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- 2026-06-24 12:06:27
- Opinion
- [Reporter’s View] Biotech’s confidence and responsibility
- by Son, Hyung-Min Mar 14, 2024 05:42am
- Several biotechnology companies in South Korea have suffered major setbacks while pursuing first-in-class new technology businesses. GenNBio, a company known for xenotransplantation of pancreatic islets, is currently facing the possibility of being dissolved. Due to management disputes, the departure of key R&D personnel, financial difficulties, and lack of market trust, the company is facing potential delisting. About a year ago, GenNBio gained Korea's attention by obtaining approval for a groundbreaking clinical trial in which a pancreas from aseptic pigs would be transplanted into humans to cure type 1 diabetes, marking the first in South Korea. The research was led by Dr. Kim Sung-joo, a former director of the Seoul National University Organ Transplant Research Center and the Center for Experimental Animals Research in Seoul, adding credibility to the trial. The trial was expected to be conducted by Professor Kim Kwang-won at Gil Medical Center, who was a mentor of Dr. Kim Sung-joo. Although the clinical trials were expected to proceed without delays, they were discontinued due to internal issues following CEO Kim's exit. It is reported that all key employees responsible for conducting the clinical trial resigned. Additionally, the company experienced a dispute between its largest shareholder and the existing management. The company was ambitious, but internal enforcement and consensus have fallen short. Due to organ shortages, only 0.1% of type 1 diabetes patients can receive pancreatic transplantation. Discontinuation of research has shattered hopes for benefits. In addition to GenNBio, other companies went through similar situations. Earlier this year, first-generation biotech ventures like Helixmith announced the failure to prove efficacy in the U.S. phase 3 clinical trial of its gene therapy candidate drug, ‘Engensis,’ for diabetic peripheral neuropathy. This is the second report of an outcome after an incident in September 2019, where a mix of placebos and test drugs were administered to patients, making it challenging to collect accurate data. The development process of Engensis may have been challenging due to the lack of successful drug development in the field. Helixmith, dedicated to commercializing Engensis since its inception as an on-campus start-up at Seoul National University in 1996 under Byromedica Pacific, has experienced continuous failures in clinical trials over the past 20 years. Due to its focus on new technology, the company has faced major and minor internal challenges. The company continues to experience various internal problems, such as internal information leaks, investment setbacks from high-risk private equity funds, and conflicts with minority shareholders. Despite recent success in changing the board of directors after the largest shareholder changed from Canariabio M to Biosolution, Helixmith still faces allegations of insider trading within the owner's family and internal noise. Additionally, minor shareholders have expressed dissatisfaction. GenNBio and Helixmith have secured significant technologies such as heterotopic pancreas transplantation and gene therapy, but they may have overlooked risks associated with uncertainty, talent retention, and investor management. The challenges are usually difficult to achieve, but they're what one strives to accomplish. This requires putting in all one's efforts and time to reach the goal. However, it's important to remember that deviating from the focus can lead to failure, even if a company succeeds in developing new drugs.
