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- 2026-04-04 15:14:15
- Company
- Imfinzi builds evidence for biliary tract cancer reimb
- by Whang, byung-woo Oct 02, 2024 05:49am
- AstraZeneca is reattempting to extend reimbursement of its immuno-oncology drug imfinzi (durvalumab) after announcing significant clinical outcomes in biliary tract cancer. Amid the rising interest in Imfinzi’s reimbursement reapplication review, with patient petitions being posted on the National Assembly's e-petition website, the outcome of the Korean subgroup analysis has been recently announced, gaining attention. 임핀지 제품사진According to industry sources, the Health Insurance Review and Assessment Service will hold the 7th Cancer Disease Deliberation Committee (CDDC) meeting on the 2nd of this month. This time, AstraZeneca is knowingly reattempting to extend Imfinzi’s reimbursement after failing to extend its reimbursement as a first-line treatment for biliary tract cancer last year. Last year, the company was not able to receive full coverage for the Imfinzi and GemCis (gemcitabine plus cisplatin) combination, and only GemCis was granted reimbursement at the time. AstraZeneca has now reapplied to CDDC for full coverage based on several additional grounds. Highlights include a Korean subgroup analysis of TOPAZ-1, Imfinzi’s Phase III study in patients with locally advanced or metastatic biliary tract cancer, which was presented at the Korean Society of Medical Oncology (KSMO) International Conference on October September 27th. The 3-year follow-up of 120 South Korean patients who were enrolled in the TOPAZ-1 study showed that the Imfinzi combination improved median overall survival (mOS), 3-year OS rate, and clinical safety compared to conventional therapy. Korean patients treated with the Imfinzi combination showed an mOS of 16.6 months, compared to the 11.3 months found in Korean patients treated with conventional therapy, which is a 5.3-month extension in overall survival. The OS rate at 3 years also improved over twofold, being 21.0% in the Imfinzi combination arm and 8.8% in the conventional therapy arm. Another factor that can also influence the decision is patient demand. A petition had been uploaded to the National Assembly on September 13 called for prompt insurance reimbursement of Imfinzi. The petitioner, who described herself as the child of a patient with stage IV intrahepatic biliary tract cancer, said she had been paying more than KRW 10 million a month for Imfinzi as out-of-pocket cost because of its non-reimbursement, and that she was now unable to afford the treatment because she had exhausted her insured actual expense limit. Despite Imfinzi’s proven effect, the petitioners believe that many patients have difficulty accessing the treatment due to financial reasons. As of September 30, the petition had received 5,114 signatures. Imfinzi is now recommended as a first-line standard of care in major biliary tract cancer treatment guidelines, including the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO), and is reimbursed in major countries, including the United States and the United Kingdom. However, there is also a view that the cost of Imfinzi, an immuno-oncology drug, is burdensome for Korea’s health insurance finances and that the company’s proportion of financial sharing will determine whether it passes CDDC review, regardless of the drug’s clinical performance. The industry's view is that the fact that only GemCis was reimbursed in the Imfinzi combination regimen illustrates such government concerns. The government had decided to not fully reimburse the Imfinzi-GemCis combination because this would require significant additional health insurance funding to cover its use as first-line treatment for biliary tract cancer.
- Policy
- EUA for Novavax's COIVD-19 vaccine targeting the variant
- by Lee, Hye-Kyung Oct 02, 2024 05:49am
- The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced emergency use authorization of Novavax's 'COVID-19 Vaccine corresponding to JN.1 strain of SARS-CoV-2 (2024-2025 Formula).' The emergency use authorization is a system designed to respond appropriately to a public health crisis, including infectious disease pandemics. In this system, the MFDS minister enables the supply of medical products that do not have domestic approval by ordering manufacturers and importers to manufacture or import upon requests from the central administrative agency. MFDS gathers expert opinions by reviewing companies' submitted clinical and quality documents through the official posting of the emergency use authorization upon request from the central administrative agency. Then, after review and voting from the committee for the 'Public Health Emergency Preparedness and Responses for a Medicinal Product,' the MFDS makes a final decision. The Korea Disease Control and Prevention Agency (KDCA) requested the emergency use authorization based on the vaccination plan to prevent COVID-19 for this winter. The MFDS quickly reviewed the item and approved of it. SK Chemicals will be responsible for importing and distributing the Novavax vaccine. Novavax vaccine is a direct injection of antigen protein using a recombinant protein vaccine technology to induce the synthesis of vaccine-eliminating antigens. With the Novavax COVID-19 vaccine entering South Korea, clinical fields will have wider array of choices for vaccine types. Recently approved Pfizer vaccine and Moderna vaccine are made of mRNA, which is designed to express antigen protein that induces immune responses in the body. The MFDS stated it would provide safe vaccination for people by strengthening the safety management system for COVID-19 vaccines, including managing quality and collecting reporting of adverse reaction cases.
