- LOGIN
- MemberShip
- 2026-04-13 14:48:09
- 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.
- Company
- The Galvus patent dispute continues
- by Kim, Jin-Gu Nov 03, 2021 05:47am
- Although the Supreme Court had made its ruling on the ‘Galvus (vildagliptin)’ patent dispute, it seems that the fierce battle is yet far from being over. The case will now again be dealt by Intellectual Property Trial and Appeal Board, and depending on its result, there remains the possibility that the original developer may abuse irrelevant follow-up clinical trials that were conducted abroad to extend its drug’s patent duration. ◆The battle continues… will be again dealt at IPTAB On October 28th, the Supreme Court dismissed Novartis’ appeal against Hanmi Pharmaceutical and Ahngook Pharmaceutical over the Galvus patent dispute. The written judgment showed that the court ‘found no profit in appeal for Novartis.’ As Novartis had already won the second trial and achieved its purpose, the court decided that there was no need to file an appeal in the first place. Even if Novartis was dissatisfied with the judgment from the 2nd trial, the court decided that appealing this to the Supreme Court was procedurally right. As a result, the case will again be dealt by IPTAB. The industry expects a decision will be made early next year, which will finally conclude the 4-year patent dispute over Galvus’s patent term. ◆Novartis extends substance patent duration by 2 years, of which Ahngook claims187 days invalid On the surface, the Supreme Court’s ruling is in favor of the generic companies, as the court dismissed Novartis’ appeal against the 2nd trial ruling. However, the key point of the case lies elsewhere. Domestic pharmaceutical companies are raising the concern that the original developer may abuse irrelevant follow-up clinical trials that were conducted abroad to extend its drug’s substant patent duration, depending on the ruling that will be made by IPTAB. The key issue in the 4-year long dispute was how much of the ‘extended patent duration’ of a drug’s substance patent should be considered invalid. Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and for regulatory approval is added onto the term as companies cannot release their product immediately after applying for a patent. Depending on how much of this period is recognized, patent protection for a drug can be extended to last 21 years or even 22 years. Novartis had succeeded in extending Galvus’ substance patent for 2 years, 2months, and 23 days (813 days). With the extension, the patent, which was to originally expire on December 9, 2019, was extended to expire on March 4, 2022. ◆Mixed rulings at the 1st and 2nd trial regarding the ‘132 days’ extended for overseas clinical trials of Galvus Ahn-Gook Pharmaceutical claimed that ‘187 days’ of the extended term for Galvus’s substance patent was invalid. Ahn-Gook claimed that Novartis did not do its due care during the ‘132 days,’ from the completion of the bridging trial on Koreans to the submission of API report, and the ’55 days’ from receiving the MFDS’ notice to supplement its data to the data submission, rendering the 187 days invalid. The court ruled in favor of Ahn-Gook Pharmaceutical in the first trial. The Patent Court of Korea accepted Ahn-Gook’s claim and ruled all of the 187 days invalid. With the ruling, the substance patent expiry date of Galvus was shortened to August 30th, 2021. In the second trial, the IPTAB partially accepted Novartis’ claim and ruled only 55 days of the 187 days invalid, making the substance patent expiry date of Galvus January 9th, 2022. Acceptance of Novartis’ claims on the 132 days that the company conducted clinical trials overseas was what made the difference between the rulings The claim, which was not accepted at the 1st trial, was then accepted at the 2nd. In other words, the overseas trial that was deemed irrelevant to the drug’s domestic approval in the 1st trial was deemed necessary in the 2nd trial. ◆Dispute continues for no real benefit on either side Novartis, discontent with the 132-day extension recognized at the 2nd trial, appealed to the Supreme Court to receive acceptance for the remaining 55 days. However, the Supreme Court returned the case to IPTAB. Right now, how hard the two parties will continue to fight this battle remains unclear as both parties - the original developer and generic companies – have little to earn from the continued battle. On Novartis’ part, it is now difficult to implement a strategy to delay the entry of latecomer drugs through litigations, as its substance patent is likely to expire while the case is reassigned to IPTAB and again reviewed. Novartis can always file a claim for damages after winning the dispute and being recognized for patent infringement. However, even so, the period of infringement will only be around 2 months, and not be very profitable. The cost of litigation may be greater than the profit earned from the suit for damages. Also, on the generic companies’ part, the companies have already succeeded in moving up the release of their latecomer drugs by 2 months and have no need to actively continue the dispute. ◆Original developers may ‘abuse’ the system to extend the duration of their substance patent The issue arises when the IPTAB follows the existing ruling of its higher court, the Patent Court of Korea. If the companies do not actively engage in the legal dispute, the IPTAB will highly likely follow the existing ruling made by the Patent Court. If the dispute ends this way, Novartis’ claim of ‘132 days of follow-up trial overseas’ will also be recognized for the extension. This has been raising concern among domestic pharmaceutical companies that it may be abused as a basis for original developers in extending their substance patents in the future. Until now, no period for overseas follow-up trials was accepted for extension of substance patents. Until now, the Korean Intellectual Property Office and the Ministry of Food and Drug Safety both had deemed follow-up trials that were only conducted overseas irrelevant, unlike global trials that include Koreans or bridging studies on Koreans. The Patent Act stipulates that the patent duration may be extended to 5 years at most. If overseas follow-up trials are included in the term of patent duration, original developers may abuse the system to extend their patent’s duration to the maximum 5 years. In other words, the concern is that the existing substance patent duration of ‘20+2 years’ may be prolonged to ‘20+5 years.’
- 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.
- Company
- New ATTR-CM drug Vyndamax to be prescribed at GHs
- by Eo, Yun-Ho Nov 02, 2021 05:54am
- Vyndamax, a new drug for transthyretin amyloid cardiomyopathy (ATTR-CM), is now available for prescription at general hospitals. According to industry sources, Pfizer Korea’s ATTR-CM drug, 'Vyndamax (tafamidis 61mg),' passed the review of drug committees (DCs) at various medical institutions including Samsung Medical Center, Seoul Asan Medical Center, Hanyang University Medical Center, etc. However still, the landing may not directly translate to active prescriptions, as Vyndamax is being prescribed to certain patients without reimbursement. After the company failed to receive designation as an essential drug earlier this year, the company had applied for reimbursement once again after conducting the PE assessment for the Risk Sharing Agreement (RSA) scheme. Being deemed inappropriate even after submitting data for PE evaluation, reimbursement of Vyndamax is at a standstill. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. Vyndamax is the only drug that demonstrated its survival benefit in patients with ATTR-CM (ATTR amyloidosis with cardiomyopathy) and is virtually the only drug available, as there are no alternatives. Vyndamax's efficacy was demonstrated through the Phase III ATTR-ACT and a long-term extension study. Analysis of the results of the Phase III ATTR-ACT study and its long-term extension study that was presented recently demonstrated a 30% relative reduction in the risk of death among patients with ATTR-CM who transitioned to Vyndamax 61mg after being initially treated with Vyndaqel 80 mg versus patients who transitioned to Vyndamax 61 mg after being initially treated with Vyndaqel 20 mg. When adjusting for covariates, including age, biomarkers, and functional capacity, the risk reduction was increased to 43% for Vyndaqel 80 mg/Vyndamax 61 mg versus Vyndaqel 20 mg. Both Vyndaqel 80 mg/Vyndamax 61 mg and Vyndaqel 20 mg were associated with safety profiles similar to placebo.
