{"id":1731,"date":"2022-09-19T19:01:00","date_gmt":"2022-09-19T17:01:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1731"},"modified":"2024-03-23T12:56:56","modified_gmt":"2024-03-23T11:56:56","slug":"3-liecivo-brigatinib-alunbrig","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/3-liecivo-brigatinib-alunbrig\/","title":{"rendered":"3: Lie\u010divo brigatinib (Alunbrig) na lie\u010dbu nemalobunkov\u00e9ho karcin\u00f3mu p\u013e\u00fac s pozitivitou ALK pre pacientov v prvej l\u00ednii a v druhej a vy\u0161\u0161\u00edch l\u00edni\u00e1ch po predch\u00e1dzaj\u00facej lie\u010dbe krizotinobom\u00a0"},"content":{"rendered":"
    \n
  1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Liek Alunbrig obsahuje lie\u010divo brigatinib. Je ur\u010den\u00fd na lie\u010dbu typu rakoviny p\u013e\u00fac (nemalobunkov\u00fd karcin\u00f3m p\u013e\u00fac, v angl. non-small lung cancer, NSCLC)  so \u0161pecifickou mut\u00e1ciou, tzv. genetickou prestavbou (pozitivitou) prote\u00ednu kin\u00e1za anaplastick\u00e9ho lymf\u00f3mu (ALK+). Brigatinib cielene nar\u00fa\u0161a funkciu ALK a br\u00e1ni tak rastu a pre\u017eitiu rakovinov\u00fdch buniek.<\/p>\n\n\n\n

    Vo v\u00e4\u010d\u0161ine pr\u00edpadov sa u\u017e\u00edva jedna tableta raz denne v sile 90 mg po\u010das prv\u00e9ho t\u00fd\u017ed\u0148a. Obvykle nasleduje pod\u00e1vanie jednej tablety denne v sile 180 mg. <\/p>\n\n\n\n

    Alunbrig bol registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou (EMA) d\u0148a 22.11.2018, \u010do znamen\u00e1, \u017ee mohol by\u0165 n\u00e1sledne dostupn\u00fd aj na slovenskom trhu. <\/p>\n\n\n\n

      \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

      Rakovina p\u013e\u00fac je druh\u00fdm naj\u010dastej\u0161\u00edm typom n\u00e1dorov\u00e9ho ochorenia. <\/p>\n\n\n\n

      Progn\u00f3za rakoviny p\u013e\u00fac je \u010dasto nepriazniv\u00e1. Zvy\u010dajne sa v skor\u00fdch \u0161t\u00e1di\u00e1ch neobjavuj\u00fa \u017eiadne zn\u00e1mky ochorenia, a\u017e u dvoch tret\u00edn pacientov je diagnostikovan\u00e9 v neskorom \u0161t\u00e1diu. Nelie\u010den\u00ed pacienti s rakovinou p\u013e\u00fac \u017eij\u00fa v priemere 7 mesiacov. Pod\u013ea WHO sa faj\u010denie podie\u013ea na 71 % pr\u00edpadov rakoviny p\u013e\u00fac, rizikov\u00e9 je aj vystavenie karcinog\u00e9nnym l\u00e1tkam ako je azbest alebo arz\u00e9n.  <\/p>\n\n\n\n

      Zo v\u0161etk\u00fdch pacientov s rakovinou p\u013e\u00fac m\u00e1 ochorenie NSCLC ALK+ menej ako 5 % pacientov. Ochorenie je netypick\u00e9 t\u00fdm, \u017ee postihuje mlad\u0161iu popul\u00e1ciu okolo 50. roku \u017eivota a preva\u017ene nefaj\u010diarov alebo slab\u00fdch faj\u010diarov. Ochorenie vytv\u00e1ra ve\u013ek\u00fa z\u00e1\u0165a\u017e po fyzickej a psychickej str\u00e1nke na pacientov, ale aj ich bl\u00edzkych a opatrovate\u013eov.<\/p>\n\n\n\n

        \n
      1. Ako sa na brigatinib pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

        Odborn\u00edci uviedli, \u017ee z lie\u010dby brigatinibom profituj\u00fa najm\u00e4 pacienti s mozgov\u00fdmi metast\u00e1zami. Tie\u017e pom\u00e1ha pacientom, u ktor\u00fdch hrozia ne\u017eiad\u00face \u00fa\u010dinky pri u\u017e\u00edvan\u00ed u\u017e prepl\u00e1can\u00e9ho lieku s lie\u010divom alektinib. <\/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 podal \u017eiados\u0165 o kategoriz\u00e1ciu Alunbrigu na lie\u010dbu NSCLC ALK+ pre pacientov (1.) v prvej l\u00ednii, teda bez predch\u00e1dzaj\u00facej lie\u010dby, a (2.) v druhej a vy\u0161\u0161\u00edch l\u00edni\u00e1ch po predch\u00e1dzaj\u00facej lie\u010dbe krizotinobom.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti<\/strong> o kategorizovanie lieku Alunbrig v oboch indik\u00e1ci\u00e1ch<\/strong>, ak dr\u017eite\u013e registr\u00e1cie lieku neposkytne z\u013eavu<\/strong> z navrhovanej maxim\u00e1lnej \u00fahrady z verejn\u00e9ho zdravotn\u00e9ho poistenia za ka\u017ed\u00e9 balenie lieku.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da po\u017eadova\u0165 z\u013eavu najm\u00e4 preto, \u017ee sa ned\u00e1 s istotou poveda\u0165, \u010di je Alunbrig efekt\u00edvnej\u0161\u00ed a bezpe\u010dnej\u0161\u00ed (teda \u010di m\u00e1 dostato\u010dn\u00fd klinick\u00fd pr\u00ednos) ne\u017e in\u00e9 u\u017e prepl\u00e1can\u00e9 lieky na dan\u00e9 ochorenie. Z\u00e1rove\u0148 z ekonomick\u00e9ho poh\u013eadu bol liek vzh\u013eadom na jeho (neist\u00fd) klinick\u00fd pr\u00ednos pridrah\u00fd, teda nesplnil podmienku n\u00e1kladovej efekt\u00edvnosti pri po\u017eadovanej \u00fahrade pod\u013ea z\u00e1kona 363\/2011 Z.z.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o\u00a0kategorizovanie lieku Alunbrig v\u00a0oboch indik\u00e1ci\u00e1ch, ak dr\u017eite\u013e registr\u00e1cie lieku neposkytne z\u013eavu z navrhovanej maxim\u00e1lnej \u00fahrady z verejn\u00e9ho zdravotn\u00e9ho poistenia za ka\u017ed\u00e9 balenie lieku.<\/p>","protected":false},"author":3,"featured_media":1732,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[17,16],"class_list":["post-1731","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-alunbrig","tag-brigatinib"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1731","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1731"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1731\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1732"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1731"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1731"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1731"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}