Oleg Borisenko1, Joachim Beige, Eric G Lovett, Uta C Hoppe, Staffan Bjessmo. 1. aSynergus AB, Stockholm, Sweden bDepartment of Nephrology, Kuratorium for Dialysis and Transplantation (KfH), Hospital St Georg, Leipzig, Leipzig, Germany cCVRx Inc., Minneapolis, Minnesota, USA dDepartment of Internal Medicine II, Paracelsus Medical University Salzburg, Salzburg, Austria eSynergus AB and Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.
Abstract
OBJECTIVE: The purpose of this study is to simulate the cost-effectiveness and the long-term clinical performance of the Barostim neo System for the treatment of resistant hypertension when compared to optimal medical treatment. METHODS: A decision analytic model with a combination of a decision tree and Markov process was used to evaluate the cost-effectiveness of Barostim. The clinical effectiveness of Barostim was based on the results of the randomized, placebo-controlled Rheos trial and the follow-up substudy of the DEBuT-HT trial. The cost-effectiveness was modelled from a German societal perspective over a lifetime horizon. Patients with high SBP levels have an increased risk of myocardial infarction, stroke, heart failure and end-stage renal disease. RESULTS: In a simulated cohort of 50-year-old patients at high risk of end-organ damage, Barostim therapy generated 1.66 additional life-years and 2.17 additional quality-adjusted life years with an incremental cost of &OV0556;16 891 when compared with continuation of medical management. Barostim was estimated to be cost-effective compared with optimal medical treatment with an incremental cost-effectiveness ratio of &OV0556;7 797/QALY. In the model, Barostim reduced over a lifetime the rates of myocardial infarction by 19%, stroke by 35%, heart failure by 12% and end-stage renal disease by 23%. The cost-effectiveness of Barostim can be greater in younger patients with resistant hypertension and in patients with significant risk factors for end-organ damage. CONCLUSION: Barostim may be a cost-effective treatment when compared with optimal medical management in patients with resistant hypertension.
RCT Entities:
OBJECTIVE: The purpose of this study is to simulate the cost-effectiveness and the long-term clinical performance of the Barostim neo System for the treatment of resistant hypertension when compared to optimal medical treatment. METHODS: A decision analytic model with a combination of a decision tree and Markov process was used to evaluate the cost-effectiveness of Barostim. The clinical effectiveness of Barostim was based on the results of the randomized, placebo-controlled Rheos trial and the follow-up substudy of the DEBuT-HT trial. The cost-effectiveness was modelled from a German societal perspective over a lifetime horizon. Patients with high SBP levels have an increased risk of myocardial infarction, stroke, heart failure and end-stage renal disease. RESULTS: In a simulated cohort of 50-year-old patients at high risk of end-organ damage, Barostim therapy generated 1.66 additional life-years and 2.17 additional quality-adjusted life years with an incremental cost of &OV0556;16 891 when compared with continuation of medical management. Barostim was estimated to be cost-effective compared with optimal medical treatment with an incremental cost-effectiveness ratio of &OV0556;7 797/QALY. In the model, Barostim reduced over a lifetime the rates of myocardial infarction by 19%, stroke by 35%, heart failure by 12% and end-stage renal disease by 23%. The cost-effectiveness of Barostim can be greater in younger patients with resistant hypertension and in patients with significant risk factors for end-organ damage. CONCLUSION: Barostim may be a cost-effective treatment when compared with optimal medical management in patients with resistant hypertension.