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1.
Artigo em Inglês | MEDLINE | ID: mdl-38588554

RESUMO

Objective: To compare the effectiveness of cellular tissue products (CTP) versus standard care in U.S. Medicare beneficiaries with diabetic lower extremity ulcers (DLEUs) or venous leg ulcers (VLUs). Approach: We performed a retrospective cohort study using real-world evidence from U.S. Medicare claims for DLEUs or VLUs between 2016 and 2020. There were three cohorts evaluated: viable cryopreserved placental membrane (vCPM) or viable lyopreserved placental membrane (vLPM); other CTP; and standard care. Claims were collapsed into episodes of care. Univariate and bivariate statistics were used to examine the frequency distribution of demographics and clinical variables. Multivariable zero-inflated binomial regressions were used to evaluate mortality and recurrence trends. Logistic regression compared three adverse outcomes (AOs): amputation; 1-year mortality; and wound recurrence. Results: There were 333,362 DLEU episodes among 261,101 beneficiaries, and 122,012 VLU episodes among 80,415 beneficiaries. DLEU treatment with vLPM was associated with reduced 1-year mortality (-26%), reduced recurrence (-91%), and reduced AOs (-71%). VLU treatment with vCPM or vLPM was associated with reduced 1-year mortality (-23%), reduced recurrence (-80%), and 66.77% reduction in AOs. These allografts were also associated with a 49% and 73% reduced risk of recurrence in DLEU and VLU, respectively, compared with other CTPs. Finally, vCPM or vLPM were associated with noninferior prevention of AOs related to amputation, mortality, and recurrence (95% CI: 0.69-1.14). Conclusions: DLEUs and VLUs treated with vCPM and vLPM allografts are associated with lowered 1-year mortality, wound recurrence, and AOs in DLEUs and VLUs compared with standard care. Decision makers weighing coverage of placental allografts should consider these added short- and long-term clinical benefits relative to costly management and high mortality of Medicare's most frequent wounds.

2.
BMJ Open ; 14(4): e082540, 2024 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-38594078

RESUMO

OBJECTIVE: To predict the risk of hospital-acquired pressure injury using machine learning compared with standard care. DESIGN: We obtained electronic health records (EHRs) to structure a multilevel cohort of hospitalised patients at risk for pressure injury and then calibrate a machine learning model to predict future pressure injury risk. Optimisation methods combined with multilevel logistic regression were used to develop a predictive algorithm of patient-specific shifts in risk over time. Machine learning methods were tested, including random forests, to identify predictive features for the algorithm. We reported the results of the regression approach as well as the area under the receiver operating characteristics (ROC) curve for predictive models. SETTING: Hospitalised inpatients. PARTICIPANTS: EHRs of 35 001 hospitalisations over 5 years across 2 academic hospitals. MAIN OUTCOME MEASURE: Longitudinal shifts in pressure injury risk. RESULTS: The predictive algorithm with features generated by machine learning achieved significantly improved prediction of pressure injury risk (p<0.001) with an area under the ROC curve of 0.72; whereas standard care only achieved an area under the ROC curve of 0.52. At a specificity of 0.50, the predictive algorithm achieved a sensitivity of 0.75. CONCLUSIONS: These data could help hospitals conserve resources within a critical period of patient vulnerability of hospital-acquired pressure injury which is not reimbursed by US Medicare; thus, conserving between 30 000 and 90 000 labour-hours per year in an average 500-bed hospital. Hospitals can use this predictive algorithm to initiate a quality improvement programme for pressure injury prevention and further customise the algorithm to patient-specific variation by facility.


