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- 2025-12-25 13:57:35
- Policy
- Pitavastatin-Ezetimibe by JW Pharmaceutical was applied
- by Lee, Tak-Sun Mar 22, 2021 06:18am
- JW Pharmaceutical is participating in the Statin-Ezetimibe hyperlipidemia complex market, which has more than 600 products in Korea. It is a combination of Livalo (Pitavastatin) and Ezetimibe. According to industry sources on the 21st, JW Pharmaceutical recently applied for permission for Pitavastatin-Ezetimibe to the MFDS. It was known as Livalozet. It will be the third Livaro series if approved. Livalo is a product jointly developed by Japan's Kowa and Nissan Chemical, and is being introduced and sold in Korea by JW Pharmaceutical. It received the first product approval in 2005, and since its launch in Korea, it has recorded high performance as an original Statin formulation. The amount of outpatient prescriptions based on UBIST last year amounted to ₩73.4 billion. Following Livalo's success, JW Pharmaceutical received approval in 2015 for the hyperlipidemia-hypertensive combination drug Livaro V, which combines Pitavastatin and Valsartan. Livaro V recorded an outpatient prescription of ₩8.2 billion last year. The most recent hyperlipidemia treatments include MSD's Vytorin (Simvastatin-Ezetimibe), Atozet (Atorvastatin-Ezetimibe), and Rosuzet (Rosuvastatin-Ezetimibe). Many generics for Atozet have been released,except for JW Pharmaceutical. While other pharmaceutical companies have focused on introducing Statin combinations, including Ezetimibe. However, JW Pharmaceutical has focused on Livalo (Pitavastatin). Clinical trials for the combination of Pitavastatin-Ezetimibe by JW Pharmaceutical began in 2017, and clinical trials have now been completed. Pitavastatin is known to have a lower risk of side effects of blood sugar compared to other Statins. Accordingly, it is attracting attention from the medical community in that it has a low risk of diabetes and shows excellent cardiovascular disease prevention effects. Because of these advantages of Pitavastatin, it is expected that the combination drug combined with Ezetimibe will be competitive if it comes to the market. There may be difficulties in settling the market as there are more than 600 Statin-Ezetimibe products on the market. It is noteworthy whether JW Pharmaceutical will be able to create a new cash cow item that succeeds Livalo's reputation.
- Policy
- New standard for Adcetris combination has been established
- by Lee, Hye-Kyung Mar 22, 2021 06:17am
- Takeda's antibody-drug conjugate (ADC) and Adcetris (Brentuximab) are now available in combination with chemotherapy during the first-line administration of patients with non-Hodgkin lymphoma and Hodgkin lymphoma. The HIRA announced on the 17th that the revised bill 'Details on the criteria and methods for applying medical care benefits to drugs prescribed and administered to cancer patients' was released and that opinion inquiry will be conducted by the 25th. The scheduled enforcement date is April 1. The revised bill of this announcement contains the new and changed reimbursement standards for combination therapy including Adcetris, a lymphoma treatment. ◆Non-Hodgkin's lymphoma= It is recognized when Adcetris and chemotherapy drugs (Cyclophosphamide, Doxorubicin, Prednisone) are administered in combination with CD30-positive peripheral T-cell lymphoma that have not been treated before (sALCL). In the case of ALK-positive sALCL, it is possible by limiting to 'IPI (international prognostic index) ≥ 2 points' included in the clinical literature. As a result of reviewing textbooks, there is a mention of a clinical study of Adcetris combination therapy for sALCL, and NCCN recommends ALK-positive sALCL as a preferred regimen category 1A and other peripheral T-cell lymphoma as category 2A. In a randomized phase 3 clinical trial, it was confirmed that progression-free survival was increased as a result of comparison with CHOP (Cyclophosphamide, Doxorubicin, Vinblastine, Prednisone), an alternative therapy. ◆Hodgkin's lymphoma= Adcetris and chemotherapy drugs (Doxorubicin, Vinblastine, Dacarbazine) in combination therapy for stage 3 or 4 Hodgkin lymphoma that have not been treated before are recommended for NCCN. Reflecting the expert opinion that it is difficult to establish objective standards and prove relevance as symptomatic improvement, it was decided to be reimbursed only for 'IPS (international prognostic score) ≥ 4 points'. In the case of non-Hodgkin's lymphoma and Hodgkin's lymphoma combination therapy, it was decided to classify it as a therapy with a risk of febrile neutropenia exceeding 20%, reflecting the NCCN guidelines, related clinical trials (ECHELON-2), and expert opinions.
