CH EPL (R5)
1.0.0 - trial-use
CH EPL (R5)
1.0.0 - trial-use
CH EPL (R5), published by Federal Office of Public Health FOPH. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions
{
"resourceType" : "RegulatedAuthorization",
"id" : "FOPH-20416",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization FOPH-20416</b></p><a name=\"FOPH-20416\"> </a><a name=\"hcFOPH-20416\"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><blockquote><p><b>url</b></p>FOPHDossierNumber</blockquote><p><b>value</b>: <a href=\"NamingSystem-Dossier.html\" title=\"Identifier holding the Dossier number of FOPH\">FOPH Dossier Number</a>/20416</p><blockquote><p><b>url</b></p>status</blockquote><p><b>value</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}\">Reimbursed</span></p><blockquote><p><b>url</b></p>statusDate</blockquote><p><b>value</b>: 2023-01-01</p><blockquote><p><b>url</b></p>expiryDate</blockquote><p><b>value</b>: 2025-03-31</p><blockquote><p><b>url</b></p>listingStatus</blockquote><p><b>value</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}\">Listed</span></p><blockquote><p><b>url</b></p>listingPeriod</blockquote><p><b>value</b>: 2023-01-01 --> 2024-12-31</p><blockquote><p><b>url</b></p>firstListingDate</blockquote><p><b>value</b>: 2017-09-01</p><blockquote><p><b>url</b></p>costShare</blockquote><p><b>value</b>: 10</p><blockquote><p><b>url</b></p>gamme</blockquote><p><b>value</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme 756002004009}\">Parenteral Depot</span></p><p><b>value</b>: <span title=\"Swiss Franc\">CHF4,407.68</span> (CHF)</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005002}\">Ex-factory price</span></p><p><b>changeType</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006006}\">Normal price mutation</span></p><p><b>changeDate</b>: 2023-01-01</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-productPrice.html\">CH - EPL Product Price</a></blockquote><p><b>value</b>: <span title=\"Swiss Franc\">CHF4,768.50</span> (CHF)</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005001}\">Retail price</span></p><p><b>changeType</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006005}\">VAT-change</span></p><p><b>changeDate</b>: 2024-01-01</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-productPrice.html\">CH - EPL Product Price</a></blockquote></blockquote><p><b>subject</b>: <a href=\"PackagedProductDefinition-PMP-Keytruda-100mg-4ml-Solution-for-Infusion.html\">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-7601001001138-6623101-001; containedItemQuantity = 1 Vial; description = KEYTRUDA Inf Konz 100 mg/4ml Durchstf</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002003}\">Reimbursement SL</span></p><h3>Indications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td>, </td><td><a href=\"ClinicalUseDefinition-IND-10075566.html\">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href=\"#hcFOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG\">Organization MSD Merck Sharp & Dohme AG</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-MSD-Merck-Sharp-Dohme-AG</b></p><a name=\"FOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG\"> </a><a name=\"hcFOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-epl-organization.html\">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100080484, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001001138</p><p><b>name</b>: MSD Merck Sharp & Dohme AG</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-MSD-Merck-Sharp-Dohme-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100080484"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001001138"
}
],
"name" : "MSD Merck Sharp & Dohme AG"
}
],
"extension" : [
{
"extension" : [
{
"url" : "FOPHDossierNumber",
"valueIdentifier" : {
"system" : "urn:oid:2.16.756.1",
"value" : "20416"
}
},
{
"url" : "status",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status",
"code" : "756001021001",
"display" : "Reimbursed"
}
]
}
},
{
"url" : "statusDate",
"valueDate" : "2023-01-01"
},
{
"url" : "expiryDate",
"valueDate" : "2025-03-31"
},
{
"url" : "listingStatus",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status",
"code" : "756001002001",
"display" : "Listed"
}
]
}
},
{
"url" : "listingPeriod",
"valuePeriod" : {
"start" : "2023-01-01",
"end" : "2024-12-31"
}
},
{
"url" : "firstListingDate",
"valueDate" : "2017-09-01"
},
{
"url" : "costShare",
"valueInteger" : 10
},
{
"url" : "gamme",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme",
"code" : "756002004009",
"display" : "Parenteral Depot"
}
]
}
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 4407.68,
"currency" : "CHF"
}
},
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
"code" : "756002005002",
"display" : "Ex-factory price"
}
]
}
},
{
"url" : "changeType",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
