{"id":1760,"date":"2024-09-30T13:28:31","date_gmt":"2024-09-30T11:28:31","guid":{"rendered":"http:\/\/klubcf.sk\/?p=1760"},"modified":"2024-09-30T13:43:10","modified_gmt":"2024-09-30T11:43:10","slug":"stanovisko-pacientskych-organizacii-konani-o-liekoch-na-cysticku-fibrozu","status":"publish","type":"post","link":"https:\/\/klubcf.sk\/index.php\/2024\/09\/30\/stanovisko-pacientskych-organizacii-konani-o-liekoch-na-cysticku-fibrozu\/","title":{"rendered":"Stanovisko pacientskych organiz\u00e1ci\u00ed do konan\u00ed o liekoch na cystick\u00fa fibr\u00f3zu"},"content":{"rendered":"

Stanovisko pacientskych organiz\u00e1ci\u00ed do konan\u00ed o liekoch na cystick\u00fa fibr\u00f3zu \u010d\u00edslo<\/strong>
\n32704, 32705, 32706, 32707, 32708, 32709, 32710, 32711
\n(roz\u0161\u00edrenie indik\u00e1ci\u00ed pre pr\u00ed\u010dinn\u00fa lie\u010dbu na ochorenie cystick\u00e1 fibr\u00f3za,
\nhodnoten\u00e9 lie\u010div\u00e1 korektory a modul\u00e1tory).<\/p>\n

