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- 2025-12-24 12:42:40
- Policy
- Supply of Oseltamivir has declined 55% since COVID outbreak
- by Lee, Hye-Kyung Aug 10, 2021 05:54am
- After COVID-19 epidemic, the supply of respiratory medicine has dropped by nearly half. According to the HIRA's "Medicine Distribution Newsletter No. 1" published on the 5th, the supply of respiratory drugs in spring and winter since 2020 decreased by 40.6% compared to the same period last year, and the supply of Oseltamivir used to treat flu also decreased by 55.1% compared to the same period last year. According to the period, 10,719,850 respiratory drugs (based on ATC code 'R05'cough and cold preparation OTC) were supplied from November 2019 to April 2020, while only 597,997,447 were supplied, down 40.6% from November 2020 to April 2021. During the same period, the supply of Oseltamivir (based on ATC code "J05AH02") decreased 55.1% from 155,716 to 69,870. The information center has launched a newsletter for drug distribution to share changes in the drug distribution information management system and recent trends and issues. According to the newsletter, as of 2020, the total number of drug suppliers is 3,654 and the size of the distribution market is ₩75.9 trillion per year. By business type, wholesale drug dealers account for 3,170 (86.8%), pharmaceutical manufacturers and importers account for 484 (13.3%) and companies based in Seoul and Gyeonggi account for 48.9% by region. The top 5% of drug suppliers account for 71% of the total drug distribution market. The proportion of manufacturers and importers directly supply medicines to medical institutions is 10.6% of all transactions, and in most cases, they supply them to medical institutions through wholesalers.The distribution amount of medicines supplied to medical institutions among all drug supplies in 2020 is ₩30.3 trillion, and the amount of distribution other than the supply of medical institutions such as transactions between companies is ₩45.5 trillion. The supply amount of Rx drugs was ₩27 trillion (89%), the supply amount of OTC was ₩3.3 trillion(11%), and most of the medicines supplied were Rx drugs.
- Policy
- Vaccination agencies are expected to work too hard in Oct
- by Lee, Tak-Sun Aug 10, 2021 05:54am
- Confusion is expected in October, when COVID vaccinations and flu vaccinations overlap, due to a significant increase in the work of inoculation institutions. In October, the largest number of people are scheduled to receive the second round of COVID vaccinations, and vaccinations to prevent seasonal flu will also begin in earnest. Front-line health centers, hospitals, and clinics expect that vaccination work will be excessive from reservation due to increased demand for vaccinations. The MFDS said Tuesday that it released 878,000 people of the seasonal flu vaccine for the first time this year. A total of 28 million flu vaccines are expected to be released this year. The MFDS said that considering 14.6 million people eligible for free vaccination (children, pregnant women, and elderly) and the target vaccination rate (80.0% for children aged 6 months to 13 years, 50.0% for pregnant women, and 85.0% for elderly people, about 11.92 million are expected to be vaccinated. Flu vaccines usually begin in September, with the largest number of people administered in October and November. Since December to March is the flu epidemic in Korea, many people are given vaccines before then. The problem is that large-scale COVID vaccinations are also scheduled in October. The KDCA announced its plan to vaccinate people in their 40s and under on the 30th. There are 17.77 million people in their 40s and They plan to complete the first round of inoculation from August 26 to September 30. Those in their 40s or younger will be vaccinated with Pfizer or Moderna, and the second vaccination is likely to be crowded in October because the interval between the first and second vaccinations is four weeks. Therefore, the flu vaccine and COVID vaccine will overlap in October, adding to the work at the front site. The MFDS plans to increase the number of people working for stable supply to help the rapid national lot release of COVID and flu vaccine. Therefore, COVID vaccine will be released in the new infectious disease vaccine test and the flu vaccine will be released in the vaccine test. However, health centers and local hospitals, which are difficult to expand personnel immediately, are unlikely to be able to fully respond to the vaccine demand. As a result, it is feared that vaccination will not take place on time or that there will be an accident of misuse. An official from the pharmaceutical industry said, "In October, the work load of front-line inoculation agencies will increase significantly due to the overlapping demand for flu vaccines and COVID vaccinations. If we fail to respond properly, there is a possibility that the number of people waiting will increase and the vaccination will be pushed back." The official said, "The government should make a thorough plan for inoculation in consideration of this."
