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- 2026-04-10 18:48:21
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- Can Jakavi be reimbursed for GvHD within the year?
- by Eo, Yun-Ho Feb 13, 2023 05:58am
- Whether reimbursement of ‘Jakavi’ be extended to cover Graft versus Host Disease (GvHD) is gaining attention. Novartis Korea submitted an application to extend reimbursement of its Jakavi (ruxolitinib) to GvHD immediately after receiving approval for the indication in May 2022. However, 8 months have passed and no progress has been made at the Health Insurance Reimbursement and Assessment Service’s level. Therefore, whether the agenda will be deliberated during HIRA’s Drug Reimbursement Evaluation Standard Subcommittee meeting that is expected to be held within the week is gaining attention. When considering the remaining review process, it may be difficult to extend the drug’s reimbursement within the year if HIRA does not complete evaluations by the first half of this year. GvHD is a potentially serious complication that may occur after allogeneic stem cell transplantation (allo-SCT). The donor’s T cells (the graft) view the patient’s healthy cells (the host) as foreign and attack and damage them, affecting various organs including the skin, the gastrointestinal tract, the liver, and the lungs. As symptoms can appear throughout the body, GvHD poses another challenge to patients who have survived allogeneic hematopoietic stem cell transplantations by affecting the patient’s quality of life. Steroids are used as standard first-line therapy, but unmet needs exist as no standard therapy exists in the second-line for the 50% of patients that fail treatment in the first-line. In this area, Jakavi arose as an option that can be used to treat patients aged 12 years and older with acute or chronic GvHD who have an inadequate response to corticosteroids or other systemic therapies. Hee-Jae Kim, the Chief Chair of the Korean Society of Blood and Marrow Transplantation (Professor of Hematology at the Catholic University of Korea), said, “Jakavi demonstrated superior effect in treating acute and chronic GvHD patients in clinical studies and has shown similar outcomes in the field, opening up new possibilities for patients suffering from lack of an appropriate treatment option” He added, “Treatment access to Jakavi has been restricted in Korea due to its non-reimbursement. A considerable amount of time has passed since its approval, and Jakavi’s reimbursement should be applied as soon as possible so as not to further increase the burden of the patients that have already suffered enough, from hematopoietic stem cell transplantation to GvHD.” Meanwhile, Jakavi has demonstrated its efficacy in the Phase III REACH2 trial. Results showed that the overall response rate with Jakavi at Day 28 was 62%, which was higher than the 39% that was achieved with the best available therapy (61/155) Also, the durable overall response was found to be nearly twice higher in the Jakavi group at Day 56 at 40% (34/155), compared with the 22% (61/154) in the control group.
- Policy
- MFDS prepares a cost-sharing plan
- by Lee, Hye-Kyung Feb 10, 2023 05:53am
- The Ministry of Food and Drug Safety plans to prepare measures to disperse risk responsibility in preparation for the occurrence of drug safety accidents such as unintentional impurity generation and mixed drugs. According to the 4th plan for drug safety management recently released by the Ministry of Food and Drug Safety, related industries such as pharmaceutical organizations and user organizations will be discussed to compensate for costs incurred in exchanging drugs. This is to come up with social sharing measures for costs incurred due to the exchange of drugs that are feared to be harmful as unintentional impurity accidents may continue to occur in the future following NDMA detection accidents such as Valsartan and Ranitidine. In 2021, according to the re-prescription, re-prescription, or exchange procedure prepared by the Ministry of Health and Welfare and related associations, the remaining amount of impurities produced by consumers can be re-prescribed, re-prescribed, or exchanged for normal products of the same drug at hospitals, clinics, and pharmacies. Hospitals and clinics have been charging pharmaceutical companies for the cost of re-prescribing and re-preparing impurities-producing drugs as normal manufactured products through the Korea Appraisal Board and the Health Insurance Corporation. However, 36 companies are responding to a lawsuit to confirm the absence of debt when the National Health Insurance Service requested 69 companies to make up 2.03 billion won for the loss of health insurance related to valsartan. At the time of the Valsartan impurity accident, the Pharmaceutical Affairs Act was revised, and after consultation between ministries through the Legislative Policy Council of the Ministry of Government Legislation, the Pharmaceutical Affairs Act was revised. Accordingly, the Ministry of Food and Drug Safety plans to provide legal grounds by reflecting on the discussions of the consultative body and the results of research services this year. When revising the Pharmaceutical Affairs Act, the goal is to prepare and revise sub-laws that set details such as applications for compensation for the operation of the Deliberation Committee for the calculation and collection of the cost compensation charges. The Ministry of Food and Drug Safety said, "We plan to establish a social safety net to protect public health and create a safe use environment for drugs by preparing measures to disperse risk in case of drug safety accidents such as unintentional impurity generation."
