V roce 2017 vstoup\u00ed na trh v \u010cR nov\u00e9 l\u00e9ky pro onkologickou a hematonkologickou l\u00e9\u010dbu \u2013 biosimil\u00e1rn\u00ed rituximab, trastuzumab a pegfilgrastim. Tyto l\u00e9ky mohou sn\u00ed\u017eit finan\u010dn\u00ed n\u00e1ro\u010dnost l\u00e9\u010debn\u00e9 terapie a\u017e o stovky mili\u00f3n\u016f ro\u010dn\u011b, a l\u00e9\u010dba se tak k pacient\u016fm dostane rychleji a ve v\u011bt\u0161\u00ed m\u00ed\u0159e. Shodli se na tom dnes \u00fa\u010dastn\u00edci odborn\u00e9ho setk\u00e1n\u00ed Biosimilars: budoucnost biologick\u00e9 l\u00e9\u010dby v pra\u017esk\u00e9m IKEMu.<\/p>\n
<\/p>\n
Dostupnost modern\u00edch biologick\u00fdch l\u00e9k\u016f omezuje jejich extr\u00e9mn\u011b vysok\u00e1 cena. N\u00e1klady na biologickou l\u00e9\u010dbu nav\u00edc v \u010cR ka\u017edoro\u010dn\u011b stoupaj\u00ed o zhruba 20 % a bohu\u017eel i p\u0159es zv\u00fd\u0161en\u00fd v\u00fdb\u011br pojistn\u00e9ho nedoch\u00e1z\u00ed k vytv\u00e1\u0159en\u00ed rezerv poji\u0161\u0165ovnami. Mo\u017en\u00e9 \u0159e\u0161en\u00ed situace p\u0159edstavuj\u00ed stejn\u011b \u00fa\u010dinn\u00e9, ale cenov\u011b dostupn\u011bj\u0161\u00ed biosimilars, kter\u00e9 vstupuj\u00ed na trh po vypr\u0161en\u00ed patent\u016f origin\u00e1ln\u00edch biologick\u00fdch l\u00e9k\u016f a maj\u00ed stejnou \u00fa\u010dinnost a bezpe\u010dnost jako jejich origin\u00e1ln\u00ed p\u0159edch\u016fdci.<\/p>\n
\u201eBiosimil\u00e1rn\u00ed p\u0159\u00edpravky jsou v pr\u016fm\u011bru o 15 % levn\u011bj\u0161\u00ed ne\u017e origin\u00e1ln\u00ed biologick\u00e9 l\u00e9ky, a\u010dkoli nap\u0159\u00edklad biosimil\u00e1rn\u00ed filgrastim zlevnil d\u00e1vku tohoto l\u00e9ku pro \u010desk\u00e9 pacienty v roce 2011 tak\u0159ka o polovinu,\u201c vysv\u011btluje v\u00fdkonn\u00fd \u0159editel \u010cesk\u00e9 asociace farmaceutick\u00fdch firem (\u010cAFF), Martin M\u00e1tl a dod\u00e1v\u00e1 \u201eLeto\u0161n\u00ed vstup biosimil\u00e1rn\u00edho rituximabu, trastuzumabu a pegfilgrastimu m\u016f\u017ee \u010desk\u00e9mu zdravotnictv\u00ed nejenom u\u0161et\u0159it a\u017e stovky mili\u00f3n\u016f korun ro\u010dn\u011b, ale p\u0159edev\u0161\u00edm se d\u00edky nim biologick\u00e1 l\u00e9\u010dba dostane k onkologick\u00fdm pacient\u016fm rychleji a ve v\u011bt\u0161\u00ed m\u00ed\u0159e.\u201c<\/p>\n
Dostupn\u011bj\u0161\u00ed onkologick\u00e1 l\u00e9\u010dba d\u00edky biosimilars<\/p>\n
\u201eOd doby sv\u00e9ho n\u00e1stupu na trh se origin\u00e1ln\u00ed rituximab stal prakticky rutinn\u00ed sou\u010d\u00e1st\u00ed l\u00e9\u010dby pacient\u016f s chronickou lymfocyt\u00e1rn\u00ed leuk\u00e9mi\u00ed. Z\u00e1rove\u0148 se bohu\u017eel jedn\u00e1 o ekonomicky extr\u00e9mn\u011b n\u00e1ro\u010dnou l\u00e9\u010dbu. N\u00e1klady na terapii jednoho pacienta se pohybuj\u00ed mezi 300 000\u2013400 000 K\u010d,\u201c popisuje n\u00e1ro\u010dnost biologick\u00e9 l\u00e9\u010dby MUDr. David Belada, Ph.D. z IV. intern\u00ed hematologick\u00e9 kliniky v Hradci Kr\u00e1lov\u00e9.<\/p>\n
\u201eVstup biosimilarn\u00edch produkt\u016f je skute\u010dn\u011b jednou z mo\u017enost\u00ed, jak zajistit ekonomicky udr\u017eiteln\u00fd stav a poskytnout l\u00e9\u010dbu v\u00edce pacient\u016fm. S filgrastimem m\u00e1me dobr\u00e9 zku\u0161enosti ji\u017e n\u011bkolik let. V p\u0159\u00edpad\u011b biosimil\u00e1rn\u00edho rituximabu se potenci\u00e1ln\u00ed \u00faspora m\u016f\u017ee pohybovat v \u0159\u00e1dech stovek milion\u016f korun ro\u010dn\u011b,\u201c uzav\u00edr\u00e1 Belada.<\/p>\n
