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Ministerstvo zdravotníctva SR - Kategorizácia liekov a úradné určenie cien liekov

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KON - Konanie začaté z podnetu ministerstva
Ministerstvo zdravotníctva (Mgr. Michaela Cesnaková)
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12.3.2012 17:06:08

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application/vnd.openxmlformats-officedocument.wordprocessingml.document Revízia_úhrad.docx Oznámenie o začatí konania 12.3.2012 Podpis Mgr. Michaela Cesnaková
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R 528 1 R_KON application/pdf S02986_OKCLP_2012_LR_072.pdf 15.4.2012 Detaily
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R 556 2 R_KON application/pdf S02986-OKCLP-2012-N33.pdf 15.5.2012 Detaily
R 359 1 R_KON application/pdf S02986_OKCLP_2012_LR_075.pdf 15.4.2012 Detaily Konanie o námietkach
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R 554 2 R_KON application/pdf S02986-OKCLP-2012-N34.pdf 15.5.2012 Detaily
R 352 1 R_KON application/pdf S02986_OKCLP_2012_LR_067.pdf 15.4.2012 Detaily Konanie o námietkach
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R 549 2 R_KON application/pdf S02986-OKCLP-2012-N30.pdf 15.5.2012 Detaily
R 307 1 R_KON application/pdf S02986_OKCLP_2012_LR_019.pdf 15.4.2012 Detaily Konanie o námietkach
R 543 2 R_KON application/pdf S02986-OKCLP-2012-N24.pdf 15.5.2012 Detaily
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R 542 2 R_KON application/pdf S02986-OKCLP-2012-N23.pdf 15.5.2012 Detaily
R 305 1 R_KON application/pdf S02986_OKCLP_2012_LR_017.pdf 15.4.2012 Detaily Konanie o námietkach
R 541 2 R_KON application/pdf S02986-OKCLP-2012-N22.pdf 15.5.2012 Detaily
R 304 1 R_KON application/pdf S02986_OKCLP_2012_LR_016.pdf 15.4.2012 Detaily Konanie o námietkach
R 540 2 R_KON application/pdf S02986-OKCLP-2012-N21.pdf 15.5.2012 Detaily
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R 552 2 R_KON application/pdf S02986-OKCLP-2012-N32.pdf 15.5.2012 Detaily
R 271 1 R_KON application/pdf S02986_OKCLP_2012_LU094.pdf 15.4.2012 Detaily Konanie o námietkach
R 538 2 R_KON application/pdf S02986-OKCLP-2012-N19.pdf 15.5.2012 Detaily
R 270 1 R_KON application/pdf S02986_OKCLP_2012_LU093.pdf 15.4.2012 Detaily Konanie o námietkach
R 269 1 R_KON application/pdf S02986_OKCLP_2012_LU091.pdf 15.4.2012 Detaily
R 539 2 R_KON application/pdf S02986-OKCLP-2012-N20.pdf 15.5.2012 Detaily
R 268 1 R_KON application/pdf S02986_OKCLP_2012_LU090.pdf 15.4.2012 Detaily Konanie o námietkach
R 267 1 R_KON application/pdf S02986_OKCLP_2012_LU089.pdf 15.4.2012 Detaily
R 266 1 R_KON application/pdf S02986_OKCLP_2012_LU088.pdf 15.4.2012 Detaily
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R 261 1 R_KON application/pdf S02986_OKCLP_2012_LS001.pdf 15.4.2012 Detaily
Vyjadrenia a pripomienky účastníkov konania a registrovaných používateľov
Autor: MVDr. Magdaléna Petrová - Novartis s.r.o. 
Zaslal: 23.4.2012 12:50:35
Nezohľadňovaný
Namietka voci rozhodnutiu S02986-OKCLP-2012/LR067
Autor: Zuzana Némethová, Ing - Biotika a.s. 