- Policy
- Poteligeo and Livtencity may likely be reimbursed in April
- by Lee, Tak-Sun Mar 14, 2024 05:42am
- Two rare disease drugs, Poteligeo (mogamulizumab, Kyowa Kirin Korea) and Livtencity (maribavir, Takeda Pharmaceuticals Korea), are likely to be added to the reimbursement list next month after completing pricing negotiations with the National Health Insurance Service. According to industry sources on the 13th, the companies have completed pricing negotiations with the NHIS for the two drugs. Accordingly, the drugs will likely be reimbursed from April if the negotiation results are reported to the Health Insurance Policy Deliberation Committee at the end of this month. The two drugs are both rare disease drugs that have passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review in December last year. Poteligeo Inj is a treatment for patients with mycosis fungoides (MF) or Sézary syndrome (SS). MF and SS are two typical types of cutaneous T-cell lymphoma (CTCL), a chronic condition that causes disfiguring lesions, itching, and psychological stress that affects the patient’s quality of life. Poteligeo is a a humanized monoclonal antibody (mAb) that targets CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain hematologic malignancies including CTCL, such as MF and SS. Livtencity is an antiviral drug used to treat post-transplant cytomegalovirus (CMV) infection. is a virus that remains asymptomatic and latent after infection, but reactivates when the immune system is compromised, such as after organ transplantation, causing serious disease. Livtencity is an oral antiviral agent that inhibits viral proliferation by reducing the activity of the UL97 protein kinase,’ which is involved in the replication and proliferation of the cytomegalovirus. Kyowa Kirin accepted the negotiated price at the DREC level and negotiated only the estimated reimbursement amount with the NHIS for Poteligeo. In addition, whether ‘Enthertu 100mg Inj (trastuzumab deruxtecan),’ a targeted therapy for breast 100 mg (trastuzumab deruxtecan, Daiichi Sankyo, Korea) and 7 morning sickness drugs (doxylamine succinate -pyridoxine hydrochloride) will also be listed for reimbursement in April is receiving attention. Currently, Enhertu, which patient groups have been requesting coverage, was dramatically approved in February after struggling through the pharmacoeconomic evaluation process. The government plans to expedite the drug's reimbursement due to the high demand from society. Negotiations are currently underway with the MFDS on its reimbursed price and is likely to be approved in April. The coverage of morning sickness drugs is being promoted as a government measure to support pregnant women with the promise of exceptional treatment. Although negotiations are yet to begin, the process is expected to progress rapidly.
- Policy
- “Calling for promotion of substitute drug dispensation“
- by Lee, Jeong-Hwan Mar 13, 2024 05:32am
- Article 27 (Dispensation of Substitute Drugs) of the Pharmaceutical Affairs Act currently permits the dispensation of substitute drugs and is being implemented. The Ministry of Health and Welfare (MOHW) announced that they are not officially reviewing specifics of a potential policy to promote the dispensing of substitute drugs. Yet, the MOHW agreed on the need to promote the dispensing of a substitute drug for the drug prescribed in a prescription. Promoting the dispensation of substitute drugs may help solve patient inconvenience, including situations with an unstable supply and demand for medications, such as long-term out-of-stock essential medicines and prescription drugs being unavailable at a pharmacy after non-face-to-face medical care. An official from the People Power Party stated on the 8th that the MOHW has commented on the policy aimed at increasing the dispensing of substitute drugs, “There is a call for promotion of substitute drug dispensation. However, it has not been officially reviewed yet.” The issue of substitute drugs is drawing attention in the medical community amid the ongoing conflict between the government and the medical community over the proposal to increase the medical school enrollment quota to 2,000. The government and the People Power Party have stated their intention to pursue a policy aimed at increasing the dispensing of substitute drugs. However, the MOHW announced that the dispensing of substitute drugs is currently officially permitted and being implemented in accordance with the Pharmaceutical Affairs Act. Following the press release by the government and the ruling party about the issue, they have not engaged in discussions about the potential changes to the policy. The MOHW emphasized that the government is already implementing this policy based on the current Article 27 (Dispensation of Substitute Drugs) of the Pharmaceutical Affairs Act. Regarding the policy aimed at promoting the dispensation of substitute drugs, the MOHW acknowledges the inconvenience in the medical field, including situations involving unstable supply and demand for medications, as well as the complexity of the process for obtaining substitute drugs, which requires patients to locate pharmacies where the prescribed drugs are available. This means that the MOHW has recognized the need to consider the dispensation of substitute drugs as a measure to partially alleviate the problems where pharmacists and patients face difficulties in dispensation and drug administration due to long-term shortages of essential medicines at frontline pharmacies. Furthermore, this can address the inconveniences of implementing the pilot project for non-face-to-face medical care without limitations. These inconveniences include situations where drugs prescribed during non-face-to-face sessions are not available at pharmacies. However, the MOHW's stance is that there has been no specific internal discussion or external consultation regarding the promotion of substitute dispensing. “While there have been press releases suggesting the promotion of dispensing substitute dispensing due to the medical community's backlash against the government's policy of increasing medical school quotas, it appears that there hasn't been specific discussion between the government and the ruling party on this matter,“ an official from the People Power Party commented. “The MOHW acknowledges the challenges regarding unstable drug supplies and the difficulty patients face in finding pharmacies with prescribed drugs in stock. While there is recognition of the necessity to discuss the promotion of substitute dispensing as a solution, it is not currently under consideration, as per the MOHW's explanation,” the official added.
