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Valmiste on tarkoitettu hyv\u00e4kuntoisille (WHO 0 \u2013 1) uusiutunutta tai hoitoon reagoimatonta manttelisolulymfoomaa sairastaville aikuisille, joita on hoidettu v\u00e4hint\u00e4\u00e4n kahdella aiemmalla hoitolinjalla, joihin sis\u00e4ltyy hoito Brutonin tyrosiinikinaasin (BTK) est\u00e4j\u00e4ll\u00e4. Hankintayksikk\u00f6 on tehnyt tapauskohtaisen arvioinnin, ja todennut, ett\u00e4 perusteet suorahankintaan ovat olemassa. Suorahankintap\u00e4\u00e4t\u00f6s on voimassa 11.10.2022 \u2013 31.12.2024 v\u00e4lisen ajan." ], "disagreeAwardCriteriaToBePublished": false, "awardCriteria": { "criterionTypes": 4, "qualityCriteria": [], "costCriteria": [], "priceCriterion": {}, "criterion": [ "" ], "criteriaStatedInProcurementDocuments": false }, "estimatedValue": { "type": 0, "currency": "EUR", "disagreeToBePublished": false, "doesNotExceedNationalThreshold": false }, "timeFrame": { "type": 0, "canBeRenewed": false, "renewalDescription": [] }, "candidateNumberRestrictions": { "envisagedNumber": 0, "envisagedMinimumNumber": 0, "envisagedMaximumNumber": 0, "objectiveCriteriaForChoosing": [], "selected": 0 }, "optionsAndVariants": { "variantsWillBeAccepted": false, "partialOffersWillBeAccepted": false, "options": false, "optionsDescription": [], "optionType": 0 }, "tendersMustBePresentedAsElectronicCatalogs": false, "euFunds": { "procurementRelatedToEuProgram": false, "projectIdentification": [] }, "additionalInformation": [], "awardContract": { "contractAwarded": 1, "noAwardedContract": { "failureReason": 0, "originalNoticeSentVia": 0, "originalEsender": { "login": "", "customerLogin": "", "tedNoDocExt": "" }, "originalNoticeSentViaOther": "" }, "awardedContracts": [ { "conclusionDate": "2022-10-18T00:00:00", "contractNumber": "2022-113576-001-001", "contractTitle": "Sopimus Tecartus-valmisteen hinnasta", "numberOfTenders": { "disagreeTenderInformationToBePublished": false, "total": 1 }, "disagreeContractorInformationToBePublished": false, "contractors": [ { "officialName": "Gilead Sciences Finland Oy", "nationalRegistrationNumber": "", "nutsCodes": [ "FI1B" ], "postalAddress": { "streetAddress": "", "postalCode": "", "town": "Vantaa", "country": "FI" }, "telephoneNumber": "", "email": "", "mainUrl": "", "isSmallMediumEnterprise": false, "validationState": 0 } ], "initialEstimatedValueOfContract": { "currency": "EUR" }, "finalTotalValue": { "type": 2, "minValue": 1, "maxValue": 1800000, "currency": "EUR", "disagreeToBePublished": false, "doesNotExceedNationalThreshold": false }, "likelyToBeSubcontracted": false, "valueOfSubcontract": { "currency": "EUR" }, "subcontractingDescription": [], "exAnteSubcontracting": { "allOrCertainSubcontractsWillBeAwarded": false, "shareOfContractWillBeSubcontracted": false }, "pricePaidForBargainPurchases": { "currency": "" }, "notPublicFields": { "communityOrigin": false, "nonCommunityOrigin": false, "countries": [], "awardedToTendererWithVariant": false, "abnormallyLowTendersExcluded": false }, "concessionRevenue": { "currency": "" }, "pricesAndPayments": { "currency": "" }, "concessionValueAdditionalInformation": [] } ] }, "qualificationSystemDuration": { "type": 