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- 2025-12-22 07:37:47
- Policy
- Quick diagnosis is essential for Hepatitis C
- by Nov 18, 2022 06:03am
- Pharmaceutical companies such as BMS, Gilead, and Abbvie introduced direct anti-virus (DAA) treatments, and hepatitis C opened the era of complete recovery. Re-treatment options for a small number of patients who failed to treat also appeared this year. The goal of hepatitis C is to find "hidden patients" who have not yet been diagnosed. Experts stress that national checkups should include hepatitis C. Bruce Kreter, general manager of Global Medical, who was in charge of the development of hepatitis C treatment at Gilead, and Ahn Sang-hoon, a professor of gastroenterology at Yonsei University Severance Hospital, asked about the current status of hepatitis C screening at home and abroad. ◆ Government-led hepatitis C screening test vs. repeated discussions for years The World Health Organization (WHO) declared the fight against hepatitis C by 2030 and urged international efforts. As the treatment is completed, it can be managed by simply finding hepatitis C carriers. The domestic prevalence rate is estimated to be around 1%, and it is considered an important strategy to quickly find and treat patients who can be the source of infection because there is no separate vaccine. Unlike the United States, which conducted a government-led hepatitis C screening test under the WHO's declaration, Korea has been only discussing whether to include hepatitis C tests in national checkups for years. The paradigm of hepatitis C treatment completely changed after the introduction of DAA preparations. With a treatment success rate of nearly 100%, complete recovery can be expected, treatment can be performed regardless of genotype, and the treatment period, which was up to one year, has been greatly reduced to two to three months. Even this year, a re-treatment system has been created that can be used by a small number of patients who have failed to treat due to resistance. The success rate of re-treatment is also close to 100%. It is evaluated that treatment is close to completion among the two factors for eradicating disease, "prevention" and "treatment." The problem is prevention. Hepatitis C does not have a vaccine, so a quick diagnosis is the best. Professor Ahn pointed out that it is meant to treat only patients without prevention. In particular, it is analyzed that Korea has never been tested for hepatitis C and does not even know that it is a carrier. Professor Ahn said, "More than 70% of hepatitis C patients in Korea were asymptomatic patients who did not know that they were hepatitis C, and more than 60% had never been tested for hepatitis C in their lives," and stressed, "There are more recent situations such as drugs and tattoos, so we need to quickly detect and treat the source of infection." In 2020, the United States began recommending screening tests for hepatitis C under the leadership of the CDC. This is a change to keep pace with the WHO's announced goal of eradicating hepatitis C. The United States recommends that all adults undergo at least one hepatitis C screening test. Countries with national examination programs such as Taiwan, Japan, and Egypt included hepatitis C tests in the category. " Hepatitis C is asymptomatic and the patient cannot be recognized as a carrier unless diagnosed through a test. However, these patients may have been in poor condition for a long time, but they feel that their quality of life is improved through treatment. At the national level, medical costs can be lowered by lowering the probability of liver cirrhosis or hepatocellular carcinoma when hepatitis C is completely cured, he explained. In Korea, discussions have also been made since late 2015 to include hepatitis C tests in the national health examination category, but no conclusion has been reached even seven years later. It is not that the utility value that can be included in national projects has not been proven. Although the Korean Association for the study of the Liver has consistently proven cost-effectiveness through feasibility studies and pilot projects, there is still no progress. The Korean Association for the study of the Liver is conducting additional research to analyze the government's financial impact assessment. Professor Ahn said, "The Korean Association for the study of the Liver confirmed the cost-effectiveness of national hepatitis C screening through an early detection pilot project for hepatitis C for 105,000 people aged 55 in 2020. "When comparing the costs of treatment with screening tests and neglecting liver cirrhosis, it was much more effective to conduct screening tests for high-risk groups," he explained. He said, "In addition, research to verify whether the government's financial consumption of national checkups is possible through the government's fiscal impact assessment will be announced within this year as it is almost the final stage."
