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- 2026-05-04 12:32:31
- Policy
- Negotiations on Strepto, concluded in the early 20% range
- by Lee, Tak-Sun Nov 15, 2022 05:39am
- Major pharmaceutical companies of the anti-inflammatory enzyme Streptokinase and Streptodornase have reportedly reached an agreement with the NHIS in redemption negotiations. The recovery rate, which has been an issue, is said to be in the early 20% range. It is interpreted as the result of the two sides' concessions to each other. According to the industry, major pharmaceutical companies such as the NHIS, Hanmi Pharmaceutical, and SK Chemicals, which held negotiations for the return with a deadline of the 14th, succeeded in reaching an agreement on the last day. Hanmi Pharmaceutical and SK Chemicals are ranked first and second in sales in related markets and are currently leading clinical re-evaluations. The recovery rate agreed by the two sides is said to be in the early 20% range, which is higher than that of the Choline alfoscerate sanctions that previously negotiated the recovery. Until now, pharmaceutical companies have stuck to less than 20% and the NHIS has stuck to more than 20%. The shorter recovery period than the Choline alfoscerate formulation seems to have affected it. As negotiations with major pharmaceutical companies have been concluded, the results of the negotiations are expected to be reported to the Committee this month without renegotiation. There are many opinions within the government that there is an extension of the negotiations on the premise of a settlement this month, but there is no renegotiation. The HIRA conducted sanctions evaluations on Streptokinase and Streptodornase and concluded that the evaluation would be suspended for one year only for items agreed to be recovered negotiations based on the results of clinical re-evaluation. In order to avoid the deletion of benefits, pharmaceutical companies had to agree on redemption negotiations with the NHIS. It is interpreted that the negotiations have been concluded without taking time, given that the final clinical re-evaluation results will be released next year. The analysis also reflected that class action lawsuits, such as choline alfoscerate pharmaceutical companies, will not have much profit. This is because the annual prescription is only 20 billion won, and when the clinical re-evaluation result report is released next year, the salary status will be sorted out. Major pharmaceutical companies have reached an agreement this time, but some consignment production pharmaceutical companies are said to have decided to accept the deletion of benefits without any intention of negotiation. A total of 37 pharmaceutical companies are subject to negotiation, and it is not known exactly how many companies agreed.
- Policy
- The vaccine fund will be increased by ₩40 billion
- by Lee, Jeong-Hwan Nov 14, 2022 06:07am
- Expectations in the pharmaceutical industry are soaring as the National Assembly's Health and Welfare Committee decided to increase next year's budget for the "K-Global Vaccine Fund" to 50 billion won, up 40 billion won from the government's plan. As the Ministry of Health and Welfare is constantly sending signals to the pharmaceutical community to focus on developing domestic vaccines and new drugs based on Korean bio funds, attention is being paid to whether the budget approved by the Welfare Committee will pass the plenary session. Looking at the Ministry of Health and Welfare's budget plan for next year, which was recently approved by the Welfare Committee, the budget for supporting the development of the pharmaceutical industry increased sharply from 44.07 billion won to 11.128 billion won. Among them, the largest increase in budget is the "K-Global Vaccine Fund" project. The government had set aside 10 billion won, a reduction of 40 billion won from this year's budget, as a global vaccine fund budget. During the screening process, the 10 billion won budget was too small, which could dampen private investment, followed by demands from welfare committee members for an increase. The move is aimed at providing aggressive R&D investment support for pipelines that are likely to succeed among vaccine and new drug candidates preparing for domestic and foreign clinical trials for the purpose of final marketing approval and market launch. The Welfare Committee adopted a 50 billion won bill among the plans to increase the fund budget by 20 billion won from 10 billion won to 30 billion won and increase it by 40 billion won to 50 billion won. The remaining gateway is the Special Committee on Budget and Accounts. If the plenary session is passed without reduction adjustment in the special committee on the budget and settlement, the vaccine fund budget, which is increased by 40 billion won compared to the government's plan, is expected to be operated from next year. The domestic pharmaceutical industry is voicing its voice that the National Assembly and budget authorities should agree to a review without reduction in order to increase the possibility of developing