Latest news with #costeffectiveness
Associated Press
7 days ago
- Health
- Associated Press
Health Economic Study Shows That enVVeno Medical's VenoValve(R) Would be a Cost-Effective Treatment Option for Patients with Severe Chronic Venous Insufficiency
Clinical data and cost-effectiveness analysis demonstrates the VenoValve would provide both better health outcomes and lower costs compared to current standard of care treatments The VenoValve could potentially save $5.9 billion annually in healthcare costs for the approximately 2.5 million U.S. patients with severe CVI Company to host live webcast with lead author of the cost-analysis manuscript, today, August 6th, at 12:00 PM ET; Access the Webcast Here IRVINE, CA / ACCESS Newswire / August 6, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ('enVVeno' or the 'Company'), a company setting new standards of care for the treatment of deep venous disease, today announcedpreliminary findings from a VenoValve health economic study, which indicate that the VenoValve would be a cost-effective treatment option for patients with severe Chronic Venous Insufficiency (CVI) caused by deep valvular incompetency. The Company announced it will host a live webcast to discuss the cost-effectiveness analysis results today, Wednesday, August 6th at 12:00 PM ET (details below). Key Findings from the Study Include: Results remained consistent across multiple sensitivity analyses and scenarios (different age populations, various assumptions), confirming the model's reliability. Mark H. Meissner M.D., surgeon at the Vascular and Endovascular Surgery Clinic at University of Washington (UW) Medical Center, a UW professor of Surgery, and the lead author of the manuscript added, 'There remains a significant need for better treatment options for patients with severe, deep venous CVI, an advanced disease that affects millions of Americans annually and accounts for 1-2% of total healthcare expenditures, roughly ~$90 billion. These comprehensive economic analysis results, coupled with the robust clinical data demonstrated in the VenoValve U.S. pivotal trial, well positions the VenoValve to address the significant treatment gap while providing substantial economic value to the healthcare system.' 'There are several factors that need to align in order to promote wide adoption of a first-in-class medical device. Two of the more important factors are good clinical results, and a willingness to pay for the device and the procedure. This health economic study provides evidence that the VenoValve would be extremely cost-effective, resulting in substantial health cost savings over time. This cost-effectiveness data, together with the strong clinical evidence from the pivotal trial, make a compelling package for commercial payors such as private health insurance providers and employers, that often make coverage decisions based upon both clinical and cost-effectiveness data', added Robert Berman, enVVeno Medical's Chief Executive Officer. While private payors generally make coverage decisions based upon clinical evidence and cost effectiveness, Medicare makes coverage decisions based upon clinical effectiveness to support reasonable and necessary criteria for the Medicare population. As part of the health economic study, a de novo cost-effectiveness model was developed to simulate clinical and economic outcomes for patients with deep venous CVI caused valvular incompetence. The model structure was based on health states defined by the revised Venous Clinical Severity Score (rVCSS), which were derived from a post-hoc analysis of the one-year results from the VenoValve U.S. pivotal trial. Key input values for transition probabilities, clinical events, costs of care, and utilities were sourced from the pivotal trial and publicly available sources. Six-month cycles were assumed for the first year, to match the VenoValve pivotal trial, followed by annual cycles; outcomes were compared over a 5-year time horizon.A manuscript describing the full methodology and findings has been submitted for peer review and publication. The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that approximately 2.5 million people in the United States could be candidates for the VenoValve, including approximately 1.5 million diagnosed with venous ulcers. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025. Webcast Details The Company will host a webcast presentation to discuss the results for investors, analysts and other interested parties today, August 6, 2025, at 12:00 PM ET. Joining enVVeno management for the event will be Dr. Meissner. The live webcast will be accessible on the Events page of the enVVeno website, and will be archived for 90 days. About CVI Severe deep venous CVI is a serious and debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments that repair deep venous valve dysfunction, the #1 cause of severe CVI-a disease estimated to cost the U.S. healthcare system in excess of $26 billion each year. About enVVeno Medical Corporation enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous CVI. The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVIcalled enVVe®. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the VenoValve U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the 'Company') related thereto contain, or may contain, among other things, certain 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as 'projects,' 'may,' 'will,' 'could,' 'would,' 'should,' 'believes,' 'expects,' 'anticipates,' 'estimates,' 'intends,' 'plans,' 'potential' or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. INVESTOR CONTACT: Jenene Thomas, JTC Team, LLC [email protected] (908) 824-0775 MEDIA CONTACT: Glenn Silver, FINN Partners [email protected] (973) 818-8198 SOURCE: enVVeno Medical Corporation press release
Japan Times
10-07-2025
- Health
- Japan Times
Japan to cut price of Alzheimer's drug lecanemab
Japan is expected to lower the price of lecanemab, an Alzheimer's drug codeveloped by Japanese drugmaker Eisai and Biogen of the United States, following a health ministry panel's report citing its low cost-effectiveness. Based on the assessment report, the ministry is expected to cut the official price of the drug by up to 15% from the current level of about ¥3 million per patient a year. The report, submitted to the Central Social Insurance Medical Council, which advises the health minister, on Wednesday, pointed to lecanemab's lower cost-effectiveness compared with conventional Alzheimer's drugs such as donepezil. The margin of the expected price cut will be formally decided after the council discusses lecanemab's effect in reducing costs of public nursing care services. Lecanemab is innovative because it removes abnormal proteins that accumulate in patients' brains, hopefully slowing the progression of the disease. As the number of dementia patients is expected to increase rapidly due to the aging population, there are concerns that the expensive drug will pressure the finances of the nation's public health insurance programs. Eisai rebutted the ministry panel's report, arguing that lecanemab's cost-effectiveness has been underestimated. While noting that the company and the panel used different analytical models, Eisai emphasized that its analysis better reflects the value of the drug.
Medscape
26-06-2025
- Health
- Medscape
Trimodal Therapy Costs Offset QOL Benefit in Bladder Cancer
TOPLINE: In patients with muscle-invasive bladder cancer, trimodal therapy modestly improved quality of life compared with radical cystectomy but was not cost-effective at either 5 or 10 years. The high costs associated with trimodal therapy exceeded commonly accepted 'willingness-to-pay' thresholds, a new analysis found. METHODOLOGY: Trimodal therapy, which includes maximal transurethral resection followed by chemotherapy and radiation, is an alternative for patients who are unable or unwilling to undergo radical cystectomy. However, there are no randomized trials comparing the two approaches, and data on cost and utility trade-offs are limited. Researchers compared the cost-effectiveness of trimodal therapy and radical cystectomy using a simulation model that incorporates health economics. The index patient reflected patients in a large 2023 retrospective study: aged 71 years with clinical stage T2-4aN0M0 muscle-invasive bladder cancer, solitary tumor < 7 cm in size, adequate bladder function, and no multifocal or extensive carcinoma in situ. The model simulated outcomes over 5 and 10 years, using cost data from a Medicare payer perspective (adjusted to 2021 US dollars) and assumed the two treatment approach es had equivalent oncologic efficacy. Primary outcomes included costs, effectiveness measured in quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). Cost-effectiveness was assessed using a willingness-to-pay threshold of $100,000 per QALY. TAKEAWAY: The average cost of trimodal therapy was more than $30,000 higher than the cost of radical cystectomy at 5 years ($71,014 vs $40,489) and 10 years ($85,137 vs $49,570). Trimodal therapy demonstrated a small advantage over radical cystectomy in terms of quality of life, due to fewer acute and long-term toxic effects: 3.94 vs 3.87 QALYs at 5 years and 6.61 vs 6.49 QALYs at 10 years. Compared to radical cystectomy, trimodal therapy was not cost-effective overall at either timepoint, with ICERs of $464,291 per QALY at 5 years and $308,636 per QALY at 10 years. However, trimodal therapy was considered cost-effective for 21% of patients at 10 years — supporting its use for some 'appropriately counseled' patients. Sensitivity analysis revealed that trimodal therapy would become broadly cost-effective if the initial cost dropped by more than half (to $17,605), or if it achieved an 11.6% improvement in metastasis-free survival. IN PRACTICE: The results underscore two ongoing needs: a better understanding of patients' long-term outcomes with trimodal therapy vs radical cystectomy and measures to rein in the high cost of bladder cancer care. 