- Policy
- It will be reviewed by the Regulatory Reform Committee
- by Lee, Jeong-Hwan Aug 09, 2021 06:02am
- Whether or not to introduce the "no change in manufacturing" policy of consignment generic, which is being opposed by the domestic pharmaceutical industry, will eventually be decided based on the results of the Regulatory Reform Committee review. The MFDS finished collecting opinions on the related industries by March this year after announcing the regulations last year, began reviewing internal regulations, and even completed reporting to the president and the National Assembly. On the 8th, the pharmaceutical industry is stressed by the MFDS' move to prevent pharmaceutical companies with consignment generics from changing manufacturing sources. The MFDS has begun discussions such as the regulatory reform legal affairs office's own review of the Regulatory Reform Committee, which is necessary to introduce administrative regulations restricting changes to manufacturers. Until just before the review of the Regulatory Reform Committee, work related to regulations on new and strengthened regulations has been carried out. Regarding the reason for the introduction of the restriction on change of manufacturers, the MFDS explained, "It is to continuously improve the quality of medicines by strengthening the management of manufacturing methods such as the manufacturing process of Rx drugs." The MFDS said that "systematic management and international harmony are needed for changes in the manufacturing method of finished drugs that can affect the quality, safety and effectiveness of impurities." The KIPCO and the KPBMA are confronting the MFDS, saying that it is excessive and double regulation to prevent changes in manufacturers now that the "1+3 Restricted Act" has been introduced and implemented. The reason why regulations against the domestic pharmaceutical industry have proceeded such as administrative notice, opinion check, and internal regulatory review by the Ministry of Food and Drug Safety was uncertain whether the pharmaceutical 1+3 restriction law could pass the National Assembly. The 1+3 Act is a strong regulation that limits the number of marketing permits for generic and improved new drugs to four. The pharmaceutical industry could not oppose the MFDS' plan to solve some problems of domestic generics by banning manufacturers from changing their manufacturers because it was uncertain whether the 1+3 law would pass the National Assembly. The 1+3 Act was implemented to limit the number of commercial permits for new drugs as well as generics. In response, the pharmaceutical industry is arguing that introducing restrictions on changes in manufacturing sources is excessive regulation and overlapping regulation. In the end, it is expected that the regulation will be introduced in Korea based on the results of the Regulatory Reform Committee review. It will review the MFDS' internal regulatory review and decide whether to implement or withdraw the objection. An official from a local pharmaceutical company said, "The pharmaceutical companies are in conflict with the MFDS' position that prohibition of changes in manufacturing is excessive regulation and that no country in the world has freely released changes in manufacturing." "In particular, it was difficult for the pharmaceutical industry to oppose because it was unclear whether the 1+3 Act was passed by the National Assembly at the time of the administrative notice banning manufacturers from changing their sources," he explained. He added, "Regulatory Reform Committee has also lifted restrictions on 1+3 by the MFDS, so it may decide to withdraw the ban on changing manufacturing sources." Meanwhile, the MFDS did not elaborate except that it was conducting an internal regulatory review in this regard.
