{"id":4166,"date":"2022-07-29T12:15:26","date_gmt":"2022-07-29T10:15:26","guid":{"rendered":"http:\/\/www.cechova.sk\/?p=4166"},"modified":"2022-07-29T13:57:05","modified_gmt":"2022-07-29T11:57:05","slug":"zasadne-novinky-v-uhradach-liekov-otazky-a-odpovede","status":"publish","type":"post","link":"https:\/\/www.cechova.sk\/sk\/zasadne-novinky-v-uhradach-liekov-otazky-a-odpovede\/","title":{"rendered":"Z\u00e1sadn\u00e9 novinky v \u00fahrad\u00e1ch liekov: ot\u00e1zky a odpovede"},"content":{"rendered":"<p>1. augusta 2022 nadob\u00fada \u00fa\u010dinnos\u0165 z\u00e1sadn\u00e1 novela z\u00e1kona \u010d. 363\/2011 Z.z. o rozsahu a podmienkach \u00fahrady liekov, o ktorej sa pr\u00e1vom hovor\u00ed ako o najv\u00e4\u010d\u0161ej zmene v syst\u00e9me \u00fahrad liekov od roku 2012, odkedy plat\u00ed s\u00fa\u010dasn\u00e1 pr\u00e1vna \u00faprava. Zmeny sa dotkn\u00fa takmer v\u0161etk\u00fdch oblast\u00ed, ktor\u00e9 upravuje z\u00e1kon: podmienok na zaradenie a vyradenie liekov do a zo syst\u00e9mu \u00fahrad, zml\u00fav o podmienkach \u00fahrady liekov, podmienenej kategoriz\u00e1cie, regul\u00e1cie cien, rev\u00edzie \u00fahrad, \u00fahradov\u00fdch skup\u00edn, zmien indika\u010dn\u00fdch a preskrip\u010dn\u00fdch obmedzen\u00ed, \u00fahrad na v\u00fdnimku, fixn\u00e9ho doplatku, referencovania, \u010di procesn\u00fdch ustanoven\u00ed.<\/p>\n<p>V tomto pr\u00edspevku sumarizujeme vo forme dvadsiatich naj\u010dastej\u0161\u00edch ot\u00e1zok a odpoved\u00ed zmeny v oblasti podmienok na zaradenie a vyradenie liekov, zml\u00fav o podmienkach \u00fahrady liekov, a podmienenej kategoriz\u00e1cie.<\/p>\n<ol>\n<li><strong>Ak\u00e9 bud\u00fa podmienky zaradenia lieku?<\/strong><\/li>\n<\/ol>\n<p><strong>\u00a0<\/strong>Z\u00e1kladn\u00fdm krit\u00e9riom na zaradenie lieku do zoznamu kategorizovan\u00fdch liekov (ZKL) na\u010falej zost\u00e1va n\u00e1kladov\u00e1 efekt\u00edvnos\u0165, ktor\u00e1 sa m\u00e1 hodnoti\u0165 na z\u00e1klade prahovej hodnoty dodato\u010dn\u00fdch n\u00e1kladov za jeden z\u00edskan\u00fd rok \u017eivota \u0161tandardizovanej kvality (ICER\/QALY), alebo na z\u00e1klade anal\u00fdzy minimaliz\u00e1cie n\u00e1kladov (CMA).<\/p>\n<p>Druh\u00fdm krit\u00e9riom na zaradenie lieku rovnocenn\u00fdm s\u00a0n\u00e1kladovou efekt\u00edvnos\u0165ou bude udr\u017eate\u013enos\u0165 verejn\u00fdch financi\u00ed a\u00a0s\u00falad s\u00a0tzv. programov\u00fdm rozpo\u010dtovan\u00edm zdravotn\u00fdch pois\u0165ovn\u00ed (\u00a7 90).<\/p>\n<ol start=\"2\">\n<li><strong>Ak\u00e1 bude prahov\u00e1 hodnota na zaradenie liekov do ZKL?<\/strong><\/li>\n<\/ol>\n<p>Maxim\u00e1lna prahov\u00e1 hodnota bude 3x HDP v\u00a0be\u017en\u00fdch cen\u00e1ch v\u00a0SR za dva roky pozadu pod\u013ea \u0160tatistick\u00e9ho \u00faradu SR. Pre orphan lieky m\u00e1 plati\u0165 maxim\u00e1lna prahov\u00e1 hodnota 10x HDP.