{"id":1821,"date":"2023-03-10T15:10:00","date_gmt":"2023-03-10T14:10:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1821"},"modified":"2024-03-30T15:16:52","modified_gmt":"2024-03-30T14:16:52","slug":"21b-liecivo-tisagenlekleucel-kymriah-na-liecbu-dospelych-pacientov-s-relabujucim-alebo-refrakternym-difuznym-velkobunkovym-lymfomom-b-buniek-dlbcl-po-dvoch-alebo-viacerych-liniach-systemovej-liec","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/21b-liecivo-tisagenlekleucel-kymriah-na-liecbu-dospelych-pacientov-s-relabujucim-alebo-refrakternym-difuznym-velkobunkovym-lymfomom-b-buniek-dlbcl-po-dvoch-alebo-viacerych-liniach-systemovej-liec\/","title":{"rendered":"21B: Lie\u010divo tisagenlekleucel (Kymriah) na lie\u010dbu dospel\u00fdch pacientov s relabuj\u00facim alebo refrakt\u00e9rnym dif\u00faznym ve\u013ekobunkov\u00fdm lymf\u00f3mom B-buniek (DLBCL) po dvoch alebo viacer\u00fdch l\u00edni\u00e1ch syst\u00e9movej lie\u010dby"},"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) je agres\u00edvne n\u00e1dorov\u00e9 ochorenia, ktor\u00e9, ak nie je lie\u010den\u00e9, vedie ku smrti pacienta. Pacienti s opakovane relabovan\u00fdm\/refrakt\u00e9rnym DLBCL 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>Tisagenlekleucel je autol\u00f3gne, imunobunkov\u00e9 onkologick\u00e9 lie\u010divo, ktor\u00e9 obsahuje vlastn\u00e9 imunitn\u00e9, takzvan\u00e9 T-bunky, pacienta, ktor\u00e9 boli v laborat\u00f3riu upraven\u00e9 tak, aby vytv\u00e1rali prote\u00edn naz\u00fdvan\u00fd chim\u00e9rick\u00fd antig\u00e9nov\u00fd receptor (CAR). CAR sa n\u00e1sledne dok\u00e1\u017ee na povrchu n\u00e1dorov\u00fdch buniek naviaza\u0165 na prote\u00edn s n\u00e1zvom CD19. Takto upraven\u00e9 T-bunky podan\u00e9 pacientovi sa maj\u00fa naviaza\u0165 na n\u00e1dorov\u00e9 bunky a usmrti\u0165 ich.<\/p>\n\n\n\n<p>Zjednodu\u0161en\u00e1 sch\u00e9ma pr\u00edpravy a podania CAR-T bunkovej terapie:<\/p>\n\n\n\n<p><img loading=\"lazy\" decoding=\"async\" width=\"571\" height=\"457\" src=\"https:\/\/lh7-us.googleusercontent.com\/a33mxjd-xiOVYvR1BuWRdJ-FDhk5zx8b75IgQ8JKj6nUJk59TtozX90DdvqK0DTHgkgs4u0hy62iM73uh7zr2X_iNyiIImx2upebgaPO8zg5Sf5fh4NDgg-KitYYrQYLC8bcKNH2ykan\"><\/p>\n\n\n\n<p>Kymriah bol Eur\u00f3pskou komisiou schv\u00e1len\u00fd pre pou\u017eitie v r\u00e1mci Eur\u00f3pskej \u00fanie pre dan\u00fa indik\u00e1ciu d\u0148a 22.08.2018.<\/p>\n\n\n\n<p><strong>Ako sa na tisagenlekleucel pozeraj\u00fa odborn\u00edci?&nbsp;<\/strong><\/p>\n\n\n\n<p>Klinick\u00fd odborn\u00edk, ktor\u00e9ho NIHO pozvalo k hodnoteniu, sa vyjadril, \u017ee nedostupnos\u0165 adopt\u00edvnej bunkovej lie\u010dby v SR n\u00e1s vz\u010fa\u013euje od \u0161tandardu medic\u00edny, ktor\u00e1 je dostupn\u00e1 v zahrani\u010d\u00ed. Uviedol, \u017ee v danej skupine pacientov neexistuje lie\u010debn\u00e1 alternat\u00edva a terapia CART predstavuje potenci\u00e1lne vylie\u010dite\u013en\u00fd lie\u010debn\u00fd postup. Pod\u013ea odborn\u00edka je \u010das\u0165 pacientov lie\u010den\u00e1 v \u010ceskej republike a ur\u010dit\u00e1 \u010das\u0165 pacientov sa k lie\u010dbe v zahrani\u010d\u00ed nedostane z \u010dasov\u00fdch a administrat\u00edvnych d\u00f4vodov. U lek\u00e1rov pracuj\u00facich s DLBCL pacientmi m\u00f4\u017ee teda nekategorizovanie lieku Kymriah podpori\u0165 frustr\u00e1ciu zo zaost\u00e1vania za najlep\u0161\u00edm \u0161tandardom.<\/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 (Novartis Europharm) podal \u017eiados\u0165 o zaradenie lieku Kymriah (lie\u010divo tisagenlekleucel) do \u00fahrad z verejn\u00e9ho zdravotn\u00e9ho poistenia pri pou\u017eit\u00ed na lie\u010dbu dospel\u00fdch pacientov s relabuj\u00facim alebo refrakt\u00e9rnym dif\u00faznym ve\u013ekobunkov\u00fdm lymf\u00f3mom B-buniek (DLBCL) po dvoch alebo viacer\u00fdch l\u00edni\u00e1ch syst\u00e9movej lie\u010dby&nbsp;<\/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 n\u00e1kladovej efekt\u00edvnosti 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 jednorazov\u00e9 podanie lieku s t\u00fdm, \u017ee bud\u00fa s dr\u017eite\u013eom registr\u00e1cie dohodnut\u00e9 podmienky, za ktor\u00fdch nepr\u00edde k \u00fahrade, ak nie je liek pacientovi po v\u00fdrobe lieku podan\u00fd.<\/p>\n\n\n\n<p>NIHO taktie\u017e 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 tisagenlekleucelom 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>Zv\u00e1\u017ei\u0165, aby sa liek indikoval len pacientom, ktor\u00fdch v\u00fdkonnostn\u00fd stav dosahuje dobr\u00e9 sk\u00f3re na ECOG \u0161k\u00e1le (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 n\u00e1kladovej efekt\u00edvnosti a preto NIHO odpor\u00fa\u010da vyhovie\u0165 predmetnej \u017eiadosti&#8230;<\/p>","protected":false},"author":3,"featured_media":1822,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[78,77],"class_list":["post-1821","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-kymriah","tag-tisagenlekleucel"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1821","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=1821"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1821\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1822"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1821"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1821"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1821"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}