- LOGIN
- MemberShip
- 2026-04-12 05:55:21
- Policy
- Alecensa's price cut 4.5%, Remodulin 4% due to excess sales
- by Kim, Jung-Ju Jun 22, 2022 05:59am
- Roche Korea’s non-small cell lung cancer treatment Alecensa 150mg Cap. (alectinib hydrochloride) became subject to negotiations under the Price-Volume Agreement (PVA) and will be supplied at a 4.5% discounted price starting next month. Price of Remodulin Inj. (treprostinil) that is used to treat patients with pulmonary arterial hypertension will also be discounted 4% for each strength. Also, premium pricing on Daewon Pharmaceutical’s Pelubi S Tab. (pelubiprofen tromethamine) will expire on August 1st, after which its price will fall 23.2%. According to industry sources on the 20th, the Ministry of Health and Welfare planned an ‘Amendment to the drug reimbursement list and reimbursement ceiling price table’ that contains the changes mentioned above for application on July 1st. ◆PVA negotiation results= The government and the National Health Insurance Service conduct PVA negotiations with pharmaceutical companies after classifying drugs with increased claims by each type, then discount each drug’s price according to the negotiation results. As a result, six items will receive price cuts after completing negotiations. Price of Roche Korea’s Alecensa 150mg Cap. (alectinib hydrochloride) has been cut by 4.5%, and the price of each strength of Antereogen’s Remodulin Injection was cut by 4%. Lilly Korea’s diabetes treatment supplement Trulicity 0.75mg/0.5ml (dulaglutide) disposable pen will be supplied at a 3% reduced price. ◆Preimimum pricing expiry and ex-officio adjustments = The premium pricing provided for Daewon Pharmaceutical’s Pelubi S Tab will expire as of August 1st, and its price will be reduced by 23.3%. The government applies premium pricing for first generics for 1 year since its date of listing. After the period expires, the drug’s price is automatically discounted to 53.55% of the original drug's price under the drug price reduction system. As a result, a total of two items received price cuts through ex-officio adjustments. The government makes ex-officio adjustments to the price ceiling of the first listed drug and the other product with the same administration route, ingredient, and formulation when the second product becomes listed. The drugs subject to price cuts under the system are two strengths of GE Healthcare AS’s Visipaque 270mg Injection (Iodixanol). The price of the 50mL strength is reduced by 2.6%, and the 100mL strength reduced by 0.1%. The price cuts will be applied as of July 1st. ◆Drugs designated for preservation of production cost prevention and price ceiling adjustments under the drug shortage prevention program = One drug received ‘mandatory designation’ and was designated for the preservation of production cost. The drug is Yuyu Pharm’s Allopurinol tablet, and its price ceiling will be set at ₩70 for supply. Two items have received ex-officio adjustments after being designated for the preservation of production cost. The drugs, Samil Pharmaceutical’s Zyloric (allopurinol)’s price ceiling was increased from ₩70 to ₩72, and Access Pharma’s Tuberculin PPD AJV from ₩23,760 to ₩26,554. Also, two other drugs received an increase in their price ceiling to preserve production costs. The price ceiling of Ildong Pharmaceutical’s Ativan 4mg/1mL Injection (lorazepam) will be increased from ₩612 to ₩804, and the 2mg/0.5mL strength will be increased from ₩574 to ₩782. The new drug price will be applied as of the 1st of next month.
