{"id":2282,"date":"2024-03-18T17:00:00","date_gmt":"2024-03-18T16:00:00","guid":{"rendered":"https:\/\/niho.sk\/?p=2282"},"modified":"2025-02-08T22:05:24","modified_gmt":"2025-02-08T21:05:24","slug":"57-liecivo-nivolumab-opdivo-v-monoterapii-na-liecbu-dospelych-pacientov-s-pokrocilym-karcinomom-z-renalnych-buniek-po-predchadzajucej-liecbe","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/57-liecivo-nivolumab-opdivo-v-monoterapii-na-liecbu-dospelych-pacientov-s-pokrocilym-karcinomom-z-renalnych-buniek-po-predchadzajucej-liecbe\/","title":{"rendered":"57: \u00a0Lie\u010divo nivolumab (Opdivo) v monoterapii na lie\u010dbu dospel\u00fdch pacientov s pokro\u010dil\u00fdm karcin\u00f3mom z ren\u00e1lnych buniek po predch\u00e1dzaj\u00facej lie\u010dbe\u00a0"},"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 RCC je \u0165a\u017eko vylie\u010dite\u013en\u00e9 mal\u00edgne ochorenie s negat\u00edvnym dopadom na fyzick\u00e9 aj psychick\u00e9 zdravie pacientov. RCC tvor\u00ed pribli\u017ene 80% \u2013 85% pr\u00edpadov karcin\u00f3mu obli\u010dky. V pokro\u010dilom \u0161t\u00e1diu n\u00e1dor prerast\u00e1 mimo obli\u010dku tak, \u017ee nie je mo\u017en\u00e1 oper\u00e1cia alebo sa roz\u0161iruje do iny\u0301ch vzdialenej\u0161\u00edch \u010dast\u00ed tela. Pokro\u010dil\u00e1 forma RCC je \u0165a\u017eko vylie\u010dite\u013en\u00e1, vo v\u00e4\u010d\u0161ine pr\u00edpadov je cie\u013eom lie\u010dby spomalenie progresie ochorenia a pred\u013a\u017eenie \u017eivota v \u010do najlep\u0161ej kvalite. Pre\u017e\u00edvanie variuje od nieko\u013eky\u0301ch mesiacov a\u017e po viacero rokov. 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. Aktu\u00e1lne hraden\u00e1 lie\u010dba nezodpoved\u00e1 odpor\u00fa\u010daniam pod\u013ea medzin\u00e1rodny\u0301ch postupov a \u0161tandardov. <\/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 uviedol, \u017ee by okrem uvedenej indik\u00e1cie preferoval zaradenie nivolumabu najm\u00e4 do prvej l\u00ednie lie\u010dby. Klinicky\u0301 odborn\u00edk sa v r\u00e1mci hodnotenia vyjadril, \u017ee 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<\/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 zaradenie lie\u010diva o kategorizovanie lieku Opdivo v indik\u00e1cii monoterapia dospely\u0301ch pacientov s pokro\u010dily\u0301m karcin\u00f3mom z ren\u00e1lnych buniek (RCC) po predch\u00e1dzaj\u00facej lie\u010dbe.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 <\/strong>\u017eiadosti o kategorizovanie lieku Opdivo v predmetnej indik\u00e1cii, 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 n\u00e1kladovej efekt\u00edvnosti je aj pri zn\u00ed\u017eenej \u00fahrade spojen\u00fd so strednou 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 adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>\n\n\n\n

          Z\u00e1rove\u0148 NIHO odpor\u00fa\u010da zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00e9ho obmedzenia o dobr\u00fd v\u00fdkonnostn\u00fd stav pacienta.<\/p>","protected":false},"excerpt":{"rendered":"

          Pokro\u010dily\u0301 RCC je \u0165a\u017eko vylie\u010dite\u013en\u00e9 mal\u00edgne ochorenie s negat\u00edvnym dopadom na fyzick\u00e9 aj psychick\u00e9 zdravie pacientov. RCC tvor\u00ed pribli\u017ene 80% \u2013 85% pr\u00edpadov karcin\u00f3mu obli\u010dky. V pokro\u010dilom \u0161t\u00e1diu n\u00e1dor prerast\u00e1 mimo obli\u010dku tak, \u017ee nie je mo\u017en\u00e1 oper\u00e1cia alebo sa roz\u0161iruje do iny\u0301ch vzdialenej\u0161\u00edch \u010dast\u00ed tela. Pokro\u010dil\u00e1 forma RCC je \u0165a\u017eko vylie\u010dite\u013en\u00e1, vo v\u00e4\u010d\u0161ine pr\u00edpadov […]<\/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-2282","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\/2282","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=2282"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/2282\/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=2282"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=2282"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=2282"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}