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- 2025-12-24 12:41:36
- Policy
- Evrenzo has been approved in Korea
- by Lee, Tak-Sun Jul 12, 2021 06:11pm
- A new oral drug that can treat anemia, one of the complications of patients with chronic kidney disease, has been approved in Korea. Until now, the standard therapy for treating the disease has been administered with a red blood cell production stimulating injection called EPO (Erythropoietin) or ESA (Erythropoiesis stimulating agent), and attention is being paid to whether a new oral drug with high convenience will replace ESA. The MFDS approved AstraZeneca Korea's (Roxadustat) 5 items on the 9th. This drug is used to treat syndrome anemia in patients with chronic nephropathy. In particular, patients who are or are not on dialysis can also be used. It can also replace the ESA injections that have been used. People with chronic nephropoientin develop anemia due to fewer kidney-generated Erythropoientin. This is because hematopoietic hormones are involved in the process of making red blood cells in the bone marrow. The hematopoietic hormone preparation made by recombination technology is ESA. The first generation of ESA required injections every two to three days, but the latest ESA has been improved to allow injections once a month. One of the most popular injections is Roche's Mircera. Mircera is a blockbuster drug that sold ₩18.8 billion (IQVIA) in South Korea last year. Other ESAs are also being used in addition to Mircera. Since oral oral medicine is more convenient to take than injections, attention is being paid to whether Evrenzo, which is approved this time, will replace existing ESA drugs. Roxadustat has a mechanism to activate hypoxia-inducible factors (HIFs) that regulate gene expression by engaging in red blood cell formation. By reversibly inhibiting HIF-PH, which targets HIFs and decomposes them under normal oxygen conditions, Roxadustat induces a response similar to the body's natural response to hypoxia. High efficacy was confirmed in three clinical trials (ANDES, OLYMPUS, and ALPS) and maintained the hemoglobin concentration in patients switching from conventional ESA therapy. Roxadustat, co-developed by AstraZeneca and FibroGen, was first approved in China in December 2018, and was also approved in Japan the following year. European EMA and the U.S. FDA are also likely to approve it soon. Attention is expected to continue to be paid to whether the existing market structure will be reorganized with the release of the drug.
- Policy
- MFDS orders minimized use of varenicline
- by Lee, Tak-Sun Jul 12, 2021 05:58am
- The Ministry of Food and Drug Safety ordered minimized use of the smoking-cessation treatment, ‘varenicline.’ The measure was announced 3 weeks after safety investigations had started for the products, from the 22nd of last month. The MFDS announced that it has issued a Dear Healthcare Professional Letter regarding the precautions to take when prescribing and using smoking cessation treatment aids using ‘varenicline,’ with regards to the recall of these products abroad due to N-nitroso-varenicline impurities found in some of its products. The MFDS explained that the letter was issued as a precautionary measure for domestic HCPs and patients, as the possibility of nitrosamine impurities cannot be completely ruled out, although the results of the safety investigations that started on the 22nd of June have not been released yet. Measures to recall some of the finished drug products containing ‘varenicline’ are already in force in Canada and the U.S. In the letter, the MFDS informed the experts and patients of the types of finished drugs and their related information. To HCPs including doctors and pharmacists, the ministry recommended minimizing the use of finished drug products that contain ‘varenicline’ and asked experts to consider other treatment methods, if possible, according to the patient’s condition, until the investigation results regarding the nitrosamine impurities are announced. To patients who are using affected products, the ministry advised them to continue using the treatment until the HCPs provide an alternative treatment, and to consult with doctors and pharmacists if any health concerns arise while using the medications. The ministry also added that it is working closely with relevant companies to ensure that the ongoing investigation for impurities is completed as soon as possible and that it will announce measures as soon as the key results are released. Also, products that do not complete testing by August 31st will be suspended from sales as a precautionary measure until it is confirmed that no impurities are detected in the products. An official from MFDS said, “Public safety is of our utmost priority, and we plan to quickly implement necessary measures including completing the development of test methods for impurities and collecting and inspecting related products if necessary.” The letter was issued in the midst of the confusion arising in the field as the Korean health authorities had made no measures after ordering investigations for impurities despite ongoing product recalls for some varenicline products in the U.S. and Canada.