- Policy
- Benefits for Imotun, Tagen-F and Legalon have been deleted
- by Lee, Hye-Kyung Aug 09, 2021 06:01am
- As it was classified as a health functional food in major foreign countries, it was decided to delete the benefit of four already registered medicines. However, Hanlim's Entelon, (Vitis vinifera) can be reimbursed only for lymph edema supplementary therapy due to breast cancer treatment. The remaining two indications, blood circulation, retinal and choroid circulation, are excluded from the benefit. The HIRA (Director Kim Sun-min) conducted a review on the adequacy of health care benefits for drugs already listed in the "7th Pharmaceutical Benefits Advisory Committee 2021." The Pharmaceutical Benefits Advisory Committee, which was held today, deliberated on the benefit quality review criteria approved by the Health Insurance Policy Committee on January 29. Over the past six months, the HIRA has reviewed relevant academic and pharmaceutical institutions and textbooks and clinical care guidelines, and the final ingredients reviewed are Vitis vinifera, Avocado soya unsaponifables, Bilberry fruit dried ext., and Silymarin, etc. The deliberation agenda was finalized at the Pharmaceutical Post-Evaluation Subcommittee held on the 30th of last month, and three out of four ingredients were decided to delete benefits because all of them were inadequate, and withdraw benefits for blood circulation, retina, and choroid coat circulation. If the HIRA notifies companies with Pharmaceutical Benefits Advisory Committee's results, the MOHW will file an objection for a month in August and undergo an announcement of standards after the committee's re-assigned next month. Vitis vinifera and Ginkgo biloba, which were originally subject to revaluation, were finally excluded after a conference and a pharmaceutical company's opinion check process.
- Policy
- No. of refunded RSA drugs become 23 with addition of Onivyde
- by Lee, Hye-Kyung Aug 09, 2021 06:00am
- With the new addition of Servier Korea's pancreatic cancer treatment 'Onivyde (irinotecan liposome)' that was approved for reimbursement, a total of 23 drugs are now being covered under the Risk-sharing Agreement (RSA) scheme. Patients who take RSA drugs need to bear the full cost of the drug, then request refunds to the applicable pharmaceutical company. Recently, the National Health Insurance Service (NHIS) provided information on drugs eligible for the refund and the contact information of relevant reimbursement officials in each company for patients who paid a 100/100 copayment for the use of RSA drugs. 23 drugs are currently maintaining the RSA contract. 5 drugs whose RSAs were terminated - 'Pirespa tab,' 'Revlimid cap.,' 'Xalkori cap.,' 'Soliris inj.,' and 'Naglazyme inj.,' - may also apply for refunds if the patients received the drugs within the RSA term. NHIS monitors the RSA claims data regularly and notifies the pharmaceutical companies of the RSA refund amount and the financial expense each company has incurred according to their RSA scheme. Refunds of the additional cost borne by patients who paid 100/100 copayment for their drugs are directly conducted by the pharmaceutical companies or their agencies. In 10 of the 23 companies, the patients may directly contact the company to receive the refund, however, for the other 13 drugs including 'Erbitux,' patients need to ask an agency or academic society for reimbursement. The NHIS receives a monthly notice on the details of refunds from pharmaceutical companies and sends a notice to patients who did not receive refunds after comparing the refund details with the 100/100 copayment claims records. Meanwhile, when a medical care institution such as a hospital or pharmacy prescribes or dispenses an RSA drug with 100/100 copayment by the patient, the doctor or pharmacist responsible should file a claim under Section code U (Health insurance 100/100) according to the 'Method on claiming medical care benefit expenses, and form and tips for filling out review claims and statements.' ▶RSA drugs eligible for a refund for the f00/100 patient copayment cost Erbitux Inj., Xtandi Soft Cap., Stivarga Tab., Pomalyst Cap., Opdivo Inj., Keytruda Inj., Ibrance Cap., Kyprolis Inj., Cyramza Inj., Darzalex Inj., Spinraza Inj., Perjeta Inj., Dupixent Prefilled Inj., Imfinzi Inj., Strensiq Inj., Verzenio Tab., Bavencio Inj., Kisqali Tab., Benlysta Injection, Ninlaro Cap., Hemlibra S.C Inj., Defitelio Inj., Onivyde Inj.
