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- 2026-03-11 12:50:48
- Policy
- MFDS reviews COVID-19 drugs Xocova and Lagevrio
- by Lee, Hye-Kyung Aug 21, 2024 05:47am
- Amid the resurgence of the COVID-19 pandemic, The food and drug authorities in Korea have been taking steps to approve COVID-19 treatments. According to the Ministry of Food and Drug Safety (MFDS) on the 19th, the agency began reviewing Ildong Pharmaceutical's ‘Xocova’ and MSD Korea’s ‘Lagevrio,' which the companies have submitted applications for approval in Korea. “Currently, three drugs are licensed or approved for emergency use in Korea - the oral drugs 'Paxlovid' and ‘Lagevrio’ and the injectable drug ‘Veklury.’” said an MFDS official, ”and we are reviewing the applications of additional products that have applied for marketing authorization thereafter.” Paxlovid and Veklury are officially approved in Korea, while Lagevrio, which was used under the Emergency Use Authorization, is undergoing a formal approval process. In the case of Xocova, the company hasn't even been approved for emergency use, according to an MFDS official, who added, “Emergency use approval requires close communication with the Korea Disease Control and Prevention Agency due to regulations.” Xocova is an oral COVID-19 treatment co-developed by Ildong Pharmaceutical and Japan's Shionogi Pharma. The companies applied for Xocova’s domestic marketing authorization in December last year, but the application is still stuck in the review stage. In Japan, it was granted emergency approval in November 2022 and received full approval from the Ministry of Health, Labor and Welfare in March this year. Xocova is regarded to have provided improved convenience for patients as patients only need to take Xocova once daily for 5 days as a single tablet compared to other conventional treatments that are administered twice a day. Ildong Pharmaceutical completed the technology transfer and trial production of Xocova last year and will be able to proceed with production and supply once the authorities grant domestic approval. Meanwhile, the number of hospitalized COVID-19 patients increased 5.1 times from 91 in the first week of July to 465 in the fourth week, according to data submitted by KDCA to the office of Representative Ye-ji Kim of the People's Power Party. Also, the weekly usage of COVID-19 drugs increased about 32 times from 1,272 doses in the fourth week of June to over 42,000 doses in the fifth week of July. However, as of the 9th, only 70,557 doses of COVID-19 treatments - 41,790 doses of Lagevrio and 28,767 doses of Paxlovid - were available in stock in Korea.
- Policy
- New criteria set for flexible ICER threshold evaluations
- by Lee, Tak-Sun Aug 20, 2024 06:34am
- The National Health Insurance Review and Assessment Service (HIRA) established new criteria for drugs that apply flexible ICER (incremental cost-effectiveness ratio) thresholds during the Drug Reimbursement Evaluation Committee (DREC) meeting that was held on the 8th. The previous criteria only stipulated that a flexible ICER threshold could be applied, but specifics were established. this time. In February, DREC recognized reimbursement adequate for the breast and stomach cancer drug Enhertu (trastuzumab deruxtecan, Daiichi Sankyo Korea) by flexibly applying the ICER threshold. On the 8th, HIRA disclosed the "Criteria for detailed evaluation of drugs subject to negotiation, such as new drugs" which was newly amended based on DREC deliberations. The amendments include ▲ New criteria for flexible ICER threshold evaluation; ▲ Addition of severe diseases to the risk-sharing agreement scheme; ▲ Omission of the Drug Evaluation Committee review when expanding the reimbursement range of RSA drugs that claim less than KRW 1.5 billion; ▲ New conditions that require submission of clinical evidence such as RWD and RWE when renewing RSA schemes. ◆ New criteria for flexible ICER threshold evaluation=The existing regulations only stipulated that the ICER threshold “need not be explicit, and can be flexibly applied with regards to the results of previous deliberations in consideration of the severity of the disease, the burden of disease on society, the impact on quality of life, and innovativeness.” In the amendment, the 'innovativeness' requirement has been specifically established for the flexible evaluation of new drugs. A new drug is regarded as ‘innovative’ when it satisfies all of the following criteria: ▲ there