- Policy
- MenQuadfi has entered the licensing process
- by Lee, Hye-Kyung Feb 10, 2023 05:53am
- MenQuadfi, Sanofi Pasteur's tetravalent meningococcal vaccine, is expected to be released soon. According to the pharmaceutical industry on the 7th, Sanofi Pasteur completed receiving product licenses from the Ministry of Food and Drug Safety, including clinical trials of MenQuadfi, a vaccine for meningococcal (A, C, Y, W) to prevent invasive meningococcal infections in children and adults over the age of 2. MenQuadfi is designed to induce high immune responses for four serum groups across a wide range of ages from 2 to 56 and was FDA-approved as the first and only tetravalent meningococcal vaccine in the United States using tetanus toxoid as a protein carrier in April 2020. FDA approval was based on clinical data from five double-blind, random, multi-organ, phase 2, and phase 3 trials conducted on 5,000 children and adults over the age of 2. Tests have shown that MenQuadfi-induced immune responses are inferior to other approved tetravalent meningococcal vaccines. Four clinical trials were conducted on those who have not been vaccinated against the meningococcal vaccine and one on those who have been vaccinated against the meningococcal vaccine. In a study of those who have not been vaccinated against the meningococcal vaccine, most (55.4-97.2%) were confirmed to have an immune response after 30 days of vaccination.
- Policy
- Rosuvastatin 2.5mg/Ezetimibe, Hanmi from Daewoong,& Yuhan
- by Lee, Tak-Sun Feb 10, 2023 05:53am
- Rosuzet 10/2.5 mg (left) and Daewoong Crezet 10/2.5 mg (right)The combination market, which combines low-dose (2.5 mg) Rosuvastatin + Ezetimibe, is fluctuating with the addition of large pharmaceutical companies. Yuhan Corporation will also join the market, which Hanmi Pharmaceutical first entered at the end of 2021, following Daewoong Pharmaceutical. As the market size is not expected to be small, competition between the three pharmaceutical companies is expected to intensify. According to the industry on the 9th, Yuhan received a license for Rosuvastatin 2.5mg + Ezetimibe complex developed by its affiliate Addpharma and received a license for Rosuvamibe 10/2.5mg on the 7th. Earlier, the original developer Addpharma has also licensed for Addrose 10/2.5mg in December last year. However, it is said that this product has not yet been applied. Rosuvastatin + Ezetimibe complex has become a trend in the treatment market for dyslipidemia. It is characterized by the combination of statins and Ezetimibe to increase the therapeutic effect. However, there has been a steady demand for low capacity due to the burden of existing statins. The Rosuvastatin 2.5 mg + Ezetimibe complex has the advantage of reducing side effects of high-dose statins such as diabetes-induced and muscular dystrophy while having a similar effect to a single drug, high-dose Rosuvastatin. Accordingly, it is becoming a new prescription option for patients with low and moderate-risk groups and elderly patients. Hanmi Pharmaceutical pioneered the market by launching Rosuzet 10/2.5 for the first time in Korea in December 2021. This product is known to have shown a blockbuster aspect as its monthly prescription (based on Ubist) has recently risen to about 1.4 billion won. Daewoong Pharmaceutical then joined the market by releasing Crezet 10/2.5mg in November last year. There is little difference in the drug prices of the two products. Rosuzet 10/2.5 mg is 751 won and Crezet 10/2.5 mg is 750 won. It's only a one-won difference. Yuhan is expected to be on the payroll list in May with permission this time. As the three pharmaceutical companies have a high market share in the Rosuvastatin+Ezetimibe combination market, market reactions are expected to be high. Last year, Rosuzet recorded 140.3 billion won, Crezet 25.8 billion won, and Rosuvamibe 66.8 billion won in outpatient prescriptions. They are expected to implement a strategy to maximize sales through the Rosuvastatin+Ezetimibe. Meanwhile, in addition to these three companies, other pharmaceutical companies such as NVP Healthcare are also said to have jumped into the development of Rosuvastatin 2.5mg + Ezetimibe complex. It is also leading to the development of Atorvastatin low-dose + Ezetimibe complex.
