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- 2025-12-21 08:01:55
- Policy
- AD drug Dupixent’s fails 1st negotiations for RSA renewal
- by Lee, Tak-Sun Oct 12, 2023 05:37am
- The first round of negotiations to renew the risk-sharing agreement (RSA) contract for the severe atopic dermatitis treatment ‘Dupixent (dupilumab, Sanofi)’ has fallen through. The company and the National Health Insurance Service plan to discuss Dupixent’s RSA renewal through additional negotiations. According to the industry on the 11th, the first round of negotiations for Dupixent's RSA renewal fell through. Dupixent was listed for reimbursement through the RSA in 2020. Three types of RSA - refund type for initial treatment, refund type, and expenditure cap type, were applied for reimbursement. At the time, the Ministry of Health and Welfare explained, "The pharmaceutical company signed an agreement to refund a part of the amount administered for a certain period of time, and then refund a certain percentage of the drug claims amount to the NHIS while limiting the total expenditure amount." Accordingly, the first biological drug used to treat severe atopic dermatitis was listed with reimbursement in Korea. At the time of the initial reimbursement listing, its subjects were limited to adult patients with moderate-to-severe atopic dermatitis who are not adequately controlled with topical treatments or for whom these treatments are not recommended. However, starting in April of this year, a new reimbursement category was added to reimburse the drug for the treatment of severe atopic dermatitis in children and adolescents aged 6 to 17. Dupixent’s sales rose vividly after the reimbursement listing. Based on IQVIA, it posted sales of KRW 72.2billion in 2021, and KRW 105.2 billion in 2022, As the treatment of pediatrics and adolescent are now also covered and the company is seeking to expand coverage to include severe asthma and atopic dermatitis in infants and toddlers, the amount of health insurance claims are likely to only increase further. Therefore, price cuts and refund rate adjustments are inevitable during RSA contract renewal. With the RSA term expiring by the end of this year, the NHIS and Sanofi were unable to reach an agreement in the first round of negotiations that began at the end of July. However, as additional negotiations are legally granted, it is expected that an agreement will be reached before the end of the RSA term. So far, no final breakdown has occurred during RSA contract renewal negotiations. If the RSA contract is not renewed, the drug will be converted to non-reimbursed status.
- Policy
- 75% of patients who administered Kymriah is not effective
- by Lee, Jeong-Hwan Oct 11, 2023 05:37am
- More than 75% of patients who received the ultra-high-priced drug Kymriah, which costs 360 million won in one dose, did not have an improvement effect. On the 6th, Kim Young-joo, a member of the National Assembly Health and Welfare Committee (the Democratic Party, Yeongdeungpo Gap) received data from the Health Insurance Review and Assessment Service on the 'Current status of administration of ultra-high-value drugs such as Kymriah and Zolgensma and patient response evaluation'. The world's first CAR-T treatment drug, Kymria,h has an indication for the treatment of adult patients with ▲post-transplant recurrence or secondary recurrence and subsequent recurrence or impresistible B cell-grade lymphoma in children and young adult patients under the age of 25 ▲reactive or non-resistible large B-cell lymphoma (DLBCL) after two or more systemic treatments. Since April 2022, health insurance benefits have been applied, and the patient's copayment has been reduced to a maximum of about 6 million won. Zolgensma, a treatment for spinal muscular atrophy (SMA), costs 1.98 billion won for a single dose of non-paid. Zolgensma was reimbursed in July 2022. Since December 2022, the HIRA has been operating a 'high-drug management system' that monitors the dosing information of ultra-high-drug patients such as Kimlia and Jolgensmaju and the evaluation of the response to drugs after administration. Kymriah had 146 patients who were dosed after reimbursement. Of these, there were 21 cases of pediatric leukemia and 125 patients with megabloid B-cell lymphoma. Their salary contract cost was 52.6 billion won. Jolgensmaju was dosed by 12 people and the cost of the payroll was 23.8 billion won. The cost-effectiveness of these ultra-high-securing new drugs is unclear, so it is implementing a 'patient-based risk-based risk-sharing system' so that the pharmaceutical company will refund a certain percentage of the amount to the healthcare company