- Company
- K-botulinum products are expanding globally
- by Jun 22, 2022 05:59am
- Hugel Botulex (Letybo) Domestic botulinum toxin is entering various parts of the world. Feeling limited in the domestic market, developers are targeting the U.S., Europe, and China, which are the largest markets in the world, while expanding their scope to countries such as Australia and the Middle East. ◆ Hugel is targeting Europe and North America, and China is expanding its market According to the pharmaceutical industry on the 20th, Hugel won the license for the botulinum toxin drug Letybo developed in Canada on the 16th. It is Hugel's first North American entry. According to Hugel, the Canadian botulinum toxin market is estimated to be worth 180 billion won as of last year. Starting with Southeast Asia, Hugel has attempted to enter Botulinum overseas in earnestly. It is understood that the license registration has been completed in about 40 countries so far. Last year, it applied for permission for Botulinum in the U.S. and Canada to target North America. In particular, the United States is one of the largest botulinum toxin markets worth about 2 trillion won. The U.S. approval, which was originally expected to be approved at the end of March, is expected to take place at the end of this year or early next year. Starting in February, news of Letybo continued in Europe, starting with France. In January, HMA issued a permit recommendation for botulinum. The HMA receives individual decisions in each country after the recommendation for approval, so the date of approval varies. Letybo has obtained product permits from 10 countries, including key European countries such as France, the United Kingdom, Germany, and Italy. ◆Daewoong Nabota Launches Third Quarter in Europe. U.S. Sales Close to 300 Billion Daewoong Pharmaceutical's botulinum toxin drug Nabota is doing good performance in the North American market, which was the first to enter. Nabota posted nearly $100 million in sales last year, up 77.3% from the previous year. This is the result of the North American sales of Daewoong Pharmaceutical's U.S. partner Evolus. Nabota's cumulative sales, which were approved by the U.S. in February 2019, amounted to $223.04 million. In the first quarter of this year, Nabota has continued its upward trend, recording $33.23 million (42.5 billion won), up 171.5% from the previous year. Nabota In the third quarter, Nabota is also set to enter Europe, the second largest market in the world. Evolus, a U.S. partner, will be in charge of sales. Previously, Evolus obtained an item license from the European Commission (EC) in October 2019 under the name Nuceiva. Nuceiva can be sold in 28 countries in the European Union and a total of 31 European countries, including the UK and Switzerland. Daewoong Pharmaceutical recently expanded its scope to Eastern Europe and the Middle East. It has obtained Nabota permission from Saudi Arabia, one of the largest markets in the Middle East, and Ukraine, the representative country of Eastern Europe. Its goal is to expand its market share in the Middle East and Eastern Europe starting with Saudi Arabia and Ukraine. In December last year, Daewoong Pharmaceutical filed an application for permission for Nabota with the NMPA. While Hugel and Daewoong Pharmaceutical are expanding their market to one item developed by themselves, Medy Tox is trying to diversify its products. It was the first in Korea to commercialize botulinum toxin preparations and enter the development of next-generation toxin preparations early. Meditoxin is exported to more than 30 countries around the world under the name Neuronox. However, exports have been decreasing every year since 2019. Overseas exports of Medy Tox, which were 133.3 billion won (including filler products) in 2018, decreased to 120.6 billion won in 2019 and 89.8 billion won in 2020. It recorded 70.6 billion won last year. Neuronox Newlux, which applied for item permission from the MFDS in May, is a new product that Medy Tox applied the latest process to reduce the possibility of contamination by impurities. Medy Tox is also speeding up its overseas licensing work for Newlux exports.
- Policy
- The benefit discussion for Steglatro was excluded
- by Lee, Tak-Sun Jun 22, 2022 05:58am
- While the HIRA is discussing the standard for combination therapy benefits for SGLT-2-suppressing diabetes treatments, only Steglatro (MSD Korea) has been excluded from the combination of TZD affiliates, drawing attention. While the combination of DPP-4 inhibitors between families is recognized, the combination between TZD families is differentiated by component. Kim Ae-ryeon, head of the HIRA Pharmaceutical Management Office, said at a briefing with the Korea Special Press Association on the 14th that she is conducting a financial impact analysis after reviewing the benefit criteria for Metformin + SGLT-2 inhibitor + DPP-4 inhibitor and Metformin + SGLT-2 inhibitor. The HIRA plans to review the pharmaceutical company's financial impact analysis, academic societies, and expert opinions, and then review the Drug Reimbursment Evaluation Committee within the processing deadline to complete the standard change and drug price evaluation. As a result, standards are expected to be prepared at least within this year. However, MSD's Ertugliflozin was excluded from the discussion in the combination of Metformin+SGLT-2+TZD among the three-drug therapy. It is different from the fact that Metformin+SGLT-2+DPP-43 drugs recognized combination between series regardless of ingredients. An official from the HIRA explained, "It reflected the approval of the MFDS." The efficacy set by the MFDS for SGLT-2 drugs only broadly define monotherapy and combination therapy for adult type 2 diabetes patients, but did not present specific ingredients. This is a simplification of the MFDS' permission to prepare a combined benefit standard for diabetes treatments. However, unlike other SGLT-2 inhibitors, only Steglatro does not have the results of combined clinical trials with the TZD family in the information for experts in the permit. However, clinical trial information with DPP4 inhibition such as Sitagliptin is provided. In the end, drugs that have not been verified for combined effect through clinical trials are believed to have been excluded from the discussion on standards. Metformin+SGLT2+DPP43 drug therapy seems to be possible because all of the SGLT-2 drugs (Forxiga, Jardiance, Suglat, and Steglatro) on the market in Korea have proven their efficacy through DPP-4 combined clinical trials. Steglatro has the lowest domestic market share compared to other SGLT-2 drugs. Another weakness is that it is excluded from the three-drug treatment benefit standard between TZD in the situation of chasing competitors.
