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-21529"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization FOPH-21529</b></p><a name="FOPH-21529"> </a><a name="hcFOPH-21529"> </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>/21529</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>: 2023-12-01</p><blockquote><p><b>url</b></p>expiryDate</blockquote><p><b>value</b>: 2026-03-31</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>: 2023-12-01 --> 2025-12-31</p><blockquote><p><b>url</b></p>firstListingDate</blockquote><p><b>value</b>: 2023-12-01</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 756002004001}">Oral</span></p><p><b>value</b>: <span title="Swiss Franc">CHF958.62</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 756002006007}">Price mutation after triennal review of pharmaceuticals</span></p><p><b>changeDate</b>: 2023-12-01</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">CHF1,113.95</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-Paxlovid-Filmcoatedtablet.html">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-7601001010604-6879301-001; containedItemQuantity = 30 Tablet; description = PAXLOVID Filmtabl 4x150mg/2x100mg</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><a href="ClinicalUseDefinition-IND-10084529.html">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href="#hcFOPH-21529/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-21529/holder-Pfizer-AG"> </a><a name="hcFOPH-21529/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="21529"/>
</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="2023-12-01"/>
</extension>
<extension url="expiryDate">
<valueDate value="2026-03-31"/>
</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="2023-12-01"/>
<end value="2025-12-31"/>
</valuePeriod>
</extension>
<extension url="firstListingDate">
<valueDate value="2023-12-01"/>
</extension>
<extension url="costShare">
<valueInteger value="10"/>
</extension>
<extension url="gamme">
<valueCodeableConcept>
<coding>
<system
value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme"/>
<code value="756002004001"/>
<display value="Oral"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="958.62"/>
<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="756002006007"/>
<display
value="Price mutation after triennal review of pharmaceuticals"/>
</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="1113.95"/>
<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="2024-01-01"/>
</extension>
</extension>
</extension>
<subject>🔗
<reference
value="PackagedProductDefinition/PMP-Paxlovid-Filmcoatedtablet"/>
</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="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="2023-12-01"/>
</extension>
<extension url="period">
<valuePeriod>
<start value="2023-12-01"/>
<end value="2025-12-31"/>
</valuePeriod>
</extension>
<extension url="reimbursementEndDate">
<valueDate value="2026-03-31"/>
</extension>
<extension url="firstLimitationDate">
<valueDate value="2023-12-01"/>
</extension>
<extension url="limitationText">
<valueString
value="Befristete Limitation bis 31.12.2025. PAXLOVID wird als antivirale Monotherapie für die Behandlung einer bestätigten Covid-19 Infektion (Positiver Erregernachweis Antigen/PCR und vorhandener Covid-19-Symptome) in folgenden Fällen vergütet:
• in einer Dosierung von 300 mg Nirmatrelvir (zwei Tabletten zu je 150 mg) und 100 mg Ritonavir (eine Tablette zu 100 mg) zur gleichzeitigen Einnahme alle 12 Stunden, über einen Zeitraum von 5 Tagen
• zur Frühbehandlung (ausser bei immunsupprimierten Personen vorzugsweise innerhalb von 5 Tagen nach Symptombeginn) bei Erwachsenen, die keine Sauerstofftherapie oder Hospitalisierung aufgrund von COVID-19 benötigen und für welche gemäss der aktuell gültigen Kriterienliste der Schweizerischen Gesellschaft für Infektiologie (SSI) (https://www.bag.admin.ch/bag/de/home/medizin-und-forschung/heilmittel/versorgung-covid-19-arzneimittel.html) ein erhöhtes Risiko für einen schweren COVID-19-Verlauf besteht."/>
</extension>
<extension url="limitationIndication">
<valueReference>🔗
<reference value="ClinicalUseDefinition/LIM-840539006"/>
</valueReference>
</extension>
<extension
url="http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice">
<extension url="value">
<valueMoney>
<value value="958.62"/>
<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="756002006007"/>
<display
value="Price mutation after triennal review of pharmaceuticals"/>
</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="1113.95"/>
<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="2024-01-01"/>
</extension>
</extension>
</extension>
<reference>🔗
<reference value="ClinicalUseDefinition/IND-10084529"/>
</reference>
</indication>
<holder>
<reference value="#holder-Pfizer-AG"/>
</holder>
</RegulatedAuthorization>