according to the contract if it is ineffective by tracking the treatment performance of each patient. According to the HIRA, as of August this year, 130 patients with lymphoma who had been treated with Kymriah for 6 months had submitted a response evaluation, of which 99 were classified as eligible for refunds. This means that more than 75% of Kymriah patients did not have a significant improvement effect. Only 1 out of 9 patients who submitted the results were eligible for reimbursement, and more than 88% of patients who received Zolgensma had the treatment effect. Health insurance and pharmaceutical companies negotiate to set the refund ratio, but the refund ratio is kept private. In the case, it is known that the refund rate is less than 50% even if there is no medicinal effect, and the refund rate is more than 50% for Jolgensmaju. The problem is that hundreds of billions of dollars are spent on medicines with low treatment performance. Rep. Kim Young-joo suggested, "In order to prevent blind spots, the target of the benefit should be expanded to patients who need ultra-high-paying treatment, such as Kymriah and Zolgensma. However, it is necessary to increase the refund rate of pharmaceutical companies if there is no treatment effect by strengthening the risk-sharing agent for the sustainable benefits of ultra-high-high-high-high-mouth new drugs." In addition, he emphasized, "The system should be improved so that patients can receive a certain part of the refund if there is no treatment effect because the patient's own burden is high even after paying," he emphasized.
- Policy
- ‘Little progress for NIP support of 9-valent HPV vaccines'
- by Lee, Jeong-Hwan Oct 11, 2023 05:36am
- The number of patients receiving treatment for head and neck cancer and oropharyngeal cancer, both of which are caused by HPV (human papillomavirus), is on the rise. In just a decade, from 2013 to last year, the number of head and neck cancer patients increased by 41.6%, and the number of oropharyngeal cancer patients increased by 56%. In this situation, voices have been raised on how President Suk-Yeol Yoon should actively and promptly fulfill its pledge to ‘expand the subject of HPV vaccination to males and provide support’ through relevant policies. On the 10th, Rep. In-Soon Nam of the Democratic Party of Korea, announced so after analyzing the ‘Patients Treated for Head and Neck Cancer and Oropharyngeal Cancer' data that was submitted by the Health Insurance Review and Assessment Service. The number of head and neck cancer patients increased by 41.6% from 302,960 in 2013 to 429,054 in 2022, and oropharyngeal cancer increased by 56% from 3,847 in 2013 to 6,003 in 2022. By gender, of the 429,054 patients with head and neck cancer, 104,881 (24.4%) were men and 324,173 (75.6%) were women. Among the 6,003 patients with oropharyngeal cancer, 4,890 were men. 81.5%), and 1,113 (18.5%) were women. The national HPV (human papillomavirus) vaccination program began for girls aged 12 in 2016 and then was expanded to include female adolescents aged 12 to 17 and low-income women aged 18 to 26 since 2022. The vaccines provided with national support are bivalent and quadrivalent vaccines, and 9-valent vaccines were not included. Rep. Nam said, “President Yoon, who had been a candidate back then, promised he would extend insurance coverage to Gardasil 9-valent vaccine during his’59-second shorts’ pledge. Also, the People Power Party’s presidential election policy pledge contains ‘Free national HPV vaccination for men starting from the age of 12. However, the expansion of HPV vaccine vaccination to men and support for vaccination has not been implemented.” Meanwhile, according to the 'HPV National Vaccination Status in OECD Countries' data submitted by the Korea Disease Control and Prevention Agency, only 7 countries, including Japan and Mexico, support bivalent or quadrivalent vaccines for female adolescents only like Korea. 18 countries including the United States, Canada, and France provide support for the use of the 9-valent vaccine for both men and women. Rep. Nam said, “The recent HPV vaccine cost-effectiveness analysis report concluded that expanding the target population or converting to a 9-valent vaccine is not agreeable in the current domestic situation. HPV is not only responsible for cervical cancer, but also head and neck cancer, oropharyngeal cancer, and anal cancer. This is why many OECD countries are actively administering HPV vaccines. cost-effectiveness studies. As we are promoting reconducting the cost-effectiveness research, I hope the government will also abide by its word and actively engage in the provision of 9-valent vaccines.”