- Company
- Yuhan Corp and BMS will copromote Sotyktu and Zeposia
- by Nho, Byung Chul Mar 13, 2024 05:32am
- (From the left) Hye-Young Lee, Country Manager of BMS Korea and Wook-Je Cho, CEO of Yuhan Corp Yuhan Corp (CEO: Wook-Je Cho) announced that the company has signed a copromotion agreement with BMS Korea (Country Manager: Hye-Young Lee) for BMS’s plaque psoriasis drug ‘Sotyktu (deucravacitinib)’ and ulcerative colitis drug ‘Zeposia (ozanimod)’ on the 11th. This strategic partnership for joint sales and marketing in Korea marks the first partnership between the two companies and will begin in March. Sotyktu is the first TYK2 inhibitor approved by the Ministry of Food and Drug Safety for moderate-to-severe plaque psoriasis in adults. The convenient, once-daily oral treatment was approved by the MFDS in August 2023 for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy. The drug’s efficacy and safety profile were demonstrated through the Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials. Zeposia is the first shingosine 1-phosphate receptor (S1P) modulator to be approved in Korea to treat moderate-to-severe active ulcerative colitis. The drug was granted reimbursement in January of this year for the treatment of adult patients with moderate-to-severe active ulcerative colitis who have not had an adequate response to or are intolerant of conventional therapies (such as corticosteroids, 6-mercaptopurine or azathioprine) or for whom these agents are contraindicated. Zeposia’s clinical efficacy and safety were confirmed through the ‘TRUE NORTH’ trial. Wook-Je Cho, CEO of Yuhan Corp, said, “We expect the partnership and the innovative medicines will help us provide new therapeutic benefits to patients in Korea with plaque psoriasis and ulcerative colitis.” Hye-Young Lee, Country Manager of BMS Korea, said, “We look forward to promptly bringing the therapeutic benefits of the orally-administered, convenient Sotyktu and Zeposia to more patients in Korea, We will continue to work with other members of Korea’s healthcare ecosystem to improve patient access in a variety of disease areas with high unmet need."
