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{}, "validationState": 0 }, "electronicCommunicationRequiresSpecialTools": false, "electronicCommunicationInfoUrl": "", "documentsEntirelyInHilma": false, "specsAndAdditionalDocuments": 0, "specsAndAdditionalDocumentsAddress": { "nutsCodes": [], "postalAddress": {}, "validationState": 0 }, "electronicAccess": "", "validationState": 2 }, "contactPerson": { "name": "Pirkanmaan sairaanhoitopiirin sairaala-apteekki", "email": "[email protected]", "phone": "" }, "procurementObject": { "shortDescription": [ "Suorahankinta koskee nusinerseeni-injektionestett\u00e4 Spinraza\u00ae (ATC-koodi M09AX07) kromosomiin 5q liittyv\u00e4n spinaalisen lihasatrofian hoitoon." ], "estimatedValue": { "type": 0, "currency": "EUR", "disagreeToBePublished": false, "doesNotExceedNationalThreshold": false }, "estimatedValueCalculationMethod": [], "mainCpvCode": { "code": "33000000", "name": "L\u00e4\u00e4ketieteelliset laitteet, farmaseuttiset valmisteet ja henkil\u00f6kohtaiseen hygieniaan liittyv\u00e4t 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false, "electronicAuctionWillBeUsed": false, "additionalInformationAboutElectronicAuction": [], "namesOfParticipantsAlreadySelected": [], "procurementGovernedByGPA": true, "criteriaForEvaluationOfProjects": [], "disagreeCriteriaForEvaluationOfProjectsPublish": false, "urlNationalProcedure": "", "mainFeaturesAward": [], "defence": { "candidateNumberRestrictions": { "envisagedNumber": 0, "envisagedMinimumNumber": 0, "envisagedMaximumNumber": 0, "objectiveCriteriaForChoosing": [], "selected": 0 }, "awardCriteria": { "criterionTypes": 0, "economicCriteriaTypes": 0, "criteria": [] } }, "national": { "otherProcedure": [], "additionalProcedureInformation": [], "transparencyType": 0, "limitedNumberOfParticipants": false, "numberOfParticipants": 0, "selectionCriteria": [] }, "validationState": 2 }, "tenderingInformation": { "languages": [], "tendersMustBeValidOption": 0, "tenderOpeningConditions": { "place": [], "informationAboutAuthorisedPersons": [] }, "defence": { "previousPublicationExists": false, "previousPriorInformationNoticeOjsNumber": { "number": "" }, "hasPreviousContractNoticeOjsNumber": false, "previousContractNoticeOjsNumber": { "number": "" }, "hasPreviousExAnteOjsNumber": false, "previousExAnteOjsNumber": { "number": "" }, "payableDocuments": false, "documentPrice": { "currency": "" }, "paymentTermsAndMethods": [], "languageType": 0, "languages": [], "otherLanguage": false, "otherLanguages": "" }, "estimatedExecutionTimeFrame": { "type": 0, "canBeRenewed": false, "renewalDescription": [] }, "validationState": 0 }, "rewardsAndJury": { "prizeAwarded": false, "numberAndValueOfPrizes": [], "detailsOfPayments": [], "serviceContractAwardedToWinner": false, "decisionOfTheJuryIsBinding": false, "namesOfSelectedMembersOfJury": [], "validationState": 0 }, "resultsOfContest": { "contestWasTerminated": false, "noPrizeType": 0, "originalNoticeSentVia": 0, "originalEsender": { "login": "", "customerLogin": "", "tedNoDocExt": "" }, "originalNoticeSentViaOther": "", "participantsContemplated": 0, "participantsSme": 0, "participantsForeign": 0, "disagreeParticipantCountPublish": false, "winners": [], "disagreeWinnersPublish": false, "valueOfPrize": { "currency": "" }, "disagreeValuePublish": false, "validationState": 0 }, "tedNoDocExt": "2022-099183", "attachments": [], "hasAttachments": false, "changes": [], "isCorrigendum": false, "isMigrated": false, "isCancelled": false, "isContractAwardCancellationNotice": false, "cancelledReason": [], "isLatest": true, "language": "FI", "proceduresForReview": { "reviewBody": { "officialName": "Markkinaoikeus", "nationalRegistrationNumber": "", "department": "", "nutsCodes": [], "postalAddress": { "streetAddress": "S\u00f6rn\u00e4istenkatu 