'These findings highlight the importance of developing policy initiatives that help reduce [trimodal therapy] costs and of providing patients with accurate expectations of long-term toxic effects to help guide preference-sensitive care,' the study authors wrote. SOURCE: The study, led by Daniel Joyce, MD, MS, Vanderbilt University Medical Center, Nashville, Tennessee, was published online in JAMA Network Open. LIMITATIONS: The findings were limited by model assumptions and potential selection bias from the retrospective studies used. The model inputs were based on the best available evidence. All nonmuscle-invasive recurrences after trimodal therapy were assumed to be treated with Bacillus Calmette-Guérin, possibly overestimating costs by excluding intravesical chemotherapy options. DISCLOSURES: The authors did not disclose any funding information. Several authors declared receiving consulting fees or grants or having other ties with various sources. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
South China Morning Post
14-05-2025
- Business
- South China Morning Post
Surprise lay-offs hit Hong Kong's Hang Seng Bank amid HSBC's sweeping revamp
Hong Kong retail lender Hang Seng Bank is laying off staff as part of its parent company HSBC Holdings' aggressive restructuring aimed at enhancing cost-effectiveness and growth. Advertisement The lender, 62.14 per cent owned by HSBC , informed staff in various departments over the past few weeks that they would lose their jobs as part of the restructuring plan, two separate sources told the Post. The affected units were mainly supporting departments such as information technology and corporate communications, as well as index compiler Hang Seng Indexes and some units that were being consolidated in the restructuring, the sources said. The total number of people affected was not disclosed. Some departments lost up to 20 per cent of their staff, while the hardest-hit team was cut in half, the sources said. Wealth management and other key growth areas would not be affected and were instead the focus of expansion, the sources said. The bank is currently recruiting for about 100 vacancies. 'Hang Seng's lay-off plan is a surprise to the market, because the domestic lenders in Hong Kong tend not to have massive lay-offs and tend to keep a stable headcount even during the previous financial crises,' said Kenny Ng Lai-yin, a strategist at Everbright Securities International. Advertisement 'The surprise lay-offs may reflect the challenging operating environment and weak local economy in Hong Kong, as both the retail and property sectors have performed badly. Hang Seng has no choice but to cut down staff headcount to reduce costs.' The lay-offs were expected to continue in the coming two months, the sources said. Remaining employees must apply for their positions again, competing with new external applicants.
South China Morning Post
14-05-2025
- Business
- South China Morning Post
HSBC's Hong Kong unit Hang Seng Bank lays off staff as part of sweeping revamp
Hong Kong retail lender Hang Seng Bank is carrying out lay-offs as part of its parent company HSBC Holdings' aggressive restructuring aimed at enhancing cost-effectiveness and growth. The lender, 62.14 per cent owned by HSBC , informed staff in various departments over the past few weeks that they would lose their jobs as part of the restructuring plan, two separate sources told the Post. The affected units were mainly supporting departments such as information technology and corporate communications, as well as index compiler Hang Seng Indexes and some units that are being consolidated in the restructuring, the sources said. The total number of people affected was not disclosed. Some departments lost up to 20 per cent of their staff, while the hardest-hit team was cut in half, the sources said. Wealth management and other key growth areas would not be affected and were instead the focus of expansion, the sources said. The bank is currently recruiting for about 100 vacancies. The lay-offs were expected to continue in the coming two months, the sources said. Remaining employees must apply for their positions again, competing with new external applicants. Hang Seng Bank did not directly comment, but said it commonly reviewed and made adjustments to its organisation and departments to meet customers' needs. 'This includes creating new roles, restructuring the organisation [and] upgrading staff's technical skills so as to offer a better quality of service for customers,' the bank said in a statement in Chinese.
