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- 2026-05-12 09:47:19
- Company
- Organon sold 3 types of infertility & contraceptives
- by Dec 21, 2022 06:05am
- Organon announced on the 19th that it will conduct direct sales and marketing of infertility and contraceptive products. According to Organon, the company will directly sell and market the infertility treatments Puregon and Organutran, and the implantable contraceptive Impranon in the body from next year. The company explained that it is a strategic business decision to realize the promotion of women's health. The goal is to strengthen competitiveness in infertility and contraception markets, including existing women's health products. Impranon will start direct marketing on January 1, 2023. Puregon and Orgalutran will be in charge of Organon Korea after the co-promotion contract with Han Wha, scheduled for the first half of next year. The three products that are converted to direct sales are representative infertility and contraceptive drugs sold in Korea over the past 20 years. Puregon has established himself as a representative of follicle-stimulating hormone, an ovulation-inducing agent. Orgalutran is a GnRH antagonist and has been used to prevent early ovulation spikes in women undergoing hyperovulation induction for assisted reproduction.Impranon is a long-term persistent reversible contraceptive inserted under the skin, with a 99% contraceptive effect lasting up to three years. CEO Kim So-eun said, "We will make significant progress in promoting women's health by strengthening expertise and differentiating based on various women's health product portfolios."
- Company
- Verzenio attempts reimb in early breast cancer in Korea
- by Eo, Yun-Ho Dec 20, 2022 06:06am
- The anticancer drug ‘Verzenio’ is attempting reimbursement listing for early breast cancer in Korea. According to industry sources, Lilly Korea has recently submitted an application for the reimbursement listing of its CDK4/6 inhibitor ‘Verzenio (abemaciclib)’ as a treatment for early-stage breast cancer with a high risk of recurrence. The company has been rapidly progressing its reimbursement procedure since the drug’s indication was expanded last month. The drug was approved by the Ministry of Food and Drug Safety as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence, in combination with endocrine therapy. Verzenio’s efficacy in early breast cancer was demonstrated through the monarchE trial. The Phase III monarchE trial was the only trial to confirm successful results in 20 years as an adjuvant treatment for HR+/HER2- early breast cancer in combination with endocrine therapy in 20 years. The results from Cohort 1 of the monarchE trial, which became the basis for the indication expansion last month, showed that Verzenio+endocrine therapy not only demonstrated a reduction in the risk of recurrence compared to endocrine therapy alone through an improvement in invasive disease-free survival (IDFS), but it also confirmed a reduction in risk of remote recurrence through an improvement in distant relapse-free survival (DRFS). Joohyuk Sohn, Professor of Medical Oncology at Severance Hospital said, “Early breast cancer patients mainly experience recurrence after primary treatment in their first 1-2 years. This is why these patients need a more effective adjuvant treatment to reduce the risk of recurrence and death. An unmet medical continued to exist in the field due to a lack of new treatment options for patients with HR+/HER2- early breast cancer after the introduction of aromatase inhibitors in the early 2000s." Verzenio is currently reimbursed in Korea for the treatment of HR+, HER2- advanced or metastatic breast cancer ▴ in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; ▴in combination with Faslodex for women with disease progression following first-line therapy.
