Unbiased Analysis of Today's Healthcare Issues
The U.S. is one of the the few developed nations without a government-run health technology assessment (HTA) body. Or are they? A recent perspective in the New England Journal of Medicine by Peter Neumann and Sean Tunis argues that the Centers for Medicare and Medicaid Services (CMS) already is serving as a de facto HTA…
That is one of the key questions from the IVI”s recent Value Blueprint paper titled “Prioritized Attributes to Better Define and Measure Innovation in Health Technology Assessment“. The expert roundtable convened by IVI examines not only whether there is a consensus about how to implement the value element (“method readiness”) but also if their is…
Last month, the Office of Health Economics published a report titled “Health Technology Assessment of Gene Therapies: Are Our Methods Fit for Purpose?” I summarize some of the key challenges and solutions below. Challenge #1: Initial assessment of clinical effectiveness. Since gene therapies often target rare disease, the sample size from clinical trials is often…
What considerations beyond quality adjusted life years and cost should be considered when evaluating gene therapies? A panel from ISPOR provided just such a discussion. As summarized an ISPOR’s Value and Outcomes Spotlight article titled “Can Pharmaceutical Pricing Move Beyond Cost QALY for Value Consideration?“, Michael F. Drummond pointed out that: …there are other values…
The value of medical devices caries with it less certainty than pharmaceuticals for a variety of reasons. As described in Kovács et al. (2022) medical devices: often have multiple applications, frequently, undergo product modifications and during their product lifecycle, multiple incremental technological innovations take place affecting both clinical and economic consequences of their adoption into…
In the United Kingdom, the National Institute for Health and Care Excellence (NICE) made an update to their health technology evaluations manual in January 2022. Of particular interest, section 6.2 of the manual states that the review committee “will consider the associated absolute and proportional QALY shortfall.” The committee defined QALY shortfall two ways: Absolute…
That is a title of a new white paper from FTI Consulting and Alexion. The key findings from the article are: HTA practices are designed to be used for medical technologies and pharmaceuticals that treat commonly-occurring diseases, and are not fit to determine the value of orphan drugs for rare disease, which face unique challenges.…
Check out an event this Friday, December 10, at 10am EST/7am PST on at The Hill on Rare Diseases: A Conversation on Value Assessments. A summary of the topic and the speaker list are below. One in 10 Americans suffers from a rare disease—that’s 30 million Americans who need access to treatment. According o the NIH,…
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.…
A new drug comes on the market. Is the health benefit worth the cost? What is it’s value? Value assessment frameworks are one way to answer this question. Value frameworks take the evidence of the treatments benefits, risk and cost and output some notion of the treatment’s value. Ideally, if anyone applied a given value…