{"id":1815,"date":"2023-02-24T15:02:00","date_gmt":"2023-02-24T14:02:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1815"},"modified":"2024-03-30T15:04:07","modified_gmt":"2024-03-30T14:04:07","slug":"19b-liecivo-nintedanib-liek-ofev-na-liecbu-dospelych-pacientov-s-idiopatickou-plucnou-fibrozou","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/19b-liecivo-nintedanib-liek-ofev-na-liecbu-dospelych-pacientov-s-idiopatickou-plucnou-fibrozou\/","title":{"rendered":"19B: Lie\u010divo nintedanib (liek Ofev) na lie\u010dbu dospel\u00fdch pacientov s idiopatickou p\u013e\u00facnou fibr\u00f3zou"},"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

    Idiopatick\u00e1 p\u013e\u00facna fibr\u00f3za (IPF) patr\u00ed medzi ochorenia p\u013e\u00fac. \u0160pecifick\u00e1 je zjazven\u00edm p\u013e\u00facneho tkaniva a nevratnej strate funkcie p\u013e\u00fac. Pacienti s\u00fa d\u00fdchavi\u010dn\u00ed, maj\u00fa ka\u0161e\u013e, zhor\u0161uj\u00fa sa im p\u013e\u00facne funkcie a oxygen\u00e1cia. Okrem toho s\u00fa vystaven\u00ed riziku ak\u00fatnej exacerb\u00e1cie (n\u00e1hla akceler\u00e1cia ochorenia), ktor\u00e1 m\u00f4\u017ee a\u017e v 85% pr\u00edpadov vies\u0165 k smrti. Prejavmi ochorenia s\u00fa probl\u00e9my s d\u00fdchan\u00edm aj pri aktivit\u00e1ch ako kr\u00e1\u010danie po schodoch, r\u00fdchla ch\u00f4dza a upratovanie. Pacienti s fibr\u00f3zou p\u013e\u00fac, ktor\u00ed nedost\u00e1vaj\u00fa antifibrotick\u00fa lie\u010dbu, maj\u00fa medi\u00e1n pre\u017e\u00edvania po diagn\u00f3ze 2-3 roky.<\/p>\n\n\n\n

    Aktu\u00e1lne nie je na Slovensku v lie\u010dbe idiopatick\u00e1 p\u013e\u00facna fibr\u00f3za kategorizovan\u00e9 \u017eiadne lie\u010divo, hraden\u00e1 lie\u010dba tak nezodpoved\u00e1 najnov\u0161\u00edm medzin\u00e1rodn\u00fdm postupom.<\/p>\n\n\n\n

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

      Ofev obsahuje lie\u010divo nintedanib, liek patriaci do triedy takzvan\u00fdch inhib\u00edtorov tyroz\u00ednkin\u00e1z, a pou\u017e\u00edva sa, okrem in\u00e9ho, na lie\u010dbu idiopatickej p\u013e\u00facnej fibr\u00f3zy.<\/p>\n\n\n\n

      V randomizovan\u00fdch kontrolovan\u00fdch klinick\u00fdch \u0161t\u00fadi\u00e1ch nintedanib v porovnan\u00ed s placebom nepreuk\u00e1zal \u0161tatisticky signifikantn\u00fd pr\u00ednos v troch k\u013e\u00fa\u010dov\u00fdch ukazovate\u013eoch – mortalita, morbidita (\u010das do prvej ak\u00fatnej exacerb\u00e1cie – n\u00e1hleho zhor\u0161enia stavu) a kvalita \u017eivota. Z\u00e1rove\u0148 preuk\u00e1zal \u0161tatisticky signifikantn\u00e9 zlep\u0161enie v ukazovateli morbidity (\u00fasiln\u00e1 vit\u00e1lna kapacita) a dobr\u00fa tolerovate\u013enos\u0165 lie\u010dby.<\/p>\n\n\n\n