native vaccines and new drugs. The Ministry of Strategy and Finance urged the government to avoid tightening its fiscal stance in the vaccine fund sector to achieve the goal of fostering the domestic pharmaceutical bio industry. An official from A Pharmaceutical Company in Korea said, "Unlike expected, the Welfare Committee voted to increase the amount by 40 billion won. "It is encouraging that they seem to agree on the need to foster the pharmaceutical bio-industry and develop blockbuster domestic vaccines and new drugs," he said. "The resolution to increase the amount is the same as this year's budget, and support for vaccines and new drugs, which may be possible only when the budget is passed as it is, will be able to become a reality," he expected. An official from A said, "I understand that the Ministry of Health and Welfare and the welfare committee members are greatly aware of the importance of the vaccine fund budget. He said, "I think I felt the need for a native vaccine starting from COVID-19," adding, "The Ministry of Economy and Finance, which is a financial authority, should sympathize with this urgency and work hard to pass the budget without reduction." An official from company B in Korea also said, "The increase has been decided, but this game is from now on when the Special Committee on Budget and Accounts begins." He said there are concerns that the reduction will be inevitable as the government is tightening its fiscal stance. "However, the government's vision to grow the pharmaceutical bio-industry as a new engine is a goal it has put forward every year." "It is time to realize our will in this budget review," he said. "The vaccine fund business is in the form of receiving private investment compared to government investment. If government investment increases, private investment will be able to be activated in proportion, he said. "The National Assembly and the Ministry of Economy and Finance should recognize that pharmaceutical companies equipped with clinical trials at home and abroad are waiting for R&D support."
- Policy
- Some companies give up negotiations to recover Strepto
- by Lee, Tak-Sun Nov 11, 2022 05:51am
- Some pharmaceutical companies with the anti-inflammatory enzyme Streptokinase-streptodornase have conveyed to the NHIS that they are not willing to negotiate. Currently, about five of the 37 pharmaceutical companies subject to negotiation are known to have given up negotiations. However, as the end of the negotiations approaches, more pharmaceutical companies are likely to give up negotiations. According to the industry on the 9th, some pharmaceutical companies of Streptokinase-Streptodornase are giving up negotiations with the NHIS and accepting the deletion of benefits. Last month, the HIRA conducted a re-evaluation of the drug and decided to suspend the evaluation for one year only for items that were agreed to be recovered according to the results of the clinical re-evaluation, although there was no benefit adequacy. The clinical re-evaluation will end next year after submitting a result report. Accordingly, the NHIS is negotiating with pharmaceutical companies to recover salaries according to the results of clinical re-evaluation until the 14th. Pharmaceutical companies that have not reached an agreement in the redemption negotiations will be deleted due to a lack of benefit adequacy depending on the results of the revaluation. Some pharmaceutical companies are believed to have judged that the deletion of benefits is better. This is because if the recovery ratio is high and the clinical revaluation fails, the profit from product sales will also fall significantly. As a result, it is judged that it may be more profitable to close the business at all by deleting benefits. In the ongoing redemption negotiations, the NHIS and pharmaceutical companies are reportedly divided over the redemption rate. The NHIS sticks to more than 20% and pharmaceutical companies to less than 20%. Therefore, some predict that it will be difficult to conclude the negotiations by the deadline of the 14th of this month. Some predict that the delay in negotiations may be more disadvantageous for pharmaceutical companies as the Ministry of Health and Welfare may no longer issue a negotiation order and follow the HIRA opinion that there is no adequacy. As time goes by, there is a high possibility that more pharmaceutical companies will give up negotiations and accept the deletion of benefits. An industry official explained, "If a pharmaceutical company is disadvantaged in the negotiation for a refund, there is a high possibility that the pharmaceutical company with a small sales volume of the drug will choose to give up its business at all." The annual market size of Streptokinase-Streptodornase is about 35 billion won, which is not large. Among them, Hanmi Pharmaceutical's Mucorase and SK Chemicals' Varidase are said to be leading the way, so these pharmaceutical companies are also leading the clinical re-evaluation and negotiations for recovery.
- Policy
- Will expedited listing be possible within the year?
