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- 2025-12-24 19:51:36
- Policy
- Off-label Mabthera use on NMO patient rejected
- by Lee, Hye-Kyung Mar 09, 2020 07:59am
- Non-reimbursed use of Mabthera injection (rituximab) on a female patient with neuromyelitis optica (NMO), who is planning on a pregnancy, has been denied. Korea’s Health Insurance Review and Assessment Service (HIRA) preliminarily reviews off-label non-reimbursed use of drugs to prevent using drugs lacking medical evidence or having safety risk. The detailed information regarding ‘Unapproved Use of Off-label Non-reimbursed Drug’ was recently disclosed by HIRA, which stated total 173 cases of off-label non-reimbursed use of drugs have been rejected including the latest three cases of Mabthera, Sirturo (bedaquiline fumarate) and Truxima (rituximab). HIRA informed on Mar. 5, a healthcare institute’s approval application to administer 375 mg of Mabthera once-weekly for four times, or to intravenously inject 1000 mg once-biweekly for two times, considering patient’s condition and drug’s adverse reaction and treatment effect, has been unapproved due to ‘insufficient submission of medical data.’ Currently, Mabthera has been approved to treat patients with lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s granulomatosis with polyangiitis and microscopic polyangiitis. Another healthcare institute has applied for a non-reimbursed use of Sirturo on an adult patient with mycobacterium tuberculosis lung disease (without general disease like severe underlying liver or renal disease) and on a patient with chronic and advanced nontuberculous mycobacteria lung disease not responding to existing treatment option. However, both of the applications were rejected as well. Due to insufficient medical data, the healthcare institute’s application to orally administer 400 mg of Sirturo everyday for first two weeks and to continuously administer half the dose for three times a week, was unapproved even though the institute said the administration would be stopped when the treatment fails. Lastly, the off-label non-reimbursed use of Truxima was turned down, because the submitted data of bioequivalent pharmaceutical lacked sufficient medical evidence. The off-label non-reimbursed use of Truxima was submitted initially to treat a patient diagnosed with inflammatory myopathy, who experienced adverse reaction or is refractory to existing steroidal treatment, immunosuppressant treatment, or immunoglobulin treatment.
- Policy
- ₩11 trillion is organized in supplementary budget
- by Lee, Jeong-Hwan Mar 06, 2020 06:06am
- The government will finalize the revised supplementary budget for COVID-19 at ₩11.7 trillion and submit it to the National Assembly. The budget details include reinforcing infectious disease prevention system, restoration of damages to small business owners, support for public welfare and employment, and support for stagnant local economy. In particular, the government organized a total of ₩2.1 trillion in the compensation for damages to COVID-19 medical institutions and pharmacies. Clinics, hospitals and pharmacies are eligible for payment. Direct compensation of ₩350 billion, loan support of ₩400 billion, and loss compensation reserve of ₩1.35 trillion will be given to the hospitals, clinics, and pharmacies that actively participated in the defense. On the 4th, the Ministry of Economy and Finance announced its revised supplementary budget for minimizing the impact of COVID-19 and overcoming. The Ministry of Economy and Finance recognizes that it is an economic emergency state due to COVID-19, and plans to go beyond existing emergency support to make efforts for stability of people and economic vitality. ₩11,700 billion revised supplementary budget has been finalized by the Ministry of Economy and Finance. First of all, it raised ₩2.3 trillion to reinforce and enhance the quarantine system such as quarantine, diagnosis and treatment of infectious diseases. The government will invest ₩2.4 trillion to support the recovery of small business owners, ₩3 trillion in public welfare and employment stability, ₩800 billion in recovery of stagnant local economy, and ₩3.2 trillion in tax revenues. Measures and scale of additional budget The Ministry said that the COVID-19 response would be given priority as the basis for urgency, feasibility, and time limit, while minimizing the number of projects to obtain additional budget. The financial resources will be raised to ₩700 billion, including surplus level of the Bank of Korea and ₩700 trillion for free funds, and ₩10.3 trillion for government bonds. In detail, the budget for reinforcing and upgrading the defense system (₩2.3 trillion) will amount to ₩100 billion for strengthening the capability to respond to infectious diseases, and ₩2.2 trillion for compensation for loss of medical facilities for COVID-19 victims and support for living expenses for the quarantine. For support for recovery of damaged SMEs and small business owners (₩2.4 trillion), The Ministry raised ₩1.7 trillion to expand loans and ultra-low interest rate loans to victims, small businesses, and ₩600 billion to support employment retention of small businesses and lower rents, and support ₩100 million for damage stores and traditional markets. The public welfare and employment security support (₩3 trillion) budget is estimated at ₩2.4 trillion for low-income consumption coupons, special care coupons, and senior citizens' job coupons, ₩600 billion to expand youth employment incentives, successful employment