Treatment of venous leg ulcers using bilayered living cellular construct

2020 ◽  
Vol 9 (13) ◽  
pp. 907-918
Author(s):  
Aseel Bin Sawad ◽  
Fatema Turkistani
Keyword(s):  
Healthcare System ◽  
Cost Savings ◽  
Standard Of Care ◽  
Healthcare Resource Utilization ◽  
Psychological Status ◽  
Leg Ulcers ◽  
Venous Leg Ulcers ◽  
Time Period ◽  
The Us ◽  
Economic Analyses

Background: Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). Aim: To evaluate the quality of life (QoL) of patients with VLUs; to analyze the limitations of standard of care (SOC) for VLUs; and to explain how using bilayered living cellular construct (BLCC) with SOC for treatment of VLUs can help heal more VLUs faster (than using SOC alone) as well as help improve QoL and help reduce the burden on the US healthcare system and payers. Materials & methods: This is a review study. The search was conducted in February 2020 by way of electronic databases to find relevant articles that provided information related to QoL of patients with VLUs, limitations of SOC for VLUs and economic analyses of using BLCC for treatment of VLUs. Results: VLUs impact patients’ physical, functional and psychological status and reduce QoL. A total 75% of VLU patients who used SOC alone failed to achieve healing in a timely fashion, which led to increased healthcare costs and healthcare resource utilization. Although the upfront cost is high, the greater effectiveness of BLCC offsets the added cost of the product during the time period of the studies. Therefore, BLCC helps to improve the QoL of VLU patients. As an example, for every 100 VLU patients in a healthcare plan, the use of BLCC can create cost savings of US$1,349,829.51. Conclusion: Payers’ coverage of BLCC results in reduction of the overall medical cost for treating VLU patients.

scholarly journals Potential cost-savings from the use of the biosimilars filgrastim, infliximab and insulin glargine in Canada: a retrospective analysis

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Kerry Mansell ◽  
Hishaam Bhimji ◽  
Dean Eurich ◽  
Holly Mansell
Keyword(s):  
Insulin Glargine ◽  
Retrospective Analysis ◽  
Healthcare System ◽  
Healthcare Providers ◽  
Cost Savings ◽  
Sensitivity Analyses ◽  
Potential Cost ◽  
Biologic Drugs ◽  
Cross Sectional ◽  
Time Period

Abstract Background In 2014 and 2015, biosimilars for the drugs filgrastim, infliximab, and insulin glargine were approved for use in Canada. The introduction of biosimilars in Canada could provide significant cost savings for the Canadian healthcare system over originator biologic drugs, however it is known that the use of biosimilars varies widely across the world. The aim of this study was to estimate the use of biosimilars in Canada and potential cost-savings from their use. Methods We performed a retrospective analysis of Canadian drug purchases for filgrastim, infliximab, and insulin glargine from July 2016 to June 2018. This was a cross-sectional study and the time horizon was limited to the study period. As a result, no discounting of effects over time was included. Canadian drugstore and hospital purchases data, obtained from IQVIA™, were used to estimate the costs per unit and unit volume for biosimilars and originator biologic drugs within each province. Potential cost-savings were calculated as a product of the units of reference originator product purchased and the cost difference between the originator biologic and its corresponding biosimilar. Results The purchase of biosimilars varied by each province in Canada, ranging from a low of 0.1% to a high of 81.6% of purchases. In total, $1,048,663,876 Canadian dollars in savings could have been realized with 100% use of biosimilars over the originator products during this 2 year time period. The potential savings are highest in the province of Ontario ($349 million); however, even in smaller markets (PEI and Newfoundland), $28 million could have potentially been saved. Infliximab accounted for the vast majority of the potential cost-savings, whereas the purchases of the biosimilar filgrastim outpaced that of the originator drug in some provinces. In sensitivity analyses assuming only 80% of originator units would be eligible for use as a biosimilar, $838 million dollars in cost savings over this two-year time period would still have been realized. Conclusions The overall use of biosimilar drugs in Canada is low. Policy makers, healthcare providers, and patients need to be informed of potential savings by increased use of biosimilars, particularly in an increasingly costly healthcare system.

scholarly journals Comparative effectiveness of a bilayered living cellular construct and an acellular fetal bovine collagen dressing in the treatment of venous leg ulcers

