oddb2xml 3.0.5 → 3.0.7

checksums.yaml

@@ -1,7 +1,7 @@
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data/CLAUDE.md

@@ -47,7 +47,7 @@ The system follows a **download → extract → build → compress** pipeline:
 
 6. **Compressor** (`lib/oddb2xml/compressor.rb`) — Optional ZIP/TAR.GZ output compression.
 
-7. **FHIR support** (`lib/oddb2xml/fhir_support.rb`) — Self-contained module providing `FhirDownloader` and FHIR NDJSON parsing. Activated via `--fhir` (or `--fhir-url=<URL>`). Downloads per-language NDJSON files (`foph-sl-export-latest-{de,fr,it}.ndjson`) from `epl.bag.admin.ch` to populate French and Italian product names/descriptions. Maps legal status codes `756005022007` and `756005022008` to Swissmedic category D.
+7. **FHIR support** (`lib/oddb2xml/fhir_support.rb`) — Self-contained module providing `FhirDownloader` and FHIR NDJSON parsing. Activated via `--fhir` (or `--fhir-url=<URL>`). Downloads per-language NDJSON files (`foph-sl-export-latest-{de,fr,it}.ndjson`) from `epl.bag.admin.ch` to populate French and Italian product names/descriptions. Maps legal status codes `756005022007` and `756005022008` to Swissmedic category D. Parses `ClinicalUseDefinition` resources and combines each indication's `.NN` id-suffix with the reimbursement RA's `FOPHDossierNumber` to construct the BAG **Indikationscode** (`XXXXX.NN`); exposed as `item[:indication_codes]` and per-package `:indication_codes` (each entry a `{code:, cud_id:, text:}` hash). From 3.0.7 onwards, `Builder#build_product` emits one `<INDICATION_CODE code="XXXXX.NN" cud_id="DRUG.NN">limitation text</INDICATION_CODE>` child per indication on every `<PRD>` in `oddb_product.xml`; live feed numbers: 539 products / 1,293 codes / 100 % with non-empty indication text. Mandatory on prescriptions/invoices for SL price-model drugs from 2026-07-01 — see issue [#113](https://github.com/zdavatz/oddb2xml/issues/113).
 
 8. **Refdata cleanup** (`lib/oddb2xml/refdata_cleanup.rb`) — Compensates for known data-quality issues in upstream Refdata.Articles.xml before they reach the output. Each fix is guarded by a Swissmedic-side heuristic (e.g. comma in `substance_swissmedic` to distinguish mono products from real combinations). Currently fixes the doubled-dose template bug (`X mg / X mg / Stk`). Called from `Builder#apply_refdata_description_cleanups!` at the start of `prepare_articles`. See GitHub issue #112 for the catalogue.
 

data/Gemfile.lock

@@ -1,7 +1,8 @@
 PATH
   remote: .
   specs:
-    oddb2xml (3.0.4)
+    oddb2xml (3.0.7)
+      csv
       htmlentities
       httpi
       mechanize (>= 2.8.5)
@@ -26,7 +27,7 @@ PATH
 GEM
   remote: https://rubygems.org/
   specs:
-    addressable (2.8.8)
+    addressable (2.9.0)
       public_suffix (>= 2.0.2, < 8.0)
     akami (1.3.3)
       base64
@@ -43,6 +44,7 @@ GEM
     crack (1.0.1)
       bigdecimal
       rexml
+    csv (3.3.5)
     diff-lcs (1.6.2)
     domain_name (0.6.20240107)
     flexmock (3.0.2)
@@ -57,7 +59,7 @@ GEM
       rack
       socksify
     io-console (0.8.2)
-    json (2.18.1)
+    json (2.19.5)
     language_server-protocol (3.17.0.5)
     lint_roller (1.1.0)
     logger (1.7.0)
@@ -114,7 +116,7 @@ GEM
       pry (~> 0.11)
       yard (~> 0.9.21)
     psych (3.3.4)
-    public_suffix (7.0.2)
+    public_suffix (7.0.5)
     racc (1.8.1)
     rack (3.2.6)
     rainbow (3.1.1)
@@ -208,7 +210,7 @@ GEM
     webrobots (0.1.2)
     xml-simple (1.1.9)
       rexml
-    yard (0.9.38)
+    yard (0.9.43)
 
