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- Company
- Expectations rise for the reimbursement of Phesgo in Korea
- by Whang, byung-woo Oct 4, 2024 04:38am
- On the 30th, Roche Korea announced that the socio-economic benefits of Phesgo (pertuzumab/trastuzumab) for early-stage and metastatic HER2-positive breast cancer were highlighted at the 2024 Korean Society of Medical Oncology (KSMO) Congress. The 2024 Korean Society of Medical Oncology (KSMO) Fall Meeting, which was held at COEX, brings together domestic and international experts from approximately 45 countries to share the latest research and innovative approaches for treating cancer. At a symposium held under the theme of Phesgo on the 26th, Kyong-Hwa Park, Professor of Medical Oncology at the Korea University Anam Hospital, chaired the session, with Professor Matteo Lambertini, Chair of the ESMO Young Oncologists Committee, participating as a speaker. Professor Lambertini emphasized the treatment effect of Phesgo through his presentation, ‘Patient Centricity with PHESGO: Achieving a Win-Win Strategy.’ The idea is that Phesgo, as a subcutaneous injection, can improve the efficiency of treatment, allowing patients with early and metastatic HER2-positive breast cancer to maintain an improved quality of life in the long term. “Phesgo is a treatment that can effectively reduce treatment and monitoring time for patients, in addition to the superior therapeutic efficacy of the trastuzumab-pertuzumab combination, which was confirmed to be non-inferior to existing intravenous agents in Phase III FeDeriCa study, with a comparable safety profile,” said Professor Lambertini. The idea is that the use of Phesgo can reduce treatment time, which will bring socioeconomic benefits for patients, hospitals, and healthcare providers, as well as improve treatment efficiency. In fact, as a maintenance therapy, Phesgo can be administered in as little as 20 minutes, reducing treatment time for dosing and observation by up to 90% compared to a total of 270 minutes required for conventional intravenous infusions. In addition, it was designated as the first biobetter for cancer in Korea in 2021, demonstrating reduced dosing time and improved patient convenience.&160; Phesgo is a single subcutaneous injection formulation that contains trastuzumab and pertuzumab, which were previously administered intravenously and separately, The combination of trastuzumab and pertuzumab is currently the standard of care for a variety of early-stage HER2-positive breast cancers. Professor Lambertini said, “‘In fact, a study of the socioeconomic impact of Phesgo in Italy showed that switching to subcutaneous Phesgo could reduce healthcare professional involvement time per patient by 25% compared to existing intravenous formulations.” Meanwhile, the National Comprehensive Cancer Network (NCCN) guidelines recommend the combination of trastuzumab and pertuzumab as a Category 1 recommendation for the first-line treatment of HER2-positive metastatic breast cancer.
- Company
- Biologics seek to expand indications…is approved for COPD
- by Son, Hyung Min Oct 4, 2024 04:38am
- Biological agents are expanding their reach beyond inflammatory diseases such as atopic dermatitis, oesophagitis, and asthma to lung disease. Recently, Sanofi and Regeneron's biologic Dupixent was approved by the US Food and Drug Administration (FDA) for the treatment of chronic obstructive pulmonary disease (COPD). Other biologics, such as GSK's Nucala and AstraZeneca's Fasenra, have also shown progress in treating COPD in clinical trials and are looking to expand their indications. Biologics are manufactured from pathogenic microorganisms, such as proteins, antibodies, nucleotides, and cells. They have specific effects on specific proteins or cells, which enables them to treat diseases, and are characterized by low side effects compared to chemical drugs. Dupixent secures first COPD indication among biologics According to industry sources on the 3rd, the FDA approved Dupixent for the treatment of COPD. This is the first COPD indication secured by a biologic.&160; Dupixent is the first biologic to target the signaling of interleukin (IL)-4 and IL-13, which are key drivers of type 2 inflammation. It has been shown to be effective in inflammatory conditions such as asthma, atopic dermatitis, and eosinophilic esophagitis. The expansion of Dupixent’s indication to COPD was based on the Phase III BOREAS and NOTUS trials. The trials included 1,874 COPD patients. Patients were randomly assigned to receive Dupixent or placebo every 2 weeks in addition to triple therapy with an inhaled corticosteroid (ICS), long-acting beta-agonist (LABA), and long-acting muscarinic antagonist (LAMA) or dual LABA and LAMA dual therapy. Results showed that Dupixent reduced the annualized rate of moderate or severe COPD exacerbations by up to 34% compared to placebo over 52 weeks, which was the primary endpoint. In addition to Dupixent, Sanofi, and Regeneron are developing the IL-33 inhibitor itepekimab for COPD. The companies are currently