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"reasonDescriptionEconomic": [], "reasonDescriptionCircumstances": [], "increaseBeforeModifications": { "currency": "" }, "increaseAfterModifications": { "currency": "" }, "validationState": 0 }, "contractAwardsDefence": [], "hilmaStatistics": { "validationState": 0 }, "annexes": { "d1": { "noTenders": false, "procedureType": 0, "suppliesManufacturedForResearch": false, "providedByOnlyParticularOperator": true, "reasonForNoCompetition": 1, "extremeUrgency": false, "additionalDeliveries": false, "repetitionExisting": false, "designContestAward": false, "commodityMarket": false, "advantageousTerms": false, "advantageousPurchaseReason": 0, "justification": [ "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.", "", "Spinaalinen lihasatrofia (SMA) on harvinainen perinn\u00f6llinen neuro-muskulaarinen sairaus, jossa selk\u00e4ytimen hermosolujen vaurioituessa toimintak\u00e4skyt eiv\u00e4t etene lihaksiin. SMA-taudin esiintyvyyden on arvioitu olevan noin 9,4 tapausta 100 000 el\u00e4v\u00e4n\u00e4 syntynytt\u00e4 lasta kohti. Suomessa syntyy muutama SMA-lapsi joka vuosi. SMA-taudissa on useita alaryhmi\u00e4, jotka m\u00e4\u00e4ritell\u00e4\u00e4n SMA2-geenin kopioiden lukum\u00e4\u00e4r\u00e4n, kliinisen kuvan ja sairastumisi\u00e4n perusteella. SMA1 on eritt\u00e4in vaikea, varhaisessa lapsuusi\u00e4ss\u00e4 kuolemaan johtava sairaus. Arviolta 60% uusista SMA-tapauksista on SMA1-tyyppi\u00e4. ", "", "SMA1-taudin hoitoon on olemassa ja markkinoilla geeniterapiahoito onasemnogeeniabeparvoveekki (Zolgensma\u00ae). Se on saanut myyntiluvan toukokuussa 2020. Myyntiluvan mukaan se on tarkoitettu SMA-tautia sairastaville potilaille, joilla on SMN1-geenin bialleelinen mutaatio, ja joko SMA1:n kliininen diagnoosi tai enint\u00e4\u00e4n kolme SMN2-geenin kopiota. Kyseess\u00e4 on kertahoito, joka annetaan laskimoinfuusiona. ", "", "Onasemnogeeniabeparvoveekkia ei voi sairaalak\u00e4yt\u00f6ss\u00e4 ja sairaalan l\u00e4\u00e4kevalikoimassa korvata mill\u00e4\u00e4n toisella saatavissa olevalla myyntiluvallisella valmisteella. SMA-taudin hoitoon on aikaisemmin Euroopassa hyv\u00e4ksytty nusinerseeni-l\u00e4\u00e4ke vuonna 2017, mutta toisin kuin onasemnogeeniabeparvoveekki , se ei ole geeniterapiavalmiste, ja se eroaa ratkaisevasti onasemnogeeniabeparvoveekista mm. antotavan ja -tiheyden, vaikutuksen keston sek\u00e4 mahdollisten haittavaikutusten osalta. Nusinerseenia annostellaan selk\u00e4ytimeen useita kertoja vuodessa potilaan koko elini\u00e4n ajan. Onasemnogeeniabeparvoveekki puolestaan on laskimoinfuusiona annosteltava kertahoito. Onasemnogeeniabeparvoveekki ja nusinerseeni eiv\u00e4t siis tosiasiallisesti kilpaile kesken\u00e4\u00e4n, vaikka niiden avulla hoidetaan samaa potilasryhm\u00e4\u00e4.", "", "Zolgensma\u00ae 2 \u00d7 10\u00b9\u00b3 vg\/ml infuusioneste 5,5ml\u00ae on l\u00e4\u00e4kealan turvallisuus- ja kehitt\u00e4miskeskus Fimean mukaan ainoa markkinoilla oleva myyntiluvallinen onasemnogeeniabeparvoveekkivalmiste Suomessa. Sen myyntiluvanhaltija ja edustaja Suomessa on Novartis Gene Therapies EU Limited. 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