Cost-effectiveness of endovascular thrombectomy for acute ischemic stroke with established large infarct in Germany: a decision tree and Markov model.

BACKGROUND: Recent studies, including the TENSION trial, support the use of endovascular thrombectomy (EVT) in acute ischemic stroke with large infarct (Alberta Stroke Program Early Computed Tomography Score (ASPECTS) 3-5). OBJECTIVE: To evaluate the cost-effectiveness of EVT compared with best medical care (BMC) alone in this population from a German healthcare payer perspective. METHODS: A short-term decision tree and a long-term Markov model (lifetime horizon) were used to compare healthcare costs and quality-adjusted life years (QALYs) between EVT and BMC. The effectiveness of EVT was reflected by the 90-day modified Rankin Scale (mRS) outcome from the TENSION trial. QALYs were based on published mRS-specific health utilities (EQ-5D-3L indices). Long-term healthcare costs were calculated based on insurance data. Costs (reported in 2022 euros) and QALYs were discounted by 3% annually. Cost-effectiveness was assessed using incremental cost-effectiveness ratios (ICERs). Deterministic and probabilistic sensitivity analyses were performed to account for parameter uncertainties. RESULTS: Compared with BMC, EVT yielded higher lifetime incremental costs (€24 257) and effects (1.41 QALYs), resulting in an ICER of €17 158/QALY. The results were robust to parameter variation in sensitivity analyses (eg, 95% probability of cost-effectiveness was achieved at a willingness to pay of >€22 000/QALY). Subgroup analyses indicated that EVT was cost-effective for all ASPECTS subgroups. CONCLUSIONS: EVT for acute ischemic stroke with established large infarct is likely to be cost-effective compared with BMC, assuming that an additional investment of €17 158/QALY is deemed acceptable by the healthcare payer.

Costs associated with insufficient physical activity in Germany: cross-sectional results from the baseline examination of the German national cohort (NAKO).

BACKGROUND: Insufficient physical activity (PA) is a leading risk factor for non-communicable diseases posing a significant economic burden to healthcare systems and societies. The study aimed to examine the differences in healthcare and indirect costs between sufficient and insufficient PA and the cost differences between PA intensity groups. METHODS: The cross-sectional analysis was based on data from 157,648 participants in the baseline examination of the German National Cohort (NAKO) study. Healthcare and indirect costs were calculated based on self-reported information on health-related resource use and productivity losses. PA in the domains leisure, transport, and work was assessed by the Global Physical Activity Questionnaire and categorized into sufficient/insufficient and intensity levels (very low/low/medium/high) based on PA recommendations of the World Health Organization. Two-part models adjusted for relevant covariates were used to estimate mean costs for PA groups. RESULTS AND CONCLUSION: Insufficiently active people had higher average annual healthcare costs (Δ €188, 95% CI [64, 311]) and healthcare plus indirect costs (Δ €482, 95% CI [262, 702]) compared to sufficiently active people. The difference was especially evident in the population aged 60 + years and when considering only leisure PA. An inverse association was observed between leisure PA and costs, whereas a direct association was found between PA at work and costs. Adjusting for the number of comorbidities reduced the differences between activity groups, but the trend persisted. The association between PA and costs differed in direction between PA domains. Future research may provide further insight into the temporal relationship between PA and costs.

Budget impact analysis of a Lifestyle-integrated Functional Exercise (LiFE) program for older people in Germany: a Markov model based on data from the LiFE-is-LiFE trial.

BACKGROUND: Fall prevention is important for healthy ageing, but the economic impact of fall prevention are scarcely investigated. A recent cost-effectiveness analysis compared a group-delivered Lifestyle-integrated Functional Exercise Program (gLiFE) with an individually-delivered program (LiFE) in community-dwelling people (aged ≥ 70 years) at risk of falling. In addition, the current study aimed to analyze the budget impact of LiFE and gLiFE, compared with standard care in Germany. METHODS: A Markov model was developed to reflect falls and associated care needs for community-dwelling persons over 5 years. The intervention effects of LiFE and gLiFE were shown to be equivalent in a non-inferiority trial, although the costs differed. Outpatient, inpatient, and intervention costs were assessed from a payer's perspective. The effect of parameter uncertainty was assessed in sensitivity analyses. RESULTS: The budget impact due to intervention costs was €510 million for LiFE and €186 million for gLiFE. Over five years, health care expenditures were €35,008 million for those receiving standard care, €35,416 million for those receiving LiFE, and €35,091 million for persons receiving gLiFE. Thereby, LiFE and gLiFE could prevent 2700 deaths and 648,000 falls over 5 years. Parameter uncertainties in the risk of falling, uptake of an intervention offer, and in the intervention effects had a major influence; thus cost savings for LiFE and gLiFE compared with standard care could be achieved for individuals with a high risk of falling. CONCLUSIONS: The results revealed that cost savings for LiFE and gLiFE compared with standard care could only be achieved for individuals at high risk of falling, with gLiFE being superior to LiFE. Future research should consider benefits and aspects of fall prevention beyond falls (e.g., physical activity, social aspects, and personal preferences of participants). TRIAL REGISTRATION: The study was preregistered under underclinicaltrials.gov (identifier: NCT03462654) on 12th March 2018; https://clinicaltrials.gov/ct2/show/NCT03462654 .