 PLATFORMS
   arm64-darwin-25

data/History.txt

@@ -1,3 +1,13 @@
+=== 3.0.7 / 06.05.2026
+* oddb_product.xml: emit one <INDICATION_CODE code="XXXXX.NN" cud_id="DRUG.NN">limitation text</INDICATION_CODE> child per indication on each <PRD>. Source: FHIR ClinicalUseDefinition resources joined with the reimbursement RegulatedAuthorization's FOPHDossierNumber. Counted on the live FOPH feed: 539 products carry a total of 1,293 codes; all have non-empty indication text. Resolves the missing wiring between FhirExtractor and Builder noted in 3.0.6 (issue #113).
+
+=== 3.0.6 / 06.05.2026
+* FHIR: extract Indikationscode (XXXXX.NN) from ClinicalUseDefinition resources by combining FOPHDossierNumber with each CUD's .NN id-suffix; expose as item[:indication_codes] (and per package) so downstream builders can include it on prescriptions and invoices as required by BAG from 2026-07-01 (issue #113)
+* Declare csv as a runtime dependency in the gemspec (csv was removed from Ruby's default gems in 3.4)
+
+=== 3.0.5 / 25.04.2026
+* Refdata cleanup: compensate the doubled-dose template bug in Refdata.Articles.xml (e.g. "30 mg / 30 mg / 100 Tablette") by collapsing to a single token. Guarded by a Swissmedic-side comma check so real combination products are untouched (issue #112)
+
 === 3.0.4 / 24.04.2026
 * Firstbase: switch -b/--firstbase from the deprecated pillbox.oddb.org XLSX to the GS1 Switzerland CSV at https://id.gs1.ch/01/07612345000961 (full firstbase barcode registry, ~189k items). Downloaded file is now firstbase.csv; FirstbaseExtractor now parses CSV with headers instead of XLSX.
 

