{"id":1912,"date":"2023-10-11T16:05:00","date_gmt":"2023-10-11T14:05:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1912"},"modified":"2024-04-10T16:10:33","modified_gmt":"2024-04-10T14:10:33","slug":"40b-liecivo-brexukabtagen-autoleucel-tecartus-na-liecbu-dospelych-pacientov-s-recidivujucim-alebo-refrakternym-lymfomom-z-plastovych-buniek-mcl-po-dvoch-alebo-viacerych-liniach","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/40b-liecivo-brexukabtagen-autoleucel-tecartus-na-liecbu-dospelych-pacientov-s-recidivujucim-alebo-refrakternym-lymfomom-z-plastovych-buniek-mcl-po-dvoch-alebo-viacerych-liniach\/","title":{"rendered":"40B: Lie\u010divo brexukabtag\u00e9n autoleucel (Tecartus) na lie\u010dbu dospely\u0301ch pacientov s recidivuj\u00facim alebo refrakt\u00e9rnym lymf\u00f3mom z pl\u00e1\u0161\u0165ovy\u0301ch buniek (MCL) po dvoch alebo viacery\u0301ch l\u00edni\u00e1ch syst\u00e9movej lie\u010dby vr\u00e1tane inhib\u00edtora Brutonovej tyroz\u00ednkin\u00e1zy (BTK)"},"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>Lymf\u00f3m z pl\u00e1\u0161\u0165ov\u00fdch buniek (MCL &#8211; mantle cell lymphoma) je zriedkav\u00fd nevylie\u010dite\u013en\u00fd podtyp B-bunkov\u00e9ho non-Hodgkinovho lymf\u00f3mu (NHL) so v\u0161eobecne agres\u00edvnym priebehom. Ochorenie m\u00e1 v\u00fdrazn\u00fd fyzick\u00fd, psychick\u00fd a finan\u010dn\u00fd dopad na pacientov a ich opatrovate\u013eov. MCL sa sp\u00e1ja so zlou progn\u00f3zou v d\u00f4sledku agres\u00edvneho klinick\u00e9ho priebehu ochorenia a pacienti zvy\u010dajne vy\u017eaduj\u00fa viacero l\u00edni\u00ed terapie. Napriek vysokej miere po\u010diato\u010dnej odpovede na terapie prvej l\u00ednie, takmer v\u0161etci pacienti s MCL nakoniec po terapi\u00e1ch prvej l\u00ednie recidivuj\u00fa.&nbsp;<\/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>Tecartus (brexukabtag\u00e9n autoleucel) je liek zalo\u017een\u00fd na geneticky modifikovan\u00fdch bunk\u00e1ch samotn\u00e9ho pacienta.<\/p>\n\n\n\n<p><img loading=\"lazy\" decoding=\"async\" width=\"571\" height=\"457\" src=\"https:\/\/lh7-us.googleusercontent.com\/DvcQwRboJlT5nGZ3zgQjZM99evznnsP22MXEtc1Pkf69Ko0TqD1Xd3IujjAsfSYyzLJYIRcgauCmP78PtuLwLsORJP_hoWlCPKvZZqZVN3FHKvOTNVBYDDa0yYo8y25C0cHanqvUJP_7h-aUkFk-2Xs\"><\/p>\n\n\n\n<p>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) (predmet tohto hodnotenia); d\u0148a 02.09.2022 mu bola roz\u0161\u00edren\u00e1 indik\u00e1cia aj na lie\u010dbu refrakt\u00e9rnej a relabuj\u00facej ALL.<\/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>Odborn\u00edk vyjadril pozit\u00edvne o\u010dak\u00e1vania v s\u00favislosti s implement\u00e1ciou technol\u00f3giou, nako\u013eko pod\u013ea neho prinesie roz\u0161\u00edrenie zmyslupln\u00fdch, efekt\u00edvnych terapeutick\u00fdch mo\u017enost\u00ed pre pacientov s indikovan\u00fdm ochoren\u00edm. Predpoklad\u00e1me, \u017ee u lek\u00e1rov staraj\u00facich sa o pacientov s r\/r MCL m\u00f4\u017ee nekategorizovanie lieku Tecartus podpori\u0165 frustr\u00e1ciu zo zaost\u00e1vania za najlep\u0161\u00edm \u0161tandardom dostupn\u00fdm v zahrani\u010d\u00ed.<\/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>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 dospel\u00fdch pacientov s recidivuj\u00facim alebo refrakt\u00e9rnym lymf\u00f3mom z pl\u00e1\u0161\u0165ov\u00fdch buniek (MCL) po dvoch alebo viacer\u00fdch l\u00edni\u00e1ch syst\u00e9movej lie\u010dby vr\u00e1tane inhib\u00edtora Brutonovej tyroz\u00ednkin\u00e1zy (BTK).<\/p>\n\n\n\n<p class=\"has-custom-highlight-background-color has-background\">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>Z\u00e1rove\u0148, v\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je aj pri uvedenej \u00fahrade spojen\u00fd s 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>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>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-1912","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\/1912","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=1912"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1912\/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=1912"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1912"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1912"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}