packages, and Durunuri. Regional economic recovery support (₩800 billion) budget included ₩100 billion for special support for regional employment in the affected areas, ₩200 billion for the issuance of regional gift certificates, ₩500 billion for local financial reinforcement, and support for elementary, middle, and high quarantine requirements. The budget is to be specially allocated for the Daegu and Gyeongbuk budgets. ◆Reinforcement and enhancement of the quarantine system=The main project of supplementary budget is to expand the negative pressure room on the nationally designated inpatient treatment bed and to provide national aid for the transportation of ambulances to infected patients.. The KCDC will invest ₩9.8 billion to reinforce the testing capabilities of new infectious diseases and to expand inspection and analysis equipment. In preparation for the outbreak of large-scale new infectious diseases, a total of ₩4.5 billion was added to add two specialty infectious diseases hospitals with negative pressure wards. The budget for the establishment of a virus research institute affiliated with the KCDC to study new viruses and strengthen the response system is ₩3 billion. ◆Compensation for Loss of Damaged Medical Institutions =₩350 billion in compensation for the loss of medical institutions resulting from the implementation of the government's quarantine measures and ₩400 billion for financial support for management stabilization. The cost of living support and paid leave will be provided to the employer for ₩80 billion. In preparation for the increase in the cost of indemnity for medical institutions in the future, the preliminary reserve of ₩1,350 billion was reinforced. In particular, the Ministry plans to provide support for the mask support plan quickly, with a reserve fee, but will gradually increase support in consideration of supply and demand trends. More than 130 million copies will be provided free of charge to medical workers, daycare centers, kindergartens, elementary schools, and low-income families nationwide by April. We also support the reinforcement of mask production facilities for smooth supply, with Daegu and Gyeongbuk supplying 8.98 million of masks. Key investment direction of additional budget ◆Support for the recovery of the damaged SMEs and small business owners. The company raised 100 trillion won in emergency management fund loans for small business owners & SMEs and raised 100 billion won to support capital investment funds for rehabilitation of SMEs in Daegu and Gyeongbuk. ◆Daegu-Gyeongbuk Special Assistance=The Ministry has organized ₩6 billion for the construction of a medical infrastructure for special assistance in the Daegu-Gyeongbuk COVID-19. The goal is to reinforce the quarantine system by establishing a hospital specializing in infectious disease in Yeongnam area and expanding 15 negative pressure beds. Emergency funds of ₩1.4 trillion will be provided to local SMEs and small business owners. A total of ₩1 billion was provided to support the recovery of the local exonomy and damaged stores.
- Policy
- COVID-19 Special Committee announced a“Pincette Meeting”
- by Lee, Jeong-Hwan Mar 05, 2020 06:34am
- The National Assembly's COVID-19 Countermeasures Special Committee is the first to resolve the issue of 'Daegu hospital bed & medical facilities shortage' and 'mask shortages' and will hold a 'Pincette Meeting' for about 4 hours. The committee decided to receive a report on issues related to the lack of mask supply to the MFDS, the Ministry of Economy & Finance, the Ministry of Health, and the Ministry of SMEs and Startups, and to Daegu quarantine and medical care to the Office for Government Policy Coordination, the Ministry of the Interioir & Safety, and the Ministry of Welfare on the second meeting, which will be held at 9 am on the 5th Looking at the second agenda, they discuss about the shortage of Daegu beds and medical facilities for about two hours from 9 am to 11 am. After 11am to 1pm, they will report on the current shortage of mask supply. The management group of the ruling/the opposition parties also agreed to the schedule and contents of the third meeting as the infectious disease situation is urgent. The opening date is set for the morning of the scheduled session of the second week of March. The intention is to operate flexibly in response to changes in the national parliamentary schedule. The agenda of the 3rd meeting is about entering and responding to Chinese students and to report the issue of urgent care problems caused by the adjustment of the academic schedule (postponement of entrance and departure). The target institution is the Ministry of Education. On the 4th, the special committee’s management group discussed plans to conduct public hearings on the agenda for the 2nd and 3rd special meetings after consultation during the break. The committee had its first meeting since its launch on the 2nd. The special committee, which elected Democratic Party Kim Jin-pyo as its chairman, put their heads together and form a solution. The Special Committee agreed to operate a “ Pincette Meeting” on key issues such as masks with Daegu and Gyeongbuk, which are the most affected by infectious diseases, but there were also signs of conflict over the government's responsibility for preventing infectious diseases. It is expected that the progress of the second and third meetings will determine whether the Special Committee should overcome the disagreement and succeed in establishing effective policies in future meetings.
