- LOGIN
- MemberShip
- 2025-12-22 13:54:43
- Policy
- Only K-CAB continues to be applied refund-type PVA
- by Lee, Tak-Sun Dec 07, 2022 05:55am
- HK Inno.N’s ‘K-CAB Tab’ is the only drug that is applied the refund-type Price-Volume Agreement (PVA) system in Korea. The fact that the system is only applied to homegrown new drugs, and some companies do not prefer double pricing caused by refunds are pointed to as reasons for the low utilization rate of the PVA system. The National Health Insurance Service announced this at a training session organized by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on the revision direction of the 'drug pricing negotiation guideline' and how to conduct drug pricing negotiations. The refund-type PVA is a system that allows pharmaceutical companies to maintain the insurance ceiling price of their drugs rather than undergo price cuts by refunding a portion of the pharmaceutical expenditures back to the authorities when a drug is subject to pricing negotiations with NHIS due to increased usage. The system is advantageous for domestic pharmaceutical companies that plan to emerge into overseas markets because their listed drug price is set higher than the actual drug price. The refund-type PVA system had been introduced in 2014 to encourage and foster exports of homegrown new drugs. However, the conditions required to be eligible for the system are strict. Only drugs from Korea Innovative Pharmaceutical Companies that meet the Health Insurance Review and Assessment Service’s standards as a ‘drug that affects healthcare’ may apply for the system. Therefore, drugs whose entire process was manufactured in Korea and was approved as a first-in-class drug, or drugs for which the clinical trials for approval were conducted in Korea, or whole annual R&D investment ratio to annual sales exceed that of the average invested by Korea Innovative Pharmaceutical Companies are eligible to apply for the refund-type PVA. When taking into account drugs that have given up domestic release and drugs that have not considered overseas expansions, only a few drugs are eligible to use the refund-type PVA system among the 36 approved homegrown new drugs, This is why only the new gastroesophageal reflux disease drug K-CAB and new hypertension drug Kanarb (Boryung Pharmaceuticals) had signed a contract for the refund-type PVA so far. In the case of Kanarb Tab, the company signed a refund-type PVA contract in August 2015. Without extending the contract term in 2018, its insurance price ceiling was lowered in August 2018 under the PVA system. Accordingly, the price of Kanarb 60mg, which was listed at KRW 665 in March 2016, was lowered to KRW 653. In the case of K-CAB, its company signed a contract with NHIS in June last year and applied the refund-type PVA. Although the drug was eligible for ceiling price cuts, the company decided to refund the increased pharmaceutical expense to the NHIS and maintain its ceiling price. Accordingly, the price of K-CAB 50mg is currently maintained at KRW 1,300 since its listing in 2019. This year, K-CAB became subject to monitoring under the PVA system for the second time. During the monitoring period, the refund amount is deducted from the claims amount for analysis. If K-CAB’s usage increases further, negotiations will be held to set an additional refund rate compared to the existing refund rate. If the refund contract is terminated or a generic is listed, the ceiling price is lowered to the predetermined price. Since K-CAB’s contract was signed last year, the ceiling price of KRW 1,300 will be maintained until June 2024. However, its actual price is expected to be less than this due to the two PVA negotiations that were conducted until now. The maximum price reduction rate during PVA negotiations is set at 10%. The industry is claiming that the system’s scope application should be broadened to activate the refund system. A pharmaceutical industry official said, "This system, which can only be used for homegrown new drugs, should be applied to incrementally modified drugs (IMDs) so that pharmaceutical companies can increase their options and decide between lowering their drug price or making refunds."