is no substitutable or therapeutically equivalent product or treatment ▲ has shown significant clinical improvement, such as prolonged survival, is recognized in the final outcome, ▲is a new drug is approved by the MFDS under Article 35(4)(2) of the Pharmaceutical Affairs Act through expedited review or is recognized as equivalent by the committee. ◆ Addition of severe diseases to the risk-sharing agreement scheme = In principle, anti-cancer drugs or rare disease drugs were subject to RSA. However, the previous regulation had allowed drugs that are not necessarily anti-cancer or rare disease drugs to be applied to RSA if the committee recognizes the drugs as equivalent. However, the amended regulations clarified the ‘equivalent disease’ condition. The amendment stipulates that an ‘equivalent disease’ to a severe disease does not qualify for the currently recognized special calculations, but is difficult to cure, causes irreversible disability or organ damage due to the progression of the disease, and has a significant burden of disease. DREC had already recognized reimbursement of severe atopic dermatitis drugs like Dupixent and severe asthma drugs as reimbursable using RSA. ◆ Omission of the Drug Evaluation Committee review when expanding the reimbursement range of RSA drugs that claim less than KRW 1.5 billion = The new amendment allows RSA drugs to skip DREC review if the expanded claims amount amounts to less than KRW 1.5 billion. Specifically, if the expected additional claims of refund-type RSA drugs, excluding the mixed-type RSA drugs, is less than KRW 1.5 billion, DREC’s evaluation can be skipped and the insurance ceiling price and refund rate be re-negotiated through NHIS negotiations. ◆RWD, RWE, etc. to be submitted when RSA is renewed =The new amendment also requires drugs with a certain condition to submit RWD, RWE, etc. when renewing their RSA contract. This is in line with how Ilaris (canakinumab, Novartis Korea) was recently approved for reimbursement based on the condition of submitting prospective clinical trial data. As such, the amendment specifies that drugs that are listed under the condition of collecting clinical evidence, such as RWD and RWE, should collect and submit clinical evidence when renewing their RSA contract. On the other hand, the new amendment does not include terms for the preferential treatment of homegrown new drugs. The pharmaceutical industry had expected that the preferential treatment for domestic new drugs would be included by revising the ‘1.7. Cases where necessary in consideration of the impact on healthcare' clause of the ‘Criteria for detailed evaluation of drugs subject to negotiation, such as new drugs.’ The industry expected that preferential treatment of non-inferior new drugs and domestically developed new drugs utilizing natural products would be added in the amendment, but were not included. However, there are opinions that the condition for preferential treatment for domestic drugs may be included in other regulations.
- Policy
- KDCA apologizes for COVID-19 drug shortages
- by Lee, Hye-Kyung Aug 19, 2024 05:47am
- The Korea Disease Control and Prevention Agency (KDCA) apologizes for the COVID-19 medication shortages due to the increased volume of usage than expected. The KDCA stated that after acknowledging the need for medication supply, it had secured medication for 260,000 people after discussing it with the office for national finance. Additional distribution will be made in part starting this week. During the 'COVID-19 Status Report and Measures' briefing on August 16th, KDCA's Assistant Director of Reserve Material Park Jee-yeong stated, "The KDCA is considerably acknowledging the current medication shortage, and we are deeply sorry about the issue." Park said, "We will strive to stabilize the supply." According to the KDCA, pharmacies running out of stock of COVID-19 medications, such as 'Paxlovid,' are due to difficulty in predicting demand as the volume of usage surges compared to last year's summer. Park said, "Currently, more medications are being used than before. Once we were aware of the situation, we were closely in contact with global pharmaceutical companies and have been supplying a portion of the stock starting this week. Park added, "Unlike oral treatments, injectables are being provided as requested. We will also provide additional supplies to tertiary general hospitals."
- Policy
- Will Paxlovid soon be reimbursed in Korea?
