{"id":1832,"date":"2023-03-09T16:12:00","date_gmt":"2023-03-09T15:12:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1832"},"modified":"2024-03-30T16:13:30","modified_gmt":"2024-03-30T15:13:30","slug":"23-liecivo-axikabtagen-ciloleucel-yescarta-na-liecbu-dospelych-pacientov-s-recidivujucim-alebo-refrakternym-difuznym-velkobunkovym-b-lymfomom-dlbcl-a-primarnym-mediastinalnym-velkobunkovym-b-lymf","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/23-liecivo-axikabtagen-ciloleucel-yescarta-na-liecbu-dospelych-pacientov-s-recidivujucim-alebo-refrakternym-difuznym-velkobunkovym-b-lymfomom-dlbcl-a-primarnym-mediastinalnym-velkobunkovym-b-lymf\/","title":{"rendered":"23: Lie\u010divo axikabtag\u00e9n ciloleucel (Yescarta) na lie\u010dbu dospel\u00fdch pacientov s recidivuj\u00facim alebo refrakt\u00e9rnym dif\u00faznym ve\u013ekobunkov\u00fdm B lymf\u00f3mom (DLBCL) a prim\u00e1rnym mediastin\u00e1lnym ve\u013ekobunkov\u00fdm B lymf\u00f3mom (PMBCL) po dvoch alebo viacer\u00fdch l\u00edni\u00e1ch syst\u00e9movej terapie"},"content":{"rendered":"<p><strong>Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/p>\n\n\n\n<p>Dif\u00fazny ve\u013ekobunkov\u00fd lymf\u00f3m B-p\u00f4vodu (DLBCL) a prim\u00e1rny mediastin\u00e1lny ve\u013ekobunkov\u00fd B lymf\u00f3mom (PMBCL) s\u00fa agres\u00edvne n\u00e1dorov\u00e9 ochorenia, ktor\u00e9, ak nie s\u00fa lie\u010den\u00e9, ved\u00fa ku smrti pacienta. Pacienti s opakovane relabovan\u00fdm\/refrakt\u00e9rnym DLBCL a PMBCL maj\u00fa nepriazniv\u00fa progn\u00f3zu s limitovanou alebo \u017eiadnou odpove\u010fou na lie\u010dbu. Pod\u013ea pacientskej organiz\u00e1cie OZ LyL pacienti trpia celkovou \u00fanavou, ne\u0161pecifickou boles\u0165ou, \u010di probl\u00e9mami so sp\u00e1nkom, do\u010dasne s\u00fa odk\u00e1zan\u00ed na invalidn\u00fd d\u00f4chodok. Ochorenie m\u00e1 v\u00fdrazn\u00fd dopad aj na rodinn\u00fdch pr\u00edslu\u0161n\u00edkov (najm\u00e4 partnerov), ktor\u00ed zabezpe\u010duj\u00fa chod dom\u00e1cnosti a starostlivos\u0165 o chor\u00e9ho za snahy zachovania zamestnania.<\/p>\n\n\n\n<p><strong>O ak\u00fd liek ide?<\/strong><\/p>\n\n\n\n<p>Yescarta (axikabtag\u00e9n ciloleucel) je inovat\u00edvny liek z kateg\u00f3rie g\u00e9nov\u00fdch terapi\u00ed, obsahuj\u00faci suspenziu pacientovi vlastn\u00fdch T buniek, ktor\u00e9 produkuj\u00fa chim\u00e9rick\u00fd antig\u00e9nov\u00fd receptor (CAR) schopn\u00fd rozpozn\u00e1va\u0165 CD19 antig\u00e9n (= anti-CD19 CAR-T bunky) na povrchu n\u00e1dorov\u00fdch B buniek, a tak ich eliminova\u0165.<\/p>\n\n\n\n<p>Axikabtag\u00e9n ciloleucel sa pod\u00e1va intraven\u00f3zne vo forme bunkovej suspenzie, ktor\u00e1 je ur\u010den\u00e1 v\u00fdhradne na autol\u00f3gne jednorazov\u00e9 podanie pacientovi.&nbsp;<\/p>\n\n\n\n<p>Ved\u013eaj\u0161\u00edm efektom elimin\u00e1cie rakovinov\u00fdch buniek je, \u017ee sa uvo\u013e\u0148uj\u00fa takzvan\u00e9 cytok\u00edny vo ve\u013ekom mno\u017estve. To m\u00f4\u017ee vies\u0165 k v\u00e1\u017enym, a\u017e fat\u00e1lnym n\u00e1sledkom, pokia\u013e nie s\u00fa lie\u010den\u00e9.&nbsp;<\/p>\n\n\n\n<p>Sch\u00e9ma pr\u00edpravy CAR-T terapie:<\/p>\n\n\n\n<p><img loading=\"lazy\" decoding=\"async\" width=\"624\" height=\"535\" src=\"https:\/\/lh7-us.googleusercontent.com\/tvG8KIvFkRcIpcFH7hcPuw7kneAJhnoYytfm4Ax44RqzcQM3Rfkfr-pKjGSP4VLwZ-KpFTjqO3s3lI50IYoMaiIjUT6KpCnqU14eHM4gof_7ebKjLiBlECnnBZoOmdirCYh1WaxQocYH\"><\/p>\n\n\n\n<p><strong>Ako sa na axikabtag\u00e9n ciloleucel pozeraj\u00fa odborn\u00edci?