Health Technology Assessment (HTA) is a comprehensive analysis of medical technologies that includes evaluating their clinical, ethical, economic, and financial impact on the healthcare system and patients’ health. It serves as an important source of information for policymaking. HTA concerns not only medicines but also medical devices, diagnostic methods, procedures, and organizational models of healthcare delivery.

HTA enables informed, transparent, and evidence-based decision-making — both at the national level (procurement, reimbursement, inclusion in registries) and at the hospital level (hospital-based HTA, prioritization of procurement).

Situation in Ukraine

The implementation of HTA in Ukraine has seen both successes and setbacks, but progress continues. The first HTA reports focused on high-cost drugs for centralized national programs. In 2020, a legislative requirement was introduced to conduct HTA for decision-making on the inclusion of medicines in the National List of Essential Medicines.

At the same time, the system remains fragmented. State-level HTA is performed by a limited group of specialists with a heavy workload, and there is a lack of developed infrastructure for hospital-based HTA. At the regional level, implementation and awareness remain low. Data on clinical outcomes, consumption, and costs are limited or unavailable.

Why It Matters

Ukraine has limited resources, while patient needs — especially during wartime — are increasing. Transparent and rational use of funds is only possible when decisions are based on data and evidence. HTA is an important tool for this approach, though not the only one. It helps identify which innovative treatments are effective, safe, and economically viable. Decision-making in healthcare based on HTA improves the quality of care and reduces inefficient spending.

Key Aspects of HTA Application

HTA is applied only to innovations. In this context, healthcare systems in many countries that widely use HTA pay special attention to the criteria and detailed definitions of innovation. Some countries (including Ukraine) apply HTA to single-source medicines, including generics that have no analogues in Ukraine at the time of assessment. For drugs represented by multiple generics, HTA is not applied.

Main Gaps in Ukraine’s HTA System

Despite progress in creating an institutional framework for HTA, Ukraine still lacks a holistic vision of its role in the healthcare system. Several systemic issues can be identified:

1) Lack of a clearly defined purpose and national HTA policy.
The HTA procedure exists but remains largely formal. The state uses HTA mainly to confirm that a technology is effective, safe, and economically viable — meaning it can be purchased with public funds. This minimalist understanding of HTA’s role is not entirely wrong but far too limited. In international practice, HTA is not merely a “check” of technology but a part of a broader process of public investment in health and nation-building.

HTA as a key component of investment decision-making involves:

• strategic planning (which technologies to assess and why);
• assessing value impact on patients and the system;
• setting priorities for public funding;
• linking HTA with budgeting, procurement, clinical guidelines, and reimbursement programs;
• regularly updating data and real-world evidence (effectiveness, outcomes, impact);
• intersectoral coordination at the ministerial level.

HTA should not be just a reactive procedure based on manufacturers’ dossiers, but a proactive tool for strategic management.

2) Excessive expectations: a “magic pill” for forming positive lists.
The formation of positive lists is mainly based on HTA results. This creates a significant barrier to affordability: the HTA process — from dossier preparation to draft report — takes 12–18 months; the time from publication of a state HTA report to the payer’s final decision can take 3–4 years.

In Ukraine, generic medicines are also subject to HTA (with an exception if the molecule is on the WHO list and represented by at least four generics on the market). Globally, HTA is not applied to medicines already represented by generics.

Thus, having an HTA report alone does not guarantee access to medical technologies or rational resource allocation. Proper implementation, monitoring, and feedback mechanisms are essential.

3) Lack of planning for HTA needs at the state level.
The current system operates in a “passive mode”: reports are mainly prepared based on manufacturers’ submissions. As a result, national priorities may not be reflected in the assessment focus. There is no “horizon scanning” mechanism — prioritization of topics for assessment based on disease burden, social importance, epidemiological situation, or risks.

4) Fragmentation and weak integration into related processes.
HTA results often remain isolated from key decisions in budgeting, state programs, clinical guidelines, healthcare financing, and management of the electronic health system. There is little development of needs and efficiency analysis at the institutional (hospital) level.

5) Lack of comprehensive data for analysis.
HTA requires access to data on prevalence, incidence, patient outcomes, medicine consumption, economic indicators, and demand structure. In Ukraine, such data are often not collected, not integrated, or inaccessible for analysis.

What’s Next?

The following steps are needed:

• defining the purpose of HTA application in Ukraine;
• developing a pricing policy that integrates HTA into price setting;
• using a broader range of tools for forming positive lists, such as Multi-Criteria Decision Analysis (MCDA);
• adopting a more detailed and structured approach to defining “innovation,” aligned with the needs and specifics of the Ukrainian healthcare system;
• expanding analytical capacity;
• improving data integration;
• training specialists.

Cross-sector partnerships play a key role — between government, academic institutions, expert organizations in health policy, economics, and financing, hospitals, the patient community, and international experts.