{"id":1744,"date":"2022-10-25T12:21:00","date_gmt":"2022-10-25T10:21:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1744"},"modified":"2024-03-23T13:00:19","modified_gmt":"2024-03-23T12:00:19","slug":"6-liecivo-darolutamid-nubeqa","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/6-liecivo-darolutamid-nubeqa\/","title":{"rendered":"6: Lie\u010divo darolutamid (Nubeqa) na lie\u010dbu kastra\u010dne rezistentn\u00e9ho nemetastatick\u00e9ho karcin\u00f3mu prostaty (nmCRCP)"},"content":{"rendered":"
    \n
  1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Nubeqa (\u00fa\u010dinn\u00e1 l\u00e1tka darolutamid) m\u00e1 pred\u013a\u017ei\u0165 pre\u017e\u00edvanie pacientov bez v\u00fdskytu metast\u00e1z a oddiali\u0165 prechod do metastatick\u00e9ho \u0161t\u00e1dia ochorenia.<\/p>\n\n\n\n

    Lie\u010dba darolutamidom m\u00e1 zni\u017eova\u0165 mno\u017eenie n\u00e1dorov\u00fdch buniek prostaty, \u010do m\u00e1 vies\u0165 k silnej protin\u00e1dorovej aktivite. Liek je vo forme tablety pod\u00e1van\u00fd \u00fastne, spravidla doma. Odpor\u00fa\u010dan\u00e1 d\u00e1vka je 600 mg darolutamidu (dve tablety po 300 mg), u\u017e\u00edvan\u00e1 dvakr\u00e1t denne, \u010do zodpoved\u00e1 celkovej dennej d\u00e1vke 1 200 mg. <\/p>\n\n\n\n

    Liek bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare roku 2020.<\/p>\n\n\n\n

      \n
    1. \u010co je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako je z\u00e1sadn\u00e9?<\/strong><\/li>\n<\/ol>\n\n\n\n

      Rakovina prostaty je celosvetovo druh\u00fdm naj\u010dastej\u0161\u00edm zhubn\u00fdm n\u00e1dorom (po rakovine p\u013e\u00fac) u mu\u017eov. Naj\u010dastej\u0161ie postihuje \u013eud\u00ed vo vy\u0161\u0161om veku \u2013 viac ako polovica pr\u00edpadov rakoviny prostaty vznik\u00e1 u mu\u017eov star\u0161\u00edch ako 70 rokov. Na Slovensku je rakovina prostaty naj\u010dastej\u0161\u00edm typom mu\u017esk\u00e9ho urologick\u00e9ho zhubn\u00e9ho n\u00e1dora. \u201cnmCRPC\u201d predstavuje jedno z nieko\u013ek\u00fdch klinick\u00fdch \u0161t\u00e1di\u00ed, ktor\u00e9 predch\u00e1dzaj\u00fa vzniku metastatick\u00e9ho ochorenia pri rakovine prostaty.<\/p>\n\n\n\n

      Pri prvej diagnostike ochorenia rakoviny prostaty m\u00e1 pribli\u017ene 20% pacientov detekovan\u00e9 metast\u00e1zy, zvy\u0161n\u00fdch 80% pacientov je diagnostikovan\u00fdch bez metast\u00e1z. Pacienti s \u0161t\u00e1diom nmCRPC s\u00fa popisovan\u00ed ako vo v\u0161eobecnosti asymptomatick\u00ed. Pr\u00edznaky, ktor\u00e9 sa m\u00f4\u017eu objavi\u0165 po\u010das \u0161\u00edrenia n\u00e1doru vznikaj\u00fa \u010dastokr\u00e1t v d\u00f4sledku utla\u010denia mo\u010dovej r\u00fary (\u010dast\u00e9 mo\u010denie, s\u0165a\u017een\u00e9 mo\u010denie alebo naliehav\u00e9 nutkanie na mo\u010denie \u010di probl\u00e9m s erekciou).<\/p>\n\n\n\n

      Pri \u0161t\u00e1diu nmCRPC ide o aktu\u00e1lne o nevylie\u010dite\u013en\u00e9 ochorenie. Medi\u00e1n celkov\u00e9ho pre\u017e\u00edvania pacientov s t\u00fdmto \u0161t\u00e1diom je cca 40 mesiacov od diagnostiky.<\/p>\n\n\n\n

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

        Pod\u013ea odborn\u00edka, ktor\u00e9ho oslovilo NIHO, na Slovensku nie s\u00fa kategorizovan\u00e9 lieky na lie\u010dbu nmCRPC. Uviedol, \u017ee by uv\u00edtal, ak by bol na SR dostupn\u00fd jeden z trojice liekov apalutamid \/ darolutamid \/ enzalutamid pre lie\u010dbu tohto \u0161t\u00e1dia ochorenia. (pozn. Po\u010das pr\u00e1ce na tomto hodnoten\u00ed bol registrovan\u00fd a na Slovensku kategorizovan\u00fd liek Apalutamid)<\/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 (spolo\u010dnos\u0165, ktor\u00e1 vlastn\u00ed pr\u00e1va na predaj lieku) \u017eiada o kategorizovanie lieku na lie\u010dbu nemetastatickej rakoviny prostaty (\u0161t\u00e1dia nmCRPC) v kombin\u00e1cii chemickou kastr\u00e1ciou u dospel\u00fdch mu\u017eov, u ktor\u00fdch je vysok\u00e9 riziko vzniku metastatick\u00e9ho ochorenia. Hraden\u00e1 lie\u010dba podlieha predch\u00e1dzaj\u00facemu s\u00fahlasu zdravotnej pois\u0165ovne.<\/p>\n\n\n\n

          V\u0161eobecne plat\u00ed, \u017ee oddialenie progresie ochorenie do metast\u00e1z m\u00f4\u017ee ma\u0165 v\u00fdznamn\u00fd pozit\u00edvny dopad na \u017eivot pacientov s ochoren\u00edm. <\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165<\/strong> \u017eiadosti o kategorizovanie lieku Nubeqa (darolutamid) v predmetnej indik\u00e1ci\u00ed (nmCRCP). S prihliadnut\u00edm na ve\u013ek\u00fa mieru neistoty navrhujeme dohodn\u00fa\u0165 s dr\u017eite\u013eom registr\u00e1cie z\u013eavu. Neistota pramen\u00ed najm\u00e4 z mierne z\u00e1porn\u00e9ho v\u00fdsledku pri porovn\u00e1van\u00ed rokov kvalitn\u00e9ho \u017eivota (QALY) vo\u010di apalutamidu. <\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Nubeqa (darolutamid) v predmetnej indik\u00e1ci\u00ed (nmCRCP). S prihliadnut\u00edm na ve\u013ek\u00fa mieru neistoty navrhujeme dohodn\u00fa\u0165 s dr\u017eite\u013eom registr\u00e1cie z\u013eavu. <\/p>","protected":false},"author":3,"featured_media":1745,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[22,23],"class_list":["post-1744","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-darolutamid","tag-nubeqa"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1744","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=1744"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1744\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1745"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1744"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1744"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1744"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}