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
<RegulatedAuthorization xmlns="http://hl7.org/fhir">
<id value="FOPH-21203-2-Pre-Filled-Pen"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization FOPH-21203-2-Pre-Filled-Pen</b></p><a name="FOPH-21203-2-Pre-Filled-Pen"> </a><a name="hcFOPH-21203-2-Pre-Filled-Pen"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><ul><li>FOPHDossierNumber: <a href="NamingSystem-Dossier.html" title="Identifier holding the Dossier number of FOPH">FOPH Dossier Number</a>/21203</li><li>status: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}">Reimbursed</span></li><li>statusDate: 2021-06-01</li><li>listingStatus: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}">Listed</span></li><li>listingPeriod: 2021-06-01 --> (ongoing)</li><li>firstListingDate: 2021-06-01</li><li>costShare: 10</li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title="Swiss Franc">CHF742.20</span> (CHF)</li><li>type: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005002}">Ex-factory price</span></li><li>changeType: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006006}">Normal price mutation</span></li><li>changeDate: 2023-12-01</li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title="Swiss Franc">CHF823.50</span> (CHF)</li><li>type: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005001}">Retail price</span></li><li>changeType: <span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006005}">VAT-change</span></li><li>changeDate: 2023-12-01</li></ul></blockquote><p><b>subject</b>: <a href="PackagedProductDefinition-PMP-Abrilada-40mg-0.8ml-2-Pre-Filled-Pen.html">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-7601001010604-6783101-002; containedItemQuantity = 2 Pre-filled pen; description = ABRILADA Inj Lös 40 mg/0.8ml Fertpen 2 x 0.8 ml</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-10020041.html">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href="#hcFOPH-21203-2-Pre-Filled-Pen/holder-Pfizer-AG">Organization Pfizer AG</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-Pfizer-AG</b></p><a name="FOPH-21203-2-Pre-Filled-Pen/holder-Pfizer-AG"> </a><a name="hcFOPH-21203-2-Pre-Filled-Pen/holder-Pfizer-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>/100015286, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601001010604</p><p><b>name</b>: Pfizer AG</p></blockquote></div>
</text>
<contained>
<Organization>
<id value="holder-Pfizer-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"/>
</meta>
<identifier>
<system value="urn:oid:1.2.276.0.76"/>
<value value="100015286"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001010604"/>
</identifier>
<name value="Pfizer AG"/>
</Organization>
</contained>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL">
<extension url="FOPHDossierNumber">
<valueIdentifier>
<system value="urn:oid:2.16.756.1"/>
<value value="21203"/>
</valueIdentifier>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status"/>
<code value="756001021001"/>
<display value="Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2021-06-01"/>
</extension>
<extension url="listingStatus">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status"/>
<code value="756001002001"/>
<display value="Listed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="listingPeriod">
<valuePeriod>
<start value="2021-06-01"/>
</valuePeriod>
</extension>
<extension url="firstListingDate">
<valueDate value="2021-06-01"/>
</extension>
<extension url="costShare">
<valueInteger value="10"/>
</extension>
</extension>
<extension url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="742.2"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005002"/>
<display value="Ex-factory price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006006"/>
<display value="Normal price mutation"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2023-12-01"/>
</extension>
</extension>
<extension url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="823.5"/>
<currency value="CHF"/>
</valueMoney>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type"/>
<code value="756002005001"/>
<display value="Retail price"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeType">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change"/>
<code value="756002006005"/>
<display value="VAT-change"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="changeDate">
<valueDate value="2023-12-01"/>
</extension>
</extension>
<subject>🔗
<reference
value="PackagedProductDefinition/PMP-Abrilada-40mg-0.8ml-2-Pre-Filled-Pen"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type"/>
<code value="756000002003"/>
<display value="Reimbursement SL"/>
</coding>
</type>
<indication>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
<extension url="limitationIndication">
<valueReference>🔗
<reference value="ClinicalUseDefinition/LIM-69896004"/>
</valueReference>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
<code value="756002071001"/>
<display value="Limitation Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2024-05-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2024-05-01"/>
<end value="2100-12-31"/>
</valuePeriod>
</extension>
<extension url="reimbursementEndDate">
<valueDate value="2100-12-31"/>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2022-03-01"/>
</extension>
<extension url="limitationText">
<valueString
value="Aktive rheumatoide Arthritis
Behandlung mit ABRILADA, wenn die vorausgegangene antirheumatische Standardtherapie mit krankheitsmodifizierenden Antirheumatika (DMARDs) unzulänglich war."/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
<extension url="limitationIndication">
<valueReference>🔗
<reference value="ClinicalUseDefinition/LIM-156370009"/>
</valueReference>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
<code value="756002071001"/>
<display value="Limitation Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2024-05-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2024-05-01"/>
<end value="2100-12-31"/>
</valuePeriod>
</extension>
<extension url="reimbursementEndDate">
<valueDate value="2100-12-31"/>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2022-03-01"/>
</extension>
<extension url="limitationText">
<valueString
value="Psoriasis-Arthritis
Behandlung mit ABRILADA, wenn die vorausgegangene Standardtherapie mit krankheitsmodifizierenden Antirheumatika (DMARDs) unzulänglich war.