Assuntos
Lesão por Pressão , Humanos , Idoso , Estados Unidos/epidemiologia , Estudos de Coortes , Lesão por Pressão/epidemiologia , Lesão por Pressão/prevenção & controle , Registros Eletrônicos de Saúde , Medicare , Aprendizado de Máquina , Estudos Retrospectivos , Curva ROC
3.
J Foot Ankle Res ; 17(2): e12013, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38613833

RESUMO

BACKGROUND: This study examined the efficacy of an interdisciplinary limb preservation service (LPS) in improving surgical outcomes for diabetic foot ulcer (DFU) patients compared to traditional care. METHODS: Data from January 1, 2017 to September 30, 2020 were retrospectively reviewed. An interdisciplinary LPS clinic began on August 1, 2018, coexisting with a preexisting single specialty service. Primary outcomes were major/minor amputation rates and ratios and hospital length of stay. Surgical endpoints pre- and post-LPS launch were compared. RESULTS: Among 976 procedures for 731 unique DFU patients, most were male (80.4%) and Hispanic (89.3%). Patient demographics were consistent before and after LPS initiation. Major amputation rates decreased by 45.5% (15.4%-8.4%, p = 0.001), with outpatient procedures increasing over 5-fold (3.3% pre-LPS to 18.7% post-LPS, p < 0.001). Hospital stay reduced from 10.1 to 8.5 days post-LPS (p < 0.001). The major to minor amputation ratio declined from 22.4% to 12.7%. CONCLUSIONS: The interdisciplinary LPS improved patient outcomes, marked by fewer major amputations and reduced hospital stays, suggesting the model's potential for broader application.


Assuntos
Pé Diabético , Lipopolissacarídeos , Humanos , Masculino , Feminino , Estudos Retrospectivos , Amputação Cirúrgica , Pé Diabético/cirurgia , Extremidades
4.
Gynecol Oncol Rep ; 52: 101351, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38449799

RESUMO

Over the past five years (2019-2023), several new targeted therapies and immunotherapy has been approved in treating relapsed cervical, ovarian, and endometrial cancers. Concurrently, there has been growing recognition of financial toxicity associated with cancer care during this time period. As such, we reviewed FDA approvals from 2019 to 2013 and identified the following approvals in gynecologic oncology: pembrolizumab plus lenvatinib, pembrolizumab for recurrent endometrial cancer that is MSI-H/dMMR, tisotumab vedotin, dostarlimab as single-agent therapy, and dostarlimab plus chemotherapy. We focused on approvals for endometrial cancer, and conducted a cost-effectiveness analysis for combination options approved in treating recurrent or advanced endometrial cancer (i.e. pembrolizumab plus lenvatinib versus placebo; dostarlimab plus chemotherapy versus placebo), and found neither regimen was cost-effective at a willingness-to-pay of $100,000 per Equal Value of Life Years Gained (evLYG). While these costs may not necessarily be translated to an individual patient, these costs are absorbed by healthcare systems and insurance providers on a larger scale with downstream effects on individuals contributing to healthcare costs a whole.

5.
J Wound Care ; 33(Sup3): S24-S38, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38457290

RESUMO

OBJECTIVE: To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU). METHOD: This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30-45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015-2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results. RESULTS: DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold. CONCLUSION: In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds. DECLARATION OF INTEREST: Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US.


Assuntos
Análise de Custo-Efetividade , Úlcera Varicosa , Idoso , Humanos , Estados Unidos , Âmnio , Cicatrização , Córion , Medicare , Úlcera Varicosa/terapia , Análise Custo-Benefício
7.
Int Wound J ; 21(3): e14452, 2023 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-37909183

