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- 2026-05-18 18:57:17
- Product
- Consult with MD about controversy over Champix?
- by Jul 07, 2021 05:53am
- Concerns over the detection of carcinogens in the anti-smoking supplementary drug Champix (Varenicline), pharmacies are also making a series of inquiries. However, there are no clear guidelines for existing patients, adding to the confusion. As part of preemptive measures related to the impurity crisis, the domestic supply has been completely suspended and the investigation is underway at the global headquarters level, but no guidelines have been prepared for refunds or suspension. Therefore, pharmacists explain that it is difficult to respond to questions about whether pharmacies continue to take them. Pharmacist A said, "There have been more than a few recent inquiries from existing users asking if they can continue taking the medicine after hearing media reports." "There is a risk of cancer, so we are asking the pharmacy whether the dose continues or not," he said. Pharmacist B also had patients taking Champix asking the same question through the pharmacy, and he was confused when he asked Pfizer whether to take it continuously. The pharmacist asked the patient how to guide him in terms of safety, and the pharmaceutical company replied, "We can't give you advice that you can't take it steadily, so I have to discuss it with the doctor in charge." "It is sensitive to give accurate and clear answers because it is currently under investigation. As there are people who have already been prescribed and taken, we expect many inquiries from pharmacies." The pharmacist said, "It is absurd why they ask us to consult a doctor about impurities," and added, "There should be guidance from pharmaceutical companies on how to respond." The pharmacist actually asked the lawmaker, but the doctors also did not give a clear answer. He stressed the need to prepare guidelines for refunds and inquiries. The MFDS has launched an investigation into the impurities of the Sartan hypertension drug and the anti-smoking drug Varenicline. Regarding the guidelines, Pfizer explained, "We are currently investigating the possibility of Nitrosamine impurities, so we are guiding you to consult with a doctor about whether to take them. It is said that it is difficult for pharmaceutical companies to express their position on the suspension or recommendation of medication because they have not received additional recommendations from regulators other than the suspension of supply. The official predicted that follow-up guidelines will be prepared based on the results of the inspection. "The risk of exposure to Nitrosamine from taking Varenicline is very low," a Pfizer headquarters spokesman said. "The benefits of taking drugs are better than the risks," he 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."
- Company
- The NPS bought shares in Samsung BioLogics & SK Bio
- by Kim, Jin-Gu Jul 06, 2021 05:51am
- The National Pension Service (NPS), the nation's largest institutional investor, significantly reduced its investment in the local stock market in the first half of last year. Investment in pharmaceutical bio stocks has rather increased. Investments in Samsung BioLogics, SK Bioscience, and SK Biopharm were significant. It sold more than ₩300 billion in shares of Celltrion. According to the KRX on the 5th, The NPS bought Samsung BioLogics shares worth ₩586.4 billion in the first half of this year. Not only pharmaceutical bio shares but also all stocks ranked first in net buying. The NPS' stake in Samsung BioLogics rose 0.12%p to 5.10% at the end of June from 4.98% at the end of last year. As of the end of June, Samsung BioLogics' stock valuation held by the NPS is close to ₩3 trillion as of the closing price of the 5th. In addition to Samsung BioLogics, four out of the top 10 net purchases of the NPS were pharmaceutical bio shares. SK Bioscience (3rd), SK Biopharm (6th), and Celltrion Healthcare (9th) ranked high. Net purchases of The NPS amounted to ₩259.1 billion from SK Bioscience, ₩157.6 billion from SK Biopharmaceutics, and ₩116.4 billion from Celltrion Healthcare. In addition, it sold ₩69.3 billion in GC LabCell shares, ₩49.5 billion in Hanmi Science, ₩45.2 billion in Daewoong Pharmaceutical, ₩41.6 billion in LegoChem Bioscience, ₩36 billion in Hugel, ₩35.5 billion in Medy Tox, ₩35.3 billion in ST PharmaReaserch, ₩26.2 billion in Celltrion, PharmaReaserch ₩17.5 billion in Pharmicell, ₩15.6 billion in Dong-A Socio Holdings, ₩15.2 billion in Alteogen, ₩13.4 billion in Daewoong, ₩12.5 billion in Macrogen, and ₩12 billion in Huons Global. The