{"id":1853,"date":"2016-07-10T16:40:31","date_gmt":"2016-07-10T15:40:31","guid":{"rendered":"http:\/\/slanedeti.sk\/cms\/?p=1853"},"modified":"2016-07-10T16:40:31","modified_gmt":"2016-07-10T15:40:31","slug":"kalydeco-a-orkambi-prichadzaju-do-europy","status":"publish","type":"post","link":"https:\/\/slanedeti.sk\/cms\/kalydeco-a-orkambi-prichadzaju-do-europy\/1853","title":{"rendered":"Kalydeco a Orkambi prich\u00e1dzaj\u00fa do Eur\u00f3py"},"content":{"rendered":"

Na americk\u00fd a eur\u00f3psky trh boli uveden\u00e9 nov\u00e9 lieky, ktor\u00e9 ako prv\u00e9 ovplyv\u0148uj\u00fa z\u00e1kladn\u00fd defekt CF a znamenaj\u00fa jeden z historick\u00fdch prielomov v lie\u010dbe ochorenia. Jedn\u00e1 sa o Kalydeco (ivakaftor) a Orkambi (kombin\u00e1cia lumakaftoru a ivakaftoru). O ich v\u00fdvoji sme V\u00e1s priebe\u017ene <\/span>informovali na na\u0161ej str\u00e1nke<\/span><\/a>. Oba lieky vyvinula americk\u00e1 farmaceutick\u00e1 spolo\u010dnos\u0165 Vertex a maj\u00fa podobn\u00e9 farmakologick\u00e9 vlastnosti. Kalydeco m\u00f4\u017eu u\u017e\u00edva\u0165 pacienti, ktor\u00ed maj\u00fa jednu zo vz\u00e1cnej\u0161\u00edch CF mut\u00e1ci\u00ed (G551D, G1244E, G1349D, G178R, G551S, S1251N, S549N, S549R, R117H), celkov\u00fd po\u010det pacientov pre ktor\u00fdch je Kalydeco vhodn\u00e9 je n\u00edzky. Oproti tomu Orkambi \u00fa\u010dinkuje u pacientov, ktor\u00ed maj\u00fa dve k\u00f3pie mut\u00e1cie F508del, \u010do je naj\u010dastej\u0161ia kombin\u00e1cia v CF popul\u00e1cii. V klinickej praxi sa potvrdila \u00fa\u010dinnos\u0165 liekov, probl\u00e9mom ich \u0161ir\u0161ieho pou\u017eitia (v Eur\u00f3pe) je ich vysok\u00e1 cena. Teraz prin\u00e1\u0161ame inform\u00e1cie o s\u00fa\u010dasnom stave a vyhliadkach, ak\u00e9 maj\u00fa pacienti v Eur\u00f3pe re\u00e1lne sa dosta\u0165 k tejto lie\u010dbe.<\/span><\/p>\n