- Policy
- Companies with superior CP ratings get reduced fines
- by Lee, Jeong-Hwan Mar 13, 2024 05:32am
- The Korea Fair Trade Commission announced the enforcement of the amendment to the Enforcement Decree of the Fair Trade Act, which grants up to a 20% penalty reduction to companies that receive superior ratings through the operation of a Compliance Program (CP), drawing industry-wide attention. Companies that have been operating for more than one year and meet the CP requirements will be able to receive a one-time penalty reduction of 10% if they receive an AA rating in FTC's CP evaluation, and 15% if they receive an AAA rating. An additional 5% penalty reduction is possible if the company (business operator) proves that it has detected and stopped the violation of the law under investigation through effective CP operation before the initiation of an unfair trading practice investigation. In the case of pharmaceutical and biotech companies, if the KFTC calculates and imposes fines for unfair practices including illegal drug rebates, the companies can receive a reduction in fines from 10% to up to 20% if they meet the conditions under the amended provision. The KFTC (Chairperson Ki-Jeong Han) will finalize the recently announced ‘Amendment to the Enforcement Decree to legislate the Compliance Program’ by April 15, and the ‘Notification on the Establishment of the CP Operation by the 25th of this month after an opinion-collecting process. Korea will reduce fines by 20% for superior CP companies”’unexpected and unusual" e The biggest significance of the KFTC's legislative and administrative notice is that it revived the provision for reducing fines for companies caught engaging in unfair behavior that had been abolished in the past. This is due to the amendment to the Enforcement Decree of the Act on Monopoly Regulation and Fair Trade that passed the National Assembly review in June last year, the effective date of which was set as June 21 this year. Article 120(2) of the amended Fair Trade Act states that the KFTC can take corrective measures, reduce penalties, reward, and support businesses (companies) that have received CP evaluation in accordance with the standards set by the Presidential Decree to promote CP. In particular, Korean CP experts have expressed that "the results are encouraging" over the provision of up to 20% penalty reduction in the KFTC's legislation draft. When looking at incentives provided to companies in major countries around the world that have CP systems in place, no other country has reduced fines by up to 20%. As such, the Korean government has shown its determination to encourage and induce companies to adopt CP by operating a wide range of penalty reduction incentives to implement internal compliance systems. Specifically, the UK reduces fines by up to 10% if a company demonstrates that its CP activities were appropriate. Italy provides a 15% penalty reduction for effective CP operation, 10% for CP that is not manifestly inadequate, and 5% for inadequate CP that is corrected within six months. The US law stipulates that CP operations and efforts to prevent recurrence may be taken into account in determining the level and reduction of penalties during the sentencing phase for companies found guilty of unfair trade acts. What are the criteria for receiving the 20% penalty reduction in Korea? Korea plans to adopt a penalty reduction rate of 10% to 20%, which is significantly higher than that of other foreign countries. To be eligible, companies need to meet the requirements for adopting the CP as notified by the KFTC and have operated a CP for more than one year. Then, the company must apply with the necessary documents and receive the KFTC's CP evaluation. The actual CP operation evaluation will be conducted by an evaluation agency designated and delegated by the KFTC, or an organization that has been engaged in fair trade-related certification and evaluation business for more than 2 years. According to the KFTC's incentives for CP implementation and operation, such as the reduction of fines, companies with a CP rating of A or higher can receive a reduction of the corrective action order once within the period of two years. The size and number of media requirements for publicizing the corrective action will be reduced by one level for companies rated as AA and A and by two levels for companies rated as AAA. The period for mandatory publication of corrective measures in workplaces and electronic media will also be reduced. The reduction in fines will be capped at a maximum of 20%. Companies with AA ratings will receive a 10% reduction and AAA ratings a 15% reduction in the second adjustment phase of a single penalty notice within the 2-year validity period. Companies that demonstrate that they have identified and stopped the violation of the law through CP operations before the start of the investigation can receive an additional 5% reduction in their fine. Also, new conditions were set for not applying the corrective orders and penalty reductions. As the penalty reduction benefit that was abolished was reintroduced with the amendment, the exclusion requirement was also revived to apply the corrective order and penalty reduction benefit more strictly, according to the KFTC. The exclusion requirements apply when the person in charge of the CP is found to have participated in the violation of the law, the violation of the law occurred before the introduction of the CP, the violation is an unfair collaborative act, or the director or senior executive is directly involved in the violation.