2018 ◽  
Vol 7 (8) ◽  
pp. 797-805 ◽  
Author(s):  
Michael L Sabolinski ◽  
Gary Gibbons
Keyword(s):  
Comparative Effectiveness ◽  
Wound Closure ◽  
Cost Savings ◽  
Leg Ulcers ◽  
Significant Cost ◽  
Venous Leg Ulcers ◽  
Bovine Collagen ◽  
Kaplan Meier ◽  
Fetal Bovine

Aim: To compare the effectiveness of bilayered living cellular construct (BLCC) and an acellular fetal bovine collagen dressing (FBCD) for the treatment of venous leg ulcers. Methods: Data from WoundExpert® (Net Health, PA, USA) was used to analyze 1021 refractory venous leg ulcers treated at 177 facilities. Results: Kaplan–Meier analyses showed that BLCC (893 wounds) was superior to FBCD (128 wounds), p = 0.01 for: wound closure by weeks 12 (31 vs 25%), 24 (55 vs 43%) and 36 (68 vs 53%); reduction in time to wound closure of 37%, (19 vs 30 weeks); and improvement in the probability of healing by 45%. Conclusion: BLC versus FBCD showed significant differences in both time to and frequency of healing suggesting that BLCC may provide significant cost savings compared with FBCD.

scholarly journals Assessment of the use of Unna boot in the treatment of chronic venous leg ulcers in adults: systematic review protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032091
Author(s):  
Thalita Paranhos ◽  
Caroline S B Paiva ◽  
Fernanda C I Cardoso ◽  
Priscila P Apolinário ◽  
Flavia Figueiredo Azevedo ◽  
...  
Keyword(s):  
Systematic Review ◽  
New York ◽  
Cochrane Library ◽  
Leg Ulcers ◽  
Venous Flow ◽  
Cross Sectional ◽  
Venous Leg Ulcers ◽  
The Us ◽  
Registration Number ◽  
Review Protocol

IntroductionChronic venous insufficiency (CVI) is an anomaly of the normal functioning of the venous system caused by valvular incompetence with or without the obstruction of venous flow. This condition can affect either or both of the superficial and the deep venous systems. Venous dysfunction can even result in congenital or acquired disorders, and its complications include venous leg ulcers (VLUs). The objective of this systematic review is to determine the effectiveness of Unna boot in the treatment of wound healing of VLU by assessing the quality of the available evidence.Methods and analysisA literature search in PubMed, CINAHL, Scopus, Web of Science, Cochrane Library, BVS/BIREME, Embase, ProQuest, BDTD, Thesis and Dissertation Catalog, Sao Paulo Research Foundation/Thesis and dissertation, OPEN THESIS, A service of the US National Institute of Health, Center for Reviews and Dissemination-University of New York and SciElo published in the last 10 years, the period from January 1999 to March 2019. The review will include primary studies (original), and Controlled Trials or Observational studies (cross-sectional, case–control or longitudinal studies) with VLU. The exclusion will include leg ulceration due to different causes, such as pressure, arterial, diabetic or mixed-aetiology leg ulcers. Data synthesis will be performed using a narrative summary and quantitative analysis.Ethics and disseminationThis systematic review does not require approval by the ethics committee, as individual patient data will not be collected. Dissemination of findings will be through publications in peer-reviewed journals and/or via conference presentations.PROSPERO registration numberCRD42019127947

Randomized standard-of-care-controlled trial of a silica gel fibre matrix in the treatment of chronic venous leg ulcers

2014 ◽  
Vol 24 (2) ◽  
pp. 210-216 ◽  
Author(s):  
Anneke Brown ◽  
Matthias Augustin ◽  
Michael Jünger ◽  
Markus Zutt ◽  
Joachim Dissemond ◽  
...  
Keyword(s):  
Silica Gel ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Leg Ulcers ◽  
Venous Leg Ulcers ◽  
Fibre Matrix

Biomodulation induced by fluorescent light energy versus standard of care in venous leg ulcers: a retrospective study

2019 ◽  
Vol 28 (11) ◽  
pp. 730-736 ◽  
Author(s):  
Valentina Dini ◽  
Agata Janowska ◽  
Giulia Davini ◽  
Jean-Charles Kerihuel ◽  
Stéphane Fauverghe ◽  
...  
Keyword(s):  
Wound Care ◽  
Standard Of Care ◽  
Light Energy ◽  
Fluorescent Light ◽  
Wound Age ◽  
Leg Ulcers ◽  
Venous Leg Ulcers ◽  
Wound Breakdown ◽  
And Gender ◽  
Matching Criteria