- by Lee, Tak-Sun Aug 19, 2024 05:47am
- The government has announced that it will expedite the insurance listing process for COVID-19 drugs due to COVID-19 resurgence in Korea. As a result, attention is focused on whether the government will speed up the reimbursement coverage of the COVID-19 drug Paxlovid, which has remained under review by Korea’s Health Insurance Review and Assessment Service ever since Pfizer applied for reimbursement in October last year. On the afternoon of the 14th, the government held a meeting to urgently review the 'COVID-19 epidemic trend and response plan’ with officials from the Ministry of Health and Welfare, Korea Disease Control and Prevention Agency, Office of the Government Policy Coordination, Ministry of Education, Ministry of Interior and Safety, Ministry of Food and Drug Safety, and the National Fire Agency. At the meeting, the MOHW announced that it will promptly review COVID-19 treatments that apply for reimbursement upon approval by the Ministry of Food and Drug Safety by hastening the reimbursement adequacy evaluation, NHIS negotiations, and Health Insurance Policy Review Committee deliberations. The two COVID-19 drugs currently under reimbursement review are Pfizer's Paxlovid (nirmatrelvir/ritonavir) and Gilead's Veklury (remdesivir). The companies had submitted applications for their respective treatments to HIRA in early October of last year. However, none had yet passed the internal review stage. Drugs under review are subject to a final review of their reimbursement adequacy by HIRA’s Drug Reimbursement Evaluation Committee (DREC) before moving on to the negotiation stage with the NHIS, but the 2 drugs have not yet been placed on an agenda for deliberation by DREC. In particular, HIRA has reportedly instructed the company to submit supplementary data for Paxlovid 8 times. However, the government is believed to have changed its policy to expedite review after it was pointed out that the resurgence of COVID-19 is hampering the supply of drugs and that the government needs to hasten its approval to stabilize the supply for severe COVID-19 patients. After the joint ministry meeting, MOHW Minister Kyoo-hong Cho, said, “We will expedite the procurement and reimbursement listing of COVID-19 drugs so that high-risk patients can stably receive supply.” It is reported that HIRA, which is conducting the reimbursement review, and the NHIS, which will negotiate the insurance drug prices in the future, held a business meeting to discuss measures. The NHIS is expected to first conduct preliminary negotiations with pharmaceutical companies for COVID-19 treatments to shorten the time to their reimbursement listing. Preliminary negotiations are conducted for severe disease treatments that do not require pharmacoeconomic evaluation, but the negotiations are likely to be applied this time just like how they were conducted to raise the price of respiratory drugs that had difficulty being supplied due to COVID-19 The 60-day negotiation period can be shortened to 30 days or less if preliminary negotiations with the MFDS are conducted from the drug review stage. Accordingly, if Paxlovid is reviewed by DREC in September, pricing negotiation can be completed within the month, be deliberated by HIPDC, and be reimbursed in October at the earliest. The problem is the price of the drug. Paxlovid’s insured price is likely to be higher than the KRW 50,000 that patients currently pay out of pocket with state support. The non-reimbursed price of Paxlovid is reportedly around KRW 700,000, and if the out-of-pocket cost paid by the patients becomes much higher than it is now, the insurance authorities may face another round of criticism.
- Policy
- KDCA operates Public-Private Council for COVID-19 response
- by Kang, Hye-Kyung Aug 16, 2024 05:56am
- The Korea Disease Control and Prevention Agency (KDCA) announced that it will do its utmost to respond to COVID-19 by reorganizing its COVID-19 task force and forming a public-private council with experts. The agency expects the outbreak to continue until the end of August. On the 13th, the KCDA said, “The number of hospitalized COVID-19 patients began to increase from the end of June in the COVID-19 sampling surveillance. 861 were reported in the first week of August, approaching the peak of 875 hospitalized patients that was recorded in February this year. Considering the epidemic trend over the past 2 years, the number of COVID-19 patients is expected to increase until the end of August,” it said. The KCDA plans to expand its COVID-19 Task Force currently in operation. The response system, which was initially operated as 2 teams under 1 Task Force, will be expanded to 12 teams under five Units, with the head of the KCDA serving as the lead, to respond more quickly and thoroughly to epidemic investigation and analysis, overseas surveillance, and treatment supply and demand management. In addition, the KDCA explained that it had organized a public-private council with experts from the medical and academic fields related to COVID-19 to collect expert opinions, share the status of the COVID-19 outbreak with the medical community, and discuss countermeasures, and will hold regular meetings starting on the 14th. “This number of COVID-19-related hospitalizations has been increasing this summer, and it is likely to reach the scale of last year's summer epidemic, with 65% of confirmed cases occurring among the elderly aged 65 and older,” explained KDCA Commissioner Young-mee Jee. However, Commissioner Jee added, “Based on the analysis of domestic and international organizations on the KP.3 variant, which is currently the most common variant, the severity and fatality rates are not assessed to be significantly different from the previous Omicron variant, and the COVID-19 fatality rate in Korea in 2022-2023, which was after the Omicron outbreak, was less than 0.1%, especially for those under 50 years old. There is no need to be overly anxious.” “The most important thing to do for a healthy and safe summer is to take precautions to prevent infectious diseases, such as ventilating your home, washing your hands, and wearing a mask.”