- Policy
- Eisai’s Jyseleca completes negotiations with NHIS for reimb
- by Lee, Tak-Sun Oct 11, 2023 05:36am
- Eisai Korea has completed negotiations with the National Health Insurance Service for its JAK inhibitor ‘Jyseleca Tab (filgotinib).’ As a result, Jyseleca is now on the verge of being listed for reimbursement in Korea. This drug is the 5th JAK inhibitor introduced to Korea. It has a mechanism of action that selectively inhibits JAK1, the main treatment target for rheumatoid arthritis. JAK1 is a substance that transmits inflammatory cytokine signals. Results of the global FINCH Phase 3 study showed that the drug improved arthritis symptoms by more than 20% at 12 weeks when administered to patients with moderate-to-severe active RA (rheumatoid arthritis) despite continued methotrexate (MTX) treatment. When evaluating the response rate during the 12-week period during which patients showed no response to methotrexate, 66% of patients responded to Jyseleca, and symptom improvement was observed. Last July, HIRA’s Drug Reimbursement Evaluation Committee approved conditional reimbursement for the drug in treating rheumatoid arthritis and ulcerative colitis. At the time, DREC judged reimbursement was adequate when the company accepted a price below the assessed amount. Eisai Korea appears to have accepted a price below the assessed value. In particular, it is said that the company skipped negotiations on the insurance price ceiling that is set with the National Health Insurance Service by accepting a price that is below 90% of the weighted average price of its alternative. Negotiations with the NHIS on the expected claims amount were also recently completed. Accordingly, this drug is expected to be listed for reimbursement after being reported to the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee. Other JAK inhibitors that were previously introduced to Korea include Pfizer’s ‘Xeljanz,’ Lilly’s ‘Olumiant,’ ‘Abbove’s ‘Rinvoq,’ and Pfizer’s ‘Cibinqo.’
- Policy
- Hyaluronic acid eye drops, start to revise the standard
- by Lee, Tak-Sun Oct 11, 2023 05:36am
- The HIRA has started to revise the standards to limit the use of Hyaluronic acid sodium eye drops. It is known that the revision of standards will be completed as early as the end of the year, and will be implemented from next year. According to an industry example on the 10th, the HIRA has entered a review of the revision of the standards for sodium hyaluronic acid eye drops at the request of the Ministry of Health and Welfare. Therefore, we plan to hold an expert advisory meeting soon to continue related discussions. Earlier, the Pharmaceutical Benefit Evaluation Committee held on the 6th of last month recognized the benefit of endogenic diseases for Hyaluronic acid eye drops that have been reassessed. Exogyneutic disease is caused by post-surgery, pharmaceutical, trauma, wearing of content lenses, etc. Endogenic diseases include Sjogren's syndrome, skin blemish syndrome (Steven's Johnson syndrome), and dry eye syndrome. The main indication of hyaluronic acid eye drops is an endogenic disease, so related companies sighed with relief. However, instead of recognizing the benefit of endogenic diseases, the drug review committee put a clue that it is necessary to set the prescribed amount per patient's visit and the total annual prescription amount per patient in the standard for proper use. As a result, it is more likely to affect sales due to the revision of standards. During the discussion of the re-evaluation, it was known that a plan to limit 1 bottle of 60 to 4 per year was also considered. It is said that the HIRA reported the results of the drug level to the Ministry of Health and Welfare, and the Ministry of Health and Welfare requested a revision of the salary standard. Therefore, it is expected to speed up the revision of salary standards through expert advisory meetings, etc. Since the results of this year's benefit decent revaluation will be reflected from January next year, it is known that the discussion on the revision of the salary standard of the Hyaluronic acid drop system will be completed within this year and implemented at the same time as the results of the reassessment in January next year. An official from a related company explained, "If you limit the amount of use, even if the benefit is recognized for endogenic diseases, damage to sales is inevitable." The three-year average claim amount of hyaluronic acid eye drops is 231.5 billion won, and about 400 items are listed as reimbursement.