- Policy
- ‘A multifaceted approach to reimburse high-priced drugs'
- by Lee, Jeong-Hwan Mar 13, 2024 05:32am
- It has been pointed out that a financial management plan needs to be established for high-priced drugs listed through the general system, as well as a system to evaluate and manage the performance of high-priced drugs that were granted reimbursement through the risk-sharing agreement (RSA) scheme in order to manage the soundness of the National Health Insurance drug finances. In other words, the criticism was that health authorities need to devise multifaceted drug price negotiation models to manage health insurance finances spent on high-priced drugs listed through the general process as no other mechanism than the one that reduces a drug’s price upon patent expiry exists in the current state. In the case of the RSA system, although there had been requests to expand the scope of eligible drugs, the same people pointed out that it is necessary to carefully review such expansions in consideration of the uncertainty of Korea’s health insurance finances. The suggestions above were made in the “Patterns of National Health Insurance Spendings for High-Priced Medicine in Korea,” which was researched by Hye-Jae Lee (Professor, Korea National Open University), Ji-Hyung Hong (Professor, Gachun University ), Eun-Young Bae. (Professor. College of Pharmacy, Gyeongsang National University) The research team analyzed the claims data of Korea’s National Health Insurance from 2010 to 2021, and defined drug with annual per-patient costs exceeding KRW 10 million as 'high-priced drugs. The claims of such high-priced drugs, which accounted for 3.0% of the NHI pharmaceutical expenditure in 2010 (KRW 388.4 billion), rose to account for 8.0% of the NHI pharmaceutical expenditure by 2021 (KRW 1.69 trillion). This is over a 4.4% increase in 11 years, underlining the need and importance of strengthening management of high-priced drugs. During the same period, the annual amount of pharmaceutical expenditures rose by 4.7%, compared with the 14.3% rise in expenditures spent on high-priced drugs. The number of covered high-priced drugs rose from 34 to 209 in the same period and the number of patients from 17,896 to 77,737. This research team defined high-priced drugs based on per-patient costs into low-high-priced drugs (KRW 10 million to 500 million), moderately-high-priced drugs (KRW 50 million to 100million), high-priced drugs (KRW 100 million to 300 million), and ultra-high-priced drugs (over KRW 300 million). By price, low--high-priced drugs, and moderately high-priced drugs accounted for most of the total drug expenditure, accounting for 79.1% of all high-priced pharmaceutical expenditures. 6.0% were moderately high-priced drugs, 10.4% were high-priced drugs, and 4.5% were ultra-high-priced drugs. Among the findings, one thing to note was that among low-high-priced drugs that accounted for 79.1% of all , high-priced pharmaceutical expenditures., the proportion higher for RSA drugs (87.7% ) compared with generally listed drugs (65.4%). The research team also found it interesting that low-high-priced drugs were more likely to be listed through RSA, while ultra-high-cost drugs were more likely to be listed through the general listing process. In particular, the proportion of high-priced drugs was higher among drugs that were granted reimbursement through RSA than through the general listing process. In terms of the proportion of claims filed for high-priced drugs with per patient expenses exceeding KRW 100 million, the rate was 23.0% for generally listed high-priced drugs, much higher than the 9.9% of RSA high-priced drugs. Based on the results, the research team suggested that a financial management plan for generally listed high-priced drugs needs to be established. The research team pointed out that there is a lack of innovative financial management measures to reduce healthcare expenditures for generally registered high-value drugs other than the mechanism of reducing the drug price when the patent expires. In particular, the researchers analyzed that high-priced drugs listed through the general listing process that have been on the market for more than 10 years have already passed the period of surge in usage, and because of the nature of rare diseases, there is often no surge in claims, so the drugs cannot be applied price cuts through price-volume agreement negotiations. "Nevertheless, the absolute number of patients using such drugs is rising due to the introduction of new hemophilia drugs and enzyme drugs, and claims for these two drug types are steadily increasing. When applying PVA negotiations, the parties need to take into account various circumstances such as price changes in overseas reference price countries and listing status of alternative treatments." Furthermore, given that many high-cost drugs are anticancer drugs and are managed within the RSA framework, the researchers suggest that the RSA system should be reviewed and the performance of the financially based types of reimbursement and expenditure-cap types should be evaluated. "Some have suggested expanding the number of drugs eligible for financial-based RSA schemes, but this should be done with caution to effectively manage the uncertainties in health insurance finances. The RSA system should be reviewed and a long-term financial monitoring system be established for high-priced drugs."
