aged 1 and older and under 12 years of age may be re-administered if they fail the Immune Tolerance Induction (ITI) or if they meet the ITI target criteria (Trial 2020-164, 2020. 6.1.), or if they are unable to try, or if an antibody is re-implemented in ITI. Therefore, patients with severe type A hemophilia under the age of 12 must receive ITI over two to three years in order to receive Hemlibra's benefits. Some medical institutions wrote a report on pediatric patients who could not attempt ITI and asked the Heartlands for their benefits, but they did not acknowledge their benefits due to "insufficient objective data such as efforts to secure sufficient intravenous blood vessels. In the first half of this year, the MOHW and the HIRA also expressed their intention to review the standards, judging that Hemlibra's benefit standards were problematic at the National Assembly and Anti‑Corruption and Civil Rights Commission. In this regard, Lee Jin-soo, chairman of HIRA's medical review and evaluation committee, said at the Korea Special Press Association on the 10th, "The revision of Hemlibra notification is under way." "The implementation of ITI is a priority, but we are preparing for a revision notice for patients," he said. Hemlibra, meanwhile, is eligible for benefits from 5BU (Bethesda unit)/mL or higher in patients with severe hemophilia (less than 1% coagulation factor activity) with Factor VIII inhibitor since June 1 last year.
- Policy
- President called for stronger health insurance coverage
- by Kang, Shin-Kook Aug 12, 2021 06:04am
- President Moon called Yong-Ik Kim, President of NHIS and Sun-min Kim, Executive Director of the HIRA to discuss the results of measures to strengthen health insurance coverage and supplement the people's benefits at meeting with his senior secretaries on the 9th. President Moon presides over Meeting with His Senior Secrets (provided by Cheongwadae) President Moon ordered, "In case of not receiving medical benefits due to concerns over COVID infection, please carefully examine and review measures." He said, "The number of people visiting hospitals has decreased due to compliance with quarantine rules such as washing hands and wearing masks, which may have improved the financial status of health insurance, but they may not receive medical benefits." He also called for ways to revitalize the operation of dementia safety centers. In addition, he said, "Consider the current non-reimbursed items in health insurance so that they can be guaranteed treatment methods using new medical technology." "The government supports vaccination of pneumonia, but please consider ways to support vaccination of diseases such as shingles," he said. He pointed out that it is not easy to maintain children's hospitals due to insurance price issues, saying, "Consider comprehensive support for children's hospitals." Four years ago today, strengthening security policy (Moon Jae-in care) health insurance was announced.
- Company
- Eybelis can be prescribed at general hospitals
- by Eo, Yun-Ho Aug 11, 2021 05:58am
- The new glaucoma treatment ‘Eybelis’ that has been released can now be prescribed at general hospitals in Korea. According to industry sources, Santen Pharmaceutical Korea’s selective EP2 receptor Eybelis Ophthalmic Solution (Omidenepag Isopropyl) has recently passed the review of drug committees (DC) in two of the ‘Big 5’ major hospitals in Korea - the Seoul National University Hospital and the Samsung Medical Center. Eybelis is a treatment for open-angle glaucoma and ocular hypertension that contains the active pharmaceutical ingredient omidenepag isopropyl, which has a non-prostaglandin structure that lowers intraocular pressure with a new mechanism of action. Omidenepag Isopropyl is a receptor agonist that selectively works on EP2, a type of prostanoid receptor. The omidenepag ingredient reduces intraocular pressure by binding to the EP2 receptor and improving drainage of uveoscleral and trabecular outflow. Eybelis has the benefit of not developing cosmetic side effects such as prostaglandin-associated periorbitopathy (PAP), which includes upper eyelid ptosis, hyperpigmentation of the skin, elongation of eyelashes, and changes in iris color that occur with the long-term use of FP receptor antagonists that are most commonly used as first-line treatment. Also, the company explained that in glaucoma patients that require long-term treatment, Eybelis has the advantage of providing a superior intraocular pressure-lowering effect while improving the development of cosmetic side effects compared to existing treatments with a convenient, once-daily administration as a monotherapy. Eybelis has been listed for insurance benefit in Korea at a price cap of ₩13,628 since February.
