- LOGIN
- MemberShip
- 2025-12-18 02:39:58
- Policy
- Priority mkt authorization for Trajenta generics ends
- by Lee, Tak-Sun Feb 25, 2025 05:57am
- Product photo of TrajentaAs the priority marketing authorization for the generic version of Trajenta (linagliptin), a DPP-4 inhibitor used to treat diabetes, launched last year will end on March 8, generics that have been waiting for 10 months will be launched. The list of generics to be launched includes Hanmi Pharmaceutical and Genuone Sciences. According to the industry sources on February 23, 12 generics containing linagliptin such as Hanmi Pharmaceutical's 'Linaglo Tab' will be added to the reimbursement list, starting March 9. The market for a generic version of Trajenta became available after the patent of the original drug expired in June 2024. At that time, 16 monotherapy products were launched into the market. Only a portion of the 60 approved items have been launched because of the priority marketing authorization. Sixteen pharmaceutical companies have avoided two Trajenta patents, and they challenged the market when the composition patent expired on June 8, 2024, following the substance patent expiration. These companies also obtained priority marketing authorization, a policy established in February 2019 granting items meeting the first approval·patent avoidance criteria. The priority sales were approved for 10 months, between June 9, 2024, and March 8, 2025. During this period, generics with the same ingredient cannot be launched. Pharmaceutical companies with priority marketing authorization include Dongkoo Bio, Daewon Pharmaceutical, Jeil, Huons, Shinil Pharma, KyungDong Pharm, Kukje Pharm, Hana Pharm, Ildong Pharmaceutical, Dong Wha Pharm, Hanlim Pharmaceutical, Boryung, Aju Pharm, Albogen Korea, Hutecs Korea Pharmaceutical, and Arlico. These companies took the market for the first 10 months and gained a favorable spot. As priority marketing authorization ends on March 8, these companies will face new competitors. Changes to the competition landscape are expected since the late-launching group includes big pharmaceutical companies with established sales, such as Hanmi Pharmaceutical. Among the later-launch products, Hanmi Pharmaceutical's 'Linaglo Tab' is priced the same as the highest price (KRW 510) of the previous generics for meeting all criteria requirements and receiving credit (68%) for innovative-type pharmaceutical companies. Genuone Sciences' 'Tra-K Tab' and Aprogen Biologics 'Linahana Tab' will be reimbursed at KRW 447 for meeting all criteria requirements and receiving credits for first generics (the number of drugs with the same ingredient below 19, 59.5%). Products from Jinyang Pharm, Nexpharm Korea, DaehanNupharm, PharmGen Science, Genupharma, Withus Pharmaceutical, and Unimed Pharm meeting only one of the criteria requirements will be listed for reimbursement at KRW 341. Il Wha's 'Trina Tab 5mg' will be listed at KRW 402, which has been priced lower than the estimated price. However, credited prices for newly reimbursed drugs will end in June, at the same time as the products launched last year, because they were added to the reimbursement list late. After three months, the ceiling prices for all items will be adjusted to 53.55% of the highest price. Meanwhile, according to the market research firm UBIST, generics with linagliptin recorded KRW 4.7 billion in prescription sales between the launching date of June 2024 and December. The market share is about 4%. As they are in the early phases of the market launch, robust growth has not been achieved. It will likely present an opportunity for generic companies to launch late. An employee of the pharmaceutical industry said, "The group with priority marketing authorization launched 10 months earlier, but it has been reported that they did not achieve noticeable growth due to the original drug." Adding, "This will present an opportunity for the second group to launch." The sales for the original drugs Trajenta·Trajenta Duo decreased by 16%, from KRW 123.5 billion to KRW 103.9 billion. Despite a 30% reduction in mandatory drug pricing, they defended well.