- Policy
- Budget increase for drugs and vaccines under NA review
- by Lee, Jeong-Hwan Nov 17, 2022 05:54am
- The proposal to set a new budget worth KRW 14.4 billion to support the patients’ medical expenses of ultra-high-priced new drugs for rare diseases will be reviewed by the Adjustment Subcommittee of the National Assembly’s Special Committee on Budget and Accounts. A plan to increase the budget for the K-global vaccine fund project by KRW 40 billion or KRW 20 billion from the KRW 10 billion that was originally submitted by the government, will also be discussed at the Adjustment Subcommittee of the Special Committee on Budget and Accounts. The Adjustment Subcommittee of the Special Committee on Budget and Accounts will be reviewing the agendas above on the 16th. The budget to support the medical expense for non-reimbursed new orphan drugs is a new budget that had not been reflected in both the government’s original proposal or the resolution bill of NA’s Health and Welfare Committee The agenda became subject to review after Rep. Cheol-Gyu Lee and Dong-Hyuk Jang, Hee-Young of the Special Committee on Budget and Accounts raised the need for a new budget. The plan is to increase the budget by KRW 14.4 billion to support medical expenses for non-reimbursed drugs before they are applied insurance coverage. If the budget plan is reflected, rare disease patients that use ultra-high-priced drugs that are yet to be reimbursed may receive benefits. Also, for the ‘K-Global Vaccine Fund Project’ that had been passed by the NA Health and Welfare Committee, two budget increase proposals – one to increase the budget by KRW 40 billion requested by Rep. Hyun-Young Shin and Hye-Young Choi, and the other to increase the budget by KRW 20 billion requested by Rep. Dae-Sik Kang, Sun-Woo Kang, Jin-Gyo Bae, Hyun-Jin Bae, Jung-Sook Suh, Yong-Ho Lee, Hye-Sook Jun, Su-Jin Cho will be reviewed by the special subcommittee. In other words, plans to increase the budget for the fund to support the development of local homegrown vaccines and new drugs to KRW 50 billion and KRW 30 billion are set to be reviewed side by side. The pharmaceutical and bio-industry is of the opinion that it is necessary to secure as much government budget as possible to actively support companies that develop homegrown vaccines and new drugs who are preparing to conduct Phase II or III trials. All the plans are for budget increases, and the subcommittee review of the agendas is scheduled for next week.
- Policy
- Use of Evusheld extended to the severely immunocompromised
- by Kim, Jung-Ju Nov 16, 2022 06:10am
- The COVID-19 Vaccination Response Promotion Team (Head: KDCA Commissioner Kyung-Ran Baek) announced that it had expanded the eligibility of Evusheld as of the 14th to protect the severely immunocompromised from the next wave of COVID-19 outbreak that may arise in the winter season. With the expansion, blood cancer patients, transplant recipients, and people with congenital immunodeficiency who are severely immunocompromised; those with solid cancer, HIV, or rheumatism following deliberation by the Infectious Disease Control Committee; and patients who are receiving serious immunosuppressive treatment such as chemotherapy or B-cell depletion treatment regardless of disease are eligible for Evusheld. Also, the treatment period for patients to apply for the treatment has been extended from the previous 2-4 months to 6-12 months. The dose, which had previously been 300mg, was also increased to 600mg based on MFDS’ Emergency Use Authorization which allows ‘patents to recieve 600mg in the event variants arise,’ cases in the US where the authorities granted increasing the dosage to 600mg to respond to the Omicron variant, and committee deliberation, etc. Those who already received the 300 mg dose within 3 months may receive an additional dose of 300mg, and those who received Evusheld over 3 months ago may receive an additional dose of 600mg. The COVID-19 Vaccination Response Promotion Team said, “As we have expanded the target and increased the administered dose of Evusheld in preparation for the next wave of COVID-19 that may arise in the winter season, we ask the severely immunocompromised that receive serious immunosuppressive treatments to receive Evusheld for further protection. Healthcare professionals at medical institutions that administer Evusheld should actively explain the changes to eligible patients and encourage prompt administration and apply for Evusheld.”
- 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.