Objective: The recently completed EUREKA study confirmed the efficacy and safety profile of fluorescent light energy (FLE) in treating hard-to-heal wounds. To supplement the EUREKA prospective, observational, uncontrolled trial results, researchers selected one of the EUREKA clinical centres to conduct a retrospective analysis of matching wound care data for 46 venous leg ulcers (VLU) patients who had received standard wound care over a five-year period, compared with 10 EUREKA VLU subjects. Method: The study centre selected 46 patients with VLUs based on the matching criteria (wound age and size, patient's age and gender). They compared the healing rates of these matching VLUs with 10 VLU patients treated at the same centre during the EUREKA study. Results: The EUREKA patients had larger and significantly older wounds (p<0.05) and significantly more risk factors (p<0.05) than the matching wounds. However, they had better outcomes (EUREKA: 40% versus matching group: 7% for full wound closure by 16 weeks). No wound breakdown was observed at 16 weeks in the EUREKA group, compared with 25% in the matching group. No EUREKA patient developed infections requiring antibiotics, compared with 37% in the matching group. EUREKA wounds had a mean relative wound area regression (RWAR) of 32% at week six and 50% at week 16, compared with −3% at week six and −6% at week 16 for the matching group. Conclusion: These findings show that the system based on FLE was well-tolerated and efficacious, with better clinical outcome results compared with the wounds analysed in this retrospective matching study and treated with standard of care alone.

Wound dressings, does it matter and why?

2016 ◽  
Vol 31 (1_suppl) ◽  
pp. 63-67 ◽  
Author(s):  
Marjolein Birgitte Maessen-Visch ◽  
Catherine van Montfrans
Keyword(s):  
Cochrane Review ◽  
Standard Of Care ◽  
Compression Therapy ◽  
Wound Dressings ◽  
Leg Ulcers ◽  
Venous Leg Ulcers ◽  
Compression Bandages ◽  
Wide Range ◽  
The Cost

Compression therapy and treating venous insufficiency is the standard of care for venous leg ulcers. The need for debridement on healing venous leg ulcers is still debated. Dressings are often used under compression bandages to promote faster healing and prevent adherence of the bandage to the ulcer. A wide range of dressings is available, including modern dressings with different kinds of biological activity. Microbial burden is believed to underlie delayed healing, but the exact role of microbiofilm in wound healing is uncertain. Before choosing a specific wound dressing, four main functions should be considered: (1) cleaning, (2) absorbing, (3) regulating or (4) the necessity of adding medication. There is no clear evidence to support the use of one dressing over another, as demonstrated by many Cochrane review studies. In addition, the prescriber should enquire about contact allergies that may also develop during wound treatment. It is shown that early intervention and early investment may reduce the cost of treatment. The choice of wound dressings should be guided by cost, ease of application and patient and physician preference and be part of the complete strategy. The role of the medical specialist is evident. Wound dressings matter as part of the optimal treatment in VLU patients.

scholarly journals Prophylactic Treatment in People with Severe Hemophilia B in the US: An Analysis of Real-World Healthcare System Costs and Clinical Outcomes

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2118-2118
Author(s):  
Declan Noone ◽  
Gabriel Pedra ◽  
Sohaib Asghar ◽  
Jamie O'Hara ◽  
Eileen K Sawyer ◽  
...  
Keyword(s):  
Healthcare System ◽  
Resource Utilization ◽  
Real World ◽  
Annual Cost ◽  
Healthcare Resource Utilization ◽  
Hemophilia B ◽  
Severe Hemophilia ◽  
The Us ◽  
The Usa ◽  
The Cost

