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- 2026-04-09 06:29:30
- 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.
- Company
- Kwangdong and Moderna strengthen partnership
- by Nho, Byung Chul Oct 16, 2023 05:24am
- Kwangdong Pharmaceutical (CEO Choi Seong-won) announced on the 13th that it will begin full-scale activities to provide medical information to medical staff about Moderna's newly updated COVID-19 vaccine 'Spikevax X', which was recently approved by the Ministry of Food and Drug Safety. Moderna's monovalent vaccine against the XBB.1.5 mutation contains neutralizing antibodies against prevalent mutations such as BA.2.86, EG.5, and FL.1.5.1, as well as the Clinical data confirming the response has been published. The vaccine approved this time is for those 12 years of age or older, and is strongly recommended for the elderly, those with weakened immune systems, and members of facilities vulnerable to infection. Kwangdong plans to engage in various activities to provide product information on Spikevax The plan is to expand its position in the coronavirus vaccine market based on its own sales and marketing competitiveness. Previously, health authorities decided to use the FDA-recommended XBB.1.5 target vaccine for fall/winter vaccination due to the prevalence of the Recently, the World Health Organization (WHO) emphasized the need for vaccination in winter, citing the increase in hospitalizations of COVID-19-infected people in Europe and other countries. An official from Kwangdong Pharmaceutical said, “Moderna's COVID-19 vaccine is a vaccine that has proven excellent protective effect and safety in all age groups, including the elderly, immunocompromised, and those with underlying diseases through clinical trials and actual use evidence (single-use vial formulation) “The advantage is that it is manufactured with an increased ease of vaccination at medical institutions.” Meanwhile, Kwangdong Pharmaceutical established a relationship with Moderna, starting with a vaccine partnership in November last year. This is the first case where Moderna has signed a business partnership agreement with a local pharmaceutical company, and the industry says that the sales power that Kwangdong Pharmaceutical has built based on collaboration with multinational pharmaceutical companies has shone. Over the past 10 years since its establishment, Moderna has transformed from a research company that led the advancement of mRNA technology to a company with a diverse portfolio of clinical trials for vaccines and treatments. Based on mRNA platform technology, 43 research and development programs are underway in the fields of infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune diseases.
- Company
- Lioresal Intrathecal can be prescribed in general hospitals
- by Eo, Yun-Ho Oct 16, 2023 05:24am
- The skeletal muscle relaxant and antispastic ‘Lioresal Intrathecal (baclofen injection)’ may now be prescribed in general hospitals in Korea According to industry sources, Novartis' Lioresal (baclofen), which will be supplied through the Korea Orphan & Essential Drug Center, has passed the Drug Committees (DCs) of tertiary hospitals including the Seoul National University Hospital and Seoul Asan Medical Center. Lioresal was listed for reimbursement last June. It is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses. It is reimbursed for when administered in patients who show insufficient response to orally administered muscle relaxants or cannot receive the drug due to side effects. The reimbursement price ceiling was set at KRW 148,375. Lioresal works by relaxing the muscles used to treat severe spasms and preventing spasms, caused by damage to the brain or spinal cord or other specific conditions. Severe spasms are caused by an injury to the brain or spinal cord or a disease and can cause muscles to feel tight, stiff, and difficult to move. Severe spasms may cause the muscles to feel locked up or cause muscles to move uncontrollably and irregularly when trying to use them. The intrathecal injectable formulation of Lioresal is used to manage such severe spasms. Meanwhile, Lioresal did not show carcinogenic potential in a 2-year study on rats. Pelvic ovarian cysts and enlarged hemorrhagic adrenal glands were observed at the highest doses (50 to 100 mg/kg) in female rats that were treated for 2 years.