- Policy
- Vaccine sales reached 3.4178 trillion won in Korea last year
- by Lee, Hye-Kyung Dec 07, 2022 05:55am
- About half of the companies complain of difficulties due to lack of funds in the research and commercialization process. Last year, domestic sales in the vaccine industry totaled 3.4178 trillion won and exports amounted to 628.7 billion won. The Ministry of Health and Welfare (Minister Cho Kyu-hong) and the Ministry of Trade, Industry, and Energy (Minister Lee Chang-yang) selected 159 companies through a full survey and announced the results of the 2021 Korea Vaccine Industry Survey, including domestic sales, exports, employment, and investment. As a result, domestic sales totaled 3.4178 trillion won, with 2.6865 trillion won in vaccine finished products, 86.5 billion won in vaccine raw materials, 69.4 billion won in vaccine equipment, and 636.1 billion won in vaccine-related services. Exports to the vaccine industry totaled 628.7 billion won, with 563.7 billion won in vaccine finished products, 141 billion won in vaccine raw materials, 43 billion won in vaccine equipment, and 73.3 billion won in vaccine-related services. Investment in the vaccine industry is expected to increase year-on-year, considering the ongoing or planned facility investment of more than 13 trillion won, including 214 billion won in R&D and 117.4 billion won in facility investment. According to the survey, 159 domestic vaccine companies were found to have 29.6% of vaccine finished products, 32.1% of vaccine raw materials, 15.1% of vaccine equipment, and 35.8% of vaccine-related services. Based on the headquarters, these companies were concentrated in Seoul (53, 33.3%), Gyeonggi (51, 32.1%), and the size of the business was 3.1% (5), 26.4% (42), and 70.4% (112), which is quite high compared to the total manufacturing industry. Based on the established capital, 90% (143 pure domestic capital), 5% (foreign capital), and 5% (foreign capital) were found to be joint ventures (foreign capital + domestic capital). More than 10,758 people worked in vaccine-related departments, and my job, 4,715 (43.8%), 2,772 (25.8%) were researchers, and 3,271 (30.4%) were in other jobs such as sales and management. According to a survey of corporate difficulties experienced by vaccine companies, they cited the difficulties in R&D in the order of lack of funds (47.2%, 75 companies), lack of professional manpower (25.2%, 40 companies), and lack of infrastructure (22.0% and 35 companies). In the process of commercialization, there are difficulties in the order of lack of funds (40.3%, 64 companies), lack of information such as market trends (24.5%, 39 companies), and lack of professional manpower (20.8%, 33 companies). The survey was conducted by KPBMA, KSCIA, and KoDATA, a credit survey and evaluation agency, and is meaningful in that it conducted the first survey specializing in the vaccine industry. The government plans to start reviewing the domestic vaccine industry survey next year after consultation with the National Statistical Office, considering the connection, consistency, and population design with the bio-industry survey conducted annually by the Ministry of Trade, Industry, and Energy. Meanwhile, the Ministry of Health, Welfare and the Ministry of Trade, Industry and Energy jointly held a public-private vaccine industry innovation forum today (6th) to introduce private R&D and investment tax credits for vaccines and bio industries, K-bio and vaccine funds, smart factory construction, low-interest financing projects, and overseas expansion projects. The government plans to increase the size of the company and provide timely pan-ministerial support tailored to the growth cycle so that the vaccine industry can grow into a solid hub industry leading the bio-industry in the future, and provide customized support for each ministry.