- Company
- One step left to Dupixent’s reimb in pediatric patients
- by Eo, Yun-Ho Feb 10, 2023 05:53am
- The atopic dermatitis treatment ‘Dupixent’ has entered the last phase of extending its reimbursement coverage to children and adolescents. According to industry sources, Sanofi-Aventis Korea is conducting drug pricing negotiations for the low-dose formulation (200mg) of Dupixent (dupilumbab) with the National Health Insurance Service. The reimbursement agenda has made smooth progress after passing deliberation by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service on the 12th of last month. When considering the set negotiation period, the results are expected to come out by March. Being an RSA (Risk Sharing Agreement) drug and the addition of the separate 200mg dose, the drug had to pass HIRA’s cost-effectiveness review process and complete drug pricing negotiations with the National Health Insurance Service to receive reimbursement. If the drug successfully completes drug pricing negotiations, Dupixent will finally be able to see results two years after applying for the reimbursement extension in April 2021. The journey had not been so easy for the drug. IT first took 7 months for expert opinion inquiries to begin on extending reimbursement of Dupixent to pediatric and adolescent patients, and the reimbursement standards for the indication were only set in May last year. Although the specific indications may differ, the difference in speed of progress is evident when compared to other JAK inhibitors that applied for reimbursement extensions in atopic dermatitis, such as Lilly Korea’s ‘Olumiant (baricitinib),’ Abbvie Korea’s ‘RInvoq (upadacitinib)’ etc. The price of JAK inhibitors is also relatively lower than that of Dupixent. The two drugs were both listed for reimbursement in May last year and Rinvoq is also attempting to extend its reimbursement to pediatric adolescent patients. Meanwhile, the 300mg dose of Dupxient is currently reimbursed for adult patients aged 18 years or older with chronic severe atopic dermatitis who have had the condition for over 3 years and satisfy all three of the following criteria: ▲ who are unable to control their symptoms after receiving topical treatment for over 4 weeks, and ▲ unable to use systemic immunotherapies due to side effects or saw no response (50% or more decrease in EASI, EASI 50) after receiving treatment with systemic immunotherapies, and ▲ had an EASI score of 23 or higher before administering Dupixent.
- Policy
- MOHW opposes legislating premium pricing for KIPC drugs
- by Lee, Jeong-Hwan Feb 10, 2023 05:53am
- The Ministry of Health and Welfare virtually opposed the bill that legislates preferential treatment for drugs manufactured by accredited Korea Innovative Pharmaceutical Companies. The MOHW’s position is that drugs manufactured by Korea Innovative Pharmaceutical Companies already receive preferential treatment, such as premiums provided on insurance price ceilings as well as other support such as additional points for R&D, levy discounts, etc.” On the 9th, the MOHW submitted the opinion above regarding the bill for the ‘Partial Amendment of the Special Act to Foster and Support for the Pharmaceutical Industry’ that was submitted by NA Rep. Jung-sook Suh of the People Power Party. Suh’s bill contains a clause that changes the official name of the Pharmaceutical-Bio Industry Innovation Committee and upgrades its status, as well as a clause that obligates the provision of preferential treatment on drugs manufactured by Korea Innovative Pharmaceutical Companies. Pharmaceutical companies have shown interest in the bill as the bill seeks to obligate the existing arbitrary regulation on preferential treatments for drugs manufactured by Korea Innovative Pharmaceutical Companies, including those that provide premiums on price ceilings set for reimbursement, etc. The industry is also in favor of upgrading the status of the Pharmaceutical-Bio Industry Innovation Committee to an agency directly operated by the Prime Minister. However, the MOHW expressed caution in reviewing the two provisions. Although the ministry agreed on the need to systematically support and foster the pharmaceutical and bio-industry, it opposed the provision of preferential drug pricing. The MOHW said, “Drugs manufactured by Korea Innovative Pharmaceutical Companies are already receiving preferential treatment with premiums provided on the reimbursed price ceilings of their drugs. Also, additional points for R&D, and payment discounts are also provided as support." Regarding upgrading the status of the committee, the MOHW explained, “The government plans to discuss the establishment of a pan-ministerial governance body that not only covers the pharmaceutical industry but also medical devices and digital healthcare. During legislative discussions for that agenda, it will be necessary to review the scope of jurisdiction of each committee, as well as their function, system, and operation method.” However, the Health and Welfare Expert Committee deemed it necessary to revise the mandatory regulations on preferential drug prices for Korea Innovative Pharmaceutical Companies. Article 17-2 of the current Act that stipulates preferential treatment such as providing a premium to the ceiling price of reimbursed drugs was newly established in December 2018 and is an arbitrary rule that provides preferential treatment for drugs manufactured by Korea Innovative Pharmaceutical Companies. However, due to the lack of follow-up legislation, it has been criticized that no preferential treatment other than the price ceiling is being provided under the clause. In other words, the committee believes the optional regulation alone is not enough for the preferential system to be properly applied to drugs manufactured by Korea Innovative Pharmaceutical Companies. The Health and Welfare Expert Committee said, “Effective support measures for drugs manufactured by Korea Innovative Pharmaceutical Companies are needed to increase incentives to attract investment into R&D in the pharmaceutical industry. Therefore measure to provide preferential treatment to benefiting companies and drugs should be specified and stipulated as legislations through discussion with the public-private consultative body.”
