Atezolizumab monotherapy as first-line treatment for non-small cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a cost-effectiveness analysis in the USA

Objective
This study explores the cost-effectiveness of atezolizumab monotherapy compared with chemotherapy as first-line treatment for stage IIIB or IV non-small cell lung cancer (IIIB/IV-NSCLC) ineligible for platinum-based chemotherapy from a US payer perspective.

Design
This is based on the IPSOS clinical trial. We conducted a comprehensive assessment of the cost-effectiveness of atezolizumab monotherapy versus single-agent chemotherapy over a 15-year duration. Employing a robust Markov model incorporating data from 453 patients, we calculated total costs, life-years (LYs), quality-adjusted life-years (QALYs) and the incremental cost-effectiveness ratio (ICER) at a willingness-to-pay (WTP) threshold of $150 000 per QALY. We performed one-way, two-way and probabilistic sensitivity analyses to validate our model.

Setting
The US payer perspective.

Participants
A cohort with NSCLC ineligible for treatment with a platinum-containing regimen from IPSOS clinical trial.

Interventions
Atezolizumab monotherapy versus chemotherapy.

Primary outcome measure
Cost, QALYs, LYs and ICER.

Result
Chemotherapy resulted in an average survival of 0.930 QALYs (1.528 LYs) per patient at an average cost of $67 579. Atezolizumab treatment provided an additional 0.309 QALYs but incurred an extra cost of $66 472, leading to an ICER of $215 069 per QALY compared with chemotherapy. The cost of atezolizumab had the most significant impact on the model outcomes. Probabilistic sensitivity analysis showed that atezolizumab had a 30.2% probability of being considered cost-effective at a WTP threshold of $150 000 per QALY in the USA. These results remained consistent across various scenarios and sensitivity analyses employing both deterministic and probabilistic approaches.

Conclusion
The current price of atezolizumab renders it an unlikely cost-effective treatment option for patients with IIIB/IV-NSCLC from the payer’s perspective in the USA. To achieve cost-effectiveness, substantial discounts are necessary.

Trial registration number
The IMpower-110, an open-label, randomised, phase 3 clinical trial (NCT02409342). The IPSOS clinical trial (NCT03191786).

Read More
Novembre 2024

Prevalence of steatotic liver disease, advanced fibrosis and cirrhosis among community-dwelling overweight and obese individuals in the USA

Background
There are limited prospective data among overweight and obese individuals on the prevalence of advanced fibrosis, and cirrhosis using advanced MRI-based methods in the USA. The aim of this study was to fill that gap in knowledge by prospectively determining the MRI-based prevalence of steatotic liver disease (SLD) and its subcategories, advanced fibrosis and cirrhosis among overweight and obese individuals residing in the USA.

Methods
This is a cross-sectional analysis of prospectively enrolled overweight or obese adults aged 40–75 years from primary care and community-based settings in Southern California. Participants were classified as having SLD if MRI proton density fat fraction ≥5%, and subclassified as metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction and alcohol-associated liver disease (MetALD) and alcohol-related liver disease (ALD) consistently with the new nomenclature guidance per AASLD–EASL–ALEH. Advanced fibrosis and cirrhosis were defined as magnetic resonance elastography (MRE) ≥3.63 kPa and MRE ≥4.67 kPa, respectively.

Results
The cohort included 539 participants with mean (±SD) age of 51.5 (±13.1) years and body mass index of 32.6 (±6.2) kg/m2, respectively. The prevalence of SLD, advanced fibrosis and cirrhosis was 75%, 10.8% and 4.5%, respectively. The prevalence of MASLD, MetALD and ALD was 67.3%, 4.8% and 2.6%, respectively. There was no difference in prevalence of advanced fibrosis and cirrhosis among subcategories.

Conclusions
Using advanced MRI methods among community-dwelling overweight and obese adults, the prevalence of cirrhosis was 4.5%. Most common SLD subcategory was MASLD with 67% of individuals, whereas MetALD and ALD were less common. Systematic screening for advanced fibrosis among overweight/obese adults may be considered.