- Policy
- Pfizer & Novartis generic drugs disappear from the market
- by Lee, Tak-Sun Dec 20, 2022 06:06am
- All generic drugs released by Novartis and Pfizer Korean branches in the domestic market have disappeared. Although it was successfully released, it is interpreted that it left the market after losing a lot of competition with domestic pharmaceutical companies. According to industries on the 19th, Novartis' Pneumast 10mg and Pneumast 3mg were removed this month due to voluntary withdrawal of item permits. Pneumast is an organon asthma treatment Singulair generic drug licensed by Novartis Korea in October 2012. In the domestic market, Singulair generic was released in December 2011. Pneumast came out belatedly, and it is analyzed that it failed to show off its presence among numerous domestic generics. Sandoz, a generic subsidiary that Novartis recently decided to spin off, has also withdrawn from the Singulair generic business in the Korean market. As the benefit of Pneumast of Novartis Korea was deleted, all generic drugs under the name of Novartis Korea disappeared. Earlier in June 2020, Novartis withdrew its license to treat hyperlipidemia, Atorvin. Atorvin is Viatris' Lipitor generic drug. Pfizer also lost all generic drugs in a few years. Pfizer introduced Pfizer Vitals, a generic brand, in 2012. It was a business that LG Chem produced and sold licensed products by Pfizer. All products that were approved at that time have disappeared. Norvasc V withdrew the permit due to the Balzartan impurity incident in December 2019, followed by Montelu V in February 2020, Cilo V in May 2021, and Clo V in December 2021. In addition, in December 2021, Norvasc T, a high blood pressure compound, was involved in the false preparation of Jeil's data, and the license was revoked. As a result, domestic generics of Pfizer and Novartis have all disappeared. "At first, foreign pharmaceutical companies put forward their brands and quality through quality generics, but it was difficult to compete with domestic pharmaceutical companies with large hospital distribution networks based on their sales power," said an official in the domestic pharmaceutical industry.
- Company
- MSD-Boryung Bio will copromote Prodiax 23 in Korea
- by Dec 20, 2022 06:05am
- On the 19th, MSD Korea announced it has selected Boryung Biopharma as its new distributor and supplier for its pneumococcal vaccine, ‘Prodiax 23.’ Under the agreement, Boryung Biopharma will be distributing and supplying both the private and contract Prodiax 23 products under the National Immunization Program starting January 1, 2023. MSD Korea’s copromotion agreement with its previous supplier, HK.Inno.N, is set to end at the end of this year. MSD Korea explained that the agreement had been made after reviewing the company’s vaccine product portfolio and long-term strategy from various angles. Boryung Biopharma’s main portfolio consists of vaccines and biological agents and owns a stable cold chain system. MSD Korea believed that Boruyng Biopharma’s experience in directly supplying flu vaccines for the NIP will create a synergy effect. MSD’s 23-valent pneumococcal polysaccharide vaccine, Prodiax23, was approved in 2000. The vaccine covers the widest spectrum of serotypes among pneumococcal vaccines available in Korea. People aged 65 or older may receive pneumococcal vaccines for free under the NIP. Jaeyong Cho, Executive Business Unit Director of Vaccines at MSD Korea, explained, “The interest and demand for our pneumococcal vaccine has been rising in line with the rising public interest in infectious respiratory diseases. Our agreement with Boryung Biopharma was made to instantly and actively respond to this rise in demand.”
- Policy
- President Yoon said, block medical shopping
- by Kang, Shin-Kook Dec 20, 2022 06:05am
- As concerns arose that it might lead to a reduction in health insurance coverage, President Yoon Suk Yeol mentioned a second plan to reform health insurance. Regarding the direction of health insurance reform at the first state affairs inspection meeting at the Blue House guesthouse on the 15th, President Yoon said, "It means that we will eliminate it and re-define the insurance system because moral hazard hurts other good insurance subscribers." President Yoon said, "When I and my family have a serious disease that is really expensive, we will normalize the health insurance system to get proper treatment and recover health without worrying about the money (treatment cost)." "There is a person who goes to the hospital thousands of times a year because it is so-called medical shopping." In addition, there are cases where expensive MRI (Magnetic Resonance Imaging Device) is used indefinitely, he said. "We want insurance subscribers to receive fair support for serious diseases and essential medical care." President Yoon said, "I don't think it's desirable for us to set up a principle called the Medical Judgment Rule and treat it according to normal medical judgment. We'll design and operate a very effective objection procedure system for screening and evaluation." Health and Welfare Minister Cho Kyu-hong, who attended the National Policy Task Inspection Meeting, also stressed that the recent measures to improve the sustainability of health insurance do not reduce the role of health insurance. Minister Cho said, "What the government is trying to reorganize is to provide essential and severe medical care to the public as it is, not to reduce its role, but to improve sustainability," adding, "However, it is to prevent medical abuse or theft of qualifications." The Ministry of Health and Welfare held a public hearing on measures to improve health insurance sustainability and support essential medical care on the 8th and announced measures to recognize benefits only when medical needs are recognized in large-scale items such as paid brain and cerebrovascular MRI and ultrasound. When the Yoon Suk Yeoln government formalized health insurance reform that virtually abolished the so-called "Moon Jae In Care" (a policy to strengthen health insurance coverage), the opposition party strongly protested, saying that there was no case of reducing coverage in the conservative government.