- Policy
- Only Rinvoq to undergo drug pricing reduction
- by Lee, Tak-Sun Feb 25, 2025 05:57am
- Rinvoq ER Tab has been subjected to the preliminary drug pricing reduction after approval of drug switching between biological agents and JAK inhibitors for severe atopic dermatitis. The ceiling price will remain unchanged for Dupixent, Adtralza, Cibinqo, and Olumiant. As the reimbursement of drug switching between biological agents and JAK inhibitors for the treatment of severe atopic dermatitis will be implemented next month, additional claim amounts are reported to be insignificant. Rinvoq ER Tab (AbbVie, upadacitinib) is the only product to see drug pricing reduction due to the expected additional claim amount following approval of drug switching. According to the industry sources on February 21, the ceiling price of Rinvoq ER Tab 15 mg will reduced from KRW 18,740 to KRW 18,328, and that of Rinvoq ER Tab 30 mg will be reduced from KRW 29,850 to KRW 29,193 due to expanded scope of use. The reduction rate is 2.2%. The rate has been calculated according to the preliminary drug pricing index table. The preliminary drug pricing reduction following expanded scope of use is a system where drug pricing reduction is determined based on a calculation during the Health Insurance Review and Assessment Service (HIRA)'s evaluation process for pharmaceuticals with the expected additional claim amount below KRW 10 million following expanded scope of use. When the calculation is applied, companies do not undergo negotiations with the health insurance authority. The preliminary drug pricing reduction has been applied because the expected claim amount is below KRW 10 billion following approval of drug switching between biological agents and JAK inhibitors for severe atopic dermatitis. Only Rinvoq ER Tab has been subjected to the reduction. Pharmaceuticals with expanded reimbursement following drug switching approval include biological agents such as Dupixent and Adtralza and JAK inhibitors like Cibinqo, Olumiant, and Rinvoq ER Tab. However, besides Rinvoq, the other agents have not been subjected to drug price reduction because their additional claim amounts are below KRW 1.5 billion following expanded reimbursement. It is reported that Dupixent, which holds 80% of the severe atopic dermatitis treatment market in South Korea, is priced higher than other agents. Patients who used Dupixent and then switched to JAK inhibitors will likely benefit from the drug-switching approval. According to the study published in the Journal of the American Academy of Dermatology (JAAD) in 2023, the patient group switching from Dupixent 30 mg to Rinvoq 30 mg experienced an improvement in dermatological symptoms and itching regardless of previous responses to Dupixent. Furthermore, Rinvoq is the first JAK inhibitor used in atopic dermatitis and is cheap. Rinvoq costs about KRW 600,000 per month, which is less than half of the monthly drug cost of Dupixent. Consequently, patients will likely choose less expensive pharmaceutical after drug-switching approval. Considering the National Health Insurance finance, the additional claim amount burden will not be significant. The drug pricing reduction rate for Rinvoq is 2.2%, and the expected additional claim amount falls between over KRW 2.5 billion and below KRW 5 billion. Rinvoq's additional claim amount is likely below KRW 5 billion. An employee of the industry said, "Approval of drug switching between biological agents and JAK inhibitors is essentially patient moving from expensive Dupixent to cheap Rinvoq, so the loss of finance is expected to be none." Adding, "Yet, if the authority had allowed drug-switching to include pharmaceuticals of the same class, expansion of reimbursement would not have been easy due to financial burden."
- Policy
- Generic drugs enter KRW 150 billion Prolia market
- by Lee, Tak-Sun Feb 25, 2025 05:57am
- A competitor to Prolia (Amgen, co-marketed by Chong Kun Dang), which has dominated the market for osteoporosis treatment with its convenience and efficacy, will be released next month. Celltrion will make the launch. Celltrion plans to launch its biosimilar after the expiration of the Prolia product patent on the 17th of next month. According to industry sources on the 24th, Celltrion's Prolia biosimilar ‘Stoboclo Prefilled Syringe (denosumab)' will be listed as a reimbursed drug on March 18. The insurance ceiling price of the drug is KRW 111,384, which is cheaper than Prolia (KRW 154,700). Celltrion could have charged a higher price, but it lowered the price. This is interpreted as a measure that takes into account the drug’s price competitiveness in the market. As a result, patients can now receive the same drug at a lower price. Initially, Celltrion could have listed the drug at KRW 123,760 by receiving an additional 80% premium as a bio-equivalent drug by an innovative pharmaceutical company. Prolia, which was launched in Korea in November 2016, dominates the domestic osteoporosis treatment market. Conventional treatments are affected by meal intake, and if the dose is increased, Prolia maintains its effectiveness with a single injection every 6 months, greatly improving convenience. This drug is a biopharmaceutical that targets the RANKL protein, which forms osteoclasts that destroy bones. In particular, there is clinical evidence that the drug remains effective even after 10 years of administration. Its sales in 2023, based on IQVIA sales, had been a whopping KRW 151.1 billion. It has been dominating the market without any competitors, but with the entry of Celltrion's biosimilar, it will face competition. Meanwhile, Celltrion will also launch the biosimilar Xgeva, a treatment for multiple myeloma based on denosumab, on the same day. The 2 drugs have the same ingredients but different uses. Since the ingredients are the same, the expiration date of the product patent is also the same. Xgeva recorded sales of KRW 10.5 billion in 2023 based on IQVIA's data.
