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- 2026-05-04 15:38:44
- 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."
- Policy
- Roche’s Lunsumio receives 1st GIFT designation in Korea
- by Lee, Hye-Kyung Dec 01, 2022 05:46am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had designated Roche Korea’s ‘Lunsumio Inj (mosunetuzumab)’ as the first product subject to the Global Innovative product on Fast Track (GIFT) program it has been operating since September to support the development of innovative medical products in Korea. Lunsumio is used to treat adults with refractory or relapsed follicular lymphoma. With no other existing treatment options available for the disease, its urgent need for introduction had been recognized and designated as an item subject to the GIFT program. Drugs subject to GIFT receive various support for the rapid commercialization of its product including support for preparing approval data, rolling review support, and provided opportunities for close communication between the reviewer and developer, expert consulting on regulatory affairs, etc. The MFDS also newly established a page for GIFT on its webpage to ensure transparency in GIFT designations and allow easy access to related information in one place. The page provides information on GIFT and its main areas of support, eligibility for GIFT, the application process, submitted data, and the fast-track designation status of drugs, etc. As a result, information on Roche Korea’s Lunsumio Inj which received the first GIFT designation has also been disclosed on the GIFT information webpage. The information page can be accessed through www.mfds.go.kr → Public communication → active administration → GIFT The MFDS said, “We will continue to actively support the research and development of innovative new drugs and their rapid commercialization through the effective operation of the GIFT program.
- Policy
- The price of Donepezil 5mg fell below 500 won
- by Lee, Tak-Sun Dec 01, 2022 05:46am
- Dementia tx original AriceptDonepezil, which is most commonly used to treat dementia, fell to less than 500 won for 5mg due to the step-type drug price implemented in July 2020. The drug prices refer to 85% of the lowest price of the upper limit of the same product registered if more than 20 products are registered. According to industries on the 29th, Donepezil HCl applied by C.L.Pharm will be listed on the 1st of next month at 85% of the lowest price with step-type drug prices. Accordingly, C.L.Pharm's Bielpezil 5mg will be listed for 425 won and Bielpezil 10mg for 544 won. It has fallen to 85% from the previous lowest price product. In the case of 5mg of Donepezil HCl hydrate, 122 pharmaceutical products are listed. If newly registered, the upper limit will continue to fall depending on the price of the stepped drug. In the case of Donel 5m of i-World Pharm, the previous lowest price of 5mg of Donepezil, it was lowered from 1,223 won to 500 won in June through a voluntary cut. C.L.Pharm product is listed at 425 won, which is 85% of 500 won. price for Donepezil 5mg is 2,060 won, which is now about five times the difference. The industry analyzes that hospitals and clinics are receiving incentives under the drug-saving incentive system when they switch from high-priced drugs to low-priced drugs, so the lowest prices in Donepezil formulations are continuing.
- Policy
- Pediatric drugs eligible for PE exemptions from January
- by Kim, Jung-Ju Dec 01, 2022 05:46am
- Chang-Hyun Oh, Director of MOHW The government expects the ‘Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments’ that gained industry attention for increasing the scope of use of the pharmacoeconomic evaluation exemption system (PE exemption system) will be applied to drugs that apply for reimbursement in January. In other words, the government plans to confirm and apply final revisions in December. The revisions to the Health Insurance Review and Assessment Service’s guidelines are currently complete and are being reflected in the National Health Insurance Service’s detailed standards for negotiations (negotiation guidelines). After the process is complete, it will be possible to extend the application of the PE exemption system to pediatric new drugs that apply for reimbursement in January. In the case of the 200 set as the ‘small number of patients’ standard, the government reaffirmed its position that extending PE exemption to drugs for adults deviates from the purpose and priority of reimbursement while emphasizing the flexibility of the Drug Reimbursement Evaluation Committee review as it had responded at the last NA audit. Chang-Hyun Oh, Director of the Pharmaceutical Benefits Division replied so at the QA session on pending issues at a recent meeting with the multinational pharmaceutical company press on the 29th. Also, Oh drew the line and said that it was different from the government’s intentions regarding the market’s prediction that the measures will be immediately applied from November upon notice. The following is the QA script between the press corp and Director Oh. ▶After the administrative notice, HIRA has not yet publicly announced the expansion of the PE exemption system to pediatric drugs. Were there any problems in the implementation process? “We are currently changing the NHIS negotiation guidelines. The Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments does not only include expanding PE exemptions to pediatric drugs. It also includes the expedited listing of severe disease treatments and expanding the scope of reference countries to A9 which is set for December 11. These revisions have to be made collectively (none of them have been publicly announced yet). We will be able to confirm and revise the plan in December. ▶The pharma and bio industry expected the measures to be implemented immediately upon notice this month (in November) and awaited HIRA’s public notification. But at the current pace, the system will be applied next year at the earliest. Is this a delay or a deferment? “Since other revisions that need to be implemented also need to be reviewed and unilaterally implemented, the measure will be applicable to drugs that apply for reimbursement from January. Since the government had not announced that it will be implemented from November, it is not a delay." ▶The industry is still strongly voicing the need to extend the PE exemptions to drugs used in adults.” “A clause ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee’ has been added to HIRA’s guidelines. At the same time, ‘when the drug’s main indication is for pediatric patients’ condition has been added to NHIS’s reimbursement standard procedure improvement plan. As these two are being applied together, reimbursement will be extended to drugs whose main indication is for ‘pediatric’ patients among drugs used for both children and adults. Therefore, the extension will be applied to pediatric patients. There have been many requests for expanding the reimbursement benefit to drugs that affect adult patients. We can review it, but our current priority is in benefiting pediatric patients rather than adults.” ▶The NA and others have pointed out how the extension had rather raised the threshold for PE exemptions and reimbursement. What is the government’s opinion on this? "I have already explained the reason why the ‘small number of patients’ clause had been included at the past NA audit. The restriction was set to clarify that PE exemptions are applied when the drugs have difficulty producing evidence. DREC had answered to the National Assembly that it will deliberate reimbursements in consideration of the severity of the disease for drugs that affect a small number of patients. The same is true for the 200 range that had been set. Considering the severity of the disease, even if the number of patients exceeds 200, the drug can be considered and reviewed as a drug that affects a small number of patients. I believe DREC will make a reasonable decision."