&nbsp;<\/strong><\/p>\n\n\n\n<p>Klinick\u00fd odborn\u00edk uv\u00e1dza, \u017ee v danej indik\u00e1cii neexistuje lie\u010debn\u00e1 alternat\u00edva. Dod\u00e1va, \u017ee CAR-T terapia predstavuje potenci\u00e1lne kurat\u00edvny lie\u010debn\u00fd postup pre ve\u013ek\u00fa \u010das\u0165 refrakt\u00e9rnych pacientov s DLBCL, ktor\u00e1 v\u0161ak na Slovensku nie je dostupn\u00e1, \u010do pod\u013ea neho nie je v s\u00falade so \u0161tandardnou lie\u010dbou v z\u00e1padn\u00fdch krajin\u00e1ch. Z\u00e1rove\u0148, implement\u00e1cia lie\u010diva prin\u00e1\u0161a v\u00fdzvu na zdokonalenie monitoringu pacienta a komunika\u010dn\u00e9 strat\u00e9gie, hlavne po jeho prepusten\u00ed z 58 hospitaliz\u00e1cie po aplik\u00e1cii CAR-T. Pod\u013ea OZ LyL je pacientom po nieko\u013ek\u00fdch ne\u00faspe\u0161n\u00fdch l\u00edni\u00e1ch lie\u010dby pon\u00faknut\u00e1 iba udr\u017eiavacia lie\u010dba a pacienti, ktor\u00ed nedostan\u00fa lie\u010dbu v zahrani\u010d\u00ed r\u00fdchlo umieraj\u00fa. Klinick\u00fd odborn\u00edk dod\u00e1va, \u017ee \u010das\u0165 pacientov je lie\u010den\u00fdch v \u010cesku. Z \u010dasov\u00fdch a administrat\u00edvnych d\u00f4vodov sa v\u0161ak nieko\u013eko pacientov k lie\u010dbe CAR-T v zahrani\u010d\u00ed nedostane.<\/p>\n\n\n\n<p><strong>\u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/p>\n\n\n\n<p>Dr\u017eite\u013e registr\u00e1cie (Kite Pharma EU) podal \u017eiados\u0165 o zaradenie lieku Yescarta (lie\u010divo axikabtag\u00e9n ciloleucel) do \u00fahrad z verejn\u00e9ho zdravotn\u00e9ho poistenia pri pou\u017eit\u00ed na lie\u010dbu dospel\u00fdch pacientov s recidivuj\u00facim alebo refrakt\u00e9rnym dif\u00faznym ve\u013ekobunkov\u00fdm B lymf\u00f3mom (DLBCL) a prim\u00e1rnym mediastin\u00e1lnym ve\u013ekobunkov\u00fdm B lymf\u00f3mom (PMBCL) po dvoch alebo viacer\u00fdch l\u00edni\u00e1ch syst\u00e9movej terapie.<\/p>\n\n\n\n<p class=\"has-custom-highlight-background-color has-background\">\u017diados\u0165 <strong>sp\u013a\u0148a <\/strong>z\u00e1konn\u00e9 krit\u00e9ri\u00e1 a preto NIHO odpor\u00fa\u010da <strong>vyhovie\u0165 <\/strong>predmetnej \u017eiadosti.<\/p>\n\n\n\n<p>NIHO v pozit\u00edvnom odpor\u00fa\u010dan\u00ed predpoklad\u00e1, \u017ee bud\u00fa s dr\u017eite\u013eom registr\u00e1cie dohodnut\u00e9 podmienky, za ktor\u00fdch nepr\u00edde k \u00fahrade ak je liek opakovane podan\u00fd, alebo liek pacientovi po v\u00fdrobe lieku nie je podan\u00fd.<\/p>\n\n\n\n<p>NIHO v\u0161ak z\u00e1rove\u0148 odpor\u00fa\u010da:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u017eiada\u0165 od firmy dodato\u010dn\u00fa z\u013eavu vzh\u013eadom na stredn\u00fa mieru neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ria n\u00e1kladovej efekt\u00edvnosti. Hlavn\u00fdm d\u00f4vodom neistoty je, \u017ee DR predpoklad\u00e1, \u017ee \u010das\u0165 pacientov sa po lie\u010dbe vylie\u010di, pri\u010dom nie s\u00fa dostupn\u00e9 dostato\u010dne dlhodob\u00e9 d\u00e1ta o pre\u017e\u00edvan\u00ed.<\/li>\n\n\n\n<li>aby sa liek indikoval len pacientom, ktor\u00fdch v\u00fdkonnostn\u00fd stav dosahuje \u0161pecifick\u00e9 sk\u00f3re na \u0161k\u00e1le ECOG (Eastern Cooperative Oncology Group performance status).<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>\u017diados\u0165 sp\u013a\u0148a z\u00e1konn\u00e9 krit\u00e9ri\u00e1 a preto NIHO odpor\u00fa\u010da vyhovie\u0165 predmetnej \u017eiadosti&#8230;<\/p>","protected":false},"author":3,"featured_media":1833,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[82,81],"class_list":["post-1832","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-axikabtagen-ciloleucel","tag-yescarta"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1832","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=1832"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1832\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1833"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1832"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1832"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1832"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}