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"Kyseess\u00e4 on suorahankinta. Voimassaolevan hankintalains\u00e4\u00e4d\u00e4nn\u00f6n (1397\/2016) 40 \u00a7 2 mom 2 kohdan mukaan hankintayksikk\u00f6 voi valita suorahankinnan, mik\u00e4li teknisest\u00e4 tai yksinoikeuden suojaamiseen liittyv\u00e4st\u00e4 syyst\u00e4 vain tietty toimittaja voi toteuttaa hankinnan; lis\u00e4edellytyksen\u00e4 on, ett\u00e4 j\u00e4rkevi\u00e4 vaihtoehtoisia tai korvaavia ratkaisuja ei ole eik\u00e4 kilpailun puuttuminen johdu hankinnan ehtojen keinotekoisesta kaventamisesta. ",
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"Neuronaalinen seroidilipofuskinoosi on joukko neurodegeneratiivisia lysosomaalisia sairauksia, joille on ominaisia vaikealiukoisten rappeumav\u00e4riaineiden (seroidi, lipofuskiini) kertyminen kudoksiin ja aivojen surkastuminen. N\u00e4m\u00e4 luokitellaan eri tyyppeihin sairauden alkamisajankohdan sek\u00e4 puutteellisesti toimivan geenin mukaan. Tyypin 2 neuronaalista seroidilipofuskinoosia (CLN2) sairastavilta potilailta puuttuu tripeptidyylipeptidaasi 1 (TPP1) -entsyymi. T\u00e4t\u00e4 lysosomaalista entsyymi\u00e4 tarvitaan aivojen normaaliin kehittymiseen. CLN2-tautiin ei ole parantavaa hoitoa, vaan hoito on oireenmukaista ja palliatiivista tukihoitoa.",
"",
"Serliponaasi alfa on ainoa hyv\u00e4ksytty CLN2-taudin hoitoon tarkoitettu l\u00e4\u00e4ke. Terveydenhuollon palveluvalikoimaneuvosto (Palko) on syyskuussa 2021 antanut Suomessa suosituksen, jonka mukaan serliponaasi alfa kuuluu julkisesti rahoitettuun terveydenhuollon palveluvalikoimaan tietyin edellytyksin. Kansallinen l\u00e4\u00e4keneuvottelukunta puoltaa k\u00e4ytt\u00f6\u00e4 neuvotellulla hinnalla.",
"",
"EU:n markkinoilla on vain yksi serliponaasi alfa -valmiste, Brineura\u00ae. Brineura\u00ae on tarkoitettu neuronaalisen seroidilipofuskinoosi tyyppi 2:n (CLN2), toiselta nimelt\u00e4\u00e4n tripeptidyylipeptidaasi 1:n (TPP1) puute, hoitoon. Serliponaasi alfa annostellaan infuusiona aivo-selk\u00e4ydinnesteeseen kirurgisesti implantoidun s\u00e4ili\u00f6n ja katetrin (aivokammioon asennettava annostelulaite) kautta joka toinen viikko. ",
"",
"Helsingin ja Uudenmaan sairaanhoitopiiri hankkii Brineura\u00ae 150 mg 5ml infuusionesteliuosta BioMarin International Limitedilt\u00e4 aikav\u00e4lill\u00e4 12.4.2022\u2013 11.4.2024 sek\u00e4 mahdollisen optiovuoden (12.4.2024-11.4.2025) ajan. Hankinnan arvioitu arvo on noin 3,0 milj.\u20ac (ALV 0 %). BioMarin International Limitedin kanssa on neuvoteltu erillinen sopimushinta em. aikav\u00e4lille, joten hankinnan todellinen ennakoitu arvonlis\u00e4veroton arvo on t\u00e4t\u00e4 tukkuhintaa alhaisempi.",
"",
""
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