conducting 2 clinical studies on itepekimab and expect to present new data next year. Biologics continue to look to expand COPD indications In addition to Dupixent, other biologics are also looking to expand their indications to COPD. GSK recently announced positive clinical trial results for its IL-5 inhibiting biologic, Nucala. The trial was conducted in 806 COPD patients aged 40 years and older without asthma who required triple therapy with an ICS, LABA, or LAMA to determine the efficacy of Nucala in moderate/severe exacerbations. Results showed that Nucala reduced the primary endpoint of moderate/severe annualized exacerbation rate. Patients treated with Nucala for up to 104 weeks demonstrated a statistically and clinically significant reduction in the annualized exacerbation rate compared to placebo. AstraZeneca is investigating the biologic Fasenra for several diseases, including COPD, chronic rhinosinusitis, and hypereosinophilic syndrome (HES). Fasera is a biologic that binds directly to the IL-5 receptor alpha on eosinophils, leading to rapid depletion of blood and tissue eosinophils. However, Fasenra did not demonstrate an effect in COPD in 2 clinical studies - GALATHEA and TERRANOVA, which were published in 2019. AstraZeneca is conducting a third Phase III study on Fasenra in patients with high eosinophil levels, as it has confirmed the drug’s benefit in this population. The ongoing Phase III RESOLUTE trial, which is studying Fasenra in more than 600 COPD patients, is expected to be completed by next June. AstraZeneca is also seeking to expand the indication for Tezspire, a biologic the company had co-developed with Amgen, to COPD as well. Tezspire is an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody therapy that binds to TSLP, which causes airway inflammation. Other biologics inhibit IL-5, lgE, and others, and Tezspire is the first to target this mechanism. Currently, Tezspire is only approved for the treatment of severe asthma.
- Company
- "Importance of fungal infections TX amid COVID-19 spike"
- by Son, Hyung Min Oct 4, 2024 04:38am
- "Fungal infections usually occur in immunocompromised patients and have a high fatality rate. Because fungal infections can be fatal to patients, especially during the resurgence of infectious diseases, such as COVID-19, it is of paramount importance to secure various treatment options." During a recent meeting with Daily Pharm, Sung-Yeon Cho, a professor in the Department of Infectious Diseases at the Catholic University of Korea Seoul St. Mary's Hospital, suggested potential improvements to treatment settings for fungal infections in South Korea. In August, the number of patients hospitalized for severe COVID-19 symptoms was a record high for this year, and concerns about the pandemic increased, posing threats to public healthcare due to fungal infections. The U.S. Center for Disease Control and Prevention (CDC) has designated September 16-20, 2024, as 'Fungal Disease Awareness Week' and notifies the importance of managing fungal infections. The most reported fungal infections are COVID-19 associated pulmonary aspergillosis (CAPA), COVID-19 associated mucormycosis (CAM), and Candida auris. These diseases worsen the prognosis of immunocompromised patients, leading to death. As infectious diseases resurge, the emphasis on fungal disease management and treatment becomes increasingly important. However, there are unresolved issues regarding the timely treatment of Korean patients, as the focus of governmental support has been on antibiotics among antimicrobials, and patient access to treatments is limited. European and U.S. guidelines suggest Vfend (voriconazole) and Cresemba (isavuconazonium) as first-line treatments for invasive CAPA. Cresemba won the Ministry of Food and Drug Safety (MFDS) approval in 2020 and it has been listed as the 'National Essential Drug.' However, it still has unmet medical needs because it is not reimbursed by national health insurance. This is in contrast with Cresemba's reimbursable status in Europe, the UK, Hong Kong, Taiwan, and China. Cho strongly suggested that fungal infections can be fatal to immunocompromised patients, and thus, patient access to treatments must be improved. Fungal infections, the fatality rate↑ in patients with COVID-19 CAPA is categorized as the highest-ranked, 'Critical Priority Group,' in the WHO-published 'Fungal Priority Pathogen List.' It shows the highest antifungal tolerability, mortality, and occurrence rate. CAPA is a variety of fungal infections induced by the 'aspergillosis' fungus, which exists in nature. Patients with respiratory diseases or are immunocompromised can commonly contract 'invasive CAPA.' Invasive CAPA is the most serious form of CAPA, usually occuring in immunocompromised patients. It commonly invades the lungs but can induce infections in any part of the body. "Fungus exists naturally, but infections do not happen when the immune system normally works. Patients receiving anticancer therapies, with a lowered number of neutrophils in white blood cells or taking extended steroids are vulnerable to fungal infections, " Cho said. "COVID-19-associated infections reduce normally working protective mechanism of upper/lower respiratory airways and make the body susceptible to all secondary infections related to the respiratory system," Cho added. Based on the results of a study involving 2427 patients with severe COVID-19 symptoms, 4.6% of all hospitalized patients and 11.2% of intensive care unit patients had CAPA infections. The median value of time it takes until CAPA diagnosis was 9.5 days. In particular, corticosteroid use in throughout the body has increased the risk of CAPA infections in COVID-19 patients. 