- Policy
- Reimb of antidiabetic SGLT-2+DPP-4 combo near
- by Kim, Jung-Ju Dec 07, 2022 05:55am
- Reimbursement of antidiabetic SGLT-2+DPP-4 class combinations near Expanding reimbursement to the combined use of SGLT-2 inhibitors and DPP-4 inhibitors as treatment for diabetes has entered its final stages. As the reimbursement will be carried out through voluntary price cuts by pharmaceutical companies as intended by the government, the process may proceed faster than when companies take the drug price negotiation track. However, the fiscal burden on NHI finances, which remains the biggest issue, depends on the size of the voluntary price cuts that will be made by pharmaceutical companies. Therefore, agreeing on the amount of the price cuts may continue for several months. Extending reimbursement to the combined use of three ingredients including SGLT-2 inhibitor class and DPP-4 inhibitor class drugs had been deferred several years due to various reviews and procedures, such as integrating the opinions of the Korean Diabetes Association, analyzing their fiscal impacts, and revising phrases for reimbursement standards. Chang-Hyun Oh, Director of the Pharmaceutical Benefits Division of the Ministry of Health and Welfare explained to the multinational pharmaceutical company press corps, “We have completed analysis on the fiscal impact and selected drugs that will be sharing finances with the reimbursement expansion, and explained to the 10 companies that will be affected on how they will be required to share finances. We are currently collecting opinions from the companies.” As the reimbursement requires changes in the drug price, both the payer and the supplier must agree on the price cut. According to MOHW, all the companies have agreed on making voluntary price cuts and will be subject to voluntary price cuts rather than drug pricing negotiations. The time required for reimbursement can be shortened with voluntary price cuts, as it is a sort of fast track system that allows the omittance of pricing negotiations. This is beneficial for both the government and the payers as it can reduce the financial burden on NHI finances and the company can also raise more sales with extended reimbursement standards. However, the government and the companies still need to reach an agreement after comparing the scale of voluntary price cuts and the amount of NHI finances the government is willing to share. Even afterward, the agenda needs to undergo remaining administrative procedures including signing the quality supply contract and making reports to Health Insurance Policy Deliberation Committee. Therefore, the government explained that it is unsure how long it would take for reimbursements to be extended. Director Oh said, “I can't guarantee that the remaining procedures (such as the opinion collection from companies and other follow-up procedures) will be completed within the month. All companies must sign quality supply contracts with NHIS and complete other procedures. The reimbursement extension can be implemented quicker if its fiscal impact is not so large, but if the parties involved do not reach a complete agreement, the implementation may be further delayed.
- Policy
- One-shot Zolgensma fulfills terms of its RSA contract
- by Kim, Jung-Ju Dec 06, 2022 05:57am
- Zolgensma (onasemnogene abeparvovec), the ultra-high-priced ‘one-shot treatment’ that succeeded in receiving reimbursement in Korea in May this year, will start fulfilling the terms of its risk-sharing agreements (RSA) contract. If the drug was administered at the time its reimbursement was approved in Korea, the medical institutions that administered Zolgensma would need to prepare a report on the effectiveness of the drug every 6 months and submit it to the Health Insurance Review and Assessment Service for 5 years. HIRA’s New Drug Performance Management Division issued a notice to the hospital community that contains the ‘Operation Plan for the Performance Management of Zolgensma inj’ to inform the medical institutions that use the drugs on the need to carry out the RSA contract. Zolgensma is a new treatment for spinal muscular atrophy (SMA) that had attracted social attention in the long term for being an ‘ultra-high-priced new drug.’ Despite being a one-shot treatment that can provide a transformative effect with a single administration, its insurance reimbursement listing had remained a challenge due to its very high price. In Korea, only 7 patients are expected to be eligible for its use, but the expected pharmaceutical expense for the 7 patients amounted to KRW 13.87 billion. The drug was applied for reimbursement in August. Its insurance ceiling price in Korea had been agreed on at KRW 1.98 billion under RSA after pricing negotiations with the National Health Insurance Service. The terms of the RSA contract were built around the financial-based RSA with an added outcome-based RSA. Zolgensma was applied the Refund type, Expenditure Cap type, and Patient-unit performance-based type RSA in its reimbursement. The refund type mandates the company to refund a certain rate (refund rate) of the claims amount, the Expenditure Cap type mandates the company to refund an amount that exceeds a prespecified amount (Cap), and the Patient-unit performance-based type where the pharmaceutical company refunds a certain proportion of the expenditures when treatment fails after following up on the treatment outcome of each patient. Therefore, to fulfill its patient-unit performance-based RSA, long-term follow-up evaluation data must be prepared and submitted to HIRA. Data must be submitted to HIRA on the progress of patients who have been administered Zolgensma every 6 months for a total of 5 years by the attending physician and the affiliated medical institution that signed an agreement to conduct the long-term follow-up study for administering Zolgensma. The attending physician can evaluate the treatment response and effect in line with the evaluation period after dividing the period into 10 terms. In addition, the patient's motor function evaluation result sheet and progress record sheet, etc., can be submitted to the system on the medical institution’s work portal by the end of the month of each evaluation period. However, HIRA’s system for the submission is in development, so the data must be submitted via notified email until the development is complete. HIRA plans to distribute related manuals in the future.
