Assessing the value of catheter-directed therapy for the management of patients with pulmonary embolism

Principal investigators: Carla Rognoni  

Team UB/Cergas: Carla Rognoni – Rosanna Tarricone

Client: Center for Thrombosis and Hemostasis (CTH), Johannes Gutenberg University Mainz

Duration: 7 months

Abstract:

Venous thromboembolism, especially acute pulmonary embolism (PE), is a major cardiovascular cause of death, following myocardial infarction and stroke. It significantly affects morbidity and mortality rates in Europe and worldwide. Current data suggest that recently introduced catheter-directed treatment (CDT) options for PE may improve survival, reduce complications, and shorten hospital stays. However, healthcare systems in many countries are still hesitant to reimburse the costs of these new treatment options. The aim of the project is to assist stakeholders in systematically evaluating the choices related to the use of CDT in patients with PE. In particular, the objective of the study is to compare CDT with standard medical treatment (SMT) and to develop models to carry out a Cost-Effectiveness Analysis (CEA) and a Budget Impact Analysis (BIA) from the National Healthcare Service (NHS) perspective in Germany.

Methods:

The development of the CEA model will start from the identification of the clinical pathways and healthcare resources consumption for the considered strategies: CDT and SMT. The model will include patients’ clinical outcomes and possibly quality of life data for the considered strategies. Clinical outcomes will focus on mortality, hemodynamic decompensation, bleedings and adverse events. The monetary quantification of the healthcare resource consumption will be conducted from the NHS/payer perspective in Germany to obtain preliminary model results. In case data on costs borne by the patients (out-of-pocket costs) and patients’ productivity losses (for the disease or for premature mortality) will be available, they will be included in the model to consider the societal perspective for the analysis.  

A BIA model structure will be developed starting from the CEA model to evaluate the impact on the NHS expenditure in Germany of the adoption of CDT for the management of patients with PE, over a period of 3 or 5 years.