- Policy
- Tepmetko attempts reimb again in KOR
- by Lee, Tak-Sun Oct 10, 2023 05:27am
- Merck is reattempting reimbursement listing of its MET-targeted anticancer therapy ‘Tepmetko (tepotinib)’ in Korea. The drug was unable to pass the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review in February. The company voluntarily withdrew its reimbursement process at the time. The company had later reorganized the data to reapply for reimbursement. According to the industry on the 6th, Merck Korea recently applied to request a reimbursement decision for its Tepmetko to HIRA. Tepmetko is a treatment for locally advanced or metastatic non-small cell lung cancer with confirmed MET exon 14 skipping mutations. It was approved in Korea in November 2021. Afterward, Tabrecta Tab (capmatinib), a same-class drug, also sought reimbursement in Korea. MET exon 14 skipping mutation is a rare type of cancer that is present in approximately 3-4% of patients with non-small-cell lung cancer (NSCLC). Due to the lack of suitable treatments, expectations had been high for anticancer drugs targeting the disease. However, both drugs are having difficulty being listed for reimbursement. Tepmetko failed to set reimbursement standards at the Cancer Disease Deliberation Committee meeting that was held in February this year. Tabrecta also failed to pass HIRA review. The HIRA's Drug Reimbursement Evaluation Committee decided not to reimburse Tabrecta, saying there was insufficient evidence to judge its clinical usefulness. Despite such delays in reimbursement, Tepmetko has landed in major general hospitals in Korea and became available for prescription. This is proof that its need is well recognized in the field. Tepmetko’s efficacy was evaluated through the VISION study, which enrolled the largest number of patients among clinical trials targeting NSCLC patients with MET exon 14 skipping mutations. Results showed a significant life extension effect with a median progression-free survival (PFS) of 15.3 months and an objective response rate (ORR) of 56.8%. Also, the median duration of response (DoR) was 46.4 months, and the median overall survival (OS) was 25.9 months, showing continuous antitumor activity in the long term. With its need in the medical field rising, expectations are also rising for the second time to be the charm for Tepmetko’s reimbursement.
- Policy
- Will Leclaza also begin drug price negotiations soon?
- by Lee, Tak-Sun Oct 10, 2023 05:26am
- The expansion of reimbursement for Leclaza, a third-generation EGFR TKI non-small cell lung cancer treatment developed by Yuhan Corporation, as a first-line treatment will be discussed at the HIRA Pharmaceutical Reimbursement Evaluation Committee on the 12th. If the Pharmaceutical Reimbursement Evaluation Committee recognizes the adequacy of the benefit on this day, the drug price will be negotiated with NHIS and placed on the final benefit list. According to the industry on the 6th, Leclaza is on the agenda for deliberation by the evaluation committee to be held on the 12th. The Pharmaceutical Review Committee deliberates on the registration of new benefits, expansion of benefits, and adjustment of the maximum amount of drugs. A total of 40 people, including 17 committee members and government officials, will attend. Leclaza was approved as a first-line treatment for non-small cell lung cancer last June. It is the second third-generation EGFR TKI treatment for non-small lung cancer, following Tagrisso. However, the speed of salary registration is almost the same as Tagrisso. While Tagrisso's reimbursement standards were set by the HIRA Cancer Disease Review Committee last March, five years after approval from the Ministry of Food and Drug Safety, Leclaza's reimbursement standards were established two months after approval last August. If it passes the Pharmacy Review Committee this time, the gap in registration speed with Tagrisso will be further reduced. Tagrisso passed the committee held on the 7th of last month. There is also a possibility that the two drugs may be listed on the insurance plan at the same time through NHIS drug price negotiations. Once the drug price negotiation is concluded, it will be included in the final benefit list after deliberation by the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare. The domestic market size for first-line non-small cell lung cancer treatment is said to be approximately 300 billion won. If the third-generation treatment that has proven its excellence in effectiveness becomes the first-line treatment, it is expected to record high sales performance. Recently, Yuhan's stock price has risen by 40% in three months as expectations for Leclaza's expanded first-line treatment coverage and entry into the global market have grown.
