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- 2026-04-13 23:21:32
- Policy
- “Mooncare a success…37 million people saved ₩9 tril.
- by Lee, Jeong-Hwan Aug 13, 2021 05:57am
- President Moon Jae-in said the government will continue and accelerate its efforts to further broaden the NHI coverage in 2022 as in this year. Moon also stated that 37 million people in Korea were able to save a total of 9.2 trillion won in medical costs during the 4 years since Mooncare was implemented. Also, he personally announced that insurance benefits on thyroid and sinus ultrasounds will be applied in Q4 of this year, which is earlier than planned, and NHI coverage will be extended to severe heart diseases, psoriasis, and root canal treatment by next year. The news was announced by President Moon at the ‘Performance review meeting for the 4th anniversary of Mooncare’ that was held on the 12th. He assessed that Mooncar, which was announced in 2017, has played an integral part in realizing the goal of building a nation free from worries about hospital bills while exceeding the target level of health insurance reserves. Moon's understanding was that Mooncare is one of the policies that the people were most satisfied with. As such, the president plans to further broaden and accelerate the NHI coverage enhancement policy. Specifically, he pledged to implement NHI coverage to sinus and thyroid ultrasounds from Q4 this year, and to severe heart diseases, psoriasis, and root canal treatment by the next year. In addition, Moon said the government will expand support for children's public centers and establish a short-term hospitalization service center for severely ill pediatric patients to expand NHI support for children. Also, the government plans to designate a regional hospital as a base hospital for critically ill patients from the second half of this year so that the severely ill may receive treatment in hospitals near their residence. Furthermore, President Moon said that the health insurance will prime and accelerate the development of medical technology in Korea and that the government will make the effort to catch both birds – of securing NHI’s sustainability and expanding coverage. “Mooncare not only tended to disease of individuals, but it also allowed us to promptly and appropriately respond to all areas of healthcare related to infectious diseases, from prevention and diagnosis of COVID-19, its treatment expense, to securing support for medical personnel. In other words, NHI well-played its role as the last defender in controlling the COVID-19 crisis. I would like to express my gratitude to the NHIS and medical personnel for their efforts in strengthening NHI coverage.” The president continued, "The government had focused on enhancing coverage for severe diseases that bring a high medical burden such as cancer. We are also in the progress of abolishing the selective consultation fee system, applying insurance to upper-grade wards, expanding the integrated nursing care service, expanding insurance to MRIs and ultrasounds, and reimbursing non-reimbursed drugs. Also, we will institutionalize disaster medical expenses support for 4 major severe diseases in low-income families, and cover up to 30 million won for all diseases and lower the annual copayment ceiling.” “We enhanced the coverage rate for children who are 5 years or younger, as well as for seniors 65 years and older that more frequently visit hospitals. As a result, 37 million people have saved a total of 9.2 trillion won in medical costs. As a high level of citizenship is central to NHI’s sustainability, the government will make efforts to more transparently manage NHI finances.” MOHW·NHIS "will continue enhancing coverage next year” The Ministry of Health and Welfare and the National Health Insurance Service also added on details to support Moon’s performance report on Mooncare. In 2017, the MOHW had presented measures to lower the patients’ burden by reimbursing the medically necessary non-reimbursed items and drastically reducing the medical cost for the underserved population such as the elderly, children, women, and low-income families. ‘ The coverage enhancement measures that were planned to be implemented by 2022 focused on the following three core areas:▲reimbursing the non-reimbursed ▲relieving out-of-pocket costs for the underserved population ▲reinforcing the medical safety net. To reimbursee the non-reimbursed the authorities had abolished the selective consultation fee, and applied insurance to 2-person and 3-person wards in hospital levels or higher medical institutions. The integrated nursing care service was also expanded by over two times. Also, the non-reimbursed items that are necessary for treatment such as ultrasounds and MRI tests were applied insurance in phases to reduce the medical cost. As a result, NHI coverage in tertiary hospitals increased from 65.1% in 2017 to 69.5% in 2019, and coverage in general hospitals also increased from 63.8% to 66.7% during the same period. By easing the medical cost borne by the underserved population, the burden of hospital expenses for children, the elderly, the disabled, and women were reduced. For children, the copayment rate of the hospital treatment cost was reduced to 5% from 10-20%, and the outpatient cost was also reduced for children under the age of 1. The copayment rate for outpatient cost in premature infants and low birth weight infants was also reduced, and insurance was applied to cavity treatment, cleft lip treatment, and orthodontic braces treatment. For the elderly, the copayment rate for the treatment of severe dementia and other major conditions such as dentures and implants was lowered. For the disabled, eligibility in receiving reimbursement for assistive devices was expanded, and the reimbursed amount for prosthetic legs and hands was raised. In addition, in order to strengthen the medical safety net, the upper ceiling of the out-of-pocket cost paid by the bottom 50% of the income class was reduced to a level near 10% of their annual income, thereby increasing the reimbursed amount for low-income families. As a result, about 37 million people saved 9.2 trillion won in medical cost reduction from 2018 to 2020. Positive responses from the public regarding the coverage enhancing measures also jumped from 39.7 % at the time the policy was announced to 94% in August 2020.
