This is a subtitle of a paper by Vreman et al. (2020). Writers look at all the remedies approved by FDA and EMA which were later reviewed by HTA bodies in both courts between 1995 and 2018. ICER was used by the authors as the US HTA body; European HTA bodies included Ecuig (Germany), Nice (UK), Zin (Netherlands), and Unitha. From these reports, the authors classified any uncertainty mentioned in six categories:
- Security: Small sample size, cause of adverse events uninterrupted, long -term security
- Test validity: selection bias, performance bias, prejudice for detection, attachment bias, reporting bias
- population: Population does not match exercise, subgroups have not done enough studies/reports
- Interference: Unreliable or missing information on interaction with other drugs, incredible or missing information about monotherapy or combination, incredible or missing information about proper treatment period
- Comparative effect: Unrerimal or missing information on effects against relevant comparables, incredible indirect comparison, incredible or missing information on proper treatment line
- Pranam: Incredible or missing information on long -term effects, not measured or reported relevant results
Using this approach, the authors evaluated 33 drugs covering 34 signals. The authors found that 7.4 uncertainties (SD 3.8) were raised per drug per institution, with HTA bodies more likely to increase uncertainties than regulators. What did the authors find:
Safety issues – such as causes related to size or uncertainties, raised by regulators for almost all drugs (94% for FDA and 85% for EMA). HTA bodies raised safety issues for only 59% (ICER) and 53% (AGG-EUR).
HTA bodies raised the uncertainties related to the impact against almost all drugs (100%in the United States and 88%in Europe), while this category was rarely addressed by FDA (12%) and only Slightly more %by EMA (32 %)).
In the graph below, you can see a breakdown by the visually category.
Is interesting. You can read full paper Here,