- Policy
- Pfizer applies for reimb of its COVID-19 Tx Paxlovid
- by Lee, Tak-Sun Oct 06, 2023 05:36am
- Pfizer applied for the reimbursement of its COVID-19 treatment 'Paxlovid' in Korea. With the government planning to end the current free support system for COVID-19 treatments in the 1H next year, the company has begun the process of applying for reimbursement accordingly. According to the industry on the 5th, Pfizer Korea recently submitted a drug decision application for its COVID-19 treatment ‘Paxlovid Tab’ to the Health Insurance Review and Assessment Service. Paxlovid was first introduced to Korea through the Emergency Use Authorization system in December 2021. At the time, the need for oral treatment was raised due to the increased number of confirmed COVID-19 cases and critically ill patients and the spread of the Omicron variant, leading to the prompt introduction of Paxlovid. On July 18, the drug received official marketing authorization from the Ministry of Food and Drug Safety. Until now, Paxlovid had been provided 100% free of charge through government support. However, the government announced a provisional plan to convert COVID-19 into a level 4 infectious disease starting August 31 and end the free support for COVID-19 treatments from the 1H next year, raising the need for Paxlovid’s reimbursement. Without reimbursement, a single set of Paxlovid for 5 days will cost KRW 700,000. Also, Pfizer Korea announced at a press conference celebrating the official approval of Paxlovid in July that it was discussing with the government to quickly list the drug before 1H of next year. If reimbursed, patients will be able to use it cheaper through national health insurance support. The drug had established itself as Pfizer’s cash cow, posting global sales of $4.069 billion (KRW 5.4492 trillion) in Q1 last year.
- Policy
- Reducing criminal liability for essential healthcare
- by Lee, Jeong-Hwan Oct 06, 2023 05:36am
- The ruling party proposed legislation to reduce criminal liability for doctors embroiled in medical malpractice suits while providing essential health services, and for the state and local governments to support and foster essential healthcare personnel. The legislation is in line with the Yoon Suk Yeol administration's policies to strengthen essential healthcare. With regards to how the government considers it as the biggest agenda in health and welfare, the medical community, led by the Korean Medical Association, had been consistently requesting the legislation of 'exemption of criminal liability for doctors providing essential healthcare services.’ On the 5th, Rep. Suk-Joon Hong of the People Power Party proposed the ‘Bill for the Promotion and Support of Essential Healthcare’ as representative that contained the contents above. Rep. Hong pointed out that a gap existed in protecting the lives and health of the people in Korea due to the recent lack of essential healthcare infrastructure. In particular, some essential healthcare treatment departments are facing a serious shortage of personnel, so measures to foster and support essential healthcare are urgently needed. In addition, in fields that provide essential healthcare services such as childbirth, the risk of medical accidents is relatively high, and excessive criminal punishment places an excess burden on the doctors, leading to an increase in the doctors’ avoidance of essential healthcare services. Therefore, Rep. Hong proposed a bill to encourage the national and local governments to prepare and promote policies to support and promote essential healthcare, and to reduce criminal liability for medical malpractice suits in essential healthcare under strict requirements. The bill’s main purpose is to contribute to protecting and improving public health by resolving the avoidance of practicing essential healthcare and preventing the collapse of Korea’s essential healthcare system.
