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- 2025-12-22 05:56:45
- Policy
- HIRA, established a management system for high-priced drugs
- by Lee, Tak-Sun Dec 19, 2022 04:34am
- Medical institutions submit administrative information and response evaluation results to the Board of Audit and Inspection. The HIRA (Director Kim Sun-min) announced that it has been operating a "high-priced drug management system" since the 12th to increase the work efficiency of analyzing the results of response evaluations for patients receiving high-priced drugs and to facilitate data submission. It is explained that the high-priced drug management system was promoted to analyze and monitor the entire administration process from administration information of ultra-high-priced drug administration patients such as Kymriah and Zolgensma to response evaluation of drugs. Medical institutions that claim expensive drugs log in to the "care institution work portal" and fill out and submit "administration information and response evaluation results" according to the drug-specific evaluation form, and the application will be completed after inspection by the evaluation agency. Looking at the evaluation period by drug, Kymriah submits it for one year every six months and Zolgensma for five years every six months. Medical institutions that administer ultra-high-priced drugs such as Kymriah and Zolgensma, which were registered this year, were cumbersome and uncomfortable by submitting patient-specific administration information by e-mail, but it was improved by directly entering or uploading data according to the system. It is explained that the administrative convenience of medical institutions' submission of data has been increased, and the HIRA has improved work efficiency as accurate data can be collected through real-time data checks. Recently, as social demands for expensive new drugs with high treatment effects are increasing, there is a need to strengthen patient access and secure the sustainability of health insurance through proper management of expensive drugs. In response, the HIRA Pharmaceutical Management Office established a salary management roadmap for the proper management of high-priced drugs in July and formed a dedicated organization to prepare a driving force for the post-management of high-priced drugs. In the future, it will lay the legal foundation for the stable promotion of high-priced drug performance management by specifically defining the targets for high-priced drug management, follow-up management period, and billing method. "The establishment of a high-priced drug management system is the first step to establish a performance-based follow-up system for ultra-high-priced new drugs," Yoo Mi-young, head of the drug management office, said. "The performance evaluation results will be used as data to calculate the NHIS's drug refunds and contribute to securing health insurance sustainability."
- Policy
- Discard Moon Care Policy
- by Lee, Jeong-Hwan Dec 19, 2022 04:34am
- President of Yoon Suk YeolPresident Yoon Suk Yeol announced a normalization policy, emphasizing the necessity and urgency of reforming the health insurance system. Analysts say that it has virtually formalized the abolition of the policy to strengthen health insurance coverage, which is the core of the so-called "Moon Jae-in Care" promoted by the previous government. "We urgently need to normalize health insurance, the last bastion of protecting public health," President Yoon Suk Yeol said in a statement at a Cabinet meeting held at the presidential office in Yongsan this morning (13th). "Health insurance reform is not an option, but a necessity," he said. President Yoon criticized, "We have spent more than 20 trillion won on strengthening coverage over the past five years, but the government has neglected medical abuse and free riding of health insurance," adding, "The burden is being passed on to the majority of the people." This is a criticism of the Moon Jae In government's policy to strengthen coverage, and the Ministry of Health and Welfare has recently decided to review whether to apply benefits to MRI and ultrasound tests suspected of abuse among salary items covered by health insurance. President Yoon said, "Popular populism that wastes taxpayers' money is supposed to destroy finances, harm the foundation of the health insurance system, and eventually force the public to make great sacrifices," and stressed, "We need to strengthen health insurance benefits and qualification standards and prevent waste and leakage of health insurance." "We will strongly support those suffering in medical blind spots with reduced funds," he said. "The key to the health insurance system is to ensure that essential medical care that is expensive like serious diseases but must be included."