- Product
- ‘Disclose the pricing rationale used for COVID-19 drugs'
- by Kang, Hye-Kyung Oct 02, 2024 05:49am
- The Korean Pharmacists for Democratic Society (CEO Kyungrim Jeon, KPDS) has called for the disclosure of the cost-effectiveness evaluation results of the COVID-19 treatments Paxlovid and Veklury Inj. “The Ministry of Health and Welfare is engaging in the atrocity of setting excessive drug prices for COVID-19 treatments,” said the KPDS on the 30th, adding, “Much question remains on the clinical utility of current COVID-19 treatments among vaccinated elderly patients, and the KPDS criticizes the Ministry of Health and Welfare for setting an unreasonable price and the arbitrary co-payment rates, which only filling the bellies of pharmaceutical companies.” “In addition to filling the medical gap with national health insurance finances, the MOHW is now lining the back pockets of pharmaceutical companies,” criticized KPDS. “One course of Paxlovid and Veklury is priced at KRW 941,940 and KRW 312,000, respectively. In principle, the price of drugs is set based on clinical utility, taking into account the cost of existing treatments, but the cost of COVID-19 drugs is tens of times more expensive than drugs for similar diseases.’ Oseltamivir (brand name: Tamiflu), a treatment for influenza, a type of respiratory system infection, costs about KRW 17,000 per course, and zanamivir (brand name: Relenza Rotadisk) costs KRW 23,000. In addition, the influenza treatment PeramiFlu, which was not reimbursed in 2012 despite its high clinical utility but high price, is currently purchased by patients at KRW 100,000 to KRW 150,000. “According to the statutory infectious diseases classifications set by the Korea Disease Control and Prevention Agency, novel influenza is a Class 1 reportable disease. On the other hand, COVID-19 is not highly contagious or fatal - which is why it falls under Class 4. Why is the price of a Class 4 treatment drug set several times more expensive than the price applied for the common respiratory infectious disease treatments?,” questioned KPDS. He also demanded an explanation as to why cancer patients and those with severe, rare, and incurable diseases have to pay higher coinsurance rates than those infected with COVID-19. The claim follows the MOHW’s decision to limit the out-of-pocket costs for Paxlovid and remdesivir to KRW 50,000. “Considering the prices of the drugs - being KRW 940,000 and KRW 312,000 - the co-insurance rates of the drugs are 5% and 1.6%, respectively, which is the same or lower than the 5% co-insurance rate paid by patients with severe, rare and incurable diseases or cancer to purchase the drugs,’ the KPDS pointed out. “The amendment to the enforcement decree was made in response to the provision which stipulates the Minister of Health and Welfare can lower the co-insurance rate for infectious disease treatments to reduce the burden of infectious disease treatment and increase access, but the logic of the bill does not disallow lowering access to treatment for patients with severe, rare and difficult diseases and cancer,” he said. The general consensus is that the co-insurance rate needs to be lowered for all essential medical treatments to increase access. The KPDS pointed out, “The Ministry of Health and Welfare should not our requests for clarification while charging suspicious prices for treatments that are not yet clear in terms of reimbursement standards or proven effectiveness, and applying suspicious co-insurance rates to increase the burden on health insurance finances. The national health insurance finances are not the MOHW’s private finances.” ‘The MOHW should stop its recent rush of determining drug benefits at questionable prices in the name of rewarding innovative value. It must increase transparency in the drug price determination process and consider the public interest first in drug production and supply.”
- Company
- Will the Imfinzi·Imjudo combo be reimb within the year?
