{"id":1739,"date":"2022-07-13T19:20:00","date_gmt":"2022-07-13T17:20:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1739"},"modified":"2024-03-23T12:58:36","modified_gmt":"2024-03-23T11:58:36","slug":"5-liecivo-tucitinib-tukysa","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/5-liecivo-tucitinib-tukysa\/","title":{"rendered":"5: Lie\u010divo tucitinib (Tukysa) v kombin\u00e1cii s trastuzumabom a kapecitab\u00ednom na lie\u010dbu HER2+ karcin\u00f3mu prsn\u00edka\u00a0"},"content":{"rendered":"

Kombin\u00e1cia tucitinib + trastuzumab + kapecitab\u00edn m\u00e1 spoma\u013eova\u0165 rast n\u00e1doru. M\u00e1 od\u010fa\u013eova\u0165 \u0161\u00edrenie n\u00e1doru a predl\u017eova\u0165 celkov\u00fa d\u013a\u017eku \u017eivota pacientov viac, ako porovn\u00e1van\u00fd re\u017eim lapatinib + kapecitab\u00edn.<\/p>\n\n\n\n

Tucitinib sa pod\u00e1va ako tableta \u00fastne v d\u00e1vke 300 mg 2x denne.<\/p>\n\n\n\n

Liek Tukysa s lie\u010divom tucitinib bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare v roku 2021.<\/p>\n\n\n\n

\u010co je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako je z\u00e1sadn\u00e9?<\/h2>\n\n\n\n

Rakovina prsn\u00edka je vo svete, ako aj na Slovensku, naj\u010dastej\u0161\u00edm n\u00e1dorov\u00fdm ochoren\u00edm \u017eien. Pod\u013ea d\u00e1t NCZI N\u00e1rodn\u00fd onkologick\u00fd register Slovenskej republiky na rok 2022 odhaduje 3705 nov\u00fdch pacientov s diagn\u00f3zou zhubn\u00e9ho n\u00e1doru prsn\u00edka. 15% a\u017e 20% z diagnostikovan\u00fdch pr\u00edpadov rakoviny prsn\u00edka je podtyp \u201cHER2+\u201d.<\/p>\n\n\n\n

V ranej f\u00e1ze je rakovina prsn\u00edka vylie\u010dite\u013en\u00e9 ochorenie. Pre skor\u00fd z\u00e1chyt, a tak zn\u00ed\u017eenie \u00famrtnosti, s\u00fa pravideln\u00e9 samovy\u0161etrenia prsn\u00edkov, prevent\u00edvne prehliadky a mamografick\u00e9 vy\u0161etrenia k\u013e\u00fa\u010dov\u00e9. Takmer v\u0161etky \u017eeny diagnostikovan\u00e9 v skor\u00fdch \u0161t\u00e1di\u00e1ch v Brit\u00e1nii pre\u017e\u00edvaj\u00fa 5 a viac rokov po diagn\u00f3ze (98%, respekt\u00edve 90% pacientiek). Pri diagn\u00f3ze v neskor\u0161\u00edch \u0161t\u00e1di\u00e1ch toto \u010d\u00edslo kles\u00e1 na 70% a iba 25% \u017eien pre\u017eije 5 a viac rokov, ak je ich ochorenie diagnostikovan\u00e9 v metastatickom \u0161t\u00e1diu. <\/p>\n\n\n\n

Na Slovensku m\u00e1 n\u00e1rok na bezplatn\u00e9 prevent\u00edvne mamografick\u00e9 vy\u0161etrenie ka\u017ed\u00e1 \u017eena vo veku 40 \u2013 69 rokov raz za dva roky, pri\u010dom \u017een\u00e1m so zv\u00fd\u0161en\u00fdm rizikom rakoviny prsn\u00edka sa odpor\u00fa\u010da absolvova\u0165 mamografiu ka\u017ed\u00fd rok. \u00da\u010das\u0165 na mamografick\u00fdch skr\u00edningoch na Slovensku je jedna z najni\u017e\u0161\u00edch v Eur\u00f3pskej \u00fanii (E\u00da). V roku 2017 menej ne\u017e jedna tretina \u017eien vo vekovej skupine 50-69 rokov absolvovala v posledn\u00fdch dvoch rokoch mamografick\u00e9 vy\u0161etrenie. <\/p>\n\n\n\n