- Policy
- MFDS approves Jemperil, the third PD-1 inhibitor in Korea
- by Lee, Hye-Kyung Dec 15, 2022 05:55am
- The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) approved GlaxoSmithKline's new drug endometrial cancer treatment Jemperil on the 14th. Jemperil will be the third PD-1 inhibitor to be licensed in Korea after Opdivo of Ono and BMS and Keytgruda of MSD. Jemperil is a monoclonal antibody targeting cell predetermined history 1 (PD-1), an immune gateway receptor for immune cells (T cells). PD-1 is an inhibitory immune checkpoint receptor belonging to the CD28 family and is expressed in activated T cells, B cells, NK cells, and bone marrow cells, and plays a pivotal role in immune regulation. The drug has been approved as an indication for the treatment of adult patients with recurrent or progressive inconsistency recovery defects (dMMR)/high-frequency microsatellite instability (MSI-H) endometrial cancer, which has been treated or progressed after treatment. It uses PD-1 expressed on the surface of immune cells (T cells) to block the survival mechanism of cancer cells avoiding immune cell attacks, and helping immune cells remove cancer cells. The Ministry of Food and Drug Safety said, "We will continue to do our best to quickly supply treatments that have been sufficiently confirmed for safety and effectiveness based on regulatory science."
- Policy
- MFDS “Increasing AAP manufacturing well in progress”
- by Lee, Hye-Kyung Dec 14, 2022 05:57am
- To the issue that had been raised on how the supply shortage is continuing in the field even after increasing the price of acetaminophen, the Ministry of Food and Drug Safety replied that it has reviewed the monthly production schedule and the increase in production is progressing according to plan. Also, the MFDS added that the acetaminophen stock shortages found in some online malls may not be an actual lack of stock, and that it would be necessary to check with the distributors. In other words, some online malls may be leaving the category as out of stock to prevent the large pharmacies to preoccupy the whole stock in online malls at once and allow small pharmacies the purchasing opportunity. Eun-hee Moon, Director of the Pharmaceutical Policy Division Eun-hee Moon, Director of the Pharmaceutical Policy Division at MFDS, said so at a briefing with the medical trade journal correspondents on the 13th. Director Moon said, “Even at the increased price, it is said that the companies cannot manufacture more because they are already at their maximum capacity, and some pharmacies are saying there isn’t enough supply. However, when checking with the manufacturers and reviewing their monthly production schedule, no company has yet said they are having difficulty matching the demand.” The Ministry of Health and Welfare raised the ceiling price of 18 products that contain acetaminophen 650mg to at least KRW 70 to a maximum of KRW 90 as of December 1st. The different ceiling prices have been set according to the manufactured amount. After holding drug pricing negotiations with pharmaceutical companies, the National Health Insurance Service and the companies agreed to increase the monthly average manufacture amount by 50% more for 13 months until September of next year. Also, in consideration of the increased demand and exhaustion of market inventory in the winter and in-between seasons, the period from this month to April next year will be set as an intensive management period, and the monthly target manufacture amount set by 60% more during that period. The average monthly supply will rise the previous 45 million tablets per month to 67.6 million per month for the 13 months, and to 72 million tablets per month during the intensive management period. Also, the MFDS issued an ‘Emergency management and import order for medical products,’ ordering companies that supply prescription acetaminophen 650mg to report their manufacture and import plans, expected monthly manufacture and import and manufacture and import results from December 1, 2022, to April 30, 2023. Director Moon said, “The monthly manufacture amount submitted by the pharmaceutical companies has been set by adjusting the manufactured volume of other drugs. It was not vaguely made." For companies that consign productions, the companies agreed on the price increase after making the production plans for all of its products and confirming their production schedule with their factories. Director Moon emphasized, “Hanmi Pharmaceutical and Chong Kun Dang switched their consigned acetaminophen products to self-manufacturing and submitted their specific manufacture schedules before signing the price increase agreement. The companies are working hard to achieve the goal of expanding production by 50% and 60% more from the previous period according to the plans set by the government.” The MFDS believes that the supply shortages raised in the field will not occur as the contracts that were signed mandate companies to refund the drug price if the production volume does not reach the target amount. Director Moon said, “The MFDS’ manufacture and import order was issued to address the concern that not enough acetaminophen will be supplied in the file even after the NHIS signed agreements with companies that link the production and supply amount to the drug price. As the MFDS and NHIS are managing the issue together, I believe the production of acetaminophen will be carried out as planned." Moon added, “Companies that cannot fulfill the manufacture/import orders were directed to consult with the MFDS, but there has been no talk of companies being unable to meet the volume yet. I have reviewed the production volume until early December, and more acetaminophen is being supplied compared to November." However, as the specific production volumes of acetaminophen in November and December need to be compared, the actual difference can only be found at the end of the year. The MFDS is also preparing a plan to prepare for the supply shortage of raw materials for cold medicine that may arise due to China’s recent lifting of COVID-19 restrictions. Director Moon said, “When checking the raw material suppliers, most were from the US, China, and India, and we think we can use Indian suppliers if there is a disruption in the supply of raw materials in China. While receiving plans for increased production of acetaminophen from companies, we are also checking the current status of raw material supply” The exemptions from the mandatory small-package packaging of prescription cold medicine also continue to be in effect. Moon explained, "We had originally decided to apply the small packaging exemption for the period when we monitor the supply and demand, which is conducted once every two weeks."