- Policy
- # of subjects in Phase 3 of SK's COVID vaccine is 93
- by Lee, Tak-Sun Aug 11, 2021 05:58am
- SK Bioscience researcher is conducting research to develop vaccines When looking at SK Bioscience's clinical plan for "GBP510," which entered phase 3 for the first time as a vaccine developed in Korea, the number of people tested in Korea was 93. This is only 2.3% of 3,990. The MFDS recommends that domestic test subjects recruit more than 10% of the total subjects for domestic development vaccines, which is not enough. Accordingly, SK Bioscience said, "There are 93 test subjects in Korea based on the approved plan," adding, "Nothing has been decided yet." The clinical trial plan for SK Bioscience's COVID-19 vaccine "GBP510," approved by the MFDS on the 10th, contains this. GBP510 is a recombinant vaccine that injects surface antigen protein of COVID, which is made using genetic recombination technology, to induce immune responses. When surface antigen protein is administered, it stimulates immune cells in the body to induce the production of neutralized antibodies, and neutralizes and removes the virus when COVID enters the body. In particular, it increases immune effects by exposing antigens to produce a lot of antibodies. The vaccine includes GSK's immune enhancer "AS03. In January, SK Bioscience received approval for phase 1/2 and is currently completing phase 1 and proceeding with phase 2. It was planned to recruit 320 people (80 people for phase 1 and 240 for phase 2). According to the company, as a result of phase 1 administering GBP510 to 80 healthy adults, antibodies that neutralize COVID were formed in the entire dosing group, which was administered with immune enhancers, showing 100% neutral antibody formation rate. The level of inducing neutralized antibodies is five to eight times higher than that of serum panels of people cured of COVID-19. In terms of safety, no significant adverse event has occurred that is related to the administration of GBP510. It is also explained that 247 participants in phase 2, which includes elderly people, have completed the second injection in late June and are monitoring safety, and no special safety issues have occurred so far. Based on the interim results of phase 1/2, SK Bioscience applied to the MFDS for phase 3 in June. Phase 3 is conducted in multi-agency, parallel comparison, observer blindfolding, active contrast, and random allocation to evaluate the immunogenicity and stability of COVID-19 vaccine using immunosuppressive AS03 in adults over the age of 18. To confirm this, it is conducted in a comparative clinical manner with AZ vaccine. The test vaccine will be given to 3,000 people out of 3,990 test subjects, and the control vaccine will be given to 990 people twice every four weeks, 0.5ml each. The number of test subjects in Korea was 93 people. This is not more than 10% of all test subjects recommended by the MFDS. The MFDS recommended in its comparative clinical guidelines for the domestic COVID vaccine that multinational clinical trials, including more than 10% of the domestic population, are possible. However, SK Bioscience said that there are 93 subjects in the plan, but nothing has been decided yet. Clinical trials will be conducted in South Korea, Southeast Asia, and Eastern Europe. It will be held at Korea University Medicine, Ewha womans university medical center, KNUH Chilgok, Hallym University Medical Center, Severance Hospital, CNHU, KNUH, Dong-A university hospital, Inha university hospital, Ajou University Hospital , Korea University Ansan Hospital, Korea University Guro Hospital. It is expected that interim analysis results of Phase 3 will be produced as early as the first quarter of next year. Based on this, the MFDS plans to conduct a quick review.
- Company
- Changes after Pfizer and Moderna vaccines' full approval
- by Aug 11, 2021 05:58am
- Expectations are rising that COVID-19 vaccines of multinational pharmaceutical companies such as Pfizer-BioNTech and Moderna will receive full regulatory approval early next month. If the vaccines are formally approved, what changes will we see in the current landscape where people worldwide are already receiving vaccinations under the EUA? Pfizer and Moderna’s COVID-19 vaccines are the most widely used vaccines around the globe. Both have received the Emergency Use Authorization (EMA) from the US Food and Drug Administration (FDA) in December last year. Janssen’s vaccine also received the EUA approval in February this year. However, no COVID-19 vaccine has been formally approved after submitting a Biologic License Application (BLA) to the FDA. Among the three EUA-issued vaccines, Pfizer and Moderna have been taking steps for the full regulatory approval of their drugs since May and June, respectively. EUA is granted when no preventive therapies or treatments are currently available, and a product in development is known to be effective or has potential benefits that outweigh the known and potential risks. However, the EUA only remains effective during a public health emergency. In other words, when the government lifts the declaration of the COVID-19 pandemic, vaccines that are not fully approved cannot be used for vaccination. A company seeking a BLA for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials. Unlike EUAs, the procedure requires extensive paperwork, which takes months to review. Unlike EUAs that only require a minimum of two months’ worth of follow-up data, the full approval requires at least six months of follow-up data. In addition, the regulatory authorities require more detailed CMC data in the manufacturing process and quality control in a BLA submission. Simply put, the full