- Policy
- Report of severe skin SE such as rash of Phenytoin
- by Lee, Hye-Kyung Jun 21, 2022 05:55am
- Precautions for severe skin abnormalities will be newly established in the anticonvulsant Phenytoin. The Drug Safety Evaluation Division of the MFDS has prepared a change (proposal) in domestic drug permits based on the results of the EMA's review of drug safety information. The changes will be checked by the pharmaceutical industry and others until the 29th under the terms of "careful administration", "general caution", "Adverse reaction" and "interaction" of the precautions for use. As a result of the EMA safety information review, severe skin adverse reactions such as deprivation dermatitis, dermal mucosal eye syndrome (Stephens-Johnson syndrome), and toxic epidermal necrosis (Lyell's syndrome) may occur in phenytoin preparations. Severe skin reactions occur without warning, but patients should be warned about signs or symptoms of hypersensitivity (skin rash, blisters, fever, itching, or other symptoms), and a cautionary phrase is added that medical advice should be sought immediately if significant symptoms or symptoms occur. If a rash appears, the doctor should advise the patient to stop treatment, and if the rash is mild, the treatment can continue after the rash has completely disappeared. If the rash occurs again after re-dosing, additional Phenytoin should not be administered. In addition, holders of impaired CYP2C9*2 or CYP2C9*3 mutants (middle or slow metabolites of the CYP2C9 substrate) may have increased Phenytoin plasma concentration and the resulting toxicity risk. Domestic licensed Phenytoin PO formulations include Bukwang's Phenytoin Cap100mg, Whanin's Hydantoin Tab, Myungin's Penytoin 100mg, Samjin's Penytoin Sodium Injection100mg & 200mg, Hanlim's Peniton, Jeil's Phenytoin Sod 50mg/ml, and Union Korea's Union Phenytoin Sodium.
- InterView
- “Roche reborn through customer-centric reorganization”
- by Eo, Yun-Ho Jun 21, 2022 05:54am
- Nic Horridge, General Manager of Roche Korea Multinational pharmaceutical companies are known to endlessly pursue change. In addition to active acquisitions, mergers, and spin-offs, the companies boldly reduce and expand their many originations in line with the new drug development trend, and show no hesitation in consolidating or reorganizing departments. Their endless evolution for efficiency and survival continues on even now. The same goes for Roche. Roche, which used to hold a strong image as a company specializing in anticancer drugs, have continued to maintain its strength in that area while expanding its interest to other diseases. The company released ‘Xofluza,’ a follow-up of its antiviral ‘Tamiflu,’ and is also spurring up the development of its new Alzheimer's treatment in CNS. The company had also undergone great change in the organization as well. The company had promoted ‘"agile transformation" at the global level to improve flexibility and responsibility as an organization. Unlike conventional organizations where employees are assigned specific products, at Roche, employees are assigned to each disease-specific indication. Roche Korea also joined in this transformative journey in 2018. In the process, quite a few issues in personnel adjustments and departures arose. General Manager Nic Horridge, who has been running Roche Korea for 4 years since being appointed GM in October 2018, has led this transformation in Roche Korea. Dailypharm met with Nic Horridge to hear about the transformations made and those to come for Roche Korea in the future. -Two years have passed since the company decided to undergo an agile transformation. What are the advantages of agile transformation? Agile transformation is an innovation that is being pursued at the global level to transform our organizational culture. In line with the rapidly changing healthcare technology, medical environment, and the exponential increase in information, Roche’s portfolio has continuously evolved and entered new treatment areas. The company