<\/p>\n<p>Ak v\u0161ak liek strat\u00ed orphan status, MAH bude povinn\u00fd do 120 dn\u00ed predlo\u017ei\u0165 MZ farmako-ekonomick\u00fd rozbor lieku (FER). Ak MZ na z\u00e1klade FER zist\u00ed, \u017ee liek nie je n\u00e1kladovo efekt\u00edvny pod\u013ea z\u00e1kladnej prahovej hodnoty, m\u00e1 by\u0165 povinne vyraden\u00fd zo ZKL.<\/p>\n<p>Presn\u00e9 v\u00fd\u0161ky prahov\u00fdch hodn\u00f4t v\u00a0z\u00e1vislosti od z\u00edskan\u00fdch QALY ur\u010d\u00ed nov\u00e1 vyhl\u00e1\u0161ka o\u00a0prahovej hodnote.<\/p>\n<ol start=\"3\">\n<li><strong>Ak\u00e9 bud\u00fa podmienky pou\u017eitia CMA?<\/strong><\/li>\n<\/ol>\n<p>CMA m\u00e1 preuk\u00e1za\u0165 na z\u00e1klade priamo porovn\u00e1vaj\u00facich \u0161t\u00fadi\u00ed alebo nepriamych porovnan\u00ed vykonan\u00fdch s pou\u017eit\u00edm vhodn\u00fdch \u0161tatistick\u00fdch met\u00f3d \u0161tatisticky nev\u00fdznamn\u00fd rozdiel v \u00fa\u010dinnosti a bezpe\u010dnosti medzi liekom, ktor\u00fd je predmetom \u017eiadosti a porovn\u00e1van\u00fdmi medic\u00ednskymi intervenciami, a\u00a0z\u00e1rove\u0148 \u017ee n\u00e1klady vynalo\u017een\u00e9 z verejn\u00e9ho zdravotn\u00e9ho poistenia pri pou\u017eit\u00ed lieku, ktor\u00fd je predmetom \u017eiadosti v s\u00falade s navrhovan\u00fdm indika\u010dn\u00fdm obmedzen\u00edm a navrhovan\u00fdm preskrip\u010dn\u00fdm obmedzen\u00edm s\u00fa ni\u017e\u0161ie ako n\u00e1klady vynalo\u017een\u00e9 z verejn\u00e9ho zdravotn\u00e9ho poistenia pri pou\u017eit\u00ed inej medic\u00ednskej intervencie.<\/p>\n<ol start=\"4\">\n<li><strong>M\u00e1 sa n\u00e1kladov\u00e1 efekt\u00edvnos\u0165 hodnoti\u0165 pre ka\u017ed\u00fa indik\u00e1ciu zvl\u00e1\u0161\u0165 alebo pre liek ako tak\u00fd?<\/strong><\/li>\n<\/ol>\n<p>N\u00e1kladov\u00e1 efekt\u00edvnos\u0165 sa m\u00e1 hodnoti\u0165 pre ka\u017ed\u00fa indik\u00e1ciu zvl\u00e1\u0161\u0165, a\u00a0pre ka\u017ed\u00fa indik\u00e1ciu m\u00e1 by\u0165 ur\u010den\u00e1 samostatn\u00e1 \u00daZP2. N\u00e1vrh na posudzovanie cez tzv. v\u00e1\u017een\u00fd ICER (n\u00e1kladov\u00e1 efekt\u00edvnos\u0165 pre viacer\u00e9 indik\u00e1cie posudzovan\u00e9 spolo\u010dne) sa do novely nedostal.<\/p>\n<ol start=\"5\">\n<li><strong>M\u00f4\u017ee by\u0165 zaraden\u00fd aj n\u00e1kladovo neefekt\u00edvny liek?