Spain Explores Italy’s HTA Model to Advance EU HTA Regulation Implementation | iPharmaCenter
- Badari Andukuri
- 2 hours ago
- 2 min read
A study mission focused on the European Health Technology Assessment (HTA) framework, involving the Spanish Agency for Medicines and Health Products (AEMPS), has officially wrapped up following a visit to Italy. The initiative, titled “Supporting AEMPS in the implementation of the HTA Regulation, study visit to Italy,” was conducted under the European Commission’s TAIEX Technical Support Instrument (TSI).
This engagement provided a valuable platform for both technical exchange and institutional dialogue on how to operationalize the European HTA Regulation alongside national systems.
Italy’s Medicines Agency (AIFA) emerged as a point of reference due to its integrated approach, which combines clinical assessment, economic evaluation, and pricing and reimbursement decisions within a unified framework. This model attracted strong interest from the Spanish delegation, which examined AIFA’s structure as a practical example to better understand HTA system organization, governance frameworks, evaluation methodologies, and coordination with pricing and reimbursement pathways.
The overarching goal was to facilitate effective adoption of EU Regulation 2021/2282 while minimizing redundancy between European-level and national-level assessments.
Throughout the visit, AEMPS representatives engaged with AIFA leadership, including President Robert Nisticò and Technical-Scientific Director Pierluigi Russo. These discussions offered insights into Italy’s mechanisms for evaluating medicines and enabling patient access. Delegates also observed the operations of the Scientific and Economic Commission (CSE), gaining firsthand exposure to how scientific evidence, economic considerations, and negotiation processes converge in decision-making.
The two-day program delivered detailed sessions on the core components of the Italian HTA model. Topics included clinical and economic evaluation techniques, integration of Joint Clinical Assessments from the European level into national processes, and methodologies for determining therapeutic value. The agenda also emphasized pricing and reimbursement strategies, including managed entry agreements, as well as the role of registries and real-world evidence in supporting decision-making.
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