- Company
- Bosulif prescriptions now available at general hospitals
- by Eo, Yun-Ho Mar 13, 2024 05:32am
- Pfizer Korea’s Bosulif (bosutinib). Bosulif (bosutinib), a drug used to treat leukemia, is now available for prescription at general hospitals. According to the industry sources, Pfizer Korea’s Bosulif, a drug used to treat Chronic Myelogenous Leukemia (CML), has passed the drug committee (DC) of general hospitals, including Seoul National University Hospital, Seoul St. Mary's Hospital, and Pusan National University Hospital. It is also preparing for the landing at other tertiary general hospitals, including Samsung Seoul Hospital and Seoul Asan Hospital. After securing a reimbursement listing in January, Bosulif has been expanding its prescription domain. However, patients are complaining about the reimbursement criteria. Bosulif is reimbursed for ‘the second-line treatment of adult patients over ages of 18 years old with chronic phase, accelerated phase, or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who have previously demonstrated resistance or intolerance to neoadjuvant therapy including Glivec (imatinib).’ However, since the indication for the basis of approval does not include age limits and the drug can be prescribed beginning from the first-line treatment, patients are pointing out the problem of the narrow reimbursement criteria. The Korean Leukemia Patients Organization has stated, "As suggested by the medical community, Bosulif may be considered the preferred choice for patients who suffer from, or are at risk of, cardiovascular diseases. Therefore, we request that Pfizer and the government take necessary steps to improve reimbursement criteria, enabling the drug to receive reimbursement benefits even when used as a first-line treatment.” It is to be watched if Bosulif, a new drug for CML, can resolve issues of reimbursement criteria and expand its prescription domain. Bosulif is a second-generation, targeted anti-cancer drug alongside Novartis Korea’s ‘Tasigna (nilotinib)’, BMS Korea’s ‘Sprycel (dasatinib)’, and Il-Yang Pharmaceutical’s ‘Supect (radotinib).’ The efficacy and safety of Bosulif have been confirmed in the Phase 3 NCT02130557 clinical study, which involved newly diagnosed patients with CML. The primary endpoint of Bosulif was major molecular response (MMR) by 12 months. Bosulif-treated patients had MMR of 47%. Patients treated with the comparator drug, first generation drug Glivec (imatinib), had MMR of 36%. MMR by Month 60 was 74% for Bosulif versus 66% for Glivec. After 60 months of follow-up, the median time to MMR in responders was 9.0 months for bosutinib and 11.9 months for Glivec.
- Opinion
- [Reporter’s View] Need momentum to boost investments
- by Kim, Jin-Gu Mar 12, 2024 05:49am
- Investment in the domestic pharma-bio industry is slowly rising, awakening from its long winter slumber. Although it is still too early to call it a full spring compared to the boom the industry had enjoyed in 2021-2022, however, significant signs of recovery are being shown through various indicators. Such change is usually most often noted first in the stock market. The KRX Healthcare Index, a leading index for the pharma and biotech sector, has been consistently above 3,000 since the start of the year. This is in contrast to last year when the score remained in the low 2000 range for most of the year. On the 8th, the index reached 3441.04. This is the highest index reached since January 13, 2022, when it reached 3556.92. The market has begun to rebound from the sluggish performance it had shown throughout the past year. Investment in the unlisted sector is also active. According to the Korean startup database TheVC, 37 investments in unlisted pharma and biotech companies had been made in the first 2 months of this year, totaling KRW 907.9 billion. This is a significant change from last year's 29 deals and KRW107.9 billion. The average investment per company also soared from KRW 3.7 billion to KRW 24.5 billion. The IPO market also saw a number of successful IPOs. Osang Healthcare, which is set to go public on the 13th, finalized an offering price of KRW 20,000, which exceeded the upper end of the price band (KRW 13,000-15,000) in its