RESUMO

Pressure injury (PrI) prevention guidelines recommend 2-h repositioning intervals in healthcare settings, requiring significant nursing time investment. We analysed the cost-effectiveness of PrI prevention protocols with 2-, 3- and 4-h repositioning intervals in US nursing homes according to 'Turn Everyone and Move for Ulcer Prevention' (TEAM-UP) randomized controlled trial findings. Markov modelling compared 2-, 3- and 4-h repositioning intervals, controlling for other practice guidelines, to prevent PrIs in nursing home residents from a US health sector perspective over one year using TEAM-UP trial data for model structure, sampling and parameterization. Costs, captured in 2020 US dollars, and quality-adjusted life years (QALYs) were used to derive an incremental cost-effectiveness ratio and net monetary benefit (NMB) at $50 000/QALY-$150 000/QALY cost-effectiveness thresholds. Sensitivity analyses tested model uncertainty. Repositioning intervals between 3 and 4 h were cost-effective based on reduced costs at slightly lower QALYs than 2 h at a $50 000/QALY threshold, and the NMB of 4-h repositioning was also more efficient than at 3 h ($9610). Repositioning labour cost and prevention routines were among the most sensitive parameters. Sensitivity analyses demonstrated that 3- and 4-h intervals were cost-effective in over 65% of simulations at any cost-effectiveness threshold. Repositioning intervals of 3 to 4 h have potential to reduce nursing time costs without significant decrements in clinical benefits to nursing home residents. Clinical guidelines for PrI prevention should be updated to reflect TEAM-UP clinical and economic findings. Facilities can use cost-savings recuperated from nursing time to deploy to other patient safety priorities without seriously jeopardizing PrI safety.

8.
J Adv Nurs ; 2023 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-37994188

RESUMO

BACKGROUND: Pressure injury prevention is complex, and rates continue to rise. Checklists reduce human error, improve adherence and standardization with complex processes, focus attention on evidence-based practices derived from clinical practice guidelines and are arranged in a systematic manner to manage the entirety of a patient's risk for preventable outcomes. The original Standardized Pressure Injury Prevention Protocol was created to provide a checklist of pressure injury prevention measures but needed revision and validation. PURPOSE: This article describes the revision and content validity testing of the Standardized Pressure Injury Prevention Protocol Checklist 2.0 that took place in 2022. METHODS: Using the International 2019 Clinical Practice Guideline as a foundation, items were identified/revised, and expert review of the items was obtained. The Standardized Pressure Injury Prevention Protocol 2.0 underwent three rounds of revision by experts from the National Pressure Injury Advisory Panel. A panel of eight national experts completed the content validity survey. Individual item content validity index and total scale content validity index were used to summarize the content validity survey scores. RESULTS: The individual item content validity index scores ranged from 0.5 to 1.0. One item (using a mirror to look at heels) was rated as 0.5, three items were 0.75, 20 items were 0.875 and 23 items were 1.0. The item scoring 0.5 was deleted. Those items scoring 0.75 were revised using the content experts' recommendations. The total scale content validity index was 0.93. CONCLUSION: The Standardized Pressure Injury Prevention Protocol 2.0 provides a standardized checklist of evidence-based items that operationalize a rigorous clinical practice guideline for the prevention of pressure injuries. Early intervention using a standardized approach and evidence-based checklist that can be integrated into the workflow of the direct-care nurse and provider provides the best opportunity for successful and sustainable pressure injury prevention.

9.
Pediatr Neonatol ; 2023 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-37758594

RESUMO

BACKGROUND: Respiratory syncytial virus (RSV) hospitalizations have increased since the 2014 guideline update recommended against the use of palivizumab for preterm infants born ≥29 0/7 weeks' gestational age (GA) without additional risk factors. A novel drug candidate, nirsevimab, has been developed for this population. We analyzed the cost-effectiveness of palivizumab/nirsevimab vs. no prophylaxis in this population. METHODS: A hybrid-Markov model predicted the RSV clinical course in the first year of life and sequelae in the subsequent four years for preterm infants from the healthcare and societal perspectives. Model parameters were derived from the literature. We calculated costs and quality-adjusted life-years (QALYs) to produce an incremental cost-effectiveness ratio (ICER) evaluated at a willingness-to-pay threshold of $150,000/QALY. Sensitivity analyses assessed model robustness. A threshold analysis examined nirsevimab pricing uncertainty. RESULTS: Compared to no prophylaxis, palivizumab costs $9572 and $9584 more from the healthcare and societal perspectives, respectively, with 0.0019 QALYs gained per patient over five years, resulting in ICERs >$5 million per QALY from each perspective. Results were robust to parameter uncertainties; probabilistic sensitivity analysis revealed that no prophylaxis had a 100% probability of being cost-effective. The threshold analysis suggested that nirsevimab is not cost-effective when compared to no prophylaxis if the price exceeds $1962 from a societal perspective. CONCLUSION: Palivizumab is dominated by no prophylaxis for preterm infants 29 0/7-34 6/7 weeks' GA with no additional risk factors. Relevant stakeholders should consider alternatives to palivizumab for this population that are both effective and economical.

