What is wrong with QALYs?

A paper by Rand and Kesselheim (2021) in Health Affairs this month conducts a systematic literature review to answer this question. Based on 113 articles they identified in peer-reviewed journals, they identify the following 10 criticisms categories. The graph above has each criticism category and the number of peer-reviewed articles that mention this critique type.…

Is the value of a QALY constant?

Standard cost-effectiveness analysis assumes that any gain in quality-adjusted life years (QALYs) should be valued equally. This does not sound unreasonable, but is it true in practice? Consider two potential violations of constant value of QALY gains: scope insensitivity and severity independence. I define each of these below: Scope insensitivity. This assumes that individuals value…

What kind of HTA does the US need?

Should the US have a formal, centralized health technology assessment (HTA) organization? In the United Kingdom, the National Institute for Health and Care Excellence (NICE) plays this roles and has a significant impact on drug pricing in the UK. However, the UK relies on a single payer system and NICE’s recommendations can be directly implemented…

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…

What do HTA decisionmakers care about?

Is it clinical benefit? Cost? Value? The availability of treatment alternatives? To answer this question, a paper by Wranik et al. (2019) conducted a discrete choice experiment DCE to determine HTA stakeholders stated preferences. The sample consisted of HTA stakeholders from 5 countries: Australia, Canada, Germany, Poland, and the United Kingdom. The stakeholders included not…

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…