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- 2025-12-23 01:55:50
- Policy
- GSK meningococcal vaccine Bexero PFS was approved in Korea
- by Lee, Hye-Kyung May 25, 2022 05:47am
- The MFDS recently approved the item permission of Bexero PFS applied by GlaxoSmithKline (GSK). Bexero PFS is used to prevent invasive meningitis disease by Neisseria meningitidis B group at least 2 months of age. The safety and effectiveness of this vaccine in infants under 8 weeks of age have not been established. This vaccine injects deeply into the muscles. It is recommended to inoculate infants under 12 months of age to the outside of the thigh and to the upper arm deltoid area for those older than that. If inoculated at the same time as other vaccines, the injection site is different. Bexero PFS should not be intravenously, subcutaneous, or intradermally injected, nor should it be mixed in the same syringe as other vaccines. Bexero PFS is the only vaccine approved in Europe in 2016 to prevent type B meningitis and is a drug obtained by GSK through asset exchange with Novartis in 2015. The vaccination purpose of this vaccine is to prevent invasive meningococcal disease (IMD) by promoting antibody production that recognizes the vaccine antigens NHBA, NadA, fHbp, and PorAP1.4 (immune dominant antigen present in OMV components). In approximately 1000 meningococcal B group isolates collected in 5 European countries from 2007 to 2008, between 73 and 87% of meningococcal B group isolates, depending on the country of origin, showed MATS antigen profiles prevented by this vaccine. Phase 3 clinical trials showed that the vaccine was inoculated twice every two months for complement deficiencies (40 patients) aged 2 to 17, asymptomatic or spleen impaired patients (107), and healthy subjects (85) of the same age, with 87% and 97% for fHbp antigens, 95% and 100% for PorA P1.4 antigens, and 73% and 94% for NHBA. In the UK in September 2015, Bexsero PFS was introduced as NIP with a schedule of two additional inoculations (two months of age and four months of age) to infants.
- Policy
- Atopic Dupixent Pen will be available in Korea
- by Lee, Hye-Kyung May 24, 2022 05:54am
- Dupixent, an atopic treatment that is expected to improve convenience when self-injecting at home with easy operation, will be available in Korea. The MFDS recently approved 200mg and 300mg of Dupixent PF Pen applied by Sanofi Aventis. Dupixent PF Pen formulation, which was approved by the U.S. FDA in June 2020, secured adaptations to atopic dermatitis and asthma among the existing Dupixent PFS-approved indications. Existing Dupixent was approved in Korea as a treatment for atopic dermatitis that was ineffective with existing treatment in January 2018, and additional indications were approved as a severe or intractable bronchial asthma treatment that cannot control asthma symptoms with existing treatment in March 2019. Dupixent PF Pentype has the advantage of being able to inject drugs with simple operation. It consists of a visual and auditory feedback device that shows visual indications and sounds when the administration function is executed, as well as a pre-filled pen with hidden need or syringe with need shield. Existing PF pen is used for self-administration after being administered at hospitals and clinics or trained by medical personnel on how to administer it.
- Policy
- Fexclu priced at 90% of the weighted average of K-CAB+PPIs
- by Lee, Tak-Sun May 20, 2022 06:12am
- The price of ‘Fexclu Tab (fexuprazan), the potassium-competitive acid blocker (P-CAB) class gastroesophageal reflux disease (GERD) treatment developed by Daewoong Pharmaceutical was set at 90% of the weighted average price of the same class drug ‘K-CAB (tegoprazan, HK Inno.N) and PPI (proton-pump inhibitors) drugs. On the 12th, the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service had deemed that reimbursement for the drug was adequate if the company accepts a price below the appraised amount. The appraised amount was set at 90% of the price of ‘K-CAB+PPI’ after classifying the alternative of Fexuclu as 'K-Cap + PPI’ in the calculation formula. According to industry sources on the 19th, HIRA delivered its appraised amount to Daewoong Pharmaceutical. Daewoong Pharmaceutical, which had been hoping to be appraised using only K-CAB’s price, received the results with some disappointment. The price of K-CAB had been set at a more expensive level than others, being applied the 'preferential treatment for new drugs that entered the global market’ system that does not exist anymore. The current price ceiling for K-CAB is set at ₩1,300, but as most PPIs are now off-patent and have received significant price discounts, the weighted average price that includes PPIs as alternatives will widen the price gap between Fexclu and K-Cab. The current ceiling price of major PPIs are Nexium 40mg (esomeprazole) ₩1,015, Lanston LFDT tab 30mg (lansoprazole) ₩829, Noltec tab 10mg (ilaprazole) ₩1,131. If a drug’s price is set low in Korea, other countries that reference Korea’s price would also set a lower price for the drug, ultimately creating an unfavorable environment for overseas expansion of drugs. This is why the domestic pharmaceutical industry had requested a preferential clause be added for new homegrown drugs. An industry official pointed out, "In some cases, domestic prices are what impedes overseas penetration of the drugs, and the current drug price calculation standards do not properly reflect the efforts invested by the companies in developing new drugs." However, it is expected that Daewoong Pharmaceutical will accept the given price and proceed to conduct pricing negotiations with the NHIS, as the company has been conducting pre-marketing activities with the aim to release the drug in July, and the low possibility that the decision will be overturned even if the company raises an objection to HIRA’s appraised price. Therefore, Fexclu is expected to engage in a one-on-one competition with K-CAB in Korea with its lower price. K-CAB had raised ₩109.6 billion in outpatient prescriptions (source:UBSIT) last year.
