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- 2026-03-11 23:26:51
- Policy
- Pharma-Bio Control Tower launched…first meeting next month
- by Lee, Jeong-Hwan Oct 18, 2023 05:48am
- A presidential order to establish the Biohealth Innovation Committee, a control tower to foster the pharmaceutical bio-industry, has been issued. The government plans to hold its first meeting next month to begin discussing major agendas. With the launch of a pan-ministerial organization, financial and administrative support is expected to be strengthened in addition to support for domestic pharmaceutical and bio companies' research and development (R&D), new drug development, and entry into overseas markets. The Ministry of Health and Welfare announced on the 17th that regulations regarding the establishment and operation of the Biohealth Innovation Committee (Presidential Order No. 461) have been issued. Until now, issues related to products and services of biohealth in the industry, including the use of pharmaceuticals, medical devices, and healthcare technology, have been blocked by inconsistent regulations between ministries, fields, and stages. To address this, the MOHW has been working to launch the 'Biohealth Innovation Committee' as a government-wide control tower chaired by the Prime Minister that encompasses all areas of biohealth, taking advantage of the strategy that seeks to open a biohealth market that was announced at the pan-ministerial biohealth new market creation strategy meeting held on February 28th. The newly established Biohealth Innovation Committee will appoint the Prime Minister as the chair and will consist of the head of 12 ministries, including the 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, and field and academic private experts. The government plans to concentrate on reviewing and deliberating policies to support the full cycle from biohealth technology development, commercialization, and insurance registration, to market entry. Seung-Hyun Hwang, Director-General of the Global Vaccine Hub at the Ministry of Health and Welfare, said, "Through the Biohealth Innovation Committee, we will bring together public and private capabilities to lay the foundation for the biohealth industry as a future growth engine and a key national strategic industry. The first meeting, which will be held in November, will focus on urgent agendas.”
- Policy
- Daewoong's new diabetes drug 'Envlo',
- by Lee, Tak-Sun Oct 17, 2023 05:28am
- Envlo, a new diabetes drug developed by Daewoong Pharmaceutical, is entering long-term safety and efficacy testing of the Zemiglo three-drug therapy. While triple therapy of the Metformin+SGLT2i+DPP4i has been approved for reimbursement since last April, Daewoong Pharmaceutical is expected to establish its position as a latecomer, Envlo, in the triple therapy through this long-term trial. On the 13th, the Ministry of Food and Drug Safety approved the phase 3 clinical trial to evaluate the safety and efficacy of Envlo + Metformin + Gemigliptin applied by Daewoong Pharmaceutical. Envlo is the first domestically produced SGLT-2 type diabetes drug developed by Daewoong Pharmaceutical. It received approval in November 2022 and has been commercially released since May of this year. Gemigliptin, which is included in the three-drug combination therapy along with metformin, is a new domestic diabetes drug of the DPP-4 series developed by LG Chem and is being jointly promoted in the market with Daewoong Pharmaceutical. Daewoong Pharmaceutical confirmed the safety and effectiveness of the metformin and gemigliptin triple therapy through phase 3 clinical trials at the time of Envlo approval. At that time, the clinical trial lasted 24 weeks. The long-term clinical trial to be conducted this time will verify safety and effectiveness for 12 months. Last month, Daewoong Pharmaceutical announced that it had applied for this clinical trial to the Ministry of Food and Drug Safety and that it was a preemptive market response following the expansion of coverage for combination SGLT-2 inhibitors in April. Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "This phase 3 was conducted to respond to the changing treatment paradigm. As diabetes treatment is a representative drug that requires long-term use, we plan to expand various treatment options based on Envlo's excellent efficacy in the future." He explained. Since its launch last May, Envlo has been supplied to large hospitals one after another and is expanding its market. Last September, the two-drug combination drug 'Envlomet', which combines Envlo + Metformin, was also launched for reimbursement. Daewoong Pharmaceutical plans to develop Envlo into a large blockbuster drug with sales of 100 billion won within three years.