Introduction The treatment paradigm for people with severe hemophilia B in the US typically involves prophylaxis with factor IX (FIX) replacement therapy, the primary aim of which is to provide sufficient FIX levels to reduce the frequency of bleeding events. The clinical benefits of FIX prophylaxis are well understood, however the cost of FIX products as well as costs associated with healthcare resource utilization present a significant burden to the healthcare system. Substantive costs may also accrue in patients who continue to bleed while on prophylaxis, due to the impact on both short and long-term joint-related outcomes. In the absence of existing data in the US, the 'Cost of Hemophilia Across the USA: a Socioeconomic Survey' (CHESS US) study was conducted to establish a population-based estimate of the real-world US healthcare system burden associated with severe hemophilia. Using data drawn from the CHESS US study, this analysis examines the real-world healthcare system costs and clinical outcomes of people with severe hemophilia B on FIX prophylaxis. Methods CHESS US, a retrospective, cross-sectional dataset of adults with severe hemophilia in the USA, gathered information on patient cost via a patient record form. Data on the following parameters are included in this analysis: FIX consumption, annualized bleeding rate (ABR), the presence of one or more chronically damaged joints ("problem joint"), as well as costs associated with annual (prophylactic) factor consumption and hospitalizations (i.e., number of admissions, number of day cases, total inpatient days, and total intensive care unit [ICU] days). All variables report retrospective data of the 12 months prior to enrolment in the study. Results are presented as mean (± standard deviation) or N (%). Results In total, 132 of 576 patients profiled in the CHESS US study had severe hemophilia B. Among them, 77 patients were on FIX prophylaxis, of whom 44 patients reported FIX dosing regimen and were included in the current analyses. Among them, 20 patients were treated with conventional FIX and 24 patients with extended half-life (EHL) FIX products. The cohort has a mean age of 27.64 (± 11.05) and mean weight (kg) of 75.71 (± 13.41). In the last 12 months, the mean number of international units (IU) prescribed for FIX prophylaxis across the full cohort was 257,216 IU (± 213,591), with an associated annual cost of $610,966 (± $495,869). Among patients treated with conventional FIX, mean prescribed FIX was 287,141 IU (± 264,906) at an annual cost of $397,491 (± $359,788), while patients treated with EHL FIX reported a mean prescribed FIX of 232,278 IU (± 160,914) at an annual cost of $788,861 (± $529,258). The cohort reported a mean ABR of 1.73 (± 1.39); 8 (18%) were reported to have a target joint meeting the International Society on Thrombosis and Haemostasis (ISTH) definition; and 11% were reported to have had at least one chronically damaged joint (i.e., problem joint). Healthcare resource utilization associated with bleed events were reported as follows: hospital admissions days [0.18 (± 0.62)]; inpatient days [0.34 (± 1.22)]; and ICU days [0.23 (± 0.86)]. The direct medical cost to the healthcare system was $2,885 (± $7,857; excluding FIX cost) and $614,886 (± $498,839; including FIX cost). Discussion Data from the CHESS US study showed substantial costs and resource utilization among patients with severe hemophilia B receiving FIX prophylaxis, of which the cost of FIX replacement therapy constituted most of the total cost to healthcare system. Although the ABR observed in the analysis population was low, bleed-related hospitalizations comprised a significant non-drug cost to the healthcare system. A proportion of patients also still experienced joint arthropathy. Such substantial clinical and economic burden highlights that unmet needs remain in patients with severe hemophilia B on FIX prophylaxis in the US. Disclosures Noone: HCD Economics: Employment. Pedra:HCD Economics: Employment. Asghar:HCD Economics: Employment. O'Hara:HCD Economics: Employment, Equity Ownership. Sawyer:uniQure Inc.: Employment. Li:uniQure Inc.: Employment.

scholarly journals Venous Leg Ulcers: Advanced Therapies and New Technologies

Biomedicines ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1569
Author(s):  
Hubert Aleksandrowicz ◽  
Agnieszka Owczarczyk-Saczonek ◽  
Waldemar Placek
Keyword(s):  
New Technologies ◽  
Platelet Rich Plasma ◽  
Standard Of Care ◽  
Intermittent Pneumatic Compression ◽  
Venous Ulcer ◽  
Leg Ulcers ◽  
Plasma Therapy ◽  
Cell Therapies ◽  
Venous Leg Ulcers ◽  
Advanced Therapies

The prevalence of venous leg ulcers (VLUs) differs between 1.5% and 3% in the general population. The challenge in treating VLUs is common recurrence. Moreover, VLUs can be resistant to healing, despite appropriate treatment. In these cases, advanced wound therapies should be considered. The number of new technologies, applied in VLUs treatment, has increased in the last years. These therapies include biophysical interventions such as ultrasound therapy, electrical stimulations, electromagnetic therapy, or phototherapy. Furthermore, stem cell therapies, biologic skin equivalents, platelet-rich plasma therapy, oxygen therapies, anti-TNF therapy, or negative pressure wound therapy are advanced venous ulcer therapeutic methods that may support the standard of care. Medical devices, such as a muscle pump activator, or intermittent pneumatic compression device, may be especially useful for specific subgroups of patients suffering from VLUs. Some of the above-mentioned technologies require broader evidence of clinical efficacy and are still considered experimental therapies in dermatology.

Sign in / Sign up

Export Citation Format

Share Document