Zaslal: 21.3.2012 15:30:24
Nezohľadňovaný
Vyjadrenia za a.s. Biotika k ID návrhu 625
Autor: Dagmar Sarkar - Dr. Friedrich Eberth Arzneimittel GmbH 
Zaslal: 21.3.2012 14:57:05
Nezohľadňovaný
Zaslanie pripomienky za Dr.Friedrich Eberth Arzneimittel GmbH, Nemecko. Predchádzajúca príloha je neplatná. D. Sarkar
Autor: Dagmar Sarkar - Dr. Friedrich Eberth Arzneimittel GmbH 
Zaslal: 21.3.2012 14:50:31
Nezohľadňovaný
Zaslanie pripomienky za Dr.Friedrich Eberth Arzneimittel GmbH, Nemecko
Autor: Hana Spitzerová - Boehringer Ingelheim International GmbH 
Zaslal: 19.3.2012 23:37:29
Pripomienky ku konaniu číslo ID 625
Autor: MUDr. Branislav Obšitník - Abbott Laboratories Slovakia s.r.o. 
Zaslal: 19.3.2012 21:59:23
pripomienka ku konaniu
Autor: Jacqueline Pecimonova - Alcon Laboratories (UK) Ltd. 
Zaslal: 19.3.2012 21:49:24
Namietky voci konaniu ID625
Autor: Dana Ťažká - Bayer Schering Pharma AG 
Zaslal: 19.3.2012 20:36:31
Pripomienky voči konaniu ID625, ATC JO1MA14
Autor: Dana Ťažká - Bayer Pharma AG 
Zaslal: 19.3.2012 20:20:26
Pripomienky voči konaniu ID625, ATC B01AX06
Autor: Dana Ťažká - Bayer Pharma AG 
Zaslal: 19.3.2012 20:18:28
Pripomienky voči konaniu ID625, ATC C09CA07
Autor: Dana Ťažká - Bayer Pharma AG 
Zaslal: 19.3.2012 20:16:21
Pripomienky voči konaniu ID625, ATC JO1MA1
Autor: Mária Hanzelová - Les Laboratoires Servier 
Zaslal: 19.3.2012 19:29:43
Dobrý deň, v prílohe si dovoľujeme predoslať vyjadrenie k oznámeniu o začatí konania z podnetu MZ SR, ID návrhu 625, pre iné ako v skupine 1 až 3. S pozdravom M. Hanzelová
Autor: Mária Hanzelová - Les Laboratoires Servier 
Zaslal: 19.3.2012 19:28:45
Dobrý deň, v prílohe si dovoľujeme predoslať vyjadrenie k oznámeniu o začatí konania z podnetu MZ SR, ID návrhu 625, pre fixné kombinácie. S pozdravom M. Hanzelová
Autor: Mária Hanzelová - Les Laboratoires Servier 
Zaslal: 19.3.2012 19:27:55
Dobrý deň, v prílohe si dovoľujeme predoslať vyjadrenie k oznámeniu o začatí konania z podnetu MZ SR, ID návrhu 625, pre ACEI. S pozdravom M. Hanzelová
Autor: Mária Hanzelová - Les Laboratoires Servier 
Zaslal: 19.3.2012 19:27:00
Dobrý deň, v prílohe si dovoľujeme predoslať vyjadrenie k oznámeniu o začatí konania z podnetu MZ SR, ID návrhu 625, pre Protelos. S pozdravom M. Hanzelová
Autor: Ing. Petra Szilágyiová - Pfizer Europe MA EEIG 
Zaslal: 19.3.2012 19:07:56
Pripomienka k oznámeniu o začatí konania z podnetu ministerstva ID 625 za spoločnosť Pfizer Luxembourg SARL, organizačná zložka zástupca držiteľa Pfizer Europe MA EEIG, Veľká Británia
Autor: Dáša Pätoprstá - GlaxoSmithKline Slovakia s.r.o. 