- Policy
- The government is conducting six studies on drug prices
- by Kim, Jung-Ju Dec 06, 2022 05:57am
- With a number of drug price systems in operation within the positive list system, the government is conducting six studies on drug price policies related to insurance benefit entry permits and follow-up management, drawing attention to how the results will be reflected next year. According to the Ministry of Health and Welfare, this year, the insurance authorities are conducting six studies on the ▲ actual transaction price system, ▲ low-priced purchase incentive system, ▲ PVA improvement, ▲ RSA performance evaluation and future improvement, ▲ drug price adjustment system, and ▲ plasma raw materials. These studies are expected to be an important basis for the reorganization or improvement of the government's drug price policy because the main goal is to check the need for policy improvement and present improvement plans. In fact, Oh Chang-hyun, head of the insurance drug division at the Ministry of Health and Welfare, said, "These studies, which started this year, will be completed by early next year. Although improvement plans for the systems may be drawn, it is not known at present whether they can all lead to implementation, he said. "There will be some that can lead to improvement of the system next year and some that will be delayed further." The Ministry of Health and Welfare said that even if the foundation of these studies was to improve spending efficiency, they did not include any new drug price reduction measures. In other words, this also means that the Ministry of Health and Welfare will maintain the existing policy among the Trade-Offs that have been used as the keynote for recent years in next year's policy projects. Manager Oh said, "We have not discovered a new system (to do next year). Since the drug price system has changed a lot in 2020, we are working on follow-up work to make it well realized, he said. "We will continue to maintain this stance because we need to increase drug access for severely rare and intractable patients with reduced costs."
- Policy
- "A9 countries not used for drug pricing reevals next year"
- by Kim, Jung-Ju Dec 05, 2022 05:53am
- The government announced that it will not immediately apply its plan to increase the number of foreign drug price reference countries by 2 in its reevaluations next year. The foreign reference drug pricing system is essentially used to evaluate the price of reimbursed drugs in Korea. Also, regarding the pharma-bio industry’s concern, the government firmly said using the A9 price as a reference for unilateral drug price cuts in the future does not fit the purpose or objective of the system. At a recent meeting with the multinational pharmaceutical company press corp, Oh Chang-Hyun, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, said so regarding questions on the MOHW’s plan to expand the number of foreign drug price referencing countries. According to the government, the currently used drug price decision method has an unclear reference basis, so the MOHW commissioned a research service for 'Measures for Improving Foreign Drug Price Reference Standards' in 2019, based on which it prepared the revision plan. The plan was part of the 1st Comprehensive Plan of National Health Insurance. The research service results proposed the inclusion of Taiwan, Australia, and Canada in the current A7 (US, UK, France, Germany, Italy, Switzerland, and Japan). The government decided to amend the current standards by including Canada and Australia, countries that have similar or slightly smaller economic levels and pharmacuetical industry scales, and review the price calculation formula. Director Oh said, “We included the two countries that evaluate the economic feasibility of public health insurance through HTA (health technology assessment) as these countries assess drug price based on clinical usefulness.” The government and the Health Insurance Review and Assessment Service are collecting industry and expert opinions on systemic reform. According to Director Oh, the industry opinion inquiry that is set until the 11th is the first official external opinion inquiry being issued for the system. The industry’s concerns are clear. Australia and Canada’s drug prices are generally lower as they are not new drug developing countries, therefore referring to the price of these countries will naturally lower Korea’s price level and reduce the drive for new drug development. The area that the industry worries the new system may soon be applied was in the reevaluation of patent-expired drugs next year. Also, the industry expressed concerns about how the system may be further applied to unilateral drug price cuts in the future. Adding on to the concerns, the possibility remains that applying the steeped pricing system may further reduce the drug price. Regarding concerns over reevaluations, Director Oh clearly stated that it is physically impossible for the revision to be applied next year for patent-expired drug reevaluations. Director Oh said, “We need to prepare around 1 year in advance to conduct such reevaluations, In other words, we need to make announcements a year in advance. As we have not made any announcement until now, it is impossible to conduct reevaluations next year.” Also, another reason is that the government nor HIRA has the resources to conduct the reevaluation as large-scale reassessments on reimbursement adequacy of drugs are already set to be conducted next year. Director Oh said, “We are not ready to conduct foreign drug price reevaluations next year as the reevaluation of drugs that have submitted bioequivalence data (reevaluation of reimbursed drug prices for already-listed bioequivalence test subjects) and reevaluation of reimbursement for 8 ingredients are in progress." Also, Oh added that applying the A9 countries for unilateral drug price cuts will not be feasible as it does not meet the purpose or objective of the revision. "Using our plan to reevaluate the foreign drug reference system and applying it to unilateral price cuts does not fit the purpose of our reform. The government never mentioned that it will be used for unilateral price cuts.”
