- LOGIN
- MemberShip
- 2025-12-23 16:23:27
- 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.”
- Policy
- Suspension of Execution for Xarelto price cut continues
- by Kim, Jung-Ju Jul 05, 2021 05:54am
- Despite the two price cuts that were previously notified from the ex officio adjustment and expiry of the premium pricing application period, the price of the 4 strengths of Bayer Korea’s Xarelto tab. products will continue to be maintained as is for the time being. The company, which filed a suit against the government regarding the price cut, also requested for a suspension of execution of the price cut during the trial period, which the court accepted. On the 2nd, the 11th division of the Seoul High Court ordered the suspension of execution of Xarelto’s price cut until the 30th day from the date of the judgment made for the case the company filed against the Ministry of Health and Welfare to cancel the price cut disposition for Xarelto (No. 2021 Guhap 765811). The suit was filed after the Ministry of Health and Welfare included the 4 strengths of the Xarelto tab. products as items that will undergo price cuts as an ex officio adjustment and be up for termination of premium pricing in May. The government has been making ex officio adjustments to the original drug as well as the generic with the same route of administration, ingredient, and formulation when generics are listed. When the first generic is listed, the price of the original is adjusted to 53.55% of the original price but given a premium of 70% of the original price for 1 year. Previously, the government had issued a notice confirming the price cut of Bayer Korea’s Xarelto, effective as of June 1st. Prices of Xarelto tab. (rivaroxaban) 10mg, 20mg, 2.5mg were to be cut by 30% each, and then further lowered by 23.5%-23.6% one year later, from May 1st, 2022. With the court's decision to suspend execution, the drug price of the Xarelto tab. will remain the same for the time being, and no change will be made in medical institutions as well. However, if the government wins the case, the price cuts will again be in effect, which will once more be restored to the original price if the company appeals the case. Therefore, the possibility of price fluctuation remains. According to the government, the MOHW has never lost drug price-related lawsuits like Xareolto's. Due to this, price fluctuation of drugs during the back-and-forths has been trending in similar suits. The MOHW announced that the price maintenance will be applied as of the 2nd and that the ministry will share additional information if any further changes are made.
- Policy
- The price of 7 Seretide products will be reduced
- by Kim, Jung-Ju Jul 05, 2021 05:53am
- The government won the suit. But there is a possibility of change depending on the company's decision. Insurance prices for 7 items of asthma treatment Seretide by GSK will be lowered from the 2nd of next month. The government won the lawsuit against the company to cancel the reduction of the price. If the company disagrees with the ruling, there may be another change in drug prices. The sixth part of the Seoul Administrative Court sided with the MOHW in a lawsuit filed by the company. Therefore, suspension of execution, which had maintained the previous price without lowering the drug price during the lawsuit period, was lifted. The lawsuit was taken by the Ministry of Health and Welfare on June 1, 2019, in line with the end of the additional period of these products, on May 28, 2019. The company filed a suspension with the court and applied for a suspension of execution to keep the drug price intact during the lawsuit period, but it was lifted with the ruling. These drugs include Seretide 125 Evohaler(120 doses), Seretide 100 Diskus(60 doses), Seretide 250 Diskus(60 doses), Seretide Evohaler 250(120 doses), Seretide 250 Diskus(28 doses), Seretide 500 Diskus, Seretide 50 Evohaler(120 doses) . The MOHW said it would apply the reduction as of July 2 in accordance with suspension of execution. However, there is a possibility of change if the company disagrees. In response, the MOHW has decided to provide additional guidance if there is any change in the future.
- Policy
- The reasons why Hemlibra's benefit was not recognized?
- by Lee, Hye-Kyung Jul 03, 2021 05:56am
- The HIRA's Central Review and Coordination Committee revealed specific reasons for not recognising benefit of JW Pharma's Hemlibra (Emicizumab). The HIRA released a June review of the Review and Assessment Committee on its portal on Thursday. There are five cases of deliberation, including Hemlibra, Soliris, ventricular assistive therapy, Spinraza, and hematopoietic stem cell transplantation. In the case of Hemlibra, the HIRA unusually disclosed the results on the 8th due to controversy over the standards. Based on the data submitted by the medical institution, the central group said that cases A, B, and C lacked objective data to prove that it was difficult to secure venous blood vessels and to insert and maintain central vein tubes. ▲For pediatric administration, patients with failed Immune Tolerance Induction,▲ If there is a doctor's statement that it meets the requirements subject to Immune Tolerance Induction but is not possible to carry out it,▲ If antibodies are regenerated after the success of Immune Tolerance Induction, the patient must pay the full copayment of Hemlibra. According to the case of disapproval, which was specifically disclosed to the medical institution's business portal, A case was diagnosed with hereditary 8th factor deficiency syndrome in June 2019 and antibodies were found in December 2019 and started administering Hemlibra through clinical trials in March 2020. In February this year, the patient met the criteria for Immune Tolerance Induction benefits, but claimed Hemlibra because it was very difficult to secure venous blood vessels and difficult to insert and maintain central venous tubes as antibodies to factor VIII. However, the HIRA did not acknowledge the benefit, saying that "submitted medical records show insufficient objective data to determine that Hemlibra administration in February 2021 is difficult to secure venous blood vessels and to insert and maintain central venous ducts." Case B is a male (22 months), diagnosed with factor VIII disease in August 2019 and antibody was found in June 2020. The patient also applied for Hemlibra benefits because of the very difficulty in securing venous blood vessels, difficulty in inserting and maintaining central venous tubes due to antibodies to factor VIII, and psychological problems such as fear of intravenous injections, but was not recognized for the same reason as case A. There was also a lack of medical explanation for "stress from a vein injection". Case C was a 4-year-old boy, diagnosed with factor VIII disease in June 2016 and discovered antibodies in July 2016, but had a history of treatment in intensive care due to subgaleal hemorrhage and epidural hemorrhage at birth. The HIRA judged that "the past history of severe bleeding is not the case when immunotherapy cannot be attempted." Case D is a 3-year-old (40 months)-old male diagnosed with factor VIII disease in September 2017 and antibody was discovered in November 2017. In November 2018, chemoport was approved, but three days later, intestinal bleeding failed, and Hemlibra was charged for failing to be administered due to severe intestinal bleeding in February 2021. However, the HIRA ruled that "Immune Tolerance Induction could not be performed due to intestinal bleeding in November 2018, but medical records confirm the application for IImmune Tolerance Inductionagain in January 2019." Meanwhile, the MOHW announced that it would review the benefit standard in consultation with the HIRA as problems with the Hemlibra standard were pointed out at a plenary session of the National Assembly on the 16th.
