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- 2026-05-18 11:04:05
- 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.
- 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."
- Policy
- 342 items unable for supply voluntarily withdraw listing
- by Lee, Hye-Kyung Nov 02, 2021 05:53am
- In just one year since the pharmaceutical negotiation system that had been only used for new drugs and usage volume negotiations was expanded to include generics, etc., 342 items that cannot be immediately supplied were deleted from the reimbursement list by ‘voluntary withdrawal.’ The National Health Insurance Service announced that it had completed negotiations for 1,508 items since introducing the negotiation system on generics, etc. Specifically, 912 items were newly listed, 37 items made ex-officio adjustments, 79 items made voluntary withdrawals, and 480 items received reevaluation on their premiums. In particular, ex-officio adjustments were made for 25 original items, 2 shortage prevention items, 1 prior price cut item, and 9 labeling change items. The NHIS also stressed that the negotiations enabled companies to voluntarily withdraw reimbursement listing applications for 342 items that could not be supplied immediately after listing, initially blocking the ‘blind listing’ of drugs under the positive list system. On the 1st, the NHIS distributed the reference material on the negotiation system for generics, etc., and made the self-evaluation that the system entered the ‘stabilization phase’ in one year since its implementation. As the negotiation system for generics is a systemized measure for the supply and quality management of pharmaceuticals, the authorities also expressed gratitude to the pharmaceutical industry that participated in the negotiations and expressed that the performance was 'the result of win-win cooperation.' NHIS admitted that “There were some industry concerns that the negotiations for generics, etc. could delay reimbursement listing, and whether the system could block blind listing of drugs. However, we were able to stably implement the negotiation system without delaying listing by newly establishing a Pharmaceutical Pricing Management Office, increasing negotiating personnel, and introducing the prior consultation system to ensure a sufficient amount of period for negotiations.” NHIS added, “The new payer model that embraces both public safety and patient protection shifted the paradigm. However, the new negotiation system has been increasing the industry’s administrative burden, and the No.1 inconvenience pointed out by the industry is the increased burden of submitting documents on manufacturing and import performance." Therefore, to promptly address the inconveniences experienced by the pharmaceutical industry, the NHIS, and the MFDS are linking the information between the ministries to resolve the overlapping manufacturing and import data submissions and reduce the administrative burden within the first quarter of next year. An NHIS official said, “We will continue to work with pharmaceutical industry officials to ensure stable supply and quality management of pharmaceuticals. We will make diverse efforts to improve the system and simplify the administrative process to provide cost-effective, high-quality, and safe generic drugs to the public,”
- Policy
- Is the first generic release of the ADHD tx Concerta?
- by Lee, Tak-Sun Nov 02, 2021 05:53am
- Alvogen Korea has begun to develop a generic development of the ADHD treatment Concerta OROS (Methylphenidate, Janssen Korea). Since there is currently no generic for Concerta in Korea, it is expected to be the first generc if approved. As of the 28th, the MFDS approved AK-D309 54mg's biological equivalence test plan. In this test, Alvogen will conduct a bioequivalence test evaluation with control group on 58 healthy adults. The target disease is ADHD. It is estimated to be Concerta OROS 54mg. This is because there is only 54 mg formulation for Concerta OROS for ADHD treatment. Concerta OROS 54mg is a leading product in the ADHD treatment market. Sales amounted to 15.4 billion won based on IQVIA last year. The reason why this product is leading the market is that it is taken once a day. Bisphentin Controlled-Release Cap of Methylphenidate HCl, which was approved in 2015, is also a capsule formulation different from Concerta OROS. As a competitive product, there was also Whan In's Metadate CDER capsule, which was taken once a day, but the supply was suspended from August 2019 due to the termination of the original developer's contract, and the product license was withdrawn in May. Analysts say that the competitiveness of Concerta OROS has improved further due to the suspension of supply of Metadate CDER. Concerta's patent was also terminated on May 27, 2019. Generics can enter the market without any burden. However, despite these advantages, there have been no generic so far. Because of the ER formulation, it's hard to develop generics. This is because generic competitiveness was weak due to the nature of CNS treatments. Whan In has started to develop products as an alternative to Metadate CD ER, but it is said to have been suspended now. If Alvogen succeeds in developing generic, it will be the first generic in Korea. Alvogen is focusing on expanding related markets by introducing domestic copyrights for CNS treatments such as Novartis' Stalevo and Comtan last year. Therefore, the launch of the ADHD treatment bioequivalence test is also interpreted as a strategy as part of market expansion. Attention is focusing on whether Alvogen will emerge as a dark horse in the CNS treatment market as the first generic.
- Policy
- Generics for Jardiance have obtained generic for exclusivity
- by Lee, Tak-Sun Nov 02, 2021 05:53am
- Jardiance, a diabetes tx imported and sold by Beringer Ingelheim Korea Generics of SGLT-2 inhibitory diabetes treatment Jardiance (Empagliflozin, Beringer Ingelheim, Korea) have obtained a number of generic for exclusivity. The number of target items alone amounts to 93. Most of the licensed products have won generic for exclusivity. It will be applied for nine months from October 24, 2025, the date of sale. According to the MFDS on the 29th, 93 generics for Jardiance acquired generic for exclusivity as of the 27th. The effective date is from October 24, 2025, when Jardiance's substance license ends. The generic for exclusivity is granted to the first applicant for permission after the patent challenge is successful challenge. It can be said that all 93 companies met this standard. First of all, the patent challenge filed a passive rights scope confirmation trial with Jardiance's decisive patent (scheduled to expire on December 14, 2026) in January 2018 and received a partial trial in May 2019. As Beringer Ingelheim followed the trial, the trial was confirmed as it was. Generics also applied for permission in time for August 11, 2020, when Jardiance's PMS ends, meeting the criteria for applying for initial permission along with the success of patent avoidance. Starting with Dongkoo Pharmaceutical in February, it began to obtain product permits. The acquisition date of generic for exclusivity is eight months later than this. In response, an official from the MFDS explained the late acquisition of generic for exclusivity, saying, "The fact that the start date of generic for exclusivity is from 2025 also contributed to the review." Analysts say that the market monopoly, which can be said to be the biggest effect of generic for exclusivity, has been overshadowed by the fact that generic for exclusivity items reach more than 100. However, as the Act on the Restriction of Consigned Production Items has been enforced since July, it is expected that dozens of items will not be able to obtain preferential rights at the same time in the future. Meanwhile, Jardiance is a large diabetes treatment that recorded 35.4 billion won in outpatient prescriptions (based on UBIST) last year.