demand forecasting for institutional investors last month. The company continued the success in subscriptions for public shares for general investors, at a competition ratio of 2126 to 1. The deposit for subscription exceeded KRW 5 trillion. Such success continues to be seen in companies that have been listed on KOSDAQ since November last year, such as U2Bio, Curocell, YBiologics, and BlueMTech. A similar change can be detected in the phishing text messages that induce stock investment. While secondary battery-themed stocks were mainly used as bait until last year, several pharmaceutical and biotech stocks have started to be included this year. The texts recommend a few stocks that have risen sharply in recent years and promise high returns based on “non-public information.” In and out of the legal boundaries, the psychology for investment in the pharmaceutical and bio sectors has been showing signs of recovery. This is in stark contrast to the sharp decline in investments over the past 2 years. Although external factors do have a significant impact, it is analyzed that the domestic pharmaceutical bio industry's efforts have also played a role in overcoming the crisis. At the end of last year, Orum Therapeutics, Chong Kun Dang, LegoChemBio, and LG Chem signed a series of large technology export contracts. GC Biopharma secured marketing authorization for its immunoglobulin drug Alyglo from the U.S. Food and Drug Administration (FDA) in December last year, while Yuhan Corp is awaiting FDA approval for its non-small cell lung cancer drug Leclaza. However, the upcoming events that can keep the momentum going are as important. We are in desperate need of an event that will add momentum to the recent uptrend. If established, these events are expected to connect the dots and eventually lead to an improved investment flow for the industry as a whole. Events in the next few months will be crucial in determining whether the industry will emerge from its long winter hibernation and enter full bloom, or whether it will once again be left to freeze in the cold.
- Company
- Quadrivalent meningococcal vaccine MenQuadfi approved
- by Eo, Yun-Ho Mar 12, 2024 05:49am
- The quadrivalent meningococcal vaccine MenQuadfi has landed in Korea. The Ministry of Food and Drug Safety granted marketing authorization for Sanofi's invasive meningococcal disease (serogroups A, C, Y, W) vaccine, MenQuadfi (MenACYW-TT) on the 6th. MenQuadfi is a fully liquid quadrivalent meningococcal vaccine that protects against meningococcal serogroups A, C, W, and Y. It was approved as a single-dose vaccine for persons aged 2 to 55 years. MenQuadfi is administered intramuscularily as a single 0.5ml into the deltoid region or anterolateral thigh depending on the recipient's age and muscle mass. When evaluating immunogenicity and safety with other existing meningococcal quadrivalent vaccines, MenQuadfi demonstrated non-inferiority across all four serogroups. The seroprotection rates were 94.7% for serogroup A, 95.7% for serogroup C, 96.2% for serogroup W, and 98.8% for serogroup Y in people aged 10 to 55 years that were vaccinated with MenQuadfi. Also, compared with the company’s previous meningococcal vaccine that used the diphtheria protein, MenQuadfi uses a tetanus protein and contains more antigens. Meningococcal disease, which can be prevented with MenQuadfi, has been regarded as a global public health concern. Meanwhile, meningococcal disease is a Class 2 infectious disease with a fatality rate ranging from 10-14%. The disease affects 500,000 people worldwide each year. Symptoms include headache, fever, neck stiffness, vomiting, and decreased consciousness, and are often accompanied by petechiae or purpura fulminans. 11-19% of recovered patients suffer from sequelae such as hearing loss, cognitive impairment, and neurological disorders, underlining the importance of its prevention In particular, as meningococcal disease is transmitted person-to-person by respiratory droplets or secretions, vaccination is recommended for those who are about to enter a group setting. For example, new recruits at companies and college students who will be living in dormitories may want to consider meningococcal vaccination.