- Policy
- AZ vaccine plan can be updated after reviewing EMA's results
- by Lee, Jeong-Hwan Mar 19, 2021 06:28am
- Commissioner Jeong Eun Kyeong (left) & Rep. Jong-heon Paik KCDA Commissioner Jeong Eun Kyeong said that after reviewing the results of the analysis of side effects such as blood clots of the AstraZeneca COVID-19 vaccine of the EMA, follow-up measures such as discontinuation of vaccination in Korea will be decided. On the 17th, Commissioner Jeong responded to inquiries from the People Power Party of the National Assembly's Health and Welfare Committee, Rep. Paik Jong-heon. Rep. Paik Jong-heon explained that 16 people have died after vaccination against AstraZeneca in Korea. Commissioner Jeong Eun Kyeong, "The domestic case will also be reviewed and decided through an expert deliberation committee" Rep. Paik Jong-heon said, "Since there are 16 deaths after vaccination, we have to start causal analysis directly." KCDA Commissioner Jeong Eun Kyeong said that after reviewing the analysis results of side effects such as blood clots from the European Medicines Regulatory Authority (EMA) they will decide on follow-up measures such as discontinuation of vaccination in Korea. On the 17th, Commissioner Jeong responded to inquiries from the People Power Party of the National Assembly's Health and Welfare Committee, and Rep. Paik Jong-heon. Rep. Paik Jong-heon explained that 16 people have died after AstraZeneca vaccination in Korea. He said that Korea should also initiate a safety test for vaccines or drugs that have been discontinued overseas based on the rules on safety of drugs. He requested that the health authorities do not repeatedly say that the deaths after vaccination with AZ vaccination were simply a non-causal result of worsening the underlying disease, and he asked for a direct investigation of causality. He added, "If The EMA announces that there is a problem with the AstraZeneca vaccination, whether Korea will stop vaccination and initiate an investigation, the domestic drug safety standards are suspended by overseas governments, but if the corresponding measures are taken, the pharmaceutical companies will take measures in the domestic market. The pharmaceutical company should report its domestic action plan to the MFDS." He said, "If the EMA investigation reveals that AZ vaccine is associated with side effects, Korea should also immediately evaluate its safety. Rather than rushing to reveal that there is no problem between the vaccine and the side effects of death, people's trust must be strengthened based on accurate information and standards.," Commissioner Jeong Eun Kyeong said that she would review the analysis results of the EMA and the WHO along with domestic cases, and reflect them in the domestic vaccination plan after going through an expert deliberation committee. She said, "We are aware of the domestic regulations that must be reported to the MFDS in the event of an action taken by a foreign government. We will also review domestic cases and make decisions after reviewing the results of the EMA, the WHO and expert deliberation committee."
- Policy
- AZ and Pfizer COVID-19 vaccines to arrive on Mar. 24
- by Kim, Jung-Ju Mar 19, 2021 06:27am
- The detailed arrival schedule for the COVID-19 vaccines to be supplied this month has been finalized. When the vaccines arrive to South Korea, they would be distributed to 22 inoculation centers around the country, where the vaccines would be used to inoculate elderly citizens aged over 75, and elderly care center occupants and workers from Apr. 1. On Mar. 17, the COVID-19 Vaccination Task Force Team, led by the Korea Disease Control and Prevention Agency (KDCA) Director Jeong Eun-kyeong, has announced the vaccines by AstraZeneca and Pfizer to be used from the second quarter would be dispatched soon from Europe. The 500,000 doses of Pfizer vaccines, the South Korean health authority directly negotiated for, would arrive on Mar. 24. The vaccine has already been approved by the Ministry of Food and Drug Safety (MFDS), and it would be used for inoculation immediately after the fast-track lot release inspection. The outstanding 500,000 doses would be supplied in the last week of March. KDCA official said the vaccines are expected to be supplied to the country in April through May, but more specified dates have not been confirmed. Regarding the batch of AstraZeneca vaccines purchased through COVAX, the UNICEF told the 690,000 doses and 1.41 million doses would be dispatched on Mar. 31 and Apr. 22, respectively, from the Netherlands. Considering the customs processing in Europe and shipping take at least two to three days, the first batch would arrive early April and the latter batch would arrive late April. The COVAX-AstraZeneca vaccines are manufactured at SK Bioscience plant in Andong, South Korea, which was listed for an emergency use drug list by the WHO on Feb. 15. To distribute them consistently, the vaccines would be sent to Europe and supplied back to South Korea. The AstraZeneca vaccine has been authorized MFDS as of last Feb. 10, and the batch arriving soon would be used on occupants of nursing facility aged 65 and over, and the facility workers. Director Jeong Eun-kyeong commented, “To initiate the second-quarter inoculation plan promptly and safely, the government would put utmost care in distribution, storing and preparation for the vaccines coming to South Korea.”