- Policy
- The MFDS will gradually disclose the results of GMP survey
- by Lee, Hye-Kyung May 20, 2022 06:11am
- The MFDS has decided to disclose the results of the drug GMP survey on its website in the future. The MFDS has prepared a plan to disclose information on the results of the drug GMP survey based on the discussions discussed through the Public-Private Consultative Body on the Results of the GMP Survey. As a PIC/S member country, the results of the survey will be disclosed at the level of the U.S. and Europe, but in consideration of the need to prepare legal grounds, it will gradually disclose detailed information after the revision of the Pharmaceutical Affairs Act in the first stage. Subject to the disclosure are pharmaceuticals and herbal medicines under the jurisdiction of the Drug Safety Bureau, and the results of a survey on the status of the licensing stage, regular monitoring, and overseas manufacturing plants. Advanced biopharmaceuticals such as biological drugs are excluded. As a result of the fact-finding survey, the disclosure time is within 6 months after the approval and report of the item, the regular monitoring of the post-authorization stage is within 6 months after the issuance of the GMP conformity report, and the overseas manufacturing plant survey is within 6 months after the report. The MFDS will go through the process of inquiring opinions of the company and disclose it on the website only for summary information. If the company does not agree to disclose the results of the survey, the survey related to the company among the disclosure contents will be shaded. The scope of disclosure is a level that summarizes the outline and points of the fact-finding survey by referring to the current status of the United States and Europe, and is limited to item information in the case of the fact-finding survey. The MFDS is planning to expedite the disclosure of the results of the GMP test in May in line with the current evaluation for WLA registration.
- Policy
- Green light to Sprycel's reimb with indication expansion
- by Lee, Tak-Sun May 20, 2022 06:11am
- The chronic myeloid leukemia treatment ‘Sprycel tab (dasatinib, BMS Korea)’ has received the green light to expand its reimbursement. The Health Insurance Review and Assessment Service announced that it had set the reimbursement standards for Sprycel in pediatric patients with acute lymphoblastic leukemia (ALL) at the 5th Cancer Disease Deliberation Committee meeting that was held on the 18th. Based on the set standards, Sprycel can now progress to the next step in expanding its reimbursement to the indication set above. The drug will now undergo Drug Reimbursement Evaluation Committee review, drug pricing negotiation with the National Health Insurance Service, then receive final deliberations for reimbursement. The specific indication for Sprycel that was approved in the reimbursement standard is for ‘the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.’ Deliberation results of HIRA CDDC that was held on the 18th The other 3 drugs failed to establish reimbursement standards on the same day. Lilly Korea’s ‘Retevmo capsule (selpercatinib)’ that is gaining attention as a tumor-agnostic anticancer drug, Pfizer Korea's ‘Mylotarg injection (gemtuzumab ozogamicin),’ and Novartis Korea's ‘Jakabi tablet (ruxolitinib) all failed to establish reimbursement standards. Retvmo’s reimbursement standards were failed to be set for all its indications: ▲treatment of advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; ▲ treatment of patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or Lenvatinib treatment experience, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy; and ▲ treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC). In the case of Mylotarg, which had failed to expand reimbursement to newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults, and Jakabi which failed to expand its reimbursement standard to the treatment of patients with intermediate or high-risk myelofibrosis, the drugs are now left to reattempt reimbursement expansions at this stage.