10.
Int Wound J ; 20(8): 2953-2963, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37529854

RESUMO

Pressure injuries affect 1 to 46% of residents in aged care (long term) facilities and cause a substantial economic burden on health care systems. Remote expert wound nurse consultation has the potential to improve pressure injury outcomes; however, the clinical and cost effectiveness of this intervention for healing of pressure injuries in residential aged care require further investigation. We describe the remote expert wound nurse consultation intervention and the method of a prospective, pilot, cluster randomised controlled trial. The primary outcome is number of wounds healed. Secondary outcomes are wound healing rate, time to healing, wound infection, satisfaction, quality of life, cost of treatment and care, hospitalisations, and deaths. Intervention group participants receive the intervention over a 12-week period and all participants are monitored for 24 weeks. A wound imaging and measurement system is used to analyse pressure injury images. A feasibility and fidelity evaluation will be concurrently conducted. The results of the trial will inform the merit of and justification for a future definitive trial to evaluate the clinical and cost effectiveness of remote expert wound nurse consultation for the healing of pressure injuries in residential aged care.


Assuntos
Análise de Custo-Efetividade , Lesão por Pressão , Humanos , Idoso , Lesão por Pressão/terapia , Estudos Prospectivos , Qualidade de Vida , Cicatrização , Encaminhamento e Consulta , Análise Custo-Benefício , Ensaios Clínicos Controlados Aleatórios como Assunto
11.
Int Wound J ; 20(9): 3567-3579, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37295778

RESUMO

Pressure injuries affect 13.1% to 45.5% of patients in the intensive care unit and lead to pain and discomfort for patients, burden on healthcare providers, and unnecessary cost to the health system. Turning and positioning systems offer improvements on usual care devices, however the evidence of the effectiveness of such systems is still emerging. We conducted an investigator initiated, prospective, single centre, two group, non-blinded, randomised controlled trial to determine the effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for preventing PIs. The trial was prematurely discontinued after enrolment of 78 participants due to COVID-19 pandemic related challenges and lower than expected enrolment rate. The study groups were comparable on baseline characteristics and adherence to the interventions was high. Four participants developed a PI (in the sacral, ischial tuberosity or buttock region), n = 2 each in the intervention and control group. Each participant developed one PI. As the trial is underpowered, these findings do not provide an indication of the clinical effectiveness of the interventions. There was no participant drop-out or withdrawal and there were no adverse events, device deficiencies, or adverse device effects identified or reported. The results of our study (in particular those pertaining to enrolment, intervention adherence and safety) provide considerations for future trials that seek to investigate how to prevent PIs among ICU patients.


Assuntos
COVID-19 , Lesão por Pressão , Humanos , COVID-19/prevenção & controle , Análise de Custo-Efetividade , Lesão por Pressão/prevenção & controle , Pandemias , Estudos Prospectivos , Unidades de Terapia Intensiva , Hospitais
12.
Am J Cardiovasc Drugs ; 23(4): 429-440, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37204675