- Policy
- Ultra-high-priced drugs(Kymriah) need coverage within a year
- by Lee, Jeong-Hwan Jul 11, 2021 07:05pm
- In order to commercialize high-tech biopharmaceuticals, which are evaluated as ultra-high-priced new drugs, it has been argued that a policy to recognize insurance benefits should follow beyond Expedited Review within at least a year of approval. It is pointed out that although the enactment of the Advanced Regenerative Bio Act in 2019 established a quick marketing permit system for serious and rare diseases without alternative treatments, there is still no system to register benefit. Professor Kim Won-seok of the Department of Blood Tumor Medicine at Samsung Medical Center will present the presentation at the National Assembly's debate on how to improve accessibility of patients with advanced biopharmaceuticals on the 9th. The debate was hosted by Kim Min-seok, chairman of the National Assembly's Health and Welfare Committee, and Choi Hye-young, a member of the Democratic Party of Korea. Professor Kim Won-seok, who is in charge of the presentation, announced the "Status of Advanced Biopharmaceutical Development and Treatment in Advanced Countries." Advanced bio-medicine is a drug based on cells, tissues, and genes, and many treat the source of the disease and show a full recovery effect with a single dose. Anti-cancer drugs are leading research and development of advanced biopharmaceuticals. Cancer diseases have a large number of unmet demand and indications with fewer patients with symptoms than the stage of disease development. Professor Kim said advanced bio drugs are a new alternative to the treatment of recurrent non-responsive incurable blood cancer, which currently has no cure. Kymriah (Tisagenleucel) using CAR-T cells was cited as an example. Professor Kim said Kymriah has been performing in the actual medical environment, with a total response rate of 53% in the follow-up analysis for about 40 months. Due to the characteristics of treatments that utilize human cells, there are many problems that need to be solved for commercialization, such as preparing a new system for medical institutions and establishing standards. In fact, CAR-T treatment in Korea requires permission, manpower, system, and standards from the management industry, and professional support such as infectious medicine, neurology, circulatory medicine, and critical patient medicine for comprehensive management after treatment. In particular, there are no advanced biopharmaceuticals called Marketing Authorization Under Exceptional Circumstances (MAEC). Looking at Kymriah's global status, Japan and Europe (France, Italy, Germany and Switzerland) recognized the benefit at the same time as the permit. Australia, Britain, Canada and Scotland, which have similar insurance benefit registration systems to Korea, applied their benefits after a quick review within a year of permission. Professor Kim believes that although Korea approved Kymriah on March 1, there is no insurance review program comparable to overseas countries. He said, "High-tech bio drugs are drugs that change the treatment paradigm. Patients waiting for Kymriah is less than 200 a year, and have only three to six months to wait for insurance benefit, and high-tech bio drugs need not only quick approval but also quick insurance registration."
- Policy
- Early supply of Pfizer in exchange for a vaccine with Israel
- by Kim, Jung-Ju Jul 11, 2021 07:01pm
- The Minister of Health and Welfare, Kwon Deok-chul signed a vaccine swap agreement today (6th), which will receive 700,000 pfizer vaccines from the Israeli government in July and return them sequentially from September to November. Recently, the Israeli government was looking for ways to make effective use of the vaccine, with some of the Pfizer vaccines (valid July 31st) expected to remain in use in July. The vaccine exchange between Korea and Israel will take place in consideration of the cold chain management base and the fact that the vaccination can be completed in a short period due to the high participation rate of vaccination. Since the announcement of the expiration date in Israel, the number of applicants for vaccination has increased and the exchange volume has been confirmed to be 700,000 after consulting for the first 800,000 vaccinations. Korea has secured enough supplies to introduce about 80 million batches in the third quarter, including about 10 million in July, but the vaccine exchange will speed up the vaccination process. The exchange of vaccines between South Korea and Israel has been largely attributed to the trust between the two countries through diplomatic efforts between South Korea and Israel. Since the launch of COVAX, a multilateral consultative body for responding to COVID-19, South Korea and Israel have held close informal consultations and discussed vaccine cooperation as similar countries. Recently, the two sides discussed ways to cooperate with vaccines, including the Israeli foreign minister's visit to Korea in May this year, and such efforts served as the basis for successful exchange of vaccines. Pfizer vaccine, which will be supplied early through the exchange of vaccines with Israel, are scheduled to arrive at Incheon International Airport at 7:15 a.m. on the 7th. This vaccine is already licensed in Belgium and is also being used in Israel for vaccination in July. The government plans to complete customs