- LOGIN
- MemberShip
- 2025-12-23 09:16:47
- Policy
- Gov needs to maintain patient benefits to the public
- by Lee, Jeong-Hwan Nov 05, 2021 05:23am
- Starting next year, the Korea Organization For Patient Group expressed regret to the MOHW and the HIRA, which triggered anxiety and confusion among cancer patients by announcing plans to exclude second-tier anticancer drugs from the coverage. The Korea Organization For Patient Group urged the MOHW and the HIRA to give confidence in ensuring the continuity of treatment for patients taking anticancer drugs, which have been subject to new comprehensive applications. The Korea Organization For Patient Group released a press release on the 2nd and said, "The government and pharmaceutical companies should actively cooperate and ensure that all cancer patients receive health insurance benefits to quickly register second-tier anticancer drugs such as targeted anticancer drugs and immuno-cancer drugs." They pointed out that the HIRA caused confusion among patients by saying that all second-tier anticancer drugs and rare drugs were decided as non-target items in an official letter to hospitals participating in the pilot project for the new comprehensive fee system next year. The official document that cancer patients, who have been treated for only 5% co payment so far, have to pay 100% of the drug price from January 1 next year is tantamount to telling the patient to give up treatment. The group introduced the Democratic Party of Korea, Kang Byeongwon and Nam In-soon, urging the government to take the lead in promoting the fact that anticancer drug benefits will be maintained regardless of the system improvement. The intention is to clarify the continuity of treatment for cancer patients through explanatory press releases. The Korea Organization For Patient Group said, "Targeted anticancer drugs and immuno-cancer drugs used to treat cancer patients must be approved by the MFDS and registered as health insurance quickly." The Patient Group pointed out that "second-tier anticancer drugs that have not yet been registered as health insurance are causing conflicts between the government and pharmaceutical companies due to high drug prices and financial sharing measures." "If pharmaceutical companies do not apply for health insurance registration, they should apply quickly, and the MOHW should consult closely with insurance benefits and insurance medicine departments to expedite health insurance registration," the group said. The patient group added, "All cancer patients who need second-tier anticancer drug treatment should receive health insurance benefits and should not have victims in good faith."
- Policy
- The HIRA proceeds to improve the mediation system
- by Lee, Hye-Kyung Nov 04, 2021 05:56am
- The MOHW requests the promotion of research services for effective system operation. Improvement of the adjustment application system will be carried out to raise the upper limit of -reimbursed drugs. The HIRA recently made an open bid for a "request for research proposal on how to improve the drug adjustment application system" and announced that the project will be carried out within six months from the date of signing the contract. The study was conducted when the MOHW requested the promotion of research services to prepare specific measures to improve applications for coordination for effective system operation. Within the current positive list system, measures to increase the upper limit of the reimbursed drugs listed on the drug benefit list are limited, such as designation of Drug Shortage Prevention, cost preservation, and application for adjustment of the upper limit. The Drug Shortage Prevention designation and cost preservation system stipulates detailed standards such as cost analysis in the "Attachment 5 of Drug Determination and Adjustment Standards" through past research services, but the application system for an increase in the upper limit has not been reviewed overall. In addition, procedures and evaluation criteria are required to apply decision of application to the relevant laws and regulations, and detailed evaluation criteria are operated privately. The need to improve the system has emerged as drug prices related to this year's additional revaluation and drug price revaluation scheduled for next year are expected to surge. Through this study, The HIRA aims to diagnose and analyze the current mediation application system, compare the mediation application system with the Drug Shortage Prevention system, and derive a reasonable mediation application system improvement plan. Analysis of the current mediation application system is expected to be conducted on the recent mediation application status and operation details, identifying problems such as uncertainty in the reason for the application, ambiguity in evaluation standards, and the NHIS negotiations. The HIRA said, "We hope this study will come up with an improvement plan that will be used to improve the mediation application system." The HIRA said, "We hope for system development and efficient operation through objective and rational improvement."