RESUMO

BACKGROUND: Antithrombotic drugs, including the P2Y12 inhibitor ticagrelor, increase the risk of perioperative bleeding in patients requiring urgent cardiac surgery. Perioperative bleeding can lead to increased mortality and prolong intensive care unit and hospital stays. A novel sorbent-filled hemoperfusion cartridge that intraoperatively removes ticagrelor via hemoadsorption can reduce the risk of perioperative bleeding. We estimated the cost-effectiveness and budget impact of using this device versus standard practices to reduce the risk of perioperative bleeding during and after coronary artery bypass grafting from the US healthcare sector perspective. METHODS: We used a Markov model to analyze the cost-effectiveness and budget impact of the hemoadsorption device in three cohorts: (1) surgery within 1 day from last ticagrelor dose; (2) surgery between 1 and 2 days from last ticagrelor dose; and (3) a combined cohort. The model analyzed costs and quality-adjusted life years (QALYs). Results were interpreted as both incremental cost-effectiveness ratios and net monetary benefits (NMBs) at a cost-effectiveness threshold of $100,000/QALY. We analyzed parameter uncertainty using deterministic and probabilistic sensitivity analyses. RESULTS: The hemoadsorption device was dominant for each cohort. Patients with less than 1 day of washout in the device arm gained 0.017 QALYs at a savings of $1748 (USD), for an NMB of $3434. In patients with 1-2 days of washout, the device arm yielded 0.014 QALYs and a cost savings of $151, for an NMB of $1575. In the combined cohort, device gained 0.016 QALYs and a savings of $950 for an NMB of $2505. Per-member-per-month cost savings associated with device was estimated to be $0.02 for a one-million-member health plan. CONCLUSION: This model found the hemoadsorption device to provide better clinical and economic outcomes compared with the standard of care in patients who required surgery within 2 days of ticagrelor discontinuation. Given the increasing use of ticagrelor in patients with acute coronary syndrome, incorporating this novel device may represent an important part of any bundle to save costs and reduce harm.


Assuntos
Síndrome Coronariana Aguda , Inibidores da Agregação Plaquetária , Humanos , Ticagrelor/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Fibrinolíticos/efeitos adversos , Análise Custo-Benefício , Hemorragia/induzido quimicamente , Ponte de Artéria Coronária/efeitos adversos , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia
13.
Int J Infect Dis ; 133: 5-8, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37086868

RESUMO

OBJECTIVES: The objective of this study was to determine whether an observed peripapillary ischemia is a potential biomarker of tick-borne infection (TI). METHODS: An experimental design analyzing the optic nerve to demonstrate peripapillary ischemia and vessel density changes through ocular coherence tomography with angiography in subjects with TI. Glaucoma was ruled out and the study engaged subjects in the age range 8-40 years. All subjects in the experimental group experienced visual symptoms. Subjects in the control group were asymptomatic and not previously diagnosed with TI. The ocular coherence tomography with angiography scanned the vessel density of the pericapillary plexus surrounding the optic nerves; the images were rated by percentage of vessel density. A two-tail t-test analysis was used to analyze the results. RESULTS: The t-test for each measure comparing the difference-of-differences to a zero change at baseline returned statistically significant, demonstrating reduced vessel density for the subjects in the experimental group (P <0.0001; 95% confidence interval [32.37409-43.50091]). CONCLUSION: The appearance of peripapillary ischemia in persons below the age of 50 years represents a potential screening biomarker of TI. Primary care physicians, ophthalmologists, and optometrists who have patients presenting sudden onset of visual symptoms in addition to the appearance of peripapillary ischemia should be tested to rule out a TI.