Ke\u010f\u017ee niektor\u00e9 vydan\u00e9 stanovisk\u00e1 v r\u00e1mci vy\u0161\u0161ie uveden\u00fdch konan\u00ed vylu\u010duj\u00fa \u010das\u0165 pacientov s ojedinel\u00fdm<\/strong>
\n ochoren\u00edm z pr\u00edstupu k lie\u010dbe v\u00fdlu\u010dne na z\u00e1klade finan\u010dn\u00e9ho krit\u00e9ria<\/strong>, ktor\u00e9 nadra\u010fuj\u00fa ako jedin\u00e9
\nvylu\u010duj\u00face krit\u00e9rium pre zaradenie lieku na ojedinel\u00e9 ochorenie (tzv. prahov\u00fa hodnotu, finan\u010dn\u00e9\/ n\u00e1kladov\u00e9
\nkrit\u00e9rium). Obmedzenie pr\u00edstupu zav\u00e1dzaj\u00fa priamo, ako odpor\u00fa\u010danie neroz\u0161\u00edri\u0165 indik\u00e1cie lie\u010dby a
\nnepriamo tak, \u017ee sa vy\u017eaduj\u00fa nesplnite\u013en\u00e9\u0301 podmienky pre posudzovanie lieku na ojedinel\u00e9 ochorenie,
\nktor\u00e9 s\u00fa v rozpore so zavedenou praxou a podmienkami uplat\u0148ovan\u00fdmi pre hodnotenie produktov na
\nzriedkav\u00e9 ochorenia (OMP) v r\u00e1mci E\u00da, sveta a v okolit\u00fdch krajin\u00e1ch.
\nKe\u010f\u017ee ojedinel\u00e9 ochorenia s\u00fa definovan\u00e9 pod\u013ea Nariadenia Rady a Parlamentu E\u00da \u010d. 141\/2000 ako \u017eivot
\nohrozuj\u00faci alebo chronick\u00fd stav, ktor\u00fd postihuje vo svojej prevalencii menej ne\u017e 5 z 10.000 obyvate\u013eov a toto
\nNariadenie \u010falej definuje, \u017ee tak\u00e9to ochorenie, je tak zriedkav\u00e9, \u017ee je potrebn\u00e9 vytvori\u0165\u030c incent\u00edvy a
\nodb\u00fara\u0165 administrat\u00edvne prek\u00e1\u017eky, aby sa k pacientom mohli dost\u00e1va\u0165 tieto tzv. ORPHAN medic\u00ednske
\nprodukty. Rovnak\u00fa filozofiu uplat\u0148uje USA od roku 1983 a Japonsko od roku 1993. Podmienky pre v\u00fdvoj a
\nvstup produktov na lie\u010dbu zriedkav\u00e9ho ochorenia sa maj\u00fa nastavi\u0165 tak, aby v\u0161etci pacienti mali rovnocenn\u00fa\u0301<\/strong>
\n \u0161ancu na pr\u00edstup k lie\u010dbe bez oh\u013eadu na ojedinelos\u0165 svojho ochorenia<\/strong>. Tento princ\u00edp zakotvuje legislat\u00edva
\nE\u00da a hodnotenie liekov na ojedinel\u00e9 ochorenia v\u00fdlu\u010dne na z\u00e1klade po\u017eiadavky preuk\u00e1za\u0165 n\u00e1kladov\u00fa
\nefekt\u00edvnos\u0165 sa pova\u017euje za diskrimina\u010dn\u00e9 vo\u010di pacientom s ojedinel\u00fdm ochoren\u00edm, ke\u010f\u017ee im br\u00e1ni v
\npr\u00edstupe k lie\u010dbe. \u010casto sa pritom jedn\u00e1 o lie\u010dbu s neexistuj\u00facou alternat\u00edvou a nenaplnenou medic\u00ednskou<\/strong>
\n potrebou, \u010do je aj tento hodnoten\u00fd pr\u00edpad.<\/strong>
\nKe\u010f\u017ee krit\u00e9rium prahovej hodnoty a povinnos\u0165 preuk\u00e1za\u0165 n\u00e1kladov\u00fa efekt\u00edvnos\u0165 sa v zau\u017e\u00edvanej praxi
\nv r\u00e1mci EU ani USA nepou\u017e\u00edva pre posudzovanie liekov a produktov na ojedinel\u00e9 ochorenia, preto\u017ee sa
\njedn\u00e1 o metodicky nevhodn\u00e9 krit\u00e9rium, ktor\u00e9 kladie na liek na ojedinel\u00e9 ochorenie nesplnite\u013en\u00fa po\u017eiadavku.
\nZau\u017e\u00edvanou praxou pre hodnotenie liekov na ojedinel\u00e9 ochorenia je tzv. met\u00f3da MCDA (Multi Criteria
\nDecision Analysis) \u2013 rozhodovanie na z\u00e1klade anal\u00fdzy viacer\u00fdch krit\u00e9ri\u00ed. Prim\u00e1rnym pr\u00edkladom je \u010cesk\u00e1
\nRepublika, ke\u010f v \u00faprave identick\u00e9ho z\u00e1kona vyslovene uv\u00e1dza priamo v z\u00e1kone, \u017ee krit\u00e9rium n\u00e1kladovej
\nefekt\u00edvnosti sa predklad\u00e1 ako informat\u00edvne.
\nKe\u010f\u017ee znenie slovensk\u00e9ho z\u00e1kona 363\/2011 Z.z. o \u00fahrad\u00e1ch z verejn\u00e9ho zdravotn\u00e9ho poistenia obsahuje
\nsamostatn\u00fa cestu pre vstup liekov na zriedkav\u00e9 ochorenia.
\nKe\u010f\u017ee finan\u010dn\u00e9 krit\u00e9rium sa vo vydan\u00fdch stanovisk\u00e1ch uplat\u0148uje nepropor\u010dne a nevyv\u00e1\u017eene, nako\u013eko
\nsplnenie prahovej hodnoty neznamen\u00e1 vyhovie\u0165 \u017eiadosti, no nesplnenie prahovej hodnoty znamen\u00e1
\nneodpor\u00fa\u010danie zaradi\u0165 liek do syst\u00e9mu \u00fahrad. Tak\u00e9to hodnotenie znev\u00fdhod\u0148uje pacienta.
\nKed\u017ee m\u00e1me za to, \u017ee pri posudzovan\u00ed lieku na ojedinel\u00e9 ochorenia sa m\u00e1 v s\u00falade s postupmi v r\u00e1mci E\u00da v
\nprvom rade zoh\u013eadni\u0165 z\u00e1va\u017enos\u0165 ochorenia, na lie\u010dbu ktor\u00e9ho je liek ur\u010den\u00fd, nahradite\u013enos\u0165
\nposudzovan\u00e9ho lieku in\u00fdmi terapeutick\u00fdmi postupmi, nenaplnen\u00e1 medic\u00ednska potreba pacienta,
\npreuk\u00e1zate\u013en\u00fd pr\u00ednos na zlep\u0161enie kvality \u017eivota pacienta, terapeutick\u00e1 \u00fa\u010dinnos\u0165 a bezpe\u010dnos\u0165,
\nodpor\u00fa\u010dania odborn\u00fdch komisi\u00ed, in\u0161tit\u00faci\u00ed a spolo\u010dnost\u00ed, celospolo\u010densk\u00fd v\u00fdznam mo\u017enosti terapeuticky
\novplyvni\u0165 ochorenie, dostupnos\u0165 posudzovan\u00e9ho lieku v krajin\u00e1ch E\u00da.<\/p>\n