- Policy
- PMS of Rekovelle shows ovarian hyperstimulation
- by Lee, Hye-Kyung Feb 21, 2025 05:56am
- The reevaluation of Ferring Korea’s fertility drug ‘Rekovelle Prefilled Pen (follitropin delta)’ revealed that 0.65% of patients experienced ovarian hyperstimulation syndrome, which is expected to be added as an adverse event. The Ministry of Food and Drug Safety announced on the 20th the proposed changes to the licensed conditions following the re-examination of new drugs. A post-marketing surveillance was conducted on 611 patients over 4 years for the re-examination of Rekovelle in Korea. As a result, the incidence of adverse events reported was 17.84% (109/611, 137 cases in total), regardless of causality. Among them, ovarian hyperstimulation syndrome occurred in 4 (0.65%) of 611 patients with serious adverse drug reactions whose casualties cannot be ruled out. Unexpected adverse drug reactions were reported in 9 out of 611 patients (1.47%), including ovarian cysts, pelvic fluid accumulation, vulvar itching, acne, hair loss, cold sweats, pain at the injection site, erythema at the injection site, and palpitations. The Ministry of Food and Drug Safety will give advance notice by the 27th to add more cases of adverse reactions to the post-marketing surveillance and plans to change the label on the 28th. If there are disagreements during the opinion survey, the scheduled date for the label change order may be postponed. Since its domestic approval on December 27, 2019, Rekovelle has been prescribed at domestic infertility hospitals. Rekovelle increases the possibility of collecting the optimal number of eggs, 8 to 14, regardless of AMH levels, with a dosage that is delicately adjusted according to the patient's condition. At the time of its initial approval, the drug was only eligible for reimbursement as monotherapy, but From May 2022, controlled ovarian stimulation to mature multiple oocytes in women undergoing assisted reproductive technology such as IVF (in vitro fertilization) or ICSI (intracytoplasmic sperm injection) in combination with human menopausal gonadotropin (hMG) therapy was also covered by the National Health Insurance. The expansion of the health insurance reimbursement to the combination of Rekovelle and hMG has provided even patients with low pregnancy success rates due to age or ovarian dysfunction with an option that meets the goal of being the optimal treatment. Rekovelle’s reimbursement standard was extended based on the MARCS study, a multicenter, open-label, single-cohort clinical trial that evaluated the efficacy and safety profile of Rekovelle and hMG combination in 110 infertile patients who underwent in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI).
- Policy
- Ocrevus, DM Duo reimbursed from March
- by Lee, Jeong-Hwan Feb 21, 2025 05:56am
- Roche's new multiple sclerosis drug Ocrevus (ocrelizumab) and Hyundai Pharm’s first dementia combination drug DM Duo (donepezil + memantine) will be reimbursed by Korea’s national health insurance starting next month. Amgen's osteoporosis drug Prolia will see some changes to its reimbursement standard as Celltrion's biosimilar Stoboclo is soon to be listed on the National Health Insurance reimbursement list. The Ministry of Health and Welfare announced on the 20th that it has issued a pre-announcement of administration regarding the details of the application criteria and methods for the reimbursement of pharmaceuticals. The new multiple sclerosis drug, Ocrevus (ocrelizumab), will be reimbursed from March 1. Reimbursement for the drug is granted for patients with relapsing-remitting multiple sclerosis (RRMS) who meet the McDonald ('17) diagnostic criteria and can exclude the occurrence of other similar diseases who have failed or are intolerant of first-line treatment (Interferon β-1b, etc.) and is ambulatory (able to walk). In patients with secondary progressive multiple sclerosis (SPMS), treatment should be discontinued when the EDSS score evaluated every six months from the first dose is 7.0 or higher. The treatment method is monotherapy. Hyundai Pharm’s DM Duo (donepezil + memantine), the first dementia combination drug in Korea, will also be reimbursed in March. Patients with moderate to severe dementia of the Alzheimer's type who meet the criteria for both the Mini-Mental State Examination (MMSE) score of 20 or less and the Dementia Scale Examination are eligible for reimbursement. Re-evaluation is conducted every 6 to 12 months to determine whether to continue administration, and continued administration is granted even if the MMSE score exceeds 20 during re-evaluations. However, when concurrently using DM Duo, Tanamin Tab, and Ginexin F Tab, the patient must pay the full cost of one of the drugs with the lowest cost of treatment within the scope of the drugs’ indications. Prolia’s reimbursement standard will change as the Celltrion biosimilar Stoboclo Prefilled Syringe’s imminent reimbursement listing. The standard change is to apply the same standards for the denosumab injection and add 'etc.' to the name of the product category in the notice.