- Policy
- Yuhan’s Leclaza passes DREC review for 1st-line NSCLC
- by Lee, Tak-Sun Oct 16, 2023 05:24am
- Yuhan Corp’s application to extend coverage for its 3rd-generation EGFR TKI non-small-cell lung cancer treatment Leclaza (lasertinib)' as a first-line treatment is making rapid progress. After passing the Health Insurance Review and Assessment Service review, all that remains is drug price negotiations with the National Health Insurance Corporation. On the 12th, the HIRA held the 2023 11th Drug Reimbursement Evaluation Committee meeting and deliberated on the adequacy of reimbursement for drugs including Leclaza. Leclaza, which was the only one on the agenda for reimbursement expansion on this day, was recognized as adequate for reimbursement. Accordingly, the agenda has moved to the next stage, to conduct drug pricing negotiations with the NHIS like Tagrisso, another 3rd generation EGFR TKI that passed DREC review last month. The industry prospect is that Tagrisso and Leclaza will receive reimbursement for their first-line indication at the same time. Meanwhile, among the drugs for which a new reimbursement decision was requested on this day, Kerendia Tab (Bayer Korea) was recognized as adequate for reimbursement. The drug is used to treat chronic kidney disease in patients with type 2 diabetes. In addition, the Trimbow inhaler (Kolon Pharmaceuticals), which is used to treat asthma and COPD, and Obizur, a treatment for bleeding episodes in adult patients with acquired hemophilia A, received conditional approval. In other words, the two drugs may pass the DREC review If their companies accept a price less than the evaluation amount.
- Policy
- Regkirona approval is for the Moon care to build up records
- by Lee, Jeong-Hwan Oct 13, 2023 05:30am
- People Power Party lawmaker Lee Jong-seong pointed out the Moon Jae-in government's budget support for Celltrion's COVID-19 treatment Regkirona as a problem. Rep. Lee Jong-seong criticized the approval of Regkirona, saying it lacked proper verification of effectiveness in order to build on the previous government's legacy of the K vaccine. On the 11th, Rep. Lee pointed out to Minister Cho Gyu-hong at the Ministry of Health and Welfare's audit of government affairs, "The Moon Jae-in administration's approval of Regkirona and encouragement of its use is a fraud on the public," urging him to launch an investigation. Minister Cho responded to Rep. Lee's request, saying, "We will conduct an investigation to respond to the next pandemic." Rep. Lee argued that the previous government launched a pan-government support group for vaccine development to promote policies such as vaccine sovereignty, K-Bio, and K-vaccine, and set out to accumulate achievements. He said that there were improprieties in the licensing and distribution process of Celltrion Regkirona. Rep. Lee said, “At the time, Lee Nak-yeon, leader of the ruling party, officially set the drug price prior to government drug price negotiations, saying that the drug price should be at least 400,000 won before the committee meeting.” Lee I-won said, “During the product change approval process, it was approved through a vote even though there were opinions that it was not effective against the COVID-19 delta variant strain.” Rep. Lee said, "In December, we encouraged the elderly in an official letter to actively use it," adding, "Ultimately, they forced us to build the legacy of developing Korea's first COVID-19 treatment with Regkirona. This is a fraud on the public." did.
- Policy
- NA Rep Kang ‘Increase gov't support to treat breast cancer'
- by Lee, Jeong-Hwan Oct 13, 2023 05:29am
- It has been pointed out that the government should strengthen economic support for innovative new drugs that treat severe diseases to improve the treatment rate of breast cancer patients. The number of female cancer patients is significantly higher than that of male cancer patients in the same age group, and the number of breast cancer patients has been steadily increasing since 2020 until last year, raising the need for measures. On the 12th, Rep. Ki-Youn Kang of the People Power Party made this claim based on the statistics submitted by the Health Insurance Review and Assessment Service. According to the number of cancer patients by age in Korea over the past 3 years, there were more cancer patients among women than among men. Among the same gender, the proportion of female cancer patients in their 40s and 50s was significantly higher. As of July this year, there were 173,066 female cancer patients in their 40s, which accounted for 10.3% of all cancer patients. This figure is more than 3 times higher than that of the 3.4% taken by male cancer patients in the same age group (56,619 patients). The number of female cancer patients in their 50s accounted for 15% (252,058 patients), which was more than twice as high as the 6.9% (115,482 patients) of male cancer patients in their 50s. In addition, even within the same gender, the proportion of female cancer patients aged between 0 to those in their 30s accounted for 1.3% and 4.2% of the total cancer patients, respectively, while the number of patients in their 40s or older increased explosively to account for double digits. In particular, among all female cancer patients, the number of breast cancer patients has been steadily increasing, from 242,945 in 2020 to 262,839, then to 281,114 in 2021, and the number of patients has also been higher than that of other cancers. In the case of breast cancer, its 5-year survival rate is 90%, but for Stage IV patients, the rate plummets to 34%, indicating the importance of receiving treatment on time. However, patients in Korea cannot easily use innovative drugs due to their high cost, and many patients are thus giving up treatment. This is why the government's economic support for serious diseases is urgently needed. Rep. Ki-Youn Kang said, “In no case shall Kore give rise to a saying such as ‘the rich live longer, and the poor die faster’ where patients are unable to receive treatment due to lack of treatment costs. Receiving drug treatment on time can greatly help improve survival rates, and the Yoon Suk-Yeol administration has also set the prompt listing of treatments for severe diseases to ease the burden of high medical costs as a national task, the relevant ministries must have the will to strengthen support for serious diseases.”