- Policy
- HIRA plans to improve the overall management system
- by Lee, Tak-Sun May 20, 2022 06:11am
- Lee Jin-soo, chairman of HIRAWith the launch of Zolgensma, the HIRA plans to improve the overall management system of the pre-approval system. Accordingly, it has been confirmed that internal research is being carried out. The HIRA allows benefits for ultra-high-priced drugs such as Soliris and Spinraza or some medical procedures through a pre-approval system. However, some items have been pre-approved for a long time, and as ultra-high-priced drugs subject to pre-approval are expected to increase in the future, they are reportedly considering adjusting the target items. Lee Jin-soo, chairman of the HIRA Medical Review and Assessment Committee, made the announcement at a meeting with the Korea Special Press Association on the 17th. Chairman Lee explained, "Recently, demands for higher-priced drugs have continued to increase, and medical institutions are also expected to actively use the pre-approval system," adding, "We will improve the overall management system of the pre-approval system." Currently, hematopoietic stem cell transplantation, Soliris (subject to PNH, aHUS diseases) 'ICD&CRT, VAD, and Spinraza are allowed to administer or perform pre-approval systems. Among them, hematopoietic stem cell transplantation is under consideration. Chairman Lee said, "In the case of hematopoietic stem cell transplantation, the pre-approval system has been applied since 1992. At the beginning, it was a high-risk and high-cost act, but now it is cheaper than other expensive drugs, so I think we can go to a post-examination." However, in the medical community, there is a high opinion that it should be maintained. Hematopoietic stem cell transplantation benefited 3,323 people through preliminary screening last year, costing a total of 127.6 billion won. This is a much higher cost than other items. Soliris, an ultra-high-priced drug, cost 36.7 billion won and Spinraza 41.6 billion won last year. The number of people subject to approval is also higher. Chairman Lee said, "Hematopoietic stem cell transplantation has been a learning training for medical institutions since pre-examination was introduced for 30 years, so the approval rate is far higher than other items. However, we are considering withdrawing internally in consideration of manpower and screening capacity." The new drug to which the pre-approval system will be applied is Zolgensma, a treatment for spinal muscular dystrophy. Zolgensma was recognized of benefits on the condition of prior approval of medical care benefits at a review of the Drug Benefit Evaluation Committee held on the 12th. The Medical Review and Assessment Committee is currently considering coordinating the Spinraza review division with the same indication if Zolgensma is confirmed to be subject to the pre-approval system. "In order to improve the system, the review and evaluation laboratory is conducting internal research on the systematic operation of the pre-approval system," Chairman Lee said. "We will analyze the operation status and collect domestic and foreign cases to come up with specific improvement measures." The preliminary review department of the Medical Review and Assessment Committee plans to expand the application of the pre-approval system for severely incurable diseases who need high-risk and high-cost medical services and strengthen management. Chairman Lee said, "Last year, the number of pre-approval items increased from eight to nine, and we received about 280 billion won in medical expenses."
