That’s the subtitle of a paper by Vreman et al. (2020). The authors have a look at all therapies authorized by FDA and EMA that have 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 dimension, causality of hostile occasions uninterpretable, long-term security
- Trial validity: Choice bias, efficiency bias, detection bias, attrition bias, reporting bias
- Inhabitants: Inhabitants doesn’t match apply, subgroups not adequately studied/reported
- Intervention: Unreliable or lacking info on interactions with different treatment, unreliable or lacking info on monotherapy or mixture routine, unreliable or lacking info on acceptable therapy length
- Comparative results: Unreliable or lacking info on results towards related comparators, unreliable oblique comparisons, unreliable or lacking info on acceptable therapy line
- Outcomes: Unreliable or lacking info on long-term results, related outcomes not measured or reported
Utilizing this method, the authors evaluated 33 medicine, overlaying 34 indications. The authors discovered that 7.4 uncertainties (SD 3.8) have been raised per drug per establishment, with HTA our bodies extra prone to elevate uncertainties in comparison with regulators. What did the authors discover:
Questions of safety—comparable to these associated to pattern dimension or uncertainties in causality—have been raised by regulators for nearly all medicine assessed (94% for the FDA and 85% for the EMA). HTA our bodies raised issues 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.
Fascinating all through. You possibly can learn the total paper right here.