- by Eo, Yun-Ho Oct 02, 2024 05:49am
- Whether the combination of the immuno-oncology drugs Imfinzi and Imjudo will be reimbursed for liver cancer in Korea is gaining attention. In June, AstraZeneca Korea submitted an application for the reimbursement of the PD-L1 inhibitor Imfinzi (durvalumab) and CTLA-4 inhibitor Imjudo (tremelimumab) combination for liver cancer. Therefore, it remains to be seen if it will be presented to the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee within this year. Imjudo received approval in combination with Imfinzi from the Ministry of Food and Drug Safety in June last year. The first target indication for the combination was liver cancer, and the drug may be prescribed as a first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma (liver cancer). Specifically, patients are treated with the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen, which consists of a single dose of Imfinzi 1,500 mg plus 300 mg of Imjudo, followed by an additional dose of Imfinzi at regular intervals every 4 weeks. At the recent European Society for Medical Oncology (ESMO) Congress 2024, the 5-year overall survival data from the Phase III HIMALAYA trial that demonstrated the efficacy of the Imfinzi and Imjudo combination in hepatocellular carcinoma was presented. In the HIMALAYA trial, patients with inoperable HCC were treated with STRIDE (single dose of Imjudo followed by Imfinzi maintenance therapy), Imfinzi monotherapy, and sorafenib monotherapy. When comparing the results of the Imfinzi and Imjudo combination with sorafenib combination therapy in patients with unresectable HCC, patients who received the STRIDE regimen had a 5-year overall survival (OS) rate of 19.6%, compared with the 9.4% for patients who received sorafenib. The median overall survival was 16.43 months and 13.77 months, respectively, showing a 24% lower risk of death in the Imfinzi-Imjudo combination arm. “ The Imfinzi-Imjudo combination therapy has significant advantages in that it has a much lower risk of bleeding than conventional therapies and does not worsen liver function," said Hong Jae Chon, Professor of Hemato-Oncology at CHA Bundang Medical Center. “In particular, the combination shows potential for longer survival than existing therapies."
- Company
- "Expanded scope for the newborn screening test"
- by Whang, byung-woo Oct 02, 2024 05:48am
- "Conducting genetic testing on family members and related families when a baby is found to be a carrier from a newborn screening test can identify more individuals with carriers. For rare diseases, such as Gaucher's disease, early diagnosis improves the patient's quality of life and saves the societal cost." Starting this year, the items for the newborn screening test, which is conducted in newborns within 48-72 hours of birth regardless of any symptoms shown, has expanded. As a result, early diagnosis of rare diseases is more likely. For example, reimbursable items now include Lysosome storage disorder (LSD). Many hope that circumstances surrounding the treatment of diseases with a 'diagnostic odyssey,' like Gaucher's disease and Fabry's disease, will improve. Beom Hee Lee, Professor of the Department of Pediatrics at Asan Medical CenterDaily Pharm met with Beom Hee Lee, a Professor of the Department of Pediatrics at Asan Medical Center's Medical Genetics Center, to discuss the significance of newborn screening testing and treatment options. LSD is estimated to occur in 1 in 7,000 to 9,000 people. There are approximately 50 known LSDs, depending on specific enzyme deficiencies. Among these, six LSDs, including Pompe disease, mucopolysaccharidosis (Type 1·2), Gaucher's disease, and Fabry's disease, have treatments and are manageable. "LSD is a disease in which lysosomal degrading enzyme, which eliminates unwanted materials within the cell, is genetically deficient. Most prominent diseases include Gaucher's disease, Fabry's disease, and Pompe disease," said Lee, adding, "However, the causes and symptoms are disease-specific. For example, in Gaucher's disease, the risk of leukemia increases, and neurological symptoms are life-threatening." The government's decision to include LSD in reimbursable items for newborn screening tests this year is crucial because it could lead to early diagnosis and early treatment. Approximately 70 patients are being treated for Gaucher's disease, one of LSDs, in South Korea. Because there are only a few patients in South Asia, it is difficult to assess the prevalence rate. Gaucher's disease is also a rare disease with the 'diagnostic odyssey,' taking around 13 years on average to diagnose. Lee said that the expanded reimbursement scope of the screening test is expected to be beneficial. "Patients often visit several hospitals until getting diagnosed because rare diseases are not acknowledged well and there are only a few doctors with specialties," Lee said, adding, "There are cases of patients diagnosed with Gaucher's disease in their last years, and a teen patient was diagnosed with Gaucher's disease with hepatosplenomegaly after 10-years of testing despite reduced platelet levels." "As six types of enzyme activity tests have been included