1", "postalCode": "00580", "town": "Helsinki", "country": "FI" }, "telephoneNumber": "+358 295643300", "email": "[email protected]", "contactPerson": "", "mainUrl": "http:\/\/www.oikeus.fi\/markkinaoikeus", "validationState": 0 }, "reviewProcedure": [], "validationState": 2 }, "attachmentInformation": { "description": [], "links": [], "validationState": 2 }, "modifications": { "mainCpvCode": { "code": "", "name": "", "vocCodes": [] }, "additionalCpvCodes": [], "nutsCodes": [], "mainsiteplaceWorksDelivery": [], "descrProcurement": [], "timeFrame": { "type": 0, "canBeRenewed": false, "renewalDescription": [] }, "justificationForDurationOverFourYears": [], "justificationForDurationOverEightYears": [], "totalValue": { "currency": "" }, "awardedToGroupOfEconomicOperators": false, "contractors": [], "description": [], "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": [ "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.", "", "SMA-tauti on harvinainen geneettinen sairaus, joka hoitamattomana aiheuttaa vaikeaa etenev\u00e4\u00e4 liikuntakyvytt\u00f6myytt\u00e4 ja usein lyhent\u00e4\u00e4 el\u00e4m\u00e4n pituutta merkitt\u00e4v\u00e4sti. Suomessa syntyy muutama SMA-lapsi joka vuosi. Nusinerseeni on spinaalisen lihasatrofian (SMA) hoitoon tarkoitettu l\u00e4\u00e4ke, joka on saanut myyntiluvan toukokuussa 2017. Terveydenhuollon palveluvalikoimaneuvosto (Palko) on antanut maaliskuussa 2018 suosituksen, jonka mukaan nusinerseeni kuuluu julkisesti rahoitettuun terveydenhuollon palveluvalikoimaan tietyin edellytyksin. Suositusta on edelleen p\u00e4ivitetty syyskuussa 2019 sek\u00e4 helmikuussa 2022. ", "", "Nusinerseenia ei voi sairaalak\u00e4yt\u00f6ss\u00e4 ja sairaalan l\u00e4\u00e4kevalikoimassa korvata mill\u00e4\u00e4n toisella saatavissa olevalla myyntiluvallisella valmisteella. SMA-taudin hoitoon on Euroopassa hyv\u00e4ksytty my\u00f6s kaksi muuta valmistetta: onasemnogeeniabeparvoveekki-l\u00e4\u00e4ke (Zolgensma\u00ae) sek\u00e4 risdiplaamil\u00e4\u00e4ke (Evrysdi\u00ae 0,75mg\/ml oraaliliuos). Ne kuitenkin eroavat ratkaisevasti nusinerseenista mm. antotavan ja -tiheyden, vaikutuksen keston sek\u00e4 mahdollisten haittavaikutusten osalta. Nusinerseenia annostellaan selk\u00e4ytimeen useita kertoja vuodessa potilaan koko elini\u00e4n ajan, kun onasemnogeeniabeparvoveekki on laskimoinfuusiona annosteltava geeniterapia-kertahoito. Risdiplaami puolestaan annostellaan suun kautta joka p\u00e4iv\u00e4, ja on tarkoitettu p\u00e4\u00e4asiassa avohoidossa k\u00e4ytett\u00e4v\u00e4ksi. Nusinerseeni, onasemnogeeniabeparvoveekki ja risdiplaami eiv\u00e4t siis tosiasiallisesti kilpaile kesken\u00e4\u00e4n, vaikka niiden avulla hoidetaan samaa potilasryhm\u00e4\u00e4.", "", "Spinraza\u00ae 12mg 5ml injektioneste (myyntiluvanhaltija Biogen Netherlands B.V.) on l\u00e4\u00e4kealan turvallisuus- ja kehitt\u00e4miskeskus Fimean mukaan ainoa markkinoilla oleva myyntiluvallinen nusinerseenivalmiste Suomessa. Tuotetta edustaa Suomessa Biogen Finland Oy." ] }, "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": "9cb6d962-a78c-4979-f61b-08d989815d0d", "isPrivateSmallValueProcurement": false, "structuredRequirements": { "tenderRequirements": [], "validationState": 0 }, "espdRequestReferences": [], "hilmaSubmissionDate": "2022-04-22T10:34:36.3291334", "dateCreated": "2022-04-22T09:36:09.1604227", "dateModified": "2022-04-27T07:00:16.3968611" }