- Policy
- KDCA 'COVID-19 drug supply will be stabilized within August'
- by Lee, Hye-Kyung Aug 16, 2024 05:55am
- The government has explained that pharmacies nationwide will have enough COVID-19 drugs by the last week of August. In the case of self-test kits, the government added that it plans to produce and supply more than 5 million kits within August to ensure no shortage. The Ministry of Health and Welfare (Minister Kyoo-hong Cho) held a joint meeting with the Korea Disease Control and Prevention Agency (KDCA) (Commissioner Young-mee Jee), the Office of the Government Policy Coordination (Minister Ki-sun Bang), the Ministry of Education (Minister Ju-ho Lee), the Ministry of Interior and Safety (Minister Sang-min Lee), Ministry of Food and Drug Safety (Director Yu-Kyoung Oh), and the National Fire Agency (Commissioner Seok-gon Heo) met together on the 14th at 4:30 p.m. to review Korea’s ‘COVID-19 epidemic trend and countermeasures’ in light of the recent increase in COVID-19 infections. The weekly usage of COVID-19 treatments as disclosed by the KDCA increased to exceed 42,000 doses in the 5th week of July, compared to the 1,272 doses used in the 4th week of July, exceeding the amount used during the summer season last year. To address the increased usage, the KDCA plans to supply additional drugs sequentially from this week, so that there will be enough drugs in all pharmacies that supply COVID-19 treatments from the last week of August (8.25~8.31). “We will endeavor to ensure smooth access to the treatment everywhere in the country by the last week of August,” the KDCA said. The Ministry of Health and Welfare plans to promptly review COVID-19 treatments that apply for reimbursement upon approval by the Ministry of Food and Drug Safety by hastening the reimbursement adequacy evaluation, NHIS negotiations, and Health Insurance Policy Review Committee deliberations. The MFDS is closely monitoring the supply of COVID-19 self-test kits and the entire production and distribution process. Domestic manufacturers have been scaling back production of self-test kits since COVID-19 turned endemic, but have recently expanded their production and supply to meet the rise in demand for COVID-19 test kits since late July. Korea’s COVID-19 self-test kit manufacturers own sufficient facilities, technology, and capacity to meet domestic demand, and are expected to produce and supply more than 5 million self-test kits within August. The MFDS added, “Korea’s COVID-19 self-test kit manufacturers have produced 40 million self-test kits per week in the past.” Meanwhile, the number of hospitalized COVID-19 patients has been increasing again since the end of June, and the number of hospitalized patients reached its peak this year (1,357, provisional) in the second week of August. While respiratory viruses are primarily prevalent during the winter season, COVID-19 has also been prevalent during the summer season (July-August) in 2022 and 2023, and given this trend, the number of COVID-19 patients is expected to continue to increase in the near future. According to the Ministry of Health and Welfare, the number of emergency room visits due to COVID-19 jumped from 2,240 in June to 11,627 in July. The MOHW said, “We plan to establish a cooperative system for hospitalization of COVID-19 patients by securing free beds, mainly in public hospitals that had been previously operated as dedicated COVID-19 hub hospitals. In order to ensure prompt treatment of COVID-19 patients in their local areas according to the pandemic situation, we plan to secure a list of COVID-19 treatment hospitals by local governments in cooperation with the Ministry of the Interior and Safety and local governments, and publish it through the Emergency Medical Services System.” The 2024-2025 COVID-19 vaccination plan will utilize a new vaccine (against the JN.1 strain) that is more effective against strains currently circulating in Korea and around the world. The government is currently in the process of licensing and approving the new vaccine so that it can be administered simultaneously with the flu vaccine in October, and details of the plan will be announced in September. “To respond to the COVID-19 pandemic, we will work with relevant ministries and organizations to secure beds so that COVID-19 patients can be treated promptly, and expedite the procurement of COVId-19 treatments and their reimbursement listing so that high-risk patients can stably receive treatment,” said MOHW Minister Kyoo-hong Cho. “The fatality rate of COVID-19 in Korea in 2023 (January-August), after the Omicron variant outbreak, was in the 0.05% range, and less than 0.01% for those under 50 years old, so there is no need to be overly anxious about the outbreak this summer,” said KDCA Commissioner Young-mee Jee. ”We will do our best to ensure that the additional supplies of COVID-19 drugs we secure from next week be supplied smoothly to patients for their convenient use.”