- Policy
- 34 new global drugs, including Beleodaq, are urgently needed
- by Lee, Tak-Sun May 18, 2022 05:52am
- A study has been released that 34 new drugs, including the peripheral T-cell lymphoma treatment Beleodaq, are urgently needed to be introduced in Korea. These new drugs have not been introduced because they are judged to be insufficient in marketability due to domestic screening permits. KoNECT announced that it will select 34 new drugs that are urgently needed to be introduced in Korea and release them online on the 18th for the 2022 KoNECT Brief 1. KoNECT derived priorities through preliminary analysis of 244 in Korea. As a result, Beleodaq (peripheral T cell lymphoma treatment), Palynziq, Zinplava (lostridium difficile recurrence reduction effect), Artesunate (severe malaria treatment), and Xerava (complex abdominal infection treatment antibiotic) were the top drugs to be reviewed. Poteligeo (Fungi and Cezali Syndrome Treatment), Elzonris, Tecartus (CAR-T Cell Blood Cancer Treatment), Yescarta (CAR-T Cell Blood Cancer Treatment), Obizur (Instinctive Post-Cellular Blood Cancer Treatment), and Trumenba. The third-priority drugs mentioned by the association as urgent and unmet demand diseases were BEXSERO (menopausal bacteria serum type B vaccine), Alofisel (treatment of complex anal fistula of Crohn's disease patients), and Raxibacumab (first aid drug for anthrax). Top 4 drugs that need high introduction but require attention are Provenge (prostate cancer vaccine using cells from autologous choroid blood), Zanosar (treatment of malignant neoplasms of the pancreas), Cablivi (acquired thrombocytopenia), Audenz (immune cell-based influenza and anti-viral drugs), Audenz, Rukobia, Trogarzo, Krintafel, Nuplazid, and Apokyn. The last drugs appeared as Steboronine (BNCT), - Scenesse (erythrocytic protorphyria), Mepsevii, Ravicti, Lamzede, Myalept, Egaten (fascioliasis parasite infection treatment), Tpoxx (natural greenhead treatment), Solosec, Voraxaze, and Idenfirix. KoNECT analyzed that the main reason for the delay or non-introduction of global new drugs in Korea is to determine marketability such as whether to exempt ▲ bridge test, ▲ whether to register benefit, and ▲ product price, etc. In particular, whether to be exempted from PE system in the stage of determining drug prices is also important, and it was pointed out that blind spots exist in new drugs for rare diseases that are exempted from economic evaluation. For example, the MFDS' rare drugs and rare diseases of the KCDA are designated based on less than 20,000 people, but the HIRA's rare disease treatment system is limited to less than 200 people. KoNECT stressed the need for a specialized institution to introduce global new drugs in Korea along with the expansion of the "Expended Access Program (EAP)" and the national essential drug system, a program that provides drugs for clinical trials that have not yet been sold on humanitarian grounds. Bae Byung-joon, chairman of the National Clinical Trials Foundation, said, "Korea's drug price policy has been stingy in recognizing the innovative value of global new drugs, while generic prices are higher than the cost to protect domestic industries."
- Policy
- MFDS promotes RWD analysis of COVID-19 vaccines & txs
- by Lee, Hye-Kyung May 18, 2022 05:51am
- The MFDS (Director Kim Kang-rip) will push for a benefit and risk assessment study from May this year based on data actually used in medical sites after the COVID-19 vaccine and PO treatment were introduced in Korea. This study was prepared to analyze safety information such as the incidence of side effects, vaccine defense effects, and hospitalization/death change rates by using RWD and RWE of COVID-19 vaccines and eating treatments. The results of practical data studies will be used to examine the benefits and risks of drugs along with the results of clinical trials, and will be used to verify the causality of major adverse reactions or to establish a safety information monitoring system in the future. The main contents of the study include developing a technology to evaluate the mechanical relationship among ▲ vaccination and adverse reactions, ▲ vaccine developing criteria to evaluate the effectiveness and safety of vaccines, and ▲ therapeutic agent)analysis of domestic patients. Overseas regulatory agencies such as the United States, Europe, and Japan are also promoting various studies on COVID-19 vaccines and treatments using data actually used. The MFDS said, "We will continue to activate various studies to verify the safety and effectiveness of drugs based on scientific evidence and do our best to ensure that the public can use them with confidence based on regulatory science."