<\/strong><\/li>\n<\/ol>\n<p>\u00c1no, ak spln\u00ed pr\u00edsne podmienky na udelenie v\u00fdnimky z\u00a0n\u00e1kladovej efekt\u00edvnosti:<\/p>\n<ul>\n<li>ide o\u00a0orphan liek alebo liek na inovat\u00edvnu lie\u010dbu (ATMP);<\/li>\n<li>dr\u017eite\u013e registr\u00e1cie (MAH) uzavrel s\u00a0MZ zmluvu o\u00a0podmienkach \u00fahrady lieku (MEA);<\/li>\n<li>nie je dostupn\u00e1 in\u00e1 medic\u00ednska intervencia zaraden\u00e1 v ZKL, ktor\u00e1 m\u00e1 preuk\u00e1zan\u00fa a potvrden\u00fa \u00fa\u010dinnos\u0165 a bezpe\u010dnos\u0165 v\u00fdsledkami klinick\u00fdch sk\u00fa\u0161ok realizovan\u00fdch na princ\u00edpoch medic\u00edny zalo\u017eenej na d\u00f4kazoch;<\/li>\n<li>prim\u00e1rny klinick\u00fd v\u00fdznamn\u00fd cie\u013e v klinickom sk\u00fa\u0161an\u00ed preuk\u00e1zal, \u017ee v hodnotenom parametri, ktor\u00fd m\u00e1 vplyv na kvalitu \u017eivota, do\u0161lo pri pou\u017eit\u00ed posudzovan\u00e9ho lieku aspo\u0148 k 30% zlep\u0161eniu oproti zlep\u0161eniu pri pou\u017eit\u00ed in\u00e9ho lieku zaraden\u00e9ho v ZKL alebo inej medic\u00ednskej intervencie uhr\u00e1dzanej na z\u00e1klade verejn\u00e9ho zdravotn\u00e9ho poistenia, alebo sa pri pou\u017eit\u00ed posudzovan\u00e9ho lieku preuk\u00e1\u017ee pred\u013a\u017eenie strednej doby celkov\u00e9ho pre\u017e\u00edvania najmenej o 30% v porovnan\u00ed s in\u00fdm liekom zaraden\u00fdm v ZKL alebo inou medic\u00ednskou intervenciou uhr\u00e1dzanou na z\u00e1klade verejn\u00e9ho zdravotn\u00e9ho poistenia, najmenej v\u0161ak o tri mesiace,<\/li>\n<li>vynakladanie prostriedkov verejn\u00e9ho zdravotn\u00e9ho poistenia je \u00fa\u010deln\u00e9 a\u00a0efekt\u00edvne; a<\/li>\n<li>finan\u010dn\u00e1 stabilita syst\u00e9mu verejn\u00e9ho zdravotn\u00e9ho poistenia je zabezpe\u010den\u00e1.<\/li>\n<\/ul>\n<p><strong>\u00a0<\/strong>Ak bude liek zaraden\u00fd t\u00fdmto postupom, MAH m\u00e1 by\u0165 povinn\u00fd kedyko\u013evek ke\u010f sa dozvie alebo mohol dozvedie\u0165, \u017ee liek nesp\u013a\u0148a \u010do i\u00a0len jednu z\u00a0uveden\u00fdch podmienok, najsk\u00f4r v\u0161ak 210 \u2013 180 dn\u00ed pred uplynut\u00edm 5 rokov od zaradenia, predlo\u017ei\u0165 MZ FER. Ak sa preuk\u00e1\u017ee, \u017ee liek nesp\u013a\u0148a \u010do i len jednu podmienku na v\u00fdnimku, m\u00e1 by\u0165 povinne vyraden\u00fd zo ZKL.<\/p>\n<ol start=\"6\">\n<li><strong>Menia sa podmienky zaradenia generick\u00fdch \/ biologicky podobn\u00fdch liekov?<\/strong><\/li>\n<\/ol>\n<p><strong>\u00a0<\/strong>Namiesto doteraj\u0161ieho trojprahov\u00e9ho vstupu, ktor\u00fd vy\u017eadoval zn\u00ed\u017eenie ceny pri vstupe prv\u00e9ho, druh\u00e9ho aj tretieho generick\u00e9ho a\u00a0biologicky podobn\u00e9ho lieku, sa zav\u00e1dza jednoprahov\u00fd vstup. Po novom bude sta\u010di\u0165, ak \u00daZP2 prv\u00e9ho generick\u00e9ho lieku neprekro\u010d\u00ed 51 %, a\u00a0cena prv\u00e9ho biologicky podobn\u00e9ho lieku neprekro\u010d\u00ed 75 % z\u00a0ceny origin\u00e1lneho lieku. Pre druh\u00fd a\u00a0tret\u00ed generick\u00fd a\u00a0biologicky podobn\u00fd liek sa \u010fal\u0161ie zn\u00ed\u017eenie ceny nevy\u017eaduje.