Clinical and Economic Impact of Adopting Noninvasive Prenatal Testing as a Primary Screening Method for Fetal Aneuploidies in the General Pregnancy Population.

OBJECTIVE: To evaluate the clinical and economic impact of adopting noninvasive prenatal testing (NIPT) using circulating cell-free DNA as a first-line screening method for trisomy 21, 18, and 13 in the general pregnancy population. METHODS: A decision-analytical model was developed to assess the impact of adopting NIPT as a primary screening test compared to conventional screening methods. The model takes the Belgium perspective and includes only the direct medical cost of screening, diagnosis, and procedure-related complications. NIPT costs are EUR 260. Clinical outcomes and the cost per trisomy detected were assessed. Sensitivity analysis measured the impact of NIPT false-positive rate (FPR) on modelled results. RESULTS: The cost per trisomy detected was EUR 63,016 for conventional screening versus EUR 66,633 for NIPT, with a difference of EUR 3,617. NIPT reduced unnecessary invasive tests by 94.8%, decreased procedure-related miscarriages by 90.8%, and increased trisomies detected by 29.1%. Increasing the FPR of NIPT (from < 0.01 to 1.0%) increased the average number of invasive procedures required to diagnose a trisomy from 2.2 to 4.5, respectively. CONCLUSION: NIPT first-line screening at a reasonable cost is cost-effective and provides better clinical outcomes. However, modelled results are dependent on the adoption of an NIPT with a low FPR.

Cost-Effectiveness of Left Atrial Appendage Closure With the WATCHMAN Device Compared With Warfarin or Non-Vitamin K Antagonist Oral Anticoagulants for Secondary Prevention in Nonvalvular Atrial Fibrillation.

BACKGROUND AND PURPOSE: Once a patient with atrial fibrillation experiences an embolic event, the risk of a recurrent event increases 2.6-fold. New treatments have emerged as viable treatment alternatives to warfarin for stroke risk reduction in secondary prevention populations. This analysis sought to assess the cost-effectiveness of left atrial appendage closure (LAAC) compared with warfarin and the non-vitamin K antagonist oral anticoagulants dabigatran 150 mg, apixaban and rivaroxaban in the prevention of stroke in nonvalvular atrial fibrillation patients with a prior stroke or transient ischemic attack. METHODS: A Markov model was constructed using data from the secondary prevention subgroup analyses of the non-vitamin K antagonist oral anticoagulant and LAAC pivotal trials. Costs were from 2016 US Medicare reimbursement rates and the literature. The cost-effectiveness analysis was conducted from a US Medicare perspective over a lifetime (20 years) horizon. The model was populated with a cohort of 10 000 patients aged 70 years with a CHA2DS2-VASc score of 7 (annual stroke risk=9.60%) and HAS-BLED score of 3 (annual bleeding risk=3.74%). RESULTS: LAAC achieved cost-effectiveness relative to dabigatran at year 5 and warfarin and apixaban at year 6. At 10 years, LAAC had more quality-adjusted life years (4.986 versus 4.769, 4.869, 4.888, and 4.810) and lower costs ($42 616 versus $53 770, $58 774, $55 656, and $58 655) than warfarin, dabigatran, apixaban, and rivaroxaban, respectively, making LAAC the dominant (more effective and less costly) stroke risk reduction strategy. LAAC remained the dominant strategy over the lifetime analysis. CONCLUSIONS: Upfront procedure costs initially make LAAC higher cost than warfarin and the non-vitamin K antagonist oral anticoagulants, but within 10 years, LAAC delivers more quality-adjusted life years and has lower total costs, making LAAC the most cost-effective treatment strategy for secondary prevention of stroke in atrial fibrillation.

Cost effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin.

AIMS: Atrial fibrillation (AF) patients with contraindications to oral anticoagulation have had few options for stroke prevention. Recently, a novel oral anticoagulant, apixaban, and percutaneous left atrial appendage closure (LAAC) have emerged as safe and effective therapies for stroke risk reduction in these patients. This analysis assessed the cost effectiveness of LAAC with the Watchman device relative to apixaban and aspirin therapy in patients with non-valvular AF and contraindications to warfarin therapy. METHODS AND RESULTS: A cost-effectiveness model was constructed using data from three studies on stroke prevention in patients with contraindications: the ASAP study evaluating the Watchman device, the ACTIVE A trial of aspirin and clopidogrel, and the AVERROES trial evaluating apixaban. The cost-effectiveness analysis was conducted from a German healthcare payer perspective over a 20-year time horizon. Left atrial appendage closure yielded more quality-adjusted life years (QALYs) than aspirin and apixaban by 2 and 4 years, respectively. At 5 years, LAAC was cost effective compared with aspirin with an incremental cost-effectiveness ratio (ICER) of €16 971. Left atrial appendage closure was cost effective compared with apixaban at 7 years with an ICER of €9040. Left atrial appendage closure was cost saving and more effective than aspirin and apixaban at 8 years and remained so throughout the 20-year time horizon. CONCLUSIONS: This analysis demonstrates that LAAC with the Watchman device is a cost-effective and cost-saving solution for stroke risk reduction in patients with non-valvular AF who are at risk for stroke but have contraindications to warfarin.

