{"id":2286,"date":"2023-01-05T17:51:00","date_gmt":"2023-01-05T16:51:00","guid":{"rendered":"https:\/\/niho.sk\/?p=2286"},"modified":"2024-11-23T18:10:34","modified_gmt":"2024-11-23T17:10:34","slug":"12a-liecivo-nivolumab-opdivo-v-monoterapii-na-liecbu-pokrocileho-neresektovatelneho-alebo-metastatickeho-melanomu","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/12a-liecivo-nivolumab-opdivo-v-monoterapii-na-liecbu-pokrocileho-neresektovatelneho-alebo-metastatickeho-melanomu\/","title":{"rendered":"12A: Lie\u010divo nivolumab (Opdivo) v monoterapii na lie\u010dbu pokro\u010dil\u00e9ho (neresektovate\u013en\u00e9ho alebo metastatick\u00e9ho) melan\u00f3mu"},"content":{"rendered":"
    \n
  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

    Mal\u00edgny melan\u00f3m tvor\u00ed pribli\u017ene 4% z ko\u017eny\u0301ch n\u00e1dorov, pri\u010dom zodpoved\u00e1 za 90% \u00famrt\u00ed na rakovinu ko\u017ee. Mal\u00edgny melan\u00f3m patr\u00ed medzi najagres\u00edvnej\u0161ie n\u00e1dorov\u00e9 ochorenia, v pokro\u010dily\u0301ch \u0161t\u00e1di\u00e1ch ry\u0301chlo mestast\u00e1zuje do vzdialeny\u0301ch org\u00e1nov – do p\u013e\u00fac, pe\u010dene, kost\u00ed a centr\u00e1lneho nervov\u00e9ho syst\u00e9mu. Pri v\u010dasnom z\u00e1chyte v skor\u0161\u00edch \u0161t\u00e1di\u00e1ch je mo\u017en\u00e9 ochorenie vylie\u010di\u0165 chirurgicky\u0301m z\u00e1krokom alebo lie\u010di\u0165 radia\u010dnou terapiou. V pokro\u010dilom \u0161t\u00e1diu je v\u0161ak tak\u00e1to lie\u010dba ne\u00fa\u010dinn\u00e1 a je potrebn\u00e1 syst\u00e9mov\u00e1 terapia, medzi ktor\u00fa patr\u00ed aj hodnoten\u00e9 lie\u010divo nivolumab.<\/p>\n\n\n\n

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

      Liek obsahuje lie\u010divo nivolumab, \u010do je monoklon\u00e1lna protil\u00e1tka. Pom\u00e1ha zv\u00fd\u0161i\u0165 aktivitu T buniek (typ bielych krviniek) proti n\u00e1dorov\u00fdm bunk\u00e1m.LT2.<\/p>\n\n\n\n

      OPDIVO bol prv\u00fdkr\u00e1t registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare v j\u00fani 2015.<\/p>\n\n\n\n

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

        Odborn\u00edk sa vyjadril, \u017ee na Slovensku nebola v \u010dase, ke\u010f bol osloveny\u0301, zabezpe\u010den\u00e1 adekv\u00e1tna lie\u010dba, ke\u010f\u017ee Keytruda nebola kategorizovan\u00e1. V \u010dase publik\u00e1cie hodnotenia v\u0161ak liek Keytruda u\u017e je zaradeny\u0301 v zozname kategorizovan\u00fdch liekov, tak\u017ee dostupnos\u0165 imunoterapie bude zabezpe\u010den\u00e1 dostato\u010dne.<\/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, farmaceutick\u00e1 firma Bristol-Myers Squibb Pharma EEIG, podal \u017eiados\u0165 o kategorizovanie lieku Opdivo (nivolumab) v po\u017eadovanej indik\u00e1cii \u201eu pacientov v monoterapii na lie\u010dbu pokro\u010dil\u00e9ho (neresekovate\u013en\u00e9ho alebo metastatick\u00e9ho) melan\u00f3mu\u201c<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Opdivo v predmetnej indik\u00e1ci\u00ed, pokia\u013e bud\u00fa splnen\u00e9 dve podmienky:

          1. d\u00f4jde k zmene indika\u010dn\u00e9ho obmedzenia tak, aby bola lie\u010dba poskytnut\u00e1 len pacientom bez predch\u00e1dzaj\u00facej lie\u010dby,
          2. 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

          V\u00fdsledok hodnotenia je spojen\u00fd s ve\u013ekou mierou neistoty, \u017ee pri po\u017eadovanej \u00fahrade nebud\u00fa v praxi splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. NIHO preto odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>","protected":false},"excerpt":{"rendered":"

          Mal\u00edgny melan\u00f3m tvor\u00ed pribli\u017ene 4% z ko\u017eny\u0301ch n\u00e1dorov, pri\u010dom zodpoved\u00e1 za 90% \u00famrt\u00ed na rakovinu ko\u017ee. Mal\u00edgny melan\u00f3m patr\u00ed medzi najagres\u00edvnej\u0161ie n\u00e1dorov\u00e9 ochorenia, v pokro\u010dily\u0301ch \u0161t\u00e1di\u00e1ch ry\u0301chlo mestast\u00e1zuje do vzdialeny\u0301ch org\u00e1nov – do p\u013e\u00fac, pe\u010dene, kost\u00ed a centr\u00e1lneho nervov\u00e9ho syst\u00e9mu. Pri v\u010dasnom z\u00e1chyte v skor\u0161\u00edch \u0161t\u00e1di\u00e1ch je mo\u017en\u00e9 ochorenie vylie\u010di\u0165 chirurgicky\u0301m z\u00e1krokom alebo lie\u010di\u0165 radia\u010dnou […]<\/p>\n","protected":false},"author":3,"featured_media":2284,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[141,140],"class_list":["post-2286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-nivolumab","tag-opdivo"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/2286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/comments?post=2286"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/2286\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/2284"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=2286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=2286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=2286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}