NPS' share of these companies has also increased. GC LabCell increased 1.12%p (4.99%→6.11%), Dewoong increased 1.05%p (5.09%→6.14%), and Hanmi increased 2.02%p (6.84%→8.86%). The NPS is said to have continued its all-time selling spree in the domestic stock market in the first half of this year. Net sales in first half of this year alone amount to ₩24.598 trillion. According to the fund management guidelines, the government decided to lower the portion of investment in domestic stocks to 16.8% by the end of this year, leading to large-scale net selling. As of the end of last year, it had a share of 21.2%. However, investment in pharmaceutical bio shares has increased even among large net sales. The cumulative net purchase amount of pharmaceutical bio shares by June is estimated at ₩836.7 billion. The NPS sold Celltrion shares the most. It bought ₩1.1447 trillion for six months and sold ₩1.507 trillion, reaching ₩362.3 billion in accumulated net sales. The NPS sold ₩182.8 billion in shares of SK Chemical, ₩85.5 billion in GC Pharma shares, ₩46 billion in Bukwang shares, ₩28.9 billion in JW-Lifescience shares, ₩28.4 billion in Chong Kun-dang shares, ₩24.5 billion in G-TreeBNT shares, ₩18.8 billion in Seegene shares and ₩15 billion in Shin Poong. Celltrion shares in the NPS fell 0.88%p to 7.48% at the end of June, compared with 8.36% at the end of last year. SK Chemical's shares fell 3.99%p from 10.13% at the end of last year to 6.14% at the end of June. In addition, shares of GC Pharma fell 0.04%p (9.12%→9.08%) and shares of Bukwang fell 1.12%p (8.18%→7.06%) respectively.
- 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.”
- Company
- Hemlibra & Afstyla were released
- by Kim, Jin-Gu Jul 06, 2021 05:50am
- Domestic pharmaceutical companies have challenged the hemophilia treatment market one after another. JW Pharma released Hemlibra and SK Plasma released Afstyla in the last year. The domestic hemophilia treatment market is maintained by GC Pharma and Takeda. While Bayer, Sanofi, and Pfizer, which have challenged the market in the past, are struggling, attention is focusing on whether domestic pharmaceutical companies will produce meaningful results. ◆GC Pharma is virtually monopolizing the domestic market with a size of ₩230 billion According to the pharmaceutical industry on the 30th, SK Plasma started selling Afstyla to major general hospitals in South Korea after entering its benefit early this month. SK Plasma is a company that specializes in blood products that were separated from SK Chemical in 2015. In 2009, SK Plasma exported the drug, which was a candidate material at the time, to Australian pharmaceutical company CSL Behring. The development was completed by CSL Behring. SK Plasma CEO Kim Yun-ho (left) and CSL Behring Korea CEO Son Ji-young are signing a sales contract for Afstyla Prior to SK Plasma, JW Pharma has entered this market. JW Pharma was approved by Japan's Chugai Pharmaceutical in January 2019. It released its products in earnest in May last year. The two companies should target the hemophilia treatment market, which is dominated by the GC Pharma. The domestic hemophilia drug market is effectively monopolized by GC Pharma. GC Pharma co-sells its own items, GreenMono and Greenene F, as well as Takeda's Advate and Adynovate. They are all top sales products. Pharmaceutical industries estimate size of South Korea's hemophilia treatment market is about ₩230 billion. Among them, four products sold by GC Pharma are estimated to generate sales of ₩140 billion to ₩150 billion. ◆ Hemophilia medicine must be passed by the committe of the Korea Hemophilia Foundation Pfizer, Sanofi, Bayer and others challenged this market before JW Pharma and SK Plasma. Except for Pfizer, however, their performance does not meet expectations. This is because the proportion of prescriptions through the Korea Hemophilia Foundation is large. The Korea Hemophilia Foundation, which consists of patients with hemophilia, operates a separate drug review committee. This Committee shall deliberate on medicines that may be prescribed by members of the Foundation. It is necessary to pass this committee to prescribe. The drugs currently being prescribed by an associate doctor are Adynovate and Adynovate in Takeda, GreenMono in GC Pharma, Greengene F and Xyntha Solofuse in Pfizer. Bayer's Kogenate FS and Sanofi's Eloctate failed. Kogenate FS and Eloctate are prescribed only in general hospitals, which account for 40% of the total market. Bayer and Sanofi are not making as much sales as expected. Pfizer's Xyntha Solofuse took nearly five years to be reviewed after its release in 2014. "The