HTA criteria used to evaluate diagnostics

When evaluating a new diagnostic, HTA agencies must assess two separate issues: analytical and clinical validity. Analytical validity basically indicates whether the test works; is it able to accurately predicts the presence or absence of a particular biomarker of interest. Clinical validity is whether the test matters in clinical practice.  It could be the case…

ICER vs. NICE

A nice (pun intended) paper by Thokala et al. (2020) compares the Institute for Clinical and Economic Review (ICER) with the National Institute for Health and Care Excellence (NICE) along 4 dimensions: structure, methods, process, and use in decision-making. While ICER and NICE methods are fairly similar, ICER is a non-governmental body without any explicit…

How should we define “unmet need”?

Many health technology assessment (HTA) agencies give additional consideration to treatments if there is unmet need. But what really defines unmet need?  According to an article by Vreman et al. (2019), there are three key elements.  First, there should be no or limited treatment alternatives.  If there are lots of good treatment options available, then…

Current Value Assessment Landscape in the US

A recent report by the National Pharmaceutical Council provides an overview of seven different value frameworks. Specifically, the overview includes value frameworks developed by: American College of Cardiology and the American Heart Association (ACC-AHA), American Society of Clinical Oncology (ASCO), Avalere/FasterCures Patient-Perspective Value Framework (PPFV) Innovation and Value Initiative (IVI) Open-Source Value Project (OSVP) Institute…