- Policy
- Implementation of projects linked to permission evaluation
- by Kim, Jung-Ju Dec 05, 2022 05:53am
- The government will conduct a pilot project of the "Permission Evaluation Negotiation Linkage System" in the first half of next year, which will simultaneously carry out three tracks of the drug market-wage hurdles, including the Ministry of Food and Drug Safety's item license safety and efficacy evaluation and the NHIS drug price negotiation. Although detailed standards or appropriate drug candidates have not yet been set, the pharmaceutical industry is showing interest, and the process will be created as soon as possible and applied as soon as appropriate drugs appear in the first half of the year. The Ministry of Health and Welfare recently announced the business plan when asked about pending insurance drug issues by the Korea Special Press Association. The government is currently operating the drug approval-patent linkage system to strengthen accessibility to patients. The drug approval-patent linkage system is a system that allows insurance benefits to be applied quickly by drastically reducing the time required by the Ministry of Food and Drug Safety's product approval and the HIRA benefit adequacy evaluation stage. Usually, the Ministry of Food and Drug Safety's review of the safety and effectiveness of drugs must be passed and item permission must be obtained to apply for insurance registration by the Korea Appraisal Board. If the salary adequacy is determined here, it will be reported to the Health Insurance Policy Review Committee immediately after the drug price negotiation of the industrial complex or if the salary is confirmed by formula, the final registration will be decided. Negotiations have been added to the permit evaluation linkage system, one of the "fast tracks" listed in the drug, which reduces the time further as a total of three tracks are conducted in parallel at the same time. The target is a drug that has a short life expectancy of ▲ from 6 months to less than 1 year, meets ▲the number of patients with cancer, and rare diseases, and has ▲ sufficient improvement effects instead of alternative drugs. Judging from what pharmaceutical companies are inquiring about, Oh seems to have drugs included in the target category. He added, "We will start a pilot project next year, we will organize the process as soon as possible and start it as soon as possible." He said, "I think it's the first half of the year, but I haven't decided on the candidate group or the details yet." He said, "We can set up a candidate group for pharmaceutical companies. "We will start in the first half of the year," he said. The government plans to effectively operate the Drug Approval-Patent Linkage System, which is currently in operation. This is because the existing system has also proven effective in improving drug accessibility. Manager Oh added, "Even if the Drug Approval-Patent Linkage System is introduced, the existing Drug Approval-Patent Linkage System will be taken as it is."
