Are Companies Ready for the New EU HTA, or Is It an Impossible Task?

OBJECTIVES: To assess the preparedness of companies for the new EU HTA process and understand their attitudes and expectations. Additionally, the study aims to identify the challenges and opportunities the industry anticipates as the launch date looms closer.

METHODS: A survey was conducted with executives from biotechnology and pharmaceutical companies. The respondents predominantly represented medium to large companies, spanning various internal teams including health economics and outcomes research (HEOR), pricing, market access, and global market strategy.

RESULTS: With the 2025 implementation deadline approaching, the survey revealed that although 92% of respondents are aware of the new EU HTA process, only 38% of companies have begun implementing changes at the EU or global level to accommodate joint clinical assessments (compared to 10% in 2022). This low implementation rate may be attributed to 43% of respondents indicating that the new process has not been communicated clearly (down from 78% in 2022). There is a notable level of scepticism about the EU HTA process, with concerns that it will increase the time and resources required without necessarily accelerating patient access to new drugs. Many respondents believe that as country-specific dossiers will still be required resulting in value of EU HTA becoming unclear. Additionally, 51% of respondents do not intend to apply for joint scientific consultation for eligible products citing lack of understanding of PICO requirements and insufficient resources to support the process. Nevertheless, a higher proportion of respondents see potential benefits in aligning evidence requirements across EU.

CONCLUSIONS: While awareness of the new EU HTA is high, overall readiness is low, indicating need for clearer communication from HTA bodies regarding how EU HTA will impact local HTA decision-making. Companies need to start developing robust preparation strategies to ensure they are prepared for the impact EU HTA will have on their launch processes and resource requirements.