Read More
Novembre 2024

Abstract Sa703: Investigating Racial Disparities in Out-of-Hospital Cardiac Arrest Interventions in Salt Lake City, Utah, USA

Circulation, Volume 150, Issue Suppl_1, Page ASa703-ASa703, November 12, 2024. Aims:The primary objective of this study was to investigate ethnic disparities in out-of-hospital cardiac arrest (OHCA) interventions, specifically the administration of epinephrine and ant arrythmias. The secondary objective was to explore the association with the provision of bystander CPR (CPR) and the application of Automated External Defibrillator (AED).Methods:This was a retrospective analysis of data from the Salt Lake City Fire Department from 2010 to 2023. The study included adults 18 years or older who experienced OHCA and were treated by EMS. Ethnicity was categorized as Whites, Blacks, Hispanics, Asians, and others. Multivariable regression analysis was used to examine the association between ethnicity and the specified outcomes.Results:Unadjusted analyses revealed no significant differences across ethnic groups in epinephrine and antiarrhythmic medication administration and bystander CPR. However, significant ethnic disparities were observed in AED use: the Asian population had the highest rate (21.8%), while the Black population had the lowest (6.5%). The multivariable analysis found no significant association between ethnicity and any OHCA interventions examined in this study.Conclusions:Our multivariable analysis did not reveal any statistically significant association between ethnicity and various OHCA interventions, including epinephrine administration, antiarrhythmic medication use, bystander CPR, and AED intervention in Salt Lake City. These findings suggest that regional differences in ethnic disparities in OHCA may vary across locations, emphasizing the need for further research into disparities in other regions and the impact of factors such as socioeconomic status and neighborhood conditions.

Read More
Novembre 2024

Abstract 4145655: Association Between Social Vulnerability Index and Heart Failure Mortality in the USA

Circulation, Volume 150, Issue Suppl_1, Page A4145655-A4145655, November 12, 2024. Background:Heart failure (HF) is a primary cause of hospital readmissions with extremely high projected annual costs. Social Vulnerability Index (SVI) assesses a community’s ability to recover from external impacts on public health and provides valuable insights into community-level health outcomes. We aim to identify the association between SVI and HF.Methods:We used a national database (CDC WONDER) to identify the mortality of HF patients in the USA who were ≥25 years in 2020. HF was identified by specific ICD codes I11.0, 13.0, I13.2, and I50. We obtained the SVI per county from the CDC Database. We used the Pearson correlation coefficient (PCC) to examine the association between HF mortality and total SVI overall and within subgroups. Additionally, we employed ANOVA to evaluate the relationship between SVI quartiles and mortality.Results:In 2020, out of 215,907,184 individuals, 113,401 died of HF (40.7% were female and 37% male, 65.9% were of white race, and 8.8% Hispanic). Age-adjusted mortality rate (AAMR) was higher in males (65.3 vs 50.7 in females) and in Black race (75.8 vs 55.8 in White). However, the AAMR was lower in Hispanics (33.5 vs 58.6). Mortality rate increased from 0.044% in 2016 to 0.052% in 2020. The SVI ranged from 2.6045 to 12.7688. Texas, Mississippi, and Georgia were the states with the most counties in the 4th quartile of the SVI. In 2020, Mississippi, Alabama, and Louisiana had the highest AAMR (94.9, 88.6 and 76.4). A weak positive linear relationship was observed between HF mortality and total SVI, with a PCC of 0.2546, p

Read More
Novembre 2024

Rural-urban and regional variations in aspects of caregiving, support services and caregiver health in the USA: evidence from a national survey

Objectives
Due to substantial regional variability in available caregiving services and supports, culture and health status among informal caregivers in the USA, the study objective was to explore how rural-urban differences in aspects of caregiving—caregiving intensity, distance to care recipient, caregiver burden, caregiver health and caregiving support—vary by US Census region (Northeast, South, Midwest and West) after accounting for other social determinants of health.

