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}, "increaseAfterModifications": { "currency": "" }, "validationState": 0 }, "contractAwardsDefence": [], "hilmaStatistics": { "energyEfficiencyConsidered": false, "lowCarbon": false, "circularEconomy": false, "biodiversity": false, "sustainableFoodProduction": false, "justWorkingConditions": false, "employmentCondition": false, "codeOfConduct": false, "innovationConsidered": false, "solutionNewToBuyer": false, "solutionNewToMarketOrIndustry": false, "smeParticipationConsidered": false, "validationState": 2 }, "annexes": { "d1": { "noTenders": false, "procedureType": 0, "suppliesManufacturedForResearch": false, "providedByOnlyParticularOperator": true, "reasonForNoCompetition": 4, "extremeUrgency": false, "additionalDeliveries": false, "repetitionExisting": false, "designContestAward": false, "commodityMarket": false, "advantageousTerms": false, "advantageousPurchaseReason": 0, "justification": [ "Kyseess\u00e4 on suorahankinta. Suorahankintaperusteena on (1397\/2016) HL 40 \u00a7 2 mom 2: \"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\". ", "", "Markkinoilla on vain yksi SMA1-taudin hoitoon hyv\u00e4ksytty geeniterapiahoito onasemnogeeniabeparvoveekkivalmiste, Zolgensma\u00ae. Zolgensma\u00ae on tarkoitettu 5q spinaalista lihasatrofiaa (SMA) sairastavien potilaiden hoitoon, joilla on SMN1-geenin bialleelinen mutaatio ja tyypin 1 SMA:n kliininen diagnoosi, tai - 5q spinaalista lihasatrofiaa (SMA) sairastavien potilaiden hoitoon, joilla on SMN1-geenin bialleelinen mutaatio ja enint\u00e4\u00e4n 3 SMN2-geenin kopiota, hoitoon. ", "", "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 Zolgensma\u00ae, se ei ole geeniterapiavalmiste, ja se eroaa ratkaisevasti Zolgensmasta\u00ae mm. antotavan ja -tiheyden, vaikutuksen keston sek\u00e4 mahdollisten haittavaikutusten osalta. Nusinerseenia annostellaan selk\u00e4ytimeen useita kertoja vuodessa potilaan koko elini\u00e4n ajan. Zolgensma\u00ae puolestaan on laskimoinfuusiona annosteltava kertahoito. Kansallinen l\u00e4\u00e4keneuvottelukunta puoltaa Zolgensma\u00ae-valmisteen k\u00e4ytt\u00f6\u00e4 neuvotellulla hinnalla.", "", "Hankinnan arvioitu arvo on t\u00e4m\u00e4nhetkisen tukkuhinnan mukaan arvioituna noin 4 milj. \u20ac (ALV 0 %). Yrityksen kanssa on neuvoteltu erillinen riskinjakosopimus, joten hankinnan todellinen ennakoitu arvonlis\u00e4veroton arvo tulee olemaan t\u00e4t\u00e4 tukkuhintaa alhaisempi.", "", "" ] }, "d2": { "noTenders": false, "pureResearch": false, "providedByOnlyParticularOperator": false, "reasonForNoCompetition": 0, "extremeUrgency": false, "additionalDeliveries": false, "repetitionExisting": false, "designContestAward": false, "commodityMarket": false, "advantageousTerms": false, "advantageousPurchaseReason": 0, "bargainPurchase": false, "justification": [] }, "d3": { "noTenders": false, "procedureType": 0, "otherServices": false, "productsManufacturedForResearch": false, "allTenders": false, "providedByOnlyParticularOperator": false, "reasonForNoCompetition": 0, "crisisUrgency": false, "extremeUrgency": false, "additionalDeliveries": false, "repetitionExisting": false, "commodityMarket": false, "advantageousTerms": false, "advantageousPurchaseReason": 0, "maritimeService": false, "otherJustification": 0, "justification": [] }, "d4": { "noTenders": false, "providedByOnlyParticularOperator": false, "reasonForNoCompetition": 0, "justification": [] }, "directNational": { "purchaseType": 0, "justification": [] } }, "departmentId": "0270b656-75cc-4bd6-dbac-08d7b9e592ec", "isPrivateSmallValueProcurement": false, "espdRequestReferences": [], "hilmaSubmissionDate": "2022-06-06T09:40:36.320376", "dateCreated": "2022-06-01T11:57:55.9358627", "dateModified": "2022-06-10T07:00:06.3434008" }