Abstract
Assessments of clinical evidence vary between regulators and health technology assessment bodies, but precise differences remain unclear. To compare uncertainties raised on the clinical evidence of approved drugs, we analyzed assessments of regulators and health technology assessment (HTA) bodies in the United States and Europe. We found that US and European regulators report uncertainties related to safety for almost all drugs (85–94%), whereas HTA bodies reported these less (53–59%). By contrast, HTA bodies raised uncertainties related to effects against relevant comparators for almost all drugs (88–100%), whereas this was infrequently addressed by regulators (12–32%). Regulators as well as HTA bodies reported uncertainties related to the patient population for 60–95% of drugs. The patterns of regulator-HTA misalignment were comparable between the United States and Europe. Our results indicate that increased coordination between these complementary organizations is necessary to facilitate the collection of necessary evidence in an efficient and timely manner.
| Original language | English |
|---|---|
| Pages (from-to) | 350-357 |
| Number of pages | 8 |
| Journal | Clinical Pharmacology and Therapeutics |
| Volume | 108 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 1 Aug 2020 |
Funding
No funding was received for this study. Dr. Kesselheim?s work is supported by Arnold Ventures, as well as the Harvard-MIT Center for Regulatory Science. Dr. Naci?s work is supported by the Commonwealth Fund. The authors would like to acknowledge Sarah Emond from the Institute for Clinical and Economic Review for her review of an early draft of the manuscript.