Kalydeco<\/b><\/p>\n

Kalydeco z\u00edskalo schv\u00e1lenie FDA (americk\u00fd \u00darad pre potraviny a lieky) pre uvedenie na americk\u00fd trh v janu\u00e1ri 2012 a v Eur\u00f3pe odpor\u00fa\u010danie od EMA (Eur\u00f3pska liekov\u00e1 agent\u00fara) v m\u00e1ji 2012. Vertex stanovil v USA cenu pre Kalydeco na \u00farovni 311 000 dol\u00e1rov za ro\u010dn\u00fa lie\u010dbu, \u010do z neho spravilo v\u00f4bec jeden z najdrah\u0161\u00edch liekov na svete. Pri stanoven\u00ed ceny sa vych\u00e1dzalo z farmakoekonomick\u00e9ho parametra QALY (quality adjusted life year), liek by mal ma\u0165 porovnate\u013en\u00e9 finan\u010dn\u00e9 n\u00e1klady na rovnak\u00e9 zlep\u0161enie kvality \u017eivota ako lieky pri in\u00fdch vz\u00e1cnych ochoreniach (\u00fadajne boli ako \u0161tandard stanoven\u00e9 n\u00e1klady na lie\u010dbu Gaucherovej choroby). Ekonomick\u00fdm zd\u00f4vodnen\u00edm extr\u00e9mne vysok\u00fdch cien liekov pre vz\u00e1cne ochorenia s\u00fa vysok\u00e9 n\u00e1klady na v\u00fdskum, ktor\u00e9 musia by\u0165 splaten\u00e9 pri n\u00edzkom po\u010dte pacientov. Vertex tvrd\u00ed, \u017ee do v\u00fdvoja liekov na CF investoval miliardy dol\u00e1rov. \u00a0Firma mala takmer neust\u00e1le finan\u010dn\u00e9 straty a invest\u00edcie sa m\u00f4\u017eu vr\u00e1ti\u0165 \u00fadajne iba v\u010faka Kalydecu a Orkambi. Z\u00e1rove\u0148 prezentuje cie\u013e v\u00fdvoja lie\u010dby pre v\u0161etky relevantn\u00e9 CF mut\u00e1cie pribli\u017ene do roku 2020. Tak\u00e9to vysvetlenie nie je pre mnoh\u00fdch odborn\u00edkov posta\u010duj\u00face a cena t\u00fdchto liekov vyvolala <\/span>nemal\u00e9 rozhor\u010denie<\/span><\/a>, jedn\u00fdm z najv\u00fdznamnej\u0161\u00edch kritikov je ved\u00faci odborn\u00edk na CF, profesor Paul Quinton. Kritici pripom\u00ednaj\u00fa, \u017ee v\u00fdskum CF podporila z verejn\u00fdch zdrojov aj americk\u00e1 vl\u00e1da a nad\u00e1cia Cystic Fibrosis Foundation (CFF), ktor\u00e1 poskytla 150 mili\u00f3nov dol\u00e1rov. V zmluvn\u00fdch podmienkach poskytnutia pr\u00edspevku CFF bolo v\u0161ak aj nadobudnutie podielu z predaja lieku, ak bude \u00a0uveden\u00fd na trh a t\u00fdm, \u017ee CFF tieto pr\u00e1va n\u00e1sledne so ziskom predala dosiahla dvojn\u00e1sobn\u00fd osoh. Napriek vysokej cene viacer\u00e9 eur\u00f3pske krajiny schv\u00e1lili \u00fahradu Kalydeca zo zdrojov zdravotn\u00e9ho poistenia. Pacienti maj\u00fa pr\u00edstup ku Kalydecu napr\u00edklad v Brit\u00e1nii. National Institute for Health and Care Excellence (NICE), ktor\u00e1 posudzovala \u00fahradu lieku, v tomto pr\u00edpade akceptovala vy\u0161\u0161iu \u00fahradu ako s\u00fa jej \u0161tandardy na z\u00e1klade farmakoekonomick\u00fdch parametrov. Je vhodn\u00e9 zd\u00f4razni\u0165, \u017ee po\u010det pacientov s mut\u00e1ciou G551D je n\u00edzky, Kalydeco u\u017e\u00edva v Brit\u00e1nii iba nieko\u013eko desiatok pacientov a teda dosah na celkov\u00e9 n\u00e1klady je obmedzen\u00fd. Tie\u017e klinick\u00fd pr\u00ednos Kalydeca je vy\u0161\u0161\u00ed ako je pri Orkambi. V \u010ceskej republike v s\u00fa\u010dasnosti prebiehaj\u00fa rokovania o \u00fahrade Kalydeca zdravotn\u00fdmi pois\u0165ov\u0148ami. Na Slovensku je <\/span>zast\u00fapenie mut\u00e1cie G551D v\u00fdrazne ni\u017e\u0161ie ako v \u010cR<\/span><\/a>.<\/span><\/p>\n

