Acquisition of a Dose Management System with Consideration of Medico-Legal and Economic Aspects

Background New radiation protection regulation encompassing additional obligations for monitoring, reporting and recording of radiation exposure, was enacted on December 31, 2018. As a consequence, dose management systems (DMS) are necessary to fulfill the requirements. The process of selection, acquisition and implementation of a suitable IT solution for this purpose is a challenge that all X-ray-applying facilities, including hospitals and private practices, are currently facing. Method A target/actual-analysis as well as a cost-utility analysis is presented for this specific case as a foundation for the acquisition decision-making process. Result An actual analysis is necessary in order to record the current status of dose documentation. An interdivisional approach is recommended to include all imaging modalities and devices. An interdisciplinary steering committee can be helpful in enabling consensus and rapid action. A target analysis includes additional criteria with respect to ease of operation, technical feasibility, process optimization and research opportunities to consider in addition to the statutory requirements. By means of a cost-benefit analysis, considerations between costs and the individually weighted advantages and disadvantages of eligible DMS result in a ranking of preference for the available solutions. Conclusion Requirements of a DMS can be summarized in a specification sheet. Deploying an actual condition analysis, target state analysis and cost-utility analysis can help to identify a suitable DMS to achieve rapid commissioning and highest possible user acceptance while optimizing costs at the same time. Key Points: Citation Format

Cost-Utility Analysis of Palbociclib, Ribociclib and Letrozole in the First Line Treatment of Metastatic Breast Cancer in Iran Using Partitioned Survival Model

Background and ObjectivesPalbociclib and Ribociclib are a cyclin-dependent kinase (CDK 4/6) oral molecular inhibitors may improve overall survival (OS), progression free survival (PFS) and quality of life (QoL) in metastatic breast cancer (MBC) patients. We aimed to cost utility analysis (CUA) of Palbociclib in comparison with other alternative regimens in the first line treatment of patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) MBC in Iran.MethodsCUA was performed using partitioned survival model (PSM) from Iranian healthcare system perspective. Comparative strategies were Palbociclib+letrozole, Ribociclib+letrozole and Letrozole mono-therapy. Model structured with 1-month cycle length and 15 years as time horizon. Clinical safety and efficacy of interventions and survival functions in terms of PFS and OS for Palbociclib+letrozole, and Ribociclib+Letrozole was obtained from the latest update of PALOMA-1, 2 and MONALEESA-2 study, respectively. Direct medical costs include the cost of drugs, visits, hospitalization, CT scan, bone x-rays, monitoring and testing, and the medications side effects were considered. In order to uncertainty evaluations, deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were performed. Excel 2016 and TreeAge 2020 were used in all stages of evaluation.ResultsBase case results showed that despite the lower effectiveness, Letrozole mono-therapy was the most cost-effective strategy and Palbociclib+letrozole and Ribociclib+letrozole were not cost effective. The incremental cost effectiveness ratio (ICER) of the Palbociclib+Letrozole and Ribociclib+Letrozole compared to Letrozole mono-therapy was estimated at $137,302 and $120,478 per quality adjusted life year (QALY), respectively, indicating a large interval from the target threshold ($4956). DSA showed that the results of the CUA were not significantly sensitive to changes in the values of uncertain variables. PSA also showed Palbociclib+letrozole and Ribociclib+letrozole did not have a chance to be cost effective based on changes in various parameters and simulations.Conclusionsalbociclib and Ribociclib showed significant efficacy in the addition to Letrozole based on the PFS but were not cost effective strategies in the first line treatment of MBC.

Use of the Ring Wound Protector in Open Appendectomy: A Model-Based Cost-Utility Analysis

Objective: To evaluate cost-effectiveness of ring wound protector (RWP) used in open appendectomy. Materials and Methods: The present study was a decision-tree-based analysis. Model inputs, including costs, utilities, and probabilities of surgical site infection (SSI), were retrieved from the previous studies. The incremental cost-effectiveness ratio (ICER) represented the cost of one additional quality-adjusted life day (QALD). This ratio was calculated by dividing the incremental cost [Thai Baht (THB)] by the incremental QALD. One-way sensitivity analyses were performed by varying each input parameter to see how ICER change. Monte-Carlo simulation with 5,000 replications was used to estimate probabilistic ICER and construct the acceptability curve, demonstrating how the probability of being cost-effective changed when the willingness-to-pay (WTP) threshold was shifted. Results: The deterministic ICER of 64,630.78 THB/QALD did not favor RWP use compared with the WTP threshold of 10,000 THB/QALD. However, if the threshold was shifted to 100,000 THB/QALD, it would yield approximately 75% probability of being cost-effective from RWP. Threshold analysis indicated that RWP should cost 281, 301, and 661 THB to be cost-effective at the threshold of 500, 1,000, and 10,000 THB/QALD, respectively. Conclusion: Routine RWP use might not be cost-effective when QALD is the outcome of interest. Based on the results from the present study, policy-makers could be informed that the adoption of this health technology might not be suitable. Keywords: Ring wound protector; Appendectomy; Cost-utility analysis; Decision tree model