30-day mortality was found to be higher in CAPA-infected patients (30%) than in patients with severe COVID-19 symptoms who are CAPA-negative (7.2%). "Fungal infections have a high mortality rate because they commonly occur in patients with lowered white blood cell neutrophils, who have undergone anticancer therapies, who are taking extended steroids, and who are immunocompromised. The mortality rate for CAPA is 30%. It is known to be up to 100% when not diagnosed," Cho said. "The rate of contracting CAPA is reported to be approximately 15-25% of COVID-19 patients who are hospitalized in intensive care units in South Korea. Since there are cases where CAPA is not diagnosed, depending on institutes and patient sizes, the incidence rate is reported to be as low as 5% and up to 50%. The CAPA mortality rate differs on diagnosis," Cho added. A previous study indicated the seriousness of fungal infections, showing that CAPA has a similar incidence rate and mortality rate in patients with viral infections, including severe influenza infections, besides COVID-19. WHO recommends physicians always consider the possibility of fungal infections when treating patients. Effective treatments have emerged, but are 'pie in the sky' The importance of fungal infection treatment has been emphasized, but patient access to new drugs is limited in South Korea. Voriconazole, a class of Azole, and Cresemba are prescribed as a first-line treatment of CAPA. Antifungal agents are used in patients who are likely to have COVID-19-associated CAM, besides CAPA. However, discussions about the reimbursable status of those agents are still challenging. Antibiotics include antimicrobials effective for treating germs, antifungals effective for treating fungus, and antivirals effective for treating virus. Among these, antifungals and antiviral agents are not included in the scope of the 'Cost-Effectiveness Evaluation Waiver System.' During the COVID-19 pandemic, the government included antimicrobials in the 'Cost-Effectiveness Evaluation Waiver System.' However, it sees that expanding the scope to antifungals does not meet the gravity and urgency standards. As a result, some are advocating for reimbursement of new antifungal drugs, citing the increasing incidence rate of fungal infections is on the rise worldwide, including in South Korea. However, reimbursement for new antifungals has not been made lately. "Voriconazole is a treatment with extended proof of superior effects in treating CAPA than other antifungals, based on accumulated data since the 1990s. However, there are concerns of extended treatments depending on the patient's immune conditions and refractory due to antifungal tolerance," Cho said. "Cresemba is in high demand among patients likely to have multiple infections as it is effective in treating broad spectrum fungal infections as well as improved safety profiles," Cho added, "Drug interactions that may occur in antifungals of Azole class is 2-10, whereas in Cresemba is as low as 1-1.5. It has the advantage of administering to patients with severe symptoms who are taking multiple drugs." Cresemba proved non-equivalence to the first-line treatment, voriconazole, and it is regarded as having a broader antifungal spectrum. Additionally, Cresemba significantly reduced the most typical adverse reactions of antifungals, such as liver toxicity and photosensitivity, to almost none. "The biggest reason for delayed reimbursement listing of antifungals is finance, but low awareness of infectious diseases can also be attributed. Although antifungals may be crucial to patients, they are not on the priority list," Cho said, "Reimbursement listing of antifungals is often being delayed because people think it is substitutable despite the fact that none are substitutable." "There should be no cases where good new drugs with confirmed clinical data and recommended by global guidelines cannot be prescribed in 2024 due to systemic issues," Cho emphasized, "The reimbursement criteria must be improved considering that patients who need antifungals have life-threatening severe infections."
- Company
- Imfinzi builds evidence for biliary tract cancer reimb
- by Whang, byung-woo Oct 2, 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. According 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 2, 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.
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