Design
This study was a secondary analysis of multiwave, cross-sectional study data.

Setting
The data were collected on a representative sample of informal, unpaid caregivers to older adults.

Participants
A sample of n=3551 informal caregivers from the National Study of Caregiving identified by older adult care recipients from waves 1 (2011) and 5 (2015) of the National Health and Aging Trends Study.

Primary and secondary outcome measures
Primary outcome measures were caregiving intensity (provided support for/with the number of activities of daily living (ADLs) and instrumental ADL (IADLs)) caregiver assisted with, hours of caregiving per month), caregiver burden (physical, emotional and financial), support services sought (types and total number), caregivers’ self-reported health and health status (individual comorbidities and a total number of comorbidities). Analyses were stratified by US Census region and rural-urban status, as defined by the US Census Bureau, of census tract of caregiver residence.

Results
Urban caregivers provided higher levels of ADL support in the Northeast (beta=0.19, 95% CI 0.03, 0.35) and West (beta=0.15, 95% CI 0.05,0.26) regions. Urban caregivers provided significantly higher levels of ADL support (p=0.020), IADL support (p=0.033) and total ADLs plus IADLs (p=0.013) than rural caregivers. Caregivers living in the South had higher amounts of monthly hours spent caregiving, ADL support, IADL support and combined ADLs plus IADLs and were more likely to have obesity, report poor or fair health, have heart conditions and experience emotional difficulty from caregiving (all p

Read More
Ottobre 2024

Cohort profile: the ADAPT study, a prospective study of pregnancy preferences, pregnancy, and health and well-being in the southwestern USA

Purpose
Significant methodological shortcomings limit the validity of prior research on pregnancy decision-making and the effects of ‘unintended’ pregnancies on people’s health and well-being. The Attitudes and Decisions After Pregnancy Testing (ADAPT) study investigates the consequences for individuals unable to attain their pregnancy and childbearing preferences using an innovative nested prospective cohort design and novel conceptualisation and measurement of pregnancy preferences.

Participants
This paper describes the characteristics of the ADAPT Study Cohort, comprised of 2015 individuals aged 15–34 years, assigned female at birth, recruited between 2019 and 2022 from 23 health facilities in the southwestern USA.

Findings to date
The cohort was on average 25 years old. About 59% identified as Hispanic/Latine, 21% as white, and 8% as black, 13% multiracial or another race. Over half (56%) were nulliparous. About 32% lived in a household with income

Read More
Settembre 2024

Comparative effectiveness trial of metformin versus insulin for the treatment of gestational diabetes in the USA: clinical trial protocol for the multicentre DECIDE study

Introduction
Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the affected pregnant individual and the infant exposed in utero. One in four individuals with GDM will require pharmacotherapy to achieve glycaemic control. Injectable insulin has been the mainstay of pharmacotherapy. Oral metformin is an alternative option increasingly used in clinical practice. Both insulin and metformin reduce the risk of adverse pregnancy outcomes, but comparative effectiveness data from a well-characterised, adequately powered study of a diverse US population remain lacking. Because metformin crosses the placenta, long-term safety data, in particular, the risk of childhood obesity, from exposed children are also needed. In addition, the patient-reported experiences of individuals with GDM requiring pharmacotherapy remain to be characterised, including barriers to and facilitators of metformin versus insulin use.

Methods and analysis
In a two-arm open-label, pragmatic comparative effectiveness randomised controlled trial, we will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. We plan to recruit 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites using consistent diagnostic and treatment criteria for oral metformin versus injectable insulin and follow them and their children through delivery to 2 years post partum. More information is available at www.decidestudy.org.

Ethics and dissemination
The Institutional Review Board at The Ohio State University approved this study (IRB: 2024H0193; date: 7 December 2024). We plan to submit manuscripts describing the results of each study aim, including the pregnancy outcomes, the 2-year follow-up outcomes, and mixed-methods assessment of patient experiences for publication in peer-reviewed journals and presentations at international scientific meetings.

Trial registration number
NCT06445946.

Read More
Settembre 2024