data/README.md

@@ -51,7 +51,7 @@ HIN (http://hin.ch) creates daily the actual file. They can be downloaded from `
 see `--help`.
 
 ```
-    /opt/src/oddb2xml/bin/oddb2xml version 3.0.5
+    /opt/src/oddb2xml/bin/oddb2xml version 3.0.7
     Usage:
     oddb2xml [option]
       produced files are found under data
@@ -292,6 +292,43 @@ We use the following files:
 * https://epl.bag.admin.ch/static/fhir/foph-sl-export-latest-{de,fr,it}.ndjson (FHIR NDJSON, used with `--fhir`)
 * https://id.gs1.ch/01/07612345000961 (GS1 Switzerland firstbase CSV — full barcode registry, used with `-b`/`--firstbase`)
 
+## Indikationscode (BAG XXXXX.NN)
+
+In `--fhir` mode, oddb2xml extracts the BAG **Indikationscode** for SL
+price-model drugs and emits one repeated `<INDICATION_CODE>` child per
+indication on each `<PRD>` in `oddb_product.xml`:
+
+```xml
+<PRD DT="...">
+  <GTIN>7680123456789</GTIN>
+  ...
+  <INDICATION_CODE code="20403.01" cud_id="CYRAMZA.01">In Kombination mit Paclitaxel für die Behandlung ...</INDICATION_CODE>
+  <INDICATION_CODE code="20403.02" cud_id="CYRAMZA.02">In Kombination mit FOLFIRI ...</INDICATION_CODE>
+  <PackGrSwissmedic>...</PackGrSwissmedic>
+</PRD>
+```
+
+The code is built per FHIR bundle by combining the
+`FOPHDossierNumber` from the reimbursement `RegulatedAuthorization`
+(`XXXXX`) with the `.NN` suffix of each sibling
+`ClinicalUseDefinition` whose `type == "indication"` (e.g.
+`CYRAMZA.01` / `CYRAMZA.02` → `20403.01` / `20403.02`).  The element
+body carries the human-readable indication text from
+`indication.diseaseSymptomProcedure.concept.text`.
+
+The same data is also exposed in-memory on each item and package as
+`item[:indication_codes]` (an array of `{code:, cud_id:, text:}`
+hashes) for downstream consumers that build their own emitters.
+
+Counted on the live FOPH feed (`foph-sl-export-latest-de.ndjson`,
+6'775 bundles): **539** products carry a total of **1'293** codes.
+
+Per BAG Rundschreiben vom 19. Februar 2026, the Indikationscode must
+be transmitted with every prescription and invoice for SL price-model
+drugs from **2026-07-01**; from **2027-01-01** insurers may reject
+invoices without it. See issue
+[#113](https://github.com/zdavatz/oddb2xml/issues/113).
+
 ## Refdata data-quality compensation
 
 Refdata.Articles.xml from `files.refdata.ch` ships with a number of recurring

data/lib/oddb2xml/builder.rb

@@ -780,6 +780,14 @@ module Oddb2xml
               # xml.REMD
               # xml.REMF
               # }
+              # BAG Indikationscode (XXXXX.NN) for SL price-model drugs.
+              # Mandatory on prescriptions/invoices from 2026-07-01 — see
+              # GitHub issue #113.
+              if seq && seq[:indication_codes].is_a?(Array)
+                seq[:indication_codes].each do |ic|
+                  xml.INDICATION_CODE ic[:text].to_s, code: ic[:code], cud_id: ic[:cud_id]
+                end
+              end
               xml.PackGrSwissmedic obj[:siz] unless obj[:siz].empty?
               xml.EinheitSwissmedic obj[:eht] unless obj[:eht].empty?
               xml.SubstanceSwissmedic obj[:sub] unless obj[:sub].empty?

data/lib/oddb2xml/fhir_support.rb

@@ -159,7 +159,7 @@ module Oddb2xml
   module FHIR
     # Bundle represents one line in the NDJSON file
     class Bundle
-      attr_reader :medicinal_product, :packages, :authorizations, :ingredients
+      attr_reader :medicinal_product, :packages, :authorizations, :ingredients, :clinical_use_definitions
 
       def initialize(json_line)
         data = JSON.parse(json_line)
@@ -174,6 +174,7 @@ module Oddb2xml
         @packages = []
         @authorizations = []
         @ingredients = []
+        @clinical_use_definitions = []
 
         @entries.each do |entry|
           resource = entry["resource"]
@@ -186,11 +187,32 @@ module Oddb2xml
             @authorizations << Authorization.new(resource)
           when "Ingredient"
             @ingredients << Ingredient.new(resource)
+          when "ClinicalUseDefinition"
+            @clinical_use_definitions << ClinicalUseDefinition.new(resource)
           end
         end
       end
     end
 
+    # ClinicalUseDefinition carries one indication. Its `id` ends in ".NN",
+    # the per-indication suffix that combines with the FOPHDossierNumber
+    # (XXXXX) on the reimbursement RegulatedAuthorization to form the
+    # Indikationscode XXXXX.NN required by BAG from 2026-07-01.
+    class ClinicalUseDefinition
+      attr_reader :id, :nn_suffix, :type, :text