Cost-effectiveness of a specialist palliative care nurse-patient consultation followed by an interprofessional case conference for patients with non-oncological palliative care needs: results of the KOPAL trial.

BACKGROUND: Worldwide, progressive chronic, non-malignant diseases are highly prevalent. Especially with increasing age, they are characterised by high hospitalisation rates and high healthcare costs. Improved interprofessional collaboration between general practitioners (GPs) and specialist palliative home care (SPHC) teams might reduce hospitalisation while improving symptoms and quality of life, or preventing them from deterioration. The aim of this study was to examine the cost-effectiveness of a newly developed intervention in patients with advanced chronic, non-malignant diseases consisting of a structured palliative care nurse-patient consultation followed by an interprofessional telephone case conference. METHODS: The analysis was based on data from 172 participants of the KOPAL multi-centre, cluster randomised controlled trial. Patients with advanced congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), or dementia were randomised into intervention group (IG) and control group (CG, usual care). Cost-effectiveness was examined over 48 weeks from a societal and healthcare payer's perspective. Effects were quantified as quality-adjusted life years (QALYs, EQ-5D-5L). Incremental cost-effectiveness ratios were calculated and cost-effectiveness acceptability curves were constructed. RESULTS: Baseline imbalances in costs and effects could be observed between IG and CG. After adjusting for these imbalances and compared to the CG, mean costs in the IG were non-significantly higher from a societal and lower from a payer's perspective. On the effect side, the IG had marginally lower mean QALYs. The results were characterized by high statistical uncertainty, indicated by large confidence intervals for the cost and effect differences between groups and probabilities of cost-effectiveness between 18% and 65%, depending on the perspective and willingness-to-pay. CONCLUSIONS: Based on the results of this study, the cost-effectiveness of the KOPAL intervention was uncertain. The results highlighted (methodological) challenges of economic evaluations in patients with chronic, non-malignant diseases related to sample size, heterogeneity of participants, and the way the intervention effectiveness is typically captured in economic evaluations.

Cost-effectiveness of early rhythm control vs. usual care in atrial fibrillation care: an analysis based on data from the EAST-AFNET 4 trial.

AIMS: The randomized, controlled EAST-AFNET 4 trial showed that early rhythm control (ERC) reduces the rate of a composite primary outcome (cardiovascular death, stroke, or hospitalization for worsening heart failure or acute coronary syndrome) by ∼20%. The current study examined the cost-effectiveness of ERC compared to usual care. METHODS AND RESULTS: This within-trial cost-effectiveness analysis was based on data from the German subsample of the EAST-AFNET 4 trial (n = 1664/2789 patients). Over a 6-year time horizon and from a healthcare payer's perspective, ERC was compared to usual care regarding costs (hospitalization and medication) and effects (time to primary outcome; years survived). Incremental cost-effectiveness ratios (ICERs) were calculated. Cost-effectiveness acceptability curves were constructed to visualize uncertainty. Early rhythm control was associated with higher costs [+€1924, 95% CI (-€399, €4246)], resulting in ICERs of €10 638 per additional year without a primary outcome and €22 536 per life year gained. The probability of ERC being cost-effective compared to usual care was ≥95% or ≥80% at a willingness-to-pay value of ≥€55 000 per additional year without a primary outcome or life year gained, respectively. CONCLUSION: From a German healthcare payer's perspective, health benefits of ERC may come at reasonable costs as indicated by the ICER point estimates. Taking statistical uncertainty into account, cost-effectiveness of ERC is highly probable at a willingness-to-pay value of ≥€55 000 per additional life year or year without a primary outcome. Future studies examining the cost-effectiveness of ERC in other countries, subgroups with higher benefit from rhythm control therapy, or cost-effectiveness of different modes of ERC are warranted.

Comparison of falls and cost-effectiveness of the group versus individually delivered Lifestyle-integrated Functional Exercise (LiFE) program: final results from the LiFE-is-LiFE non-inferiority trial.