had determined it would be difficult for Roche to achieve its goal of bringing the best results faster to our patients with the existing ways of business and operation model and decided to pursue agile transformation. We now have teams organized according to the treatment area or patient group to identify the practical needs necessary for each patient’s treatment journey and make optimal decisions. In the past, we had unmet needs in rapidly identifying how diagnoses and treatments were being made in areas unfamiliar to Roche, such as Alzheimer’s and Ophthalmology, but this organizational evolution now allows each team to rapidly identify, understand and strategize what’s needed. -The transformation process would not have been easy. How did the employees and executives at Roche Korea receive the change? We have now passed the adaptation period, and our efforts are now coming to fruition. The autonomous decision-making system was one thing that many employees and executives had first found difficult, as each employee, as his/her own leader, was required to contemplate and find an answer on 'what role he/she should play to bring value to the domestic medical ecosystem?’ Some employees have decided to part ways with the company in the process. I consider this positive as these former Roche employees continue to contribute to the development of the healthcare industry in their respective positions. At the time, we had candid discussions with the employees who believed the new business model was not right for them, and some had decided to seek new opportunities. In the process, younger employees were given the opportunity to take on a leadership role in the company, and this gave rise to fresh and new perspectives that could help achieve Roche's vision. The ideas were successfully incorporated into the organization. --Roche is developing ‘gantenerumab’ as a treatment for Alzheimer’s disease. Many other companies that have jumped into the scene are struggling, such as in the case of Aduhelm. What is your opinion on this? Roche’s gantenerumab is an anti-amyloid-beta monoclonal antibody that reduces brain amyloid plaques, which are known to induce brain cell death, to improve symptoms of Alzheimer’s disease. Its Phase III trial results are expected to come up in the second half of the year, and we are confident that we would be able to see good results. Also, in treating Alzheimer’s, Roche believes early detection of the disease is as important as new drug development. If a patient is prescribed treatment after his or her symptoms have progressed to a certain extent, the brain damage that has already occurred will most likely not be regenerated. Assuming that gantenerumab's clinical findings are successful, we believe that Roche’s approach of early detection and treatment will provide patients with an invaluable solution. -You served 4 years as the head of Roche Korea. What is your impression of the Korean healthcare ecosystem? I am pleased to have been awarded this opportunity to promote various changes in Roche Korea for the past 4 years. Due to the unprecedented crisis brought on by the pandemic, we have undergone many changes in our daily life and work, but I believe the Korean government showed excellent leadership in the containing COVID-19, and that Korea has received less damage than neighboring countries. This was very impressive. Statistics show that Korea’s accessibility to new drugs is 35%, which is significantly lower than other countries such as the US (87%), the UK (59%), and Japan (51%). Also, it takes an average of 601 days to reimburse listing, and new drugs account for only around 20% of the pharmaceutical expenditures spent in NHI finances. This is far below average in other OECD countries. I believe there would be a way to increase access to innovative drugs without significantly increasing the overall drug expenditure without affecting national finances. Roche will do its best to support the government in fulfilling its pledge on relevant tasks.
