Health technology assessment in Europe: A comparison of organizations and introduction to the European regulation

Abstract

Health Technology Assessment (HTA) is a multidisciplinary process that evaluates the medical, social, economic, legal, and ethical aspects of health technologies to determine their value throughout their lifecycle. With rising healthcare costs in Europe, robust HTA processes are crucial for making informed decisions that promote an equitable and efficient health system. HTA practices date back to 1967 in France and have expanded across Europe, with most countries adopting HTA models to guide pricing and reimbursement decisions. An analysis of European Health Technology Assessment bodies (HTAb) was conducted through an online survey to showcase the diversity of HTA systems while highlighting their shared goals. The survey, sent to 33 HTAb from July 8 to August 25, 2024, included 11 multiple-choice questions about their organization and processes, allowing for optional free text responses. Data collected were self-reported and analysed using descriptive statistics, with minimal verification of responses. Despite some differences in remit and scope, European HTAb remain steadfast in their resolve to collaborate. The European Commission and EU member states have fostered collaboration among HTA bodies through initiatives like EUnetHTA, culminating in the adoption of the HTA Regulation (EU) 2021/2282, which will be implemented starting January 12, 2025 with the production on joint clinical assessment and joint scientific consultation for some medicinal products and high-risk medical devices. The HTAR offers numerous opportunities for collaboration. Joint productions will foster a culture of mutual learning, allowing countries to benefit from shared expertise and data while ensuring the rigorous and transparent assessment of new health technologies. Moreover, a more unified approach to HTA could accelerate the adoption of new and effective technologies at the continental level, ultimately improving patient outcomes across Europe.

Keywords: European collaboration for health; Evidence-based medicine; HTAR; Health technologie assessment.