- Policy
- Gov’t raises service fee for difficult surgeries
- by Lee, Tak-Sun Aug 14, 2024 05:51am
- The government is promoting a plan to completely reform the unbalanced structure of Korea’s fee-for-service system. For this, the government is reviewing whether to raise the compensation level for severe surgeries and reforming the relative value system and conversion index used to calculate medical service fees. Kyung-sil Jeong, Head of the Healthcare Reform Promotion Team at MOHW explained so at a briefing on the progress of Korea’s healthcare reform on the 13th. "Korea's reimbursement system is based on a 'fee-for-service system' that sets a unit price for every individual act of service," Jeong said, pointing out that "among the types of services, basic medical treatment, surgery, and treatment have lower fee levels, while testing, imaging, and functional type services have higher fee levels." The system has constantly been criticized as it incentivizes more tests than serious, high-risk surgeries. "We are promoting an overall reform to increase the compensation level in low-compensated areas and decrease the compensation level in high-compensated areas," Jeong said, adding, "First of all, we are considering raising the compensation level of about 1,000 severe surgeries, which are mainly performed at tertiary hospitals and general hospitals but have low fees." The government has established a 'Medical Cost Analysis Committee' within the Health Insurance Policy Review Committee to establish a system where medical fees can be quickly adjusted based on scientific evidence. The committee is also looking to reform the relative value system and conversion index, which are the basis of the fee-for-service system. "The committee has identified 6 priority areas that require concentrated investment: severe disease treatment, difficult essential medical treatment, emergency treatment, night and holiday treatment, pediatrics and childbirth, and vulnerable regions," Jeong said, adding, "In consideration of these priorities, we plan to more systemically introduce the public policy fee.” Furthermore, the government plans to transform the fee-for-service system into a "value-based payment system" to fundamentally improve the problem of how the current fee-for-service system increases the volume of procedures rather than improves the outcome of treatment. "The current system, which applies a uniform 15% premium to the reimbursement rate for services provided at tertiary general hospitals without distinguishing between severe and mild cases, will be converted to a system in which hospitals will be rewarded more for treating severe cases and less for treating mild cases," said Jeong, adding, "To this end, we will select and apply ‘appropriate disease groups' that are suited to the functions of each medical institution." Discussions are also underway to reform the management of non-reimbursed items and indemnity insurance. In July, the government formed a non-reimbursement and indemnity insurance subcommittee within the Specialized Committee for Essential Healthcare and Fair Compensation under the Special Committee on Healthcare Reform to discuss non-reimbursed management and indemnity insurance reform. During subcommittee discussions, it was suggested that non-reimbursed items with obvious excessive use concerns, such as manual therapy, cataract surgery with non-reimbursed lenses, and non-valve reconstruction, should be restricted, and that a management system should be established using the current positive listing system to set standard prices for non-reimbursed items that bring concerns over excessive use based on the non-reimbursed item status monitoring result and continuously manage the items through data analysis and re-evaluation. Regarding the reform of indemnity insurance, the role of the indemnity insurance as a complement to health insurance should be clarified and the system should be improved in line with this principle. During subcommittee discussions, an opinion was raised that the statutory coinsurance rate of the national health insurance should be adjusted to a reasonable level to minimize some of the negative impacts of indemnity insurance on the healthcare delivery system and access to healthcare. In particular, Jeong explained that there were suggestions that the scope of non-reimbursed coverage should be rationalized in conjunction with the government’s non-reimbursed item management measures to improve the issue of insufficient examination and follow-up due to the nature of indemnity insurance, where an agreement is made only between the insurer and the patient, and to reinforce the review and management system for proper use and supply of healthcare, "In order for the healthcare reform to succeed, we need to change the way people use healthcare, different to what they have been accustomed to," Jeong said, adding, "If you have relatively minor symptoms, please refrain from visiting emergency rooms of tertiary hospitals to make room for severe and urgent patients."
