Performance of the accelerated assessment of the European Medicines Agency.

Abstract

Aims: In Europe, the European Medicines Agency (EMA) has an accelerated pathway to prioritize approval of medicines. Approved drugs are then assessed by Health Technology Assessment (HTA) bodies before being made available to patients. The aim of the study was to evaluate the characteristics of the drugs admitted to the EMA accelerated assessment (AA) and scrutinize the downstream HTA procedures regarding these medicines and the final assessment regarding added therapeutic value (ATV).

Methods: Regulatory publicly available documents were scrutinized for all medicines authorized by the EMA between 2019 and 2021 to create a regulatory database. A second database was created by extracting data of the medicines that had requested the EMA accelerated pathway from three national HTA bodies (AIFA, HAS and G-BA).

Results: Standard assessments by the EMA had a median of 364 days while AAs were significantly shorter (189 days). Only 12 out of 164 authorized medicines were assessed in this manner. Small chemical entities had a significantly lower chance of being assessed under the AA, while biological and PRIME scheme medicines had a higher chance; AA had a higher chance of leading to authorizations under exceptional circumstances. These 12 products were assessed more quickly compared to other products by HTA bodies, although this did not always lead to decisions of major ATV over alternatives.

Conclusions: A minority of medicinal products are assessed under the accelerated pathway. HTA bodies also assess these products more quickly, but do not always perceive an important clinical advantage over alternatives.