{"id":1877,"date":"2023-06-06T17:44:00","date_gmt":"2023-06-06T15:44:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1877"},"modified":"2024-03-30T17:47:08","modified_gmt":"2024-03-30T16:47:08","slug":"33-liecivo-ibrutinib-imbruvica-v-kombinacii-s-venetoklaxom-na-liecbu-dospelych-pacientov-s-doposial-neliecenou-chronickou-lymfocytovou-leukemiou","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/33-liecivo-ibrutinib-imbruvica-v-kombinacii-s-venetoklaxom-na-liecbu-dospelych-pacientov-s-doposial-neliecenou-chronickou-lymfocytovou-leukemiou\/","title":{"rendered":"33: Lie\u010divo ibrutinib (Imbruvica) v kombin\u00e1cii s venetoklaxom na lie\u010dbu dospely\u0301ch pacientov s doposia\u013e nelie\u010denou chronickou lymfocytovou leuk\u00e9miou"},"content":{"rendered":"
    \n
  1. Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Chronick\u00e1 lymfocytov\u00e1 leuk\u00e9mia (CLL) je v chronick\u00e9 nevylie\u010dite\u013en\u00e9 ochorenie, ktor\u00e9 vytv\u00e1ra ve\u013ek\u00fa z\u00e1\u0165a\u017e pre pacientov hlavne po psychickej a soci\u00e1lnej str\u00e1nke. Niektor\u00ed pacienti v skor\u0161om \u0161t\u00e1diu bez akt\u00edvneho ochorenia s\u00fa dlh\u00e9 roky v tzv. \u201ewatch and wait\u201c f\u00e1ze, bez prim\u00e1rnej lie\u010dby a s minim\u00e1lnymi prejavmi ochorenia. Pri akt\u00edvnom ochoren\u00ed a v neskor\u0161\u00edch \u0161t\u00e1di\u00e1ch doch\u00e1dza k zhor\u0161eniu zdravotn\u00e9ho stavu a m\u00f4\u017ee d\u00f4js\u0165 a\u017e ku komplik\u00e1ci\u00e1m ako s\u00fa napr. z\u00e1va\u017en\u00e9 syst\u00e9mov\u00e9 infekcie s potrebou hospitaliz\u00e1cie pacienta. Ochorenie m\u00e1 \u010dasto v\u00fdrazn\u00fd dopad na bl\u00edzkych pacienta, ke\u010f\u017ee vznik\u00e1 potreba starostlivosti o pacienta a jeho dom\u00e1cnos\u0165.<\/p>\n\n\n\n

      \n
    1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

      IMBRUVICA je protin\u00e1dorov\u00fd liek, ktor\u00fd obsahuje lie\u010divo ibrutinib. Patr\u00ed do skupiny liekov naz\u00fdvan\u00fdch inhib\u00edtory prote\u00ednkin\u00e1zy.<\/p>\n\n\n\n

      Pri ist\u00fdch druhoch rakov\u00edn IMBRUVICA \u00fa\u010dinkuje blokovan\u00edm Brutonovej tyroz\u00edn kin\u00e1zy, prote\u00ednu v tele, ktor\u00fd pom\u00e1ha t\u00fdmto rakovinov\u00fdm bunk\u00e1m r\u00e1s\u0165 a pre\u017e\u00edva\u0165. Blokovan\u00edm tohto prote\u00ednu IMBRUVICA pom\u00e1ha zni\u010di\u0165 a zn\u00ed\u017ei\u0165 po\u010det rakovinov\u00fdch buniek. Spoma\u013euje tie\u017e zhor\u0161ovanie rakoviny.<\/p>\n\n\n\n

      Liek IMBRUVICA bol registrovan\u00fd na pou\u017eitie v E\u00da v okt\u00f3bri 2014. Pre hodnoten\u00fa indik\u00e1ciu bola lieku roz\u0161\u00edren\u00e1 indik\u00e1cia v j\u00fani 2022.<\/p>\n\n\n\n

        \n
      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

        Klinick\u00fd odborn\u00edk sa vyjadril, \u017ee fixn\u00e1 kombin\u00e1cia lie\u010div v tomto hodnoten\u00ed v lie\u010dbe CLL predstavuje v\u00fdznamn\u00fd krok k zlep\u0161eniu starostlivosti \u2013 \u00fa\u010dinnos\u0165ou, zlep\u0161en\u00edm kvality \u017eivota ako aj zn\u00ed\u017een\u00edm toxicity vo\u010di kontinu\u00e1lnemu pod\u00e1vaniu.<\/p>\n\n\n\n

          \n
        1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

          Dr\u017eite\u013e registr\u00e1cie (Janssen – Cilag International N.V. (BEL)) podal \u017eiados\u0165 o zaradenie lie\u010diva ibrutinib (Imbruvica) v kombin\u00e1cii s venetoklaxom na lie\u010dbu dospel\u00fdch pacientov s doposia\u013e nelie\u010denou chronickou lymfocytovou leuk\u00e9miou.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Imbruvica v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

          V\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je aj pri uvedenej \u00fahrade spojen\u00fd s extr\u00e9mne vysokou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. Preto NIHO odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktorou by sa t\u00e1to neistota kompenzovala.<\/p>\n\n\n\n

          NIHO taktie\u017e odpor\u00fa\u010da kategoriza\u010dnej komisii zv\u00e1\u017ei\u0165 zachovanie indika\u010dn\u00fdch centier a zos\u00faladenie indika\u010dn\u00fdch obmedzen\u00ed ibrutinibu a akalabrutinibu (ABR).<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Imbruvica v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti…<\/p>","protected":false},"author":3,"featured_media":1878,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[104,103],"class_list":["post-1877","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-ibrutinib","tag-imbruvica"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1877","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1877"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1877\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1878"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1877"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1877"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1877"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}