Orkambi<\/b><\/p>\n

Vertex pribli\u017ene pred dvoma rokmi zverejnil <\/span>v\u00fdsledky klinick\u00fdch \u0161t\u00fadii<\/span><\/a>, ktor\u00e9 boli n\u00e1sledne predlo\u017een\u00e9 ako s\u00fa\u010das\u0165 \u017eiadosti pre registr\u00e1ciu lieku. Liek bol schv\u00e1len\u00fd v USA v j\u00fali 2015 a v Eur\u00f3pe v novembri 2015. Cena lieku bola stanoven\u00e1 pre americk\u00fd trh na 259 000 dol\u00e1rov za ro\u010dn\u00fa lie\u010dbu. Napriek tejto vysokej sume boli za prv\u00fd \u0161tvr\u0165rok 2016 celkov\u00e9 predaje Orkambi 223 mili\u00f3nov dol\u00e1rov a pod\u013ea vyjadrenia spolo\u010dnosti Vertex u\u017e\u00edva Orkambi v USA <\/span>65 % pacientov, ktor\u00ed sp\u013a\u0148aj\u00fa indika\u010dn\u00e9 krit\u00e9ri\u00e1<\/span><\/a>. Predaje mimo USA boli v rovnakom obdob\u00ed 9 mili\u00f3nov dol\u00e1rov, pri\u010dom sa zrejme vz\u0165ahuj\u00fa v\u00fdlu\u010dne na Nemecko, v s\u00fa\u010dasnosti jedin\u00fa eur\u00f3psku krajinu, kde maj\u00fa pacienti na z\u00e1klade zdravotn\u00e9ho poistenia pr\u00edstup k Orkambi. Po schv\u00e1len\u00ed od EMA za\u010dal Vertex vyjedn\u00e1vania vo viacer\u00fdch eur\u00f3pskych krajin\u00e1ch o \u00fahrade lieku. Cena pon\u00faknut\u00e1 v Brit\u00e1nii bola pribli\u017ene o 40 % ni\u017e\u0161ia ako v USA, ponuka v\u0161ak bola zamietnut\u00e1. Podobn\u00fd <\/span>postoj zaujali \u00farady v \u00cdrsku<\/span><\/a>, pri\u010dom nazna\u010dili, \u017ee pre dosiahnutie dohody je potrebn\u00e9 v\u00fdrazn\u00e9 zn\u00ed\u017eenie ceny. Profesor Michael Berry, riadite\u013e National Centre for Pharmaeconomics sa vyjadril, \u017ee je potrebn\u00e9 5-n\u00e1sobn\u00e9 zn\u00ed\u017eenie ceny, \u010do by zodpovedalo pribli\u017ene sume 30 000 euro za ro\u010dn\u00fa lie\u010dbu. To je z\u00e1rove\u0148 pribli\u017en\u00e1 \u00farove\u0148, ktor\u00fa zrejme o\u010dak\u00e1va NICE vo Ve\u013ekej Brit\u00e1nii. Vo v\u0161eobecnosti vyjadrili z\u00e1stupcovia CF pacientov v \u00cdrsku nad rozhodnut\u00edm sklamanie. Na druhej strane sa zd\u00e1, \u017ee popri Nemecku bude s\u00fa\u010dasn\u00fa cenu akceptova\u0165 Rak\u00fasko a Franc\u00fazsko, kde sa pl\u00e1nuje obmedzen\u00fd pr\u00edstup pacientov k lieku na z\u00e1klade \u0161peci\u00e1lneho programu. Vertex v s\u00fa\u010dasnosti pl\u00e1nuje a pripravuje podania \u017eiadost\u00ed o zaradenie Orkambi medzi lieky hraden\u00e9 na z\u00e1klade zdravotn\u00e9ho poistenia (kategoriz\u00e1cie) v \u010ceskej aj Slovenskej republike.<\/span><\/p>\n

Lumakaftor a ivakaftor dobre ilustruj\u00fa trend vo v\u00fdvoji inovat\u00edvnych liekov \u2013 s\u00fa cielen\u00e9 na konkr\u00e9tne mut\u00e1cie (n\u00e1stup farmakogenetiky) a extr\u00e9mne drah\u00e9. Ceny liekov v\u017edy bud\u00fa ve\u013emi citliv\u00e1 t\u00e9ma, kde je nemo\u017en\u00e9 posudzova\u0165 iba ich ekonomick\u00fa hodnotu, preto\u017ee s\u00favisia s hodnotou \u017eivota. Na druhej strane ekonomick\u00e9 mo\u017enosti s\u00fa v\u017edy limituj\u00face. Ceny liekov s\u00fa vo v\u0161eobecnosti v USA vy\u0161\u0161ie ako v Eur\u00f3pe, v r\u00e1mci EU trhu nie s\u00fa medzi krajinami pre jeden konkr\u00e9tny pr\u00edpravok pr\u00edli\u0161 ve\u013ek\u00e9 rozdiely a \u010dasom m\u00e1 cena inovat\u00edvneho lieku tendenciu klesa\u0165 (najviac v obdob\u00ed uplynutia tzv. ochrannej doby, ke\u010f m\u00f4\u017eu za\u010da\u0165 liek vyr\u00e1ba\u0165 generick\u00ed v\u00fdrobcovia, v EU je to 11 rokov). <\/span><\/p>\n

