卷 69 编号 5 (2023), ОБЗОРЫ

卷 69 编号 5 (2023)

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

ОБЗОРЫ

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

已出版 01.11.2023

Виталий Владимирович Омельяновский⁺⁻
Анна Владимировна Никитина⁺⁻
Ольга Романовна Рыжова⁺⁻
Полина Алексеевна Мухортова⁺⁻
Юлия Витальевна Струнина⁺⁻

Виталий Владимирович Омельяновский

ФГБУ «Центр экспертизы и контроля качества медицинской помощи» Минздрава России, Москва, Россия; ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия; ФГБУ «Научно-исследовательский финансовый институт Министерства финансов Российской Федерации», Москва, Россия ФГБНУ «Национальный научно-исследовательский институт общественного здоровья имени Н.А. Семашко» Минобрнауки России, Москва, Россия

https://orcid.org/0000-0003-1581-0703

Анна Владимировна Никитина

ФГБУ «Центр экспертизы и контроля качества медицинской помощи» Минздрава России, Москва, Россия

https://orcid.org/0000-0002-6462-7027

Ольга Романовна Рыжова

ФГБУ «Центр экспертизы и контроля качества медицинской помощи» Минздрава России, Москва, Россия;

https://orcid.org/0000-0003-1060-2948

Полина Алексеевна Мухортова

ФГБУ «Центр экспертизы и контроля качества медицинской помощи» Минздрава России, Москва, Россия

https://orcid.org/0000-0001-7261-3461

Юлия Витальевна Струнина

НКО «Ассоциация специалистов по оценке технологий в здравоохранении», Москва, Россия

https://orcid.org/0000-0002-6751-2903

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关键词

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

How to Cite

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. VOPROSY ONKOLOGII, 69(5), 805–814. https://doi.org/10.37469/0507-3758-2023-69-5-805-814

摘要

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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