{"id":1930,"date":"2024-01-09T16:33:00","date_gmt":"2024-01-09T15:33:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1930"},"modified":"2024-04-10T16:36:30","modified_gmt":"2024-04-10T14:36:30","slug":"46-liecivo-tebentafusp-kimmtrak-na-liecbu-dospelych-pacientov-s-neresekovatelnym-alebo-metastatickym-uvealnym-melanomom","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/46-liecivo-tebentafusp-kimmtrak-na-liecbu-dospelych-pacientov-s-neresekovatelnym-alebo-metastatickym-uvealnym-melanomom\/","title":{"rendered":"46: Lie\u010divo tebentafusp (Kimmtrak) na lie\u010dbu dospel\u00fdch pacientov s neresekovate\u013en\u00fdm alebo metastatick\u00fdm uve\u00e1lnym melan\u00f3mom"},"content":{"rendered":"
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  1. Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Uve\u00e1lny melan\u00f3m (UM) je naj\u010dastej\u0161\u00edm a najagres\u00edvnej\u0161\u00edm typom vn\u00fatroo\u010dn\u00e9ho n\u00e1doru u dospel\u00fdch. A\u017e v 50 % pr\u00edpadov je n\u00e1lez charakteristick\u00fd pozitivitou na \u013eudsk\u00fd leukocytov\u00fd antig\u00e9n (HLA)-A*02:01. UM je naj\u010dastej\u0161ie diagnostikovan\u00fd u pacientov vo veku 70 \u2013 79 rokov s medi\u00e1nov\u00fdm vekom okolo 60 rokov. Ochorenie m\u00e1 v\u00fdrazn\u00fd dopad na psychiku pacienta a jeho bl\u00edzkych, ktor\u00ed \u017eij\u00fa v neust\u00e1lom strachu z progresie ochorenia, preto\u017ee vedia, \u017ee metastatick\u00fd UM (mUM), ktor\u00fd sa vyvinie u pribli\u017ene polovice pacientov s UM, je nelie\u010dite\u013en\u00fd a o\u010dak\u00e1van\u00e1 d\u013a\u017eka \u017eivota s touto diagn\u00f3zou je 4 \u2013 15 mesiacov. <\/p>\n\n\n\n

      \n
    1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

      Tebentafusp je forma imunoterapie zameran\u00e1 na detekciu takzvan\u00fdch (HLA)-A*02:01 pozit\u00edvnych n\u00e1dorov\u00fdch buniek UM a ich prezent\u00e1ciu T-bunk\u00e1m, ktor\u00e9 sa aktivuj\u00fa a maj\u00fa sp\u00f4sobi\u0165 de\u0161trukciu n\u00e1dorov\u00fdch buniek.<\/p>\n\n\n\n

      Kimmtrak bol registrovan\u00fd v Eur\u00f3pskej \u00fanii pre hodnoten\u00fa indik\u00e1ciu v apr\u00edli 2022.<\/p>\n\n\n\n

        \n
      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ol>\n\n\n\n

        Odborn\u00edk participuj\u00faci na hodnoten\u00ed sa vyjadril, \u017ee na Slovensku nie je s\u00fa\u010dasn\u00e1 lie\u010dba mUM v s\u00falade s najnov\u0161\u00edmi medzin\u00e1rodn\u00fdmi odpor\u00fa\u010daniami. Odhaduje, \u017ee kategoriz\u00e1ciou tebentafuspu by sa naplnila medic\u00ednska potreba, nako\u013eko o\u010dak\u00e1va, \u017ee liek bude ma\u0165 v\u00fdznamn\u00fd klinick\u00fd pr\u00ednos v porovnan\u00ed so s\u00fa\u010dasnou klinickou praxou na Slovensku.<\/p>\n\n\n\n

          \n
        1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

          Dr\u017eite\u013e registr\u00e1cie (Immunocore Ireland Limited (IRL)) podal \u017eiados\u0165 o zaradenie lie\u010diva tebentafusp (Kimmtrak) na lie\u010dbu dospel\u00fdch pacientov s neresekovate\u013en\u00fdm alebo metastatick\u00fdm uve\u00e1lnym melan\u00f3mom.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Kimmtrak v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady za balenie na n\u00e1kladovo efekt\u00edvnu \u00farove\u0148.<\/p>\n\n\n\n

          Z\u00e1rove\u0148 v\u0161ak pri lieku Kimmtrak m\u00f4\u017ee by\u0165 zv\u00e1\u017een\u00e9 aplikovanie v\u00fdnimky zo splnenia n\u00e1kladovej efekt\u00edvnosti. Liek Kimmtrak sp\u013a\u0148a niektor\u00e9 z podmienok tohto odseku, zatia\u013e v\u0161ak v\u0161etky podmienky nie s\u00fa splnen\u00e9. Podmienkou je napr\u00edklad aj uzavretie zmluvy o podmienkach kategoriz\u00e1cie lieku (MEA), ktorou bude zabezpe\u010den\u00e9 efekt\u00edvne vynakladanie prostriedkov.<\/p>\n\n\n\n

          NIHO tie\u017e odpor\u00fa\u010da zv\u00e1\u017ei\u0165 \u00fapravu indika\u010dn\u00e9ho obmedzenia pod\u013ea n\u00e1vrhu NIHO.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Kimmtrak v predmetnej indik\u00e1ci\u00ed, pokia\u013e…<\/p>","protected":false},"author":3,"featured_media":1931,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[123,124],"class_list":["post-1930","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-kimmtrak","tag-tebentafusp"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1930","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=1930"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1930\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1931"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1930"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1930"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1930"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}