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- 2026-04-13 14:48:10
- 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.
- Company
- AstraZeneca co-sells Qtern with Ildong Pharmaceutical
- by Eo, Yun-Ho Nov 01, 2021 05:56am
- According to related industries, AstraZeneca Korea and Ildong Pharmaceutical have decided to jointly promote Qtern, which combines DPP-4 inhibitor Onglyza (Saxagliptin) and SGLT-2 inhibitor Forxiga(Dapagliflozin), which will be released today (1st). Since March 2014, the two companies have already been conducting co-marketing on diabetes treatments such as Onglyza and Kombiglyze XR(Metformin·Saxagliptin). Qtern jointly conducts sales and marketing of the product at general hospitals and Ildong Pharmaceutical alone at clinics. With the official launch of Qtern, the market for diabetes combination drugs is expected to change. Currently, in addition to Qtern, combinations of DPP-4 inhibitors and SGLT-2 inhibitors are licensed in Korea, Beringer Ingelheim's Esglito(Linagliptin+Empagliflozin) and MSD's Stegluzan(Ertugliflozin+Sitagliptin). It has been confirmed that they are also preparing to launch along with resolving benefit issues. GC Pharma received approval from the MFDS on the 25th for the biological equivalence test plan of GC2123A. The active ingredient of this product candidate is known as Empaglipozin+Linaglipin. Meanwhile, Qtern was approved in Korea in March 2017, but its launch in Korea was delayed as the problem of combined diabetes insurance benefits was not resolved. However, a change in the market is expected as insurance authorities have recently discussed recognizing the combined benefits of SGLT-2 inhibitors. Not long ago, a meeting of diabetes experts convened by the HIRA is trying to integrate and recognize the combined use and three-drug benefits between DPP-4 inhibitors and SGLT-inhibitors.
- Policy
- Redundancies in CDRD and PBAC roles in continuous dispute
- by Lee, Hye-Kyung Nov 01, 2021 05:56am
- [News follow-up from a friendly reporter] The functional redundancies in the Cancer Disease Review Committee (CDRC) and Pharmaceutical Benefit Appraisal Committee (PBAC) arose as an issue at the NA Health and Welfare Committee audit recently. At the audit, the National Assembly Health and Welfare Committee member Sun-woo Kang of the Democratic Party of Korea had pointed out that a long-term delay has occurred in discussions on expanding reimbursement for a new anti-cancer drug due to the redundant functions of the two committees. The new anti-cancer drug that Kang referred to was MSD Korea’s ‘Keytruda (pembrolizumab).’ ‘Keytruda is an immuno-oncology drug that was first approved reimbursement for NSCLC patients with ‘Opdivo (nivolumab)’ on August 21st, 2017. The issue arose with the reimbursement for Keytruda in first-line in lung cancer delayed for 4 years. According to the data disclosed by Kang, MSD Korea applied to extend reimbursement of Keytruda to first-line NSCLC in September 2017, but the agenda finally passed the CDRC in July 2021. Why the delay? The CDRC had delayed making the decision for 4 years due to concern over its fiscal sharing plan despite having no disagreement over the drug’s clinical usefulness. New anti-cancer drugs require CDRC review for setting reimbursement standards, but the fiscal sharing discussions that should be discussed at the PBAC were also conducted at the CDRC level. The CDRC has less than half the personnel of PBAC, and remarks of Ministry of Health and Welfare officials at public hearings or debates indicate that they expect CDRC to make decisions based on objectivity rather than expertise. In other words, objective reimbursement standards are set at the CDRC level without input from the pharmaceutical company. But Keytruda’s review was put on hold for 4 years over its ‘fiscal sharing’ at CDRC, not its reimbursement standards. That was why the drug was mentioned as an example at the NA audit. What about HIRA? To what extent does the HIRA stipulate the scope of the work for CDRC? The scope of work for CDRC and PBAC are stipulated in the ‘Regulations on the Criteria for NHI Insurance Benefits.’ Article 5-2 of the regulation stipulates that ‘HIRA should organize a CDRC to deliberate the methods and standards for applying insurance benefit to medicines prescribed and administered to severe disease patients.’ The members of the committee should be comprised of 45 or fewer members with extensive experience and profound knowledge in the field of public health.’ In other words, under the regulations, the CDRC deliberates the standards and methods for drugs used for patients with rare, severe diseases or cancer. HIRA sees that the committee may assess a drug’s medical feasibility, alternative drugs and treatment cost, fiscal impact, etc. to deliberate its reimbursement standards. This was included in the written QA that was submitted after Kang’s NA audit, but the contents of the deliberation for setting the reimbursement standards could not be found. However, DREC’s role is clearly stated in the regulations. Article 11-2 of the regulation is the basis for DREC, and it reviews insurance benefits of drugs that applied for assessment under Article 10-2(3). DREC has subcommittees for drug benefit standards, economic evaluation, RSA, fiscal impact assessment, herbal medicine, post-marketing evaluation, etc. The manpower pool for DREC is 102, and the members evaluate whether new drugs are eligible for medical care insurance benefits, reimbursement standards, and the price cap for drugs based on calculation standards. The stipulated standards show that the functions of CDRC and DREC need not overlap. HIRA explained that a delay in deliberation had occurred at the CDRC level due to the fiscal burden that may arise in NHI finances due to the high price of new anticancer drugs. However, financial sharing is an agenda that needs to be reviewed by DREC or the NHI that has fiscal power, not the CDRC. Therefore the question that lies is whether the 45 non-expert members of the CDRC had the authority to neglect the patients’ 4 years’ worth of time over the fiscal sharing plan.