<\/p>\n<ol start=\"7\">\n<li><strong>Ak\u00e9 maj\u00fa by\u0165 nov\u00e9 d\u00f4vody na vyradenie lieku zo ZKL?<\/strong><\/li>\n<\/ol>\n<p>Popri s\u00fa\u010dasn\u00fdch d\u00f4vodoch na vyradenie lieku zo ZKL sa maj\u00fa prida\u0165 viacer\u00e9 nov\u00e9 d\u00f4vody.<\/p>\n<p>Liek m\u00e1 by\u0165 povinne vyraden\u00fd zo ZKL ak:<\/p>\n<ul>\n<li>MAH neuhradil ZP payback pod\u013ea MEA;<\/li>\n<li>liek prestal sp\u013a\u0148a\u0165 d\u00f4vody na v\u00fdnimku z\u00a0n\u00e1kladovej efekt\u00edvnosti;<\/li>\n<li>liek stratil orphan status a\u00a0nie je z\u00e1kladovo efekt\u00edvny pod\u013ea z\u00e1kladnej prahovej hodnoty; alebo<\/li>\n<li>ide o\u00a0podmienene kategorizovan\u00fd liek a\u00a0MAH neuzavrel s\u00a0MZ zmluvu o\u00a0podmienkach \u00fahrady lieku do 31.12.2023.<\/li>\n<\/ul>\n<p>MZ bude ma\u0165 mo\u017enos\u0165 (nie v\u0161ak povinnos\u0165) vyradi\u0165 liek zo ZKL, ak sa t\u00fdm neohroz\u00ed \u017eivot alebo zdravie a ak:<\/p>\n<ul>\n<li>nie je n\u00e1kladovo efekt\u00edvny pod\u013ea \u00a7 7 alebo\u00a0nesp\u013a\u0148a podmienky na udr\u017eate\u013enos\u0165 verejn\u00fdch financi\u00ed alebo programov\u00e9 rozpo\u010dtovanie ZP pod\u013ea \u00a7 90;<\/li>\n<li>s\u00fa splnen\u00e9 \u010fal\u0161ie d\u00f4vody na nezaradenie lieku do ZKL pod\u013ea \u00a7 16 ods. 4 p\u00edsm. b) \u2013 g);<\/li>\n<li>MAH neuzatvoril MEA s\u00a0MZ, ak ide o\u00a0orphan, liek na z\u00e1va\u017en\u00e9 ochorenie, ATMP, alebo liek s\u00a0\u00fahradou aspo\u0148 1,5 mili\u00f3na eur za 1., 2. alebo 3. rok (bude sa vyhodnocova\u0165 sp\u00e4tne); alebo<\/li>\n<li>MEA zanikla z\u00a0in\u00fdch ako v\u00a0z\u00e1kone predpokladan\u00fdch d\u00f4vodov alebo MEA nebola zos\u00faladen\u00e1 so zmenou charakterist\u00edk referen\u010dnej skupiny.<\/li>\n<\/ul>\n<ol start=\"8\">\n<li><strong>Kedy m\u00e1 ma\u0165 MAH povinnos\u0165 pri vyraden\u00ed lieku povinnos\u0165 uhradi\u0165 n\u00e1klady na dolie\u010denie pacientov?<\/strong><\/li>\n<\/ol>\n<p>MAH bude ma\u0165 povinnos\u0165 uhradi\u0165 n\u00e1klady na lie\u010dbu rozlie\u010den\u00fdch pacientov liekom vyraden\u00fdm zo ZKL, ktor\u00fdm bol liek poskytnut\u00fd e\u0161te po\u010das jeho zaradenia, za podmienok uveden\u00fdch v\u00a0ZKL, a\u00a0to a\u017e k\u00fdm im nebude poskytnut\u00e1 in\u00e1 vhodn\u00e1, porovnate\u013ene \u00fa\u010dinn\u00e1 a bezpe\u010dn\u00e1 lie\u010dba uhr\u00e1dzan\u00e1 z prostriedkov verejn\u00e9ho zdravotn\u00e9ho poistenia, najviac v\u0161ak po dobu 24 mesiacov. T\u00e1to povinnos\u0165 m\u00e1 plati\u0165 iba ak MZ vyrad\u00ed liek zo ZKL:<\/p>\n<ul>\n<li>MAH nezaplatil payback pod\u013ea MEA, a\u00a0v\u00a0ZKL je zaraden\u00fd in\u00fd liek, ktor\u00fd m\u00e1 preuk\u00e1zan\u00fa a potvrden\u00fa rovnak\u00fa alebo lep\u0161iu \u00fa\u010dinnos\u0165 a\u00a0bezpe\u010dnos\u0165;<\/li>\n<li>pri strate podmienok na v\u00fdnimku z\u00a0n\u00e1kladovej efekt\u00edvnosti; a<\/li>\n<li>pri strate orphan statusu, ak liek nie je n\u00e1kladov efekt\u00edvny pod\u013ea z\u00e1kladnej prahovej hodnoty.