- Policy
- Remdesivir, clinical trial of 195 patients with COVID-19
- by Lee, Tak-Sun Mar 05, 2020 06:33am
- Gilead Science's 'Remdesivir', which is attracting attention as a treatment for COVID-19, is conducting clinical trials on a total of 195 patients in Korea. There are three medical institutions with clinical trials: Kyungpook National University Hospital, National Medical Center, and Seoul Medical Center. The Ministry of Food and Drug Safety approved the Phase III clinical plan of Remdesivir of Gilead Science Korea, which will be conducted for patients with moderate to severe COVID-19. The test will begin this month. First, randomized trials are conducted in moderate patients to evaluate the safety and antiviral activity of Remdesivir compared to standard treatment. The total number of target subjects was 600 (including overseas), of which 120 were domestic. The primary efficacy endpoint was the rate of subjects discharged up to 14 days post-dose. Clinical trials will be conducted at Seoul Medical Center (Professor Mi-young Ahn, Infectious Medicine), National Medical Center (Professor Bum-sik Jin, Infectious Medicine), and Kyungpook National University Hospital (Professor Shin-woo Kim, Infectious Medicine). Clinical trials in critical patients are also conducted in the same institution. The total number of target subjects is 400 (including overseas), but the number of domestic subjects is 75. Severe patient trials are conducted in randomized trials to evaluate the safety and antiviral activity of Remdesivir without comparison with conventional treatment. The proportion of subjects whose fever and oxygen saturation were normalized until 14 after administration was used as the primary efficacy endpoint. Remdesivir is a candidate for nucleotide analogues that has shown extensive antiviral activity in in vitro and in vivo animal models of new viral pathogens such as Ebola, MERS and SARS. Remdesivir was given to the first patient infected with Corona19 in the United States, which showed improvement. Currently, 761 patients are in clinical trials in Wuhan, China.
- Policy
- Finalized gradual drug pricing in effect from July
- by Kim, Jung-Ju Mar 04, 2020 06:27am
- The government finalized the so-called ‘gradual drug pricing system revision’ that differentiates reimbursed generic pricing based on individual bioequivalence test. The approval qualification and pricing linkage, such as conducting individual bioequivalence test and using registered substance with DMF, would come in effect from July 1. While the weighted pricing benefit for incrementally modified drug (IMD) would be maintained as the pharmaceutical industry has demanded. Korea’s Ministry of Health and Welfare (MOHW) has recently finalized and published the partially revised Pharmaceutical Decision and Adjustment Standard the authority reissued preliminary announcement on last Jan. 28. From the first version unveiled last July 2, the revision took seven months to set the seal on the final version. ◆ Drug pricing calculation standard (including eye drop): The key amendments of the finalized revision are not too far from the version revealed last July. Depending on running either individual or joint bioequivalence test, reimbursed generic pricing would be reduced ‘gradually’ by 15 percent, and ‘cut-off line’ would also limit the number of generics with same agents. In detail, the qualifications (submitting individual bioequivalence test data or clinical data, and using registered drug substance) for differentiated pricing have been set down. Limiting 19 or less registered generics in same class, the pricing of the generics would be reduced gradually based on the qualification. Qualifying all, one or none of the conditions would price the generic by 53.55 percent, 45.52 percent and 38.69 percent of the original’s price, respectively. When the 20th generic in the same class is listed, the ‘cut-off line’ system would automatically price the generic at 85 percent of either the lowest maximum price in the class or 38.69 percent of the original’s price. As for eye drop, the applicant product would follow the already-listed eye drop’s pricing calculation, based on whether it is a single-use or multi-use product. Such changes would take in effect from coming July 1. However the pricing standard for eye drop would be enforced immediately. ◆ Weighted pricing benefit: The IMD weighted pricing benefit demanded by the industry would be maintained. Lump-sum changes in benefit for synthetics and biologics, extended period of weighted pricing and other details contained in the first version were kept. The weighted pricing benefit for IMD would be maintained until another IMD or a single or combination drug with same administration method, ingredients and formulation is listed. This includes incrementally modified combination drug. However, the benefit would be not granted to a combination drug, if there are two or more companies supplying single or combination drug, a part of the combination drug, with identical administration method, ingredients and formulation. And a drug listed after the weighted pricing benefit period has expired would not receive the benefit. The pricing benefit for synthetics (chemical) and biologics are unchanged from last year’s version. The benefit-granted period and number of company set individually would be amended and unified. Basically, the weighted pricing benefit for synthetics and biologics would last for a year, and it would be maintained up to two years as long as the number of company stays under three. And the ministry stipulated Drug Reimbursement Evaluation Committee (DREC) to deliberate adjustment of weighted pricing rate and benefit period up to two years upon request by pharmaceutical company. The said revisions would come in effect from next Jan. 1, except for the pricing benefit granted to an applicant that submitted both individual bioequivalence test data and proof of using substance with DMF would also come in effect from July 1 along with other changes.