approval process with a BLA requires an average of ten times more data than the EUA submission. Nevertheless, perks do exist for receiving full regulatory approval. If one vaccine receives full approval, it can enjoy exclusivity. The EUA system is operated under the premise that there are no adequate or available vaccines, therefore, with a rollout of qualified, fully approved vaccines, the FDA will not be able to issue EUAs to latecomer vaccines. The fully approved vaccines can also be considered for off-label prescriptions. Physicians, under their own discretion, may choose to prescribe vaccines off-label to subjects that are not indicated under the EUA, such as adolescents under the age of 12. Also, the fully approved vaccines can be used regardless of the pandemic period, and if Pfizer and Moderna have a fully approved vaccine, the companies will have an easier time receiving approval for their booster shots that are in development. In particular, a full approval by the FDA may greatly influence approvals and reviews in other countries. Also, from the health authorities’ perspective, a fully approved vaccine can improve a nation’s vaccination rate, as the ‘full stamp of approval’ works as grounds for persuading some portion of the public that were reluctant in receiving vaccinations due to concerns over side effects. Also, vaccination cannot be mandated under EUA, but if a vaccine is fully approved, it will speed up mandating vaccines in companies, schools, and government agencies. For these reasons, the US FDA is speeding up its review process to fully approve the first COVID-19 vaccine in early September. The FDA is comprehensively reviewing the COVID-19 vaccines’ real-world data such as the efficacy, immune response, reduction over time, new infections in clinical trial participants, etc., as well as factory inspection data for the BLA. The authorities are also reviewing the use of booster shots on whom and when the booster shots are needed, and what vaccines may be used as booster shots. An official from the Korea Biotechnology Industry Organization explained, “The full approval may bring various ripple effects in terms of increasing the vaccination rate and market expansion. That is why pharmaceutical companies spend the additional cost and time to seek full approval and why the Biden administration supports BLA submissions."
- Policy
- South Korea recovered Sartan products with AZBT impurities
- by Lee, Tak-Sun Aug 11, 2021 05:58am
- The recovery of Sartan medicines containing 'AZBT' has also begun in Korea. Three products containing Irbesartan, manufactured in 2021, were voluntarily recovered by related pharmaceutical companies. Starting in Canada in May, recovery of Sartan containing AZBT is spreading around the world to Europe and Asia. The MFDS announced on the 6th that it would voluntarily collect three Irbesartan-containing items (Rovelito, CoAprovel, and Aprovel) manufactured before 2021. Sanofi, which supplies Irbesartan in Korea, pre-emptively delivered to distributors and vendors that it would voluntarily recover Irbesartan products produced before January 2021. Sanofi explained why the impurity (AZBT) produced since January 2021 is managed below the acceptable limit, but the previous manufactured batch of finished products was recovered because it needed time to derive test results. The recovery of Sanofi is due to the imminent submission of test results ordered by the Ministry of Food and Drug Safety. Also, the fact that recovery began in Europe affected it. Azido methyl bipheny Tetrazole (AZBT) is a genetic mutation that is believed to occur in the synthesis process of Sartans, a treatment for hypertension. It is different from the carcinogen NDMA detected in Valsartan in 2018. Valsartan has been temporarily recovered and stopped selling all items due to NDMA detection. In the following year, drugs containing Ranitidine were also banned from selling or recovered from NDMA. The AZBT issue began at the end of May when Canada's Federal Health Department voluntarily recalled three ingredients of drug products from nine pharmaceutical companies, including Teva and Sandoz, including Losartan, Valsartan, and Irvesartan. Since then, Korea's Ministry of Food and Drug Safety has also requested the AZBT impurity evaluation and test results to be submitted by the 14th of the month at medicines containing Losartan, Valsartan, and Irbesartan ingredients in early June, and the AZBT test results for all finished product lot numbers by the 31st of the month. This recovery in Korea has been confirmed in a test inspection of finished products since January 2021, but it seems that it was carried out preemptively because the test results did not secure the time of submission. It also appears that recalls of some products containing Losartan, Valsartan and Irbesartan began in some European countries, including the United Kingdom and Spain, last month. Industries are paying attention to the rest of South Korea's generic items that will be affected by the recovery of the original products. Currently, there are 55 products containing Irbesartan licensed in Korea. Also, not only Irbesartan but also Losartan and Valsartan are eligible for recall. This is because not only Canada but also Europe contained all three ingredients. The key is whether to secure the test results. In addition to Irbesartan, many prescriptions from Valsartan and Losartan are expected to cause inconvenience to pharmaceutical companies and medical institutions. However, foreign authorities that conduct recovery recommend not to stop administration of patients, saying that only some lot numbers are recovered and the impact on the human body is unknown.