- Policy
- Coinsurance rate for chronic diseases reduced from 30%→20%
- by Lee, Hye-Kyung Aug 14, 2024 05:51am
- #1 The coinsurance rate for outpatient treatment at neighborhood clinics for chronic diseases such as hypertension and diabetes will be reduced by 10%, from 30% to 20%. The Ministry of Health and Welfare announced on the 13th that a partial amendment to the ‘Enforcement Decree of the National Health Insurance Act’ was approved at a cabinet meeting. The amendment includes the legal ground for a 10% reduction (from 30% to 20%) in the coinsurance rate for outpatient visits to clinics for chronic patients who meet the requirements notified by the Minister of Health and Welfare, such as applying for integrated management services for hypertension and diabetes and establishing and establishing and receiving review for customized management plans. The co-payment reduction system will be implemented from August 21st. The Ministry of Health and Welfare said that the amendment is expected to contribute to improving health by preventing complications, improving the healthcare delivery system, and encouraging rational use of healthcare by encouraging chronically ill patients to receive comprehensive and continuous management at neighborhood clinics. In addition to improving the coinsurance rate system for chronic diseases at the clinic level, the amendment also includes an exemption from reporting the total remuneration to the National Health Insurance Service if users submit a simplified withholding tax statement. Starting with the year-end settlement in 2025 (attributable to 2024), employers will be able to submit a simplified withholding tax statement (earned income) to the tax authorities, which will allow year-end settlement of insurance premiums through data linkage with the National Tax Service without reporting the total remuneration amount to the NHIS, which is expected to reduce the workload of employers. However, users should be aware that if they have not submitted a simplified withholding tax statement to the tax authorities, or if there is an error such as an omission of information on the simplified withholding tax statement, they will need to report the total remuneration amount of the previous year as they currently do. Also, to revitalize the monthly income adjustment system, the government has expanded the number of income brackets eligible for adjustment from 2 to 6 and made it possible to apply for adjustment not only if your income has decreased from the previous year, but also if it has increased. If a subscriber has temporarily earned more income than the previous year, he or she will be charged a higher premium next year, but from January 1, 2025, he or she will have the option to pay the higher premium in the year he or she earned the income through the monthly income adjustment process. The 2024 out-of-pocket maximum for the bottom 30% of the income bracket (income quintiles 1-3) will remain the same as last year to relieve the burden of out-of-pocket costs for medical expenses for lower-income subscribers. Also, to prevent social hospitalization in long-term care hospitals, the out-of-pocket maximum for nursing hospital stays of more than 120 days will be increased by the previous year's consumer price index (3.6%) for all quintiles (1st-10th), including those that fall in the bottom 30% of the income bracket. "The amendments to the Enforcement Decree are a follow-up to the 2nd Comprehensive National Health Insurance Plan announced in February," said Joong-gyu Lee, Director of the Bureau of Health Insurance Policy at the Ministry of Health and Welfare. "By unifying the year-end tax settlement report and expanding the scope of income monthly adjustment applications, these amendments will improve the convenience of insurance premium payments and contribute to easing the burden of medical expenses for chronically ill and low-income subscribers who receive comprehensive care."