- Policy
- The supply cost of NIP quadrivalent flu vaccine is absurd
- by Lee, Tak-Sun Mar 03, 2020 06:09am
- Manufacturers are opposing the government's pricing policy ahead of the Quadrivalent flu Vaccine (NIP) program. Damages will be inevitable by setting a budget without considering production costs more expensive than trivalent vaccines. In particular, pharmaceutical companies are complaining that they have to take losses because medical institutions purchase them at a uniform price without distinguishing between NIP vaccine and general vaccine. Therefore, it is argued that, at least, the PPS should make a bulk purchase of NIP vaccines. According to the pharmaceutical industry on the 2nd, 14 million people including 6month old~12 year olds, pregnant women, and 65-year-olds can receive quadrivalent flu vaccines as NIP for free as early as September this year. Previously, only trivalent vaccines were applied for NIP. quadrivalent flu vaccines have the advantage of being able to prevent four types of influenza viruses, such as two types of A and two types of B. The Ministry of Health and Welfare is said to have set the supply price of the quadrivalent flu vaccine for around ₩9,000 this year. This is 60-70% of the current market price (₩14,000 ~ ₩15,000). Manufacturers are protesting. An official of the related company said, “The price of tetravalent vaccines set by the Ministry of Health and Welfare is about 5% higher than the trivalent influenza vaccine subject to free vaccination in 2019, and this decision is not considered at all because the production cost is more than 25% higher than the trivalent vaccine”. Moreover, it is opposed to spending much less than the huge development investment cost. Hospitals can buy them in bulk all together, As a result, inventory losses were left to pharmaceutical companies. The problem is that the unit price of the NIP vaccine also determines the price of the general vaccine. Generally, the products supplied by the country from the Public Procurement Service are collectively purchased and distributed to the relevant institutions. However, influenza vaccines are purchased and distributed only for products aged 65 or older As a result, vaccines for children aged 6 months to 12 years and pregnant women, who are eligible for free vaccination, are purchased by the hospital and charged after receiving the vaccine. Therefore, the hospital purchases the flu vaccine at a uniform price without discriminating between NIP and general vaccines. This suggests that manufacturers and suppliers have limited room for pricing and supplying general vaccines. If the supply price of tetravalent vaccine is set at ₩9,000 according to the government's budget, the supply price is lower than in previous years, and the loss of the manufacturer is inevitable. Another official in the industry said, “Especially, manufacturers should take stocks of free vaccines that have not been inoculated after supply at the cost of loss, like general vaccines”. The official said, "The low price policy of this NIP business will undermine the development of pharmaceutical companies that invest R&D of billions of dollars, and domestic manufacturers have been contributing to improving vaccine self-sufficiency in line with the government's efforts to establish vaccine sovereignty". The manufacturers of tetravalent vaccines argue that the rational price of the free vaccination market needs to be reasonable, and that the PPS should consider bulk purchasing to relieve inventory burdens. An industry official said, "At least NIP vaccination price and general vaccination price should be made in a structure that can be dualized".