in reimbursable items of newborn screening test, starting January 2024, potential for diagnosing Gaucher's disease has opened up," Lee said, adding, "It provides patient access and advantages for reducing complications by early disease diagnosis and treatment, suggesting that circumstances for treatment are improving." Lee explained that six months had passed since the testing was implemented, and no patients were reported to have abnormal findings diagnosed with Gaucher's disease. However, a positive effect is expected because the testing could expand the genetic disease LSD diagnosis to family members and related families. Gaucher disease requires early diagnosis and early treatment…unmet needs for treating neurological symptoms The standard therapy for Gaucher's disease involves receiving a bi-weekly intravenous injection of a deficient enzyme protein as part of an enzyme replacement therapy (ERT). Lee believes that different ERTs yield similar treatment effects. Since the treatment effects and safety profile have been confirmed, ERT may effectively lessen liver and spleen enlargement. "Neurological symptoms of Gaucher's disease occur regardless of age, typically found in infancy, teenage years, and early-20s, despite different timing of neurological symptom occurrence and diagnosis," Lee said, adding, "Even the patients who have improved symptoms with ERT can experience sudden neurological symptoms, significantly burdening patients and caregivers." Although there are no treatment options for effectively managing neurological symptoms, studies are being conducted with chaperone therapy using ambroxol. Ambroxol is an active ingredient used for treating respiratory diseases. In a study of ambroxol in combination with ERT, it has been reported to reduce the number of seizures and alleviate or prevent symptom worsening after around 10 years of treatment in patients with Gaucher's disease who have neurological symptoms. "Although many patients have improved neurological symptoms using ERTs, patients had the inconvenience of having to take many pills in a day. Moreover, ambroxol is not officially approved," Lee said, adding, "A treatment development is needed to fulfill unmet patient medical needs for effective neurological symptoms." Despite receiving positive review for newborn screening test, a concern for increased screening cost arises Lee expected that discussions about potential unnecessary screening increases due to the expanded scope of the newborn screening test might be needed. "When tests are being done in a broad term, an initial purpose for conducting screening may not be achieved and it may result in unwanted outcomes," Lee said, adding, "Caregivers tend to independently receive genetic testing with low accuracy in addition to the government-funded tests. As a result, the cost of conducting tests with out-of-pocket fees may be a burden." Some diseases may require immediate treatments upon the identification of a carrier. However, several diseases, within the six types of LSD testing category, do not require immediate treatment. "Testing with fees conducted in newborns may not be for diseases that must be identified at the newborn stage, and the rate of the diagnosis for certain disease at further tests are low," Lee mentioned, "It is a common issue that nations conducting similar screening program face." Regarding this issue, Lee emphasized the importance of accurate final diagnosis and treatment through enzyme analysis testing or genetic testing rather than excessive analysis at the screening stage. "For Gaucher's disease, treatments are available, and patients can maintain typical lifestyles if treated and managed well. It does not affect marriage or daily lives," Lee said, "The most crucial factor is early diagnosis and early treatment. Because Gaucher's disease can cause irreversible damages to the body, treatment must begin before symptom manifests."
- Company
- Jardiance generics prepare for final launch in Korea
- by Kim, Jin-Gu Sep 30, 2024 05:47am
- Generic companies are in the midst of last-minute preparations to enter the market for the SGLT inhibitor diabetes drug Jardiance (empagliflozin), which is set to expire in just about half a year. With Forxiga’s market withdrawal expected to leave an annual sales gap of KRW 50 billion, the race to fill this gap is expected to intensify among the generic companies. Generic companies seek to avoid Jardiance’s crystalline form patent 8 years later…are they eyeing Forxiga’s gap? According to industry sources on the 26th, Hanmi Pharmacuetical and KyungDong Pharm recently won the passive trial to confirm the scope of Jardiance’s crystalline form patent (10-1249711). In the case of Hanmi Pharmaceutical, it succeeded in avoiding Jardiance’s crystalline patent a step later than other companies. More than 50 companies, including Chong Kun Dang, have challenged Jardiance’s crystalline form patent since 2018 and won their first trial between 2019 to 2021. Hanmi Pharmacuetical had also filed to invalidate the same Jardiance’s patent in 2015 but hadn’t made much action since losing the first trial the following year. Even when the other companies filed