<\/li>\n<\/ul>\n<ol start=\"9\">\n<li><strong>Ako bud\u00fa upraven\u00e9 zmluvy o\u00a0podmienkach \u00fahrady?<\/strong><\/li>\n<\/ol>\n<p>Zmluvy potrebn\u00e9 na zaradenie lieku do ZKL alebo zmenu alebo zru\u0161enie IO alebo PO (MEA) maj\u00fa by\u0165 uzatv\u00e1ran\u00e9 s\u00a0MZ.<\/p>\n<p>Zmluvy na in\u00fd \u00fa\u010del maj\u00fa by\u0165 uzatv\u00e1ran\u00e9 s\u00a0MZ alebo so ZP. Ak v\u0161ak predmetom zmluvy maj\u00fa by\u0165 podmienky \u00fahrady lieku na v\u00fdnimku, tak\u00e1to zmluva m\u00f4\u017ee by\u0165 uzavret\u00e1 iba so ZP.<\/p>\n<ol start=\"10\">\n<li><strong>Kedy m\u00e1 by\u0165 MEA povinn\u00e1?<\/strong><\/li>\n<\/ol>\n<p>Povinn\u00e1 MEA sa m\u00e1 uzatv\u00e1ra\u0165 pri zara\u010fovan\u00ed lieku a\u00a0zmene alebo roz\u0161\u00edren\u00ed IO alebo PO:<\/p>\n<ul>\n<li>ak je liek n\u00e1kladovo efekt\u00edvny iba na z\u00e1klade MEA;<\/li>\n<li>ak ide o\u00a0orphan liek, liek na z\u00e1va\u017en\u00e9 ochorenie alebo ATMP; alebo<\/li>\n<li>ak je predpokladan\u00e1 \u00fahrada za liek za 1., 2. alebo 3. rok najmenej 1,5 mili\u00f3na eur.<\/li>\n<\/ul>\n<p>\u010ealej m\u00e1 by\u0165 zmluva s\u00a0MZ uzavret\u00e1 pre lieky, ktor\u00e9 s\u00fa v\u00a0s\u00fa\u010dasnosti zaraden\u00e9 v\u00a0ZKL na z\u00e1klade zml\u00fav uzatvoren\u00fdch so ZP, a\u00a0ktor\u00e9 s\u00fa v\u00a0s\u00fa\u010dasnosti v\u00a0podmienenej kategoriz\u00e1cii.<\/p>\n<ol start=\"11\">\n<li><strong>Ak\u00e9 maj\u00fa by\u0165 n\u00e1le\u017eitosti MEA?<\/strong><\/li>\n<\/ol>\n<p>Medzi povinn\u00e9 n\u00e1le\u017eitosti m\u00e1 patri\u0165 okrem in\u00e9ho:<\/p>\n<ul>\n<li>dojednanie o maxim\u00e1lnej sume \u00fahrad ZP za liek, ktor\u00fa ZP vynalo\u017eia za liek za ka\u017ed\u00fdch 12 mesiacov po\u010das trvania platnosti zmluvy (tzv. cap) alebo sp\u00f4sob jeho v\u00fdpo\u010dtu;<\/li>\n<li>z\u00e1v\u00e4zok uhradi\u0165 payback \u2013 rozdiel medzi re\u00e1lnou \u00fahradou a\u00a0capom, sp\u00f4sob jeho v\u00fdpo\u010dtu a\u00a0splatnos\u0165 (max. 60 dn\u00ed);<\/li>\n<li>zmluvn\u00e1 pokuta za nezaplatenie paybacku;<\/li>\n<li>inform\u00e1cia o\u00a0\u00fahrade po z\u013eave, ak sa dohaduje z\u013eava.<\/li>\n<\/ul>\n<p>Z\u00e1kon neupravuje akou metodikou sa m\u00e1 ur\u010dova\u0165 cap pri uzatv\u00e1ran\u00ed zmluvy a\u00a0na \u010fal\u0161ie obdobia \u2013 bude z\u00e1visie\u0165 iba od v\u00fdsledku vyjedn\u00e1van\u00ed o\u00a0zmluve.