{"id":2291,"date":"2023-01-04T18:42:00","date_gmt":"2023-01-04T17:42:00","guid":{"rendered":"https:\/\/niho.sk\/?p=2291"},"modified":"2024-11-30T17:01:00","modified_gmt":"2024-11-30T16:01:00","slug":"13a-liecivo-ribociklib-kisqali-v-kombinacii-s-inhibitorom-aromatazy-v-prvej-linii-liecby-metastatickeho-hr-her2-karcinomu-prsnika","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/13a-liecivo-ribociklib-kisqali-v-kombinacii-s-inhibitorom-aromatazy-v-prvej-linii-liecby-metastatickeho-hr-her2-karcinomu-prsnika\/","title":{"rendered":"13A: Lie\u010divo ribociklib (Kisqali) v kombin\u00e1cii s inhib\u00edtorom aromat\u00e1zy v prvej l\u00ednii lie\u010dby metastatick\u00e9ho HR+\/HER2- karcin\u00f3mu prsn\u00edka"},"content":{"rendered":"<ol class=\"wp-block-list\">\n<li><strong>Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Karcin\u00f3m prsn\u00edka je celosvetovo naj\u010dastej\u0161\u00edm n\u00e1dorovy\u0301m ochoren\u00edm u \u017eien a aj naj\u010dastej\u0161ou pr\u00ed\u010dinou \u00famrtia \u017eien v s\u00favislosti s onkologicky\u0301m ochoren\u00edm. Metastaticky\u0301 karcin\u00f3m prsn\u00edka sa pova\u017euje za nevylie\u010dite\u013eny\u0301, pacientky s\u00fa lie\u010den\u00e9 nekurat\u00edvnou lie\u010dbou. N\u00e1stup ochorenia je sp\u00e1jany\u0301 s vy\u0301razne zhor\u0161enou kvalitou \u017eivota vo v\u0161etky\u0301ch aspektoch a vytv\u00e1ra psychick\u00fa z\u00e1\u0165a\u017e nielen na pacientky, ale aj bl\u00edzkych, ktor\u00ed sa sna\u017eia ich podporova\u0165 a pom\u00e1ha\u0165 im.<\/p>\n\n\n\n<ol start=\"2\" class=\"wp-block-list\">\n<li><strong>O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Liek obsahuje lie\u010divo ribociklib, ktor\u00e9 patr\u00ed do skupiny liekov naz\u00fdvan\u00fdch inhib\u00edtory kin\u00e1zy 4 a 6 z\u00e1vislej od cykl\u00ednu (CDK). <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pou\u017e\u00edva sa u dospel\u00fdch \u017eien s rakovinou prsn\u00edka s pozitivitou hormon\u00e1lnych receptorov (HR) a negativitou receptora 2 pre \u013eudsk\u00fd epiderm\u00e1lny rastov\u00fd faktor (HER2), ktor\u00e1 je lok\u00e1lne pokro\u010dil\u00e1 alebo metastatick\u00e1, v kombin\u00e1cii s in\u00fdmi liekmi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kisqali bol prv\u00fdkr\u00e1t registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare v auguste 2017<\/p>\n\n\n\n<ol start=\"3\" class=\"wp-block-list\">\n<li><strong>Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?&nbsp;<\/strong><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Pod\u013ea klinick\u00e9ho odborn\u00edka je s\u00fa\u010dasn\u00e9 nezaradenie lieku Kisqali do ZKL vy\u0301znamny\u0301m probl\u00e9mom nako\u013eko je v\u0161ade vo svete \u0161tandardom v lie\u010dbe aBC a je do\u017eadovany\u0301 pacientkami. Rovnako to vid\u00ed OZ Amazonky a jeho respondentky.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Lek\u00e1r mus\u00ed vyp\u00edsa\u0165 \u017eiados\u0165 o vy\u0301nimku, ktor\u00e1 ale \u010dasto nie je schv\u00e1len\u00e1, a tak si pacientka mus\u00ed zabezpe\u010di\u0165 financie na lie\u010dbu sama. OZ Amazonky z\u00e1rove\u0148 uv\u00e1dza, \u017ee k lep\u0161iemu mana\u017ementu lie\u010dby by pomohlo, keby o vhodnosti lie\u010dby rozhodoval lek\u00e1r a nie zdravotn\u00e1 pois\u0165ov\u0148a. Podobn\u00e9 stanovisko zaujalo aj OZ Liga proti rakovine \u2013 apeluje na nedostupnos\u0165 a vysok\u00fa cenu onkologickej lie\u010dby.<\/p>\n\n\n\n<ol start=\"4\" class=\"wp-block-list\">\n<li><strong>\u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Dr\u017eite\u013e registr\u00e1cie, farmaceutick\u00e1 firma Novartis Europharm Limited, podal \u017eiados\u0165 o o kategorizovanie lieku Kisqali v prvej l\u00ednii lie\u010dby HR+\/HER2- karcin\u00f3mu prsn\u00edka.<\/p>\n\n\n\n<p class=\"has-custom-highlight-background-color has-background wp-block-paragraph\">NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Kisqali v predmetnej indik\u00e1ci\u00ed, pokia\u013e d\u00f4jde k zmene indika\u010dn\u00e9ho obmedzenia tak, \u017ee sa lie\u010dba \u0161pecifikuje len na popul\u00e1ciu postmenopauz\u00e1lnych \u017eien s metastaticky\u0301m karcin\u00f3mom prsn\u00edka.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">V\u00fdsledok hodnotenia je spojen\u00fd so strednou mierou neistoty, \u017ee pri po\u017eadovanej \u00fahrade nebud\u00fa v praxi 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 dodato\u010dn\u00fa z\u013eavu, ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Navrhovan\u00e9 indika\u010dn\u00e9 obmedzenie pod\u013ea NIHO: <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Hraden\u00e1 lie\u010dba sa m\u00f4\u017ee indikova\u0165 na lie\u010dbu <strong>postmenopauz\u00e1lnych \u017eien s metastaticky\u0301m karcin\u00f3mom prsn\u00edka<\/strong> s pozitivitou hormon\u00e1lnych receptorov (HR) a negativitou receptora 2 pre \u013eudsky\u0301 epiderm\u00e1lny rastovy\u0301 faktor (human epidermal growth factor receptor 2, HER2) v kombin\u00e1cii s inhib\u00edtorom aromat\u00e1zy v prvej l\u00ednii lie\u010dby.<\/p>","protected":false},"excerpt":{"rendered":"<p>Karcin\u00f3m prsn\u00edka je celosvetovo naj\u010dastej\u0161\u00edm n\u00e1dorovy\u0301m ochoren\u00edm u \u017eien a aj naj\u010dastej\u0161ou pr\u00ed\u010dinou \u00famrtia \u017eien v s\u00favislosti s onkologicky\u0301m ochoren\u00edm. Metastaticky\u0301 karcin\u00f3m prsn\u00edka sa pova\u017euje za nevylie\u010dite\u013eny\u0301, pacientky s\u00fa lie\u010den\u00e9 nekurat\u00edvnou lie\u010dbou. N\u00e1stup ochorenia je sp\u00e1jany\u0301 s vy\u0301razne zhor\u0161enou kvalitou \u017eivota vo v\u0161etky\u0301ch aspektoch a vytv\u00e1ra psychick\u00fa z\u00e1\u0165a\u017e nielen na pacientky, ale aj bl\u00edzkych, ktor\u00ed [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":2292,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[142,143],"class_list":["post-2291","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-kisqali","tag-ribociklib"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/2291","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=2291"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/2291\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/2292"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=2291"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=2291"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=2291"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}