Aktive polyartikuläre juvenile idiopathische Arthritis bei Kindern und Jugendlichen ab einem Körpergewicht von ≥ 30 kg
Behandlung mit ABRILADA, wenn die vorausgegangene Standardtherapie mit krankheitsmodifizierenden Antirheumatika (DMARDs) unzulänglich war."/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
<extension url="limitationIndication">
<valueReference>🔗
<reference value="ClinicalUseDefinition/LIM-9631008"/>
</valueReference>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
<code value="756002071001"/>
<display value="Limitation Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2024-05-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2024-05-01"/>
<end value="2100-12-31"/>
</valuePeriod>
</extension>
<extension url="reimbursementEndDate">
<valueDate value="2100-12-31"/>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2022-03-01"/>
</extension>
<extension url="limitationText">
<valueString
value="Ankylosierende Spondylitis (Morbus Bechterew)
Behandlung mit ABRILADA, wenn die vorausgegangene konventionelle Therapie unzulänglich war oder nicht vertragen wurde."/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
<extension url="limitationIndication">
<valueReference>🔗
<reference value="ClinicalUseDefinition/LIM-34000006"/>
</valueReference>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
<code value="756002071001"/>
<display value="Limitation Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2024-05-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2024-05-01"/>
<end value="2100-12-31"/>
</valuePeriod>
</extension>
<extension url="reimbursementEndDate">
<valueDate value="2100-12-31"/>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2022-03-01"/>
</extension>
<extension url="limitationText">
<valueString
value="Aktiver Morbus Crohn
Behandlung erwachsener Patienten mit ABRILADA, wenn die vorausgegangene konventionelle Therapie (z.B. mit Azathioprin, 6-Mercaptopurin oder Glukokortikoiden) unzulänglich war, sowie bei Patienten, die nicht mehr auf Infliximab ansprechen oder dieses nicht vertragen. Nach zwei Jahren ununterbrochener Therapie bedarf die Behandlung einer erneuten Kostengutsprache durch den Krankenversicherer nach vorgängiger Konsultation des Vertrauensarztes."/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
<extension url="limitationIndication">
<valueReference>🔗
<reference value="ClinicalUseDefinition/LIM-64766004"/>
</valueReference>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
<code value="756002071001"/>
<display value="Limitation Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2024-05-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2024-05-01"/>
<end value="2100-12-31"/>
</valuePeriod>
</extension>
<extension url="reimbursementEndDate">
<valueDate value="2100-12-31"/>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2022-03-01"/>
</extension>
<extension url="limitationText">
<valueString
value="Moderate bis schwere Colitis ulcerosa
Behandlung erwachsener Patienten mit ABRILADA, wenn die vorausgegangene konventionelle Therapie (z.B. mit Azathioprin, 6-Mercaptopurin oder Glukokortikoiden) unzulänglich war oder nicht vertragen wurde."/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
<extension url="limitationIndication">
<valueReference>🔗
<reference value="ClinicalUseDefinition/LIM-9014002"/>
</valueReference>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
<code value="756002071001"/>
<display value="Limitation Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2024-05-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2024-05-01"/>
<end value="2100-12-31"/>
</valuePeriod>
</extension>
<extension url="reimbursementEndDate">
<valueDate value="2100-12-31"/>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2022-03-01"/>
</extension>
<extension url="limitationText">
<valueString
value="Schwere Plaque-Psoriasis
Behandlung erwachsener Patienten mit schwerer Plaque-Psoriasis, bei denen eine Phototherapie oder eine der folgenden konventionellen systemischen Therapien (Ciclosporin, Methotrexat, Acitretin) keinen therapeutischen Erfolg gezeigt haben. Falls nach 16 Wochen kein therapeutischer Erfolg eingetreten ist, ist die Behandlung abzubrechen."/>
</extension>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation">
<extension url="limitationIndication">
<valueReference>🔗
<reference value="ClinicalUseDefinition/LIM-59393003"/>
</valueReference>
</extension>
<extension url="status">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus"/>
<code value="756002071001"/>
<display value="Limitation Reimbursed"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="statusDate">
<valueDate value="2024-05-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2024-05-01"/>
<end value="2100-12-31"/>
</valuePeriod>
</extension>
<extension url="reimbursementEndDate">
<valueDate value="2100-12-31"/>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2022-03-01"/>
</extension>
<extension url="limitationText">
<valueString
value="Aktive, mittelschwere bis schwere Hidradenitis suppurativa (Acne inversa)
Behandlung erwachsener Patienten, wenn die vorausgegangene systemische Therapie mit Antibiotika unzulänglich war. Bei Patienten, die nach 12 Wochen kein Ansprechen nach HiSCR von mindestens 50% zeigen, ist die Behandlung abzubrechen. Nach 52 Wochen ununterbrochener Therapie bedarf die Behandlung einer erneuten Kostengutsprache durch den Krankenversicherer nach vorgängiger Konsultation des Vertrauensarztes."/>
</extension>
</extension>
<reference>🔗
<reference value="ClinicalUseDefinition/IND-10020041"/>
</reference>
</indication>
<holder>
<reference value="#holder-Pfizer-AG"/>
</holder>
</RegulatedAuthorization>