Health technology assessment (HTA) has become an integral part of Ukraine’s health system since its formal introduction into national legislation in 2017. By 2020, HTA was mandated for evaluating publicly funded medicines, laying the groundwork for more evidence-based healthcare decisions. Although the creation of an independent HTA agency was initially planned for 2022, implementation was delayed due to the COVID-19 pandemic and Russia’s ongoing invasion. The relevant Cabinet Resolution calls for the establishment of an autonomous agency by January 2026. This commentary outlines a strategic, evidence-informed framework to guide the agency’s formation.

Drawing on the 2018 State Strategy for Access to Medicines, the 2022 Law on Medicinal Products, and international best practices, we proposed to the Government of Ukraine a two-tier structure encompassing core business functions (HTA and appraisal, guideline development, pricing, and listing) and support business functions (data and analytics, finance and strategy, IT, human resources, legal, and communications). Each department is tasked with clear mandates and supported by performance indicators to promote transparency, accountability, and operational efficiency.

A phased roadmap for 2025–2027 details the legal, institutional, and financial steps required for successful implementation. Key opportunities – including international partnerships and system-wide reform – are weighed alongside risks such as funding uncertainty, workforce limitations, and geopolitical instability.

By embedding HTA into national policy processes and ensuring institutional independence, Ukraine can enhance the value of healthcare investments and build long-term resilience into its health system.