- Policy
- It will spend ₩2.2 trillion to become a vaccine power
- by Lee, Jeong-Hwan Aug 09, 2021 06:00am
- President Moon Jae-in has announced that he would leap forward into a 'global vaccine production, the Big Five' by 2025. It also announced plans to select vaccines as one of the 'three major national strategic technologies' along with semiconductors and batteries and invest ₩2.2 trillion over the next five years. On the 5th, President Moon presided over the "K-Global Vaccine Hub Vision and Strategy Reporting Conference" at Cheongwadae and made the remarks. He plans to foster the vaccine industry as a new growth engine for the nation's economy. It said it will strengthen its global cooperation system and support the rapid development of domestic vaccines while creating an ecosystem for the vaccine industry. President Moon said, "By 2025, Korea will become one of the top five global vaccine production powerhouses and select vaccines as the top three national strategic technologies along with semiconductors and batteries." "We will invest ₩2.2 trillion over five years," he said. "Without sufficient supply of vaccines to all countries, continuous mutations and the spread of COVID cannot be prevented. After all, the fundamental solution is to dramatically increase the supply of vaccines. President Moon said, "We will greatly expand tax support related to vaccine R&D and facility investment and self-sufficiency of essential materials, parts, and equipment to maximize production capabilities of Korean companies. We will establish K-Bio Lab Hub and designate high-tech investment zones to provide various incentives." In order to strengthen the global cooperation system, President Moon said he would strengthen the vaccine partnership with foreign countries. "We will expand our vaccine partnership with other countries such as Germany and the U.K. and strengthen communication and cooperation with international organizations such as the WHO, global vaccine institutes, and companies, and prepare a stage for vaccine hubs such as revitalizing foreign investment and attracting global companies," President Moon said. He also mentioned the rapid development of domestic vaccines. He said, "Quick development of domestic vaccines to secure vaccine sovereignty is also very important. "COVID vaccine developed by domestic companies will enter phase 3 clinical trial this month," he said. "We are expected to commercialize the first vaccine in Korea in the first half of next year and are speeding up the development of the next-generation mRNA vaccine." "Domesticization of core production technologies is taking place. The government will provide medical expenses for the rapid development of domestic vaccines, and operate various support systems such as localization of raw and subsidiary materials and patent analysis. The Global Vaccine Hub Promotion Committee should take this opportunity to develop and finish the mRNA vaccine," he ordered. Prime Minister Kim Bu-gyeom and other related ministries attended the reporting meeting, which was also the first meeting of the "Global Vaccine Hub Promotion Committee," which was launched on the same day. In the private sector, 12 civilian members of the Global Vaccine Hub Promotion Committee and representatives of Korean companies that produce vaccines such as SK Bioscience, Samsung Biologics, and ST Pharm were present. The Global Vaccine Hub Promotion Committee is headed by the Prime Minister, but President Moon's direct presidency reflects his commitment to developing domestic vaccines and global vaccine production hubs to secure vaccine sovereignty.
- Policy
- Attention is focused on licensing domestic vaccines
- by Lee, Jeong-Hwan Aug 09, 2021 06:00am
- As the supply price of COVID vaccines, which relies entirely on imported products, is confirmed to increase next year's supply price in Korea, it is necessary to develop the vaccine within this year. Attention is focusing on the development status of Korean pharmaceutical bio companies, which are about to undergo phase 3 clinical trials, will be able to complete clinical trials as planned and obtain marketing permits within this year or in the first half of next year. According to the pharmaceutical bio industry on the 4th, five companies approved by the MFDS, including Genexine, SK bioscience, GeneOne, Cellid, and Eubiologics. The goal of the five companies is to obtain approval within this year for phase 3, which is evaluated as a phase just before commercialization, with phase 2 in progress or completed. It takes time for Curatis and HK Inno.N to get a commercial license after receiving a relatively recent vaccine approval last month. The development of a domestic COVID vaccine is urgently needed as the number of new confirmed cases of COVID patients in Korea is spreading and countries around the world are forced to distribute