Обзор зарубежных подходов к оценке и финансированию агностических лекарственных препаратов для лечения злокачественных новообразований
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Ключевые слова

агностические лекарственные препараты
злокачественные новообразования
зарубежный опыт
клинические рекомендации
регистрация лекарственных препаратов
оценка технологий здравоохранения

Как цитировать

Омельяновский, В. В., Никитина, А. В., Рыжова, О. Р., Мухортова, П. А., & Струнина, Ю. В. (2023). Обзор зарубежных подходов к оценке и финансированию агностических лекарственных препаратов для лечения злокачественных новообразований. Вопросы онкологии, 69(5), 805–814. https://doi.org/10.37469/0507-3758-2023-69-5-805-814

Аннотация

В связи с растущей заболеваемостью и распространенностью злокачественных новообразований (ЗНО) на территории РФ появление новых медицинских технологий является важной составляющей борьбы с данными заболеваниями. Одной из новых разработок для лечения таких заболеваний являются агностические препараты, уникальность которых связана с механизмом действия, направленным на лечение ЗНО независимо от локализации опухоли при наличии определенного биомаркера. В настоящее время существует 3 агностических лекарственных препарата (ЛП) — энтректиниб, ларотректиниб, достарлимаб. Подавляющая часть клинических исследований агностических ЛП является когортными несравнительными, что обуславливает ряд проблем при рассмотрении данных ЛП к регистрации и возмещению как в РФ, так и в зарубежных странах. Несмотря на данное ограничение, рассматриваемые ЛП зарегистрированы или чаще условно зарегистрированы в зарубежных странах (США, Канада, страны Европейского Союза, Австралия, Япония). Агностические ЛП включены в зарубежные клинические рекомендации (КР) и финансируются за счет бюджетных средств в ряде зарубежных стран, несмотря на ограниченные данные по клинической эффективности. Данная тенденция обусловлена необходимостью удовлетворить медицинские потребности в терапии заболеваний, являющихся жизнеугрожающими или приводящими к фатальным последствиям для пациента.

https://doi.org/10.37469/0507-3758-2023-69-5-805-814
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