- Policy
- Pfizer vaccine is recommended for seniors 65 and older
- by Lee, Jeong-Hwan Mar 19, 2021 06:27am
- It is suggested that the elderly 65 years of age or older with underlying diseases should be vaccinated with Pfizer vaccine, not AstraZeneca vaccine. Due to the risk of blood clots, some foreign countries, including Europe, have stopped vaccinating AstraZeneca vaccine. The question is whether Korea should also recommend Pfizer vaccination to elderly people. On the 17th, Rep. Jeong-sook Seo of People Power Party made such an inquiry to the MOHW and the KCDA at the plenary meeting of the Health and Welfare Committee of the National Assembly. As of the 15th, some EU countries, such as Italy, Germany, and France, have temporarily suspended AstraZeneca vaccination until the announcement of the EMA due to side effects such as blood clots. In Korea, AstraZeneca vaccination began on the 26th of last month, and more than 570,000 people received the vaccination until the 16th. Among them, 71 cases of anaphylaxis were suspected, 8 cases of serious side effects, and 16 cases of death occurred. Based on this, Rep. Jeong-sook Seo argued that Pfizer vaccination should be recommended to citizens aged 65 or older, taking into account the anxiety of the elderly and those with underlying diseases. She said, "I propose to the government authorities, including Minister Kwon Deok-cheol and Commissioner Jeong Eun Kyeong. Plan to vaccinate Pfizer vaccinations for those over 65." She explained that “the public anxiety and the logic of the health authorities coexist, but death cannot be recovered.” Commissioner Jeong Eun Kyeong announced that she would review the necessity through discussions with domestic experts along with EMA’s result of the causal relationship between AZ vaccine and blood clots. She said, “The EMA announcement was scheduled on the 18th, and we are in real-time discussions with domestic vaccine experts. The causal relationship between the side effects of thrombosis and the vaccine was not confirmed. We will review the European announcement and domestic reality to make a decision.”
- Policy
- Sovaldi's criteria for re-examination are relaxed
- by Lee, Tak-Sun Mar 18, 2021 08:26am
- Re-examination criteria of Sovaldi (Sofosbuvir) and Harvoni (Sofosbuvir-Ledipasvir) by Gilead Science Korea are relaxed. This is because the emergence of new drugs and the continuation of COVID-19 epidemic make it difficult to conduct sufficient usability surveys. Since the recently released hepatitis C treatment can be cured, the number of patients is decreasing. According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee held last month decided to reduce the number of cases in the post-marketing investigation plan of Sovaldi and Harvoni. Sovaldi and Harvoni received domestic permits in the second half of 2015, and re-examination ends in September and October of this year respectively. New drugs usually need to be investigated for a certain period of time in order to verify side effects after marketing. In the case of Sovaldi and Harvoni, conditions were imposed to conduct investigations of 3,000 patients each for 6 years. If this is violated, the marketing permission is finally canceled along with administrative disposition. The Central Pharmaceutical Affairs Review Committee concluded that it is reasonable to adjust the number of Sovaldi and Harvoni cases from 3000 to 1840 and 798. The reason is that although the number of patients has rapidly decreased due to the emergence of new drugs and the environment of COVID-19. In the minutes of the Central Pharmaceutical Affairs Review Committee meeting, a member said, "This drug is difficult to register for new subjects due to COVID-19 situation and the decrease in prescription itself as the use of other drugs increases and the number of subjects to be treated decreases.” He said, "The number of investigation cases is insufficient to confirm the incidence of abnormal cases according to the results of the investigation after overseas marketing, but it is judged that the plan revision is inevitable." He added, "We recommend that they submit a PSUR to maintain drug surveillance after the end of the post-marketing investigation." Most of the committee members concluded that it is reasonable to adjust the number of cases considering the environment of this drug. In fact, Sovaldi's market share in 2017 was 62% due to the decline in patients, and last year it was only 2%. Last year's outpatient prescription (UBIST) was only ₩900 million. Harvoni's outpatient prescription sales last year was ₩8.6 billion, down half from the initial launch. Sales of Mavyret are also declining. Mavyret's outpatient prescriptions last year were ₩32.6 billion, down 26.6% from the previous year. The Central Pharmaceutical Affairs Review Committee explained that although the use of Sovaldi and Harvoni has declined, it is still essential for the treatment of Hepatocirrhosis genotypes 2 and 3.