a series of challenges to avoid the crystalline patent, Hanmi Pharmaceutical chose not to join in the race. However, in March this year, the company changed its course and again filed to avoid the crystalline patent. The company’s challenge comes 8 years later than the other companies. Like the other companies, Hanmi Pharmaceutical plans to launch its generic early, when the patent for Jadian expires in March next year. Some speculate that AstraZeneca’s decision to withdraw another SGLT-2 inhibitor, Forxiga, from South Korea, may have played a role in this. AstraZeneca Korea decided to withdraw Forxiga from the Korean market last December. Forxiga was the leading SGLT-2 inhibitor in the market until recently. With the market leader withdrawing from the market, industry insiders believe that the generic companies are seeking to target this void created by the withdrawal. In fact, prior to Hanmi Pharmaceutical, Daehwa Pharmaceutical, Medica Korea, Korea Prime Pharmaceutical, and Aprogen Biologics filed challenges to avoid the crystalline patent and launch their generic versions of Jardiance in March this year. All of these challenges were filed after AstraZeneca decided to withdraw Forxiga from South Korea. According to the market research institution UBIST, Forxiga’s prescription sales amounted to KRW 51 billion in 2022. Last year, its prescriptions grew 9% to KRW 55.5 billion, despite the launch of its generics upon Forxiga’s patent expiry. The rise in prescription sales was slightly slower this year, earning KRW 21.7 billion in the first half of the year. In Q2, the drug’s sales were overtaken by the combined prescription volume of its generics. As a result, the drug’s prescriptions are expected to decline in earnest in the second half of this year. AstraZeneca Korea plans to supply Forxiga domestically only until the first half of this year, and then distribute only the stockpiled amount. This means that from next year, a KRW 50 billion gap will remain unfilled in the market in earnest. Last-minute generic approvals also in full swing...companies expected to push ahead with launch despite unregistered patent risk Due to such circumstances, the domestic pharmaceutical companies' expectations for Jardiance’s generic market have also been growing ahead of the expiration of the product patent. Companies that have previously succeeded in avoiding Jardiance’s crystalline patent are in the midst of last-minute preparations, including receiving authorizations for their generics one after another. Only this month, GC Cross and Dongkwang Pharm received approval for their generic versions of Jardiance and Jardiance Duo. Including the two, there are now 53 companies that have authorized generic versions of Jardiance and Jardiance Duo. If Hanmi Pharmaceutical and Daehwa Pharmaceutical, which succeeded in avoiding Jardiance’s crystalline patent, also receive approval for their respective generic versions, the number of approved generic companies is expected to increase to 60. In other words, fierce competition among Jardiance generics is expected from March next year. The product patent for Jardiance will expire in March next year. Other than the product patent, the crystalline patent is the only patent registered in MFDS’s green list. Generic companies plan to avoid the crystalline patent and release generics early in line with the date of Jardiance’s substance patent expiry. Although there are still patents that have not been registered in Korea’s green list, most companies are expected to push ahead and launch their respective generics. In the case of Trajenta generics, most companies pushed ahead with their generic launches without fully addressing the risk of its unlisted patents.
- Policy
- "Hundreds of doctors have received pharmaceutical rebates"
- by Kang, Shin-Kook Sep 30, 2024 05:47am
- Min Juwon, Director of Audit at the National Tax Service (NTS).After conducting a tax audit of 16 pharmaceutical companies, Korea's National Tax Service (NTS) announced that it would impose an income tax for doctors who received rebates. The NTS mentioned that over hundreds of doctors received rebates, and rebate-associated medical-pharmaceutical cartels became a significant issue. As a result, the NTS will continue to conduct intense tax audits. The following article reconstructs the briefing by Min Juwon, Director of NTS Audit, held on Septebmer 2nd in a question-and-answer format. - Min said the current audit focuses on imposing income tax on medical professionals who had received rebates. We impose income taxes on doctors who received rebates in any form. Because the customary way of rebates between the medical and pharmaceutical industries has continued for an extended period, the NTS has been paying attention and continuously conducting tax audits. During previous tax audits, we tried identifying the final recipients of rebates through pharmaceutical companies, but we could not confirm the allegations by solely relying on hearsay. However, this round of tax audits focused on eradicating rebates by imposing taxes on individuals who received rebates. - How were the companies selected for audits? We have not focused on