That is the subtitle of an article of Vreman et al. (2020). The authors analyze all the treatments approved by the FDA and EMA that were subsequently reviewed by the HTA agencies in both jurisdictions between 1995 and 2018. The authors used icer as the HTA body of the USA. UU.; The European HTA bodies included IQWIG (Germany), Nice (United Kingdom), Zin (Netherlands) and Eunethta. Of these reports, the authors classified any uncertainty mentioned in six categories:
- Security: Small sample size, causality of uninterretable adverse events, long -term safety
- Test validity: selection bias, performance bias, detection bias, dropout bias, report bias
- Population: The population does not coincide with the practice, the subgroups not studied/informed properly
- Intervention: Little reliable or missing information about interactions with other medications, unreliable or missing information about monotherapy or combination regime, unreliable or missing information about the duration of proper treatment
- Comparative effects: Little reliable or missing information on effects against relevant comparators, unreliable indirect comparisons, unreliable or missing information in the appropriate treatment line
- Results: Little reliable or missing information on long -term effects, relevant results not measured or informed
Using this approach, the authors evaluated 33 medications, covering 34 indications. The authors found that 7.4 uncertainties (SD 3.8) rose by drug by institution, and HTA bodies are more likely to increase uncertainties compared to regulators. What did the authors find?
Security problems, such as those related to sample size or uncertainties in causality, were raised by regulators for almost all medications evaluated (94% for FDA and 85% for EMA). HTA bodies raised security problems for only 59% (ICER) and 53% (AGR-UUR) of drugs …
HTA bodies increased uncertainties related to effects against relevant comparators for almost all medications (100% in the United States and 88% in Europe), while this category was barely approached by the FDA (12%) and only A little more for EMA (32 (32 %).
One can see the breakdown by category visually in the graph below.
Interesting at all times. You can read the complete paper here.