their own vaccine supplies. U.S. pharmaceutical companies Pfizer and Moderna have also decided to raise the supply price of their mRNA vaccines. Therefore, domestic supply prices are expected to rise next year. However, there is a long way to go to develop a domestic vaccine. Major foreign media reported on the 1st that Pfizer and Modena will increase the price of a single dose of vaccine supplied to the European Union by 25% and 10%, respectively. Pfizer raised its contract price from €15.5 to €19.5. The price of a single Modena rose from €19 to €21.47. The development of domestic vaccines is to ensure that Korea is not affected by such price hikes and fluctuations in volume of imported vaccines. SK Bioscience is the fastest development among domestic pharmaceutical bio companies that are close to clinical phase 3, the final step for permission. SK Bioscience submitted a clinical phase 3 plan for "GBP510," a synthetic antigen coronavirus development substance, to the MFDS in June. SK Bioscience, which received approval for phase 2 and phase 3 in Indonesia last month, aims to receive commercial approval and release it in the first half of next year after receiving phase 3. Genexine also received phase 2 and 3 of its DNA vaccine substance "GX-19N" in Indonesia last month. Along with Genexine history SK Bioscience, it is evaluated to be the closest to clinical phase 3. Cellid, which is developing the virus vector vaccine, Eubiologics and DNA vaccine developer GeneOne are also planning to enter phase 3 in the second half of this year and release the vaccine as early as the first quarter and second quarter of next year at the latest. It is not yet clear whether Korean vaccines will be available as scheduled because phase 3 clinical trials take a long time. Health authorities also have high expectations for domestic vaccine developers. The MOHW has successfully deliberated on the National Assembly by deploying ₩98 billion in phase 3 support from five companies that have started developing domestic vaccines in the second revised budget this year. Earlier in the year, Kwon Deok-chul, Minister of Health and Welfare, was convinced that domestic vaccines, which have been developed by the five companies since the beginning of this year, will enter commercialization with permission to market by the end of this year or early next year. The government has allowed domestic vaccine developers to enter clinical trials relatively quickly. The advantage of comparative clinical trials is that the number of subjects can be reduced to thousands of people compared to existing clinical trials, which require tens of thousands of people, significantly reducing clinical costs and time. If domestic vaccines enter the commercialization stage of inoculation after obtaining market permits, they will have a positive impact on the stabilization of supply and demand in Korea and the reduction of confirmed cases. It will not matter if the price of overseas development vaccines increases or supply and demand of supplies is unstable. "In the mid- to long-term, securing vaccines in Korea is very important," said Sohn Young-rae, head of Central Disaster Management. "In addition to the price issue, there are only a few vaccine supply pharmaceutical companies worldwide, and all countries are willing to purchase them, so buyers are inferior to suppliers in the negotiation process," he said.
- Policy
- PBAC results on Leclaza that was listed in 165 days show...
- by Lee, Hye-Kyung Aug 06, 2021 06:05am
- ‘Leclaza tab. (lazertinib mesylate monohydrate),' the 31st novel drug to be developed in Korea that received approval for insurance benefit in only 165 days after its approval, was reviewed as a 'new treatment alternative for non-small cell lung cancer patients' in the evaluation process for assessing the reasonableness of the medical care benefits for drugs. The Health Insurance Review and Assessment Service (HIRA) had recently disclosed the results and minutes of the benefit evaluation that was conducted on Leclaza by the Pharmaceutical Benefit Assessment Committee on April 8th. Leclaza was approved by the Ministry of Food and Drug Safety on January 18th as a ‘treatment for patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who were previously treated with an EGFR-TKI, then received reimbursement from July 1st after the notice was issued on the ‘amendment to the drug benefit list and the maximum ceiling price table’ on July 1st. Yuhan Corp had applied for the insurance benefit listing of Leclaza on December 30th, 2020 with the ‘approval-benefit appraisal linkage system.’ Through the system, the drug received insurance benefits at an unprecedented pace - in only184 days from its listing application and 165 days since receiving the marketing authorization. According to data disclosed by HIRA in 2017, it generally takes 1030 days for anticancer drugs, 475 days for rare disease drugs, 550 days for general drugs to receive notification for benefit listing since MFDS approval. Compared to the average, Leclaza shortened the listing registration period by 30 months. As a domestically developed novel drug that received its first approval this year, Leclaza’s approval status in the A7 countries, listing status in drug price reference books, and data on the clinical effectiveness in textbooks and clinical practice guidelines were not available for evaluation. In the PBAC evaluation results disclosed, the committee members concluded that “it is difficult to see a difference between Leclaza, which was approved for the treatment of patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who were previously treated with an EGFR-TKI, and the alternative drug.” Despite the review, the reason why the domestic new drug was able to be listed for reimbursement in only 165 days since its approval was because its reasonableness of receiving medical care benefits was recognized from the cost-effectiveness aspect, as the drug ‘is therapeutically equivalent to Tagrisso (osimertinib) while being cheaper than Tagrisso when using the RSA scheme proposed by the pharmaceutical company.’ The comparator in the evaluation was Tagrisso (osimertinib), and PBAC emphasized that the “evaluation results and conditions of Tagrisso’s RSA scheme should be considered in Leclaza’s pricing negotiations.” Also, relevant academic societies including the Korean Cancer Study Group, Korean Society of Medical Oncology, Korean Association for Lung Cancer added their support, saying that, “Leclaza showed a similar effect to the already-approved Tagrisso, and demonstrated an acceptable safety profile and low cardiac toxicity. We can fully expect Leclaza to become a viable substitute to Tagrisso” The societies requested reimbursement for Leclaza stating that “The drug can bring new opportunity to patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who had limited treatment options.” At the Cancer Disease Deliberation Committee meeting that was conducted on February 24th before the PBAC review, the committee had set the standard - ‘medical care benefit will be recognized for patients with Stage IIIA or higher NSCLC as second-line or later therapy that belong to one of the subject numbers (other than No.22,23,24)' for Leclaza. After deliberation and decision by the PBAC and the negotiations with NHIS that followed from April 23rd to June 8th, Leclaza was applied the RSA refund-type and expenditure cap type and listed for medical care benefit at a ceiling price of ₩68,964 per tablet.
- Policy
- Last year, the drug trade surplus was achieved
- by Lee, Tak-Sun Aug 05, 2021 08:47pm
- Domestic medicine achieved its trade surplus for the first time last year. This is because biosimilar led the export. The MFDS announced on the 1st that it analyzed the production, export, and import performance of drugs, quasi-drugs in 2020. Drugs achieved the trade surplus (₩1.394 trillion won) for the first time since 1998, when the MFDS compiled statistics. The main reason for this is that exports of finished drugs, which accounted for 79.6% of total exports (₩9.96 trillion), increased 92.3% (₩7.9308 trillion) compared to 2019. Quasi-drugs showed a 124% increase in production performance of anti-COVID-19 products (₩3.7149 trillion) compared to 2019. This is largely due to the increase in demand for products to prevent infectious diseases, with production performance of masks and disinfectants rising by 818% and 926% respectively compared to 2019. The average annual growth rate of drug production is 6.9%, which is six times higher than the manufacturing average. In 2020, drug production increased 10.1% year-on-year to ₩24.565.5 trillion, while export performance increased 5.2% year-on-year to ₩9.96 trillion ($8.44 billion), 62.5% year-on-year and import performance to ₩8.57 trillion ($7.26331 billion). Its production performance was 1.2% compared to GDP and 5.1% compared to domestic manufacturers. The MFDS explained that the average annual growth rate over the past five years is 6.9%, which is more than six times higher than the total domestic manufacturing production (1.1%), indicating the possibility of the pharmaceutical industry as Korea's future industry. In 2020, there were two companies with production performance of more than ₩1 trillion, while Celltrion rose 149.2% year-on-year to ₩1.476.9 trillion, followed by Hanmi with ₩1.14.3 trillion, similar to that of 2019. Although the size of the pharmaceutical market fell 4.7% year-on-year to ₩23.17 trillion in 2020, the size of the pharmaceutical market has grown 1.6% annually over the past five years. It was attributed to a significant increase in export performance to 62.5%, respectively, compared to the increase in production performance and