{"id":1789,"date":"2023-01-12T13:57:00","date_gmt":"2023-01-12T12:57:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1789"},"modified":"2024-03-30T14:03:33","modified_gmt":"2024-03-30T13:03:33","slug":"liecivo-palbociklib-ibrance-v-kombinacii-s-inihibitorom-aromataz-na-liecbu-lokalne-pokrocileho-alebo-metastazujuceho-karcinomu-prsnika-v-prvej-linii","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/liecivo-palbociklib-ibrance-v-kombinacii-s-inihibitorom-aromataz-na-liecbu-lokalne-pokrocileho-alebo-metastazujuceho-karcinomu-prsnika-v-prvej-linii\/","title":{"rendered":"15A: Lie\u010divo palbociklib (Ibrance) v kombin\u00e1cii s inihib\u00edtorom aromat\u00e1z na lie\u010dbu lok\u00e1lne pokro\u010dil\u00e9ho alebo metast\u00e1zuj\u00faceho karcin\u00f3mu prsn\u00edka v prvej 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

    Rakovina prsn\u00edka je zhubn\u00fd n\u00e1dor, ktor\u00fd sa vyskytuje v ktorejko\u013evek bunke prsnej \u017e\u013eazy. Toto ochorenie postihuje predov\u0161etk\u00fdm \u017eeny. U mu\u017eov sa rakovina prsn\u00edka vyskytuje iba sporadicky (0,5 \u2013 1 % zo v\u0161etk\u00fdch pr\u00edpadov). Pod\u013ea najnov\u0161\u00edch celosvetov\u00fdch \u0161tatist\u00edk s\u00fa rakoviny prsn\u00edka (po nemelan\u00f3mov\u00fdch n\u00e1doroch ko\u017ee) naj\u010dastej\u0161ie diagnostikovan\u00fdm onkologick\u00fdm ochoren\u00edm a hlavnou pr\u00ed\u010dinou \u00famrt\u00ed na rakovinu u \u017eenskej popul\u00e1cie. <\/p>\n\n\n\n

    Odborn\u00edk, ktor\u00e9ho NIHO oslovilo pre \u00fa\u010dely hodnotenia, odhadol po\u010det pacientov vhodn\u00fdch pre predmetn\u00fa lie\u010dbu na Slovensku na 600 – 800.<\/p>\n\n\n\n

    Rakovina prsn\u00edka je charakterizovan\u00e1 viacer\u00fdmi sympt\u00f3mami, av\u0161ak prv\u00fdm n\u00e1padn\u00fdm pr\u00edznakom je zvy\u010dajne hr\u010dka alebo lok\u00e1lne zhrubnutie tkaniva v prsn\u00edku. <\/p>\n\n\n\n

    Onkologick\u00e1 diagn\u00f3za a jej mana\u017ement v\u017edy predstavuje enormn\u00fa nielen fyzick\u00fa, ale aj psychick\u00fa z\u00e1\u0165a\u017e na pacienta a jeho bl\u00edzkych. Kvalitu \u017eivota onkologick\u00fdch pacientov jednozna\u010dne ovplyv\u0148uje strach zo smrti alebo relapsu ochorenia. Navy\u0161e, pri pacientkach trpiacich karcin\u00f3mom prsn\u00edka je \u0161pecifick\u00fdm n\u00e1sledkom lie\u010dby strata alebo deform\u00e1cia prsn\u00edka, symbolu \u017eenskosti, ktor\u00e1 m\u00e1 v\u00fdrazn\u00fd dopad na sebavedomie \u017eeny z d\u00f4vodu osobn\u00e9ho pocitu zn\u00ed\u017eenej fyzickej pr\u00ed\u0165a\u017elivosti, \u010do n\u00e1sledne m\u00f4\u017ee ovplyvni\u0165 nadv\u00e4zovanie zn\u00e1most\u00ed, \u010di sexu\u00e1lny \u017eivot. S pocitom menejcennosti a neust\u00e1lym strachom sa potom sp\u00e1ja vyvinutie depresie, \u00fazkosti, poruchy sp\u00e1nku, \u010di zn\u00ed\u017een\u00fd apet\u00edt.<\/p>\n\n\n\n