- Company
- Takeda Korea appoints Sun Jin Lee as head of Oncology BU
- by Jun 21, 2022 05:54am
- Sun Jin (Justine) Lee, New Head of Oncology BU, Takeda Pharmaceuticals Korea Takeda Pharmaceuticals Korea (General Manager HeeSeok Moon) announced on the 20th that it had promoted and appointed Manager Sun Jin (Justine) Lee as the Head of its Oncology BU. The new head, Lee, who joined Takeda Pharmaceuticals Korea as a marketing manager of the Hemophilia BU, developed creative marketing strategies and drew participation from internal and external stakeholders for its implementation. Lee played a pivotal role in improving the access and awareness of Takeda Korea's hemophilia business and demonstrated her leadership capabilities. In recognition of her leadership, Lee had led the product launch in the market as a Launch & Digital Excellence Lead in the Asia Pacific (APAC) region, and also successfully carried out projects such as presenting the vision and direction for the digital transformation of Takeda in the APAC region. it was recognized for its leadership capabilities, such as playing a pivotal role in improving the access and awareness of Takeda Korea's hemophilia business. Since then, he has led the product launch in the market as a Launch & Digital Excellence Lead in the Asia Pacific (APAC), and at the same time ha Junghun Kim, the former head of the Oncology BU, has been appointed Country Manager of Malaysia & Singapore in May through the 'FLP(Future Leaders Program)' that provides global networking opportunities for employees within Takeda Pharmaceutical. Kim joined Takeda Pharmaceuticals Korea as a marketing manager in 2015 and established the Inflammatory bowel disease and blood cancer BU. After being appointed head of the Oncology BU in 2019, Lee launched various innovative oncology products in Korea and exceeded the target for three consecutive years, and has been leading the company’s digital transformation in Korea. Under the value ‘Exceptional People Experience,’ Takeda Pharmaceuticals is committed to providing various experiences and opportunities for its employees to develop their capabilities. It also offers special programs for select key talents. The ‘FLP (Future Leaders Program)’, which provides global networking opportunities in Takeda, is one such program, and the recent personnel appointments were also made through the FLP. HeeSeok Moon, General Manager of Takeda Pharmaceuticals Korea, said, “The promotion has more meaning as it was achieved by Takeda’s professional development program. Takeda Pharmaceuticals Korea will continue its best efforts to support various programs for our executives and employees to develop their careers so that each and every employee may realize his or her full potential.”
- Company
- KIMS has signed a license agreement for Lipothasone
- by Nho, Byung Chul Jun 21, 2022 05:54am
- KIMS Pharmaceutical announced on the 20th that it has signed a contract with Japanese pharmaceutical company Mitsubishi Tanabe Pharma on the 17th to license Lipothasone. Through this contract, KIMS Pharmaceutical will officially release the product in August. According to KIMS Pharmaceutical, Lipothasone is the only Dexamethasone in Korea that uses Mitsubishi Tanabe Pharma's Lipid Nano Particle (LNP) technology. Steroids are excellent enough to be called panacea, but it is a drug that is reluctant to be prescribed due to serious side effects. Lipothasone is known to be a strong and safe anti-inflammatory treatment as well as targeted treatment of inflammatory areas by reducing the side effects of existing steroid injections, allowing IV, Epidural, and Intrathecal. In addition, this product is a drug carrier liposome (liposomalization) using DDS (Drug Delivery System) technology, and is considered to be a product that minimizes drug effect loss and minimizes side effects by selectively expressing effects on target lesions. Kim Seung-hyun, CEO of KIMS Pharmaceutical, said, "We are happy to have LNPS drugs through this contract." "We will continue to strengthen cooperation with Mitsubishi Tanabe Pharma Korea to promote mutual development and do our best to secure patients' access to new drugs," he said. KIMS Pharmaceutical is a company recognized for INNOBIZ, COVA, MAINBIZ, and HBA, and has a corporate research institute and a GMP plant in Osong, Chungcheongbuk-do.
- Policy
- The HIRA launched a benefit review for Tabrecta
- by Lee, Tak-Sun Jun 21, 2022 05:54am
- There are not many patients with MET mutation, but the prognosis is bad, so a treatment is urgently needed. It was found that the HIRA began a benefit review for targeted treatments for MET mutants, which appear in 3-4% of all non-small cell lung cancer patients. The MET mutation target anticancer drug landed in Korea in November last year with the approval of Novartis' Tabrecta and Merck's Tepmeko. Currently, it can be used as a non-reimbursement. According to the industry on the 17th, the HIRA has begun a process to determine the appropriateness of Tabrecta's benefit. Tabrecta was granted domestic permission on November 23 last year. It is the first drug used in patients with local progressive or metastatic non-small cell lung cancer where MET Exxon 14 deficiency was confirmed, and it was the first time that MET mutated targeted anticancer drugs were approved in Korea. MET mutations appear only in about 3-4% of all metastatic non-small cell lung cancer patients, but the prognosis is poor, so related targeted treatments are in urgent need. Tabrecta is known to block MET phosphorylation by binding to the phosphorylase region of receptors in cells. In the GEOMETRY mono-1 trial of 97 MET mutant patients, Tabrecta showed an overall response rate of 68% in patients who had never been treated and 41% in patients who had previously been treated. Tabrecta can be prescribed in major hospitals since early this year. However, since the benefit registration process is not completed, the patient must bear the price of about 10 million won. For this reason, the medical field is demanding rapid payment procedures. In the case of anticancer drugs, the HIRA's Cancer Disease Review Committee establishes standards, and then the Drug Reimbursment Evaluation Committee examines the appropriateness of benefits. It will be negotiated with the NHIS about the price and be placed on the final step through deliberation by the Health Insurance Policy Committee of the MOHW. Even if it goes fast, it takes about six months to get reimbursed.