- Policy
- MFDS to support Phase III trials of domestic COVID-19 Txs
- by Lee, Tak-Sun Nov 04, 2021 05:56am
- The Ministry of Food and Drug Safety has been supporting domestic companies that have entered Phase III trials for their domestic COVID-19 treatments through its ‘Development-focused Support Council.' The three items currently approved for Phase III trials and supported by the Support Council are: Chong Kun Dang’s ‘Nafabeltan (nafamostat),’ Daewoong Pharmaceutical's ‘Foistar(camostat),’ and Shin Poong Pharmaceutical’s ‘ Pyramax (pyronaridine/artesunate).’ The news was shared at an ‘Online briefing session regarding 2021 2H drug reviews ’ that MFDS held on the 3rd. Kyung-sook Choi, a researcher of the Oncology and Antimicrobial Products Division, said, “We have been operating a Development-focused Support Council since earlier this year to address the difficulties faced by domestic developers (of COVID-19 treatments) that are entering Phase III trials.” After completing the Phase II trial for ‘Nafabeltan,' Chong Kung Dang had applied for conditional approval earlier this year but was turned down in February. However, the company continued its pursuit and received approval for a Phase III trial in April and started the trial in July. Chong Kung Dang plans to conduct its clinical trial in Korea and 7 other countries - Ukraine, Argentina, India, Russia, Brazil, Peru, Thailand. In the Phase III trial, the company will enroll 600 patients with severe COVID-19 to verify the efficacy of its treatment candidate. Daewoong Pharmaceutical has been developing its Foistar tablet under the trademark name ‘Coviblock’ as a COVID-19 treatment. The Phase III trial protocol for the substance, DWJ1248, was approved twice - on December 31st last year and in January this year. Although the drug failed to meet the primary endpoint and reach statistical significance in its Phase II trial, its potential as a treatment still remains as the drug had shown to expedite recovery in patients who have a higher risk of progressing to severe COVID-19. The Phase III trial protocol for Shin Poong Pharmaceutical’s Pyramax tablet was approved last August. Like the other new drug candidates from Chong Kun Dang and Daewoong Pharmaceutical, Shin Poong Pharmaceutical’s Pyramax also failed to meet statistical significance for its primary endpoint in its Phase II trial. However, the drug also showed potential in reducing the rate of progression to severe COVID-19, based on which the company initiated a large-scale Phase III trial. The company plans to recruit around 1,400 participants for the trial. All three domestic COVID-19 candidates are repurposed drugs that were used to treat other diseases in the past. Chong Kun Dang’s Nafabeltan inj. was a blood anticoagulant, Daewoong Pharmaceutical's Foistar a treatment for chronic pancreatitis and reflux esophagitis, and Shin Poong Pharmaceutical’s Pyramax an antimalarial drug. The MFDS explained that it had held 16 Development-focused Support Council meetings to support the smooth progress of the companies' clinical trials. Choi said, “We first held meetings once a week, but then changed to a twice a week schedule. The council not only supports issues related to approval and reviews but also helps companies resolve non-MFDS issues by sharing such issues with the pan-government support group." The MFDS had shortened the clinical trial period for COVID-19 treatments from the previous 30 days to 7 days (15 days for new drugs) and organized an exclusive review team to shorten the review and approval process from the previous 180 days to 40 days. Currently, a total of 34 COVID-19 treatment candidates have entered clinical trials, including 25 antivirals (18 repurposed drugs, 7 new substances) and 9 immunomodulators (7 repurposed drugs, 2 new substances). Choi said, “We are doing our best to meet our promised deadline through priority and expedited review systems for COVID-19 treatments. We ask for your understanding as this may delay complaints filed for non-COVID-19 treatments."
- Policy
- NA asks NHIS to introduce the reference pricing system
- by Lee, Hye-Kyung Nov 04, 2021 05:55am
- The National Assembly raised the opinion that a reference pricing system should be introduced to induce price competition between generic drugs and encourage the use of cheaper generics. NA member Youngseok Seo of the Democratic Party of Korea inquired on introducing the reference pricing system to normalize the generic market and reduce NHI finances to the National Health Insurance Service through a written QA at the NA’s Health and Welfare Committee’s Comprehensive Audit The reference pricing system refers to a system in which a certain reimbursement level is set for all drugs with the same efficacy. Through the system, only a certain amount of a drug price is covered by NHI finances, and the patient bears the difference in high-priced drugs that exceed the set level. Seo said, “We need to prepare an institutional environment that induces price competition among generics and encourages the use of cheaper generics. The NHS should review introducing the reference price system that can prevent alliances between doctors and pharmaceutical companies, grant pharmacists the obligation to provide information, and allow patients to select medicines based on cost awareness.” Upon inquiry, the NHIS agreed on the need to prepare an institutional environment that can save NHI finances by inducing pricing competition and the use of cheaper generics. NHIS replied, “In addition to newly establishing a Pharmaceutical Pricing Management Office, we have made multilateral efforts to establish a management system that can cover the whole cycle of insured pharmaceuticals by expanding the Generic Management Department. We agree on the need to review measures to promote the use of high-quality inexpensive generic drugs and introducing a reference price system with reference to the economic burden borne by patients as well as cases overseas." The NHIS added, “We will discuss the measure with government ministries by collecting stakeholder opinions, etc."