- Company
- Shingrix presents a new paradigm for shingles prevention
- by Eo, Yun-Ho Dec 20, 2022 06:05am
- Professor YoonKorea GSK's herpes zoster vaccine "Shingrix" announced its official launch. GSK held a press conference at InterContinental Seoul COEX on the 15th to commemorate the launch of Shingrix, a shingles-prevention vaccine, in Korea. At the meeting, Yoon Kyung-young, an infectious medicine professor at Korea University Anam Hospital, introduced the epidemiology of shingles, the risk of diseases and complications, and strategies to prevent shingles through unmet needs and vaccines. Shingles occur when the varicella-zoster virus, a chickenpox-causing virus, is reactivated. Shingles are accompanied by unbearable pain, and some patients may experience neuralgia (post-shingles neuralgia) that lasts for months to years even after the shingles rash disappears. Professor Yoon said, "The risk of shingles is increasing in the elderly, where the immune system is strong and cannot maintain an effective immune response due to aging. "In the elderly and immunodeficiency cases, chronic pain caused by neuralgia after shingles, as well as complications such as invasion of eye nerves, facial paralysis, and damage to the auditory nerve are often leading," he explained. In addition, "Sherpas zoster complications lower the quality of life of patients, so it is important to prevent it in advance as a shingles vaccine." Shingrix emphasized that it will present a new paradigm for preventing herpes zoster in Korea as the first and only recombinant inactivation vaccine in Korea that has proven its preventive effect and safety profile through global clinical research. Under the theme of "Major Clinical Research Results of R&D and Shingrix in Recombinant Shingles Vaccine (RZV)," Kim Hyung-woo, managing director of GSK Medical Department, explained the implications of Shingrix's innovative mechanism and development. Shingrix, a Recombinant Zoster vaccine, is the first shingles vaccine in Korea approved by combining GSK's immune enhancer with a non-live antigen. It can help prevent the risk of developing shingles in adults over the age of 50 due to naturally weakened immunity due to aging. Shingrix showed 97.2% preventive effect in two global phases 3 clinical trials (ZOE-50, ZOE-70) conducted on 15,411 adults over the age of 50, and more than 90% preventive effect in all age groups over the age of 70. Significant adverse reactions were similar in the Shingrix administration group and the placebo administration group. An interim analysis of ZOSTER-049 (ZOE-LTFU) conducted by an extensive study of ZOE-50 and ZOE-70 confirmed that the shingles-prevention effect of Shingrix persists for at least 10 years after initial inoculation. In addition, Shingrix confirmed the safety profile through five clinical trials targeting immunocompromised people aged 18 or older. Based on this, Singrix can be vaccinated even in immunosuppressive diseases such as autologous hematopoietic stem cell transplant patients, solid cancer, blood cancer, and solid organ transplant patients, which have a higher risk of shingles than the general public. "Based on a number of clinical results, Shingrix is an innovative vaccine that is recommended to prevent shingles in adults over 50 years of age, not only in the United States but also in Canada, Germany, and the Netherlands, so it can be an effective alternative to prevent shingles in Korea," Kim said. Meanwhile, Shingrix was approved by the Ministry of Food and Drug Safety in September last year. It can be used for the purpose of preventing shingles in adults over 50 years of age or over 18 years of age who are at high or expected to have an increased risk of shingles due to immunodeficiency or immunosuppression due to disease or treatment. It is available in more than 20 countries worldwide, including the United States, Canada, Germany, Belgium, Australia, and Japan. In Korea, vaccinations are expected to be available at major general hospitals, hospitals, and clinics across the country starting this week.