- Policy
- 'JAK inh-biological agent' switching will be reimb in March
- by Lee, Jeong-Hwan Feb 21, 2025 05:56am
- The National Health Insurance reimbursement standard for severe atopic dermatitis treatments will be extended starting March 1. The key change is reimbursement coverage for switching between JAK inhibitor and biological agent. The Ministry of Health and Welfare (MOHW) announced on February 20 that it gave administrative notice of 'Partial revision to the pharmaceutical long-term care reimbursement.' In South Korea, the atopic dermatitis treatments that gained marketing authorization include JAK inhibitors such as AbbVie's Rinvoq (upadacitinib), Lilly's Olumiant (baricitinib), Pfizer's Cibinqo (abrocitinib), as well as biological agents such as Sanofi's Dupixent (dupilumab), and LEO Pharma's Adtralza (tralokinumab). According to this administrative notice, the MOHW improved the standard so that reimbursement coverage is provided for switching to JAK inhibitor if atopic diseases are not adequately responded to or a patient lacks tolerability to initial treatment with a biological agent. If a patient does not respond to a JAK inhibitor or no longer continues treatment due to side effects (recommended to stay on the switched drug for at least 6 months), one can switch to a biological agent. In this case, doctors must file a doctor's note. However, reimbursement has not been approved for switching between JAK inhibitors. Switching to a JAK inhibitor is possible if treatment with a biological agent is not effective or a patient cannot continue treatment due to side effects. Yet, Dupixent and Adtralza switching treatment has not been approved for reimbursement. Meanwhile, previously, JAK inhibitors were excluded from the list of allowed drugs for switching because approval is specified for 'patients over 65 years and older whose initial treatment has failed.' Once the switching is approved, this patient group can receive treatment.
- Policy
- Pfizer 'Vyndamax' reimbursed from March…KRW 100,000/cap
- by Lee, Tak-Sun Feb 21, 2025 05:56am
- Product photo of Vyndamax About 20% of the non-reimbursed price…significantly reduces patient with a special exemption of calculation provisions The completion of negotiations with the National Health Insurance Service (NHIS) has been reported, so the reimbursement listing was a matter of time. The ceiling price is reported to be KRW 100,000 per capsule. According to industry sources on February 19, Vyndamax Cap was the only treatment for ATTR amyloidosis with cardiomyopathy (ATTR-CM). As Vyndamax Cap becomes added to the reimbursement list in March, the ceiling price is reported to be set as KRW 100,000. The survival time for ATTR-CM is 2 to 3.5 years when it is not adequately treated. It is a disease mistaken for simply heart failure, but the treatment outcome is poor due to the unavailability of treatment. The efficacy of Vyndamax was demonstrated through the Phase 3 ATTR-ACT study, which showed Vyndamax reduced cardiovascular-related events and improved the 6-minute walking test in CM patients. However, after domestic approval in 2020, it faced difficulty in listing reimbursement. In April 2022, the drug was considered for the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC), but reimbursement appropriateness was not approved. Ultimately, high drug price was the problem. Vyndamax costs US$ 225,000 (approximately KRW 300 million) annually, and in South Korea, non-reimbursed treatment is reported to cost KRW 150 million (KRW 410,000 per capsule) annually. If the ceiling price is KRW 100,000 per capsule, it costs 20% less than when it was non-reimbursed. Patients only pay a co-payment of 10% with a special exemption of calculation provisions, so the economic burden is expected to be less. If the company has reached a risk-sharing agreement (RSA), drug cost is expected to decrease even more. The number of ATTR-CM patients in South Korea is reported to be 75 as of 2021.