- Policy
- Alunbrig coverage granted for first-line lung cancer therapy
- by Lee, Hye-Kyung Mar 17, 2021 06:10am
- The South Korean health authority approved listing Takeda Pharmaceuticals’ Alunbrig (brigatinib) for treating anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) as first-line therapy, seven months after the indication expansion. The Health Insurance Review and Assessment Service (HIRA) recently published a revised notification of drug prescribed and administered to cancer patients, and it is accepting relevant public opinion until Mar. 25. Without much of objection, the revised notification would come in effect from Apr. 1. The revised version includes details of a NSCLC treatment Alunbrig and its new reimbursement, a combination therapy of Taxotere (docetaxel) for prostate cancer, selective reimbursement on Zytiga (abiraterone), and amended copayment rate in Cardioxane (dexrazoxane). ◆New coverage on first-line NSCLC treatment: First authorized for the South Korean market on Nov. 30, 20218, Alunbrig has been used to treat ALK-positive patients with advanced or metastatic NSCLC, who have been previously treated with crizotinib since April of 2019. And on Aug. 27 last year, South Korea’s Ministry of Food and Drug Safety (MFDS) granted expanded indication to treat ALK-positive patients with advanced or metastatic NSCLC as a first-line therapy, which was later listed for reimbursement. HIRA, reviewing relevant textbooks, has found the National Comprehensive Cancer Network (NCCN) guideline recommends Alunbrig as a Category 1 preferred regimen. And ultimately, HIRA approved of the first-line therapy reimbursement considering Alunbrig’s Phase III clinical trial confirming the clinical efficacy non-inferior to Alecensa (alectinib) and Zykadia (ceritinib), currently used with coverage. ◆A new combination therapy option for metastatic hormone-sensitive prostate cancer (mHSPC): So far, the Taxotere plus androgen deprivation therapy (ADT) combination therapy used for mHSPC could have been used as an off-label treatment with restricted authorization by a health authority. Also the patients had to cover the entire cost of the treatment. But as academic society requested for reimbursement expansion on the indication last year, the Cancer Deliberation Committee reviewed the off-label anticancer therapy based on post-evaluation (literature review), and decided to grant the coverage for the clinically confirmed therapy. Zytiga, approved to treat in combination with ADT the patients newly diagnosed with mHSPC, also requested for the coverage expansion, but the health authority evaluated the combination therapy is more expensive than an alternative option regardless of the confirmed clinical efficacy. However, the health authority decided to apply selective reimbursement of 30 percent, considering the benefit of proactive administration, improvement in administration convenience with oral regimen, and high social demand. ◆50 percent selective reimbursement on Cardioxane: According to the healthcare coverage enhancement policy in effect, HIRA has reviewed approving reimbursement on administering Cardioxane for extravasation or for cardiotoxicity prevention purpose in pediatric patients, currently covered 100 percent by the patients. The health authority found a textbook mentioning of using Cardioxane for anthracycline extravasation, and reducing the cardiotoxicity in pediatric patients without impeding the anthracycline treatment effect. But HIRA decided to apply 50 percent of selective reimbursement as the indication has not been authorized, yet, and there is no amendment in a treatment guideline to be reflected on the reimbursement criteria.
