{"id":1785,"date":"2023-01-13T13:48:00","date_gmt":"2023-01-13T12:48:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1785"},"modified":"2024-03-30T13:57:01","modified_gmt":"2024-03-30T12:57:01","slug":"liecivo-tafamidis-vyndaqel-na-liecbu-dospelych-pacientov-s-transtyretinovou-amyloidozou-divokeho-typu-wild-type-s-kardiomyopatiou-wtattr-cm","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/liecivo-tafamidis-vyndaqel-na-liecbu-dospelych-pacientov-s-transtyretinovou-amyloidozou-divokeho-typu-wild-type-s-kardiomyopatiou-wtattr-cm\/","title":{"rendered":"14: Lie\u010divo tafamidis (Vyndaqel) na lie\u010dbu dospel\u00fdch pacientov s transtyret\u00ednovou amyloid\u00f3zou divok\u00e9ho typu (wild type) s kardiomyopatiou (wtATTR-CM)"},"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

    Transtyret\u00ednov\u00e1 amyloid\u00f3za divok\u00e9ho typu s kardiomyopatiou (wtATTR-CM) je zriedkav\u00e9, nevylie\u010dite\u013en\u00e9 ochorenie, ktor\u00e9 vytv\u00e1ra ve\u013ek\u00fa z\u00e1\u0165a\u017e na pacientov po fyzickej aj psychickej str\u00e1nke a skracuje ich pre\u017e\u00edvanie. S postupom ochorenia kles\u00e1 pacientom miera pohyblivosti a vitality. Ochorenie m\u00e1 tie\u017e \u010dasto v\u00fdrazn\u00fd dopad na bl\u00edzkych pacienta, ke\u010f\u017ee vznik\u00e1 potreba pom\u00e1ha\u0165 so starostlivos\u0165ou o pacienta a jeho dom\u00e1cnos\u0165. Moment\u00e1lne pre pacientov s t\u00fdmto ochoren\u00edm nie je k dispoz\u00edcii \u017eiadna farmakologick\u00e1 lie\u010dba, okrem podpornej symptomatickej.<\/p>\n\n\n\n

    V s\u00fa\u010dasnosti nie s\u00fa zn\u00e1me konkr\u00e9tne rizikov\u00e9 faktory pre rozvoj wtATTR-CM. Ke\u010f\u017ee ochorenie postihuje naj\u010dastej\u0161ie mu\u017eov vo veku nad 65 rokov, odborn\u00edci predpokladaj\u00fa, \u017ee vek a pohlavie m\u00f4\u017eu by\u0165 jedn\u00fdm z hlavn\u00fdch rizikov\u00fdch faktorov tohto ochorenia. V s\u00fa\u010dasnosti nie je na Slovensku hraden\u00e1 \u017eiadna \u0161pecifick\u00e1 terapia na lie\u010dbu wtATTR-CM.<\/p>\n\n\n\n

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

      Dr\u017eite\u013e registr\u00e1cie lieku (Pfizer Europe) predpoklad\u00e1 pr\u00ednos v redukcii celkovej mortality a po\u010dtu hospitaliz\u00e1ci\u00ed pacientov zo srdcovo-cievnych pr\u00ed\u010din, a to prostredn\u00edctvom pr\u00ednosu v d\u013a\u017eke celkov\u00e9ho pre\u017e\u00edvania. Z\u00e1rove\u0148 predpoklad\u00e1 zlep\u0161enie kvality \u017eivota pacienta dosiahnut\u00edm lep\u0161ieho sk\u00f3re v 6 min\u00fatovom teste ch\u00f4dze.<\/p>\n\n\n\n

      Lie\u010divo tafamidis preuk\u00e1zalo v oboch klinick\u00fdch \u0161t\u00fadi\u00e1ch \u0161tatisticky v\u00fdznamn\u00e9 a klinicky relevantn\u00e9 pr\u00ednosy, pri\u010dom celkov\u00e1 tolerovate\u013enos\u0165 lie\u010dby bola relat\u00edvne dobr\u00e1 a pr\u00edtomnos\u0165 ne\u017eiad\u00facich \u00fa\u010dinkov bola porovnate\u013en\u00e1 s placebom.<\/p>\n\n\n\n

