RWE in HTA Recommendations for Decision Making: Analysis From Ukrainian Perspective

OBJECTIVES: To examine how real world evidence (RWE) is used in HTA recommendations for decision making in the established HTA procedure in Ukraine as the common trend for European HTA organizations is moving towards the wider use of RWE in HTA processes.

METHODS: HTA conclusions with recommendations developed by HTA Department of the State Expert Center of MOH of Ukraine were analyzed regarding the criteria of RWE use as add-on to efficacy data in the recommendations, which are published in open access on the website (https://www.dec.gov.ua/materials/derzhavna-oczinka-medychnyh-tehnologij-zayavy-ta-dosye/).

RESULTS: Submission of RWE in HTA dossiers is recommended as additional information to efficacy data as a part of clinical chapter of submission according to HTA Guideline “The state health technology assessment for medicines” by the Order of the MoH of Ukraine №593 dated 29 March, 2021. The HTA Department led to the following main results in 2021-2022 according to the main procedure: 57 dossiers and MoH requests were submitted, for 37 of which HTA conclusions and recommendations were developed. 19% of HTA recommendations based on manufacturers submissions included RWE. RWE was consistent with the results of randomized clinical trials (RCT) of medicines in oncology and the medicines used to prevent cytomegalovirus (CMV) reactivation and disease in CMV-seropositive recipients of allogeneic hematopoietic stem cell transplantation. There were also recommendations to collect real world data in the local settings among the published HTA conclusions. For example, RWE for antibiotics plays a crucial role in filling gaps in evidence that is not addressed by traditional approaches such as RCT, especially for reserve groups of antibiotics that are indicated for the treatment of pan-resistant microorganisms.

CONCLUSIONS: Use of RWE in HTA recommendations in Ukraine showed a prospective trend as a part of the additional support of medicines’ assessment, which requires further analysis of transferability opportunities and evidence generation in local settings.