Fast In-House Next-Generation Sequencing in the Diagnosis of Metastatic Non-small Cell Lung Cancer: A Hospital Budget Impact Analysis.

Background: Targeted therapy for cancer is becoming more frequent as the understanding of the molecular pathogenesis increases. Molecular testing must be done to use targeted therapy. Unfortunately, the testing turnaround time can delay the initiation of targeted therapy. Objective: To investigate the impact of a next-generation sequencing (NGS) machine in the hospital that would allow for in-house NGS testing of metastatic non-small cell lung cancer (mNSCLC) in a US setting. Methods: The differences between 2 hospital pathways were established with a cohort-level decision tree that feeds into a Markov model. A pathway that used in-house NGS (75%) and the use of external laboratories (so-called send-out NGS) (25%), was compared with the standard of exclusively send-out NGS. The model was from the perspective of a US hospital over a 5-year time horizon. All cost input data were in or inflated to 2021 USD. Scenario analysis was done on key variables. Results: In a hospital with 500 mNSCLC patients, the implementation of in-house NGS was estimated to increase the testing costs and the revenue of the hospital. The model predicted a $710 060 increase in testing costs, a $1 732 506 increase in revenue, and a $1 022 446 return on investment over 5 years. The payback period was 15 months with in-house NGS. The number of patients on targeted therapy increased by 3.38%, and the average turnaround time decreased by 10 days when in-house NGS was used. Discussion: Reducing testing turnaround time is a benefit of in-house NGS. It could contribute to fewer mNSCLC patients lost to second opinion and an increased number of patients on targeted therapy. The model outcomes predicted that, over a 5-year period, there would be a positive return on investment for a US hospital. The model reflects a proposed scenario. The heterogeneity of hospital inputs and the cost of send-out NGS means context-specific inputs are needed. Conclusion: Using in-house NGS testing could reduce the testing turnaround time and increase the number of patients on targeted therapy. Additional benefits for the hospital are that fewer patients will be lost to second opinion and that in-house NGS could generate additional revenue.

Economic Analysis of the European Healthcare Burden of Sternal-Wound Infections Following Coronary Artery Bypass Graft.

Background: Sternal wound infections (SWIs) can be some of the most complex surgical-site infections (SSIs) and pose a considerable risk following coronary artery bypass graft surgery (CABG). Objective: To capture the cost burden of SWIs following CABG across European countries. Methods: We modeled a standardized care pathway for CABG, starting at the point of surgery and extending to 1-year post surgery. The Markov model captures the incidence and cost of an SWI (deep or superficial SWIs). The cost burden is calculated from a hospital perspective such that the main inputs relating to costs were intensive-care-unit (ICU) and general-ward (GW) days. Outpatient care, not in the hospital setting, has no cost in this analysis. Model input parameters were taken from Eurostat and a review of published, peer-reviewed literature. European countries were included in this analysis when values for 50% of the required input parameters per country were identified. Missing data points were interpolated from available data. The robustness of results was assessed via probabilistic sensitivity analysis. Results: Full required input data were available for 8 European countries; a further 18 countries had sufficient data for analysis. The median (interquartile range) for SWI incidence across the 26 countries was 3.9% (2.9-5.6%). The total burden for all 26 countries of SWIs after CABG was €170.8 million. These costs were made up of 25,751 additional ICU days, 137,588 additional GW days, and 7,704 readmissions. The mean cost of an SWI ranged from €8,924 in Poland to €21,321 in Denmark. Relative to the costs of post-CABG care without an SWI complication, the incremental cost of an SWI was highest in Greece (24.9% increase) and lowest in the UK (3.8% increase) with a median (interquartile range) of 12% (10-16%) across all 26 countries. Conclusions: SWIs following CABG present a considerable burden to healthcare budgets.

Sternal-Wound Infections following Coronary Artery Bypass Graft: Could Implementing Value-Based Purchasing be Beneficial?

BACKGROUND/OBJECTIVES: Sternal-wound infections (SWIs) are rare but consequential healthcare-healthcare-associated infections following coronary artery bypass graft surgery (CABG). The impact of SWIs associated on the cost of health care provision is unknown. The aim of this study was to quantify the burden of CABG-related SWIs across countries with mature health care systems and estimate value-based purchasing (VBP) levels based on the local burden. METHODS: A structured literature review identified relevant data for 14 countries (the Netherlands, France, Germany, Austria, the United Kingdom, Canada, Italy, Japan, Spain, the United States, Brazil, Israel, Taiwan, and Thailand). Data, including SWI rates, CABG volume, and length of stay, were used to populate a previously published Markov model that simulates the patient's CABG-care pathway and estimates the economic (US$) and care burden of SWIs for each country. Based on this burden, scenarios for VBP were explored for each country. A feasible cost of intervention per patient for an intervention providing a 20% reduction in the SWI rate was calculated. RESULTS: The SWI burden varied considerably between settings, with SWIs occurring in 2.8% (the United Kingdom) to 10.4% (the Netherlands) of CABG procedures, while the costs per SWI varied between US$8172 (Brazil) to US$54 180 (Japan). Additional length of stay after SWI was the largest cost driver. The overall highest annual burden was identified in the United States (US$336 million) at a mean cost of US$36 769 per SWI. Given the SWI burden, the median cost of intervention per patient that a hospital could afford ranged from US$20 (US$13 to US$42) in France to US$111 (US$65 to US$183) in Japan. CONCLUSIONS: SWIs represent a large burden with a median cost of US$13 995 per case and US$900 per CABG procedure. By tackling SWIs, there is potential to simultaneously reduce the burden on health care systems and improve outcomes for patients. Mutually beneficial VBP agreements might be one method to promote uptake of novel methods of SWI prevention.

Critical Review of European Health-Economic Guidelines for the Health Technology Assessment of Medical Devices.

Background: Health-technology assessment (HTA) is a recognized mechanism to determine the relative benefits of innovative medical technologies. One aspect is their health-economic impact. While the process and methodology for pharmaceuticals is well-established, guidance for medical devices is sparse. Aim: To provide an overview of the health-economic aspect in current European HTA guidelines concerning medical devices and identifying issues raised and potential improvements proposed in recent literature. Methodology: Available guidelines by European agencies were each reviewed and summarized. To complement this, a full systematic review of current literature concerning potential improvements to existing HTA practices for medical devices, from PubMed and EMBASE, was conducted; the focus was on health economics. Authors could only review documents in English, French, or German. The systematic review yielded 518 unique articles concerning HTA for medical devices, 32 of which were considered for full-text review after screening of all abstracts. Results: There is very limited consensus in-and mostly a complete lack of-guidance specific to medical devices in official HTA guidelines, for both clinical and economic analyses. Twenty two of 41 European countries had published official HTA guidance in English, French, or German. Among these only 4 (England, France, the Netherlands, and Sweden) dedicated a chapter or separate document to medical devices. In the literature, there is sufficient evidence to suggest medical devices need to be addressed separately from pharmaceuticals. However, mostly challenges are discussed rather than implementable solutions offered. We present the following set of frequently discussed issues and summarize any solutions that pertain to them: a weak evidence base, learning-curve effects, organizational impact, incremental innovation, diversity of devices, dynamic pricing, and transferability. We further combine reviewed information to suggest a set of possible best practices for health-economic assessment of medical devices. Conclusion: For greater efficiency in medical-device innovation, European agencies should look to (re-)address the specific requirements of medical devices in their HTA guidelines. When both the health-economic and data requirements for the HTA of medical devices are defined, the development of practical solutions will likely follow.