{"id":1920,"date":"2023-10-31T16:18:00","date_gmt":"2023-10-31T15:18:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1920"},"modified":"2024-04-10T16:22:31","modified_gmt":"2024-04-10T14:22:31","slug":"43a-liecivo-ekulizumab-soliris-na-liecbu-pacientov-s-refrakternou-generalizovanou-myasteniou-gravis","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/43a-liecivo-ekulizumab-soliris-na-liecbu-pacientov-s-refrakternou-generalizovanou-myasteniou-gravis\/","title":{"rendered":"43A: Lie\u010divo ekulizumab (Soliris) na lie\u010dbu pacientov s refrakt\u00e9rnou generalizovanou myast\u00e9niou gravis"},"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

    Generalizovan\u00e1 MG (gMG) je autoimunitn\u00e9 neuromuskul\u00e1rne ochorenie charakterizovan\u00e9 fluktuuj\u00facou motorickou slabos\u0165ou, pri ktorej s\u00fa postihnut\u00e9 v\u0161etky svaly ovl\u00e1dan\u00e9 v\u00f4\u013eou. Refrakt\u00e9rna gMG je definovan\u00e1 ako MG, ktorej status je nezmenen\u00fd alebo zhor\u0161en\u00fd po lie\u010dbe kortikosteroidmi a najmenej 2 \u010fal\u0161\u00edmi imunosupres\u00edvami, ktor\u00e9 sa pou\u017e\u00edvaj\u00fa v primeran\u00fdch d\u00e1vkach po\u010das ur\u010ditej doby, s pretrv\u00e1vaj\u00facimi sympt\u00f3mami alebo z\u00e1va\u017en\u00fdmi ne\u017eiaducimi udalos\u0165ami. Je to ojedinel\u00e9 ochorenie, ktor\u00e9 negat\u00edvne vpl\u00fdva na psychick\u00fd stav pacientov. Pacienti s nestabiln\u00fdm ochoren\u00edm maj\u00fa probl\u00e9my s \u00fanavou, motorikou, s\u00fa odk\u00e1zan\u00ed na pomoc najbli\u017e\u0161\u00edch, s\u00fa pr\u00e1ceneschopn\u00ed. Stabiliz\u00e1cia ochorenia by mohla vies\u0165 k n\u00e1vratu do be\u017en\u00e9ho \u017eivota s mal\u00fdmi obmedzeniami.<\/p>\n\n\n\n

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

      Soliris obsahuje lie\u010divo ekulizumab a patr\u00ed do liekovej triedy naz\u00fdvanej monoklon\u00e1lne protil\u00e1tky. Ekulizumab sa via\u017ee na \u0161pecifick\u00fd prote\u00edn v tele, ktor\u00fd sp\u00f4sobuje z\u00e1pal a inhibuje ho a tak zabra\u0148uje syst\u00e9mom tela atakova\u0165 a ni\u010di\u0165 zranite\u013en\u00e9 krvn\u00e9 bunky, obli\u010dky, svaly alebo o\u010dn\u00e9 nervy a miechu.<\/p>\n\n\n\n

      Soliris bol registrovan\u00fd v Eur\u00f3pskej \u00fanii pre hodnoten\u00fa indik\u00e1ciu v apr\u00edli 2007. N\u00e1sledne bola roz\u0161\u00edren\u00e1 registr\u00e1cia aj pre hodnoten\u00fa indik\u00e1ciu v roku 2017.<\/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

        Odborn\u00edk participuj\u00faci na tomto hodnoten\u00ed sa vyjadril, \u017ee aktu\u00e1lne hraden\u00e1 lie\u010dba nezodpoved\u00e1 najnov\u0161\u00edm medzin\u00e1rodn\u00fdm postupom. U lek\u00e1rov pracuj\u00facich s gMG pacientmi m\u00f4\u017ee nekategorizovanie Solirisu vies\u0165 k frustr\u00e1cii 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 (Alexion Europe SAS (FRA)) podal \u017eiados\u0165 o zaradenie lie\u010diva ekulizumab (Soliris) na lie\u010dbu pacientov s refrakt\u00e9rnou generalizovanou myast\u00e9niou gravis.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Soliris v predmetnej indik\u00e1ci\u00ed, pokia\u013e bud\u00fa splnen\u00e9 v\u0161etky nasleduj\u00face body:\u00a0<\/p>\n\n\n\n

            \n
          • Dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby splnila z\u00e1konn\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/li>\n\n\n\n
          • Bude \u0161pecifikovan\u00fd sp\u00f4sob \u00fahrady vakc\u00edny vo\u010di meningokokovej infekcii, ktor\u00e1 je povinn\u00e1 2 t\u00fd\u017edne pred za\u010dat\u00edm lie\u010dby Solirisom, a dr\u017eite\u013e registr\u00e1cie objasn\u00ed, k\u00fdm bude vakc\u00edna hraden\u00e1.\u00a0<\/li>\n\n\n\n
          • Indika\u010dn\u00e9 obmedzenie bude zmenen\u00e9 pod\u013ea n\u00e1vrhu NIHO.<\/li>\n<\/ul>\n\n\n\n

            Z\u00e1rove\u0148, aj pri uvedenej \u00fahrade je pr\u00edtomn\u00e1 vysok\u00e1 neistota, \u017ee krit\u00e9ria n\u00e1kladovej efekt\u00edvnosti nebud\u00fa v klinickej praxi splnen\u00e9. Neistota vypl\u00fdva najm\u00e4 z absencie d\u00f4kazu klinickej efektivity. NIHO preto odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>\n\n\n\n

            NIHO z\u00e1rove\u0148 odpor\u00fa\u010da zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00fdch centier do indika\u010dn\u00e9ho obmedzenia lieku.<\/p>","protected":false},"excerpt":{"rendered":"

            NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Soliris v predmetnej indik\u00e1ci\u00ed, pokia\u013e bud\u00fa splnen\u00e9 v\u0161etky nasleduj\u00face body…<\/p>","protected":false},"author":3,"featured_media":1921,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[120,119],"class_list":["post-1920","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-ekulizumab","tag-soliris"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1920","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=1920"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1920\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1921"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1920"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1920"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1920"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}