- Policy
- MOHW to speed up anticancer therapy reimbursement review
- by Lee, Jeong-Hwan Mar 03, 2020 06:09am
- The Korean health authority is to expedite the reimbursement review procedure for the latest anticancer therapies including Imfinzi, Bavencio, and Tecentriq. The authority is also reviewing data submitted by Opdivo and Keytruda for their additional indications. On Feb. 28, Ministry of Health and Welfare (MOHW) Pharmaceutical Benefits Division answered with the details on paper as National Assembly Health and Welfare Committee’s Lawmaker Kim Soon-rye (United Future Party) questioned about COVID-19 status report. Some patients taking a drastic measure of consuming canine dewormer fenbendazole as an anticancer treatment seems to have influenced the government accelerating the reimbursement listing and indication expanding procedure for anticancer treatments. MOHW official stated non-small cell lung cancer-targeting Imfinzi has completed negotiating with National Health Insurance Service (NHIS) and is waiting for deliberation by Health Insurance Policy Deliberation Committee (HIPDC). Cancer Deliberation Committee has recently passed Merkel cell carcinoma (MCC) treatment Bavencio, which now awaits follow-up procedure with Drug Reimbursement Evaluation Committee (DREC). Non-small cell lung cancer-targeting Tecentriq plus caboplatin plus etoposide combination therapy has been cleared by Cancer Deliberation Committee and now is in process of financial impact analysis. The reimbursement expansion reviews for Opdivo and Keytruda are still in review. MOHW explained the immunotherapies would be indicated as mono- and combination therapy for various cancer kinds. The ministry also clarified it would maintain the basic principle of primarily providing healthcare reimbursement to drugs with confirmed clinical efficacy and cost-effectiveness. MOHW official noted, “The ministry would set down reasonable reimbursement standard that enhances benefit to cancer patients and predictability of National Health Insurance expenditure.”
- Policy
- The government invests ₩16 trillion for COVID-19
- by Lee, Jeong-Hwan Mar 03, 2020 06:09am
- The government announced on the 28th that it would invest about ₩16 trillion to finance, tax and banking to solve the problems caused by the spread of COVID-19. From March to June, the check and credit card income deduction rate will be doubled to the previous level, and individual consumption tax will be cut by 70%. VAT payments for self-employed business owners who suffered the damage of COVID-19 with annual sales of less than ₩60 million will be reduced to the level of simplified taxation by the end of next year. The government is also planning to submit additional revision budgets worth ₩6.2 trillion, the similar size of MERS crisis, with the aim of COVID-19 quarantine, diagnosis, treatment, recovery of damaged small business, public welfare and employment stability, and support of the stagnant regional economy. The economic vitality council held by Nam-ki Hong, Deputy Prime Minister & Minister of Economy and Finance included the contents. Nam-ki Hong, Deputy Prime Minister said, “As the spread of infections in the community worsened, the difficulties for the public's lives and the economy became severe and included special measures worth up to ₩16 trillion. It is to support strong overcoming damage and to reinforce consumption, investment and export slowdown”. The government will invest about ₩7 trillion in finance (₩2.8 trillion), tax (₩1.7 trillion), banking (₩2.5 trillion), and ₩9 trillion. in public and financial institutions. If the government adds ₩4 trillion of measures already in place, the government will spend ₩20 trillion. In addition, if the supplementary budget of more than ₩620 trillion is included, over ₩26 trillion will be spent to overcome COVID-19 outbreak. In February, the government revised the tax law in the extraordinary parliament and the income deduction rate of workers' credit card use will be from 15% to 30%, the use of ATM cards and cash receipts from 30% to 60%, and the use of traditional markets and public transportation will raise by 40 → 80% temporarily. In the same period, the individual consumption tax will be reduced by 70% from 5% to 1.5% within the limit of ₩1 million. Compared to the 30% reduction from the second half of 2018 to the end of last year, the cut has more than doubled, and the government expects the tax benefits to reach ₩470 billion. Benefits are doubled by adding 70% reduction in the individual consumption tax, which is applied to converting old cars to new cars for more than 10 years by the end of June. It also reduces tax burdens for small business owners who have been damaged by COVID-19. By the end of next year, VAT payments for small business owners with annual sales of less than ₩60 million will be reduced to the level of simplified taxation. The plan is to keep the simple tax base of ₩48 million in annual sales and keep the VAT burden low. As a result, the government expects that 900,000 individual business owners will receive tax incentives of ₩800 billion for two years, with annual averages of ₩200,000 ~ ₩800,000 per business per person The government subsidizes ₩500,000 in family care expenses until the end of COVID-19 outbreak when parents use family care leave to take care of children under 8 years of age, with the closing of nursery schools according to COVID-19. The job coupon system, which provides 20% of the total remuneration to elderly job participants in the form of local gift certificates, is also temporarily implemented for four months. The participant, however, must receive 30% of the total remuneration as a gift certificate, including any additional payment. It also introduces vacation, culture, tourism and maternity coupons, and a system that refunds 10% of the purchase price of high efficiency home appliances will also be implemented.