import performance (10.1%, 5.2%, respectively). Remsima, Herzuma and Truxima exported the most to Germany In 2020, the drug trade balance recorded ₩1.394 trillion due to rising drug export performance, the first time since 1998, when the MFDS compiled performance statistics such as drug production, export and import. The main characteristic of the domestic pharmaceutical market in 2020 is that the export performance of finished drugs, which led to the ▲ trade surplus, increased by 92.3% and ▲ biosimilar exports are active amid strong performance in the production and export of bio pharmaceuticals,▲ and this is because the proportion of Rx drugs production has been maintained and the production of new drugs in Korea has steadily increased. In the case of finished drugs, which accounted for 79.6% (₩7.9308 trillion) of total drug exports in 2020, exports increased by 92.3% compared to 2019, and were larger than 62.5% of total drug exports, leading to a trade surplus. Among the finished drugs, the top three products in the size of exports are all bio pharmaceuticals, and bio pharmaceuticals account for a large portion of all domestic pharmaceutical exports. Among the finished drugs, Remsima was the No. 1 export, followed by Herzuma 150mg with ₩98.6 billion ($80million) and Truxima with ₩75.3 billion ($60million). Germany ($1.855.96 million), the U.S. ($780.61 million), and Turkey ($589.55 million) are the countries that Korea exports the most finished drugs. And, the largest importers of finished medicines were the United States ($977.61 million), Germany ($806.65 million), and China ($887.74 million). As a result, the U.S. and Germany have been identified as the largest trading partners. Twelve of the top 20 items in 2020 were bio-medicine products, and eight out of the 12 items accounted for 79.7% ($1.69.65 billion) as bio-similar products. Exports of bio pharmaceuticals have increased significantly in Europe and North America, which is analyzed to have been approved for new item licenses or listed on the prescription list in Europe and the United States in the second half of 2019. The production performance of Rx medicines (₩17.84 trillion) accounted for 84.9% of the finished medicines, 83-84%, which has been maintained for the past five years. Six new domestic drugs produced more than ₩10 billion, and 19 new domestic drugs produced ₩322.1 billion, up 38.2% from 2019. Meanwhile, the production performance of quasi-drugs in 2020 increased by 124% to ₩3.7149 trillion from 2019 (₩1.657 trillion), the highest growth in the past three years, and the trade balance of quasi-drugs recorded a surplus of ₩214 billion in 2020.
- Policy
- No prior approval req. filed for Soliris, 47 for Ultomiris
- by Lee, Hye-Kyung Aug 04, 2021 06:01am
- ‘Ultomiris (ravulizumab),’ a follow-on drug of ‘Soliris (eculizumab)’ that was approved for reimbursement from June, has taken away all new prescriptions for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) from Soliris. Reimbursement for Ultomiris, like Soliris, needs to be authorized in advance through a prior authorization application process to the NHIS before administration at a medical care facility equipped with the personnel and facilities as specified in the ‘Criteria on the medical care benefit for hematopoietic stem cell transplantation.' According to the eligibility for reimbursement of Soliris and Ultomiris deliberated in July by HIRA’s Healthcare Review and Assessment Committee, new approval applications filed by PNH patients were 0 for Soliris and 47 for Ultomiris. The doctors and new PNH patients were seen to have selected Ultomiris, which can be administered every 8 weeks as maintenance therapy 2 weeks after the initial dose, over Solaris, which needs to be administered biweekly. Ultomiris received approval from the U.S. FDA in December 2018, and from the EMA in July 2018. The drug received marketing authorization in Korea on May 21st, 2020. After receiving approval, Handok applied for the insurance benefit listing on August 31st last year. After receiving approval from HIRA’s Pharmaceutical Benefit Assessment Committee, going through NHIS’s drug pricing negotiations, and deliberation by MOHW’s Health Insurance Policy Deliberative Committee, Ultomiris was listed at ₩5,598,942 per vial from June 7th. Based on the clinical trial results, Ultomiris was found to be clinically non-inferior to its substitute Soliris. Also, Ultomiris was considered cost-effective if its price is set at Solaris's weighted average price of ₩5,598,942 or less. Meanwhile, 43 PNH patients receiving Soliris that were monitored received approval to continue administration of Soliris. 6 cases that were filed to newly administer Soliris for atypical hemolytic uremic syndrome (aHUS) were all disapproved, and 2 monitoring cases for Soliris were approved and the other 2 were disapproved.
