Health Technology Assessment, or HTA, is the structured evaluation of the properties and effects of a health technology, such as a medicine, device, or procedure. It considers clinical effectiveness, safety, and often cost effectiveness and budget impact, in order to inform decisions on pricing, reimbursement, and coverage. National bodies such as Germany's G-BA, the UK's NICE, and France's HAS carry out HTA in different ways. At EU level, the HTA Regulation, Regulation (EU) 2021/2282, introduced joint clinical assessments for certain new medicines and high-risk medical devices, starting to apply in January 2025 and phasing in over several years. The aim is to reduce duplication of clinical assessment across member states while leaving pricing and reimbursement decisions to national authorities.
What is Health Technology Assessment?
Health Technology Assessment evaluates the clinical and economic value of health technologies to inform reimbursement and coverage decisions.
What is the EU HTA Regulation?
The HTA Regulation (EU) 2021/2282 introduced joint clinical assessments at EU level for certain medicines and high-risk devices, phasing in from January 2025, while national bodies keep control of pricing and reimbursement.
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