Ke\u010f\u017ee sme aktu\u00e1lne jedin\u00e1 krajina E\u00da, ktor\u00e1 odopiera skupine pacientov s cystickou fibr\u00f3zou pr\u00edstup<\/strong>
\n k niektor\u00fdm indik\u00e1ci\u00e1m lie\u010dby korektormi a modul\u00e1tormi v s\u00falade so schv\u00e1len\u00edm EMA a m\u00e1me<\/strong>
\n aktu\u00e1lne pacientov v kritickom stave, ktor\u00ed spadaj\u00fa pod indik\u00e1cie v uveden\u00fdch konaniach.<\/strong>
\nKe\u010f\u017ee sa jedn\u00e1 o z\u00e1sadn\u00fa pr\u00ed\u010dinn\u00fa lie\u010dbu, ktor\u00e1 v kohorte 12+ prid\u00e1va pacientom pod\u013ea modelu 35 rokov<\/strong>
\n kvalitn\u00e9ho \u017eivota.<\/strong> Pod\u013ea preuk\u00e1zan\u00fdch vstupn\u00fdch \u0161t\u00fadi\u00ed a aj opakovan\u00fdch \u0161t\u00fadi\u00ed po 5 rokoch pod\u00e1vania
\nlie\u010dby a klinickej praxe, hodnoten\u00e1 lie\u010dba zvr\u00e1ti progresiu ochorenia. A ke\u010f\u017ee klinick\u00e9 v\u00fdsledky u\u017e aj u
\nna\u0161ich pacientov preukazuj\u00fa zvr\u00e1tenie progresie ochorenia, n\u00e1rast funk\u010dn\u00fdch ukazovate\u013eov p\u013e\u00fac,
\nprospievania, ale najm\u00e4 v\u00fdrazn\u00fd pokles hodnoty koncentr\u00e1cie chloridov v pote na \u00farove\u0148 zdrav\u00e9ho
\n\u010dloveka. To vedie k plnohodnotn\u00e9mu n\u00e1vratu na\u0161ich pacientov do \u017eivota a spolo\u010dnosti, kedy pracuj\u00fa, \u0161tuduj\u00fa,
\npodnikaj\u00fa, zakladaj\u00fa rodiny.
\nKe\u010f\u017ee je \u00fa\u010dinok hodnoten\u00fdch lie\u010div jednozna\u010dne a nespochybnite\u013ene preuk\u00e1zan\u00fd vykonan\u00fdmi \u0161tandardn\u00fdmi
\n\u0161t\u00fadiami akceptovan\u00fdmi vo v\u0161etk\u00fdch hodnotiacich syst\u00e9moch a v porovnan\u00ed s predch\u00e1dzaj\u00facimi gener\u00e1ciami
\npr\u00ed\u010dinnej a symptomatickej lie\u010dby, kde dokonca hodnoten\u00fd liek u\u017e hodnotila ako mimoriadne \u00fa\u010dinn\u00fd
\nsamotn\u00e1 na\u0161a vlastn\u00e1 HTA agent\u00fara v minul\u00fdch konaniach, rovnako ako \u010fal\u0161ie hodnotiace organiz\u00e1cie a
\nsyst\u00e9my v r\u00e1mci E\u00da.
\nKe\u010f\u017ee lie\u010dba korektormi a modul\u00e1tormi na cystick\u00fa fibr\u00f3zu je zaveden\u00e1 ako \u0161tandard v na\u0161ich vlastn\u00fdch<\/strong>
\n platn\u00fdch \u0161tandardoch Ministerstva zdravotn\u00edctva.<\/strong>
\nKe\u010f\u017ee choroba hranice nepozn\u00e1 a m\u00e1me rovnak\u00e9 genetick\u00e9 predpoklady, hist\u00f3riu, v\u00fdskyt ochoren\u00ed
\na m\u00e1me za to, \u017ee m\u00e1me ma\u0165 rovnak\u00fd podiel, ktor\u00fd spolo\u010dnos\u0165 vynalo\u017e\u00ed pre svojich pacientov, \u0161peci\u00e1lne
\nak sa porovn\u00e1me s krajinami n\u00e1\u0161ho regi\u00f3nu (opakujeme, sme jedin\u00e1 krajina E\u00da, ktor\u00e1 lie\u010dbu v ist\u00fdch
\nindik\u00e1ci\u00e1ch schv\u00e1len\u00fdch EMA moment\u00e1lne svojim pacientom odopiera).
\nPreto:<\/p>\n

pros\u00edme a \u017eiadame v\u0161etky z\u00fa\u010dastnen\u00e9 subjekty o<\/strong><\/p>\n