S\u00fa\u010dasn\u00e9 ceny pre Kalydeco a Orkambi pova\u017eujem za prehnan\u00e9, resp. za pr\u00edli\u0161 vysok\u00e9, aby si ich mohli dovoli\u0165 chudobnej\u0161ie eur\u00f3pske krajiny. Ver\u00edm, \u017ee aj pacienti na Slovensku sa \u010dasom k t\u00fdmto liekom dostan\u00fa, aj ke\u010f to m\u00f4\u017ee trva\u0165 e\u0161te aj nieko\u013eko rokov. Ve\u013ea z\u00e1vis\u00ed od v s\u00fa\u010dasnosti prebiehaj\u00facich rokovan\u00ed o \u00fahrad\u00e1ch v jednotliv\u00fdch \u0161t\u00e1toch. Aj ke\u010f pacientske asoci\u00e1cie v Brit\u00e1nii, \u00cdrsku pr\u00edjmaj\u00fa s nev\u00f4\u013eou zamietnutie \u00fahrad zo zdravotn\u00e9ho poistenia, mysl\u00edm si, \u017ee prv\u00fd krok by mal by\u0165 na strane Vertexu, teda pon\u00faknu\u0165 realistick\u00fa cenu. Cena 30 000 euro\/rok ako navrhuje \u00cdrsky \u00farad pre farmakoekonomiku by d\u00fafam bola prijate\u013en\u00e1 v r\u00e1mci v\u0161etk\u00fdch kraj\u00edn EU. Vertex v\u0161ak v s\u00fa\u010dasnosti nem\u00e1 ve\u013ea d\u00f4vodov pon\u00faka\u0165 vysok\u00e9 \u00fa\u013eavy, ke\u010f\u017ee sa mu podarilo presadi\u0165 liek v Nemecku. Ak by v\u00fdrazne zn\u00ed\u017eil cenu vznikol by tlak na redukciu ceny aj na americkom trhu, ktor\u00fd je pre firmu k\u013e\u00fa\u010dov\u00fd. V s\u00favislosti s cenou lieku je vhodn\u00e9 pripomen\u00fa\u0165, \u017ee n\u00e1klady na lie\u010dbu ivakaftorom, lumakaftorom s\u00fa re\u00e1lne ni\u017e\u0161ie, ke\u010f\u017ee ved\u00fa k zn\u00ed\u017eeniu n\u00e1kladov na \u010fa\u013e\u0161iu lie\u010dbu (v priemere o 35% menej hospitaliz\u00e1cii, oddialeniu alebo zamedzeniu n\u00e1stupu komplik\u00e1cii ochorenia), ako aj vy\u0161\u0161ej ekonomickej produktivite pacientov.<\/span><\/p>\n

Je to samozrejme aj \u00faloha pre pacientske zdru\u017eenia zastupuj\u00face CF pacientov, aby ke\u010f na to pr\u00edde vhodn\u00fd \u010das, akt\u00edvne v r\u00e1mci svojich mo\u017enost\u00ed podporili pr\u00edstup pacientov k lie\u010dbe. V\u00fdskum ivakaftoru\/lumakaftoru pokra\u010duje \u010falej a zatia\u013e jedinou mo\u017enos\u0165ou ako sa mal\u00e1 \u010das\u0165 pacientov m\u00f4\u017ee dosta\u0165 k t\u00fdmto liekom je z\u00fa\u010dastni\u0165 sa klinickej \u0161t\u00fadie. V s\u00fa\u010dasnosti tak v \u010cR zop\u00e1r pacientov Orkambi u\u017e\u00edva. Orkambi je ur\u010den\u00e9 pre pacientov star\u0161\u00edch ako 12 rokov, t\u00e1to hranica bude zrejme v doh\u013eadnej dobe zn\u00ed\u017een\u00e1 na 6 rokov, ke\u010f\u017ee FDA posudzuje nov\u00e9 klinick\u00e9 \u0161t\u00fadie u det\u00ed. Podobn\u00fa \u017eiados\u0165 na zn\u00ed\u017eenie veku potrebn\u00e9ho pre u\u017e\u00edvanie Orkambi pl\u00e1nuje Vertex poda\u0165 v Eur\u00f3pe v prvej polovici roka 2017. <\/span><\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Na americký a európsky trh boli uvedené nové lieky, ktoré ako prvé ovplyvňujú základný defekt CF a znamenajú jeden z historických prielomov v liečbe ochorenia. Jedná sa o Kalydeco (ivakaftor) a Orkambi (kombinácia lumakaftoru a ivakaftoru). O ich vývoji sme … Continued<\/a><\/p>\n","protected":false},"author":7,"featured_media":1854,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"kt_blocks_editor_width":"","footnotes":""},"categories":[3],"tags":[],"class_list":["post-1853","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lieky-a-liecba"],"yoast_head":"\nKalydeco a Orkambi prich\u00e1dzaj\u00fa do Eur\u00f3py - Slan\u00e9 deti<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/slanedeti.sk\/cms\/kalydeco-a-orkambi-prichadzaju-do-europy\/1853\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kalydeco a Orkambi prich\u00e1dzaj\u00fa do Eur\u00f3py - Slan\u00e9 deti\" \/>\n<meta property=\"og:description\" content=\"Na americký a európsky trh boli uvedené nové lieky, ktoré ako prvé ovplyvňujú základný defekt CF a znamenajú jeden z historických prielomov v liečbe ochorenia. Jedná sa o Kalydeco (ivakaftor) a Orkambi (kombinácia lumakaftoru a ivakaftoru). 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