Zaslal: 19.3.2012 19:06:49
Pripomienka k bodu 3 - Špecifické referenčné skupiny, v ktorých sú zaradené lieky s obsahom liečiv patriacich do ATC J01 antibakteriálne liečivá na systémové použitie. Žiadame zohľadniť špecifické indikácie pre Augmentin ES a Augmentin SR a nezlučovať ich s ostatnými antibiotikami liekmi s obsahom amoxicilínu/kyseliny klavulanovej. (1) Augmentin ES je suspenzné betalaktámové antibiotikum účinné aj na penicilín intermediálne citlivé a penicilín necitlivé kmene S. Pneumoniae a bol špeciálne vyvinutý na preklenutie rezistentných kmeňov S.pneumoniae PRE DETI už od 3 mesiacov. Augmentin ES obsahuje dvojnásobné množstvo amoxicilínu, pričom obsah kyseliny klavulánovej (potenciálny vyvolávateľ nežiaducich účinkov) ostáva rovnaký ako pri bežne používaných formách Augmentinu. (2) Augmentin SR je indikovaný na liečbu pneumónie získanej v komunite u dospelých a mladistvých vo veku aspoň 16 rokov, keď sa za príčinu alebo pravdepodobnú príčinu infekcie považuje Streptococcus pneumoniae rezistentný na penicilín. TABLETY S PREDĹŽENÝM UVOĽŇOVANÍM Augmentinu SR majú jedinečný FK/FD profil - hodnoty T>MIC získané po podaní Augmentinu SR nie je možné dosiahnuť po podaní rovnakej dávky tabliet Augmentinu SR s okamžitým uvoľňovaním. S pozdravom, Mgr. Ing. Dagmar Hroncová, Market Access Manager, MUDr.Pavol Trnovec, Corporate Affairs Director GSK Slovakia
Autor: Ing. Petra Szilágyiová - Pfizer Europe MA EEIG 
Zaslal: 19.3.2012 19:02:07
Pripomienka k oznámeniu o začatí konania z podnetu ministerstva ID 625 za spoločnosť Pfizer Luxembourg SARL, organizačná zložka zástupca držiteľa Pfizer Europe MA EEIG, Veľká Británia
Autor: Dáša Pätoprstá - GlaxoSmithKline Slovakia s.r.o. 
Zaslal: 19.3.2012 18:44:11
Námietky voči konaniu ID625, ATC R01AD08
Autor: Dáša Pätoprstá - Glaxo Group Limited 
Zaslal: 19.3.2012 18:41:56
Námietky voči konaniu ID625, ATC R01AD12
Autor: Ing. Miroslav Dedík - Schering-Plough Europe (SP Europe) 
Zaslal: 19.3.2012 17:53:17
Dobrý deň, v prílohe posielam vyjadrenie k oznámeniu o začatí konania z podnetu MZ SR, ID návrhu 625. S pozdravom M. Dedík
Autor: Mgr. Helena Plesníková - Zentiva k.s. 
Zaslal: 19.3.2012 17:52:28
Dovoľujeme si podať pripomienku k bodu 4. Referenčné skupiny iné ako podľa položiek č. 1 až 3Zmena maximálnej výšky úhrady zdravotnej poisťovne za štandardnú dávku liečiva. Tak, aby podiel maximálnej výšky doplatku poistenca za referenčný liek a maximálnej ceny referenčného lieku vo verejnej lekárni zostal nezmenený v porovnaní s podielom k 1. januáru 2012. Žiadame o stanovenie výšky úhrady pre molekulu Risedronát na úroveň 0,2254€/ŠDL. Osteoporóza predstavuje závažné ochorenie z celospoločenského hľadiska, nielen z pohľadu nákladov na zdravotníctvo, ale aj života spoločnosti (liečba zlomenín, predčasné úmrtia). V roku 2011 sa lieky používané v liečbe osteoporózy podieľali na celkových nákladoch na lieky na Slovensku na úrovni 1,34 % (IMS údaje v cenách výrobcov 18,76 mil. Euro vs. 1 402,32 mil. Euro). Podiel risedronátov na celkových nákladoch na lieky na Slovensku v roku 2011 bol 0,20 % (2,87 milióna Euro) a ibandronátov v príslušnom období 0,40 % (5,63 milióna Euro) (IMS údaje v cenách výrobcov). Ak budeme hovoriť o nákladoch na lieky, musíme si taktiež uvedomiť, čo znamená neliečená, alebo nesprávne liečená osteoporóza. Náklady na liečbu osteoporotických zlomenín (napr. stavce chrbtice, zápästie, bedrový kĺb), hospitalizácia, obmedzenie pohyblivosti a sebestačnosti pacienta, čo sa premietne do zvýšených nákladov spoločnosti na sociálnu starostlivosť), predčasné úmrtia. Len pre lepšiu ilustráciu uvádzame ako príklad zlomeniny bedrového kĺbu, ktoré predstavujú asi 14% zo všetkých zlomenín, avšak z hľadiska nákladov na liečbu je to až 72 % (Burge, R. et al. (2007): J. Bone Miner. Res., 22, 465-475). Analýzy ukazujú taktiež na vyššiu úmrtnosť pacientov s