- Policy
- Refund RSA may be set higher than the lowest price
- by Lee, Jeong-Hwan Nov 04, 2021 05:55am
- The HIRA said that the cost-effectiveness evaluation criteria for omitted drugs that submit economic evaluation data are less than 80% of the lowest A7 adjustment price. It also explained that the economical evaluation drug can be integrated into a risk-sharing system (RSA), which can set the indicator price higher than the lowest A7 price in case of refundable restrictions. On the 2nd, The HIRA responded like this to a written inquiry from Rep. Kim Mi-ae of the National Assembly. Rep. Kim Mi-ae pointed out that it is necessary to disclose the internal regulations of The HIRA on the criteria for lowering the level of cost-effectiveness evaluation of economic evaluation drugs. Rep. Kim also asked The NHIS' position on the basis of 80% of the lowest A7 price contradicts the NHIS' guidelines for drug price negotiations. The NHIS explained that the actual price was deliberated to evaluate the cost effectiveness at about 80% of the lowest A7 adjustment price, considering the clarity of the criteria for "considering the lowest price" and whether to apply the risk-sharing system to excluded countries. After this year's third Drug Reimbursement Evaluation Committee, it was added that it shared related information at an industry meeting on June 17 and a private consultative body on July 28. Regarding the 80% standard of the A7 lowest price, The NHIS replied with the intention that it does not contradict the industrial complex negotiations, but that it means that prices can be lowered further when negotiated if necessary. The NHIS said, "If the lowest A7 price risk-sharing contract is confirmed when determining the cost effectiveness of the economical evaluation drug, additional price cuts are needed due to uncertainty in the indicator price." It said, "Since October 8, 2021, the economic evaluation drug has also been integrated into a risk-sharing system," adding, "If the A7 lowest price is not subject to a risk-sharing contract, the A7 lowest price can be set higher."
- Policy
- Finding a system that suppresses the use of expensive drugs
- by Kim, Jung-Ju Nov 04, 2021 05:55am
- The HIRA said it will seek a system to prevent indiscriminate use of expensive drugs and manage expensive products that have already been registered. The HIRA also said it would make it mandatory to inspect the use of DUR systems for safe use. The HIRA submitted a recent written answer to Seo Young-seok, a member of the Democratic Party of Korea, who was asked during a parliamentary audit. Earlier, Rep. Seo called for the systematic management of the HIRA, saying it is necessary to establish a system to prevent indiscriminate prescription of expensive drugs. In response, the HIRA replied, "We are currently operating RSA and a pre-approval system to manage the effects of high-priced drugs and fiscal uncertainty," adding, "We will review various management measures considering the characteristics of drugs." The HIRA recognizes that it is necessary to find a way to manage expensive drugs within limited financial resources. Accordingly, the HIRA said it plans to collect opinions from various stakeholders and come up with a systematic management plan for the registration of expensive drugs. In particular, among the high-priced drug management measures, The HIRA applies a pre-approval system for Strensiq, immunotolerance therapy, Soliris, and Ultomiris. Rep. Seo stressed the need to systematize and institutionalize it. In response, the HIRA replied, "We will consult with the government to find various ways when reviewing the criteria for prescription and drug treatment because we need to consider the necessity of patient-level management, efficiency of management methods, and rapid drug prescription." Regarding the use, it also said it would actively help revise the law that mandates DUR, a system that checks safety before use. The HIRA said, "We actively sympathize with the need to mandate the inspection of drug use, and some amendments to the Pharmaceutical Affairs Act are currently pending in the National Assembly, initiated by Rep. Jeon Hye-sook." The HIRA said, "We will actively support this bill to be revised in the future."