"code" : "756002006006",
"display" : "Normal price mutation"
}
]
}
},
{
"url" : "changeDate",
"valueDate" : "2023-01-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 4768.5,
"currency" : "CHF"
}
},
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
"code" : "756002005001",
"display" : "Retail price"
}
]
}
},
{
"url" : "changeType",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
"code" : "756002006005",
"display" : "VAT-change"
}
]
}
},
{
"url" : "changeDate",
"valueDate" : "2024-01-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL"
}
],
"subject" : [
{
🔗 "reference" : "PackagedProductDefinition/PMP-Keytruda-100mg-4ml-Solution-for-Infusion"
}
],
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type",
"code" : "756000002003",
"display" : "Reimbursement SL"
}
]
},
"indication" : [
{
"extension" : [
{
"extension" : [
{
"url" : "status",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus",
"code" : "756002071001",
"display" : "Limitation Reimbursed"
}
]
}
},
{
"url" : "statusDate",
"valueDate" : "2025-11-01"
},
{
"url" : "period",
"valuePeriod" : {
"start" : "2025-11-01"
}
},
{
"url" : "firstLimitationDate",
"valueDate" : "2023-01-01"
},
{
"url" : "limitationText",
"valueString" : "Für alle vergütungspflichtigen Indikationen gilt:\nVor Therapiebeginn muss für alle vergütungspflichtigen Indikationen eine Kostengutsprache des Krankenversicherers nach vorgängiger Konsultation des Vertrauensarztes eingeholt werden. Eine Kostengutsprache hat den entsprechenden Indikationscode (20416.XX) zu enthalten.\nDie Dosierung beträgt maximal 200 mg alle drei Wochen sofern nicht anders festgelegt.\nDie maximale Anzahl Behandlungen bzw. Zyklen beträgt 35 sofern nicht anders festgelegt. Klinisch stabile Patienten mit initialem Befund einer Progression können bis zur Bestätigung der Progression der Erkrankung weiter behandelt werden.\nFalls KEYTRUDA in einer bestimmten Indikation in erster Linie vergütet wurde und es unter KEYTRUDA-Therapie nach kurzzeitigem Ansprechen zu einer Progression kam, soll KEYTRUDA in derselben Indikation in nachfolgenden Therapielinien nicht mehr vergütet werden.\n\nMSD Merck Sharp & Dohme AG erstattet nach Aufforderung durch denjenigen Krankenversicherer, bei dem die versicherte Person zum Zeitpunkt des Bezugs versichert war, für alle Indikationen einen festgelegten Betrag pro nachweislich verabreichter Packung KEYTRUDA (2 Durchstf) zurück. Es gelten die zum Verabreichungszeitpunkt aktuellen Preise und Prozentsätze. Die Mehrwertsteuer kann nicht zusätzlich zu diesem Anteil des Fabrikabgabepreises zurückgefordert werden. Die Aufforderung zur Rückerstattung soll zeitnah zur Verabreichung erfolgen.\nFür die Rückforderung von Rückerstattungen gegenüber der Zulassungsinhaberin hat der Krankenversicherer jeweils den hinter der jeweiligen Indikation angegebenen Indikationscode zwingend bekanntzugeben. Der Indikationscode ist vom Leistungserbringer an die Krankenversicherer zu übermitteln."
},
{
"url" : "indicationCode",
"valueString" : "20416.XX"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation"
},
{
"extension" : [
{
"url" : "status",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus",
"code" : "756002071001",
"display" : "Limitation Reimbursed"
}
]
}
},
{
"url" : "statusDate",
"valueDate" : "2023-01-01"
},
{
"url" : "period",
"valuePeriod" : {
"start" : "2023-01-01",
"end" : "2024-12-31"
}
},
{
"url" : "reimbursementEndDate",
"valueDate" : "2025-03-31"
},
{
"url" : "firstLimitationDate",
"valueDate" : "2023-01-01"
},
{
"url" : "limitationText",
"valueString" : "Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17"
},
{
"url" : "indicationCode",
"valueString" : "20416.17"
},
{
"url" : "limitationIndication",
"valueReference" : {
🔗 "reference" : "ClinicalUseDefinition/LIM-254837009"
}
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 4407.68,
"currency" : "CHF"
}
},
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
"code" : "756002005002",
"display" : "Ex-factory price"
}
]
}
},
{
"url" : "changeType",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
"code" : "756002006006",
"display" : "Normal price mutation"
}
]
}
},
{
"url" : "changeDate",
"valueDate" : "2023-01-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 4768.5,
"currency" : "CHF"
}
},
{
"url" : "type",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
"code" : "756002005001",
"display" : "Retail price"
}
]
}
},
{
"url" : "changeType",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
"code" : "756002006005",
"display" : "VAT-change"
}
]
}
},
{
"url" : "changeDate",
"valueDate" : "2024-01-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation"
}
],
"reference" : {
🔗 "reference" : "ClinicalUseDefinition/IND-10075566"
}
}
],
"holder" : {
"reference" : "#holder-MSD-Merck-Sharp-Dohme-AG"
}
}