{"id":1909,"date":"2023-10-11T15:52:00","date_gmt":"2023-10-11T13:52:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1909"},"modified":"2024-04-10T16:05:26","modified_gmt":"2024-04-10T14:05:26","slug":"40a-liecivo-brexukabtagen-autoleucel-tecartus-na-liecbu-pacientov-vo-veku-26-rokov-a-starsich-s-recidivujucou-alebo-refrakternou-akutnou-lymfoblastickou-leukemiou-all-b-bunkovych-prekurzorov","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/40a-liecivo-brexukabtagen-autoleucel-tecartus-na-liecbu-pacientov-vo-veku-26-rokov-a-starsich-s-recidivujucou-alebo-refrakternou-akutnou-lymfoblastickou-leukemiou-all-b-bunkovych-prekurzorov\/","title":{"rendered":"40A: Lie\u010divo brexukabtag\u00e9n autoleucel (Tecartus) na lie\u010dbu pacientov vo veku 26 rokov a star\u0161\u00edch s recidivuj\u00facou alebo refrakt\u00e9rnou ak\u00fatnou lymfoblastickou leuk\u00e9miou (ALL) B-bunkov\u00fdch prekurzorov"},"content":{"rendered":"<ul 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<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Karcin\u00f3m prsn\u00edka (BC) je celosvetovo naj\u010dastej\u0161\u00edm n\u00e1dorov\u00fdm ochoren\u00edm u \u017eien a aj naj\u010dastej\u0161ou pr\u00ed\u010dinou \u00famrtia \u017eien v s\u00favislosti s onkologick\u00fdm ochoren\u00edm. Metastatick\u00fd karcin\u00f3m prsn\u00edka (mBC) sa pova\u017euje za nevylie\u010dite\u013en\u00fd, pacientky s\u00fa lie\u010den\u00e9 nekurat\u00edvnou lie\u010dbou. N\u00e1stup ochorenia je sp\u00e1jan\u00fd s v\u00fdrazne zhor\u0161enou kvalitou \u017eivota 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. Pr\u00edtomnos\u0165 germinat\u00edvnych BRCA mut\u00e1ci\u00ed 1 alebo 2 (\u010falej iba gBRCAm) v\u00fdrazne zvy\u0161uje riziko vzniku niektor\u00fdch druhov rakoviny, vr\u00e1tane rakoviny prsn\u00edka.<\/p>\n\n\n\n<ul class=\"wp-block-list\" start=\"2\">\n<li><strong>O ak\u00fd liek ide?<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Tecartus (brexukabtag\u00e9n autoleucel) je liek zalo\u017een\u00fd na geneticky modifikovan\u00fdch bunk\u00e1ch samotn\u00e9ho pacienta.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><img loading=\"lazy\" decoding=\"async\" width=\"571\" height=\"457\" src=\"https:\/\/lh7-us.googleusercontent.com\/OF-6Z5I3gWSqh8QCVqENlJa_jSnzwUMi_qx_7UH-lmpo4GbdX4nZMWB5SjtMoqwdJK6mWW3iZT1l8Vml9B2U1zU1OFegi9rrfs_JqHlKyI1lrOIYizTJgTCYq4WnnCHRaljMY9MXuAW0Fac3Il068ws\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tecartus bol Eur\u00f3pskou komisiou v roku 2020 podmiene\u010dne schv\u00e1len\u00fd na pou\u017eitie v krajin\u00e1ch Eur\u00f3pskej \u00fanie pre indik\u00e1ciu lymf\u00f3m z pl\u00e1\u0161\u0165ov\u00fdch buniek (MCL, z angl. mantle cell lymphoma); d\u0148a 02.09.2022 mu bola roz\u0161\u00edren\u00e1 indik\u00e1cia aj na lie\u010dbu refrakt\u00e9rnej a relabuj\u00facej ALL (predmet tohto hodnotenia).<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Klinick\u00fd odborn\u00edk sa vyjadril, \u017ee implement\u00e1cia lieku Tecartus prin\u00e1\u0161a v\u00fdzvu na zdokonalenie monitoringu pacienta a komunika\u010dnej strat\u00e9gie, hlavne ke\u010f bude pacient prepusten\u00fd z hospitaliz\u00e1cie po aplik\u00e1cii CAR-T bunkovej lie\u010dby. Pod\u013ea klinick\u00e9ho odborn\u00edka nedostupnos\u0165 adopt\u00edvnej bunkovej lie\u010dby v SR n\u00e1s vz\u010fa\u013euje od \u0161tandardu medic\u00edny, ktor\u00e1 je pou\u017e\u00edvan\u00e1 v zahrani\u010d\u00ed. U lek\u00e1rov staraj\u00facich sa o B-ALL pacientov m\u00f4\u017ee teda nekategorizovanie lieku Tecartus podpori\u0165 frustr\u00e1ciu zo zaost\u00e1vania za najlep\u0161\u00edm \u0161tandardom.<\/p>\n\n\n\n<ul class=\"wp-block-list\" start=\"2\">\n<li><strong>\u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Dr\u017eite\u013e registr\u00e1cie (Kite Pharma EU B.V (NLD)) podal \u017eiados\u0165 o zaradenie lie\u010diva brexukabtag\u00e9n autoleucel (Tecartus) na lie\u010dbu pacientov vo veku 26 rokov a star\u0161\u00edch s recidivuj\u00facou alebo refrakt\u00e9rnou ak\u00fatnou lymfoblastickou leuk\u00e9miou (ALL) B-bunkov\u00fdch prekurzorov.<\/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 Tecartus v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Z\u00e1rove\u0148, v\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je aj pri uvedenej \u00fahrade spojen\u00fd so stredne vysokou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. Preto NIHO odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktorou by sa t\u00e1to neistota kompenzovala.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">K \u00fahrade lieku z VZP pod\u013ea DR nem\u00e1 d\u00f4js\u0165 pokia\u013e je liek pacientovi opakovane podan\u00fd alebo ak po v\u00fdrobe liek pacientovi nie je podan\u00fd. Tieto podmienky je potrebn\u00e9 explicitne dohodn\u00fa\u0165 v zmluve o podmienkach \u00fahrady lieku, ke\u010f\u017ee boli s\u00fa\u010das\u0165ou NIHO hodnotenia.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">NIHO tie\u017e odpor\u00fa\u010da zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00e9ho obmedzenia o dobr\u00fd v\u00fdkonnostn\u00fd stav pacientov.<\/p>","protected":false},"excerpt":{"rendered":"<p>NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Tecartus v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby&#8230;<\/p>","protected":false},"author":3,"featured_media":1910,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[116,117],"class_list":["post-1909","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-brexukabtagen-autoleucel","tag-tecartus"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1909","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=1909"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1909\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1910"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1909"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1909"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1909"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}