- Policy
- Incentive-paid items for generic substitution fell to 12,757
- by Lee, Hye-Kyung Aug 11, 2021 05:58am
- 12,757 items were found to be eligible for incentives of 30% of the difference in drug prices if pharmacies dispense generic substitution, which is cheaper than prescription drugs. It decreased 48 items compared to the previous month. The HIRA recently guided the 'Billing Method of Drugs Subjected to Incentives for low-price generic substitution in August'. As of August, 25,745 items were listed on the drug benefits, with 49.5% of the drugs available for generic substitution. Among Metformine and Ranitidines, 203 items of drug sales and suspension are excluded from incentive payments. The generic substitution to low-cost drugs is a system that allows pharmacies to get back 30% of the difference in drug prices. If the doctor's prescription medicine was ₩1,000, and the pharmacist makes generic substitution with a low-cost ₩700 medicine, he will be offered ₩90, which is 30% of the difference in drug prices (₩300). Pharmacists can substitute medicines that are the same active ingredients, and are cheaper than those prescribed by doctors or dentists. In the case of syrup, etc. according to the maintenance of the drug benefit list from January 2016, the main ingredient code and representative code should be checked as the main ingredient code changes according to the production standard (total content). The review was postponed once at a welfare committee meeting in April after the proposed amendment to the Pharmaceutical Law, which allows doctors, dentists or the HIRA to make post-notifications at the National Assembly to revitalize the Generic infrastructure. The Health and Medical Development Council, which participates in the government and medical organizations, is preparing a plan to utilize the generic substitution post-notification DUR system.
- Company
- Reimbursement for Kymriah will be deliberated by CDRC
- by Eo, Yun-Ho Aug 10, 2021 05:54am
- The discussions on listing the ultra-high-priced, one-shot treatment ‘Kymriah’ for health insurance benefits will begin. According to industry sources, Novartis Korea’s first-in-class CAR-T (chimeric antigen receptor-T) treatment will be put as an agenda for deliberation in September at Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) meeting. Kymriah, which was approved in March in Korea, used the ‘approval-benefit appraisal linkage system’ to promptly apply for insurance benefits. However, the agenda was not put up for deliberation by the Cancer Disease Review Committee last month, which gave rise to harsh criticism from the Korea Leukemia Patients Organization (KLPO) to the government and Novartis on the delay in reimbursement. Kymriah will be put as an agenda for deliberation at the next CDRC meeting, but what the results will be is difficult to predict. With a single shot of the drug costing 500 million won, whether the agreement can be reached smoothly between the government and the pharmaceutical company remains unclear. However, if Kymriah is listed for insurance benefits, the drug is expected to be quickly prescribed at hospitals. Among the ‘Big-5’ tertiary hospitals of Korea, Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital are in the process of acquiring the ‘human cell management business approval’ from the Ministry of Food and Drug Safety, and the Samsung Medical Center (SMC) already obtained approval. As such, hospitals have been rapidly preparing the environment to prescribe Kymriah. In the Seoul National University Hospital, Kymriah (tisagenlecleucel) passed the drug committee (DC) review in April, and the drug is also expected to land in Samsung Medical Center in May. Kymriah developer Novartis has allowed general hospitals to receive payment for the ancillary costs by establishing Kymriah centers in their institutions. SMC and SNUH will open their Kymriah centers in May, and other tertiary hospitals are expected to follow. To establish the center, hospitals are first required to receive a permit for the human cell management business under the newly implemented ‘Advance Regenerative Bio Act.’ CAR-T therapy takes a different approach in its method of treatment. Unlike conventional drugs that are produced as finished products, for CAR-T, the hospital first collects T cells from the patient's white blood cells, then freezes and sends them to a manufacturing facility. At the facility, the T cells are genetically engineered to express the chimeric antigen receptors (CARs) that allow the T cells to recognize tumor cells, cultivated, then sent back to the hospital. In other words, after the hospital sends the raw material (patient’s T cells) to the company, the company makes the finished ‘Kymriah’ product with the raw material and sends it back to the hospital. The hospital maximizes the effect of Kymriah by using lymphodepleting chemotherapy to reduce the white blood cell count in advance. After 4-5 weeks, the processes are all complete, and Kymriah is finally infused into the patient. “Relapsed/refractory ALL patients are very rare in Korea, however, these few young patients that are diagnosed every year are in the fight for their lives,” said Chuhl Joo Lyu, professor of pediatric Hematology-Oncology at Severance Hospital. “As in the cases seen overseas, the government, pharmaceutical company, and the medical community should work together to create an environment for these young patients to enable timely treatment with Kymriah.” Kymriah is the first CAR-T therapy and the most expensive drug in Korea up to date. The drug is indicated for adult patients with diffuse large B cell lymphoma (DLBCL) and young adult and pediatric patients with acute lymphoblastic leukemia (ALL). Both indications are for late-stage patients that are in relapse post-transplant or in second or later relapse after two or more lines of therapy.