- Policy
- HIRA deletes GDP phrase but maintains current ICER threshold
- by Lee, Hye-Kyung Nov 03, 2021 05:47am
- The industry has requested an explanation on why the Health Insurance Review and Assessment Service deleted the ‘reference to per GDP capita’ phrase in its ICER threshold regulations. On the 23rd, HIRA disclosed the ‘Detailed Evaluation Criteria for drugs subject to negotiation such as new drugs, etc.,' and changed the ICER threshold criteria to ‘Does not use an explicit ICER threshold, but refers to existing deliberation results that considers disease severity, social disease burden, impact on quality of life, and innovativeness to flexibly assess its value.’ Simply put, the ‘use the gross domestic product (GDP) per capita as reference’ phrase was changed to ‘refers to existing deliberation results.’ The authority’s intention seems to be to maintain its ICER threshold at the present level (₩25-50 million) while modifying the regulation to indicate that the threshold is not linked to the GDP level. Regarding the change, NA member Jong-Hean Baek of the People Power Party inquired through a written QA at the NA’s Health and Welfare Committee’s Comprehensive Audit on what the grounds were for HIRA to maintain the current ICER threshold. After receiving criticism at last year’s NA audit, the NHIS conducted a review on the adequacy of the ICER value and collected opinions through 6 roundtable and joint discussion sessions to conclude that there are no clear grounds on raising the ICER value from the current level. Also, the authorities added that the relation between the ICER value and GDP was found to be inadequate and therefore deleted from the regulations. Baek said, “I do not understand how deleting the ‘GDP per capita reference’ in the regulations relates to the ‘no basis for raising the ICER value.’ Isn’t this just a means used by HIRA to avoid the industry’s continuous request that the ICER value should be improved according to the current GDP level?” HIRA explained, “At the WHO-CHOICE in 2005, an ICER threshold of less than 1 to 3 times the GDP per capita of a country was suggested to be cost-effective. This was originally proposed for the purpose of prioritizing universal health coverage, but has been more widely used to determine the cost-effectiveness of certain technologies.” HIRA added that the WHO later expressed opposition in applying the 3GDP level to determine pricing or reimbursement of drugs and in assessing cost-effectiveness using a single threshold, in 2015. "If it is difficult to improve the ICER value, set a bandwidth for the ICER value so that new drugs for severe or rare diseases can also be recognized for their cost-effectiveness. By providing it as a reference during pricing negotiations, the government will be able to achieve financial management while shortening the listing period for such drugs," said Baek. HIRA said, “For severe and rare disease drugs, we have been flexibly applying the ICER value to twice the regular ICER value used for other new drugs. Also, for severe rare disease drugs with a high clinical need but difficulty in generating grounds for economic assessment, we have been assessing the adequacy of reimbursement in consideration of the lowest A7 price without a separate cost-effectiveness assessment to improve the patients’ accessibility,” and expressed reservations on setting a bandwidth on the ICER threshold.
- Policy
- The new system doesn't stop benefits for anticancer drugs
- by Lee, Jeong-Hwan Nov 03, 2021 05:47am
- The MOHW promised to operate a system that does not cause damage to patients due to the suspension of high-priced anticancer drug benefits due to the expansion of the new comprehensive insurance system. The plan is to review and operate measures to ensure continuity of treatment for existing patients taking expensive anticancer drugs such as Keytruda. On the 1st, the MOHW expressed this position when Nam In-soon of the Democratic Party of Korea and Kang Byung-won pointed out. The two lawmakers raised the issue that insurance benefits for patients who take expensive anticancer drugs were suddenly suspended in the process of improving the new comprehensive fee system by the MOHW. The intention is to come up with measures to maintain patient accessibility in the case of high-cost targeted anticancer drugs and immuno-cancer drugs with a cost of about 5 million won to 10 million won, such as Keytruda. Since the last parliamentary audit, the two lawmakers have strongly urged the need to review the abolition of anticancer drug benefits due to the expansion of the comprehensive insurance system. The MOHW agreed with the criticism of the two lawmakers and promised to operate policies to prevent some anti-cancer drug benefits from stopping due to the improvement of the new comprehensive insurance system. The plan is to implement a policy that does not cause an economic burden on patients administering anticancer drugs while achieving up to 50,000 new comprehensive insurance system operating beds targeted by 2022. The MOHW recently said that there are concerns about the National Assembly's intellectual content in the process of improving the system, adding, "We will prevent victims of good faith as a way to ensure continuity of treatment for existing patients."