Fakt, \u017ee biosimil\u00e1rn\u00ed rituximab, trastuzumab a pegfigrastim mohou letos a v n\u00e1sleduj\u00edc\u00edch letech biologickou l\u00e9\u010dbu zp\u0159\u00edstupnit v\u011bt\u0161\u00edmu po\u010dtu onkologick\u00fdch pacient\u016f potvrzuj\u00ed i zku\u0161enosti se vstupem biosimil\u00e1rn\u00edho filgrastimu, kter\u00fd se u n\u00e1s od roku 2011 pou\u017e\u00edv\u00e1 p\u0159i chemoterapii. Do roku 2015 p\u0159itom filgrastim zaznamenal t\u00e9m\u011b\u0159 dvojn\u00e1sobn\u00fd n\u00e1r\u016fst spot\u0159eby, kter\u00e1 se v\u0161ak neodrazila na r\u016fstu n\u00e1klad\u016f.<\/p>\n
D\u016fvodem je, \u017ee ve sledovan\u00e9m obdob\u00ed bylo v\u00edce ne\u017e 80 % pacient\u016f l\u00e9\u010deno biosimil\u00e1rn\u00edm p\u0159\u00edpravkem.<\/p>\n
Nebezpe\u010dn\u00e1 regulace<\/p>\n
Dostupnost biosimil\u00e1rn\u00edch l\u00e9k\u016f na \u010desk\u00e9m trhu do budoucna bohu\u017eel ohro\u017euje ned\u00e1vno p\u0159ijat\u00e1 novela z\u00e1kona o l\u00e9\u010divech, kter\u00e1 na posledn\u00ed chv\u00edli zavedla i zm\u011bny pravidel pro stanoven\u00ed ceny u generik a biosimilars. Ty byly schv\u00e1leny bez jak\u00e9koliv diskuze s odbornou ve\u0159ejnost\u00ed a jejich v\u00fdsledkem m\u016f\u017ee paradoxn\u011b b\u00fdt odd\u00e1len\u00ed vstupu nov\u00fdch l\u00e9k\u016f na \u010desk\u00fd trh. Nap\u0159. biosimil\u00e1rn\u00edho rituximabu se bude patrn\u011b t\u00fdkat s nik\u00fdm nediskutovan\u00e9 skokov\u00e9 sn\u00ed\u017een\u00ed cen o 30 %. Na prvn\u00ed pohled l\u00edbiv\u00e1 zm\u011bna bohu\u017eel m\u016f\u017ee v\u00e9st k tomu, \u017ee se v\u00fdrobce bude muset \u010cesk\u00e9 republice p\u0159\u00ed\u0161t\u011b vyhnout.<\/p>\n
Pr\u00e1v\u011b rozumn\u00e1 m\u00edra regulace je kl\u00ed\u010dov\u00e1 pro pln\u00e9 vyu\u017eit\u00ed potenci\u00e1lu biosimilars, kter\u00e9 mohou uleh\u010dit situaci nejen pacient\u016fm, ale i pl\u00e1tc\u016fm a regul\u00e1tor\u016fm,\u201c vysv\u011btluje M\u00e1tl, v\u00fdkonn\u00fd \u0159editel \u010cAFF, kter\u00e1 sdru\u017euje v\u00fdrobce biosimilars. <\/p>\n","protected":false},"excerpt":{"rendered":"
V roce 2017 vstoup\u00ed na trh v \u010cR nov\u00e9 l\u00e9ky pro onkologickou a hematonkologickou l\u00e9\u010dbu \u2013 biosimil\u00e1rn\u00ed rituximab, trastuzumab a pegfilgrastim. Tyto l\u00e9ky mohou sn\u00ed\u017eit […]<\/a><\/p>\n<\/div>","protected":false},"author":1,"featured_media":14126,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-27336","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-zdravi"],"_links":{"self":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/posts\/27336","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=27336"}],"version-history":[{"count":0,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/posts\/27336\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/media\/14126"}],"wp:attachment":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=27336"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=27336"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=27336"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}