- Policy
- Dilemmas for fostering pharma and lowering drug prices
- by Lee, Tak-Sun Feb 19, 2025 05:56am
- What would be a reasonable drug pricing policy to foster new drug development? The government is focusing on the sustainability of the National Health Insurance, while the industry expresses concerns about decreasing new drug development due to reduced drug prices. These conflicting perspectives are raising about the future direction of drug pricing policy. On February 14, a 'Policy debate to foster pharmaceutical and biotechnology industry' was held at the National Assembly Building. The debate was hosted by the Democratic Party of Korea's Future Economic Growth Strategy Committee (Lee Eun-Joo, Committee Leader and sponsored by the National Assembly's Public Healthcare Committee Rep. Seo Young-Seok and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). Photo opportunity with the debate participants. (from upper left) Kim Gook-hee, Head of the Pharmaceutical Benefits Department at HIRA, Rep. Lee Byeong-jin, Member of the Democratic Party of Korea, Noh Yunhong, President of KPBMA, Rep. Seo Young-seok, Member of the Democratic Party of Korea, and Cho Ha-Jin, Director of the Bureau of Health Insurance Policy division at the MOHW, (from lower left) Kang Hyun-Sik, Chairperson of the Drug Pricing System Specialist Committee of the KBPMA, Choi Yun Jeong, Professor of the Department of Economics at Yonsei University, Lee Eui-Kyung, a professor at the School of Pharmacy at Sungkyunkwan University, and Kim Dong-Sook, Professor of the Department of Health and Public Administration at Kongju National University. The event's speakers mentioned that a large-scale reduction in drug pricing is not effective and that the post-management system needs reform. Choi Yun Jeong, Professor of the Department of Economics at Yonsei University, said, "After the nationwide drug pricing reduction in 2012, companies directions have changed." Choi presented the research results, "The production of non-reimbursed prescription drugs increased, production of items without price reduction increased, and co-promotion of imported drugs also increased." "Changes in production types, such as an increase in production of non-reimbursed prescription drugs, have led to higher consumer drug costs, which have diminished the efforts to improve National Health Insurance improvement," Choi explained. Choi pointed, "Changes to company's production type, which was not intended by policy, may result in side effects in the long term in the pharmaceutical industry." Choi added, "The government has aimed to reduce National Health Insurance expenditure by lowering drug prices. However, this policy has not effectively improved pharmaceutical choices and volume management." Consequently, speakers stressed that before reducing drug pricing in large-scale, improvements must made to original and high-priced pharmaceutical preferences, pharmaceutical overspending, overprescription, and practices. Yu Seung-Rae, Professor of School of Pharmacy at Dongduk Women's University, stressed that regular and repetitive drug pricing reduction policy must be improved, and a comprehensive pharmaceuticals post-management system is needed. Also, the seller-distributor participation method should be established, and improvements to reimbursement monitoring, which is directly related to product quality, are required. To achieve this, Yu explained that the current policy of individually lowering the unit price of each drug should be changed to goal-oriented and comprehensive management methods. In particular, a 'refund system' can be utilized. "Seven years ago, a similar topic was discussed. If the government had initiated a mid-to-long-term project then, the current challenges would likely have been resolved," Yu said. "Other OECD countries have simplified their post-management systems and implemented policies to provide refunds based on the potential value of new drugs." As the current policy is aimed at reducing individual drug prices, all participants agreed on the need for revision. Dong-Sook Kim, Professor of the Department of Health and Public Administration at Kongju National University, remarked, "Both the universal drug price reduction and various post-management mechanisms create anxiety for pharmaceutical companies," Kim stressed, "To resolve this, we need a comprehensive approach to drug pricing management." Kim added, "Various post-management systems are available, but they are not being effectively implemented." Kim stressed that "Ongoing studies of comprehensive post-management systems show that the