{"id":1960,"date":"2024-02-06T18:04:00","date_gmt":"2024-02-06T17:04:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1960"},"modified":"2024-04-10T18:06:09","modified_gmt":"2024-04-10T16:06:09","slug":"56-liecivo-pembrolizumab-keytruda-v-kombinacii-s-chemoterapiou-obsahujucou-pemetrexed-a-platinu-na-liecbu-dospelych-pacientov-v-prvej-linii-metastatickeho-neskvamozneho-nemalobunkoveho-karcinomu-pl","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/56-liecivo-pembrolizumab-keytruda-v-kombinacii-s-chemoterapiou-obsahujucou-pemetrexed-a-platinu-na-liecbu-dospelych-pacientov-v-prvej-linii-metastatickeho-neskvamozneho-nemalobunkoveho-karcinomu-pl\/","title":{"rendered":"56: Lie\u010divo pembrolizumab (Keytruda) v kombin\u00e1cii s chemoterapiou obsahuj\u00facou pemetrexed a platinu na lie\u010dbu dospel\u00fdch pacientov v prvej l\u00ednii metastatick\u00e9ho neskvam\u00f3zneho nemalobunkov\u00e9ho karcin\u00f3mu p\u013e\u00fac"},"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

    Karcin\u00f3m p\u013e\u00fac je vo v\u00e4\u010d\u0161ine kraj\u00edn sveta naj\u010dastej\u0161ie diagnostikovanou malignitou u mu\u017eov a u \u017eien je celosvetovo na tre\u0165om mieste. Pr\u00ed\u010dinou v\u00e4\u010d\u0161iny pr\u00edpadov ochorenia je faj\u010denie. Zhubn\u00e9 n\u00e1dory p\u013e\u00fac boli v roku 2019 naj\u010dastej\u0161ou onkologickou pr\u00ed\u010dinou \u00famrtia mu\u017eov a druhou naj\u010dastej\u0161ou onkologickou pr\u00ed\u010dinou \u00famrtia \u017eien na Slovensku. Metastatick\u00e9 \u0161t\u00e1dium ochorenia je pova\u017eovan\u00e9 za nevylie\u010dite\u013en\u00e9 a lie\u010dba m\u00e1 za cie\u013e zmierni\u0165 pr\u00edznaky ochorenia a spomali\u0165 jeho \u010fal\u0161iu progresiu. Ochorenie m\u00e1 pod\u013ea pacientov dopad na ich psychick\u00e9 pre\u017e\u00edvanie, ako aj na vz\u0165ahy s bl\u00edzkymi.<\/p>\n\n\n\n

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

      KEYTRUDA obsahuje lie\u010divo pembrolizumab, ktor\u00fd je monoklon\u00e1lna protil\u00e1tka. KEYTRUDA \u00fa\u010dinkuje tak, \u017ee pom\u00e1ha v\u00e1\u0161mu imunitn\u00e9mu syst\u00e9mu bojova\u0165 proti rakovine.<\/p>\n\n\n\n

      Keytruda bol registrovan\u00fd v Eur\u00f3pskej \u00fanii pre hodnoten\u00fa indik\u00e1ciu v okt\u00f3bri 2019.<\/p>\n\n\n\n

        \n
      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ol>\n\n\n\n

        Klinick\u00e1 odborn\u00ed\u010dka o\u010dak\u00e1va v\u00fdznamn\u00fd klinick\u00fd pr\u00ednos lie\u010diva pre pacientov s karcin\u00f3mom p\u013e\u00fac, nako\u013eko nemalobunkov\u00fd karcin\u00f3m p\u013e\u00fac patr\u00ed medzi ve\u013emi \u0165a\u017eko lie\u010dite\u013en\u00e9 malignity a pr\u00e1ve kombinovan\u00e9 re\u017eimy chemo-imunoterapie s\u00fa v zahrani\u010d\u00ed jedn\u00fdm z hlavn\u00fdch \u00faspechov v tejto po\u010detnej skupine pacientov.<\/p>\n\n\n\n

        Odborn\u00ed\u010dka sa vyjadrila, \u017ee na Slovensku s\u00fa\u010dasn\u00e1 lie\u010dba metastatick\u00e9ho NSCLC v prvej l\u00ednii nie je v s\u00falade s medzin\u00e1rodn\u00fdmi odpor\u00fa\u010daniami, nako\u013eko nie je dostupn\u00e1 \u017eiadna alternat\u00edva kombinovanej lie\u010dby chemo-imunoterapie. U lek\u00e1rov pracuj\u00facich s NSCLC pacientmi m\u00f4\u017ee nekategorizovanie pembrolizumabu v danej indik\u00e1cii podpori\u0165 frustr\u00e1ciu zo zaost\u00e1vania za najlep\u0161\u00edm \u0161tandardom, ako aj nemo\u017enos\u0165 pracoviska participova\u0165 na klinick\u00fdch sk\u00fa\u0161aniach, pri ktor\u00fdch je sk\u00fa\u0161an\u00e9 lie\u010divo po prvej l\u00ednii chemo-imunoterapie.<\/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 (Merck Sharp & Dohme B.V. (NLD)) podal \u017eiados\u0165 o zaradenie lie\u010diva pembrolizumab (Keytruda) v kombin\u00e1cii s chemoterapiou obsahuj\u00facou pemetrexed a platinu na lie\u010dbu dospel\u00fdch pacientov v prvej l\u00ednii metastatick\u00e9ho neskvam\u00f3zneho nemalobunkov\u00e9ho karcin\u00f3mu p\u013e\u00fac.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Keytruda v predmetnej indik\u00e1ci\u00ed, nako\u013eko po\u017eadovan\u00e1 v\u00fd\u0161ka \u00fahrady sp\u013a\u0148a krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

          V\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je pri uvedenej \u00fahrade spojen\u00fd so strednou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. NIHO preto odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu z\u013eavum ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>\n\n\n\n

          Z\u00e1rove\u0148 NIHO odpor\u00fa\u010da zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00e9ho obmedzenia o dobr\u00fd v\u00fdkonnostn\u00fd stav pacienta.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Keytruda v predmetnej indik\u00e1ci\u00ed, nako\u013eko…<\/p>","protected":false},"author":3,"featured_media":1857,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[92,93],"class_list":["post-1960","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-keytruda","tag-pembrolizumab"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1960","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=1960"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1960\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1857"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1960"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1960"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1960"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}