- Company
- Record number of reimbursed drugs listed in 1 yr
- by Chon, Seung-Hyun Oct 16, 2023 05:24am
- The number of drugs listed for health insurance reimbursement reached a record high in one year. After the generic market for the diabetes treatment drug ‘Januvia’ opened up, the number of reimbursed drugs expanded rapidly. With single-agent and combination-drug generics of Januvia that were approved under consignment contracts signed before the enforcement of joint development regulations pouring in, the amount of reimbursed drugs, which had been on a decline after the reform of the drug pricing system, rebounded. According to the Health Insurance Review and Assessment Service on the 12th, a total of 23,924 drugs were listed for reimbursement as of the 1st of this month. This is a 291 increase in one month from the 23,633 that were listed until last month. Last August, the total number of drugs listed for reimbursement was 23,427, which increased by 206 in September, followed by an increase of over 200 this month. Over the past 2 months, the number of drugs listed for reimbursement increased by 497 in total. This is the largest market expansion in one year after recording 24,661 in October last year. No. of drugs listed for reimbursement by month Recently, a large number of generic products containing the diabetes treatment ‘sitagliptin’ were listed for reimbursement. Sitagliptin is the active substance in the DPP-4 inhibitor diabetes drug, 'Januvia'. According to the Ministry of Health and Welfare, 284 medicines containing sitagliptin were listed for reimbursement on the 1st. Also, a total of 278 combination drugs that contain sitagliptin and another diabetes drug, metformin, in 7 dosage combinations, were listed. 6 types of sitagliptin and dapagliflozin combination drugs were also listed on the 1st. Dapagliflozin is the active substance in the diabetes treatment Forxiga. A large number of sitagliptin generics were listed last month after Januvia’s patent expiry. On the 2nd of last month, 236 sitagliptin-containing drugs, including 163 single-agent sitagliptin drugs, were listed on Korea’s reimbursement list. In fact, over the past 2 months, the number of drugs containing sitagliptin has increased significantly in the reimbursement list. The overall amount of drug coverage, which had been decreasing due to the government's drug price and licensing regulations, has rebounded with the expiration of Januvia's patent. The number of drugs listed for reimbursement has been on a decline since reaching an all-time high of 26,527 in October 2020. Last August, the total number of drugs listed for reimbursement was 23,427, which was a decrease of 3,100 in 2 years and 10 months. This indicates that over the past 2 years and 10 months, 3,100 more drugs were withdrawn or removed from the market than those newly listed for reimbursement under Korea’s health insurance. The reform of the drug pricing system in 2020 triggered this reduction in the number of new listings. The main point of the reform enforced in July 2020 was that only generics that satisfy both the ‘direct bioequivalence testing’ and ‘Regulation on Registration of Drug Substances (DMF)’ requirements may receive the highest price among generics at 53.55% of the original drug’s price. Also, the reform contains a stepped drug pricing system that lowers the price ceiling of generic drugs according to their listing period. If more than 20 generic drugs are listed in the market for a specific ingredient, the ceiling price for newly listed items thereafter can only be set by up to 85% of the existing lowest price. As the price of drugs falls drastically under this structure if the generic drug company does not develop the generic drug itself or conduct bioequivalence tests, the approval of generics that are wholly manufactured under consignments has decreased significantly. The regulatory barriers to licensing have also increased. With the implementation of the revised Pharmaceutical Affairs Act in July 2021, the number of incrementally modified new drugs and generic drugs that can be approved through a single clinical trial has been restricted. The new regulation, the so-called '1+3' regulation, contains provisions to limit the number of IMDs and generics that can be approved through a single clinical trial. If all manufacturing processes are manufactured identically with the same prescription and manufacturing method at the same manufacturing facility as the pharmaceutical company that directly conducted the bioequivalence test, the use of its bioequivalence data is limited to 3 times. This means that only 4 generic drugs can be approved through 1 bioequivalence test. Its clinical trial data can also be used for 3 other items in addition to the one by the company that directly carried out the trial. Before the reform, when a specific pharmaceutical company passed a bioequivalence test and received approval for a generic product, dozens of pharmaceutical companies often received generic approval using the same data. However, the joint development regulations rendered the ‘unlimited data copying for generic approvals' impossible. However, unlimited consignment of the recently approved sitagliptin preparation was possible because the contract was made before the implementation of development regulations. Consignment contracts entered into by pharmaceutical companies before the enforcement of joint development regulations are valid. In fact, many generics have received approval before the enforcement of joint development regulations, and are waiting to be listed with reimbursement upon expiration of the original drug's patent. According to the Ministry of Food and Drug Safety, a total of 785 drugs contain sitagliptin. Of these, 629 have been approved after 2020. 72 and 118 were approved in 2020 and 2021, respectively. Last year, 254 sitagliptin preparations were approved, and an additional 185 items were approved this year.