number of drug pricing reductions is typically only two for 20,000 items listed between 2007 and 2022. The drug price remains about 87% of the initially listed price. Therefore, we must establish a post-management system to ensure that new drug values are accurately evaluated and effectively managed." Cho Wonjun, a Project Specialist at the Public Health Division of the Democratic Party of Korea, said, "The drug pricing system has operated independently from the prescription department, making it difficult to achieve specific goals and often resulting in balloon effects." Cho added, "We need to consider whether the aim of controlling prices contradicts the initiative to reduce volume. For instance, we should evaluate whether lowering drug prices as an administrative measure in response to previous illegal rebate practices is appropriate." Cho suggested, "The system should be structured so that the goals are reflected and contribute to improving practices." During the event, it has been suggested that an assessment reflecting domestic practices is needed as domestically produced, natural new drugs are included in the reevaluation of reimbursement appropriateness for this year. Kang Hyun-Sik, Chairperson of the Drug Pricing System Specialist Committee of the KBPMA, said, "Domestically developed natural new drugs face more challenges in the process of approvall-reimbursement-listing compared to new drugs originating from foreign countries." Kang emphasized the need to consider special circumstances surrounding domestically developed new drugs, stating, "Evaluating these drugs similarly as those from foreign countries would be discriminatory against Korean companies." "A drug that has been used for many years and its claim amount is high indicates that its utility in clinical practices as well as societal demands are high," Kang said. "Domestically developed new drugs need a different evaluation standard for reevaluation." Panels representing the government emphasized that the department has been putting efforts to find a balance between industry development policy, such as reflecting new drug values, and sustaining the National Health Insurance. The department promised to bring improvements to effective post-mangagment system. Kim Gook-hee, Head of the Pharmaceutical Benefits Department at HIRA, said, "The pharmaceutical industry is a national-level industry that holds greater importance than the semiconductor business." Kim stressed that, "A predictable system for the pharmaceutical industry is important but the government must prepare additional plans." "We should consistently implement policy, focusing on reimbursed pharmaceuticals, comprehensively managing goals from a macroscopic perspective, industry reform and R&D promotion, a direction to transform generic industry capacity to exports," Kim said. "In the past, we have failed to pursue a policy consistently. Therefore, we are currently assessing whether our support for the pharmaceutical industry has been effective." Kim added, "The government is working to simplify the repetitive and excessive post-management system. The department has initiated measures to improve problems, such as promoting national essential drugs made with domestically produced ingredients and considering the value assessment of new drugs and public health and security aspects." Cho Ha-Jin, Director of the Bureau of Health Insurance Policy division at the Ministry of Health and Welfare (MOHW), said, "The policy direction of the government is changing towards balanced goals, such as supporting the pharmaceutical industry, rather than saving expenses." Cho said, "In the past, the government focused on saving expenses, but now, it is thoroughly considering ways to support industries, including new drug development and drug cost coverage for drug shortages." However, Cho explained that a significant drug pricing reduction is unlikely to lead to an increase in non-reimbursed drugs, as suggested by Professor Choi. Therefore, the government must consider clinical utility and cost-effectiveness when reevaluating the reimbursement appropriateness. Generally, supporting domestically produced new drugs requires careful consideration. Choi reassured the debate participants, "Please note that the department has appointed a research team to restructure the drug pricing post-management system to formulate a comprehensive post-management method." The debate was led by Lee Eui-Kyung, a professor at the School of Pharmacy at Sungkyunkwan University who served previously as the 5th Minister to the Ministry of Food and Drug Safety (MFDS).