- Policy
- Pfizer is working hard to introduce Prevenar-20 in Korea
- by Lee, Tak-Sun Aug 10, 2021 05:54am
- Prevenar-13 Pfizer, which supplies Prevenar-13, pneumococcal vaccine that ranks overwhelmingly at the top of the domestic market, is also working hard to introduce the next-generation vaccine. It started clinical trials for East Asians to introduce Prevenar-20, which was approved by the U.S. Food and Drug Administration (FDA) in June. Prevenar-20 has a preventive effect on seven additional pneumonia streptococcus aureus serotype in Prevenar-13. Pfizer Korea received approval from the MFDS on the 30th of last month for phase 3 for PF-06482077. It is a candidate for the 20-valent pneumococcal vaccine developed by Pfizer. On June 8, the U.S. FDA approved the product name Prevenar-20. The vaccine is used to prevent invasive diseases and pneumonia that occur in adults aged 18 and older with 20 types of streptococcus aureus serotype. Prevenar-13 currently on the market prevents 13 serotypes, including 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. Prevenar-20 is known to prevent seven more serotypes, including 8, 10A, 11A, 12F, 15B, 22F and 33F. The clinical trial, approved by the MFDS, is interpreted as a test to see the effectiveness of adults in the region to be released in East Asia, including Korea. Clinical trials are conducted in Japan, Korea, and Taiwan to assess the safety and immunogenicity of the 20-valent pneumococcal vaccine for adults aged 60 or older. The total number of test subjects is 1,400, with 500 participating in Korea alone. Clinical treatment will be carried out at 12 medical institutions, including AMC in Seoul. Based on this clinical trial, Pfizer is likely to apply for permission in Korea. As Prevenar-13 currently has an overwhelming market share of 90%, sales are expected to rise as soon as Prevenar-20 is released. Last year, Prevenar-13 imported $73.94 million, more than doubling from $35.3 million a year earlier. This is attributed to the increased demand for pneumonia prevention due to COVID epidemic. Pfizer's competitors are also introducing next-generation vaccines. Pneumoccal 15-valent Conjugate Vaccine Vaxneuvance by MSD was approved on the 16th of last month. Astellas is also working on the development of Pneumococcal 24-valent Conjugate Vaccine.
- Company
- Marken establishs a cGMP cold-chain center in Korea
- by Nho, Byung Chul Aug 10, 2021 05:54am
- Image of Marken’s cold-chain logistics center that will be established near the Incheon Airport in October this year A cGMP compliant cold-chain center for the distribution of pharmaceuticals that will soon be complete in Korea is receiving attention. According to industry sources, the global biopharmaceutical·clinical trial logistics company Marken and its parent company UPS have worked together to establish a 1,000-pyeong cold chain storage and distribution center in Korea. The center will be completed in October. The importance of the cold-chain system has emerged in the process of distributing COVID-19 mRNA vaccines. Marken’s establishment of the new distribution center near the Incheon Airport is expected to contribute to the establishment of an upgraded biopharmaceutical distribution standard in Korea. An official from Marken Korea said, “To respond quickly to the surge in demand for cold-chain storage and shipping of pharmaceuticals in Korea and abroad, the company had begun construction of a GMP-compliant pharmaceutical storage and distribution center in June, which will be complete in October this year.” The Marken Cold-chain Distribution Center will be around 3305 square meters (approximately 1000 pyeong) and be equipped with various facilities suited for storage of clinical drug products, medical devices, vaccines, and biologics that require temperature control at room temperature (+15 to +8°C) or refrigeration (+2 to +8°C), freezing (15 to -25°C), and cryogenic (-80°C) storage. In addition, a liquid nitrogen (LN2) storage unit will also be prepared for the exclusive storage of cell and gene therapies. Marken has a logistics network in 17 countries in the Asia-Pacific region. With the opening of the Incheon Airport logistics center, the company will have a total of 7 GMP cold-chain drug storage facilities, 4 liquid nitrogen filling locations, and 2 clinical kit production facilities in Asia. Marken currently manages 110,000 cold-chain drug product and biological sample shipments every month in more than 220 countries around the globe. The company uses a GPS tracking system to track the route of all products in real-time and operates a 24-hour global control center that monitors and manages the tracking system. Also, the company offers differentiated and specialized services such as validation for the full course from storage, distribution to shipment of pharmaceuticals, and regulatory and compliance consulting services for each country. For more information on the storage and distribution of pharmaceuticals products in Korea and overseas, please contact info@marken.com.