      Liek Ofev s lie\u010divom nintedanib bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare d\u0148a 15. janu\u00e1ra 2015.<\/p>\n\n\n\n

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

        Odborn\u00edci, ktor\u00fdch NIHO oslovilo pova\u017euj\u00fa za relevantn\u00fd pr\u00ednos technol\u00f3gie zlep\u0161enie p\u013e\u00facnych funkci\u00ed (FVC), redukciu sympt\u00f3mov, zn\u00ed\u017eenie rizika ak\u00fatnej exacerb\u00e1cie IPF, spomalenie progresie ochorenia, zn\u00ed\u017eenie respira\u010dnej mortality a zlep\u0161enie kvality \u017eivota.<\/p>\n\n\n\n

        Odborn\u00edci sa vyjadrili, \u017ee na Slovensku s\u00fa\u010dasn\u00e1 lie\u010dba IPF nie je v s\u00falade s najnov\u0161\u00edmi medzin\u00e1rodn\u00fdmi odpor\u00fa\u010daniami, ke\u010f\u017ee na toto ochorenie nie je kategorizovan\u00fd \u017eiadny liek. Jeden z odborn\u00edkov tie\u017e zd\u00f4raznil, \u017ee exacerb\u00e1cie v\u00fdznamne zhor\u0161uj\u00fa stav pacienta, zvy\u0161uj\u00fa riziko pred\u010dasn\u00e9ho \u00famrtia a odborn\u00edci nemaj\u00fa mo\u017enos\u0165 poda\u0165 liek, ktor\u00fd by toto riziko zn\u00ed\u017eil. <\/p>\n\n\n\n

        Druh\u00fd odborn\u00edk doplnil, \u017ee za posledn\u00fdch viac ako 7 rokov sa v\u00fdznamne zlep\u0161ila diagnostika pacientov s p\u013e\u00facnymi fibr\u00f3zami v\u010faka multidisciplin\u00e1rnej spolupr\u00e1ci pneumol\u00f3ga s r\u00e1diol\u00f3gom, \u010do vedie k dobrej z\u00e1chytnosti pacientov. Probl\u00e9mom je, \u017ee pre t\u00fdchto pacientov v s\u00fa\u010dasnosti nie je \u0161tandardne hraden\u00e1 lie\u010dba. U lek\u00e1rov pracuj\u00facich s pacientmi s IPF m\u00f4\u017ee nekategorizovanie Ofevu 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 (Boehringer Ingelheim) po\u017eaduje hradenie lieku z prostriedkov verejn\u00e9ho zdravotn\u00e9ho poistenia na lie\u010dbu dospel\u00fdch pacientov s idiopatickou p\u013e\u00facnou fibr\u00f3zou.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da nevyhovie\u0165 <\/strong>\u017eiadosti o kategorizovanie lieku Ofev v po\u017eadovanej indik\u00e1cii, pokia\u013e dr\u017eite\u013e regitr\u00e1cie neuprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady za balenie, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti pod\u013ea \u00a77 z\u00e1kona 363\/2011 Z.z..<\/p>\n\n\n\n

          NIHO takisto odpor\u00fa\u010da zv\u00e1\u017ei\u0165 \u00fapravu indika\u010dn\u00e9ho obmedzenia, aby lie\u010dba nintedanibom podliehala predch\u00e1dzaj\u00facemu s\u00fahlasu zdravotnej pois\u0165ovne.<\/p>","protected":false},"excerpt":{"rendered":"

          IHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Ofev v po\u017eadovanej indik\u00e1cii, pokia\u013e dr\u017eite\u013e regitr\u00e1cie neuprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady za balenie, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti pod\u013ea \u00a77 z\u00e1kona 363\/2011 Z.z….<\/p>","protected":false},"author":3,"featured_media":1813,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[73,72],"class_list":["post-1815","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-nintedanib","tag-ofev"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1815","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=1815"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1815\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1813"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1815"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1815"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1815"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}