Healthcare Economist February 12, 2025
That is the subtitle of a paper by Vreman et al. (2020). The authors look at all treatments approved by FDA and EMA that were subsequently reviewed by HTA bodies in both jurisdictions between 1995 and 2018. The authors used ICER as the US HTA body; European HTA bodies included IQWiG (Germany), NICE (UK), ZIN (Netherlands), and EUnetHTA. From these reports the authors classified any uncertainties mentioned into six categories:
- Safety: small sample size, causality of adverse events uninterpretable, long-term safety
- Trial validity: Selection bias, performance bias, detection bias, attrition bias, reporting bias
- Population: Population does not match practice, subgroups not adequately studied/reported
- Intervention: Unreliable or missing information on interactions with other medication, unreliable or missing information on monotherapy...
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