clearance immediately and conduct Emergency Use Authorization (EUA) so that it can be used quickly after the vaccine arrives. Afterwards, the MFDS will conduct its own quality inspection and domestic delivery procedures, and will be used for vaccination from the 13th. Pfizer vaccine (700,000 doses) to be supplied this time will be used for vaccination in addition to about 10 million doses originally scheduled for July. First of all, autonomous vaccination of local governments for Seoul and Gyeonggi will be implemented early from the 13th in order to stabilize quarantine in the Seoul metropolitan area. The government plans to supply Pfizer vaccines (340,000 people) to Seoul and Gyeonggi Province, where confirmed cases are concentrated, to stabilize the quarantine by short-term intensive vaccinations for job groups with high public contact (two weeks from the 13th). The local government will select the target groups, including jobs that have a high risk of spreading due to high contact with the public, and start vaccinating each vaccination center with a Pfizer vaccine on the 13th. The vaccination will be conducted at 43 vaccination centers in Seoul (about 200,000) and 51 vaccination centers in Gyeonggi Province (about 140,000). In addition, the government will expand the size of autonomous vaccinations for local governments, which will be implemented later this month. It plans to expand the autonomous vaccination of local governments to 800,000 people, which was originally planned to be 440,000 at the end of July, to reflect Israel's introduction. Autonomous vaccination of local governments will be carried out for 2 million people by August. The government will start vaccinating daycare centers, kindergarten, and elementary school first and second-grade faculty and care workers (380,000 people) among education and childcare workers originally scheduled to be vaccinated on July 28th (Tuesday). Advance reservations will take place from midnight on the 8th to 18th on the 10th, and those who are eligible for reservation will be informed how to book by text message by tomorrow. Other reservations and vaccinations for education and childcare workers (elementary and junior high school teachers, children's facilities, etc.) shall be carried out as originally planned. Since then, the government will return Pfizer vaccine received from Israel sequentially from September to November, when much of the vaccination was carried out in Korea. Kwon Deok-chul, head of the pan-government vaccine introduction TF team, explained, "This Korea-Israel vaccine exchange is a win-win strategy that can speed up vaccination during the summer vacation season by receiving vaccines earlier than scheduled for Korea." Jeong Eun-kyeong, the Commissioner of KDCA, said, "The importance of international vaccine cooperation is increasing at a time when vaccines are scarce around the world. "The vaccine exchange means early introduction of vaccines through international cooperation domestically, and internationally, it is an example of efficient use of vaccines." She said, "In particular, each country needs a vaccine at a different time, and the exchange of vaccines between Korea and Israel is expected to serve as a model for revitalizing international cooperation. In the future, we will also provide vaccines first, considering the vaccine supply and vaccination situation, and actively review the vaccine exchange we receive when we need it, so that vaccines can be effectively received internationally."
- Policy
- Bayer applies for approval of ‘Finerenone’ in Korea
- by Lee, Tak-Sun Jul 09, 2021 05:57am
- A groundbreaking new drug developed by Bayer is undergoing review for approval in Korea. The drug is known to inhibit disease progression in chronic kidney disease (CKD) patients with diabetes. According to industry sources on the 8th, Bayer applied for the approval of its ‘finerenone (Kerendia tab)’ to the Ministry of Food and Drug Safety in Korea. Finerenone, which was developed by Bayer, is considered to be a potential global blockbuster by the company. Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that selectively acts on mineralocorticoid receptors to block harmful effects on the kidneys and the heart. It is reported to be particularly useful for patients with chronic kidney disease and diabetes. In a Phase III trial (FIDELIO-DKD) presented at the Annual Meeting held by the American Society of Nephrology in October last year, patients who took finerenone had an 18% lower risk of developing a composite of kidney failure, a sustained reduction of at least 40% in estimated glomerular filtration rate (eGFR) from baseline, or death from renal causes than those who took the placebo. The study enrolled approximately 5,700 patients with CKD and Type 2 Diabetes. Diabetic CKD patients have a risk for kidney damage and eventually kidney failure, despite currently available treatments. Bayer believes finerenone will be effective in delaying disease progression in this patient population. The drug has received a Priority Review designation by the U.S. FDA in January. With the designation, in the U.S., finerenone is expected to be approved within the second half of this year at the earliest. The drug is also under review by the EMA. Soon to face patent expiry for some of its products including Xarelto and Eylea, Bayer has expectations high for its new drugs, including finerenone.
