Presentation (CTI)

OBJECTIVES: Timely and equitable access to innovative medicines is critical for enhancing health outcomes across Europe; however, significant delays and disparities exist. In response, the European Union implemented a new Health Technology Assessment (EU-HTA) framework in January 2025, aiming to allow for more evidence-based and timely access decisions by pooling resources and expertise. Although implementing acts were published to facilitate this transition, key procedural elements remain untested in practice.
METHODS: We conducted semi-structured interviews with 17 EU/NL healthcare stakeholders, including health insurers (n=2), policymakers (n=2), policy advisors (n=3), pharmaceutical companies (n=7), patient organizations (n=1), and clinicians (n=2). Participants were recruited through purposive sampling via online outreach, the World EPA Congress, and specialist referrals. Interviews were held online or in person, lasting 30 to 60 minutes each. All sessions were audio-recorded, transcribed, and analyzed using ATLAS.ti. Thematic analysis identified recurring patterns and themes related to stakeholder perceptions of EU-HTA.
RESULTS: Participants reported high individual awareness (>80%) of EU-HTA overall, but some reported suboptimal organizational communication and preparedness, revealing a gap between personal knowledge and institutional readiness. Key concerns included limited transparency from the HTA agency, increased workload, and dossier complexity, with smaller pharmaceutical companies particularly vulnerable. While EU-HTA aims to improve timely access, only a few (n=4) expressed clear optimism. Most were cautious or skeptical, anticipating greater benefits for less mature HTA systems. Five interdependent enablers emerged as key conditions for successful implementation: early organizational readiness, effective partnerships, national integration, trust in the system, and a learning mindset.
CONCLUSIONS: Despite high individual awareness, limited optimism and differing organizational readiness may delay EU-HTA’s success. Acceptability and commitment to making the system work are crucial. Strengthening trust through greater collaboration, openness, and engagement among stakeholders will be essential to support implementation and ensure improved outcomes for patients across all Member States.