- Company
- Botulinum Xeomin can be stored at room temperature
- by Jung, Sae-Im Feb 10, 2023 05:52am
- Professor Heo Chang-hoon presenting at the Merz Xeomin press conference"Improving toxin quality and strengthening management change perceptions Merz's botulinum toxin Xeomin has been upgraded to room-temperature storage. It emphasized quality as the only room-temperature storage product with the highest purity among botulinum toxin drugs on the market in Korea. Merz held a press conference at the Grand InterContinental Seoul Parnas Hotel in Gangnam-gu, Seoul on the 9th to commemorate the Xeomin room temperature storage (1 to 25 degrees Celsius). Launched in 2011, Xeomin has recently changed its license for storage temperatures. Unlike other botulinum toxin preparations that require refrigeration at 2 to 8 degrees, Xeomin can be stored at 9 to 25 degrees Celsius. It is the only toxin product on the domestic market that is stored at room temperature. In order for biological agents such as botulinum toxin to be licensed for upper marriage storage, consistent effectiveness, and stability must be demonstrated at 1 to 25 degrees. As a result of the experiment, Xeomin confirmed that biological activity and human serum albumin content remained constant for 36 months under conditions of 25 degrees Celsius and 60% humidity. Director Park Je-young (Oracle Dermatology in Apgujeong), who served as the speaker of the meeting, said, "Xeomin has already been allowed to be stored at room temperature in the U.S. and Europe. This means that there is a low risk of decomposition and deterioration of products that may occur due to temperature changes during transportation or distribution," he explained. As a result, Xeomin is the only botulinum toxin preparation that removes complex proteins and can be stored at room temperature at the same time. It minimized the risk of developing resistance by leaving only neurotoxin, an active substance, and proved high stability by storing it at room temperature. Heo Chang-hoon, a dermatologist at Seoul National University Bundang Hospital, said, "Botulinum toxin is determined based on ▲ the purity of neurotoxin ▲ consistency of effect expression ▲ stability during distribution and storage." In particular, toxin preparations are often not consistently refrigerated in storage and movement, and Xeomin has achieved the desire of all medical staff and pharmaceutical companies to store them at room temperature, he added. Yoo Soo-yeon, CEO of Merz, said, "This permit can save the use of energy essential for refrigeration, which is in line with the ESG management pursued by Merz."
- Policy
- Drugs subject to 2nd evaluations may submit data by Oct
- by Lee, Tak-Sun Feb 09, 2023 05:50am
- Drugs that were to receive the 2nd series of reevaluations by HIRA and were required to submit data by July will also be deemed to have met their requirements even if they exceed their submission deadline and submit the Ministry of Food and Drug Safety review completion notice by the end of the objection period. This will allow companies an additional 3 months of time, until October, to submit data. The measure has been made in consideration of the unavoidable circumstances, just as the first series of drugs that were subject to receive evaluations this year. According to the Health Insurance Review and Assessment Service on the 7th, oral and sterile preparations that were subject to receive evaluations in the second review were required to submit data by July 31 will be deemed to have satisfied their requirements if they submit their MFDS review completion notice within the objection period in consideration of the delay in MFDS review. A total of 5,905 oral and sterile preparations that were expanded and designated to conduct bioequivalence tests were set to receive the second set of evaluations. Some of the items have not even started bioequivalence tests , being unable to designate reference drugs. The authorities had previously announced that it will register priority review requests from drugs subject to receive the first set of evaluations and need to submit their data by February, and deem those companies that submit MFDS review completion notice within the objection period to have satisfied standard requirements. Therefore, relevant companies will first submit review requests to the MFDS by February, then submit their review completion notice by May. The data submission deadline had been extended in consideration of the COVID-19 situation, and HIRA explained that the same consideration will be provided to drugs subject to the second series of evaluations. Therefore, drugs subject to receive the second series of evaluations will be allowed to first submit review requests by July and submit the review completion notice by October to satisfy the standard requirements. HIRA believes that the 3-month addition to the deadline of the drugs subject to receive the second series of evaluations will allow drugs whose bioequivalence tests have been delayed due to reasons including non-announcement of reference drugs or difference in the sorbitol additive with its reference drug, to fully conduct reevaluations. A HIRA official explained, “Although discussions will still need to be made with the MFDS, we believe most drugs will be able to submit data within the evaluation period." Meanwhile, HIRA will hold a briefing session on its reevaluation of standard requirements on reimbursed ceiling price of listed drugs at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association office from 3:30 p.m. on the 10th and provide guidance on frequently asked questions in a Q&A format. Afterward, after collecting the opinions of the pharmaceutical industry on the series of evaluation subjects that will follow, the final list of drugs subject to evaluation will be released on HIRA’s webpage once again.