BACKGROUND: the individually delivered Lifestyle-integrated Functional Exercise (LiFE) was shown to improve physical activity (PA) and reduce fall incidence, however being rather resource-consuming due to one-to-one delivery. A potentially less resource-intensive group format (gLiFE) was developed and compared against the original program, considering higher risk of falling due to possible PA enhancement. OBJECTIVE: to investigate non-inferiority in terms of PA-adjusted fall risk and cost-effectiveness of gLiFE at 12-month follow-up. DESIGN: single-blinded, randomised, multi-centre non-inferiority trial. SETTING: community. SUBJECTS: in total, 309 adults aged 70+ years at risk of or with history of falling; n = 153 in gLiFE, n = 156 in LiFE. METHODS: LiFE was delivered one-to-one at the participants' homes, gLiFE in a group. PA-adjusted fall risk was analysed using negative binomial regression to compare incidence rate ratios (IRR). Cost-effectiveness was presented by incremental cost-effectiveness ratios and cost-effectiveness acceptability curves, considering quality-adjusted life years, PA and falls as effect measures. Secondary analyses included PA (steps/day) and fall outcomes. RESULTS: non-inferiority was inconclusive (IRR 0.96; 95% confidence interval, CI 0.67; 1.37); intervention costs were lower for gLiFE, but cost-effectiveness was uncertain. gLiFE participants significantly increased PA (+1,090 steps/day; 95% CI 345 and 1.835) versus insignificant increase in LiFE (+569, 95% CI -31; 1,168). Number of falls and fallers were reduced in both formats. CONCLUSION: non-inferiority of gLiFE compared with LiFE was inconclusive after 12 months. Increases in PA were clinically relevant in both groups, although nearly twice as high in gLiFE. Despite lower intervention costs of gLiFE, it was not clearly superior in terms of cost-effectiveness.

Measurement properties of the EQ-5D in populations with a mean age of ≥ 75 years: a systematic review.

PURPOSE: Healthcare interventions for middle-old and oldest-old individuals are often (economically) evaluated using the EQ-5D to measure health-related quality of life (HrQoL). This requires sufficient measurement properties of the EQ-5D. Therefore, the current study aimed to systematically review studies assessing the measurement properties of the EQ-5D in this population. METHODS: The databases PubMed, Cochrane library, Web of Science, Embase, and EconLit were searched for studies providing empirical evidence of reliability, validity, and/or responsiveness of the EQ-5D-3L and EQ-5D-5L in samples with a mean age ≥ 75 years. Studies were selected by two independent reviewers, and the methodological quality was assessed using the COSMIN Risk of Bias checklist. Results were rated against updated criteria for good measurement properties (sufficient, insufficient, inconsistent, indeterminate). The evidence was summarized, and the quality of evidence was graded using a modified GRADE approach. RESULTS: For both EQ-5D versions, high-quality evidence for sufficient convergent validity was found. Known-groups validity was sufficient for the EQ-5D-5L (high-quality evidence), whereas the results were inconsistent for the EQ-5D-3L. Results regarding the reliability were inconsistent (EQ-5D-3L) or entirely lacking (EQ-5D-5L). Responsiveness based on correlations of change scores with instruments measuring related/similar constructs was insufficient for the EQ-5D-3L (high-quality evidence). For the EQ-5D-5L, the available evidence on responsiveness to change in (Hr)QoL instruments was limited. CONCLUSION: Since the responsiveness of the EQ-5D in a population of middle-old and oldest-old individuals was questionable, either using additional instruments or considering the use of an alternative, more comprehensive instrument of (Hr)QoL might be advisable, especially for economic evaluations.

Willingness to pay for a group and an individual version of the Lifestyle-integrated Functional Exercise program from a participant perspective.

BACKGROUND: Perceived benefits of intervention programs from a participant perspective can be examined by assessing their willingness to pay (WTP). Aiming to support decision-makers in their decision to implement a fall prevention program, this study examined (1) the WTP for a group-based and an individually delivered fall prevention program, (2) which factors influence WTP, and (3) whether the WTP exceeds the intervention costs. METHODS: WTP was elicited using Payment Cards from 237 individuals who participated in a randomized non-inferiority trial (LiFE-is-LiFE) comparing a group version of the Lifestyle-integrated Functional Exercise program (gLiFE) with the individually delivered version (LiFE). Linear regression models were used to examine factors associated with WTP. The net benefit for (g)LiFE was calculated as the difference between WTP and intervention costs, assuming different scenarios of intervention costs (varying group sizes of gLiFE) and hypothetical subsidy levels by a payer (€0, €50, or €75). RESULTS: The mean WTP was €196 (95% CI [172, 221]) for gLiFE and €228 (95% CI [204, 251]) for LiFE. In the linear regression model, WTP was significantly associated with delivery format (-€32, 95% CI [- 65, - 0.2], for gLiFE) and net household income (+ 68€, 95% CI [23, 113], for ≥€3000 compared to <€2000). The net benefit for gLiFE was positive in most cases. Due to higher intervention costs of LiFE compared to gLiFE (€298 vs. €113), the net benefit for LiFE was negative for the majority of the sample, even at a subsidy of €75. CONCLUSION: The results provide insight into how valuable the interventions are perceived by the participants and thereby may be used by decision-makers as complement to cost-effectiveness analyses. WTP for both programs was generally high, probably indicating that participants perceived the intervention as quite valuable. However, further research is needed on the WTP and net benefit of fall prevention programs, as results relied on the specific context of the LiFE-is-LiFE trial.