<\/p>\n<p>Nepovinnou n\u00e1le\u017eitos\u0165ou zmluvy m\u00f4\u017ee by\u0165 dojednanie o\u00a0poskytnut\u00ed z\u013eavy z\u00a0ceny in\u00e9ho lieku, z\u00a0lieku pou\u017eit\u00e9ho v\u00a0inej indik\u00e1cii, alebo z\u013eavy v\u00a0natur\u00e1li\u00e1ch vo forme posudzovan\u00e9ho alebo in\u00e9ho lieku.<\/p>\n<ol start=\"12\">\n<li><strong>Ako m\u00e1 by\u0165 o\u0161etren\u00e1 d\u00f4vernos\u0165 MEA?<\/strong><\/li>\n<\/ol>\n<p>Dojednanie o\u00a0cape, z\u00e1v\u00e4zku uhradi\u0165 payback a\u00a0o\u00a0nepovinn\u00fdch n\u00e1le\u017eitostiach sa\u00a0nem\u00e1 spr\u00edstup\u0148ova\u0165 ani zverej\u0148ova\u0165, s\u00a0v\u00fdnimkou \u010dlenov poradn\u00fdch org\u00e1nov MZ (to v\u0161ak nem\u00e1 plati\u0165 pri inform\u00e1cii o\u00a0v\u00fd\u0161ke \u00fahrady po z\u013eave). Distrib\u00fatori a\u00a0lek\u00e1rne bud\u00fa zo z\u00e1kona viazan\u00e9 ml\u010danlivos\u0165ou o v\u0161etk\u00fdch skuto\u010dnostiach vypl\u00fdvaj\u00facich zo zmluvy o podmienkach \u00fahrady, o\u00a0ktorej sa dozvedeli.<\/p>\n<ol start=\"13\">\n<li><strong>Ak\u00fd m\u00e1 by\u0165 postup uzatv\u00e1rania MEA?<\/strong><\/li>\n<\/ol>\n<p>Ak MAH po\u017eiada v\u00a0\u017eiadosti o\u00a0uzatvorenie MEA, alebo to MZ pova\u017euje za opodstatnen\u00e9, MZ vyzve dr\u017eite\u013ea na rokovania a\u00a0preru\u0161\u00ed konanie najviac na 90 dn\u00ed. V\u00a0konan\u00ed sa m\u00e1 pokra\u010dova\u0165 po uzatvoren\u00ed MEA, po uplynut\u00ed 90 dn\u00ed, alebo po ozn\u00e1men\u00ed MAH, \u017ee \u017eiada o\u00a0pokra\u010dovanie v\u00a0konan\u00ed bez MEA.<\/p>\n<p>Uzatvoren\u00e1 MEA m\u00e1 by\u0165 spr\u00edstupnen\u00e1 \u010dlenom Kategoriza\u010dnej komisie najmenej 15 dn\u00ed pred jej zasadnut\u00edm. Ak sa v\u0161etci \u010dlenovia Kategoriza\u010dnej komisie navrhnut\u00ed ZP zhodn\u00fa a\u00a0tom, \u017ee aj napriek zmluve nie s\u00fa splnen\u00e9 podmienky pre zaradenie lieku do ZKL, zmenu alebo zru\u0161enie IO alebo PO, do 7 dn\u00ed od doru\u010denia zmluvy m\u00f4\u017eu so zmluvou vyjadri\u0165 nes\u00fahlas, ktor\u00fd mus\u00ed by\u0165 od\u00f4vodnen\u00fd, a\u00a0obsahova\u0165 alternat\u00edvny n\u00e1vrh, pri ktorom bud\u00fa splnen\u00e9 z\u00e1konn\u00e9 podmienky. MZ n\u00e1sledne op\u00e4tovne preru\u0161\u00ed konanie najviac na 90 dn\u00ed. Ak MAH a\u00a0MZ uzatvoria k\u00a0zmluve dodatok v\u00a0s\u00falade s\u00a0pripomienkami z\u00e1stupcov ZP v\u00a0Kategoriza\u010dnej komisii, v\u00a0konan\u00ed sa pokra\u010duje so zmluvou v\u00a0znen\u00ed dodatku. Ak v\u0161ak dodatok uzatvoren\u00fd nebude, p\u00f4vodn\u00e1 zmluva zanikne\u00a0 v\u00a0konan\u00ed sa bude pokra\u010dova\u0165 bez nej.<\/p>\n<ol start=\"14\">\n<li><strong>\u010co sa stane s\u00a0MEA po zaraden\u00ed generick\u00e9ho \/ biologicky podobn\u00e9ho lieku?