- Policy
- $25.5 billion in exports to the health industry
- by Kim, Jung-Ju Dec 14, 2022 05:56am
- Exports of health medicine-related industries this year amounted to $25.5 billion, similar to last year, but the export of medicines such as biosimilars and vaccines was notable. The pharmaceutical sector is expected to surpass $10 billion for the first time next year based on a single item, raising expectations as a next-generation "good son export sector." The Health Industry Promotion Agency (Acting Director Kim Young-ok) announced the "2022 Major Export Performance and 2023 Export Forecast" this afternoon (7th). Although it recorded the highest performance in the first half of the year* thanks to increased demand for COVID-19 vaccines, treatments, and diagnostic products, the decline in quarantine goods (vaccines and diagnostic products) was noticeable due to full-scale enddemicization in the second half. Looking at export trends in the first half of 2022, it grew by 8.5% to a total of $13.35 billion, of which pharmaceuticals increased by 45% to $4.35 billion. Medical devices grew 5.2% to $4.93 billion, and cosmetics fell 11.9% to $4.06 billion. In particular, exports of medicines are expected to increase by 23.9% year-on-year due to biopharmaceuticals (biosimilars) and vaccines, but exports of medical devices and cosmetics are expected to decrease by 7.3% and 10.1% due to the full-fledged COVID-19 endemic and worsening external conditions. This year, the average monthly export of the health industry was $20.8 billion, continuing positive growth for 33 months since September 2019, and turning to negative growth since June this year. By industry, pharmaceutical exports are expected to rise 15.5% year-on-year to $10.1 billion, cosmetics are expected to rise 6.7% to $8.8 billion, and medical devices are expected to fall 6.2%, to $8 billion. Exports by region are expected to grow 5.8 percent to $13.6 billion, Europe to $6.8 billion, and North America to $4.2 billion, with Asia/Pacific exports expected to account for more than half. Diagnostic products, which had increased exports due to the global pandemic, are expected to continue to decline in exports, and exports of anti-pathogenic biological drugs such as biosimilars and toxins will continue to increase, accounting for 23.8% of the market share (based on division). Among them, pharmaceutical exports are expected to surpass $10 billion next year, up 15.5% from this year, based on the first single item ever. Exports of vaccines and treatments, which have soared since the end of last year, are expected to gradually decrease, and overall exports of medicines are expected to grow steadily due to continued demand for biosimilars. In the case of medical devices, exports are expected to fall 6.2% from this year to $8 billion next year. Existing major items such as ultrasound imaging devices, implants, and radiographic devices are expected to exceed exports in 2019, before COVID-19, thanks to a rapid recovery. On the other hand, exports of reagents for diagnosis in Korea are expected to gradually decrease as demand for COVID-19-related products decreases worldwide. Han Dong-woo, head of the Health Industry Innovation Planning Division at the Promotion Agency, said, "In 2023, health industry exports are expected to increase 5.4 percent year-on-year to $26.9 billion as cosmetics exports turn positive along with steady exports of medicines." "Since COVID-19, our health industry has proven its growth potential due to rapid increases in exports, but it may be more sensitive to external shocks such as weak economic conditions, global supply chain instability, high export dependence on the U.S. and China, and policies to strengthen protectionism," Han said. Meanwhile, the agency explained that it is working to support the industry and support government policies by providing information on exports and imports in the health industry, investigating overseas perceptions of the health industry, analyzing the impact of supply chain reorganization, and collecting opinions from the industry.