MAXIM\u00c1LNU S\u00da\u010cINNOS\u0164<\/strong><\/p>\n

v konan\u00ed, zdrojoch, poskytnut\u00fdch \u00fadajoch, inform\u00e1ci\u00e1ch,<\/strong>
\n koordin\u00e1cii, rokovaniach a ochote dospie\u0165 k v\u00fdsledku, ktor\u00fd<\/strong><\/p>\n

povedie<\/strong><\/p>\n

k dostupnej hodnotenej lie\u010dbe<\/strong><\/p>\n

pre slovensk\u00fdch pacientov s cystickou fibr\u00f3zou.<\/strong><\/p>\n

Spr\u00e1vna rada pacientskych organiz\u00e1ci\u00ed:
\nSlovensk\u00e1 aliancia zriedkav\u00fdch chor\u00f4b, 00421 918 893 099, \u0160tep\u00e1nek Peter
\nSlovensk\u00fd klub cystickej fibr\u00f3zy,, 00421 905 409 927, \u013dubo\u0161 Her\u00e1k
\nSlovensk\u00e1 asoci\u00e1cia cystickej fibr\u00f3zy, 00421 903 608 435, MUDr. Katar\u00edna \u0160t\u011bp\u00e1nkov\u00e1
\nPriatelia slan\u00fdch det\u00ed
\n(\u010dlenovia Eurordis)
\nV Bratislave, 28.7.2024<\/p>\n

\"\"<\/p>\n

Stanovisko pacientskych organiza\u0301cii\u0301_konania_32704-32711_SVK<\/a> Standpoint of patients organisations to proceedings_32704-32711_EN<\/a> Slovensko_Nedostupne\u0301_Kaftrio_Kalydeco<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Stanovisko pacientskych organiz\u00e1ci\u00ed do konan\u00ed o liekoch na cystick\u00fa fibr\u00f3zu \u010d\u00edslo 32704, 32705, 32706, 32707, 32708, 32709, 32710, 32711 (roz\u0161\u00edrenie indik\u00e1ci\u00ed pre pr\u00ed\u010dinn\u00fa lie\u010dbu na ochorenie cystick\u00e1 fibr\u00f3za, hodnoten\u00e9 lie\u010div\u00e1 korektory a modul\u00e1tory). Ke\u010f\u017ee niektor\u00e9 vydan\u00e9 stanovisk\u00e1 v r\u00e1mci vy\u0161\u0161ie uveden\u00fdch konan\u00ed vylu\u010duj\u00fa \u010das\u0165 pacientov s ojedinel\u00fdm ochoren\u00edm z pr\u00edstupu k lie\u010dbe v\u00fdlu\u010dne na z\u00e1klade […]<\/p>\n","protected":false},"author":1,"featured_media":1768,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ngg_post_thumbnail":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1760","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nezaradene"],"yoast_head":"\nStanovisko pacientskych organiz\u00e1ci\u00ed do konan\u00ed o liekoch na cystick\u00fa fibr\u00f3zu - klubcf.sk<\/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:\/\/klubcf.sk\/index.php\/2024\/09\/30\/stanovisko-pacientskych-organizacii-konani-o-liekoch-na-cysticku-fibrozu\/\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Stanovisko pacientskych organiz\u00e1ci\u00ed do konan\u00ed o liekoch na cystick\u00fa fibr\u00f3zu - klubcf.sk\" \/>\n<meta property=\"og:description\" content=\"Stanovisko pacientskych organiz\u00e1ci\u00ed do konan\u00ed o liekoch na cystick\u00fa fibr\u00f3zu \u010d\u00edslo 32704, 32705, 32706, 32707, 32708, 32709, 32710, 32711 (roz\u0161\u00edrenie indik\u00e1ci\u00ed pre pr\u00ed\u010dinn\u00fa lie\u010dbu na ochorenie cystick\u00e1 fibr\u00f3za, hodnoten\u00e9 lie\u010div\u00e1 korektory a modul\u00e1tory). 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