- Policy
- Health plans expected to be implemented after NA audit
- by Lee, Jeong-Hwan Oct 05, 2023 05:27am
- The preferential drug price policy plan that reflects the value of new drugs and the 2nd comprehensive national health insurance plan, which the pharmaceutical and bio-industry are closely eyeing, is expected to be unveiled after the National Assembly audit this year. The amendment to the Instructions for the Biohealth Innovation Committee under the direct control of the Prime Minister is also expected to be promoted after the National Assembly audit. The schedules have been delayed compared to the original plan, and the government plans to complete the practicalities after collecting opinions from each sector after the completion of the National Assembly audit. The results were revealed on the 4th when the Press Corp covered the Ministry of Health and Welfare’s plans on the innovative drug pricing system reform plan and the 2nd Comprehensive National Health Insurance Plan. According to the original plan, the final results of the agenda were scheduled to be announced within September or October. The reform of the drug pricing system that reflects the innovative value of new drugs and health security seeks to provide preferential drug treatment for values of new drugs such as clinical superiority essential drug status, and use of domestic APIs. The MOHW originally intended to specify the policy direction by operating a public-private consultative body for preferential pricing of innovative new drugs and announce it before the NA audit, the announcement is likely to be made after the audit due to delayed operations of the consultative body. The announcement of the 2nd Comprehensive National Health Insurance Plan is also being delayed compared to the original plan. The pharmaceutical and bio-industry is paying close attention to the direction of the pharmaceutical policies that will be included in the 2nd Comprehensive National Health Insurance Plan. This is because the pricing systems for new drugs, incrementally modified drugs, and generic drugs depend on the direction of health insurance policy operation. The MOHW said that its researchers are seeking advice from the Health Insurance Policy Deliberative Committee and that it plans to hold a public hearing after the National Assembly audit to collect a broader range of opinions for the 2nd Comprehensive National Health Insurance Plan. A MOHW official said, “We are currently establishing plans after collecting various opinions. We plan to establish the 2nd Comprehensive National Health Insurance Pla within this year at the latest for disclosure.” The launch of the Biohealth Innovation Committee which will be directly controlled by the Prime Minister, is also being delayed. The committee was being prepared as a government control tower to foster Korea’s pharmaceutical bio industry. The establishment of the Biohealth Innovation Committee, a domestic pharmaceutical and bioindustry development organization that was set to be directly operated by the Prime Minister, is expected to be announced and operated through a presidential order. The MOHW is preparing to issue a notice on the order and appoint members to the Innovation Committee, and plans to launch the committee as soon as possible. According to the proposed regulations, the Biohealth Innovation Committee will consist of less than 30 members. The government plans to appoint the Prime Minister as the chair and 30 members including 12 ministers from each ministry and 17 civilian members. The 12 ministerial members will include Ministers of the Ministry of Health and Welfare, Ministry of Strategy and Finance, Ministry of Education, Ministry of Science and ICT, Ministry of Trade, Industry and Energy, Ministry of Foreign Affairs, and Ministry of SMEs and Startups, as well as the minister for the Office for Government Policy Coordination, the Chairperson of the Personal Information Protection Committee Commission, the Minister of Food and Drug Safety, Commissioner of the Korea Intellectual Property Office, and the Commissioner of the Korea Disease Control and Prevention Agency. The committee secretariat is scheduled to be established as a department called the ‘'Biohealth Innovation Promotion Team' under MOHW’s Bureau of Health Industry Division of Health Industry Policy. The MOHW’s Health Industry Policy Director will concurrently serve as the head of the Biohealth Innovation Promotion Team. The Biohealth Innovation Committee will seek to efficiently deliberate and adjust policies and tasks to comprehensively and systematically support the development of Korea’s health industry, including products and services related to pharmaceuticals, medical devices, and health technology, and their convergence and integration with cutting-edge technologies. The committee is also expected to be launched after the National Assembly audit.
