The European Medicines Agency (EMA) has been pivotal in expediting the approval process for innovative medicines, ensuring faster patient access to new treatments. Between 2019 and 2021, the EMA utilized its accelerated assessment (AA) pathway to prioritize the approval of select drugs, a move aimed at addressing urgent medical needs and advancing therapeutic options across Europe.
Characteristics of Accelerated Assessments
Standard EMA assessments typically require a median of 364 days, whereas the accelerated pathway significantly reduces this timeframe to approximately 189 days. Out of 164 medicines authorized during the study period, only 12 qualified for the AA, highlighting its selective nature. Notably, biological products and those under the PRIME scheme were more likely to benefit from accelerated evaluation, whereas small chemical entities faced lower chances of being assessed through this expedited route. Additionally, drugs approved via AA often received authorizations under exceptional circumstances, reflecting the critical need for rapid availability.
Consequences for Health Technology Assessments
Following EMA approval, medicines undergo evaluation by Health Technology Assessment (HTA) bodies such as AIFA, HAS, and G-BA. The study revealed that drugs recognized through the AA pathway were assessed more swiftly by these organizations compared to their standard counterparts. However, this expedited assessment did not consistently translate into a perception of significant added therapeutic value (ATV) over existing alternatives, suggesting that speedier approval does not always equate to superior clinical benefits.
- Accelerated assessments represent a small fraction of total drug approvals.
- Biological and PRIME scheme medicines have higher AA eligibility.
- Faster HTA evaluations do not guarantee major therapeutic advantages.
- Exceptional circumstance authorizations are more common in AA-approved drugs.
The limited use of the accelerated pathway underscores its role in addressing specific clinical needs rather than serving as a default mechanism for drug approval. While the reduction in approval time is beneficial, the lack of consistent recognition of added therapeutic value by HTA bodies indicates a need for more robust criteria to evaluate the true impact of expedited approvals.
Ensuring that accelerated approvals align with genuine therapeutic advancements is crucial for maintaining the integrity of the drug approval process. Policymakers and regulatory bodies may need to refine the AA criteria to better identify medicines that offer substantial benefits over existing treatments. This approach will help balance the urgency of patient access with the necessity of delivering meaningful medical progress, ultimately enhancing the overall healthcare landscape in Europe.
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