The Cabinet of Ministers of Ukraine adopted amendments to the resolution of 23 December 2020 No. 1300, which updated the Procedure for conducting state health technology assessment (HTA).
The amendments were developed with the aim of fulfilling Ukraine's international obligations under the Association Agreement with the EU and harmonizing Ukrainian legislation with the provisions of EU Directives, in particular with the provisions of Regulation (EU) 2021/2282 of 15 December 2021 and the updated Directive 2011/24/EU.
This Regulation provides for the introduction of mechanisms for joint clinical assessment of health technologies at the EU level. Its results will be taken into account by states when making decisions in the field of healthcare.
The adopted amendments are an important step towards the integration of the national healthcare system into the European space, increasing the efficiency of state health technology assessment procedures and ensuring patients' access to modern and evidence-based methods of treatment.
Among the key innovations:
- taking into account the results of joint clinical assessment and other related materials in the national HTA procedure, which will help avoid duplication of information for applicants;
- introduction of a unified approach to assessing the clinical value of medical technologies, in particular determining the level of added clinical benefit with the corresponding classification;
- application of the tool for early identification of new (promising) medical technologies, if necessary upon the request of the MoH, – for prioritisation, HTA planning and preparing the healthcare system for their introduction.
The functions of conducting state HTA will continue to be performed by the State Expert Center of the Ministry of Health of Ukraine or its successor.
These changes ensure alignment of the national HTA procedure with European approaches and create conditions for using the results of joint clinical assessment at the EU level in Ukraine.
For reference. HTA (health technology assessment) is a practical tool for the process of making informed decisions on the financing of medicinal products in the healthcare sector. HTA recommendations and conclusions are used in forming the National List of Medicinal Products, the Affordable Medicines reimbursement programme, and public procurement, including through the use of managed access agreements.