- Policy
- Generic prices are 41-54% more expensive than foreign ones
- by Lee, Hye-Kyung Jul 07, 2021 05:53am
- The level of generic prices in Korea is 41 to 54% higher than that of foreign generics. This leads to an interpretation that if domestic generics are replaced with foreign medicines, 41-54% of costs will be reduced if only tariffs and transportation costs are compared. The findings were recently published by The Korean Association of Health Economics and Policy in its "The Cross-National drug price computing on the methods" (Korea University's College of Pharmacy, Bae Eun-mi, Choi Sang-eun, Kang Daewon, and Kyungsun Shin). To investigate generic drug price levels in Korea, we conducted a cross-national drug price comparison. Also, it was investigated whether the price level could differ when the price comparison method was changed. Bilateral comparisons with 15 countries were conducted for the top 23 molecules based on health insurance claims data. As a result, the price level of generic drugs in Korea was slightly different depending on the method, but it was overall higher than that of comparison countries. The weighted average price of generics was similar to that of the brand, and none of the launch date, the market share, and the number of competing items appear to affect the drug price level. This study has demonstrated the sensitivity of cross-national drug price comparisons to the methods used, including comparison countries, weights, and price type. A total of 23 ingredients are included in this analysis, and the 2016 claims for these drugs are about ₩2 trillion. It accounted for 18.4% of all claimed medicines at ₩800 billion. According to the analysis, the price level of generics in 15 countries could be seen as 61% to 78% of Korea on average (simple average comparison basis), and the average of Group A, which has a higher economic level than Korea, was 77% to 88% of Korea's drug price level. When usage weights are applied, the level of drug prices in foreign countries is lower, indicating 41%-54% of the level of drug prices in Korea. In terms of the level of drug prices by country, Switzerland and Japan were the only countries that could be said to have higher generic prices than Korea. Some countries, such as the United Kingdom and Germany, had higher generic prices than Korea, but it was not known at what level the actual price (the country's weighted average price) was formed between the highest and lowest prices. The price level of brand drugs was formed slightly higher than the generic weighted average in Korea, and the weighted average of generic drugs in Korea was located at the top of the overall generic price range. Korea's upper limit price included wholesale distribution margins and VAT without a separate retail margin, and the average of 15 countries was similar to that of Korea (94-114%) compared to that of other countries. The drug price level by ingredient was overwhelming for systemic antibiotics, digestive systems, and metabolic medicines compared to brand drugs, but the price was similar to brand drugs. When listed in order of the amount of claims, the Korean generic price was higher than the foreign generic price in the ingredients with high claims. The earlier the initial notice date, the higher the proportion of generic drugs used, but the lower the price compared to brand and foreign generic prices. Although the generic share of ingredients with a large number of items was high, the price level was not lower than that of foreign countries, apart from the presence of competition. "Considering that most countries (excluding the UK) in the analysis use a reference pricing system and that there will be price competition between generics, it can be assumed that there will be more use of low-cost generics," the research team said.