- Policy
- The fate of the drugs identified in the inspeciton inspectio
- by Lee, Tak-Sun Oct 13, 2023 05:29am
- Specifically, they are breast cancer treatment Enhertu, Parkinson's disease treatment Madopar, and other immunotherapy drugs. Enhertu was mentioned by People Power Party lawmaker Kang Ki-yoon. He said that the number of female cancer patients is rapidly increasing and ordered coverage of expensive innovative treatments. At this point, Enhertu appeared. He said, “It costs about 150 million won to cure breast cancer with Enhertu,” and asked for prompt payment, saying, “Many unfortunate cases are occurring due to lack of money.” Enhertu is currently tied up in HIRA. After a retrial last May, the Cancer Disease Review Committee established the benefit standards, but the Pharmaceutical Review Committee has not yet reviewed the adequacy of the benefits. There was no news from Enhertu at the Pharmaceutical Review Committee held on the 12th. This drug is effective, so the analysis is that the high survival rate of patients is actually holding back PE. It is difficult to prove cost-effectiveness due to increased use. Attention is being paid to whether a breakthrough in salary will be achieved thanks to Rep. Kang's order during this National Assembly inspection. There was also an order to speed up reimbursement for immunotherapy drugs whose indications are being expanded. This is the order of People Power Party lawmaker Choi Jae-hyung. He emphasized, “Please accelerate the coverage of the expansion of indications for cancer immunotherapy drugs such as Keytruda, Opdivo, Tecentriq, and Bavencio,” adding, “This is the last hope for patients with rare incurable cancers.” In response, Minister of Health and Welfare Cho Kyu-hong responded that he would review it. Part of the agenda for expanding reimbursement for cancer immunotherapy is also in the HIRA evaluation stage. In particular, in the case of Keytruda, following the expansion of reimbursement for first-line non-small cell lung cancer treatment last year, the company applied for expansion of reimbursement for 13 indications in June. On the 11th, the review committee decided to reconsider the three indications, saying that further evaluation was necessary. Fortunately, there was no failure in setting the salary standard, so attention will be paid to whether a positive result will come out in accordance with the National Assembly's request during the next discussion. Roche's 'Madopa', a treatment for Parkinson's disease, is a different case from the previous drugs for which reimbursement was promoted. This drug was already withdrawn from Korea in January. The application period for insurance benefits for inventory drugs is until December of this year. However, patients continue to request this drug. The patient personally appeared as a witness at the government inspection and appealed to be allowed to continue taking Madopa. Mr. Kim, who suffers from Parkinson's disease, said, "Patients have continued their lives by taking Madopa, but as prescriptions have become impossible, patients are suffering." He said, “Generic drugs are difficult to take due to side effects.” At the same time, he asked, “Patients are aware that generic Madopa has obvious side effects, and we ask for help so that they can continue to take Madopa tablets.” Justice Party lawmaker Kang Eun-mi said, “Many Parkinson’s disease treatments are currently being discontinued.” She asked, “The Ministry of Health and Welfare should step forward and help patients feel at ease.” Minister Cho said, “We will make efforts to resupply the original medicine as there is a demand for it.” Minister Cho responded, “We will discuss with the Ministry of Strategy and Finance.” It remains to be seen whether the Mado faction that has withdrawn from the country will return.