- Policy
- PE guideline revised for the first time in 9 years
- by Lee, Hye-Kyung Mar 17, 2021 06:10am
- The pharmacoeconomic evaluation (PE) guideline revised by South Korea’s Health Insurance Review and Assessment Service (HIRA) for the first time in nine years has been in effect from last January. The amended 2021 version of the PE guideline reflects the latest evaluation methodology, and specifies the detailed evaluation criteria based on the accumulated experiences and environment of South Korea. On last Jan. 20, HIRA (President Kim Sun-min) official announced the PE guideline was revised republished. The PE guideline explains of the criteria for PE on better effective new drug, which was first introduced by the health authority in 2006 for the positive listing system, and it was revised in December 2011 based on the domestic environment changes. The key revisions are as follow; changes in analysis perspective and discount rate; specified analysis term, methodology, subject population group, designated reference subject, cost and modeling; newly set indirectly comparison, statistical analysis, and guideline on drugs accompanied by a testing kit; and removed financial impact analysis. The analysis perspective was shifted to a perspective from healthcare system, in which the indirect medical cost (transpiration, time and etc.) was excluded from the basic analysis to generally take in account of the decision makers’ interest and to minimize the uncertainty in cost outside of the healthcare system. The discount rate was lowered from 5 percent to 4.5 percent considering the market interest rate calculated during the preliminary feasibility evaluation and the declining economic growth tendency. Beside the observation period, the analysis period was changed to confirm and inspect the uncertainty found during the process of extrapolating the long-term effect and cost, and the revised version specified the cost-utility analysis CUA is preferred as an analysis methodology. The analysis subject population group was amended to newly set a guideline on the sub-group analysis. As for designating the reference subject, the revised guideline would consider using a comparison alternative used in a clinical trial, when it is supported by quality evidence, regardless of the existing principle. Regarding the utility and health related quality of life, the guideline improved the clarification of preferring indirect measure as one of various methodologies to predict the quality of life. Also, the detailed guideline was provided for case of using formula, direct measurement and referencing other literature. The financial impact evaluation initially included was removed, although it would be included in the pharmaceutical decision application submission. Other guidelines were added for effect projection methodology and supplementary screening drug. Director Kim Ae-Ryun of Pharmaceutical Management Department at HIRA elaborated, “During the process of revising the guideline, the agency is putting much effort to hear various opinions from stakeholders, and the guideline would be revisited and revised consistently in the future.”
- Policy
- Voluntary withdrawal of benefit redemption excluding α-GPC
- by Lee, Hye-Kyung Mar 16, 2021 06:22am
- The redemption of benefits related to the drug-related 'Choline Alfoscerate', a brain function improvement agent, has been extended until April 12th. The NHIS has been negotiating benefits redemption of 230 items from 130 companies including Choline Alfoscerate in accordance with the order of the MOHW on December 14 last year. In addition to 227 Choline Alfoscerate, Alvogen Korea's Ateroid, Chodang's Mesocan 50mg, and Ajou's Aju Vesseldue-F were included in the benefit redemption negotiations. In the first round of negotiations, which took place from December 14, 2020 to February 10, 2021, about half of Choline Alfoscerate products, Ateroid, and Mesocan were decided to voluntarily withdraw. However, more than 60 Choline Alfoscerate products and Vesseldues were unable to negotiate with The NHIS, resulting in a second negotiation (~March 15). The NHIS negotiated the contents of the negotiation that was initially known in the process of the 2nd negotiation, if the clinical trial fails, pharmaceutical companies will return the entire NHIS contribution from the date of submission of the clinical plan to the date of deletion to the NHIS. They focused on finding consensus, such as making corrections. According to the pharmaceutical industry, the NHIS initially presented the redemption amount as the full amount of the NHIS charge (approximately 70% of the billed amount), and then reduced it to 50% of the final total billed amount. In the case of Vesseldue, voluntary withdrawal was decided on March 15, the date of the end of the negotiations, but in the case of the remaining 60 items of Choline Alfoscerate, negotiations for the redemption of benefits were not agreed. Therefore, the MOHW issued a third negotiation order until April 12th. In accordance with Article 11, Paragraph 7 of the Standards for Medical Care Benefits, when the NHIS chairman requests the Minister of Health and Welfare, for an additional 60 days, negotiations can be delayed or temporarily suspended.
- Policy
- Samsung Bioepis' biosimilar for Avastin was first approved
- by Lee, Tak-Sun Mar 16, 2021 06:21am
- Samsung Bioepis was the first in Korea to be licensed for the anticancer drug biosimilar for Avastin (Bevacizumab, Roche Korea). The MFDS licensed Samsung Bioepis' Onbevezy on the 11th. Onbevezy is a biosimilar for Avastin of Roche Korea. Onbevezy is the only approved biosimilar for Avastin in Korea. Like Avastin, Onbevezy is used for various cancers such as metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and cervical cancer. Last year, Avastin's domestic sales amounted to ₩118 billion based on IQVIA, ranking third. Domestic companies such as Celltrion are also developing biosimilar for Avastin.