- Policy
- Reimb of Samil·Kukje's rebamipide eye drops adequate
- by Lee, Tak-Sun Dec 13, 2022 06:07am
- Samil Pharmaceutical and Kukje Pharma’s rebamipide eye drop solutions that were developed as a treatment for dry eye were deemed adequate for reimbursement by Korea’s Health Insurance Review and Assessment Service. This is the first achievement made for the drug in 4 months since its approval in June. With the reimbursement adequacy recognized for the drug, its reimbursement listing is expected to come sooner after negotiations with NHIS. HIRA’s Drug Reimbursement Evaluation Committee (DREC) held its 12th annual meeting on the 8th and announced such results. The DREC determined that the reimbursement of Kukje Pharma’s ‘Reba-eye Eye Drops’ and Samil Pharmaceutical’s ‘Reva-K Eye Drops’ are adequate for the treatment of tear functions and ocular surface status in adult patients with dry eye symptoms. Kukje and Samil’s two drugs were approved as incrementally modified drugs by the Ministry of Food and Drug Safety in June. Rebamipide has been previously approved as a treatment for gastric ulcers and gastritis in Korea. However, after its mechanism of action that increases goblet cell density and mucus in the eye were found, Samil Pharmaceutical and Kukje Pharma developed the drug as an eye drop for affected patients. Their drug demonstrated superior efficacy over placebo in a domestic clinical trial in Koreans. Based on such evidence, the MFDS approved them as incrementally modified new drugs, recognizing their improved safety and efficacy. After receiving acknowledgment for its safety and efficacy from the MFDS, HIRA’s DREC acknowledged the adequacy of the drug’s reimbursement during its first deliberation of the drugs. If the agenda passes the drug pricing negotiation step with the NHIS, they will be listed for reimbursement. On the same day, DREC also granted conditional approval for the reimbursement of Janssen Korea’s Erleada Tab (apalutamide).' Erleada's reimbursement adequacy will be accepted if the company accepts the conditions proposed by DREC for the reimbursement.
- Policy
- Big Pharma's sale of Old Drug has increased
- by Lee, Tak-Sun Dec 13, 2022 06:07am
- The number of domestic pharmaceutical companies acquiring domestic copyrights of original drugs has been increasing recently. This is a case in which domestic copyrights have also changed as most original developers sold global copyrights as part of restructuring. Jeil announced on the 8th that it will exclusively supply Bonviva and Bonviva plus, treatments for osteoporosis, in Korea. Bonviva originally entered the domestic market with permission from Roche, a multinational pharmaceutical company. As global copyright was transferred to British pharmaceutical company Aetna Pharma in 2017, domestic copyrights are also changing. Since 2015, Handok has been selling and obtaining permission rights, but it has recently been transferred to Jeil. Pharmanovia, a subsidiary of Aetna Pharm, which has global copyright, signed an exclusive sales contract with Jeil when it established a domestic branch. Currently, Bonvia is licensed by Jeil Pharmaceutical, and Bonviva Plus is registered as a licensed company by Alvogen Korea, a developer. However, reimbursed pharmaceutical companies are still in Korea and Germany. In the future, there is a high possibility that pharmaceutical companies will also be transferred to Jeil through transfer and transfer. SK Chemicals recently acquired domestic copyright for Omnaris nasal spray, an allergic rhinitis treatment. Omnaris nasal spray was introduced and sold by Handok from Nycomed, Switzerland, but domestic copyrights were transferred to Takeda in 2011 and AstraZeneca in 2015. AstraZeneca sold Omnaris' global copyright to Covis Pharma in 2018, and the final destination of domestic copyrights was SK Chemicals. Omnaris was completely transferred to SK Chemicals through transfer and transfer of permission and rights. SK Chemicals also acquired the domestic license for AstraZeneca's asthma treatment Alvesco. LG Chem also acquired the domestic copyright of the anti-inflammatory painkiller Vimovo from AstraZeneca. Vimovo is an NSAIDs-PPI complex released in Korea by AstraZeneca in 2012. LG Chem Participates in Co-promotion Recently, both the right to permit and the right to pay have been transferred. Vimovo's global copyright was also sold to German pharmaceutical company Grünenthal in 2018. Although domestic pharmaceutical companies have acquired exclusive sales rights in Korea beyond co-promotion with overseas pharmaceutical companies, it is too much to lead to a significant increase in profits. This is because it is an old drug that is less competitive than other drugs because it has been released for a long time. Moreover, pharmaceutical companies with global copyrights may terminate their domestic copyright contracts, which cannot be considered completely attributed to assets.