Comparative Costs to Medicare and Medicare Beneficiaries of Alternative AF Stroke Risk Reduction Strategies.

Background: As healthcare costs are increasingly being shifted from payers to patients, it is important to understand the economic consequences of therapeutic strategies to both payers and patients. Objective: To determine the relative costs to Medicare and Medicare beneficiaries (patients) of warfarin, non-vitamin K oral anticoagulants (NOACs), and left atrial appendage closure (LAAC) for stroke risk reduction in nonvalvular atrial fibrillation. Methods: An economic model was developed to assess costs at 5 and 10 years. For warfarin and NOACs, inputs were derived from published meta-analyses; for LAAC with the Watchman device, inputs were derived from pooled 5-year PROTECT AF and PREVAIL trial results. The model captured therapy costs vs clinical event costs, including procedural complications and follow-up clinical outcomes. Costs were based on 2023 Medicare reimbursement and copayment rates. Results: At 10 years, overall LAAC costs ($48,337) were lower than those of NOACs ($81,198) and warfarin ($52,359). Overall LAAC costs were lower than those of NOACs by year 5 and warfarin by year 9. At 5 years, patient LAAC costs were lowest at $4,764, compared to $7,146 and $6,453 for NOACs and warfarin, respectively. LAAC patient costs were lower than those of NOACs by year 3 and warfarin by year 4. Clinical events comprised 96% of overall warfarin costs vs 48% for LAAC and 40% for NOACs. Conclusion: LAAC yielded the lowest overall and patient costs. Warfarin costs were largely driven by clinical events, which may represent an unplanned financial burden for patients. These considerations should be incorporated into shared decision-making discussions about stroke prophylaxis strategies.

Self-Reported Nonadherence Associated with Pharmacy and Home Medication Management Inconvenience Factors in a US Adult Population.

PURPOSE: Medication nonadherence is a significant and multidimensional problem contributing to an increased risk of morbidity and mortality. Inconveniences in pharmacy and home contexts may increase nonadherence. This research examined inconveniences in pharmacy and home contexts associated with self-reported nonadherence, controlling for demographic and medication-taking covariates. METHODS: Data from 4682 individuals who reported self-managing medications in an online marketing survey between October and December 2017 were analyzed in this secondary analysis. Nonadherence was dichotomized using a single question about likelihood to take medications as prescribed (adherence=always; nonadherence=most of the time, some of the time, never). Multivariable logistic regression with backwards elimination was used to examine the pharmacy (use of home delivery, number prescriptions picked up and visits to pharmacy) and home context (method used to organize/manage medications, satisfaction, and bother with management) variables and the demographic (age, sex, race/ethnicity, education, income, insurance) and medication (number of oral medications, medication changes and frequency of taking) covariates associated with nonadherence. RESULTS: Overall, 25.8% of the responses indicated nonadherence. Nonadherence was more likely for individuals making fewer separate pharmacy trips (OR 0.98; 95% CI 0.97-0.99); picking up fewer prescriptions (OR 0.96; 95% CI 0.93-0.99); never, rarely or sometimes using mail order compared with always (OR 1.71; 95% CI 1.30-2.26); not satisfied with managing medications (OR 2.13; 95% CI 1.42-3.19); and using pill pouches and being bothered by them (OR 8.28; 95% CI 1.83-37.31). Using pill pouches or a pillbox and not being bothered by them significantly decreased nonadherence likelihood. Younger and female respondents and those reporting medication changes in the last year were also more likely to report nonadherence. CONCLUSION: Though reasons for nonadherence are multidimensional, this study suggests that inconveniences in both the pharmacy and home context are important. Improving adherence requires addressing issues of inconvenience across the care continuum.

The budget impact of cervical cancer screening using HPV primary screening.

OBJECTIVES: This study assessed the clinical and budgetary impacts of human papillomavirus (HPV) primary screening with HPV16/18 genotyping, in contrast to current cervical cancer screening strategies. STUDY DESIGN: A decision-tree framework and Markov model were used to model clinical and cost implications of screening and diagnosis of disease. METHODS: A model was developed to compare the annual clinical and budgetary impact of HPV screening with genotyping versus cytology, and co-testing with and without genotyping. Epidemiology and test performance inputs are from the literature and the Addressing THE Need for Advanced HPV Diagnostics (ATHENA) trial. Costs are from a US payer perspective. Clinical impact was measured as the resulting incidence of cervical cancer, and budget impact is reported as annual cost per screened woman. The model considered the impact of patient noncompliance (loss to follow-up) at both the initial screen and re-test. RESULTS: Cytology was found to be inferior to both co-testing and HPV primary screening. Co-testing was inferior to co-testing with genotyping. Co-testing with genotyping every 3 years (incidence = 5.5 per 100,000 women; annual investment = $61) or 5 years (incidence = 7.4 per 100,000 women; annual investment = $37) was slightly more effective, but more costly than HPV primary screening every 3 years (incidence = 6.2 per 100,000 women; annual investment = $48) or 5 years (incidence = 8.1 per 100,000 women; annual investment = $30). Genotyping strategies were relatively stable to the effects of patient noncompliance. CONCLUSIONS: Primary HPV screening with genotyping represents a sensible combination of clinical effectiveness and costs, while reducing the risks associated with patient noncompliance.