<\/strong><\/li>\n<\/ol>\n<p>Ak MZ rozhodne o\u00a0zaraden\u00ed generick\u00e9ho alebo biologicky podobn\u00e9ho lieku, s\u00fa\u010dasne so zaraden\u00edm rozhodne aj o\u00a0rev\u00edzii \u00fahrady. Pr\u00e1voplatnos\u0165ou rozhodnutia o\u00a0rev\u00edzii \u00fahrady MEA na origin\u00e1lny liek zanikne.<\/p>\n<p>Ak bud\u00fa podmienky dohodnut\u00e9 v\u00a0MEA na origin\u00e1lny liek st\u00e1le v\u00fdhodnej\u0161ie ako podmienky zaradenia prv\u00e9ho generick\u00e9ho alebo biologicky podobn\u00e9ho lieku, MZ ur\u010d\u00ed \u00daZP2 pre referen\u010dn\u00fa skupinu tak, \u017ee aby bola stanoven\u00edm \u00daZP2 zachovan\u00e1 ekonomick\u00e1 v\u00fdhodnos\u0165 osobitn\u00fdch podmienok \u00fahrady lieku dohodnut\u00fdch v MEA.<\/p>\n<ol start=\"15\">\n<li><strong>\u010co sa stane s\u00a0existuj\u00facimi MEA uzavret\u00fdmi so ZP?<\/strong><\/li>\n<\/ol>\n<p>Do 28.2.2023 maj\u00fa by\u0165 uzatvoren\u00e9 nov\u00e9 MEA zmluvy s\u00a0MZ, \u010d\u00edm maj\u00fa p\u00f4vodn\u00e9 zmluvy so ZP zanikn\u00fa\u0165. Zmluvy na in\u00fd \u00fa\u010del zostan\u00fa v\u00a0platnosti.<\/p>\n<ol start=\"16\">\n<li><strong>\u010co sa stane s podmienenou kategoriz\u00e1ciou?<\/strong><\/li>\n<\/ol>\n<p>Podmienen\u00e1 kategoriz\u00e1cia m\u00e1 by\u0165 novelou\u00a0zru\u0161en\u00e1. Novo zara\u010fovan\u00e9 lieky u\u017e bud\u00fa zara\u010fovan\u00e9 \u0161tandardne bez podmienenej \u00fahrady. Podobn\u00e1 \u00faprava ako podmienen\u00e1 kategoriz\u00e1cia v\u0161ak m\u00e1 by\u0165 zachovan\u00e1 vo forme MEA s\u00a0povinn\u00fdm capom.<\/p>\n<ol start=\"17\">\n<li><strong>\u010co sa stane s liekmi, ktor\u00e9 s\u00fa aktu\u00e1lne v podmienenej kategoriz\u00e1cii?<\/strong><\/li>\n<\/ol>\n<p>Tieto lieky zostan\u00fa zaraden\u00e9 v\u00a0ZKL bez podmienenej \u00fahrady od uplynutia posledn\u00e9ho rozhodn\u00e9ho obdobia presahuj\u00faceho d\u00e1tum \u00fa\u010dinnosti novely. Do 31.12.2023 v\u0161ak bud\u00fa dr\u017eitelia povinn\u00ed uzavrie\u0165 na tieto lieky MEA s\u00a0MZ, inak maj\u00fa by\u0165 lieky povinne vraden\u00e9 zo ZKL s\u00a0povinnos\u0165ou dr\u017eite\u013ea dolie\u010di\u0165 pacientov. Prebiehaj\u00face rozhodn\u00e9 obdobie sa v\u0161ak uzavret\u00edm MEA neskon\u010d\u00ed.<\/p>\n<ol start=\"18\">\n<li><strong>Ako bude vyhodnoten\u00e1 podmienen\u00e1 \u00fahrada?<\/strong><\/li>\n<\/ol>\n<p>Podmienen\u00e1 \u00fahrada m\u00e1 by\u0165 vyhodnoten\u00e1 pre v\u0161etky podmienene kategorizovan\u00e9 lieky, vr\u00e1tane t\u00fdch, ktor\u00e9 boli podmienene kategorizovan\u00e9 pred rokom 2018 (dvojro\u010dn\u00e9 rozhodn\u00e9 obdobie). Pre rozhodn\u00e9 obdobia skon\u010den\u00e9 pred 1.8.2022 m\u00e1 MZ za\u010da\u0165 konania o\u00a0ur\u010den\u00e9 vyrovnacieho rozdielu do 28.2.2023, a\u00a0pre rozhodn\u00e9 obdobia presahuj\u00face \u00fa\u010dinnos\u0165 novely do 6 mesiacov od ich skon\u010denia.