Development of a national guideline for health technology assessment: the Estonian experience

Abstract Background Health technology assessment (HTA) is a systematic, transparent, and unbiased process of summarizing information on different aspects of health technology to inform policy decisions. To ensure transparency and consistency in HTA, agreement on assessment principles is necessary, and these principles are typically formalized in a guideline. Successful implementation of such a guideline requires the involvement of multiple stakeholders. Methods In 2023, a working group of HTA stakeholders was assembled to discuss and formulate the principles of HTA in Estonia. Led by the University of Tartu Centre for HTA, the group included representatives of policy makers, national reimbursement agency, health technology developers, and patients. Over the course of 15 monthly meetings, the group worked toward reaching a consensus on the assessment principles. Results Compared to the earlier HTA guideline, which was adopted in 2002 and focused only on pharmacoeconomic assessment, the new document also addresses the assessment of clinical effectiveness and principles for involving experts, including patient organizations. Among other aspects, the guideline outlines decision-making principles for technologies with high added value and reports the new discount rate. The guideline was enforced at the beginning of 2025, and the stakeholder organizations will continue to monitor the application of the principles. Conclusions The guideline provides instructions for health technology developers, assessors, and organizations that apply the results of HTA, including institutions and committees that review reimbursement applications for health technologies in Estonia. However, some topics, such as cost-effectiveness thresholds and the definition of rare diseases in the context of reimbursement decision-making, require further discussion. Since the working group did not include all possible stakeholders, a broader involvement should be considered when updating the guideline. Key messages • Estonia’s new HTA guideline broadens the focus beyond pharmacoeconomics, adding clinical and stakeholder involvement principles. • Further discussions and broader stakeholder input are needed for future updates of the HTA guideline.