- by Lee, Tak-Sun Nov 10, 2022 05:46am
- The implementation of the measure that allows expedited listing for serious disease treatments is expected to be deferred somewhat. Although the government started the opinion collection process with the goal of implementing the measure in November, government officials see the measure to be implemented at the end of December at the earliest. According to industry sources on the 9th, the Health Insurance Review and Assessment Service and the National Health Insurance Service made a preannouncement on the proposed amendment to regulations that reduce the listing period of drugs related to life-threatening conditions and started the opinion collection process. The amendment contains plans to reduce the reimbursement review period of treatments for life-threatening conditions by 60 days through concurrent operation of reimbursement evaluation and pricing negotiations. Under the amendment, HIRA’s drug reimbursement evaluation period is set to be reduced from 150 days to 120 days, and the NHIS’s drug pricing negotiation period from 60 days to 30 days. Severe and rare disease treatments and PE exemption drugs are eligible for the expedited listing. The NHIS and HIRA will share data during HIRA’s review process and prepare a prior consultation process so as to establish a financial sharing plan. For this, HIRA decided to amend the ‘Regulation on the standards and procedures to evaluate the eligibility of reimbursement of drugs’ and the ‘Detailed evaluation standards for drugs subject to negotiations such as new drugs, etc,’ and the NHIS to revise the drug pricing negotiation guideline, with the common goal of implementing the measures in November. However, it is now November and the opinion collection process is now complete, but the amended regulations have not been announced yet. The industry believes that the implementation is being delayed due to a delay in the review of HIRA's regulations, and preparations for revision of drug price negotiation guidelines on NHIS's part are complete. HIRA’s proposed amendments to its regulations are now being discussed with the MOHW after completing the opinion collection process. Some are speculating that HIRA's delay may be due to amendments being made to address the criticism that arose regarding drugs eligible for pharmacoeconomic evaluation exemptions. In the proposed amendment to the regulations that are under review, the government added a clause allowing PE exemption for ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option and demonstrates improvement in quality of life or is otherwise approved by the committee.’ The industry has been voicing opposition to the system, saying that the amendment narrows the pathway for PE exemptions rather than expanding it. The Korean Research-based Pharmaceutical Industry Association had issued a statement, pointing out that “Drugs that fall under Item 2(a) and 2(b) that have difficulty generating evidence were eligible for PE exemptions even if they were not used to treat a ‘small number of’ patients. However, the amended regulation mandates the ‘small number’ condition to be met. This will only reduce the scope of eligible subjects. This rather reduced the scope of eligibility.” The same had been raised as an issue at the NA Audit. Rep. Sun-Woo Kang of the Democratic Party of Korea pointed out that the proposed system rather reduces the scope of eligible drugs by changing the standard of 'a small number of patients' that had been an ‘OR’ clause for PE exemptions into a requirement.” However, HIRA explained through a written response that “The ‘small number of patients’ standard is not absolute and drugs are evaluated for PE exemption through committee deliberations in consideration of the severity of disease, etc.” HIRA added that the ‘drugs used by pediatric patients’ mean drugs whose main indication is applied to pediatric patients, and recommended that companies prove the ‘meaningful improvement in quality of life’ through the use of Multi-Attribute Utility Instrument (MAUI) and that the drugs will be evaluated through committee deliberations in consideration of the characteristic of each disease. As such, there is an opinion that the implementation of the system is being delayed in order to revise the relevant regulations due to constant issues raised by the pharmaceutical industry and the National Assembly. An industry official said, “As the measure needs to be concurrently applied by HIRA and NHIS, implementation of the expedited listing system will inevitably be delayed if either side is less prepared. Therefore, it seems unlikely that the amendment will be implemented in November, and most are expecting the amendment to be applied at the end of December at the earliest.”