- Policy
- Reimb extensions for Keytruda to be rediscussed later
- by Lee, Tak-Sun Oct 13, 2023 05:29am
- MSD Korea's immunotherapy drug 'Keytruda (pembrolizumab)', which applied for a large-scale reimbursement extension, was unable to pass the first hurdle and was determined in need of rediscussions. The authorities plan to first receive the pharmaceutical company's financial sharing plan and then decide whether to set a reimbursement standard. The Health Insurance Review and Assessment Service announced that it decided to rediscuss the agenda of expanding the reimbursement standard for Keytruda at the 7th 2023 Cancer Disease Deliberation Committee meeting that was held on the 11th. The indications for Keytruda that were deliberated for reimbursement extensions were ▲ as a first-line treatment in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either who express programmed death ligand 1 (PD-L1) [combined positive score (CPS) ≥10]; ▲ for use in combination with lenvatinib to treat patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation; and ▲the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC). The CDDC explained, “We plan to first review the medical feasibility and medical necessity for each indication among the many indications the company applied to extend Keytruda’s reimbursement to and receive the pharmaceutical companies' financial sharing plan (drafts) for the overall finances of proven indications to determine their impact before setting the reimbursement standards.” Keytruda is an anti-PD-1 immunotherapy drug, that is currently being reimbursed for 7 indications for 4 cancer types in Korea. Last year, its reimbursement was extended to include its use as a first-line treatment for non-small cell lung cancer. Keytruda has 38 indications in 18 cancers approved under the US Food and Drug Administration (FDA). In Korea, the company applied to extend reimbursement to 13 of the indications in June. The 13 indications Keytruda applied for are as follows: ▲ early-stage triple-negative breast cancer; ▲locally recurrent or metastatic triple-negative breast cancer, ▲metastatic or with unresectable, recurrent head and neck squamous cell carcinoma, ▲ locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma, ▲adjuvant treatment of patients with renal cell carcinoma, ▲non-muscle invasive bladder cancer,▲persistent, recurrent, or metastatic cervical cancer,▲ advanced endometrial carcinoma, ▲advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ▲ unresectable or metastatic MSI-H or dMMR colorectal cancer ▲metastatic MSI-H or dMMR small bowel cancer, ▲ metastatic MSI-H or dMMR ovarian cancer, and ▲ metastatic MSI-H or dMMR pancreatic cancer This time, the government deliberated on extending reimbursement to 3 of the indications. Meanwhile, the reimbursement standards for 2 new anticancer drugs have been established. Kyowa Kirin Korea’s ‘Poteligeo Inj.’ and Pfizer Korea’s ‘Mylotarg Inj.’ are the beneficiaries. However, the government decided to rediscuss the reimbursement of Handok’s ‘Pemazyre Tab.’ Also, Folfirinox (oxaliplatin + irinotecan + leucovorin + 5-FU), which has sought to expand reimbursement as neoadjuvant chemotherapy for borderline resectable pancreatic cancer, succeeded in setting reimbursement standards.
- Policy
- Overseas drug price comparison plan to be announced
- by Lee, Tak-Sun Oct 12, 2023 05:37am
- The final plan will likely be finalized after gathering opinions from the pharmaceutical industry. It is expected that a plan to reevaluate overseas drug prices will be revealed around the end of the year. Health authorities plan to prepare a reevaluation plan by the end of the year and then proceed with it starting next year. According to the industry on the 11th, the HIRA is in the process of preparing a draft plan for comparative reevaluation of overseas drug prices. The draft is expected to determine the reevaluation method and target, as well as the foreign drug price reference formula. Once the draft is completed, a working group is expected to be established to collect opinions from the pharmaceutical industry. Pharmaceutical organizations such as the Pharmaceutical and Biotechnology Association have requested a working group to establish a plan to compare and reevaluate overseas drug prices. As health authorities plan to prepare a final plan by the end of the year, discussions are expected to accelerate after the National Assembly audit. The pharmaceutical industry predicts that reevaluation will proceed sequentially, mainly focusing on chronic disease drugs whose patents have expired. There are concerns that if drug prices are reduced through reevaluation, the damage will increase. Accordingly, the possibility of filing a lawsuit against the government is already being discussed. Since the draft has not yet been released, it is difficult to make hasty predictions. An official in the pharmaceutical industry said, “If the completed plan is made public around the end of the year, there is a high possibility that the final plan will be prepared quickly through the working group after the National Assembly inspection. The pharmaceutical industry is concerned about major damage, and it seems that it will be possible to make a prediction after looking at the draft." The comparative reevaluation of overseas drug prices is also included in the 1st National Health Union Plan announced in 2019. Last year's HIRA included Canada as a reference country for overseas drug prices in addition to the existing seven countries (US, UK, Germany, France, Italy, Switzerland, and Japan), laying the foundation for reevaluation. Initially, there was an attempt to include Australia, but it was canceled due to opposition from the pharmaceutical industry. In December of last year, at a public hearing on measures to improve health insurance sustainability and support essential medical services, a plan to reevaluate foreign drug prices for chronic disease drugs whose patents have expired was formalized, and earlier this year, the HIRA announced that it would prepare a plan by the end of the year.
- 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.