- Policy
- HIRA clarifies ‘Opdivo·Keytruda·Tecentriq’ eligibility
- by Lee, Hye-Kyung Nov 01, 2021 05:56am
- The 'Stage ⅢB or higher’ phrase was added to the subjects eligible for reimbursement of ‘Opdivo (nivolumab),’ ‘Keytruda (pembrolizumab),’ and ‘Tecentriq (atezolizumab)’ in NSCLC. The Health Insurance Review and Assessment Service announced that it will implement the ‘Amendment to the Notice on Drugs Prescribed and Administered to Cancer Patients' which will take effect from November 1. The amendment was made to address the confusion that arose regarding the eligibility of reimbursement after the cancer stage criteria were deleted in subjects for immunotherapy as second-line or subsequent lines of palliative therapy on May 1st. HIRA added the 'Stage ⅢB or higher’ to ‘patients who have previous platinum-based chemotherapy experience with positive PD-L1 expression (expression rate ≧ 10%)’ in the criteria for the administration of Opdivo, Keytruda, and Tecentriq as second-line or higher therapy in NSCLC. Also, the G-CSF injection, ‘Rolontis Pre-filled Syringe (eflapegrastim)’ was included in the announced amendment. Rolontis Pre-filled Syringe was approved to reduce the incidence of severe neutropenia in patients that receive cytotoxic chemotherapy for solid cancers and malignant lymphoma. After reviewing the reimbursement standards, HIRA decided that Rolontis was necessary for treatment and set a standard for the drug after the drug demonstrated non-inferiority to the currently reimbursed eflapegrastim in the mean duration of severe neutropenia through a Phase III clinical trial in cycle 1.
- Company
- Hanmi & Ahn-Gook finally won the Galvus patent dispute
- by Kim, Jin-Gu Nov 01, 2021 05:55am
- The Supreme Court sided with Generic companies in a patent dispute over Galvus (Vildagliptin), a DPP-4 inhibitor-based diabetes treatment. On the morning of the 28th, the Supreme Court dismissed Novartis' appeal against Ahn-Gook Pharmaceutical and Hanmi Pharmaceutical to invalidate the extension of the patent duration. There is a problem with the reason for the appeal claimed by Novartis. Generics succeeded in invalidating 55 days of the material patent duration. Ahn-Gook and Hanmi Pharmaceutical began early launch of generics for Galvus in accordance with the ruling. Generic is likely to be released early next year. The issue of this case is which period of the "extended duration" of the drug substance patent will be considered invalid. So far, there has never been a case in which generic has overcome the extended duration of drug substance patents against the original company. Ahn-Gook claimed that "187 days" out of the 1,068 days of Galvus' extended material patent duration was invalid. On top of that, Hanmi also requested an extension invalidation trial. Ahn-Gook won the first trial. Intellectual Property Trial and Appeal Board sided with Ahn-Gook and said 187 days were invalid. Ahn-Gook was qualified to release the generic 187 days earlier. Novartis won some of the second trials. The patent court ruled that only 55 days out of 187 days were invalid. Novartis once again objected and filed an appeal to the Supreme Court. Novartis argued that it could not be considered invalid.