- Policy
- We will do our best to compensate for Paxlovid side effects
- by Lee, Jeong-Hwan Nov 10, 2022 05:45am
- Director Oh Yoo-kyung (Photo = Provided by the National Assembly Professional JournalistsOh Yoo-kyung, head of the Ministry of Food and Drug Safety, said she would focus on budget and legislation to compensate for side effects and damage relief for drugs approved for emergency use for the treatment of COVID-19. Oh Yoo-kyung said she will immediately process the patient's compensation as soon as the results of the side effect review of the emergency use approved drug are released. This is an answer to the question of pending issues of Choi Hye-young, a member of the Democratic Party of Korea, at the plenary session of the National Assembly's Health and Welfare Committee on the 7th. Representative Choi Hye-young pointed out that there is no national damage compensation track for side effects that occurred after the administration of oral treatments for COVID-19 such as Paxlovid and emergency use approved drugs. In fact, the side effect damage relief system is currently in operation only for drugs that have obtained official marketing permission based on the Pharmaceutical Affairs Act. Representative Choi said, "The administration rate of oral medicine for COVID-19 tripled from February to August. As the administration rate increases, the number of abnormal cases caused by the treatment taken increases, she said. "The drug has no legal basis for compensation for damage." Representative Choi said, "There are two screening procedures for emergency approval drugs, and even if the compensation is decided, there are no financial resources," adding, "We have submitted a bill to solve this problem." She said, "Please try to pass the bill and show your initiative in explaining the need for the bill and budget at each office of lawmakers." She responded to Choi's criticism that she would speed up budget and bill work. Director Oh said, "We are currently actively trying to revise related laws quickly. We are also trying to secure the budget, she said. "The Korea Pharmaceutical Safety Management Agency is receiving counseling for victims' damage compensation so that damage compensation can be paid as soon as the budget is secured." "We will push ahead with it quickly," she said.
- Policy
- Drug prices should be raised if RWD show high effect
- by Lee, Tak-Sun Nov 09, 2022 05:47am
- Jin Yong Lee, Director of HIRA Research Institute, is answering questions at the press briefing held on the 8t Jin Yong Lee, Director of the Health Insurance Review and Assessment Research Institute, expressed his personal view that the government should raise the prices of high-priced drugs that confirm improved outcomes with real-world data (RWD). Currently, the Health Insurance Review and Assessment Service conducts performance analysis for some high-priced drugs with RWD to manage NHI reimbursement expenditures. However, the purpose of the system is mostly in retrieving the reimbursed expenditures, and there is no mechanism established to allow drug price increases for better-performing drugs. However, Director Lee strongly expressed the need for a mechanism to increase the drug price as well as one to secure mutual trust with the pharmaceutical companies. Director Lee said so at the press conference that was held at The National Health Insurance Service’s Wonju headquarters with its press corps on the 8th. Director Lee is a former professor at Seoul National University Hospital who took office in August 2020 through an open position system, and his three-year term is set to be completed in August next year. HIRA’s reimbursement management model based on RWD has also been developed after Director Lee took office. The model allows for the government to apply reimbursement to high-priced drugs such as Kymriah and Zolgensma based on RWD. Therefore, the system contains a clause that regulates the companies to refund the reimbursed amount to patients that see no treatment effect. The RWD for the system is collected through data from actual claims and those used for prior approval of the drugs. However, Director Lee explained that a drug price increase is also necessary for high-priced drugs that show a high treatment effect. Lee had made the same claim at the 2021 Innovation Research Symposium,’ which was held under the theme of ‘Measures for establishing an RWD collection system to manage drug reimbursements.’ Lee said, “I still hold the same view (as the one I made at last year’s Innovation Research Symposium). It's my personal opinion, but I think that’s a kind of 'rule' to ensure mutual trust with pharmaceutical companies." He added, “From my experience, although it is difficult for drugs to receive a price increase through reevaluations, the possibility should be left open." However, Lee reiterated that it is just his personal opinion and that there is a high possibility that his claim will be agreed upon by only a few people. HIRA Research Institute has recently confirmed the difference in treatment effect according to the age of the patient through RWD analysis. In addition, the institute is conducting cost calculations after designing a pharmacoeconomic evaluation model to confirm the appropriateness of the listed drug prices. Lee said, “Use of RWD in analyzing drug effect and pharmacoeconomic evaluations will increase to improve access to high-priced drugs and for the management of NHI finances. Therefore, it is necessary to collect and continuously accumulate analysis results of various pharmaceuticals to derive more meaningful results.” The definition of high-priced drugs and measures for their reimbursement that was reported to the Health Insurance Policy Deliberation Committee in July was also one of HIRA Research Institute’s major achievements this year. Although there is no international consensus on the definition of high-priced drugs, the Institute defined the drugs as those that require price management and long-term effect confirmation due to high prices and uncertainty in effect. Also, to manage reimbursements, the institute planned to improve access by shortening the registration period, strengthening monitoring of treatment effects and safety, and securing the sustainability of NHI finances by strengthening financial management. Drugs subject to the measure were defined as drugs that are expected to bring long-term effects after a single treatment (one-shot treatment), drugs with annual financial spending exceeding KRW 300 million per person, and drugs with annual health insurance claims that exceed KRW 30 billion. Director Lee also expressed high expectations for the new administration’s plan to support treatments for pediatric patients and severe and rare diseases.
