are employees of ZRx Outcomes Research Inc. (institution founded by Endo Pharmaceuticals to conduct the present analysis), and have received grants from Endo Pharmaceuticals Inc" should read "Vladimir Zah, Djurdja Vukicevic, and Martina Imro are employees of ZRx Outcomes Research Inc. (institution funded by Endo Pharmaceuticals to conduct the present analysis), and have received grants from Endo Pharmaceuticals Inc".

Background: The purpose of this systematic literature review (SLR) was to evaluate the accuracy of noninvasive diagnostic tools in detecting significant or advanced (F2/F3) fibrosis among patients with nonalcoholic fatty liver (NAFL) in the US healthcare context. Methods: The SLR was conducted in PubMed and Web of Science, with an additional hand search of public domains and citations, in line with the PRISMA statement. The study included US-based original research on diagnostic test sensitivity, specificity and accuracy. Results: Twenty studies were included in qualitative evidence synthesis. Imaging techniques with the highest diagnostic accuracy in F2/F3 detection and differentiation were magnetic resonance elastography and vibration-controlled transient elastography. The most promising standard blood biomarkers were NAFLD fibrosis score and FIB-4. The novel diagnostic tools showed good overall accuracy, particularly a score composed of body mass index, GGT, 25-OH-vitamin D, and platelet count. The novel approaches in liver fibrosis detection successfully combine imaging techniques and blood biomarkers. Conclusions: While noninvasive techniques could overcome some limitations of liver biopsy, a tool that would provide a sufficiently sensitive and reliable estimate of changes in fibrosis development and regression is still missing.

and quality-adjusted life years(QALYs), considering the time spent in each state combined with costs and health-state utilities (HSU) values derived from EQ-5D data from MONALEESA-2. HSU was assumed to be the same regardless of treatment, differing based on the state and time spent in the state. For letrozole, parametric survival distributions best fitted to individual patient failure-time data were defined based on fit statistics, visual inspection, hazard functions, time dependent hazard ratios, diagnostic plots for treatment effects and clinical plausibility. The effects of ribociclib or palbociclib plus letrozole were modelled based on hazard ratios from network meta-analysis using efficacy data from MONALEESA-2, PALOMA-1 and PALOMA-2 trials. The costs considered included the costs of drugs acquisition, disease monitoring, subsequent treatment lines, end of life care, and the management for adverse events. Half-cycle corrections and 5% discount rate were applied. Uncertainty of the parameters and robustness of the results were evaluated using deterministic and probabilistic sensitivity analyses. Results: Ribociclib plus letrozole was dominant versus palbociclib plus letrozole, with a cost saving of 28,619 USD (1USD=3.97BRL/May/2019) and a gain of 0.14 QALYs and 0.22 LYs. The results of the sensitivity analyses showed robustness of the model, with the main uncertain parameters represented by discount rates. Conclusions: From the BPHS perspective, ribociclib plus letrozole is a cost-saving alternative to palbociclib plus letrozole for the first-line treatment of postmenopausal women HR+/HER2-ABC.

No abstract

In absence of head-to-head trials, indirect comparisons can provide useful insights to clinicians and reimbursement-decision making on relative efficacy of treatments. The probabilistic interpretation of Bayesian results suits these purposes, allowing probabilistic statements on which treatment is likely to be the most effective. Bayesian probabilities and credible intervals have different interpretation than classical p-values and confidence intervals. Bayesian results fit well in decision modelling, as resulting posterior distributions can serve as priors in probabilistic cost-effectiveness modelling. Assumptions behind NMA to generate unbiased results were considered valid for IBR vs IDEL+OFA-comparisons, as included patient-populations were nearly identical. Estimates versus PC may be conservative, given higher relative treatments effect in more severe patients. ConClusions: In absence of direct evidence, NMA-results suggest improved PFS and OS for IBR compared to IDEL+OFA and to PC in R/R CLL-patients with high certainty, and can serve as input in HTA-decision modelling.