- Policy
- ‘Immunoglobulin inj’ is reimbursed for vaccine-related TTS
- by Lee, Hye-Kyung Jul 07, 2021 05:52am
- Human Immunoglobulin G may now be used with insurance benefits for the treatment of thrombosis thrombocytopenia syndrome (TTS), a known adverse event following COVID-19 vaccinations. Expansion of benefit standards for general drugs usually takes around 80 days, however, due to the specificity of the COVID-19 situation, the reimbursement standard was expanded in a single day. The Health Insurance Review and Assessment Service announced on the 1st that it has secured a safety net for the public against side effects that arise post-vaccination by reviewing the health insurance benefit standards in the shortest period ever. TTS is a rare condition, and only two TTS cases were confirmed in Korea as of now. Patients can fully recover when the condition is detected early by a doctor and treated approximately. Human Immunoglobulin G injections, which are necessary for treating TTS, had previously been covered by health insurance for a few conditions, but not for TTS. HIRA had promptly decided on expanding the reimbursement standards for the drug by reflecting the latest medical cases and the recommendation made by the Korea Disease Control and Prevention Agency. Kim Ae-Ryun, Director of HIRA’s Pharmaceutical Management Department said, “We have reviewed and set reimbursement standards for the drug in just one single day for the public’s safety. The process conventionally takes over 80 days, but we considered the current situation where COVID-19 vaccinations are increasing day by day. It is significant we have secured a safety net for the public, and when a vaccine's side effect that is of a public concern occurs, a treatment suitable for the patient's symptom may be administered in a timely manner in the field."
- Policy
- Benefit extended for Lipiodol, reduced for Imotun from 23rd
- by Kim, Jung-Ju Jul 06, 2021 05:50am
- Reimbursement benefit for Guerbet Korea’s liver cancer contrast medium Lipiodol Ultra-Fluid (iodised oil, 12.8g/10mL) will be extended to lymphangiography and sialography. On the other hand, reimbursement benefit for Chong Kun Dang Pharmaceutical’s avocado and soyabeam unsaponifiables, Imotun Cap., will be reduced in line with its reduced indication. The Ministry of Health and Welfare made a partial amendment and issued the ‘Details on the applied standards and methods of medical benefits (drugs)’ that contained the abovementioned changes. The changes will apply on different dates for each drug. First, the reimbursement benefit for the liver cancer contrast medium Lipiodol Ultra-Fluid will be extended to match the expanded efficacy and effect in its indication. Accordingly, reimbursement will be approved within the scope set under the ‘details on the standards and method for applying medical benefits to drugs prescribed and administered to cancer patients.’ All other medication costs will fully be borne by the individual patient. Specifically, Lipiodol may be used for lymphangiography, sialography, and transarterial chemoembolization (TACE) procedures in liver cancer. The extended reimbursement will be applied to Lipiodol that is used from today (July 6th). On the other hand, the scope of reimbursement for Imotun Cap. will be reduced in line with its reduced efficacy and effect. The change in efficacy and effect from its original developer, France, to ‘relief of symptoms of osteoarthritis of the knee in adults,’ had triggered follow-up measures by the Ministry of Food and Drug Safety in Korea as well. Through the reduction, the drug will be reimbursed for the relief of symptoms of osteoarthritis of the knee in adults. The government issued an MFDS letter of safety explaining that the scope of reimbursement standards will be clarified and set according to the reduced indication. The MOHW announced that the revision and issuance for the drug will be implemented from the 23rd of this month.
- Policy
- Cholib was eventually withdrawn from the domestic market
- by Lee, Tak-Sun Jul 06, 2021 05:50am
- Abbott's Cholib, the first combination of Fenofibrate-Simvastatin released in Korea, will be withdrawn from the Korean market. This is because the Statin-Fenofibrate market was lagging behind domestic pharmaceutical companies and administrative disposition by the MFDS was underway. According to industries on the 2nd, South Korea's Abbott informed distributors that it will stop supplying Cholib after October. Cholib has already been suspended due to administrative action by the MFDS. On the 10th of last month, the MFDS issued a six-month suspension of sales (June 24-Dec 23) due to the lack of the number of subjects required for the re-examination (PMS). The disposal period has increased due to the second violation. If proper re-examination data is not submitted during the disposal period, Cholib's item permit will be revoked. But Abbott withdrew Cholib without maintaining it. In an official letter to the distributor, Abbott stops selling both Cholib 145/20 mg and Cholib145/40 mg, and earlier for Cholib145/40 mg. The reason why it is suspending sales of Cholib is because it is having difficulties in competition wit pharmaceutical companies in Korea. The No. 1 item in this market is Yoo Young's Pravafenix, which recorded ₩21.6 billion in outpatient prescriptions last year. Cholib recorded ₩1.3 billion in outpatient prescriptions. Competition intensified as eight products of the Pitavastatin Calcium Hydrate-Fenofibrate complex were sold. Unlike other competitors, Cholib has the advantage of being able to take it regardless of meals, but it did not work with domestic pharmaceutical companies. It seems that it chose to withdraw from the market as it continued to dispose of the MFDS. When Cholib is withdrawn, the Statin-Fenofibrate complex will have only nine items left. All items are manufactured domestically except Pravafenix, an imported drug.