- Policy
- ICER of general drugs KRW 15.97 mil for the past 15 yrs
- by Lee, Tak-Sun Dec 19, 2022 04:35am
- The median ICER (Incremental Cost-Effective Ratio) value of general drugs from 2007 to 2021 was KRW 15.97 million in Korea. The ICER value of anticancer drugs was KRW 45.16 million, and rare diseases KRW 15.97 million in the same period. This was the first time that the ICER results were disclosed, and the disclosed results are expected to be useful for pharmaceutical companies that seek to reimburse new drugs. On the 16th, the Health Insurance Review and Assessment Service announced that it had disclosed the cost-effectiveness evaluation results of drugs that are required to submit pharmacoeconomic evaluation data (ICER) for the past 15 years (2007-2021) since the positive-listing system was first introduced to Korea. ICER is a value used to evaluate the economic feasibility of a new drug that offers an improved effect and shows the additional cost required per unit of increased effect or efficacy of a new drug compared to its alternative. Accordingly, a new drug is interpreted as being cost-effective compared to its alternative if the ICER of a certain drug is lower than a certain threshold. However, instead of using an explicit threshold, Korea flexibly refers to the results of previous deliberations in consideration of the severity and social burden of the disease, its impact on quality of life, and innovativeness. The disclosure follows the deletion of the 'GDP per capita' standard and the addition of the ‘existing review results' standards in the revised regulations for the ICER threshold in the ‘Detailed Evaluation Standards for Drugs Subject to New Drugs, Etc.’ in September last year. HIRA explained that the revision specifies the use of the alternative reference value that is used in Korea, as Korea does not use an explicit threshold value. After the initial disclosure this year, HIRA plans to disclose the 5-year ICER data every December, but in consideration of the number of ingredients in each drug category each period to prevent specifying the evaluation results of individual drugs. In the case of the ICER results of rare disease drugs from 2007 to 2013, HIRA disclosed the minimum and maximum ICER values, but not the median value to prevent the evaluation results of individual drugs from being specified. The ingredients subject to disclosure are ingredients deemed cost-effective by the Drug Reimbursement Evaluation Committee and evaluated for reimbursement. Only for 2022, all data from 2007 to 2021 were disclosed at once. Also, the evaluation results from 2007 to 2013 and 2014 to 2021 were separately disclosed in consideration of the major policy changes that had been made in 2014, such as the ▲increased ICER limit to strengthen coverage for severe diseases (from November 2013) and the ▲ implementation of the risk-sharing system (from December 2013), etc. HIRA explained that the data disclosed are divided into three categories: general drugs, anticancer drugs, and rare disease drugs, and the number of ingredients and cost-effectiveness evaluation results for each category are disclosed. In the case of anticancer and rare disease drugs, the classification is made according to the classifications made during DREC evaluations, and all other drugs are included in the general drug category. The number of ingredients was calculated based on the results of the cost-effectiveness analysis and subject ingredients, and HIRA will be disclosing the median, minimum, and maximum values based on drug category. The ICER results of drugs that submitted data for economic evaluations showed that the median ICER of generic drugs from 2007 to 2021 was KRW 15.97 million. Also, the ICER value of anticancer drugs was KRW 45.16 million, and rare disease drugs KRW 32.32 million. The ICER results of drugs subject to PE data submissions can be found on HIRA’s webpage. Mi-Young Yoo, Deputy Minister of HIRA's Pharmaceutical Benefits Management Department, said, “The ICER results that were disclosed this time are meaningful as this is the first time the data had been disclosed since the introduction of the positive-listing system, and the annual regular disclosure of the data is expected to be used as an alternative reference value related to ICER.” Yoo added, “However, in evaluating the reimbursement adequacy of drugs, not only the ▲cost-effectiveness from PE evaluation results, but also the ▲clinical effectiveness, and ▲its impact on NHI finances, are comprehensively considered. Korea does not use an explicit ICER threshold value; it rather evaluates the value in consideration of the uncertainties based on the results of the sensitivity analysis in addition to the basic analysis results. Therefore, we ask people to play caution in interpreting the published cost-effectiveness evaluation results.”