Assuntos
Disco Óptico , Doenças Transmitidas por Carrapatos , Humanos , Criança , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Disco Óptico/diagnóstico por imagem , Disco Óptico/irrigação sanguínea , Angiofluoresceinografia/métodos , Vasos Retinianos , Pressão Intraocular , Campos Visuais , Tomografia de Coerência Óptica/métodos , Isquemia
16.
J Clin Nurs ; 32(3-4): 625-632, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33534939

RESUMO

COVID-19 has infected millions of patients and impacted healthcare workers worldwide. Personal Protective Equipment (PPE) is a key component of protecting frontline clinicians against infection. The benefits of PPE far outweigh the risks, nonetheless, many clinicians are exhibiting skin injury caused by PPE worn incorrectly. These skin injuries, ranging from lesions to open wounds are concerning because they increase the susceptibility of viral infection and transmission to other individuals. Early into the COVID-19 pandemic (April 2020), the U. S. National Pressure Injury Advisory Panel (NPIAP) developed a series of position statements to improve wear-ability of PPE and protect healthcare professionals and their patients as safe from harm as possible under the circumstances. The NPIAP positions, which were formed by conducting a systematic review of what was known at the time, include: (a) Prepare skin before and after wearing PPE with skin sealants, barrier creams and moisturisers; (b) Frequent PPE offloading to relieve pressure and shear applied to skin; (c) treat visible skin injuries immediately caused by PPE to minimise future infection; (d) non-porous dressings may provide additional skin protection, but lack evidence; (e) health systems should take care to educate clinicians about placement and personal hygiene related to handling PPE. Throughout all of these practices, handwashing remains a top priority to handle PPE. These NPIAP positions provided early guidance to reduce the risk of skin injury caused by PPE based on available research regarding PPE injuries, a cautious application of evidence-based recommendations on prevention of device-related pressure injuries in patients and the expert opinion of the NPIAP Board of Directors. Clinicians who adhere to these recommendations reduce the prospects of skin damage and long-term effects (e.g. scarring). These simple steps to minimise the risk of skin injury and reduce the risk of coronavirus infection from PPE can help.


Assuntos
COVID-19 , Equipamento de Proteção Individual , Lesão por Pressão , Pele , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Pessoal de Saúde , Pandemias/prevenção & controle , Equipamento de Proteção Individual/efeitos adversos , SARS-CoV-2 , Pele/lesões , Lesão por Pressão/prevenção & controle
19.
JAMA Netw Open ; 5(12): e2245956, 2022 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-36520440

RESUMO

Importance: Chimeric antigen receptor (CAR) T cell therapies are approved as a third-line or later therapy for several hematological malignant neoplasms. Recently, randomized clinical trials have investigated their efficacy as a second-line treatment in high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL) compared with salvage chemotherapy followed by hematopoietic stem cell transplantation (HSCT). Objective: To evaluate the cost-effectiveness of axicabtagene ciloleucel and tisagenlecleucel vs standard care (SC) as second-line or later therapy for relapsed or refractory DLBCL, from both US health care sector and societal perspectives at a cost-effectiveness threshold of $150 000 per quality-adjusted life-year (QALY). Design, Setting, and Participants: This economic evaluation assessed cost-effectiveness using a partitioned survival model with 2021 US dollars and QALYs over a lifetime horizon. Model inputs were derived from 2 randomized clinical trials (ZUMA-7 and BELINDA) and published literature. In the trials, patients who did not respond to SC received CAR T cells (treatment switching or crossover), either outside the protocol (ZUMA-7) or as part of the protocol (BELINDA). A separate scenario analysis compared second-line axicabtagene ciloleucel with SC alone without treatment crossover to CAR T cell therapy. Data analysis was performed from December 18, 2021, to September 13, 2022. Exposures: CAR T cell therapy (axicabtagene ciloleucel and tisagenlecleucel) compared with salvage chemotherapy followed by HSCT. Main Outcomes and Measures: Costs and QALYs were used to derive incremental cost-effectiveness ratios (ICERs) for the health care sector and societal perspectives. Cost and QALYs were discounted at 3.0% annually. Univariate and multivariate probabilistic sensitivity analysis using 10 000 Monte Carlo simulations were applied to test model uncertainty on the ICER. Results: Second-line axicabtagene ciloleucel was associated with an ICER of $99 101 per QALY from the health care sector perspective and an ICER of $97 977 per QALY from the societal perspective, while second-line tisagenlecleucel was dominated by SC (incremental costs of $37 803 from the health care sector and $39 480 from the societal perspective with decremental QALY of -0.02). Third-line or later tisagenlecleucel was associated with an ICER of $126 593 per QALY from the health care sector perspective and an ICER of $128 012 per QALY from the societal perspective. Based on the scenario analysis of no treatment switching, second-line axicabtagene ciloleucel yielded an ICER of $216 790 per QALY from the health care sector perspective and an ICER of $218 907 per QALY from the societal perspective, compared with SC. When accounting for patients achieving prolonged progression-free survival who would not incur progression-related costs, in this scenario ICER changed to $125 962 per QALY from the health care sector perspective and $122 931 per QALY from the societal perspective. These results were most sensitive to increased list prices of CAR T cell therapy and QALY losses associated with axicabtagene ciloleucel and tisagenlecleucel. Conclusions and Relevance: These findings suggest that second-line axicabtagene ciloleucel and third-line or later tisagenlecleucel were cost-effective in treating patients with relapsed or refractory DLBCL at the cost-effectiveness threshold of $150 000 per QALY. However, uncertainty remains regarding the best candidates who would experience value gains from receiving CAR T cell therapy.