týmto typom zlomenín. Napríklad vo vekovej skupine 60-nikov ide o stratu 10-11 rokov života, čo zjavne predstavuje výrazné skrátenie očakávaného dožitia našich starších spoluobčanov (Center, J.R. (2010): Curr. Osteoporos. Rep., 8, 227-234). Zavedenie 2. najnižšej ceny v EÚ bude znamenať obmedzenie dostupnosti celej skupiny liekov na báze liečiva risedronátu (ďalej len risedronáty), nakoľko dôjde k reexportu zo Slovenska do krajín EÚ a tiež k stiahnutiu týchto liekov zo slovenského trhu v dôsledku systému referenčných cien v rámci Európy. Spoločnosť Teva ako iniciátor, ktorá vstupuje s návrhom konečnej ceny v lekárni od 1. 5. 2012 napríklad pre svoj liek Risendros Teva tbl flm 12x35 mg (risedronát) 6,05 Euro. Podiel firmy Teva na trhu s risedronátmi bol 21,6 % v roku 2011 (IMS údaje). Je zrejme, že ostatní výrobcovia budú musieť reagovať na uvedený cenový návrh. Pri tak dramatickom poklese ceny stiahnutím svojich liekov – risedronátov zo slovenského trhu. Náhradou za lieky - risedronáty sú lieky s liečivom ibandronát (ďalej len ibandronáty), ktorých cena v súčasnosti je oveľa vyššia. Spoločnosť Teva nemá kapacity na vykrytie celého trhu s risedronátom, preto prestavenie asi 70 % pacientov na ibandronáty bude mať dramatický vplyv na náklady zdravotného systému z ekonomického hľadiska. Pre porovnanie uvádzame návrh výšky úhrady zdravotnou poisťovňou za dennú dávku liečiva (návrh k 1. aprílu 2012): risendronát tablety 0,315 Euro, ibandronát tablety 0,610 Euro. Cenový rozdiel sa lepšie zviditeľní, ak si porovnáme podiel risedronátov a ibandronátov na celkovej spotrebe liekov na liečbu osteoporózy v roku 2011: v objeme risedronáty 17,56 % a ibandronáty 17,75 %, vo financiach risedronáty 7,64 % a ibadronáty 13,59 % (IMS údaje v cenách výrobcov), pri rovnakom objeme výrazný rozdiel vo vynaložených finančných prostriedkoch na uvedené lieky. Hypotetická úspora za obdobie máj-december 2012 za predpokladu návrhov úhrad k 1. aprílu a 1. máju 2012, ak predpokladáme rovnaký objem spotreby risedronátov v roku 2012 ako v roku 2011, by bola 1,27 milióna Euro. V skutočnosti v dôsledku uvedených zmien v legislatíve a prechodu 70 % pacientov na liečbu ibandronátmi (vyššia cena) by náklady narástli o 1,70 milióna Euro, celkove by došlo k nárastu o 0,43 milióna Euro. Druhou stranou problému sú medicínske a právne aspekty danej veci. V zmysle slovenských (aj európskych) zákonov, lieky musia byť predpisované len na tie ochorenia, na ktoré boli schválené príslušnými liekovými agentúrami (ide o tzv. terapeutické indikácie), čo má svoje opodstatnenie, lebo ich účinok bol študovaný len u týchto ochorení. Ibandronáty na rozdiel od risedronátov nemajú schválené použitie v prevencii osteoporotických zlomenín bedrového kĺbu. Alternatívne by sa museli používať lieky ešte s vyššou cenou ako je ibandronát. Z ekonomického pohľadu by došlo k zjavnému paradoxu, pri vyšších nákladoch na liečbu osteoporózy, by spoločnosť dosahovala horšie výsledky, čo v konečnom dôsledku by viedlo k zvýšeným nákladom na liečbu osteoporotických zlomenín bedrového kĺbu. V tomto prípade by časť pacientov musela byť liečená biologickou liečbou (liečivo denosumab). Pre porovnanie uvádzame návrh výšky úhrady zdravotnou poisťovňou za dennú dávku liečiva (návrh k 1. aprílu 2012): risendronát 0,315 Euro, denosumab 1,223 Euro. Pre názornejšie porovnanie podiel risedronátov a denosumabu na celkovej spotrebe liekov na liečbu osteoporózy v roku 2011: v objeme risedronáty 17,56 % a denosumab 6,25 %, vo financiach risedronáty 7,64 % a denosumab 8,78 %. Ak predpokladáme platnosť návrhov úhrad k 1. aprílu a 1. máju 2012 a predpokladáme, že by 35% pacientov z risedronátov prešlo na liečbu denosumabom a 35% z risedronátov by prešlo na liečbu ibandronátmi, potom by došlo k celkovému nárastu nákladov o 2,97 milióna Euro pri zohľadnení poklesu ceny risedronátov.
