{"id":1728,"date":"2022-09-16T18:55:00","date_gmt":"2022-09-16T16:55:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1728"},"modified":"2024-03-23T13:10:08","modified_gmt":"2024-03-23T12:10:08","slug":"liecivo-daratumumab-darzalex-3","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/liecivo-daratumumab-darzalex-3\/","title":{"rendered":"2C: Lie\u010divo daratumumab (Darzalex)\u00a0v subkut\u00e1nnom sp\u00f4sobe podania v monoterapii alebo v kombin\u00e1cii s bortezomibom a dexametaz\u00f3nom na lie\u010dbu pacientov s mnohopo\u010detn\u00fdm myel\u00f3mom v tretej alebo \u0161tvrtej l\u00ednii"},"content":{"rendered":"
    \n
  1. O ak\u00fd liek sa jedn\u00e1?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Darzalex (\u00fa\u010dinn\u00e1 l\u00e1tka daratumumab) je monoklon\u00e1lna protil\u00e1tka via\u017euca sa na typ prote\u00ednu, ktor\u00fd sa nach\u00e1dza vo ve\u013ek\u00fdch mno\u017estv\u00e1ch na n\u00e1dorov\u00fdch bunk\u00e1ch mnohopo\u010detn\u00e9ho myel\u00f3mu. Daratumumab br\u00e1ni rastu n\u00e1dorov\u00fdch buniek pomocou aktiv\u00e1cie imunitn\u00e9ho syst\u00e9mu. <\/p>\n\n\n\n

    Liek bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare (European Medicines Agency, EMA) v roku 2016 pre pacientov s recidivuj\u00facim alebo refrakt\u00e9rnym mnohopo\u010detn\u00fdm myel\u00f3mom. Postupne mu bola roz\u0161\u00edrovan\u00e1 indik\u00e1cia. V roku 2020 bola registr\u00e1cia vo v\u0161etk\u00fdch indik\u00e1ciach roz\u0161\u00edren\u00e1 aj na 1 800 mg balenie ur\u010den\u00e9 na injek\u010dn\u00e9 podanie. <\/p>\n\n\n\n

      \n
    1. \u010co je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako je z\u00e1sadn\u00e9?<\/strong><\/li>\n<\/ol>\n\n\n\n

      Mnopo\u010detn\u00fd myel\u00f3m je n\u00e1dorov\u00e9 ochorenie plazmatick\u00fdch buniek. <\/strong>N\u00e1sledkom ochorenia m\u00f4\u017ee doch\u00e1dza\u0165 k \u00fatlaku fyziologickej krvotvorby a po\u0161kodeniam kostry osteolytick\u00fdmi l\u00e9ziami, n\u00edzkou kostnou hmotou a patologick\u00fdmi zlomeninami.<\/p>\n\n\n\n

      Na Slovensku pribudne pribli\u017ene 330 novodiagnostikovan\u00fdch pacientov ro\u010dne. Mnohopo\u010detn\u00fd myel\u00f3m je vo v\u00fdraznej v\u00e4\u010d\u0161ine pr\u00edpadov diagnostikovan\u00fd u pacientov vo vy\u0161\u0161om veku, medi\u00e1nov\u00fd vek v \u010dase diagnostiky je okolo 65 \u2013 70 rokov. V\u0161etci pacienti s potvrdenou diagn\u00f3zou si vy\u017eaduj\u00fa lie\u010dbu, bez lie\u010dby je medi\u00e1n pre\u017e\u00edvania u symptomatick\u00fdch pacientov 6 mesiacov.<\/p>\n\n\n\n

      OZ Lymfoma a Leuk\u00e9mia Slovensko na z\u00e1klade rozhovorov s pacientmi uv\u00e1dza, \u017ee pacienti pri prvom kontakte nav\u0161t\u00edvili najm\u00e4 neurologick\u00fa, p\u013e\u00facnu, kardiologick\u00fa a gastroenterologick\u00fa ambulanciu. Proces diagnostiky trval do 6 mesiacov. Pacienti poci\u0165ovali pr\u00edznaky ochorenia u\u017e 1-3 roky pred diagnostikovan\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

        Na z\u00e1klade svojej anal\u00fdzy NIHO odpor\u00fa\u010da nevyhovie\u0165<\/strong> \u017eiadosti o kategorizovanie lieku Darzalex v injek\u010dnom<\/strong> sp\u00f4sobe podania v monoterapii alebo v kombin\u00e1cii s bortezomibom a dexametaz\u00f3nom na lie\u010dbu pacientov s mnohopo\u010detn\u00fdm myel\u00f3mom v tretej alebo \u0161tvrtej l\u00ednii, pokia\u013e dr\u017eite\u013e registr\u00e1cie neuprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady<\/strong> tak, aby s\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti pod\u013ea \u00a77 z\u00e1kona 363\/2011 Z.z..<\/p>\n\n\n\n

        Lie\u010divo daratumumab je aktu\u00e1lne zaraden\u00e9 v zozname kategorizovan\u00fdch liekov (ZKL) vo forme <\/strong>podania inf\u00faziou<\/strong>. Dr\u017eite\u013e registr\u00e1cie pri anal\u00fdze minimaliz\u00e1cie n\u00e1kladov nezoh\u013eadnil existenciu doh\u00f4d so zdravotn\u00fdmi pois\u0165ov\u0148ami pri baleniach pre inf\u00fazie, ktor\u00e9 v praxi ved\u00fa k ni\u017e\u0161\u00edm n\u00e1kladom na pacienta, ako predpokladal dr\u017eite\u013e registr\u00e1cie. Ke\u010f sa t\u00e1to skuto\u010dnos\u0165 zoh\u013eadn\u00ed, \u017eiadan\u00e1 \u00fahrada nesp\u013a\u0148a podmienku n\u00e1kladovej efekt\u00edvnosti.<\/p>","protected":false},"excerpt":{"rendered":"

        Na z\u00e1klade svojej anal\u00fdzy NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Darzalex v injek\u010dnom sp\u00f4sobe podania v monoterapii alebo v kombin\u00e1cii s bortezomibom a dexametaz\u00f3nom na lie\u010dbu pacientov s mnohopo\u010detn\u00fdm myel\u00f3mom v tretej alebo \u0161tvrtej l\u00ednii, pokia\u013e dr\u017eite\u013e registr\u00e1cie neuprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby s\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti <\/p>","protected":false},"author":3,"featured_media":1720,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[15,14],"class_list":["post-1728","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-daratumumab","tag-darzalex"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1728","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=1728"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1728\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1720"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1728"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1728"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1728"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}