Effects, costs and implementation of monitoring kidney transplant patients' tacrolimus levels with dried blood spot sampling: A randomized controlled hybrid implementation trial.

AIMS: Dried blood spot (DBS) home sampling allows monitoring creatinine levels and tacrolimus trough levels as an alternative for blood sampling in the hospital, which is important in kidney transplant patient follow-up. This study aims to assess whether DBS home sampling results in decreased patient travel burden and lower societal costs. METHODS: In this single-centre randomized controlled hybrid implementation trial, adult kidney transplant patients were enrolled. The intervention group (n = 25) used DBS home sampling on top of usual care in the first 6 months after transplantation. The control group (n = 23) received usual care only. The primary endpoint was the number of outpatient visits. Other endpoints were costs per patient, patient satisfaction and implementation. RESULTS: There was no statistically significant difference in the average number of outpatient visits between the DBS group (11.2, standard deviation: 1.7) and the control group (10.9, standard deviation: 1.4; P = .48). Average costs per visit in the DBS group were not significantly different (€542, 95% confidence interval €316-990) compared to the control group (€533, 95% confidence interval €278-1093; P = .66). Most patients (n = 19/23, 82.6%) were willing to perform DBS home-sampling if this would reduce the number of hospital visits. Only 55.9% (n = 143/256) of the expected DBS samples were received and 1/5 analysed on time (n = 52/256). CONCLUSION: Adult kidney transplant patients are willing to perform DBS home sampling. However, to decrease patient travel burden and costs in post-transplant care, optimization of the logistical process concerning mailing and analysis of DBS samples is crucial.

Cost-Effectiveness of Nintedanib for Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD).

OBJECTIVES: Progressive fibrosing interstitial lung disease (PF-ILD) is characterised by increased pulmonary fibrosis, lung function decline, acute exacerbations, decreased quality of life and increased mortality. Nintedanib may slow down disease progression, but long-term outcomes are unknown. We aimed to assess the cost-effectiveness of nintedanib in comparison to placebo, both on top of usual care in patients with PF-ILD. METHODS: An individual PF-ILD patient simulation model was created, using data and extrapolations from the nintedanib and placebo arms of the INBUILD trial. Clinical outcomes (mortality, exacerbations, lung transplants), economic outcomes (direct and indirect costs) and the cost-effectiveness of nintedanib over a 10-year time horizon were forecasted using the Netherlands as a case example. Disease progression was driven by lung function decline, with forced vital capacity (FVC) health states ranging from < 40 to ≥ 110 FVC of % predicted. Sensitivity and scenario analyses were performed to assess the impact of parameter assumptions on the cost-effectiveness and to test model robustness. RESULTS: Over a 10-year follow-up, nintedanib gained an average of 1.31 discounted life years and an average of 0.87 discounted quality-adjusted life years (QALYs), resulting in an incremental cost-effectiveness ratio (ICER) of €60,690 per QALY. Sensitivity analyses showed cost variations had a minor impact on the ICER. Results were mainly driven by mortality probabilities and disease-related utilities. Scenario analyses indicated most sensitivity to the time horizon and lung transplantation costs. CONCLUSION: Long-term treatment with nintedanib could result in considerable health gains for patients with PF-ILD and can be considered cost-effective under the common willingness-to-pay threshold.