CardioMEMS (tm) HF System (St. Jude Medical, Inc.) and Sacubitril/Valsartan (Entresto (tm), Novartis AG) for management of congestive heart failure: effectiveness, value, and value-based price benchmarks : final report
Congestive heart failure (CHF) describes the condition of fluid build-up in the body as the heart inefficiently fills with or pumps out blood. CHF results from other conditions that weaken the heart muscle including coronary artery disease, myocardial infarction, cardiomyopathy, and hypertension, and is a major public health concern. Two new interventions for CHF have received significant attention--a device and associated software for monitoring increases in pulmonary artery (PA) pressure (a key indicator of worsening CHF) known as the CardioMEMS(tm) HF System (St. Jude Medical), and a drug, Entresto(tm) (Novartis AG), a combination of the angiotensin II receptor blocker (ARB) valsartan and the neprilysin (nep-rĭ-lī-sin) inhibitor sacubitril. The objective of this report is to evaluate the accumulated evidence on these two new interventions, to understand the context around their potential use in clinical practice, and to assess their cost-effectiveness and budgetary impact. Topic in Context. In summarizing the contextual considerations for appraisal of a health care intervention, we seek to highlight the four following specific issues: (1) Is there a particularly high burden/severity of illness? (2) Do other acceptable treatments exist? (3) Are other equally or more effective treatments nearing introduction into practice? (4) Would other societal values accord substantially more or less priority to providing access to this treatment for this patient population?
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