- Policy
- Ex officio adjustment reduces prices of Faslodex and Acelex
- by Kim, Jung-Ju Nov 08, 2022 05:43am
- AstraZeneca Faslodex and Crystal Genomics Acelex will receive a 30% discount due to the government's authority adjustment. They are expected to fall 23.5% each in the second half of next year when the addition ends. Roflumilast formulations such as Sama Roflu 500μg and AstraZeneca Daxas 500μg of Korea, which has been receiving additional assets, will maintain their added value for two more years. According to the industry on the 24th, the Ministry of Health and Welfare plans to revise the "Amendment to the Drug Benefit List and the benefit limit table" and is pushing for application as of the 1st of next month. First of all, there are three items for authority adjustment. When the same product is registered, the government is ex officio adjusting the insurance drug price of products with the same administration route, ingredients, and formulations as the first registered product. In the case of synthetic drugs, if the same drug is first registered, it will be added at 53.55%, which will be added at 70% for one year, and if the additional conditions are satisfied, it will be added at 80% for one year. Looking at the items, Faslodex is 30% and Acelex is 30.1% ex officio adjusted. Here, the addition of Faslodex will end on August 1 next year and Acelex on October 1 next year, which will fall 23.5% further. Despite the additional period of more than one year, the government maintains family wealth if the number of companies with the same product is less than three. However, if pharmaceutical companies want to extend the additional period due to a stable supply of products after two years, they can adjust the additional ratio and extend the period within the two-year limit after deliberation by the Pharmaceutical Benefit Evaluation Committee every year. Looking at the items, Sama Roflu 500μg maintains a drug price addition rate of 11.1%, and Daxas 500μg maintains 30.7%. Two years later, on November 1, 2024, these drugs ended their addiction and prices fell. The reduction rate is 10% for Sama Roflu and 23.5% for Daxas.
- Policy
- It has been four years since Eucept was released
- by Lee, Hye-Kyung Nov 07, 2022 06:06am
- The permission of LG Chem's rheumatoid arthritis treatment Eucept (Etanercept) will be changed. The MFDS will prepare an order (proposal) to change the permission items based on the results of the re-examination of Eucept Prefilled Syringe and Eucept Auto Injector and inquire about opinions until the 17th. Eucept is LG Chem's first antibody-drug and was approved in Korea in March 2018 as a treatment for rheumatoid arthritis, psoriatic arthritis, axial spinal arthritis, and psoriasis. LG Chem started developing Eucept in 2010 and launched it in Japan and Korea, even before the biosimilar market was formed. Eucept was selected as a national project for the Daedeok Special Zone Strategic Industry R&D Project hosted by the Ministry of Science and ICT in 2010 and the Health and Medical Technology R&D Project hosted by the MOHW in 2015, and conducted a 52-week long-term clinical trial for 370 rheumatoid arthritis patients in Korea and Japan. In particular, the Auto Injector type was also released to make it more convenient for patients with rheumatoid arthritis who have difficulty with their hands due to the nature of the product that patients inject themselves. LG Chem has been approved for two products, Auto-Injector and PFS formulation, which are automatic injection methods for pen formulations. For re-examination in Korea, a post-marketing survey of 351 people has been conducted over the past four years. As a result, the expression rate of abnormal cases was reported as 35.33% (124/351 people, a total of 187 cases) regardless of the causal relationship. Significant drug adverse reactions that cannot exclude causality were 0.57% (2 patients/351 patients, 2 cases), showing bacterial pneumonia, increased eosinophils, and drug reactions accompanied by systemic symptoms. Unexpected drug abnormalities were 3.99% (14/351, 14 cases), with pus blisters, insomnia, breast inflammation, abnormal sensation in the eyes, palpitations, wet cough, liver lipoma, joint swelling, rheumatoid nodules, fever, and based on this, abnormal cases will be added in the precautions for use of the permit.
