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"reason": 0, "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": [ "Voimassa olevan hankintalains\u00e4\u00e4d\u00e4nn\u00f6n (1397\/2016) viidennen luvun 40 \u00a7:n 2 momentin 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.", "", "Suomen markkinoilla on vain yksi myyntiluvallinen enfortumabi-vedotiinivalmiste (Padcev, kuiva-aine v\u00e4likonsentraatiksi infuusionestett\u00e4 varten, liuos 20 mg, 30 mg), joka on tarkoitettu monoterapiana sellaisten aikuispotilaiden hoitoon, joilla on paikallisesti edennyt tai metastaattinen uroteelisy\u00f6p\u00e4 ja jotka ovat aikaisemmin saaneet platinaa sis\u00e4lt\u00e4v\u00e4\u00e4 kemoterapiaa ja ohjelmoituneen solukuoleman reseptori 1 tai ohjelmoituneen solukuoleman ligandi 1 -est\u00e4j\u00e4\u00e4.", "", "Enfortumabi-vedotiini kuuluu kansalliseen palveluvalikoimaan paikallisesti edenneen tai et\u00e4pes\u00e4kkeisen uroteelikarsinooman hoidossa hyv\u00e4kuntoisilla aikuispotilailla, jotka ovat aiemmin saaneet platinapohjaista solunsalpaajaa ja PD-1 \/PD-L1 -vasta-ainetta. Palveluvalikoimaan kuuluminen edellytt\u00e4\u00e4, ett\u00e4 myyntiluvan haltija ja ostaja sopivat merkitt\u00e4v\u00e4sti julkista tukkumyyntihintaa alemmasta hinnasta.", "", "Hankinnan arvioitu arvo on noin 1 100 000 \u20ac (ALV 0 %) tukkuhinnan mukaan arvioituna. Astellas Pharman kanssa on neuvoteltu erillinen sopimushinta edell\u00e4 mainitulle aikav\u00e4lille, joten hankinnan todellinen ennakoitu arvonlis\u00e4veroton arvo on 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": "f475b0c1-8f17-4240-ed72-08da84cd3439", "isPrivateSmallValueProcurement": false, "espdRequestReferences": [], "hilmaSubmissionDate": "2023-03-27T07:18:12.7844427", "dateCreated": "2023-03-22T08:40:51.9677798", "dateModified": "2023-03-31T07:00:04.9935345" }