{"id":1904,"date":"2023-06-14T15:41:00","date_gmt":"2023-06-14T13:41:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1904"},"modified":"2024-04-10T15:47:10","modified_gmt":"2024-04-10T13:47:10","slug":"38-liecivo-ivakaftor-tezakaftor-a-elexakaftor-kaftrio-v-kombinacii-s-ivakaftorom-kalydeco-na-liecbu-pacientov-s-cystickou-fibrozou-cf-ktori-maju-minimalne-jednu-mutaciu-f508del-na-gene-pre-t","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/38-liecivo-ivakaftor-tezakaftor-a-elexakaftor-kaftrio-v-kombinacii-s-ivakaftorom-kalydeco-na-liecbu-pacientov-s-cystickou-fibrozou-cf-ktori-maju-minimalne-jednu-mutaciu-f508del-na-gene-pre-t\/","title":{"rendered":"38: Lie\u010divo ivakaftor, tezakaftor a elexakaftor (Kaftrio) v kombin\u00e1cii s ivakaftorom (Kalydeco), na lie\u010dbu pacientov s cystickou fibr\u00f3zou (CF), ktor\u00ed maj\u00fa minim\u00e1lne jednu mut\u00e1ciu F508del na g\u00e9ne pre transmembr\u00e1nov\u00fd regul\u00e1tor vodivosti pri CF"},"content":{"rendered":"<p class=\"has-custom-highlight-background-color has-background\"><strong>NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Kaftrio<\/strong> v kombin\u00e1cii s Kalydecom, na lie\u010dbu pacientov s cystickou fibr\u00f3zou (CF), ktor\u00ed maj\u00fa minim\u00e1lne jednu mut\u00e1ciu F508del na g\u00e9ne pre transmembr\u00e1nov\u00fd regul\u00e1tor vodivosti pri CF. <strong>\u017diados\u0165 nesp\u013a\u0148a legislat\u00edvne po\u017eiadavky stanoven\u00e9 vyhl\u00e1\u0161kou 422\/2011 Z.z. Ministerstva zdravotn\u00edctva Slovenskej republiky <\/strong>o podrobnostiach farmako-ekonomick\u00e9ho rozboru lieku.<\/p>\n\n\n\n<p><strong>Od\u00f4vodnenie:<\/strong><\/p>\n\n\n\n<p>Dr\u017eite\u013e registr\u00e1cie (DR) predlo\u017eil farmako-ekonomick\u00fd model, ktor\u00fd nesp\u013a\u0148a po\u017eadovan\u00e9 n\u00e1le\u017eitosti vo viacer\u00fdch bodoch. DR ani po v\u00fdzve v zmysle ustanovenia \u00a7 75 ods. 9 z\u00e1kona \u010d. 363\/2011 Z. z. nezrovnalosti neodstr\u00e1nil. Liek s oh\u013eadom na \u00a716 ods. 4, p\u00edsm h) preto nem\u00f4\u017ee by\u0165 zaraden\u00fd do kategoriz\u00e1cie. Za najpodstatnej\u0161ie nedostatky predlo\u017een\u00e9ho modelu (ktor\u00fd je podkladom pre rozbor) pova\u017eujeme najm\u00e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Diskontn\u00e1 sadzba nastaven\u00e1 v rozpore s \u00a71 ods. 1 p\u00edsm. g) vyhl\u00e1\u0161ky 422\/2011 Z.z.,<\/li>\n\n\n\n<li>Porovnanie s kompar\u00e1torom v rozpore \u00a71 ods. 2 vyhl\u00e1\u0161ky 422\/2011 Z.z.,<\/li>\n\n\n\n<li>Uvedenie n\u00e1kladov na liek Kaftrio v kombin\u00e1cii s Kalydecom v rozpore s \u00a71 ods. 1 p\u00edsm. c) vyhl\u00e1\u0161ky 422\/2011 Z.z.,<\/li>\n\n\n\n<li>Uvedenie \u00fahrad liekov v rozpore s \u00a71 ods. 1 p\u00edsm. c) vyhl\u00e1\u0161ky 422\/2011 Z.z.,<\/li>\n\n\n\n<li>Nepreuk\u00e1zan\u00fd predpoklad zn\u00ed\u017eenia ceny v bud\u00facnosti a teda rozpor s \u00a71 ods. 1 p\u00edsm. i) vyhl\u00e1\u0161ky 422\/2011 Z.z. a<\/li>\n\n\n\n<li>Ne\u0161tandardn\u00fd predlo\u017een\u00fd model neumo\u017e\u0148uje overenie a teda je v rozpore s \u00a7 1 ods. 1 p\u00edsm. l) vyhl\u00e1\u0161ky 422\/2011 Z.z..<\/li>\n<\/ul>\n\n\n\n<p>Nesplnenie krit\u00e9ri\u00ed kategoriz\u00e1cie bolo zisten\u00e9 u\u017e v skorej f\u00e1ze hodnotenia NIHO. Za cie\u013eom efekt\u00edvneho vyu\u017e\u00edvania person\u00e1lnych kapac\u00edt v zdravotn\u00edctve sme preto v tomto hodnoten\u00ed nepublikovali projektov\u00fd protokol a nekontaktovali odborn\u00edkov ani pacientske organiz\u00e1cie.<\/p>","protected":false},"excerpt":{"rendered":"<p>IHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Kaftrio v kombin\u00e1cii s Kalydecom&#8230;<\/p>","protected":false},"author":3,"featured_media":1905,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[113,111,114,115,112],"class_list":["post-1904","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-elexakaftor","tag-ivakaftor","tag-kaftrio","tag-kalydeco","tag-tezakaftor"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1904","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1904"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1904\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1905"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1904"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1904"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1904"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}