- Policy
- We will continue to strengthen cooperation with the HIRA
- by Kim, Jung-Ju Nov 07, 2022 06:05am
- The HIRA (Director Kim Sun-min) announced on the 4th that Rudi Eggers, director of the World Health Organization (WHO) Integrated Health Services (IHS), visited the HIRA to discuss international cooperation measures. Under the agreement with the WHO, the HIRA has been sending screening and evaluation experts to the WHO Integrated Health Service Bureau since 2016, and in December last year, it was designated as the WHO Cooperation Center in Strategic Purchasing and has strengthened practical cooperation such as holding joint training courses. The visit came within today from the 31st of last month when Director Rudy Eggs asked Director Kim Sun-min to discuss ways to cooperate with the two organizations. Director Rudi Eggers began discussing ways to cooperate by introducing the work of the healthcare system and the HIRA. He admired the HIRA's achievements in improving medical quality and efforts to collect and utilize health and medical big data, and suggested that "the WHO and the HIRA work together to expand health security in the international community and improve medical quality." Director Kim Sun-min said, "We will continue to expand the role of the HIRA in the international community to ensure universal medical care and strengthen the sustainable healthcare purchase system."
- Policy
- No budget set to compensate increasing Paxlovid AE reports
- by Lee, Jeong-Hwan Nov 07, 2022 06:05am
- It has been found that no government budget has been set to compensate for the adverse events that may occur after receiving COVID-19 treatments granted emergency use authorizations in Korea. Therefore, a claim has been raised that a supplementary budget needs to be set to review and provide damage relief from the use of EUA drugs that did not receive official approval like Paxlovid, Lagevrio, and Evusheld when patients apply for compensation to the government. In other words, a separate budget needs to be set to compensate for adverse drug reactions from EUA drugs as Korea’s current relief system for adverse drug reactions only applied to drugs that received official marketing authorization under the Pharmaceutical Affairs Act. Senior expert member SunHee Jin of the National Assembly’s Health and Welfare Committee made such a statement in the 4th in the review report for the Ministry of Food and Drug Safety's 2023 budget plan. In March 2021, the ‘Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis’ was enacted to respond to public health crises such as COVID-19. The Act allows manufacturers and importers to supply drugs that have not been granted marketing authorization or have been reported to respond to public health crises through EUA. Based on the Act, one item last year – Paxlovid, and 2 items this year – Lagevrio Cap and Evusheld, have been granted EUA in Korea. As of September of this year, 614 cases of dysgeusia, dizziness, and high blood pressure were reported and 3 cases of adverse event damage relief applications were submitted to the government from the use of EUA drugs. However, the problem is that it is unclear whether adverse events that arise from EUA drugs can be compensated through the existing relief system. The adverse drug reaction relief program, which is supported by the Korea Institute of Drug Safety & Risk Management, provides relief from adverse events of drugs approved under the Pharmaceutical Affairs Act. Therefore, the grounds are unclear as to whether it can provide compensation for adverse reactions from EUA drugs that were approved under the Public Health Crisis Response Act. The compensation for relief provided under the Pharmaceutical Affairs Act is not financed by the state but is financed by contributions paid by drug manufacturers, marketing authorization holders, and importers. Expert member Jin Seon-hee judged that adverse events from drugs that were approved under the Public Health Crisis Response Act cannot be provided compensation for damages under the Pharmaceutical Affairs Act. Therefore, Jin pointed out that such compensations for EUA drugs including Paxlovid should be made using national finances, however, this has not been reflected in the budget. Jin said, “A partial amendment to the Public Health Crisis Response Act has been presented to provide legal grounds to compensate for adverse events from EUA drugs with national finances. Rep. Hye-Young Choi and Miae Kim submitted the bill that is under review by the Health and Welfare committee, therefore, additional budget considerations are needed.”
