OBJECTIVES: To gauge awareness of the new EU HTA process within the pharmaceutical industry; how prepared companies are and the general attitudes and expectations towards it. Also, to identify what challenges and opportunities the pharmaceutical industry envisions when the new regulations come into force.

METHODS: 30 industry executives from biotechnology and pharmaceutical companies were surveyed, with most respondents being from medium to large companies across a range of internal teams including health economics and outcomes research (HEOR), pricing, market access and global market strategy.

RESULTS: While 2025 is rapidly approaching and even though 97% of respondents are aware of the new process, less than 10% of companies have started implementing changes at an EU or global level to meet the needs of joint clinical assessments. This is potentially explained by the fact that 78% of the respondents felt the new EU HTA process has not been communicated clearly. Some opinions towards the EU HTA process are surprisingly negative, with perceptions that it will increase the time and resource burden on companies and not speed up patient access to new drugs. Many also expect that country-specific dossiers will still be needed. Interestingly, respondents who have had previous engagement with the EUnetHTA, 21 were much more likely to have a negative opinion towards the new EU HTA. However, some did have a positive outlook on the opportunities for alignment on evidence requirements and overall opinion on the EU HTA is relatively evenly split.

CONCLUSIONS: In general awareness of EU HTA is high, however, there is still significant uncertainty as to how pharmaceutical companies will adapt their processes to meet the increased recourses required to deliver an EU HTA dossier, especially considering the overall preparedness is low.