- Policy
- Boehringer Ingelheim, HIRA enter drug price negotiations
- by Lee, Tak-Sun Feb 19, 2025 05:56am
- Product photo of Ofev As for reimbursement listing of 'Ofev (nintedanib),' a treatment for idiopathic pulmonary fibrosis (IPF), domestic distributor Boehringer Ingelheim and the Health Insurance Review and Assessment Service (HIRA) have entered drug price negotiations. Since the substance patent of Ofev expired last month, generic companies have already obtained approvals. Generic companies closely watch the results of negotiations because they plan to apply for reimbursement once the drug price of Ofev becomes listed. According to industry sources on February 18, drug price negotiations have been initiated for Ofev, which passed the HIRA's Drug Reimbursement Evaluation Committee (DREC) review in January. After the review, the DREC determined Ofev has reimbursement appropriateness for indications to treat ▲Systemic sclerosis-associated interstitial lung disease (ILD) ▲Advanced pulmonary fibrosis. However, Ofev's 1st indication IPF has been excluded from the reimbursement appropriateness scope. It has been reported that Boehringer Ingelheim accepted this result. After the decision, the Ministry of Health and Welfare (MOHW) ordered drug price negotiations. Besides the distributor Boehringer Ingelheim, other pharmaceutical companies also closely watch Ofev's drug price negotiations. Those include generic companies such as Yungjin Pharm and Daewoong Pharmaceutical. Yungjin Pharm received approval for its generic version of Ofev as 'Nintebro' in December 2024. Daewoong Pharmaceutical finished registering domestic approval for 'Ofevia Tab.' These companies successfully avoided the substance patent, which was unregistered, allowing them to launch in the market without any hurdles. Ofev's substance patent was expired on January 25. However, if there are no products containing nintedanib on the reimbursement list, it will be disadvantageous for market launch. Without an existing product to serve as a development benchmark, generic companies must apply for reimbursement assessment of their generics as new drugs. This process can be time-consuming and requires effort. In contrast, once the original drug Ofev becomes added to the reimbursement list, drug prices of generic drugs are estimated based on the product set as a development goal. Thus, these generic drugs can be added to the reimbursement list within three months of application. Generic companies will likely apply for reimbursement once Ofev becomes reimbursement listed. If the drug price negotiations for Ofev proceeds without any issues, it is likely to be added to the reimbursement list in April. Since the original drug has only three to four months of exclusive availability, the industry is closely monitoring how the market competition structure will be develop.
- Policy
- Lorviqua, Tevimbra, Pemazyre enter NHIS negotiations
- by Lee, Tak-Sun Feb 18, 2025 05:53am
- Pfizer Three items, including Lorviqua (lorlatinib, Pfizer Korea), Tevimbra Inj 100 mg (tislelizumab, BeiGene Korea), and Pemazyre (pemigatinib, Handok), are currently under negotiations with the National Health Insurance Service. These drugs were deliberated by the Health Insurance Review and Assessment Service Drug Reimbursement Evaluation Committee (DREC) on January 9 and were deemed adequate for reimbursement. According to industry sources on the 17th, the National Health Insurance Service updated the website with information on drug price negotiations for 3 items. The National Health Insurance Service discloses information on the progress of negotiations for new drugs, drugs exempt from drug price negotiations, and drugs with expanded indications on its website. Upon the Ministry of Health and Welfare's negotiation order, the NHIS begins drug price negotiations with individual pharmaceutical companies. However, drugs for which the company has accepted the assessed amount to receive drug price negotiation exemptions will only be subject to negotiations on the expected claim amount. Among the 3 items currently under negotiations, Tevimbra and Pemazyre are expected to have entered into negotiations with the NHIS as expected, as they were recognized by the DREC as adequate for reimbursement without conditions. However, Lorviqua Tab, which is applying for the reimbursement extension as a first-line treatment for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer, was judged by DREC to be “appropriate for reimbursement extensions if the company accepts a price less than the evaluated amount,” so NHIS negotiations for the drug was only possible after the pharmaceutical company accepted the condition. Pfizer is expected to accept the 'below the evaluation price' proposed by DREC and will again try to win the bid through negotiations with the National Health Insurance Service, as it did last year. Last year, the drug price negotiations broke down due to disagreements over the adjustment of the expenditure cap under the Expenditure Cap type of Risk Sharing Agreement (RSA). The Expenditure Cap type is a system in which the pharmaceutical company refunds the excess amount of the claim to the National Health Insurance Service if it exceeds the set total amount (cap). For this reason, in the case of Lorviqua, the profit earned by the pharmaceutical company also changes depending on how the total amount is set when expanding reimbursement. Pfizer has applied to terminate the RSA contract with NHIS and wants to expand the reimbursement without an expenditure cap. Therefore, it is expected that the termination of the RSA contract and the financial sharing plan will be the key to reaching an agreement during negotiations. Meanwhile, Tevimbra is a treatment for esophageal squamous cell carcinoma from the Chinese pharmaceutical company BeiGene Korea, and Pemazyre, which is imported by Handok, is a treatment for FGFR2 fusion or rearrangement cholangiocarcinoma. If these products reach an agreement with the NHIS, they will be added to the drug reimbursement list after reporting to the Ministry of Health and Welfare's Health Insurance Policy Review Committee.