Autor: Ing. Miroslav Dedík - Merck Sharp & Dohme Ltd. 
Zaslal: 19.3.2012 17:52:06
Dobrý deň, v prílohe posielam vyjadrenie k oznámeniu o začatí konania z podnetu MZ SR, ID návrhu 625. S pozdravom M. Dedík
Autor: Mgr. Helena Plesníková - Zentiva k.s. 
Zaslal: 19.3.2012 17:51:12
Dovoľujeme si podať pripomienku k bodu 2. Určenie skupinových úhrad podľa § 5 vyhlášky Ministerstva zdravotníctva Slovenskej republiky č. 435/2011 Z. z. o spôsobe určenia štandardnej dávky liečiva a maximálnej výšky úhrady zdravotnej poisťovne za štandardnú dávku liečiva (ďalej len „vyhláška“) Vytvorenie samostatnej úhradovej skupiny pre liečivo Rosuvastatín: Navrhujeme zaradenie liečiva Rosuvastatín do samostatnej skupiny nakoľko v porovnaní s ostatnými statínmi prináša signifikantne vyššiu hypolipidemickú účinnosť, vyššie percento pacientov dosahujúcich cieľové hladiny lipidov. Rosuvastatín je nový vysoko hepatoselektívny statín, ktorý účinnne znižuje hladiny LDL cholesterolu, triacylglycerolov a významne zvyšuje aj hladiny HDL cholesterolu. Pri porovnateľnej bezpečnosti vedie jeho podávanie k dosiahnutiu cieľo¬vých hladín lipidov u väčšieho počtu liečených pacientov ako ostatných statínoch. Výborná účinnosť a bez¬pečnosť Rosuvastatínu, potvrdená v predklinických a klinických sledovaniach (vid. Prílohy), ktorá významne znižuje kardiovaskulárne riziko potvrdzuje fakt , že Rosuvastatin by mal byt vyčlenený z úhradovej skupiny ostatných statínov s vyššou stanovenou úhradou za štandardnú dávku liečiva. Vytvorenie samostatnej úhradovej skupiny pre liečivo Telmisartan: Navrhujeme zaradenie liečiva Telmisartan do samostatnej skupiny nakoľko Telmisartan má na rozdiel od iných sartanov potvrdenú účinnosť v sekundárnej prevencii u pacientov s ischemickou chorobou srdca, s ischemickou chorobou dolných končatín po CMP a s diabetom mellitom a orgánovým postihnutím. Telmisartan je antihypertentivum s dávkovaním jeden krát denne a s 24hodinovým antihypertenzívnym účinkom. Liečba telmisartanom poskytuje pacientom lepšiu ochranu obličiek, mozgu a srdca pred kardiovaskulárnymi príhodami a zároveň lepšiu 24-hodinovú kontrolu krvného tlaku, a to aj v kritických ranných hodinách. Výsledky štúdií hovoria aj o tom, že pacienti liek lepšie znášajú, vid priloha. Z uvedených dôvodov žiadame, aby bol Telmisartan byt vyčlenený z úhradovej skupiny ostatných sartanov s vyššou stanovenou úhradou za štandardnú dávku liečiva.
Autor: Miloš Živanský - Bial - Portela & CA, S.A. 
Zaslal: 19.3.2012 16:48:06
Pripomienka ku Konaniu z podnetu MZ SR ID625 Spoločnosť BIAL - Portela & Ca , SA, `A Av. da Siderurgia Nacional N.A., Mamede do Coronado, 4745-457, Portugalská republika, zastúpená Eisai GesmbH - organizačná zložka, Moskovská 13, 811 08 Bratislava, splnomocnenou osobou MUDr. Miloš Živanský, MBA (ďalej len: "účastník konania") podáva pripomienku voči konaniu z podnetu MZ SR ID625