- Policy
- Drug price cut refund bill’s fate depends on LJC Chair
- by Lee, Jeong-Hwan Jun 20, 2022 06:04am
- Industry expectations are rising on the prospect that the constitution of the NA leadership in the second half of the year will directly affect the fate of the Bill to recover and retrieve drug price cuts. If the People Power Party, which had been criticizing the inadequacy of the bill, takes Chair of the Legislation and Judiciary committee, it may significantly increase the possibility that the bill’s non-passage. On the 19th, the pharma-bio industry and the legal community are paying close attention to the progress made between the ruling and opposition parties’ negotiations regarding the composition of the NA leadership in the second half of the year. The National Assembly’s second half of this year’s term had started in June, but with the ruling and opposition party having difficulty agreeing on the composition of the NA leadership, the position of the Legislation and Judiciary Committee Chair has remained vacant for 3 weeks now. The determination of both the ruling and opposition parties to take the position has prolonged the confrontation even despite under-the-table negotiations. If the ruling party, the People Power Party assumes the Chair of the Legislation and Judiciary committee, this is expected to increase the possibility of the bill’s non-passage at the committee level. Therefore, on which party will assume Chair of the Legislation and Judiciary committee is expected to affect the bill for the recovery and retrieval of drug price cuts that can significantly impact sales and marketing in the pharmaceutical industry. The bill, which contains the measure for the government and pharmaceutical company to retreive or recovers the pharmaceutical benefits (reimbursement) amount that had not been settled during the drug price cut disposition suspension period, is currently pending in the 2nd subcommittee of NA’s Legislation and Judiciary Committee. The bill was proposed by members Woni Kim and Insoon Nam of the Democratic Party of Korea as representatives and passed NA’s Health and Welfare Committee with consensus between the opposition and ruling parties. However, the agenda was then put on hold by members of the People Power Party during review in the Legislation and Judiciary Committee’s plenary session. At the time, People Power Party member Joo-Hyae Jeon had criticized the bill for being unconstitutional. Jeon pointed out that the bill excessively restricts the pharmaceutical companies' right to file lawsuits to prevent them from applying for an injunction to suspend the execution of the drug price cut itself. Jeon added, “I want to express my deepest regrets on the fact that a bill that completely undermines the administrative litigation system has been put up for deliberation for the Legislation and Judiciary Committee. The bill requires the company to refund the whole amount of the drug price cut disposition that was not made during the execution suspension period, but this penalizes compulsory executions and neutralizes the suspension itself. The bill was unable to pass the plenary session then and was set to remain pending in the 2nd subcommittee of NA’s Legislation and Judiciary Committee for further review. The NA’s Health and Welfare Committee which believes in the need for the bill has set out to persuade the members of NA’s Legislation and Judiciary Committee, focusing on the PPP members that have opposed the bill, but to no avail. This is why there are prospects that the bill will not pass NA or be enacted if the PPP takes over the Chair position of the Legislation and Judiciary Committee in the second half of the year. With no decisive change or event arising for the PPP to change their mind on the bill, if the ruling party takes over the Chair position that can make or break the enactment of bills, experts believe that the possibility of the bill not being deliberated or being voted down may rise significantly. Also, the legal community and the pharmaceutical industry’s rising voices on the unjustness of the bill and strong opposition are also expected to hinder the passage of the bill. Therefore, on which party, the ruling or opposition party, takes over the Chair position of the Legislation and Judiciary Committee is likely to make or break the bill. An official from the pharmaceutical industry said, “Many domestic and multinational pharmaceutical companies have been strongly appealing and opposing to the unfairness and fatality of the refund and redemption bill, he said. "The reality is the appointment of the chairman of the Legislation and Judiciary Committee will inevitably affect the introduction, deliberation, and passage of the bill. This is why we are keenly following discussions on the composition of the NA leadership.” A lawyer from a Korean law firm who requested to remain anonymous, said, “From the legal community’s point of view, the bill nullifies the execution suspension system and overthrows the judicial system. From the pharmaceutical company’s point of view, they may not file a suit to cancel the drug price cut disposition or give up making appeals due to fear of the government's retrieval and collection of the drug price cut disposition amount after the trial. This by itself is an infringement of the right of access to courts and is against the constitution.”