V prvej l\u00ednii lie\u010dby rakoviny prsn\u00edka podtypu HER+ sa naj\u010dastej\u0161ie pou\u017e\u00edva kombin\u00e1cia trastuzumab + pertuzumab + chemoterapia tax\u00e1nom (docetaxel alebo paclitaxel). Pod\u013ea uv\u00e1\u017eenia lek\u00e1ra je mo\u017en\u00e9 zvoli\u0165 aj in\u00fd pr\u00edstup v terapii.<\/p>\n\n\n\n

Ako sa na tucitinib pozeraj\u00fa odborn\u00edci? <\/h2>\n\n\n\n

Klinick\u00fd odborn\u00edk odhaduje po\u010det pacientov vhodn\u00fdch na lie\u010dbu na okolo 100. Taktie\u017e uv\u00e1dza, \u017ee tucitinib by mal predpisova\u0165 onkol\u00f3g.<\/p>\n\n\n\n

\u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/h2>\n\n\n\n

Dr\u017eite\u013e registr\u00e1cie (spolo\u010dnos\u0165, ktor\u00e1 vlastn\u00ed pr\u00e1va na predaj lieku) po\u017eaduje \u00fahradu pre dospel\u00fdch pacientov s HER2+ rakovinou prsn\u00edka, ktor\u00ed u\u017e absolvovali aspo\u0148 dva predch\u00e1dzaj\u00face lie\u010debn\u00e9 re\u017eimy.<\/p>\n\n\n\n

NIHO odpor\u00fa\u010da nevyhovie\u0165 <\/strong>\u017eiadosti dr\u017eite\u013ea registr\u00e1cie o zaradenie lieku Tukysa (lie\u010divo tucitinib) v predmetnej sile a v predmetnej indik\u00e1ci\u00ed.

NIHO p\u00f4vodne vydalo odpor\u00fa\u010denie \u017eiadosti vyhovie\u0165, ale do\u0161lo ku zmene z\u00e1kona o kategoriz\u00e1cii a bolo nutn\u00e9 vykona\u0165 dodato\u010dn\u00e9 hodnotenie n\u00e1kladovej efekt\u00edvnosti. Zrel\u0161ie d\u00e1ta pre celkov\u00e9 pre\u017e\u00edvanie poukazuj\u00fa na podstatn\u00e9 zhor\u0161enie relat\u00edvneho pr\u00ednosu re\u017eimu tucitinib <\/strong>+ trastuzumab + kapecitab\u00edn vo\u010di placebu ako \u010do nazna\u010dovali skor\u0161ie d\u00e1ta. Napriek v\u00fdzve Ministerstva zdravotn\u00edctva o doplnenie d\u00e1t do ekonomick\u00e9ho modelu, dr\u017eite\u013e registr\u00e1cie tieto d\u00e1ta nedoplnil.<\/p>\n\n\n\n

Predpoklad\u00e1me, \u017ee nov\u0161ie d\u00e1ta m\u00f4\u017eu podstatne zn\u00ed\u017ei\u0165 maxim\u00e1lnu mo\u017en\u00fa v\u00fd\u0161ku \u00fahrady za balenie Tukysa pre splnenie n\u00e1kladovej efekt\u00edvnosti. Predpoklad\u00e1me tie\u017e, \u017ee toto potrebn\u00e9 zn\u00ed\u017eenie \u00fahrady nie je mo\u017en\u00e9 plne zachyti\u0165 ani v dodato\u010dnej z\u013eave, ktor\u00fa NIHO v hodnoten\u00ed \u0161tandardne navrhuje.<\/p>","protected":false},"excerpt":{"rendered":"

NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti dr\u017eite\u013ea registr\u00e1cie o zaradenie lieku Tukysa (lie\u010divo tucitinib) v predmetnej sile a v predmetnej indik\u00e1ci\u00ed.<\/p>","protected":false},"author":3,"featured_media":1740,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[20,21],"class_list":["post-1739","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-tucatinib","tag-tukysa"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1739","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=1739"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1739\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1740"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1739"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1739"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1739"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}