domestic market for hemophilia is called the tomb of a new drug," said PM, a global pharmaceutical company. "That's how hard it is to overcome the wall of the Korea Hemophilia Foundation." ◆JW Pharma and SK are targeting general hospitals first In the case of Hemlibra and Afstyla, sales can be stable only after passing the Korea Hemophilia Foundation's deliberation committee in the long term. The two companies are not planning to directly target the Korea Hemophilia Foundation. JW Pharma emphasizes the advantages of SC (subcutaneous) injection for general hospitals and it emphasizes that administration is possible regardless of whether antibodies are produced or not. Patients also have high expectations for this. Hemlibra is the first SC formulation. Existing patients had to find their own veins and inject themselves. Moreover, many of the patients were children, making them uncomfortable. JW Pharma said it is convenient to inject under the skin, not by finding and injecting blood vessels on its own. Hemlibra has limited benefit standards. The National Assembly pointed out, and the MOHW said it would reconsider expanding the benefit range. SK Plasma is planning to focus on targeting general hospitals. SK Plasma is said to have started marketing activities at major general hospitals at the time of the release of Afstyla. "We have no specific plans right now, such as sponsorship for the Korea Hemophilia Foundation," an official at SK Plasma said. "We plan to focus on expanding our influence in general hospitals."
- Product
- AZ-Pfizer vaccine mix is "confirmed safe and effective"
- by Jul 05, 2021 05:54am
- With community pharmacists who have received their first vaccination of AstraZeneca’s COVID-19 vaccine awaiting their second jab with the Pfizer vaccine this month, the health authorities announced that there are no safety concerns regarding the ‘mix-and-match' of the vaccines. The authorities explained that though mild side effects were observed, no severe adverse events were reported after receiving the vaccine mix, therefore, there are no safety issues pertaining to mixing doses of the two vaccines. Guidelines with the said information was issued by the COVID-19 Vaccination Promotion Team in response to the safety concerns raised by some ahead of the ‘temporary mixed-dose inoculation’ that will be provided to the 76,000 people who are working in vulnerable facilities, flight attendants, healthcare workers, and essential workers that already received their 1st dose with the AstraZeneca vaccine from April to May. The move for this mix and match schedule passed deliberation of the Korea Advisory Committee on Immunization Practice (KAICP) with a review on the efficacy and safety of the mixed-dose vaccination to address the delay of the 835,000 vaccine doses that were initially scheduled to arrive by the end of June through the COVAX facility. In other words, the mixed two-dose schedule that uses the Pfizer vaccine as a second dose is a temporary measure decided upon in consideration of the current supply shortage. Community pharmacists under the age of 50 (born after January 1st, 1972) who already received their first vaccinations will have to receive their second shot with the Pfizer vaccine due to age restrictions that were set on using the AstraZeneca vaccine. However, pharmacists who are 50 years or older (born before December 31st, 1971) may receive the AstraZeneca vaccine if they desire. Reservations for the second dose are automatically made to the same institution at which the individual received their first dose, on the 7th day of the 11th week after his/her first vaccination. Individuals may change their vaccination date in the 11th-12th week period after their first vaccination. They may postpone the date by 1 week at most from the originally scheduled date, and it may not be pulled forwarded to an earlier date. “Other countries such as Germany, France, Canada, Norway, Sweden have been recommending mixing use of mRNA vaccines to those who were first vaccinated with the AstraZeneca vaccine. Also, the safety and efficacy of using the Pfizer vaccine as a second dose was confirmed in people who were first vaccinated with the AstraZeneca vaccine in Canada and Spain,” said the COVID-19 Vaccination Promotion Team. Studies from Spain and Germany have shown that vaccinating with the AstraZeneca-Pfizer mix showed a better immune effect with increased neutralizing activity against the COVID-19 variants than one or two shots of the AstraZeneca vaccine. The team added that a study on this mixed-dose vaccination is also currently underway in Korea and that the initial results