0, "renewal": false, "necessaryFormalities": [] }, "validationState": 2 } ], "communicationInformation": { "procurementDocumentsAvailable": 0, "procurementDocumentsUrl": "", "additionalInformation": 0, "additionalInformationAddress": { "nutsCodes": [], "postalAddress": {}, "validationState": 0 }, "otherAddressForProcurementDocuments": { "officialName": "", "nationalRegistrationNumber": "", "department": "", "nutsCodes": [], "postalAddress": { "streetAddress": "", "postalCode": "", "town": "", "country": "" }, "telephoneNumber": "", "email": "", "contactPerson": "", "mainUrl": "", "validationState": 0 }, "sendTendersOption": 0, "addressToSendTenders": { "nutsCodes": [], "postalAddress": {}, "validationState": 0 }, "electronicCommunicationRequiresSpecialTools": false, "electronicCommunicationInfoUrl": "", "documentsEntirelyInHilma": false, "specsAndAdditionalDocuments": 0, "specsAndAdditionalDocumentsAddress": { "nutsCodes": [], "postalAddress": {}, "validationState": 0 }, "electronicAccess": "", "validationState": 2 }, "contactPerson": { "name": "", "email": "[email protected]", "phone": "" }, "procurementObject": { "shortDescription": [ "Breksukabtageeni autoleuseeli-valmisteen (Tecartus\u00ae 0,4 \u2013 2 \u00d7 100 000 000 solua infuusioneste, dispersio) hankinta 11.10.2022\u2013 31.12.2024 valmisteyhteenvedon ja Terveydenhuollon palveluvalikoimaneuvoston (Palko) suosituksen (1.9.2021) mukaiseen k\u00e4ytt\u00f6\u00f6n hyv\u00e4kuntoisille (WHO 0 \u2013 1) uusiutunutta tai hoitoon reagoimatonta manttelisolulymfoomaa sairastaville aikuisille, joita on hoidettu v\u00e4hint\u00e4\u00e4n kahdella aiemmalla hoitolinjalla, joihin sis\u00e4ltyy hoito Brutonin tyrosiinikinaasin (BTK) est\u00e4j\u00e4ll\u00e4. 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"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\".", "", "Suomen markkinoilla on vain yksi myyntiluvallinen Breksukabtageeni autoleuseeli-valmiste (Tecartus \u00ae 0,4 -2 \u00d7 100 000 000 solua infuusioneste, dispersio), joka on tarkoitettu hyv\u00e4kuntoisille (WHO 0 \u2013 1) uusiutunutta tai hoitoon reagoimatonta manttelisolulymfoomaa sairastaville aikuisille, joita on hoidettu v\u00e4hint\u00e4\u00e4n kahdella aiemmalla hoitolinjalla, joihin sis\u00e4ltyy hoito Brutonin tyrosiinikinaasin (BTK) est\u00e4j\u00e4ll\u00e4. ", "", "Breksukabtageeni autoleuseeli (Tecartus\u00ae) kuuluu kansalliseen palveluvalikoimaan Terveydenhuollon palveluvalikoimaneuvoston (Palko) suosituksen (15.12.2021) mukaisessa k\u00e4yt\u00f6ss\u00e4. Palveluvalikoimaan kuuluminen edellytt\u00e4\u00e4, ett\u00e4 myyntiluvan haltija ja ostaja sopivat merkitt\u00e4v\u00e4sti julkista tukkumyyntihintaa alemmasta hinnasta.", "", "Hankinnan arvioitu arvo on t\u00e4m\u00e4nhetkisen tukkuhinnan mukaan arvioituna noin 1,8 milj. \u20ac (ALV 0 %). Yrityksen kanssa neuvotellaan erillinen riskinjakosopimus vuosille 2022-2024, joten hankinnan todellinen 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": "2022-11-18T08:58:08.834753", "dateCreated": "2022-11-18T08:19:18.8124707", "dateModified": "2022-11-23T08:00:05.3245478" }