- Policy
- Discussions on the benefits of migraine txs begin in earnest
- by Lee, Tak-Sun May 16, 2022 06:14am
- Emgality that passed the Drug Reimbursment Evaluation Committee on the 12thAs Lilly Korea's Emgality passed the HIRA's Drug Reimbursment Evaluation Committee, discussions on the benefit of the migraine txs are rapidly progressing. Following Emgality, Handok Teva's Ajovy, the same (CGRP) target treatment, is also seeking to enter the benefit. Reyvow of Ildong Pharmaceutical, which was approved in Korea on the 12th, is also speeding up the payment process through the approval-benefit evaluation linkage system. On the 12th, the Drug Reimbursment Evaluation Committee of the HIRA held the fifth meeting in 2022 and judged that Lilly's Emgality was eligible for the benefit. Accordingly, Emgality will enter the stage of drug price negotiations with the NHIS. Emgality is currently licensed for three products in Korea. In September 2019, Emgality 120 mg/ml PFS and Emgality 120 mg/ml PFS Pen, and Emgality 100 mg/ml PFS were licensed in May 2020. The product that passed the Reimbursment Evaluation Committee this time was Emgality 120mg/ml PFS, which was recognized as a migraine prevention drug in adults. Triptan-based painkillers are used as migraine treatments, but side effects such as vascular over-contraction are often pointed out. Recently, new drugs for migraine are attracting attention as their effects have improved as they overcome the side effects of existing drugs. A representative drug is an antibody new drug that directly targets CGRP receptors. Emgality and Teva's Ajovy are typical CGRP drugs. Emgality submitted in March last year and passed the Reimbursment Evaluation Committee more than a year ago. Ajovy also reportedly submitted in January. A new oral tx has also emerged. It is Reyvow, which acquired domestic copyrights by Ildong Pharmaceutical. It was originally confirmed to be introduced in Korea in 2013 when Ildong signed a development partnership and domestic sales license agreement with CoLucid Pharmaceuticals, a developer. Since then, Eli Lilly acquired CoLucid Pharmaceuticals in 2017, and in 2019, it has also obtained US FDA approval under the name Reyvow. Ildong then began testing bridges for domestic sales permits and submitted an application for permits immediately after the end of last year. Recently, the drug is known to be undergoing a review at the same time as permission. Accordingly, Emgality's benefit is expected to be the standard for other migraine new drugs. For now, Emgality is also expected to negotiate with the industrial complex. Teva is also expected to establish a benefit strategy while looking at the results of Emgality's negotiations. The domestic migraine treatment market is smaller than that of patients. The annual prescription amount of tryptan-based drugs remains at 15.5 billion won based on UBIST in 2020. However, the prevalence of migraine in Korea is not small at around 6%. According to the HIRA statistics in 2020, 550,000 patients visited the hospital for migraine and received treatment, but about 2 million patients have not visited hospitals. Therefore, pharmaceutical companies expect that the market size will be much larger than it is now if the migraine tx, which has been upgraded from the existing drug, is reimbursed.
- Policy
- Daewoong’s P-CAB drug Fexclu receives conditional approval
- by Lee, Tak-Sun May 16, 2022 06:14am
- Daewoong Pharmaceutical’s P-CAB class gastroesophageal reflux disease (GERD) treatment ‘Fexclu’ has received conditional approval from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee. The committee decided reimbursement was appropriate for the drugs if the company accepts a price below the appraised amount. Accordingly, their reimbursement will be determined in the drug price negotiations with NHIS that will follow. The NHIS announced that it held the 5th 2022 Drug Reimbursement Evaluation Committee (DREC) meeting on the 12th to deliberate on the adequacy of providing insurance benefits to 4 drugs including Fexclu. The 4 drugs that were deliberated were fexuprazan hydrochloride products including Fexclu Tab. 40mg, etc that Daewoong’s subsidiaries Daewoong Pharmaceutical, Daewoong Bio, Hanall Biopharma, iN Therapeutics received approval for. DREC determined that reimbursement was appropriate if the companies accept a price below the appraised amount for the treatment of erosive gastroesophageal reflux disease (GERD). In other words, the company needs to accept the appraised price to receive reimbursement. The decision will now depend on the NHIS negotiations that will follow. The reimbursement process will progress rapidly if Daewoong and the other pharmaceutical companies accept the appraised price, but be difficult otherwise. The Donerion/Donesive patch (donepezil) developed by Celltrion·Icure also received conditional approval from DREC. The drug is the first patch to be developed using donepezil, the ingredient most widely used for the treatment of Alzheimer's-type dementia. As in the case of fexuprazan, DREC determined that reimbursement for donepezil was appropriate if the companies accept a price below the appraised amount for the treatment of Alzheimer's-type dementia symptoms. On the other hand, new drugs developed by multinational pharmaceutical companies were determined appropriate for reimbursement without any condition, and their progress to reimbursement is expected to proceed more quickly. Novartis Korea’s SMA treatment ‘Zolgensma (onasemnogene abeparvovec-xioi)’ and Lilly Korea’s migraine prophylaxis drug ‘Emgality (galcanezumab)’ were recognized as appropriate for reimbursement. In the case of Zolgensma, the drug was approved appropriate for reimbursement in patients with SMA with a bi-allelic mutation in the SMN1 gene under the condition that the drug receives prior approval for medical care benefits and is applied the patient-unit performance-based RSA and an expenditure cap. Emgality was determined appropriate for reimbursement as a preventive treatment of migraine in adult patients.