- Opinion
- [Reporter’s View] Potential drawbacks of expanding RSAs
- by Lee, Tak-Sun Mar 12, 2024 05:49am
- It has been announced that more drugs will be added to the Risk Sharing Agreements (RSAs) track, which will help to improve patient access and reduce uncertainties. In December, the ‘Improvement of the Drug Pricing System to Ensure Fair-value Compensation for Innovative New Drugs and Healthcare Security’ was announced. Under this system, drugs to treat ‘Irreversible Chronic and Severe Diseases’ will be eligible for the RSAs track. The current RSAs only applies to anticancer and orphan drugs, which treat life-threatening and severe diseases that cannot be treated with substitute drugs. In the future, the RSAs will cover drugs that are used to treat chronic and severe diseases that cannot be treated with substitute drugs and result in irreversible deterioration in the quality of life. For example, RSAs will provide coverage for treatments for generalized pustular psoriasis, interstitial lung disease, hereditary angioedema, and severe asthma. The improvement in the drug pricing system will also likely include implementing a dual price system through RSAS to support the export of domestically developed new drugs. The plan is for new drugs granted preferential pricing due to domestic clinical trial status to be listed for the RSAs with essential reimbursement pricing if confirmed to be intended for foreign market distribution and technology export. The RSAs were introduced to South Korea ten years ago. Starting in December 2013, RSAs became available for orphan drugs or anti-cancer drugs without substitutes. Since then, the scope of RSAs has continued to expand through revisions and amendments. In 2020, the coverage was extended to include tuberculosis treatments, antibiotics, and emergency antidotes. Additionally, RSAs were made applicable to subsequent therapeutically equivalent and cost-effective drugs. The advantages of the RSAs are evident. Pharmaceutical companies and insurance authorities can expedite reimbursement inclusion by sharing the uncertainty of drug efficacy and the financial risk burden on health insurance. Expedited listing enables patients to access new treatments. Pharmaceutical companies can overcome the disadvantage of information disclosure in international drug price negotiations by differentiating between the list price and the actual price. However, implementing a dual price system may negatively affect price transparency, potentially disadvantaging patients. For example, patients who paid the total cost of drugs under the RSAs or those who receive selective reimbursement may be eligible for a refund of a portion of the drug cost from pharmaceutical companies, but only if they apply. Patients who are not properly informed may miss out on reimbursement. If the contract renegotiations fail, the drug may be transitioned to non-reimbursable status, potentially increasing the financial burden on patients who were previously covered. The issue of price transparency is being raised internationally. Recently, in Spain, a citizens' group filed a lawsuit demanding the disclosure of actual drug prices under a risk-sharing scheme, and the court accepted the case. Administrative burden is also a concern. Regarding patient refunds, the National Health Insurance Service (NHIS) directly handles the process. For example, a patient was charged KRW 1 million for a cancer drug, and they paid a 5% co-payment rate, which was KRW 50,000. In this case, if a refund rate of 30% is applied according to the contract, and the NHIS receives KRW 300,000 from the pharmaceutical company, the final burden on the patient is not just KRW 50,000, but 5% of KRW 700,000, which is KRW 35,000. Therefore, the NHIS should refund the difference of KRW 15,000. The issue is that the government bears the total burden of this administrative process. With increasing medications subject to RSAs, the workload is only getting heavier. The situation is worsened by the shortage of officials with pharmaceutical expertise due to the drug department's relocation to local areas. It is reported that in advanced countries such as France, medications subject to RSAs are not refunded at all. Because Korea’s initial system included patient refunds, administrative burdens have yet to be relieved in South Korea. While hiring dedicated personnel could help minimize administrative burdens, it would result in additional costs. Experts say expanding RSAs should be handled delicately due to administrative costs and price transparency issues. However, recent government policies appear to be focusing on improving patients' access to new drugs without considering the administrative burden, leading to an increase in drugs subject to RSAs. The government should strengthen the review process to ensure RSAs are applied only to essential drugs. It is important to establish measures to minimize administrative burden to create sustainable policies.
