ПРИМЕНЕНИЕ 1-, 3- И 6-МЕСЯЧНЫХ ЛЕКАРСТВЕННЫХ ДЕПО-ФОРМ ЛЕЙПРОРЕЛИНА АЦЕТАТА В ГОРМОНАЛЬНОЙ ТЕРАПИИ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ В 9 ЕВРОПЕЙСКИХ СТРАНАХ: ОБЗОР ДОКАЗАТЕЛЬСТВ И ЭКОНОМИЧЕСКАЯ ОЦЕНКА

Введение. Лейпрорелин – хорошо известный агонист лютеинизирующего гормона рилизинг-гормона, используемый в терапии рака предстательной железы (РПЖ) первой линии. В связи с тем, что использование различных лекарственных форм и режимов дозирования влечет определенные материальные расходы, целью нашего исследования являлась оценка эффективности, безопасности и стоимости применения различных лекарственных форм и режимов дозирования в 9 европейских странах: Австрии, Бельгии, Чешской Республике, Венгрии, Италии, Латвии, Нидерландах, Польше, Португалии.

Материалы и методы. В результате поиска в базах данных было выявлено 13 клинических исследований с применением лейпрорелина, применяемого в формах для введения 1 раз в месяц (1 М), 1 раз в 3 мес (3 М) и 1 раз в 6 мес (6 М). По всем 3 формам сравнивали только те данные о применении лейпрорелина с системой доставки Атригель, которые характеризовались одинаковой эффективностью, безопасностью и соблюдением предписанного режима терапии. Был проведен анализ минимизации затрат с учетом расходов на лечение препаратом Элигард, консультации специалистов, а также диагностику сроком до 12 мес последующего наблюдения. Анализ был проведен для органов государственного здравоохранения.

Результаты. В выборке пациентов «все пациенты, начавшие получать лечение», уровень тестостерона которых составил ≤ 50 нг/дл после лечения препаратом Элигард в формах 1 M (93,3 %), 3 М (98,3 %) и 6 М (97,3 %), существенного различия не наблюдалось (p > 0,05). Также сопоставимыми были профили нежелательных явлений этих 3 форм. В целом форма 6 М была наименее дорогостоящей; средние общие годовые затраты составили от 788 евро (Бельгия) до 1839 евро (Португалия). Вариант использования формы 3 M был более дорогостоящим, затраты на него превышали таковые при применении формы 6 М на 2,5 % (Венгрия) – 37,6 % (Бельгия); использование формы 1 М было наиболее дорогостоящим при увеличении расходов на 15,5 и 151,6 % в сравнении с формой 6 М для этих стран соответственно. Форма 3 M была дешевле в сравнении с формой 1 М на 11,2–45,3 %. Общая сумма затрат была связана с частотой визитов для введения препарата и проведения мониторинга. Для лечения с применением формы 1 M потребовалось 12 визитов, формы 3 M – от 4,4 до 4,8 визита и формы 6 М – от 2,1 до 2,3 визита. До 50 % дополнительных визитов может финансироваться из сэкономленных средств, полученных в результате перевода соответствующих пациентов с форм 1 М и 3 М на форму 6 М. Полученные результаты одномерных и вероятностных анализов чувствительности были стабильными.

Вывод. Формы препарата Элигард обеспечивают сопоставимую эффективность и безопасность, однако различные режимы дозирования препарата требуют различной частоты посещения лечебного учреждения пациентами. Лекарственная форма 6 М обеспечивает наибольшую экономию средств и должна рассматриваться в качестве препарата выбора для лечения соответствующих пациентов в Европе.

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