- Policy
- Will SGLT2 combi benefit expansion eventually not happen?
- by Lee, Tak-Sun Dec 12, 2022 05:48am
- #iDiscussions on the expansion of combined benefits between SGLT-2 drugs and other drugs continue to conflict. The government presented a voluntary cut rate to related companies last month to analyze their fiscal impact based on it, which is known to fall short of expectations. As a result, it is expected that it will soon be decided whether to continue the discussion or end it. According to the industry on the 11th, the results of the analysis of the financial impact of the voluntary reduction rate of the upper limit of drugs submitted by 11 diabetes companies to the Ministry of Health and Welfare last month fell short of expectations. The drugs currently under discussion for salary expansion are three-drug therapy such as metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and SGLT-2 +Sulfonylurea or insulin combination therapy. These combination treatments are effective in treating diabetes, so they have continuously demanded pay expansion, focusing on related academic societies. The Ministry of Health and Welfare planned to receive voluntary cuts from companies with these drugs and analyze the financial impact and skip drug price negotiations with the Drug Benefit Evaluation Committee if it meets the expected range and reflect them in the salary through a report by the Health Insurance Policy Review Committee. Otherwise, if the financial increase reflecting the weak cut is greater than expected, it has been delivered to companies through a meeting that it will end discussions on the expansion of combined use. An industry official said, "The voluntary cut rate submitted by companies does not seem to be at the level that the Ministry of Health and Welfare thinks," adding, "If the voluntary cut rate falls below expectations, it is highly likely to end the discussion as announced at the meeting." Since this discussion has been going on for a long time since 2016 through the Diabetes Association, the government will feel burdened to end it immediately. Some analysts say that there is a possibility of receiving another voluntary cut rate. Another official from the pharmaceutical industry said, "So far, we have not notified the company of the results of the financial impact analysis, but I don't think the ait is good," adding, "I think we will discuss ways to cut the weak price once again."
- Policy
- “Yoon admin’s healthcare policy reduces coverage"
- by Kim, Jung-Ju Dec 09, 2022 06:03am
- "Stop deceiving the public with an erroneous essential healthcare policy that lays the responsibility for wasteful spending of commercial healthcare to the patients. Civic groups related to healthcare united and strongly voiced their opposition to the essential healthcare measures that were announced by the government. The Korean Federation Medical Activist Groups For Health Rights (KFHR) issued a joint statement in the afternoon today (8th) to “condemn the erroneous essential healthcare policy that reduces coverage of the national health insurance and solidifies the commercial healthcare system.” The Ministry of Health and Welfare had previously held a public hearing after announcing ‘Measures to Improve the Sustainability of Health Insurance and Support Essential Healthcare.’ The KFHR strongly criticized, “Contrary to what’s indicated in the title, the content aims to pass the pain on to the patients by reducing health insurance coverage, and use the issue of essential healthcare that requires the expansion of public health as an excuse to provide financial support to private hospitals. The Yoon Yoon Seok-yeol administration is the first administration to propose a plan to reduce coverage ever since the universal health insurance system was introduced in 1988. The reasons for KFHR’s opposition were: ▲ The plan to reduce health insurance coverage is a historical regression that has never been proposed ever since the introduction of national health insurance, ▲It is passing on the responsibility for wasteful financial expenditures that had been generated by the commercial medical system to the patients ▲And is providing support to private medical institutions and calling them essential healthcare support. KFHR said, “Korea's level of healthcare coverage is placed at the lowest among OECD countries, and this was why all the previous governments had no choice but to come up with a target plan to strengthen