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

      Palbociklib m\u00e1 obmedzi\u0165      bunkov\u00e9 mno\u017eenie blokovan\u00edm postupu bunky v \u0161pecifickej f\u00e1ze bunkov\u00e9ho cyklu. Ibrance je tableta ur\u010den\u00e1      na u\u017eitie \u00fastami.     .<\/p>\n\n\n\n

      Ibrance bol registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou v novembri roku 2016. <\/p>\n\n\n\n

      Odpor\u00fa\u010dan\u00e1 d\u00e1vka je 125 mg palbociklibu jedenkr\u00e1t denne po\u010das 21 po sebe nasleduj\u00facich dn\u00ed, po ktor\u00fdch nasleduje 7 dn\u00ed bez lie\u010dby, aby sa zav\u0155\u0161il \u00fapln\u00fd 28-d\u0148ov\u00fd cyklus.<\/p>\n\n\n\n

        \n
      1. Ako sa na palbociklib pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

        Odborn\u00edk, ktor\u00e9ho NIHO oslovilo, sa vyjadril, \u017ee na Slovensku s\u00fa\u010dasn\u00e1 lie\u010dba nie je v s\u00falade s najnov\u0161\u00edmi medzin\u00e1rodn\u00fdmi odpor\u00fa\u010daniami, ke\u010f\u017ee ch\u00fdbaj\u00fa palbociklib alebo jemu podobn\u00e9 lie\u010div\u00e1. U lek\u00e1rov pracuj\u00facich s pacientmi s pokro\u010dilou rakovinou prsn\u00edka m\u00f4\u017ee nekategorizovanie lieku Ibrance podpori\u0165 frustr\u00e1ciu zo zaost\u00e1vania za najlep\u0161\u00edm \u0161tandardom.<\/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 (Pfizer Europe) navrhuje, aby bola lie\u010dba hraden\u00e1 pre pacientov s lok\u00e1lne pokro\u010dilou alebo metast\u00e1zuj\u00facou rakovinou prsn\u00edka s pozitivitou hormon\u00e1lnych receptorov (HR) a negativitou receptora pre \u013eudsk\u00fd epiderm\u00e1lny rastov\u00fd faktor 2 (HER2) v kombin\u00e1cii s \u010fal\u0161\u00edm lie\u010divom zo skupiny tzv. inhib\u00edtorov aromat\u00e1z.<\/p>\n\n\n\n

          N\u00e1vrh na ofici\u00e1lnu \u00fahradu v zozname kategorizovan\u00fdch liekov pre predmetn\u00fa indik\u00e1ciu je <\/p>\n\n\n\n

          2 266,38\u20ac.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da nevyhovie\u0165 <\/strong>\u017eiadosti o kategorizovanie lieku Ibrance, pokia\u013e:<\/p>\n\n\n\n

            \n
          1. ned\u00f4jde k \u00faprave podmienok hradenia na z\u00e1klade odpor\u00fa\u010dan\u00ed NIHO<\/li>\n\n\n\n
          2. a z\u00e1rove\u0148 dr\u017eite\u013e registr\u00e1cie neposkytne z\u013eavu vo v\u00fd\u0161ke, ktor\u00fa navrhuje NIHO, aby boli splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti pod\u013ea \u00a77 z\u00e1kona 363\/2011 Z.z.<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Ibrance, pokia\u013e…<\/p>","protected":false},"author":3,"featured_media":1790,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[63,62],"class_list":["post-1789","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-ibrance","tag-palbociklib"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1789","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=1789"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1789\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1790"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1789"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1789"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1789"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}