Assuntos
Imunoterapia Adotiva , Linfoma Difuso de Grandes Células B , Humanos , Análise Custo-Benefício , Antígenos CD19 , Linfoma Difuso de Grandes Células B/tratamento farmacológico
20.
JAMA Netw Open ; 5(12): e2248152, 2022 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-36542379

RESUMO

Importance: Venous leg ulcers (VLU) are the most common cause of lower extremity ulceration that commonly occur among older individuals and are characterized by a slow healing trajectory and frequent recurrence; in the United States, VLUs affect more than 600 000 people per year with an estimated cost of $3.5 billion. Clinical trial data show that early intervention with endovenous ablation substantially improves the healing rate and reduces recurrence among patients with VLUs, but there is a need to assess the cost-effectiveness of early endovenous ablation in the US context. Objectives: To evaluate the cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with VLU from the US Medicare perspective. Design, Setting, and Participants: This economic evaluation used a Markov model to simulate the disease progression of VLU for patients receiving compression therapy with early vs deferred ablation over 3 years. The simulated cohort included patients with VLU aged 65 years and older who had clinical characteristics similar to those in the randomized Early Venous Reflux Ablation trial in the United Kingdom. Data were analyzed from September 2021 to June 2022. Main Outcomes and Measures: Direct medical costs, quality-adjusted life years (QALYs), and the incremental monetary benefits at a willingness-to-pay threshold of $100 000/QALY. Univariate and probabilistic sensitivity analyses were performed to test uncertainty of model results. Results: This model used a simulated cohort of patients with VLU aged 65 years and older enrolled in Medicare. Early ablation dominated, with a lower per-patient cost of $12 527 and an increase of 2.011 QALYs, whereas compression therapy with deferred ablation yielded a per-patient cost of $15 208 and 1.985 QALYs gained. At a $100 000/QALY cost-effectiveness threshold, the incremental net monetary benefit was $5226 per patient in favor of early ablation. Probability of healing, followed by the probability of recurrence, was the parameter with greatest impact on model uncertainty. The probabilistic sensitivity analysis showed that early ablation was cost-effective in 59.2% of simulations at the $100 000/QALY threshold. Conclusions and Relevance: In this economic evaluation of compression therapy with early endovenous ablation, early intervention was dominant, as it was cost saving and generated greater QALYs over 3 years from the US Medicare perspective. Payers should prioritize coverage for early ablation to prevent VLU complications rather than treat a costly outcome that also reduces patient well-being.


Assuntos
Refluxo Gastroesofágico , Úlcera Varicosa , Humanos , Idoso , Estados Unidos , Análise Custo-Benefício , Medicare , Úlcera Varicosa/cirurgia , Reino Unido , Cicatrização
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