- Policy
- Reimb for Paxlovid still pending amid COVID-19 resurgence
- by Lee, Tak-Sun Aug 12, 2024 05:55am
- Product photo of Paxlovid. As the COVID-19 treatment supply becomes an ongoing issue amid a virus resurgence, clinical practices are frustrated by delayed reimbursement coverage of 'Paxlovid (nirmatrelvir‧ritonavir, Pfizer Korea).' The drug reimbursement application for Paxlovid was submitted to the Health Insurance Review and Assessment Service (HIRA) in early October of last year. After that, HIRA has yet to finish the evaluation. On August 8th, Paxlovid was not considered for HIRA's Drug Reimbursement Evaluation Committee (DREC) review. Initially, Pfizer aimed to acquire reimbursement for Paxlovid for the first half of the year, but it has yet to be considered for the DREC review 10 months after submission. During this period, Pfizer submitted response letters to HIRA six times. The company recently requested HIRA an extended response letter due date. While the reimbursement for Paxlovid is being delayed, the Korean Disease Control and Prevention Agency (KDCPA) discontinued the free-of-charge program in May. Now, patients are required to pay KRW 50,000, which is approximately 5% of the drug price, for the drug. However, it is still provided free of charge for medical reimbursement benefit recipients and those eligible for co-payment reduction due to having the second-lowest income. When the drug became available for co-payment, some clinical practices prescribed Paxlovid to adult patients under different conditions. The basis for Paxlovid approval in South Korea is its efficacy and effectiveness in treating adults with mild to moderate symptoms who are at a high risk of developing severe COVID-19, including hospitalization and death. As a result, prescribing it to adults with mild symptoms still meets the efficacy and effectiveness criteria. However, when the government provided Paxlovid free of charge, it was only used for patients who were senior-aged and had severe symptoms. It seems that when the drug became available for co-payment, clinical practices mistakenly thought it had reimbursement criteria and prescribed it as approved. Recently, the Korea Disease Control and Prevention Agency (KDCPA) officially requested that clinical practices prescribe oral COVID-19 medicines, including Paxlovid, only to high-risk patients who show symptoms. Those who can be prescribed are patients over 60 years old and 12 years old (Paxlovid) or 18 years old and older (Lagevrio) who are immune compromised or with underlying diseases. Additionally, it must prescribed within 5 days of showing symptoms and for patients not needing oxygen therapy. The KDCPA said, "There are no changes to who can be prescribed COVID-19 medicines before or after issuing co-payment in May." They explained, "It can only be prescribed in clinical practices designated for COVID-19 medicines prescription." To prevent such confusion, some have pointed out the necessity of prescription criteria through reimbursement coverage, as well as agreements with pharmaceutical companies for the efficient supply of drugs. A HIRA official said, "Paxlovid will be internally evaluated soon and considered for the DREC review."
- Policy
- 4th PVA negotiations complete for Prolia
- by Lee, Tak-Sun Aug 08, 2024 09:25am
- The government completed price-volume agreement (PVA) negotiations for Prolia Prefilled Syringe (denosumab), the leading product in the domestic osteoporosis treatment market, with Amgen Korea. Whether the drug’s price will be adjusted for the 4th time under the PVA is gaining attention. According to industry sources on the 4th, Amgen Korea and the National Health Insurance Service recently agreed on PVA negotiation terms for Prolia. The current upper insurance price for Prolia is KRW 156,100. Prolia is a biological drug that targets the RANKL protein, which forms osteoclasts that destroy the bone. The drug is co-marketed by Amgen Korea and Chong Kun Dang in Korea. Ever since the drug was granted reimbursement in October 2017, the drug immediately dominated the domestic osteoporosis drug market. In April 2019, the drug was granted extended reimbursement, covering its use as a first-line therapy, which rapidly increased its use. According to IQVIA, Prolia’s domestic sales in Q1 amounted to KRW 41.2 billion, ranking second among all drugs. With sales rising steadily, the company inevitably had to negotiate Prolia’s price under the price-volume agreement system. Prolia's price has already been adjusted 3 times through negotiations. The first was a "Type A" negotiation in December 2020, which resulted in a 6.5% reduction. Type A negotiations are applied when the drug’s expected use amount increases by over 30%. The second was a "Type B" negotiation that was applied in August 2022. Type B negotiations are applied when the expected use amount increased by 60% or more compared to the previous year or increased by 10% or more but the total amount exceeds KRW 5 billion. The third was also a ‘Type B’ negotiation, which resulted in a 3.7% price cut in Prolia’s insurance price ceiling in August last year. If the drug price is adjusted this time, it will be the 4th PVA price reduction. In May, Prolia's insurance price ceiling was lowered from KRW 162,600 to KRW 156,100 due to the reimbursement extension. Prior to the reimbursement extension, patients with a bone mineral density measurement of -2.5 (T-score) or less were eligible for 1 year of benefits, but after the reimbursement extension, patients with a T-score of -2.0 or less and to -.2.5 are eligible for up to 2 years of reimbursement.