- Policy
- Remdesivir, Phase III clinical trials are imminent in Korea
- by Lee, Tak-Sun Mar 02, 2020 06:22am
- Gilead has applied for Remdesivir’s IND for COVID-19 patients at the MFDS. In Asian countries, including Korea (excluding China), the study targets 1000 patients. There is no country-specific number of subjects, but it is known to be recruited on a first come, first served basis. The MFDS announced that Gilead submitted a Phase III clinical trial plan for Remdesivir. An official from the MFDS said, "The IND was submitted today and plans to be reviewed for expedited examination". It will be approved as early as this week. Gilead Science said in a press release that it will conduct two Phase III trials to evaluate the efficacy and safety of Remdesivir in adult patients diagnosed with Corona19. Many medical institutions in Asia and many other cases of COVID-19 diagnosis plan to recruit 1000 patients from March. The trial will be conducted in accordance with the prompt review and approval of the US FDA. In China, two clinical trials are underway in Hubei Province. Results are reported in April, with 761 patients in clinical trials. Gilead says the trial evaluates two different durations of Remdesivir. In the first trial, approximately 400 COVID-19 confirmed patients with severe clinical features, will be randomly assigned to the 5- or 10-day Remdesivir group. The primary endpoint in the two trials is the same as the clinical improvement. Remdesivir is a drug that Gilead has already completed in Phase II clinical trials to develop Ebola. It is being used as the first treatment for COVID-19 in the United States, and it is getting attention as a treatment for COVID-19. It is a mechanism that prevents virus replication by binding to RNA, like Kaletra, an AIDS drug currently used in COVID-19 patients in Korea.
- Policy
- Single Hib vaccine Vaxem Hib exits Korean market
- by Lee, Tak-Sun Mar 02, 2020 06:21am
- Apparently, there are now only two single Haemophilus influenzae type b (Hib) vaccines left in the market that prevents cerebromeningitis in children by blocking Hib bacteria. Experts analyze, although a part of National Immunization Program, single Hib vaccine has lost its competitiveness in Korean market against other combination vaccines covering various viral infection. According to Korea’s Ministry of Food and Drug Safety (MFDS), GlaxoSmithKline (GSK) has dropped the license on Vaxem Hib on Feb. 25. It was not a surprise. GSK has suspended supply of Vaxem Hib since August last year. The company stated, “In the process of integrating and maintaining the production line to enhance efficiency in the vaccine business, the company has inevitably decided to suspend supply of Vaxem Hib that has been supplied only to Korean market.” Previously, GSK had suspended supply of Hib vaccine Hiberix in 2016. The license on Hiberix was terminated last August. ` Vaxem Hib was absorbed to GSK when it merged with Novartis Vaccine Division in 2015. But with the latest termination of license, the company is completely pulling out from the Korean Hib single vaccine market. Rather, the global company would concentrate on combined vaccine market with Infanrix IPV/ Hib combination vaccine. Now, LG Chem’s Euhib and Sanofi Pasteur’s Activ are the only Hib vaccines in Korea. Euhib was developed solely with Korean-made technology and received license in August 2010 after eight years of development costing approximately 7.7 billion won. Thanks to Euhib, Korea has a self-sustainable supply of Hib vaccine. Hib vaccine used to be a blockbuster market generating 10 billion won per each item. But Hib vaccine lost its competitiveness as combination vaccine covering Hib virus was designated as a National Immunization Program since 2017. According to last year’s data disclosed by IQVIA, Vaxem Hib, Euhib and Activ made around 700 million won, 500 million won and 64 million won, respectively. Meanwhile, pentavalent vaccine Pentaxim by Sanofi Pasteur has generated 11.9 billion last year. With a single shot, Pentaxim can prevent diphtheria, tetanus, pertussis, poliomyelitis and invasive infection by Hib bacterium. Frequently found in children under five, Hib bacteria could cause invasive infection-induced diseases, such as meningitis, epiglottitis, septic arthritis, pneumonia and cellulitis. Approximately 90 percent of pediatric meningitis is reportedly induced from the bacteria. Accordingly, Korea’s National Immunization Program has included Hib vaccine since March 2013.
