That’s the subtitle of a paper by Vreman et al. (2020). The authors take a look at all remedies accredited by FDA and EMA that had been subsequently reviewed by HTA our bodies in each jurisdictions between 1995 and 2018. The authors used ICER because the US HTA physique; European HTA our bodies included IQWiG (Germany), NICE (UK), ZIN (Netherlands), and EUnetHTA. From these experiences the authors categorized any uncertainties talked about into six classes:
- Security: small pattern measurement, causality of antagonistic occasions uninterpretable, long-term security
- Trial validity: Choice bias, efficiency bias, detection bias, attrition bias, reporting bias
- Inhabitants: Inhabitants doesn’t match follow, subgroups not adequately studied/reported
- Intervention: Unreliable or lacking info on interactions with different medicine, unreliable or lacking info on monotherapy or mixture routine, unreliable or lacking info on acceptable remedy period
- Comparative results: Unreliable or lacking info on results towards related comparators, unreliable oblique comparisons, unreliable or lacking info on acceptable remedy line
- Outcomes: Unreliable or lacking info on long-term results, related outcomes not measured or reported
Utilizing this strategy, the authors evaluated 33 medicine, overlaying 34 indications. The authors discovered that 7.4 uncertainties (SD 3.8) had been raised per drug per establishment, with HTA our bodies extra prone to increase uncertainties in comparison with regulators. What did the authors discover:
Questions of safety—similar to these associated to pattern measurement or uncertainties in causality—had been raised by regulators for nearly all medicine assessed (94% for the FDA and 85% for the EMA). HTA our bodies raised questions of safety for less than 59% (ICER) and 53% (AGGR-EUR) of medicine…
HTA our bodies raised uncertainties associated to results towards related comparators for nearly all medicine (100% in america and 88% in Europe), whereas this class was hardly addressed by the FDA (12%) and solely barely extra by the EMA (32%).
One can see the breakdown by class visually within the graph beneath.
Attention-grabbing all through. You’ll be able to learn the complete paper right here.
