Unbiased Analysis of Today's Healthcare Issues
Let’s say that you have an international clinical trial that shows a new drug (SuperDrug) perform better than the previous standard of care (OldDrug). Also assume that individuals with a specific comorbidity–let’s call it EF–respond less well to the SuperDrug treatment. If you live in a country where comorbidity EF is common, how well do…
A Health Affairs Forefront paper by researchers Melanie Whittington, Peter Neumann, Joshua Cohen, and Jonathan Campbell makes a compelling case for incorporating drug price dynamics into cost effectiveness analysis. The first questions many people may have is ‘how do drug prices usually change over time?’ A drug’s net price often increases following launch and may…
On September 25, ICER released its 2023 value assessment framework. What is new? What stays the same? Here are a few key points you need to know. Special cases for ultra-rare and single or short-term therapies (SST): These did not change from previous. Adaptations for ultra-rare disease (from Jan 2020) Single or short-term therapies (from…
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.…