{"id":1812,"date":"2023-02-24T14:56:00","date_gmt":"2023-02-24T13:56:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1812"},"modified":"2024-03-30T15:01:52","modified_gmt":"2024-03-30T14:01:52","slug":"19a-liecivo-nintedanib-liek-ofev-na-liecbu-intersticialnych-plucnych-ochoreni-s-progresivnym-fenotypom","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/19a-liecivo-nintedanib-liek-ofev-na-liecbu-intersticialnych-plucnych-ochoreni-s-progresivnym-fenotypom\/","title":{"rendered":"19A: Lie\u010divo nintedanib (liek Ofev) na lie\u010dbu interstici\u00e1lnych p\u013e\u00facnych ochoren\u00ed s progres\u00edvnym fenotypom"},"content":{"rendered":"
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  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

    Interstici\u00e1lne p\u013e\u00facne choroby s progres\u00edvnym fenotypm s\u00fa ve\u013ekou a r\u00f4znorodou skupinou zriedkav\u00fdch a chronick\u00fdch respira\u010dn\u00fdch por\u00fach so zhor\u0161uj\u00facim sa po\u0161koden\u00edm p\u013e\u00facneho tkaniva. Okrem toho s\u00fa pacienti vystaven\u00ed riziku n\u00e1hlej akceler\u00e1cie ochorenia, ktor\u00e1 m\u00f4\u017ee a\u017e v 85% pr\u00edpadov vies\u0165 k smrti. Prejavmi ochorenia s\u00fa d\u00fdchavi\u010dnos\u0165 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 3\u20134 roky. <\/p>\n\n\n\n

    Aktu\u00e1lne nie je na Slovensku v lie\u010dbe tohto ochorenia kategorizovan\u00e9 \u017eiadne lie\u010divo, v s\u00fa\u010dasnosti hraden\u00e1 lie\u010dba nezodpoved\u00e1 najnov\u0161\u00edm medzin\u00e1rodn\u00fdm postupom.<\/p>\n\n\n\n

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    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 interstici\u00e1lnych p\u013e\u00facnych ochoren\u00ed s progres\u00edvnym fenotypom.<\/p>\n\n\n\n

      Klinick\u00e1 \u00fa\u010dinnos\u0165 nintedanibu bola hodnoten\u00e1 v \u0161t\u00fadii INBUILD, v ktorej pacienti u\u017e\u00edvaj\u00faci nintedanib dosiahli lep\u0161ie v\u00fdsledky v p\u013e\u00facnych ukazovate\u013eoch a men\u0161ie riziko ak\u00fatnych zhor\u0161en\u00ed stavu alebo smrti. Napriek tomu nintedanib neviedol k \u0161tatisticky signifikantn\u00fdm zmen\u00e1m v ukazovateli mortalita. Pr\u00ednos v ukazovateli mortalita sme akceptovali, hoci bol \u0161tatisticky nesignifikantn\u00fd.<\/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

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

        Odborn\u00edci, ktor\u00fdch NIHO oslovilo sa vyjadrili, \u017ee na Slovensku s\u00fa\u010dasn\u00e1 lie\u010dba interstici\u00e1lnych p\u013e\u00facnych ochoren\u00ed s progres\u00edvnym fenotypom 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 odborn\u00edk tie\u017e zd\u00f4raznil, \u017ee exacerb\u00e1cie (op\u00e4tovn\u00e9 vzplanutia choroby) 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. U lek\u00e1rov pracuj\u00facich s pacientmi touto diagn\u00f3zou m\u00f4\u017ee nekategorizovanie Ofevu podpori\u0165 frustr\u00e1ciu zo zaost\u00e1vania za najlep\u0161\u00edm \u0161tandardom.<\/p>\n\n\n\n

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        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 interstici\u00e1lnych p\u013e\u00facnych ochoren\u00ed s progres\u00edvnym fenotypom.<\/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: <\/p>\n\n\n\n

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          • 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..<\/li>\n\n\n\n
          • neposkytne dodato\u010dn\u00fa z\u013eavu vzh\u013eadom na neistotu zotrvania dlhodob\u00e9ho pr\u00ednosu technol\u00f3gie.<\/li>\n<\/ul>\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":"

            NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Ofev v po\u017eadovanej indik\u00e1cii, pokia\u013e dr\u017eite\u013e regitr\u00e1cie…<\/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-1812","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\/1812","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=1812"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1812\/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=1812"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1812"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1812"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}