Gene therapies and the ISPOR value flower

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…

Coverage with evidence development for medical devices in Central and Eastern Europe

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…

NICE’s new Severity Adjustment

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…

How ICER will conduct it’s “Barriers to Fair Access” Assessment

Last fall, ICER published a white paper titled “Cornerstones of ‘Fair’ Drug Coverage: Appropriate Cost-Sharing and Utilization Management Policies for Pharmaceuticals.” To paraphrase, ICER’s goal is to limit access restrictions (e.g., cost sharing, coverage limitations, prescriber restrictions, step therapy) when a drug is deemed to be cost effective. How will they do this? Their Barriers…

ISPOR Summit on Value Assessment

On June 10, I will be presenting at ISPOR’s Summit on “Value Assessment: New Insights, Approaches, and Applications,” which will highlight evolving practices, new methods, and practical applications in value assessment. The Summit will provide a multistakeholder perspective, including recent developments in the incorporation of uncertainty and risk aversion into value measures, covering both the…