<\/p>\n<p>MZ m\u00e1 ur\u010di\u0165 vyrovnac\u00ed rozdiel ako rozdiel medzi re\u00e1lnou \u00fahradou (maj\u00fa sa zoh\u013ead\u0148ova\u0165 aj osobitn\u00e9 podmienky pod\u013ea zml\u00fav o\u00a0podmienkach \u00fahrady) a\u00a0podmienenou \u00fahradou. Z\u00a0d\u00f4vodov hodn\u00fdch osobitn\u00e9ho zrete\u013ea m\u00e1 ma\u0165 MZ mo\u017enos\u0165 zn\u00ed\u017ei\u0165 alebo zv\u00fd\u0161i\u0165 vyrovnac\u00ed rozdiel. Tieto d\u00f4vody maj\u00fa by\u0165 v\u00a0z\u00e1kone uveden\u00e9 iba pr\u00edkladom.<\/p>\n<ol start=\"19\">\n<li><strong>Ako bud\u00fa veden\u00e9 konania za\u010dat\u00e9 a neskon\u010den\u00e9 pred \u00fa\u010dinnos\u0165ou novely?<\/strong><\/li>\n<\/ol>\n<p>Konania za\u010dat\u00e9 a\u00a0neskon\u010den\u00e9 pred \u00fa\u010dinnos\u0165ou novely sa dokon\u010dia u\u017e pod\u013ea novelizovan\u00e9ho z\u00e1kona.<\/p>\n<ol start=\"20\">\n<li><strong>Kde z\u00edskam \u010fal\u0161ie inform\u00e1cie?<\/strong><\/li>\n<\/ol>\n<p>Sledujte \u201ePr\u00e1vne novinky\u201c na webovej str\u00e1nke <a href=\"http:\/\/www.cechova.sk\/\">www.cechova.sk<\/a> a na\u0161e profily na soci\u00e1lnych sie\u0165ach\u00a0<a href=\"https:\/\/sk.linkedin.com\/company\/cechova-&amp;-partners\">LinkedIn<\/a> a\u00a0<a href=\"https:\/\/sk-sk.facebook.com\/CechovaPartners\/\">Facebook<\/a>. S\u00a0ak\u00fdmiko\u013evek ot\u00e1zkami sa nev\u00e1hajte obr\u00e1ti\u0165 na na\u0161ich odborn\u00edkov Tom\u00e1\u0161a Ryb\u00e1ra (<a href=\"mailto:tomas.rybar@cechova.sk\">tomas.rybar@cechova.sk<\/a>) a\u00a0Marka Holku (<a href=\"mailto:marek.holka@cechova.sk\">marek.holka@cechova.sk<\/a>).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>1. augusta 2022 nadob\u00fada \u00fa\u010dinnos\u0165 z\u00e1sadn\u00e1 novela z\u00e1kona \u010d. 363\/2011 Z.z. o rozsahu a podmienkach \u00fahrady liekov, o ktorej sa&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"episode_type":"","audio_file":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","date_recorded":"","explicit":"","block":"","itunes_episode_number":"","itunes_title":"","itunes_season_number":"","itunes_episode_type":"","filesize_raw":"","footnotes":""},"categories":["1","2","11","12","20","21","32","33"],"class_list":{"0":"post-4166","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"hentry","6":"category-dalsie-publikacie","8":"category-financial-law-news","9":"category-european-community-law-news","10":"category-aktuality","11":"category-pravne-novinky"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Z\u00e1sadn\u00e9 novinky v \u00fahrad\u00e1ch liekov: ot\u00e1zky a odpovede - \u010cechov\u00e1 &amp; 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