- Policy
- MOHW “reasonably decide on using A9 countries as reference"
- by Kim, Jung-Ju Dec 05, 2022 05:53am
- # i1 Regarding criticism from the industry on how the systemic reform of adding Australia and Canada to the existing A7 countries as drug price reference countries that are used for new drug insurance reimbursement evaluations, the government said it would make a reasonable decision after collecting industry and expert opinion. The Ministry of Health and Welfare released an explanation on the afternoon of the 2nd and emphasized that the revised plan was made as a result of lengthy discussions with the pharmaceutical industry and working-level consultative bodies. On November 21st, the Health Insurance Review and Assessment Service made a preannouncement of its revision plan to officially expand the number of reference countries used to evaluate new drugs from 7 to 9 (US, UK, Germany, France, Italy, Switzerland, Japan, Canada, Australia·A9) through the ‘Proposal for the Amendment to the Regulations on the Evaluation Standards and Procedures to Determine Eligibility for Reimbursement Benefits.’ Until now, the government had referred to the insured drug price of A7 countries when negotiating, agreeing, or designating insurance drug prices in Korea to not exceed the level set in A7 countries. Following the announcement, concerns and criticisms from interested parties arose on how adding Australia and Canada, which are not strong new drug developers, to the reference countries will decrease the price of insured drug prices in Korea and adversely affect the domestic pharmaceutical and bio-industry. On this, the MOHW explained that “The currently used drug price decision-making method has an unclear reference basis, so the MOHW organized a working-level consultative body with the pharmaceutical industry for 4 months from May this year based on the results of the policy research conducted in 2019 and expert consultation.” The MOHW added, “We will reasonably review various opinions that are submitted during the opinion inquiry period according to relevant procedures until the 11th, and then collect expert opinions to make a final decision." Meanwhile, the MOHW said that no specific plan has yet been set for the reevaluation of listed generics based on the revisited A9 plan and that it will provide information on the issue after collecting relevant opinions from the pharmaceutical industry.
- Policy
- The safety & efficacy evaluation of Jemperili was terminated
- by Lee, Hye-Kyung Dec 05, 2022 05:53am
- Authorization of domestic items for GlaxoSmithKline's immuno-cancer drug Jemperili is imminent. According to the pharmaceutical industry on the 1st, the Ministry of Food and Drug Safety recently ended Jemperili's safety and efficiency evaluation. As the safety and efficacy evaluation has been completed, permission will be obtained soon if there are no other variables. If Jemperili is approved, it will be listed as the third PD-1 inhibitor after Opdivo of Ono and BMS and Keytruda of MSD. Jemperili is the pipeline GSK acquired in 2019 when it acquired Tesaro for $5.1 billion. Unlike Opdivo and Keytruda, which had their first indication as melanoma treatments, Jemperili approved conditional sales of Jemperili in the EU in April last year, following the first approval in the U.S. as a treatment for recurrent or progressive endometrial cancer indicating "platinum-based therapy or subsequent inconsistency recovery defects." FDA approval was based on the results of the dMMR endometrial cancer cohort of the ongoing Phase 1 clinical trial GARNET study. The overall response rate of 71 patients with dMMR recurrent/progressive endometrial cancer in the study was 42.3%, with 12.7% and 29.6% for complete remission (tumor extinction) and partial remission (tumor contraction), respectively. In August of the same year, Jemperili obtained additional approval for dMMR recurrence or advanced various solid cancers that did not reach satisfactory results with existing treatment. GSK plans to add indications after endometrial cancer in Korea. Meanwhile, Keytruda and Opdivo, approved as domestic immuno-cancer drugs 1 and 2, are actively working on adding indications and expanding benefits.
- Policy
- Domestic new drug No. 36 Envlo has been approved
- by Lee, Hye-Kyung Dec 05, 2022 05:53am
- Envlo 0.3mg, the 36th domestic development new drug, has been approved in Korea. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 30th that it has approved Daewoong Pharmaceutical's Envlo to improve blood sugar control in patients with type 2 diabetes. Envlo is an adjunct to diet and exercise therapy administered to improve blood sugar control in type 2 diabetes patients. It lowers blood sugar by suppressing the reabsorption of glucose in the kidneys and allowing glucose to be released into the urine. It selectively inhibits sodium-glucose co-transporters (SGLT2 transporters) involved in the re-absorption of glucose in the kidney (neoprene tube) to block the re-absorption of glucose into the bloodstream. Currently licensed SGLT2 transporter inhibitors include Dapagliflozin, Ertugliflozin, Empagliflozin, and Ifragliflozin. The Ministry of Food and Drug Safety said, "We expect this approval of the new drug to help expand the scope of treatment options and treatment opportunities for type 2 diabetes patients. The Ministry of Food and Drug Safety will continue to do its best to expand treatment opportunities to patients by quickly supplying treatments that have been sufficiently confirmed in safety and effectiveness based on regulatory science expertise."