coverage, however insufficient. But the Yoon administration is attempting to reduce the little coverage that we have under the pretext of fiscal soundness rather than reinforcing it. The federation also voiced criticism on how the government is shifting the responsibility for wasteful financial expenditures caused by the commercial medical system to the patients. “Excessive medical treatment is prevalent in Korea because the government maintains a system that encourages profit in an extremely commercialized system where private medical institutions account for 95%. Many countries in Europe that run nearly free healthcare systems have fewer issues with excessive medical treatment because this is not caused by high coverage, rather, it is due to the commercialization of healthcare.” Regarding the support for essential healthcare, KFHR criticized it as an attempt to increase compensation to private medical institutions. In other words, the government is repeating the failures of the past. KFHR said, “Many premium fee systems are already in place in Emergency, Pediatrics, and Thoracic Surgery departments, the departments are still being avoided by private medical institutions due to their small number of non-reimbursed services and difficulty in filing excessive medical treatments. These issues cannot be resolved just by raising medical service fees.” KFHR added, “We oppose the government’s enforcement of such erroneous policy after holding a public hearing in which only some interested parties as a formality. Citizens have no choice but to resist if the government, the one that caused the Itaewon disaster, tries to cause a medical catastrophe that will drive people to death and suffering. The government must rescind the health insurance reforms and erroneous policies it is pursuing under the name of essential healthcare.” The KFHR consists of the Korean Nurses Association for Health Rights, the Pharmacists’ Association for Healthy Society, the Dentists' Association for Healthy Society, Solidarity for Worker's Health, the Association of Physicians for Humanism, and Doctors of Korean Medicine for Health Rights.
- Policy
- Dong-A launches its first generic Dapapro
- by Lee, Tak-Sun Dec 08, 2022 06:05am
- Despite the patent dispute, Dong-A ST has released Dapapro, the first generic of SGLT-2 diabetes treatment Forxiga. Dapapro was listed for the upper limit of 684 won this month. According to industries on the 7th, Dong-A ST started selling with Dapapro salary registration. Dapapro is a prodrug product with a different chemical structure from the original. When Dapapro is absorbed, the structure changes afterwards, showing the same medicinal effect as Forxiga. SGLT-2 inhibitors such as Forxiga and Dapapro have the effect of lowering blood sugar by selectively and reversibly blocking SGLT-2 involved in glucose absorption, inducing the remaining glucose to be discharged into urine. It succeeded in evading the material patent of Forxiga. Exactly, the argument that the 917 days of existence added to the Forxiga material patent are not included in the patent rights restricting Dapapro was accepted. This is the decision of the Patent Tribunal last month. However, there is a high possibility that AstraZeneca, the patentee, will appeal to the patent court against the trial decision. There is a possibility that the ruling will change. Earlier, Dong-A requested a trial to confirm the scope of rights for the same patent, but it was cited in the first trial, but it is difficult to predict the conclusion of the patent dispute because it has a history of losing in the second trial. Dong-A's rush to sell products seems to be a willingness to preoccupy the generic market before the patent expires in April next year. This is because other generics are likely to pour out after April next year. Currently, 266 Dapagliflozin products are licensed only by the Ministry of Food and Drug Safety. An industry official analyzed, "From Dong-A's point of view, it would have been difficult to miss the opportunity he had taken for the first time in a while." Dong-A also has a DPP-4 diabetes treatment new drug called Suganon. It is calculated that sufficient synergy can be seen in conjunction with Dapapro, an SGLT-2 formulation. With Dong-A's launch of the product, attention is now focused on the direction of patent disputes. It remains to be seen whether Dong-A will resolve patent disputes and preoccupy the generic market of Forxiga worth 100 billion won.