- Policy
- The number of licenses for Rx drugs in October exceeded 100
- by Lee, Tak-Sun Nov 03, 2021 05:46am
- Xigduo XR The number of monthly permits increased again as the generic release of AstraZeneca's diabetes combination drug "Xigduo XR (Metformin+Dapagliflozin Propanediol Hydrate)" first appeared in October. As many as 31 generics for Xigduo XR were approved in October, all of which are consignment items manufactured by Richwood Trading Company. It is interpreted that the number of consigned items was large because the consignment manufacturer applied for permission before the enforcement of the Bioequivalence Restriction Act (a law that can only be consigned to three companies by restricting the sharing of BA test data) enforced in July. According to the MFDS on the 31st, there were 62 OTCs and 119 Rx drugs approved in October, a total of 189 items. Compared to September, the number of OTCs increased by 36 and Rx drugs increased by 57. In particular, the number of Rx drugs permits has continued to be less than 100 since May, but it recorded more than 100 again in five months. The reason for the increase in the number of Rx drugs permits was largely due to the emergence of late Xigduo XR. Xigduo XR expired its PMS in November 2019, but it received its first approval this month due to delayed development. The first pharmaceutical company that succeeded in licensing was Richwood Trading Company. Richwood Trading Company created a patent avoidance item using a salt-changing drug using citrate in Dapagliflozin.. Accordingly, items manufactured by Richwood Trading Company are expected to be available after April 7, 2023, when the Dapagliflozin material license ends. As of last year, Xigduo XR's outpatient prescription amount was 28.6 billion won, less than 36.1 billion won in single drug Forxiga (Dapagliflozin), but it is forming a huge market. Domestic pharmaceutical companies are also planning to release generics after the end of the substance patent, so generics for Xigduo XR is urgently needed to create synergy effects. For this reason, 31 items from 16 companies are expected to have been approved in October alone. If Richwood Trading Company and other development successful companies also participate, the generics for Xigduo XR are expected to increase further. This is because 42 companies are licensed for generics for Forxiga, more than twice as many as those licensed for generics for Xigduo. However, due to the Bioequivalence Restriction Act, it is expected that there will be fewer than three consignment producers who apply for permission later.
- Policy
- It is impossible to exclude PVA from domestic new drugs
- by Lee, Jeong-Hwan Nov 02, 2021 05:54am
- The government has virtually expressed opposition to the National Assembly and the pharmaceutical industry's demand to exclude PVA from innovative development drugs. PVA is a system that shares the burden of health insurance spending between health insurance financial authorities and pharmaceutical companies, and the government explains that if only certain drugs are provided with preferential treatment, equity issues are concerned. On the 1st, the MOHW explained as follows when Rep. Seo Jung-sook and Rep. Kang Ki-yoon of the People Power Party of the National Assembly Health and Welfare Committee pointed out. The National Assembly and the domestic pharmaceutical industry said that in the process of operating the PVA system, domestic new drugs are being reversely discriminated against compared to global new drugs. In particular, domestic companies argued that health insurance authorities must limit the number of PVA applications to new drugs developed by innovative pharmaceutical companies or suspend them for a certain period of time to properly settle in the market. Rep. Seo Jung-sook and Kang Ki-yoon of the People Power Party also asked the government to consider the need to provide PVA incentives to innovative pharmaceutical companies, but the MOHW said it was impossible. PVA is a system in which the NHIS and pharmaceutical companies share the burden of health insurance financial expenditures when drug use increases or claims actually increase to a certain level or more, and it is important to be cautious in creating exceptions. The MOHW said, "Unlike other drug price adjustment systems, there is a risk of equity problems except for specific drugs." The MOHW said, "It is also necessary to carefully review the impact on health insurance finances." The MOHW said that instead of immediately implementing the exclusion of new drug PVA from innovative pharmaceutical companies, a double price system will be applied if pharmaceutical companies apply for drug price adjustment negotiations due to increased usage. The MOHW explained, "In order to revitalize the overseas expansion of new drugs by innovative pharmaceutical companies, we are operating a system that applies a double price system that refunds a part of the drug's contract price reduction to the NHIS when pharmaceutical companies want it."