- Company
- 11 of the national essential drugs are non reimbursed
- by Eo, Yun-Ho Jun 20, 2022 06:04am
- It was found that 11 of the drugs designated by The National Essential Medicine, excluding vaccines, are still non-reimbursed. As of December 31, 2021, 511 species have been designated as the National Essential Medicine, and 158 types of infectious disease-related drugs excluding vaccines. Of these, 11 drugs were not on the insurance benefit list. However, Remdesivir, a treatment for COVID-19, is not reimbursed, but the government pays the full cost of the drug. The national essential medicine refers to medicines that must be prepared in the country for national health, and was first discussed and introduced by the World Health Organization. Through the pandemic of infectious diseases such as MERS and COVID-19, securing stable national essential drugs such as vaccines and treatments for preventing infectious diseases is recognized as the core of national security and national competitiveness. However, it is pointed out that the problem of accessibility of the National Essential Medicine is still a blind spot. In fact, the National Health and Welfare Committee's parliamentary audit last year raised questions about the suspension of the supply of The National Essential Medicine and the low health insurance benefit registration rate. Non-payment drugs include Ceftolozane/Tazobactam injections (Zerbaxa), Isabuconazonium sulfate (Cresemba), Baloxavir (Xofluza), which had many clinical demands. Zerbaxa is an antimicrobial drug that was expected to be introduced in Korea as a new treatment alternative to Carbapenem, which was approved in Korea in April 2017 as an indication of complex urinary tract infection and complex intraperitoneal infection by effective strains in adult patients. Carbapenem-resistant-P. aeruginosa is one of the top-priority pathogens that require research and development of new antibiotics. Although Zerbaxa is an effective treatment for resistant bacteria that is not effective for Meropenem, it has been restricted from using Meropenem as an alternative and failed the benefit list despite high demand, but its appropriateness was recognized at the 6th Pharmaceutical Benefit Evaluation Committee held on the 2nd. Cresemba is an antifungal drug that was licensed and non-reimbursed in Korea in January 2020 for invasive aspergillosis and mucormycosis. Like Zerbaxa, it is blocked by PE, which has to prove cost-effectiveness by comparing old drugs with alternatives, and despite the occurrence of COVID-19-related inert aspergillosis in Korea, it is currently non-reimbursed. Invasive aspergillosis is one of the three major invasive fungi threatening humans, which occur in patients with reduced immunity, and is one of the causes of death in immunodeficiency patients due to the recent increase in chemotherapy or AIDS patients in Korea. The flu treatment Xofluza was a new drug that was expected to replace Tamiflu and was approved in Korea in November 2019, just before the COVID-19 pandemic. Since receiving conditional non-reimbursement from the Drug Benefit Evaluation Committee in October 2020, there has been no update yet. The experience of the COVID-19 pandemic has raised awareness of the rapid response of infectious diseases and the importance of drugs in policy and society, while access to infectious diseases, especially new drugs, remains before the pandemic. Since drugs related to severe infectious diseases such as multidrug-resistant infections and invasive fungal infections are used in emergency situations, it is essential to secure various types of drugs so that they can be used immediately if necessary. Choo Eun-joo, director of KSID's Insurance dept. (Professor of Infectious Medicine at Bucheon Hospital at Sooncheonhyang University), said, "There are no antibacterial and antifungal drugs that have been reimbursed for the past five to seven years. As drugs necessary for the treatment of fatal infectious diseases play a key role not only in the survival of individual patients but also in preventing the spread of infectious diseases, they should not be evaluated only from an economic perspective, she said.
