Use of real‑world evidence in comprehensive drug assessment

Background. The rapid development of digital technologies and the increasing recognition of real‑world evidence (RWE) underscore the need for its broader integration in comprehensive drug assessment, including the development of national restrictive lists of drugs). In this context, an analysis of the availability of local (Russian) real‑world studies (RWS) and their use in comprehensive drug assessment is highly relevant.

Objective: To analyze the availability of RWE and the frequency of its use in comprehensive drug assessment.

Material and methods. The availability of RWS was assessed for 172 drug proposals for inclusion in national restrictive lists between 2020 and 2024. The study was conducted by calculating the proportion of proposals, for which publications reporting the results of local RWS were available at the time of submission. RWS were identified through a systematic search. The frequency of RWE use in comprehensive drug assessment was evaluated through a content analysis of 28 drug dossiers submitted for inclusion in 2022. The frequency of RWE use was also determined in published cost-effectiveness analyses (CEAs) and budget impact analyses (BIAs) of drugs proposed for inclusion in 2018–2024 (116 publications).

Results. Over the period from 2020 to 2024, local RWS were published for 34% of drugs proposed for inclusion in the national restrictive lists. In 2022, 86% of drug dossiers included RWS. Among the published CEAs and BIAs submitted in 2018–2024, RWE was used in 42% and 63% of cases, respectively.

Conclusions. Russian RWS can already be regarded as a promising source of evidence for comprehensive drug assessment. At the same time, the relatively low publication rate of local RWS indicates the need to further accelerate the generation of such evidence. The high demand for RWE in comprehensive drug assessment underscores the importance of its integration in the development of national restrictive drug lists.

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