- Policy
- Enhertu's referral to the National Petition Welfare Committe
- by Lee, Jeong-Hwan Feb 09, 2023 05:49am
- It was referred to the National Assembly's Health and Welfare Committee as the number of people's consent to the application of breast cancer treatment Enhertu's health insurance reached 50,000. Enhertu is an antibody-drug conjugate that obtained a domestic marketing license last year due to the petition of the National Assembly. The petition for the approval of Enhertu Health Insurance rose on the 30th of last month, and 50,000 people agreed on the 3rd of this month, five days later. The petitioner pointed out that Enhertu is a high-priced drug that costs 5 million won per injection, and expressed the need to strengthen the accessibility of breast cancer patients. In June and August last year, Enhertu also filed a petition calling for approval of health insurance. In particular, Enhertu was designated as a subject of rapid permission in June 2021, but it was not approved for more than a year, so it was approved due to the influence of the national petition. Both Enhertu developers Daiichi Sankyo Korea and AstraZeneca Korea completed submitting a salary application for the approved indication in November last year and are currently waiting for the HIRA to review it. The public is paying keen attention to whether the government will respond quickly. The petition review subcommittee of the Welfare Committee is expected to review the petition calling for Enhertu health insurance approval according to the procedure.
- Company
- 80 billion won worth of Anticonvulsant Market
- by Nho, Byung Chul Feb 09, 2023 05:49am
- In the 80 billion Anticonvulsant market, Topiramate-based treatments form 30 billion units, leading the market. The epilepsy drug consists of about 10 components, including Topiramate, Lamotrigine, sodium Valproate, Oxcarbazepine, and Perampanel. According to the drug distribution performance data, as of last year, the performance of Lamotrigine, sodium valproate, Oxcarbazepine, and Perampanel drugs was 14.9 billion won, 10.4 billion won, 7.6 billion won, and 4.5 billion won, respectively. It is also notable that the rest of the formulations, excluding topiramate, show an annual growth rate of around 100 million won to 300 million won. About 10 products of Topiramate formulations have been released, forming the largest number of epilepsy drugs. Total sales in 2018, 2019, and 2020 were 23.2 billion won, 25.7 billion won, and 28.9 billion won, with the highest growth rate. The leading product of topiramate ingredients was the Janssen Topamax Sprinkle capsule, which generated about 10 billion won in sales last year. SK Chemicals Qudexy and Huons Ceti followed with 2.2 billion won and 2.1 billion won. GSK Lamicta, the No. 1 product of Lamotrigine ingredients, maintained its appearance of 11.9 billion won in 2021. It has the highest performance based on a single product of epilepsy drugs. Lamostal and Bukwang Lamotigine ranked second and third in the same ingredient, which recorded 800 million won 600 million won in performance. Myungin Camazepine and Novartis Tegretol Korea form an appearance of 2.9 billion won and 2.4 billion won. Perampanel-based product Eisai Korea Fycompa's 2021 performance is 4.5 billion won, while Handok Sentil is moving within 900-1 billion won for five years. According to academia, the prevalence of epilepsy is about 4 to 10 per 1,000 people, and it is known that 20 to 70 people per 100,000 people occur newly every year, especially in childhood (under 9) and old age (over 60). Genetic defects cannot be excluded as the cause of epilepsy, but it is a general classification criterion to classify it into structure, metabolism, and unknown cause. It is a case of seizures due to acquired diseases such as stroke, brain damage, and infection due to structural and metabolic causes, and can come from brain nerve cell stimulation due to hypoglycemia, uremia, withdrawal of alcohol, and sleep deprivation. Most likely causes include cerebrovascular disease, encephalitis, hippocampus sclerosis, cerebral palsy, brain tumors, vascular deformities, and degenerative diseases, but more than half of the causes are unknown. Looking at the guidelines for treatments of the Korean Epidemiology Association, epilepsy can be improved with drug treatment, and 60-70% of patients can control seizures with treatments. Since drug treatment should be maintained for a long period of at least two years, it is important to choose a drug that suits each patient's condition.
