{"id":2289,"date":"2023-01-05T18:10:00","date_gmt":"2023-01-05T17:10:00","guid":{"rendered":"https:\/\/niho.sk\/?p=2289"},"modified":"2024-11-23T18:21:30","modified_gmt":"2024-11-23T17:21:30","slug":"12b-liecivo-nivolumab-opdivo-na-liecbu-pacientov-s-pokrocilym-karcinomom-z-renalnych-buniek-v-druhej-alebo-tretej-linii","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/12b-liecivo-nivolumab-opdivo-na-liecbu-pacientov-s-pokrocilym-karcinomom-z-renalnych-buniek-v-druhej-alebo-tretej-linii\/","title":{"rendered":"12B: Lie\u010divo nivolumab (Opdivo) na lie\u010dbu pacientov s pokro\u010dily\u0301m karcin\u00f3mom z ren\u00e1lnych buniek v druhej alebo tretej l\u00ednii"},"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

    Pokro\u010dily\u0301 karcin\u00f3m z ren\u00e1lnych buniek je \u0165a\u017eko vylie\u010dite\u013en\u00e9 mal\u00edgne ochorenie s negat\u00edvnym dopadom na fyzick\u00e9 aj psychick\u00e9 zdravie pacientov. Ochorenie ovplyv\u0148uje aj bl\u00edzkych pacienta, ke\u010f\u017ee pacient m\u00f4\u017ee vy\u017eadova\u0165 zvy\u0301\u0161en\u00fa starostlivos\u0165 a opateru. Vo v\u00e4\u010d\u0161ine pr\u00edpadov je cie\u013eom lie\u010dby spomalenie progresie, stabiliz\u00e1cia ochorenia a pred\u013a\u017eenie \u017eivota v \u010do najlep\u0161ej kvalite. Aktu\u00e1lne hraden\u00e1 lie\u010dba nezodpoved\u00e1 odpor\u00fa\u010daniam pod\u013ea medzin\u00e1rodny\u0301ch postupov a \u0161tandardov, \u010do sp\u00f4sobuje frustr\u00e1ciu u klinicky\u0301ch odborn\u00edkov.<\/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

        Klinicky\u0301 odborn\u00edk pova\u017euje nivolumab za lie\u010divo s vy\u0301znamny\u0301m klinicky\u0301m pr\u00ednosom v porovnan\u00ed so \u0161tandardom zdravotnej starostlivosti. Za klinicky vy\u0301znamn\u00fa odpove\u010f pova\u017euje zlep\u0161enie pre\u017e\u00edvania nad 3 mesiace. Vyjadril sa, \u017ee nivolumab by mal patri\u0165 do 1. l\u00ednie lie\u010dby v kombin\u00e1cii s TKI (Inhib\u00edtory tyroz\u00ednkin\u00e1zy) alebo ipilimumabom, kde by bol pr\u00ednos nivolumab jednozna\u010dnej\u0161\u00ed.<\/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 indik\u00e1cii lie\u010dba pacientov s pokro\u010dily\u0301m karcin\u00f3mom z ren\u00e1lnych buniek.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Opdivo 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

          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>\n\n\n\n

          Odpor\u00fa\u010dame tie\u017e zv\u00e1\u017ei\u0165 \u00fapravu indika\u010dn\u00e9ho obmedzenia tak, aby sa liek pod\u00e1val len pacientom s dobr\u00fdm v\u00fdkonnostn\u00fdm stavom, s ECOG sk\u00f3re 0-1. <\/p>","protected":false},"excerpt":{"rendered":"

          Pokro\u010dily\u0301 karcin\u00f3m z ren\u00e1lnych buniek je \u0165a\u017eko vylie\u010dite\u013en\u00e9 mal\u00edgne ochorenie s negat\u00edvnym dopadom na fyzick\u00e9 aj psychick\u00e9 zdravie pacientov. Ochorenie ovplyv\u0148uje aj bl\u00edzkych pacienta, ke\u010f\u017ee pacient m\u00f4\u017ee vy\u017eadova\u0165 zvy\u0301\u0161en\u00fa starostlivos\u0165 a opateru. Vo v\u00e4\u010d\u0161ine pr\u00edpadov je cie\u013eom lie\u010dby spomalenie progresie, stabiliz\u00e1cia ochorenia a pred\u013a\u017eenie \u017eivota v \u010do najlep\u0161ej kvalite. Aktu\u00e1lne hraden\u00e1 lie\u010dba nezodpoved\u00e1 odpor\u00fa\u010daniam pod\u013ea […]<\/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-2289","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-nivolumab","tag-opdivo"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/2289","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=2289"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/2289\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/2284"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=2289"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=2289"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=2289"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}