whether the audited pharmaceutical company has been prosecuted by the Fair Trade Commission (FTC). The NTS selected companies that have internal issues. Once audits are completed, we plan to decide whether we will share audit outcomes with other agencies, according to regulations. Regarding the rebates being investigated by the prosecution and the Korean National Police Agency, we expect them to cooperate with the NTS regarding tax issues. When we receive documentation, we plan to investigate tax issues and impose on it thoroughly. -Some argue that the tax audit has a political agenda amid the conflict between the medical community and the government. Before today's announcement, we were aware of the concern. According to the law, the NTS conducts audits within the National Tax Imposition Exclusion Period, defined as the past five years. The NTS conducts audits of allegations within the designated period. Moreover, individuals who are involved in medical conflicts are not being audited. Audits are being conducted in individuals across the nation, including primary, secondary, and tertiary medical centers. We want people to know that the NTS focuses on rebates rather than the current issues related to the medical community. The conflict between the medical community and the government is recent. Auditing takes time because companies have to report, the NFS analyzes them, and commences on audits. Consequently, we are focusing on records dating 3-4 years back. For this audit, we have not collaborated with the Ministry of Health and Welfare (MOHW) in any form. We have conducted the audit based on NTS criteria for selecting auditing subjects and identified the degree of tax invasion. - How many medical professionals have received rebate? Subjecting companies that are being audited, hundreds of medical professionals have received rebates. If we continue, the number is expected to increase. - Min stated the medical-pharmaceutical cartel is a grave problem. Medical professionals are of superior status to pharmaceutical companies. When a certain pharmaceutical company names rebate recipients, it will no longer be able to operate in South Korea. As a result, we used the word, "medical cartel." It is a grave problem.
- Company
- New myelodysplastic syndrome drug 'Reblozyl' lands Big 5 DC
- by Eo, Yun-Ho Sep 30, 2024 05:46am
- Product photo of Reblozyl. The treatment for myelodysplastic syndrome (MDS), 'Reblozyl,' is available for prescription at tertiary general hospitals. Sources said that Bristol Myers Squibb (BMS) Pharmaceutical Korea's Reblozyl (luspatercept) has passed all drug committees (DC) of the 'Big 5' medical centers, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. However, Reblozyl is still non-reimbursable. The drug was not approved for reimbursement appropriateness at the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA), held August last year. It has not been updated since then. Reblozyl can be prescribed to treating ▲patients with very-low risk, low-to intermediate-risk MDS or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis ▲anemia in adult patients with myeloproliferative neoplasms ▲patients with Beta Thalassemia who may need RBC transfusions. Reblozyl is for adults who have not responded well to an Erythropoiesis-Stimulation Agent (ESA) or may need red blood cell (RBC) transfusions. Reblozyl can be administered once every 3 weeks in patients with MDS or Beta Thalassemia at an initial dosage of 1.0 mg/kg. Reblozyl's mechanism works by binding to TGF-β superfamily ligands, thereby diminishing the overactivation of the Smad 2/3 pathway. The drug promotes erythroid maturation. The efficacy of Reblozyl was demonstrated through the Phase 3 MEDALIST study. During the 24-week follow-up period, the study results showed that 13% of the placebo group reached consecutive transfusion-free periods, whereas 38% reported in the Reblozyl group. During the same period, the percentages of patients who reached a transfusion-free period over 12 weeks were 8% for the placebo group and 28% for the Reblozyl group. Those for over 16 weeks were 4% for the placebo group and 19% for the Reblozyl group. Extending the follow-up period to 48 weeks, the percentages of patients who reached a transfusion-free period over 16 weeks were 7% for the patient group, whereas 28% for the Reblozyl group. Meanwhile, MDS is a type of malignant disease affecting blood stem cells in the bone marrow. It is a disease of the elderly, with higher occurrence in elderly over 60 years of age. MDS is characterized by immature blood cells and low counts of healthy white blood cells, red blood cells, or platelets in the peripheral blood. The most common adverse reactions are fatigue from anemia, systemic weakness, and loss of motor ability. Worsened anemia could cause palpitation, trouble breathing, chest pain, and the possibility of advancing to acute myeloid leukemia (AML). The clinical outcomes and the progress were found to be categorically diverse. There were cases of a stable life with slight anemia, but a case of death within a few months from complications associated with low counts of red blood cells or acute leukemia was reported.