- Policy
- Pfizer Cibinqo, re-applied to the HIRA
- by Lee, Tak-Sun Dec 19, 2022 04:35am
- Pfizer Cibinqo, which aims to pay for atopic dermatitis indications as a JAK inhibitor, is being paid later than expected. It was expected to be deliberated by the Drug Benefit Evaluation Committee within the year after passing the HIRA Drug Benefit Standards Subcommittee in August, but it is expected to take some time for the salary to be converted as it is known to have recently withdrawn and submitted a new application. According to the industry on the 15th, Pfizer Cibinqo recently withdrew its application for benefits decision and immediately resubmitted it. The screening is expected to be delayed further as the salary application has been withdrawn and resubmitted. Initially, Cibinqo applied for salary registration in April and passed a review by the Drug Benefit Standards Subcommittee in August. According to the procedure, it should have been reviewed by the Drug Benefit Evaluation Committee this month, but it was not. In the industry, Cibinqo was expected to proceed without difficulty as the same JAK inhibitors Oluminant and Rinvoq were previously applied not only to rheumatoid arthritis but also to adult atopic dermatitis since May. Pfizer is currently leading the related market with JAK inhibitor Xeljanz. However, compared to competing drugs, there is no atopic dermatitis indication, so we are counting on Cibinqo. Cibinqo has dropped the permit The reasons for reapplying are not known exactly. Although Cibinqo is struggling with salary, it has recently passed the Drug Commission (DC) of large hospitals such as Seoul National University Hospital one after another, laying the foundation for a prescription. If the salary is made, it is expected to settle in the market quickly. Cibinqo has the efficacy and effect of treating severe atopic dermatitis in moderate symptoms of adults and adolescents aged 12 or older who are subject to systemic therapy.
- Company
- Reimb for Revlimid as maintenance therapy near after 4 yrs
- by Eo, Yun-Ho Dec 19, 2022 04:35am
- After 4 long years of await, Revlimid as maintenance therapy is nearing reimbursement listing in Korea. According to industry sources, the agenda of reimbursing Revlimid as maintenance therapy that has passed deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in June will be deliberated at this year’s final Health Insurance Policy Deliberation Committee meeting. If this last procedure progresses and is completed without issues, the drug’s reimbursement is expected to be expanded from 2023. The agenda of using Revlimid as maintenance therapy had undergone various twists and turns in Korea. Since 2019, BMS Korea had actively sought to list the drug for reimbursement, but made no progress. The agenda has also been listed for deliberation by the CDDC in September 2019, June 2020, then again in September last year at the CDDC meeting that gained attention due to its deliberation of the CAR-T therapy ‘Kymriah (tisagenlecleucel),’ but to no avail. “A drug that prevents or delays recurrence of cancer” This is an extraordinary concept. All cancer survivors would jump to take that option. Revlimid has presented such an option for the first time in the field of multiple myeloma, a type of blood cancer that has a recurrence rate of 70-80%. The National Comprehensive Cancer Network made a Category 1 recommendation for the Revlimid maintenance therapy as the only option allowed for in all patients, regardless of eligibility for transplant. The European Society for Medical Oncology guidelines also recommends Revlimid as the only maintenance therapy to be used after autologous stem-cell transplantation. The significance of Revlimid, which has settled as the global standard of care as a maintenance therapy, has been demonstrated through a meta-analysis of 3 clinical trials (CALGB 100104, IFM 2005-02, GIMEMA RV-MM-PI-209). In a median follow-up of 79.5 months on 1,209 patients, PFS (progression-free survival) of patients that used Revlimid maintenance as monotherapy was 52.8 months, which was a significant improvement from the 23.5 months observed in the control arm that did not use maintenance therapy. the study demonstrated Revlimid’s clinical efficacy with more than double extension in PFS. In the follow-up study that was conducted for 88.8 months, the OS (overall survival) of the control group that did not receive maintenance therapy was 86.9 months. On the other hand, the Revlimid maintenance therapy arm’s OS was 111 months, demonstrating a significant improvement. The study showed that maintenance therapy can be a solution to prevent recurrence and improve the quality of life in multiple myeloma patients that experience frequent recurrence. Since patients with multiple myeloma experience worse symptoms when their cancer recurs, it is most important to prevent or delay recurrence after transplantation. Ki-Hyun Kim, Professor of Hemato-oncology at the Samsung Medical Center (Chair of the Multiple Myeloma Research Committee of the Korean Society of Hematology), said, “The prognosis for multiple myeloma deteriorates significantly and the treatment options narrow greatly with every recurrence, therefore using good treatments at the start of treatment is important. It is a shame that we cannot actively recommend maintenance therapy to patients despite their proven clinical efficacy due to the realistic issue of ‘non-reimbursement’.” “If the maintenance therapy is also approved for reimbursement in addition to RVD therapy, it will greatly improve the long-term quality of life in patients in Korea.”
- Policy
- Green light for the reimb of Onureg, Rolontis, etc.
- by Lee, Tak-Sun Dec 19, 2022 04:35am
- A green light has been lit for the reimbursement of BMS Korea’s leukemia treatment ‘Onureg tab,’ with its agenda passing deliberations for setting reimbursement standards. Also, reimbursement standards have been prepared for 5 neutropenia treatment products including Hanmi Pharmaceutical’s Rolontis. The Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee (CDDC) held its 10th meeting on the 14th and made the deliberations above. First, Onureg tab (azacitidine, BMS Korea), which is attempting to establish a new reimbursement category, succeeded in establishing reimbursement standards as ‘maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT). On the other hand, Novartis Korea failed to receive reimbursement standards for Scemblix tab (asciminib, Novartis Korea) as a treatment for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs). Also, the CDDC did not approve the establishment of reimbursement standards for Inrebic cap (fedratinib hydrochloride, BMS Korea) as a treatment for enlarged spleen or other symptoms related to primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythaemia myelofibrosis in adult patients that have been previously treated with ruxolitinib. In addition, Nerlynx tab (neratinib maleate, Bixink) failed to receive reimbursement for use as monotherapy as extended adjuvant treatment for patients with early-stage HER2-positive breast cancer in those who have received adjuvant trastuzumab-based therapy within a year. 10th CDDC deliberation results On the other hand, the green light has been lit for neutropenia treatment products that are in use in Korea. The products are: Neulasta prefilled syringe inj (pegfilgrastim, Kyowa Kirin Korea), Neulapeg (pegteograstim, GC Corp), Dulastin prefilled syringe (tripegfilgrastim, Dong-A ST), Lonquex prefilled inj (lipegfilgrastim), and Rolontis prefilled syringe ing (eflapegrastim, Hanmi Pharmaceutical). The products succeeded in establishing reimbursement standards on reducing the incidence and period of febrile neutropenia in patients undergoing cytotoxic chemotherapy for malignant tumors, and on reducing the period of severe neutropenia in patients undergoing cytotoxic chemotherapy for solid tumor and malignant lymphoma.