Cost-Effectiveness of a Group vs Individually Delivered Exercise Program in Community-Dwelling Persons Aged ≥70 Years.

OBJECTIVES: Interventions aimed at reducing falls and physical inactivity could alleviate the economic burden attributable to these factors. The study aimed to analyze the cost-effectiveness of a group-delivered version of the Lifestyle-integrated Functional Exercise Program compared with an individually delivered program version. DESIGN: An economic evaluation conducted alongside the LiFE-is-LiFE randomized non-inferiority trial. INTERVENTIONS: Group and individually delivered version of a program consisting of strength and balance exercises integrated into everyday activities to prevent falls. SETTING AND PARTICIPANTS: 309 community-dwelling older adults (aged ≥70 years) at risk of falling recruited around Heidelberg and Stuttgart (Germany). METHODS: Cost-effectiveness of the group program was assessed over 6 months using different effect measures [quality-adjusted life years (QALYs, EQ-5D-5L), physical activity (mean number of steps/day), and falls] and cost perspectives (societal and payer's). Incremental cost-effectiveness ratios were determined, and cost-effectiveness acceptability curves were constructed. RESULTS: From a societal perspective, mean costs, the number of falls, and the number of steps/day were somewhat higher in the group program, whereas QALYs were almost identical between the 2 interventions. From the payer's perspective, the incremental cost-effectiveness ratio for the group compared to the individual program were €56,733 per QALY and €4755 per fall prevented. Based on the cost-effectiveness acceptability curves, the cost-effectiveness of the group program had to be rated as uncertain for both effect measures and perspectives. In contrast, it demonstrated cost-effectiveness for increasing physical activity at willingness-to-pay values per additional 1000 steps/day of €1600 (societal perspective) or €600 (payer's perspective). CONCLUSIONS AND IMPLICATIONS: Compared to the individual program, the group program might be cost-effective for increasing physical activity in older adults but was unlikely to be cost-effective with regard to QALY or for preventing falls. The cost-effectiveness should be evaluated long-term and compared to a regular care group.

Psychometric Properties of the EQ-5D for the Assessment of Health-Related Quality of Life in the Population of Middle-Old and Oldest-Old Persons: Study Protocol for a Systematic Review.

Introduction: Health care interventions for middle-old and oldest-old individuals (75 years or older) are often economically evaluated using the EuroQol questionnaire (EQ-5D) to measure health-related quality of life. However, the psychometric performance of the EQ-5D in this population has been questioned, as it probably does not adequately capture relevant aspects of quality of life in the older population. Because the results of economic evaluations using the EQ-5D often guide decision-makers, it is important to know whether the EQ-5D has satisfactory psychometric properties in the middle-old and oldest-old population. Therefore, studies assessing the psychometric properties of the EQ-5D in this population should be synthesized by a systematic review. Methods and Analysis: A systematic review of studies providing empirical evidence of reliability, validity, and/or responsiveness of the EQ-5D in a sample with a mean age ≥75 years will be conducted. The databases PubMed, Web of Science, and EconLit will be searched. In addition, reference lists of included studies will be hand-searched. Two independent reviewers will select studies and assess their risk of bias with the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) Risk of Bias checklist. Relevant data will be extracted by one reviewer and cross-checked by a second reviewer. Potential disagreements in any phase will be resolved through discussion with a third person. The guidelines for systematic reviews of measurement properties proposed by the COSMIN group, including criteria of good measurement properties, will guide the synthesis and interpretation of the results. Discussion: The review's results could facilitate the making of recommendations for the use of the EQ-5D in a population of middle-old and oldest-old people and thereby being of interest for decision-makers or for researchers designing new intervention studies for older people. Heterogeneity of individual studies regarding the population under study could limit the possibility of making a synthesized statement on the appropriateness of the EQ-5D for the middle-old to oldest-old population.