- Policy
- Domestic companies attempt at hemophilia treatment market
- by Moon, sung-ho Jul 06, 2021 05:50am
- Domestic pharmaceutical companies have thrown their hats into the domestic hemophilia treatment market, forewarning a change in the prescription market. The attempts will mainly target the large major hospitals that treat hemophilia, but the possibility of any significant change in the treatment market is considered low in the field. According to industry sources on the 2nd, SK Plasma was found to have started domestic sales and marketing activities for Afstyla (lonoctocog alfa) in large major hospitals as the drug started receiving reimbursement benefits as a hemophilia A treatment. SK Plasma is a spin-off of SK Chemical that specializes in blood products. Afstyla is based on SK Chemical’s original candidate substance NBP601 and was developed into the finished product after a technology export to CSL Behring in 2009. Contrary to existing hemophilia treatments that are composed of two separate protein chains, Afstyla’s single-chain molecule structure joins combines two protein chains into one to extend circulation time and improve safety. SK Plasma is the second company to throw a hat into the market following JW Pharma’s introduction of Chugai Pharmaceutical’s Hemlibra (emicizumab-kxwh) that made its way into the market in May last year after receiving reimbursement approval. In particular, expectations and interest is rising for Afstyla as Hemlibra is having trouble making its place in the treatment market. Recently, insurance cutbacks that were made on prescriptions for pediatric hemophilia patients aged 12 or younger had been in much dispute. Also, whether the drug can survive the competition in the ₩230 billion market dominated by GC Pharma is a key area of interest. In addition to their own products ‘GreenMono’ and ‘Greengene F,’ GC Pharma has also been jointly marketing Takeda’s ‘Advate’ and ‘Advonate,’ which, as a whole, accounts for over 60% of the hemophilia treatment market. Also, the industry is keen on whether Afstyla may survive the competition of similar-class drugs that are already in the market, including Sanofi’s ‘Eloctate’ and Takeda’s ‘Adynovate.’ The insured drug price set by NHI for these drugs is 675 won per 1IU. On this, Chuhl Joo Lyu, professor of Pediatric Hematology and Oncology at the Yonsei University Severance Hospital, said, “Large hospitals are currently using Eloctate and Adynovate, which have similar MOAs with Afstyla. However, even these are not prescribed much at hospitals because the dose and administration set under Korea’s reimbursement standards differ from those set overseas.” Lyu continued, “Basically, the drugs are approved abroad in higher doses but are restricted in Korea. To increase the dose and administration level to meet the standards overseas, the insurance fee setting process must be conducted again at a lower price.” In fact, the approved dose for Eloctate as routine prophylaxis is 25~65 IU/kg based on the patient’s clinical response. Pediatric patients under 12 years of age may require more frequent doses or a dose increase to 80 IU/kg Under the Health Insurance Review and Assessment Service’s reimbursement standards, a single dose of administration is 20-25 IU/kg, and for moderate or higher forms of bleeding, up to 30 IU/kg is allowed at the doctor’s discretion. The basic approved dose for severe conditions is twice weekly, 8 times every 4 weeks. For on-demand treatment of bleeding after administration, two injections per hospital visit are approved. Therefore, with Afstyla’s price set at the same level, unless the reimbursement criteria are improved, the drug will not have competitivity in the prescription market. A member of the Korean Society of Pediatric Hematology-Oncology who wished to remain anonymous said, “Afstyla’s efficacy is equivalent rather than superior to other long-acting agents. That was why its insurance fee was set at the same level as Eloctate and Adynovate. The price should be adjusted for the drug to have competitivity.”