      Lie\u010dba pacientov sa m\u00e1 za\u010da\u0165 pod doh\u013eadom odborn\u00e9ho lek\u00e1ra so sk\u00fasenos\u0165ami v lie\u010dbe pacientov s amyloid\u00f3zou alebo kardiomyopatiou. Odpor\u00fa\u010dan\u00e1 d\u00e1vka je jedna kapsula Vyndaqelu 61 mg (tafamidis) pod\u00e1van\u00e1 \u00fastne jedenkr\u00e1t denne.<\/p>\n\n\n\n

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

        Odborn\u00edk, ktor\u00e9ho oslovilo NIHO uviedol, \u017ee moment\u00e1lne pre v\u0161etk\u00fdch pacientov s wtATTR-CM nie je k dispoz\u00edcii \u017eiadna farmakologick\u00e1 lie\u010dba (okrem podpornej symptomatickej lie\u010dby), ktor\u00fa z\u00e1rove\u0148 pova\u017euje za nedostato\u010dn\u00fa. Hraden\u00edm predmetnej technol\u00f3gie by sa t\u00fdm p\u00e1dom spr\u00edstupnila nov\u00e1 a \u00fa\u010dinn\u00e1 lie\u010dba pre v\u0161etk\u00fdch pacientov s predmetn\u00fdm ochoren\u00edm.<\/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 navrhuje, aby bola hraden\u00e1 lie\u010dba dospel\u00fdm pacientom s transtyret\u00ednovou amyloid\u00f3zou divok\u00e9ho typu (wild type) s kardiomyopatiou (ATTR-CM).<\/p>\n\n\n\n

          Na Slovensku po\u017eaduje kategoriz\u00e1ciu balenia 61 mg vo forme m\u00e4kk\u00fdch kaps\u00fal ur\u010den\u00fdch na \u00fastne podanie, pri\u010dom sa m\u00e1 pod\u00e1va\u0165 jedna kapsula jedenkr\u00e1t denne. <\/p>\n\n\n\n

          N\u00e1vrh maxim\u00e1lnej v\u00fd\u0161ky \u00fahrady zdravotnej pois\u0165ovne za liek Vyndaqel 61 mg, ktor\u00fd bol odvoden\u00fd od eur\u00f3pskej referen\u010dnej ceny lieku bol stanoven\u00fd na sumu 9 423,97 EUR.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da nevyhovie\u0165 <\/strong>\u017eiadosti o kategorizovanie lieku Vyndaqel, pokia\u013e:<\/p>\n\n\n\n

            \n
          1. ned\u00f4jde k \u00faprave podmienok hradenia na z\u00e1klade odporu\u010dan\u00ed NIHO<\/li>\n\n\n\n
          2. a z\u00e1rove\u0148 dr\u017eite\u013e registr\u00e1cie neposkytne z\u013eavu vo v\u00fd\u0161ke, ktor\u00fa navrhuje NIHO, aby:\n
              \n
            • boli splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti pod\u013ea \u00a77 z\u00e1kona 363\/2011 Z.z..<\/li>\n\n\n\n
            • bola zoh\u013eadnen\u00e1 mierne ve\u013ek\u00e1 neistota, ktor\u00e1 vypl\u00fdva najm\u00e4 zo sp\u00f4sobu v\u00fdpo\u010dtu mortality a z metodick\u00fdch riz\u00edk<\/li>\n<\/ul>\n<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"

              NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Vyndaqel, pokia\u013e…<\/p>","protected":false},"author":3,"featured_media":1786,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[61,60],"class_list":["post-1785","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-tafamidis","tag-vyndaqel"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1785","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=1785"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1785\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1786"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1785"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1785"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1785"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}