- Company
- Will Paxlovid open a market for elderly people’s benefits?
- by Eo, Yun-Ho Oct 16, 2023 05:24am
- As the sense of crisis regarding COVID-19 infection is decreasing, attention is being paid to whether Paxlovid, a treatment drug, can successfully be registered for insurance benefits. Pfizer Korea is currently proceeding with the registration process for Paxlovid, which has been approved as an oral treatment for COVID-19, with the goal of listing it for insurance benefits in the first half of next year. The government announced that it will pursue the registration of Paxlovid insurance benefits within the first half of 2024 in accordance with the plan to ease the COVID-19 crisis level adjustment roadmap. This measure is due to the fact that Paxlovid, which is currently supplied free of charge, is about to be converted to a paid supply like general medicines. When stage 2 of the COVID-19 crisis level adjustment roadmap, which further relaxes the quarantine system, is implemented next month, COVID-19 will transform into a level 4 infectious disease like influenza. The government said that even if the second stage roadmap is implemented, it will provide oral COVID-19 treatments free of charge for the time being, but it is unknown how long the free provision period will last. Therefore, the smooth prescription of Paxlovid will be determined depending on whether or not it is registered for future benefits. The need for COVID-19 measures for the elderly was also raised during the National Assembly audit. At the Ministry of Health and Welfare inspection held at the National Assembly on the 11th, Secretary of the Health and Welfare Committee Koh Young-in (Democratic Party of Korea) said, "As COVID-19 has reached an epidemic level, free support such as PCR tests and treatments has been discontinued, and starting next year, health insurance coverage will also be extended to general medical care. "The system changes. For the elderly, the fatality rate is 50 times that of those in their 40s, and the treatment costs from about 800,000 won to 1 million won, and when the patient copayment becomes 30%, the treatment cost is about 300,000 won," he pointed out. The government also says it will consider a plan for this. Minister of Health and Welfare Cho Gyu-hong said, "There are cases where the epidemic trend increases at certain times, but it is currently decreasing. The transition to the medical system is being decided after listening to the opinions of the Korea Disease Control and Prevention Agency and experts." He added, "I agree that the fatality rate is still high for the elderly. “There is a burden on the cost of the treatment, so we will consider a plan. Even if it is not necessarily free support, we will discuss a plan to ease the burden,” he replied.
- 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.”
- Company
- Bayer Korea appoints JinA Lee as new Managing Director
- by Eo, Yun-Ho Oct 13, 2023 05:29am
- JinA Lee, new Managing Director of Bayer Korea Bayer Korea appointed JinA Lee (54) as the new Managing Director. With this appointment, Lee will become the first Korean head to be appointed to the establishment of Bayer Korea. The company recently announced through an internal announcement that it will appoint JinA Lee, former CDH (Country Division Head) of Pharmaceuticals and Managing Director of Bayer Thai, as the new Managing Director of Bayer Korea as of November. The current Managing Director, Freda Lin, who has led the Korean subsidiary since December 2019, will resign accordingly. After graduating from the Department of Pharmacy at Duksung Women’s University, Lee worked at Roche in 1994 and Merck Serono in 2006, and joined Bayer as the head of the cardiovascular disease BU in 2013. In 2018, she was assigned to take responsibility for New Launching Brand Lead at Bayer headquarters in Germany. She returned to Korea in February last year. From October 2018, Lee also served as the interim head of the Korean subsidiary's pharmaceutical BU due to the appointment of former Managing Director Ingrid Drechsel to Bayer Turkiye. Bayer consists of three divisions - Pharmaceuticals, Consumer Health, and Crop Science. The company has been led by foreigners including Friedrich-Wilhelm Gause, Niels Hessman, and Ingrid Drechsel as heads, and the appointment of Managing Director JinA Lee is the company’s first transition to a domestic head.
- 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.