will be shared in early July. Regarding the adverse events of the dose-mixing, the team added, “Dose-mixing studies abroad have shown that fever increased when the AstraZeneca vaccine was administered first and followed by Pfizer compared to when a same vaccine was administered both times. The results were also the same for the occurrence of mild adverse events such as fatigue, injection site pain, headaches, and muscle pain, but no serious abnormalities were confirmed." The inoculation schedule for the administration of the mixed second dose will follow the period set during the first vaccination. The mix currently planned is the 1st AstraZeneca-2nd Pfizer vaccine mix, and will be administered with an 11-12 week dosing interval according to the AstraZeneca vaccine’s dosing interval. People who must postpone receiving their second shot while following the AstraZeneca-AstraZeneca vaccine schedule are recommended to receive their shots within 16 weeks, which means the second dose should be administered from July 26th to July 31st. In cases where ‘an individual does not receive their second dose due to fear of mixing vaccines,’ the team said, “The second vaccination, as in the first vaccination, will be administered based on each individuals’ consent, so we cannot force an individual to vaccinate with a different vaccine if he/she is not comfortable receiving the AstraZeneca-Pfizer mix. Those who wish to receive the AstraZeneca vaccine rather than Pfizer’s may be able to receive their shots after August 1st, depending on the supply situation.”
- Opinion
- [Reporter’s view] Request for suspension of execution
- by Kim, Jin-Gu Jul 05, 2021 05:54am
- The MOHW has announced that it will improve the system so that drug costs paid during the suspension of the enforcement of the drug reduction can be recovered. The plan calls for improvements to numerous revocation litigation and request for suspension of execution. request for suspension of execution in drug prices includes a lawsuit filed by pharmaceutical companies to cancel the reduction after the MOHW announced a reduction in the upper limit of insurance benefits. Pharmaceutical companies request for suspension of execution in the reduction of the drug price until the results of the lawsuit are released. The court accepts the request for suspension of execution. It follows the outcome of Lawsuit on the Merits. Each time the request for suspension of execution is repeated. The court accepts as well. This process takes up to five years. The court cites most of the request for suspension of execution because the outcome of lawsuit on the merits is unclear. So far, the only case in which the application for suspension of execution has been rejected is the case of a reduction in eyedrops. For pharmaceutical companies, the suspension of investment citation is as important as drug price reduction. The drug price maintained during the proceedings is much higher than the cost of the lawsuit. If pharmaceutical products with annual performance of ₩50 billion are subject to a reduction due to the launch of generics, they can keep more than ₩70 billion for five years during the lawsuit. Even if a pharmaceutical company loses at lawsuit on the merits, it already benefits enough. The pharmaceutical industry opposes the government's announcement of system improvement. It is argued that it is unconstitutional for the administration to effectively restrict the rights guaranteed by the judicial system. It is argued that the MOHW should not arbitrarily judge whether pharmaceutical companies abuse the disposition of the reduction of drugs. In April, the Supreme Court sided with the original company in patent suit of Eliquis. Generics were released based on the verdict of the first trial, and the reduction of drug price was taken accordingly. The MOHW is aware of this situation. "We are considering compensation for damages and recovery at the same time. "If it is not systemized, we will consider more ways to respond to the lawsuit results." The pharmaceutical industry should look at why the MOHW is worried. The MOHW believes that there are too many applications for suspension of execution. It is judged that pharmaceutical companies are abusing their rights guaranteed by the judicial system. The pharmaceutical and distribution industries believe that there is a lot of confusion in this process. The MOHW stresses, "So far, the government has never lost in a drug-price lawsuit." The pharmaceutical industry should think about why the MOHW is even reforming the system by limiting its jurisdiction.
- 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.