- Policy
- Regkirona's indication expansion has been requested
- by Lee, Tak-Sun Aug 13, 2021 05:57am
- Celltrion's COVID-19 antibody therapy Regkirona is pushing for an expansion of indications based on global phase 3. Regkirona was conditionally approved to submit a clinical trial result report for therapeutic confirmation in February and was used only in patients with mild to secondary COVID groups. Celltrion submitted a report on the results of the clinical trial and applied for a change in efficacy from all mild cases over the age of 12 to secondary patients. The MFDS announced on the 10th that Celltrion has applied for a change in permission of the COVID-19 antibody treatment drug Regkirona (Regdanvimab) based on a global phase 3. Changes include ▲ deletion of permission conditions ▲ expansion of effectiveness ▲ reduction of time spent. Celltrion submitted a clinical trial report on August 10, which should be submitted by December 31. Regkirona's effectiveness was conditionally granted only for "improvement of clinical symptoms in patients with mild to secondary COVID-19" in high-risk groups, but it was changed to "treatment for patients with secondary COVID-19 in adults and 12 years of age and older." Celltrion also requested a change in administration time from IV for 90 minutes to IV for 60 minutes. "We plan to quickly and closely examine the application for the change," said an official at the MFDS. "We will continue to do our best to provide safe and effective treatments to our people quickly," he stressed.
- Company
- SGLT-2 inhibitor Forxiga lands in Korea with CKD indication
- by Eo, Yun-Ho Aug 12, 2021 06:05am
- An SLGT-2 inhibitor is soon expected to be available for use in chronic kidney disease (CKD) patients in Korea. According to industry sources, the indication of AstraZeneca’s diabetes treatment ‘Forxiga(dapagliflozin)’ will be expanded to ‘the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes' within a few days. After receiving approval from the US FDA in April, the company had immediately begun the approval process in other major countries including Korea. In September, the company received EMA approval for the additional indication in September. With the indication, Forxiga can be used to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or hospitalization for HF (hHF). The approval of Forxiga’s CKD indication is based on positive results from the DAPA-CKD Phase III trial. The FDA had granted Priority Review for Forxiga earlier this year. In the DAPA-CKD trial, Forxiga reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39% compared to placebo in patients with CKD Stages 2-4 and elevated urinary albumin excretion (UAE) levels. The absolute risk reduction of Forxiga was 5.3% in the 2.4 year median study period. CKD is a progressive condition that affects around 700 million patients around the world. With only a limited amount of treatment options available for CKD patients at present, a new treatment option had been necessary in the field as CKD increases the incidence of cardiovascular events such as heart failure and the risk of premature deaths. Forxiga is currently used as a treatment for Type 2 diabetes and chronic kidney disease. Its competitor, Boehringer Ingelheim’s ‘Jardiance (empagliflozin)’ also received the fast-track designation in the first half of last year and the company is conducting the EMPA-KIDNEY trial to expand the drug's indication like Forxiga. Unlike Forxiga’s DAPA-CKD trial, Jardiance's EMPA-KIDNEY trial includes severe CKD patients.
- Policy
- With Ultomiris, 9 items require prior approval for reimb.
- by Lee, Hye-Kyung Aug 12, 2021 06:05am
- Improvements are expected to be made to the ‘pre-approval' system that may be actively used in the process of reimbursement listings for ultra-high-priced drugs. Starting with the stem cell transplantation procedure in 1992, the Health Insurance Review and Assessment Service (HIRA) has been operating the pre-approval system to deliberate in advance whether an insurance benefit should be applied to high-risk, high-cost, irreplaceable drugs and procedures. With the most recent addition of ‘'Ultomiris inj.,’ a total of 9 items are on the list for deliberation for pre-approval of insurance benefits. The other 8 include ▲ Stem Cell Transplantation; ▲ Immune Tolerance Induction; ▲Soliris Inj. ▲ Implantable Cardioverter Defibrillator& Cardiac Resynchronization Therapy ▲ Ventricular Assist Device therapy ▲Spinraza inj. ▲Strensiq inj. ▲Clinical studies A total of 6,001 cases applied for pre-approval last year, 5,785 of which were approved for reimbursement. The approval rate is high at 96.4%. Among all the cases filed, 79 were disapproved, and 137 were dropped. Excluding Ultomiris, which was added this year as a pre-approval item, the medical and pharmaceutical expenses spent on pre-approval items last year recorded 231.43 billion won. Despite the increase in medical care benefits caused by the added items and the increase in the number of applications, no item has been removed from the list since the system was implemented in 1992. Also, no dedicated department exists for the pre-approval system, raising the need for systemic improvements. Jin-Su Lee, Chair of HIRA who met with the Korea Special Press Association reporters on the 10th, said, “As of last year, the number of applications seeking for pre-approval increased to 6,001 cases for 26,910 people. Therefore, we would need to review adding or removing items subject to the pre-approval, and systemize the approval process.” In other words, HIRA will analyze and review the whole operation process of the pre-approval system and collect the stakeholders' opinions for reflection to come up with a plan for improving the operation of the prior approval system. Kim Moo-sung, director-general of HIRA's Committee Operations, said, “Since the system was implemented in 1992, no items were excluded (removed) from the list. Opinions that items that have been constantly reviewed without change should be switched from pre-approval to the post-approval system have been raised, and we plan to discuss this with the Ministry of Health and Welfare after collecting expert and internal opinions." Regarding newly establishing a department for pre-approvals, Kim said, “Currently, 10 people in 2 teams are in charge of the prior approval review. With the government requesting more items to be added to the pre-approval list this year, the committee agrees on the need for a dedicated department that manages the pre-approval system.” Kin added, “We will discuss newly establishing an independent department for the pre-approval system with relevant departments during the next reorganization process."
- 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.