- Policy
- Stelara biosimilar Steqeyma IV approved for use in Korea
- by Lee, Hye-Kyung Sep 30, 2024 05:46am
- Upon receiving approval for ‘Steqeyma IV,’ a biosimilar version of the autoimmune disease treatment Stelara (ustekinumab), Celltion has now received approval for all its Steqeyma formulations. By adding the interleukin (IL) inhibitor option to the existing family of tumor necrosis factor (TNF)-α inhibitors, which includes Remsima, Remsima SC, and Yuflyma, the company has strengthened its autoimmune disease portfolio. On the 27th, the Ministry of Food and Drug Safety (MFDS) approved Celltrion's Steqeyma IV. Celltrion received approval for the prefilled syringe-type subcutaneous (SC) formulation of the same drug in June for the treatment of autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease (CD), and ulcerative colitis (UC) With the approval of the IV formulation, the company can now compete with the original with the same formulation. Earlier, in April, Samsung Bioepis first received approval for 2 Stellara biosimilars – Epyztek IV and Epyztek SC. The insurance drug prices of Steqeyma and Epyztek were set at the same level - about 26% lower than the original - being priced at KRW 1,298,290 for the 45 mg formulation and KRW 1,342,320 for the 90mg formulation, respectively. The original, Stelara, is a global blockbuster drug developed by Janssen, whose product patent expired in July this year in Europe and last year in the United States. According to the drug market research institution IQVIA, the global ustekinumab market was valued at around KRW 26.42 trillion last year. Starting with the domestic marketing authorization of Steqeyma, the company plans to acquire approvals in major global countries such as the U.S. and Europe and target the global ustekinumab market in earnest. Meanwhile, Samsung Bioepis was the first to obtain marketing authorization for a Stelara biosimilar in Korea, and in addition to Celltrion, Dong-A ST (DMB-3115) is also developing a biosimilar of Stelara.
- Company
- Phesgo can be prescribed in Korea with reimbursement
- by Eo, Yun-Ho Sep 30, 2024 05:46am
- Breast cancer biobetter ‘Phesgo’ can now be prescribed in general hospitals in Korea with insurance reimbursement. According to industry sources, Phesgo (pertuzumab/trastuzumab), which is a subcutaneous injection combination of Roche's Perjeta and Herceptin, has passed drug committees (DC) reviews of tertiary hospitals in Korea, including Samsung Medical Center and Seoul National University Hospital. As a biobetter drug, the drug has been reimbursed since August, being applied to the preferential drug pricing plan. Phesgo is a combination of Herceptin and Perjeta, drugs that were previously administered intravenously, into a single subcutaneous injection. The primary benefit of the change from an intravenous to a subcutaneous formulation is its reduced administration time. When treating HER2-positive breast cancer, the existing intravenous regimen required a total of 270 minutes (4.5 hours) for a single dose administration and observation. In the case of Phesgo, the treatment can be completed within 20 minutes as it requires 5 minutes of administration and 15 minutes of observation time, reducing the time by up to 90% compared to traditional therapy. The coinsurance rate of Phesgo was set at the same as for Perjeta: ▲30% when administered in combination with chemotherapy as neo-adjuvant therapy for patients with locally advanced inflammatory or early-stage (>2 cm in diameter) HER2-positive breast cancer; ▲100% when administered in combination as adjuvant therapy for patients who are HER2-positive and have lymph node-positive breast cancer (up to 18 cycles of trastuzumab and pertuzumab combination therapy); and▲5% when administered in combination for patients with metastatic or unresectable locally advanced recurrent breast cancer who are HER2-positive and have not received prior HER2 therapy or chemotherapy. In the Phase III FeDeriCa study that studied 500 patients with HER2-positive early-stage breast cancer, the Phesgo subcutaneous arm was found to be non-inferior to the trastuzumab and pertuzumab intravenous arms. In general, because intravenous and subcutaneous injections have different routes of administration, their anticancer effect is identified based on the trough level and the probability of being cancer-free at the time of surgery. In the case of Phesgo, there was no difference in the trough level according to the route of administration, and the anti-cancer effect and survival period of the two therapies were the same, offering added strength of convenience to the existing advantages. “In the FeDeriCa study, Phesgo subcutaneous injection demonstrated equivalent trough levels as intravenous trastuzumab and pertuzumab,” said Seock-Ah Im, Professor of hematology-oncology at Seoul National University Hospital. ”It provides convenience to both patients and healthcare providers by reducing treatment time while maintaining the effectiveness and safety of intravenous trastuzumab and pertuzumab.” Meanwhile, the insurance authorities have also decided to reimburse Phesgo through the risk-sharing agreement scheme, to save health insurance finances. This is because Phesgo’s development target product, Perjeta, is also currently covered by the risk-sharing agreement scheme.
