{"id":1907,"date":"2023-09-22T15:47:00","date_gmt":"2023-09-22T13:47:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1907"},"modified":"2024-04-10T15:52:07","modified_gmt":"2024-04-10T13:52:07","slug":"39-liecivo-pembrolizumab-keytruda-v-kombinacii-s-chemoterapiou-ako-neoadjuvantna-liecba-s-naslednym-pokracovanim-vo-forme-adjuvantnej-liecby-u-dospelych-s-trojnasobne-negativnym-karcinomom-prsnika","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/39-liecivo-pembrolizumab-keytruda-v-kombinacii-s-chemoterapiou-ako-neoadjuvantna-liecba-s-naslednym-pokracovanim-vo-forme-adjuvantnej-liecby-u-dospelych-s-trojnasobne-negativnym-karcinomom-prsnika\/","title":{"rendered":"39: Lie\u010divo pembrolizumab (Keytruda) v kombin\u00e1cii s chemoterapiou ako neoadjuvantn\u00e1 lie\u010dba s n\u00e1sledn\u00fdm pokra\u010dovan\u00edm vo forme adjuvantnej lie\u010dby u dospel\u00fdch s trojn\u00e1sobne negat\u00edvnym karcin\u00f3mom prsn\u00edka."},"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

    Trojn\u00e1sobne negat\u00edvny karcin\u00f3m prsn\u00edka (TNBC) patr\u00ed medzi agres\u00edvne typy n\u00e1dorov\u00e9ho ochorenia prsn\u00edka, ktor\u00fd postihuje \u010dastej\u0161ie pacientky v mlad\u0161om veku. S progresiou ochorenia kles\u00e1 miera vitality pacientok a \u010dasto s\u00fa odk\u00e1zan\u00e9 na pomoc rodinn\u00fdch pr\u00edslu\u0161n\u00edkov pri ka\u017edodenn\u00fdch aktivit\u00e1ch, najm\u00e4 po\u010das akt\u00edvnej lie\u010dby. Ochorenie tie\u017e negat\u00edvne vpl\u00fdva na psychick\u00fd stav pacientok a \u010dasto okrem lie\u010dby ochorenia potrebuj\u00fa vyh\u013eada\u0165 aj pomoc psychol\u00f3ga. <\/p>\n\n\n\n

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

      KEYTRUDA obsahuje lie\u010divo pembrolizumab, ktor\u00fd je monoklon\u00e1lna protil\u00e1tka. KEYTRUDA \u00fa\u010dinkuje tak, \u017ee pom\u00e1ha v\u00e1\u0161mu imunitn\u00e9mu syst\u00e9mu bojova\u0165 proti rakovine.<\/p>\n\n\n\n

      Liek KEYTRUDA bol pre hodnoten\u00fa indik\u00e1ciu registrovan\u00fd Eur\u00f3pskou liekovou agent\u00farou v m\u00e1ji 2022.<\/p>\n\n\n\n

        \n
      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ol>\n\n\n\n

        Pod\u013ea osloven\u00e9ho odborn\u00edka sa lie\u010dba pembrolizumabom v predmetnej indik\u00e1cii pova\u017euje v krajin\u00e1ch s kvalitnou zdravotnou starostlivos\u0165ou za dostupn\u00fa a \u0161tandardn\u00fa. S\u00fa\u010dasn\u00e1 situ\u00e1cia na Slovensku, ktor\u00e1 neumo\u017e\u0148uje predpisova\u0165 lie\u010dbu pembrolizumabom v indik\u00e1cii TNBC, vytv\u00e1ra tlak na onkol\u00f3gov zo strany pacientok, ktor\u00e9 s\u00fa o tejto lie\u010debnej mo\u017enosti informovan\u00e9 (napr\u00edklad z internetu). Naopak informovanie pacientok o tejto terapeutickej mo\u017enosti, av\u0161ak bez \u00fahrady zdravotnou pois\u0165ov\u0148ou dost\u00e1va pacientky do psychologicky ve\u013emi zlej situ\u00e1cie rozhodnutia o \u00fahrade lie\u010dby z vlastn\u00fdch prostriedkov, v niektor\u00fdch pr\u00edpadoch s dopadom na \u010fal\u0161iu d\u00f4veru a vz\u0165ah s o\u0161etruj\u00facim lek\u00e1rom. Implement\u00e1cia hodnoten\u00e9ho lie\u010diva by pod\u013ea odborn\u00edka v\u00fdrazne zlep\u0161ila situ\u00e1ciu a posunula indik\u00e1ciu do medic\u00ednskej \u00farovne.<\/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 (Merck Sharp & Dohme B.V. (NLD)) podal \u017eiados\u0165 o zaradenie lie\u010diva pembrolizumab (Keytruda) v kombin\u00e1cii s chemoterapiou ako neoadjuvantn\u00e1 lie\u010dba s n\u00e1sledn\u00fdm pokra\u010dovan\u00edm vo forme adjuvantnej lie\u010dby u dospel\u00fdch s trojn\u00e1sobne negat\u00edvnym karcin\u00f3mom prsn\u00edka..<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Keytruda v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady a pokia\u013e bude v podmienkach zmluvy s dr\u017eite\u013eom registr\u00e1cie o podmienkach \u00fahrady lieku dostato\u010dne adresovan\u00e1 extr\u00e9mna neistota, \u017ee krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti nebud\u00fa splnen\u00e9.<\/p>\n\n\n\n

          Z\u00e1rove\u0148 NIHO odpor\u00fa\u010da prehodnoti\u0165 klinick\u00fd pr\u00ednos a n\u00e1kladov\u00fa efekt\u00edvnos\u0165 do troch rokov od roz\u0161\u00edrenia indika\u010dn\u00e9ho obmedzenia v Zozname kategorizovan\u00fdch liekov.<\/p>\n\n\n\n

          NIHO tie\u017e odpor\u00fa\u010da zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00e9ho obmedzenia o dobr\u00fd v\u00fdkonnostn\u00fd stav pacienta.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Keytruda v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady a pokia\u013e bude…<\/p>","protected":false},"author":3,"featured_media":1857,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[92,93],"class_list":["post-1907","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-keytruda","tag-pembrolizumab"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1907","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=1907"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1907\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1857"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1907"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1907"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1907"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}