- Policy
- Concerns about the introduction of the Reference Price
- by Kim, Jung-Ju Nov 01, 2021 05:55am
- The government expressed concern over the National Assembly's proposal to review the introduction of the Reference Pricing System. Although they sympathize with the need for rational drug price management, side effects such as an increase in the patient's economic burden are predicted from the reference price system itself. Regarding price policies, such as proposals for mandatory general administration, it said that the pros and cons of the pharmaceutical industry and conflicts will be reviewed through collecting various opinions because social consensus is important. The MOHW recently submitted a written response to such issues related to drug price policies proposed and inquired by the Health and Welfare Committee during the last parliamentary audit. Through written inquiries, lawmakers belonging to the Welfare Committee asked about generic drug price policies such as discussing the reference price system to normalize the generic drug market and reduce health insurance finances. The MOHW agreed on the need for drug price management to reasonably manage health insurance drug costs and create a cost-effective generic use environment. In fact, after the Valsartan crisis in 2018, the government has implemented a generic drug price reorganization since July last year to prevent competition for generic turmoil. However, the government was virtually negative regarding the Reference Pricing System. The MOHW explained, "The Reference Pricing System can contribute to reducing health insurance finances, but it is likely to bring about significant changes in the current drug price system and increase the economic burden on patients." The government said, "It is necessary to refer to overseas cases and carefully review them through collecting social opinions." In the case of generic substitution, social consensus is needed in consideration of the principle of division of medicine established in 2000. Currently, one out of every two benefit drugs is given incentives for items that can be generalized, but it is negative in the medical community. The MOHW replied, "We will review it by collecting opinions from related ministries, related organizations, and experts." The Welfare Committee also inquired about the necessity of establishing an expensive drug to prevent it from being recklessly prescribed. In response, the government explained, for example, that in the case of Spinraza, the HIRA is operating a pre-approval system to prevent disputes, and said, "We will consider various drug management measures considering individual drug characteristics of individual drugs."
- Policy
- 'Symbenda' withdraws from Korean market 3 years after reimb.
- by Lee, Tak-Sun Oct 29, 2021 05:54am
- A blood cancer drug that took 7 years from approval to reimbursement is being removed from the market only 3 years since starting its sale in earnest. The company that sells the product has pointed to the termination of their agreement as to the cause of its market withdrawal, however, the analysis is that profitability has declined due to drug price cuts following the introduction of generic drugs earlier this year. According to the Ministry of Food and Drug Safety, Eisai Korea withdrew its license for ‘Symbenda inj. (bendamustine hcl.)’ on the 27th. The withdrawal comes after 10 years since its approval in May 2011. The drug is used to treat blood cancers such as lymphoma and chronic lymphatic leukemia. The drug, which was approved 10 years ago, has only been sold in the market for around 3 years. Symbenda was finally approved for reimbursement 7 years after its approval in September 2018, as combination therapy with rituximab. With the reimbursement, a price cap of 283,793 won per 100mg vial was set for the drug. According to IQVIA, the drug sold 2.5 billion won and 2.2 billion won in 2019 and 2020, respectively. Analysts have said that Symbenda’s performance as a new anticancer drug that finally received reimbursement after 7 years was below than expected. Moreover, the drug’s price has been cut in April this year by 30% with the introduction of its generics and set at 198,655 won per 100mg vial. After Boryung Pharmaceutical received the first approval for Symbenda’s generic in November last year, Samyang Holdings and Handok Teva followed into the market with their Symbenda generics. Boryung Pharmaceutical has started selling its first Symbenda generic with reimbursement in April. Eisai Korea, the seller of Symbenda in Korea, notified the MFDS that it would discontinue the supply of Symbenda in April, a month before Handok Teva received the approval for Symbenda’s third generic in May. At the time, Eisai explained, “With the expiry of the partnership agreement that was made between Eisai and the original developer of Symbenda due in October 2021, the company had made the necessary decision to discontinue supply Symbenda in Korea.” The company expected that the 100mg dose will be discontinued in July and the 25mg dose in August. The company added that “Many drugs with the same ingredient that was approved for the same indications are being sold in the market and are available as a replacement for Symbenda. Therefore, the discontinuation of Symbenda’s supply will not affect patients’ treatments. The industry believes that the lower-than-expected performance and the decline in profitability due to the introduction of its generics were what made it difficult for the company to continue on the business in Korea, rather than the two companies'' agreement expiry. With the original’s withdrawal from the Korean market, competition between the three bendamustine generics that are left in the markets and is expected to intensify to compete in filling the original's gap.
