Review of International Approaches to Assessing and Financing Tumor-agnostic Drugs
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Keywords

tumor-agnostic drugs
malignant neoplasms
foreign experience
clinical guidelines
drug registration
healthcare technology assessment

How to Cite

Omelyanovskiy, V. V., Nikitina, A. V., Ryzhova, O. R., Mukhortova, P. A., & Strunina, J. V. (2023). Review of International Approaches to Assessing and Financing Tumor-agnostic Drugs . Voprosy Onkologii, 69(5), 805–814. https://doi.org/10.37469/0507-3758-2023-69-5-805-814

Abstract

Due to the increasing incidence and prevalence of malignant neoplasms (MN) in Russia, the development of new treatment options is the main component of successful therapy.

One of the newest treatments in this field are the tumor-agnostic therapies, distinguished by their action aimed at targeting MN regardless of localization, if there are specific biomarkers present. Presently, there are tumor-agnostic drugs: entrectinib, larotrectinib and dostarlimab. The majority of clinical trials of these drugs are single-arm trials, which pose several challenges when considering their authorization and funding both in Russia and abroad. Despite this limitation, the discussed drugs are registered or conditionally approved more frequently abroad (USA, Canada, European Union countries, Australia, Japan). Tumor-agnostic drugs are included in foreign clinical guidelines and are funded through public budgets in several countries, despite limited data on clinical effectiveness. This trend is driven by the need to meet the medical requirements for the treatment of life-threatening diseases or those leading to fatal consequences for patients.

https://doi.org/10.37469/0507-3758-2023-69-5-805-814
##article.numberofdownloads## 162
##article.numberofviews## 196
pdf (Русский)

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