+
+      def initialize(resource)
+        @id = resource["id"]
+        @type = resource["type"]
+        @nn_suffix = @id&.[](/\.(\d{2})\z/, 1)
+        @text = resource.dig("indication", "diseaseSymptomProcedure", "concept", "text")
+      end
+
+      def indication?
+        @type == "indication"
+      end
+    end
+
     class MedicinalProduct
       attr_reader :names, :atc_code, :classification, :it_codes
 
@@ -427,6 +449,11 @@ module Oddb2xml
         prep.OrgGenCode = map_org_gen_code(mp.classification)
         prep.ItCode = mp.it_code  # Add IT code
 
+        # Indikationscodes (BAG: XXXXX.NN, mandatory on prescriptions/invoices
+        # from 2026-07-01). Build from FOPHDossierNumber (reimbursement auth)
+        # plus each ClinicalUseDefinition's .NN suffix. See issue #113.
+        prep.IndicationCodes = build_indication_codes(bundle)
+
         # Map packages
         prep.Packs = OpenStruct.new
         prep.Packs.Pack = bundle.packages.map do |pkg|
@@ -535,6 +562,21 @@ module Oddb2xml
         reimbursement&.cost_share
       end
 
+      def build_indication_codes(bundle)
+        reimbursement = bundle.authorizations.find(&:reimbursement_sl?)
+        dossier = reimbursement&.foph_dossier_no
+        return [] unless dossier && !bundle.clinical_use_definitions.empty?
+
+        bundle.clinical_use_definitions.each_with_object([]) do |cud, acc|
+          next unless cud.indication? && cud.nn_suffix
+          acc << OpenStruct.new(
+            code: "#{dossier}.#{cud.nn_suffix}",
+            cud_id: cud.id,
+            text: cud.text
+          )
+        end
+      end
+
       def map_org_gen_code(classification)
         return nil unless classification
 
@@ -616,6 +658,13 @@ module Oddb2xml
         item[:comment_it] = ""
         item[:it_code] = (itc = seq.ItCode) ? itc : ""  # NOW available in FHIR!
 
+        # Indikationscodes (BAG XXXXX.NN, see issue #113). Each entry is a
+        # Hash with :code, :cud_id, :text — mandatory on rx/invoices from
+        # 2026-07-01.
+        item[:indication_codes] = Array(seq.IndicationCodes).map do |ic|
+          {code: ic.code, cud_id: ic.cud_id, text: ic.text}
+        end
+
         # Build substances array
         item[:substances] = []
         if seq.Substances && seq.Substances.Substance
@@ -673,7 +722,8 @@ module Oddb2xml
               sl_entry: true,
               swissmedic_category: (cat = pac.SwissmedicCategory) ? cat : "",
               swissmedic_number8: (num = pac.SwissmedicNo8) ? num : "",
-              prices: {exf_price: exf, pub_price: pub}
+              prices: {exf_price: exf, pub_price: pub},
+              indication_codes: item[:indication_codes]
             }
 
             # Map limitations from FHIR

data/lib/oddb2xml/version.rb

@@ -1,3 +1,3 @@
 module Oddb2xml
-  VERSION = "3.0.5"
+  VERSION = "3.0.7"
 end

data/oddb2xml.gemspec

@@ -38,6 +38,7 @@ Gem::Specification.new do |spec|
   spec.add_dependency "htmlentities"
   spec.add_dependency "webrick", ">= 1.8.2"
   spec.add_dependency "rexml", ">= 3.3.9"
+  spec.add_dependency "csv"  # bundled with Ruby <= 3.3, gem from 3.4 onwards
   spec.add_dependency "standardrb"
   spec.add_dependency "rack", ">= 3.1.20"
 

data/spec/data/fhir/cyramza.ndjson

@@ -0,0 +1 @@
+{"resourceType":"Bundle","id":"9a91dc6e-3410-4020-9375-b2cae207e1bf","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"]},"type":"collection","entry":[{"fullUrl":"http://fhir.epl.bag.admin.ch/MedicinalProductDefinition/de872be1-02ff-4b8e-8691-658099182eb7","resource":{"resourceType":"MedicinalProductDefinition","id":"de872be1-02ff-4b8e-8691-658099182eb7","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition"]},"text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">Cyramza Inf Konz 100 mg/10 ml</div>"},"classification":[{"coding":[{"system":"http://www.whocc.no/atc","code":"L01FG02","display":"Ramucirumab"}]},{"coding":[{"system":"http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus","code":"070000","display":"07. STOFFWECHSEL"}]},{"coding":[{"system":"http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus","code":"071600","display":"07.16. Oncologica"}]},{"coding":[{"system":"http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus","code":"071610","display":"07.16.10. Cytostatica"}]}],"name":[{"productName":"Cyramza Inf Konz 100 mg/10 ml","usage":[{"country":{"coding":[{"system":"urn:iso:std:iso:3166","code":"CH","display":"Switzerland"}]},"language":{"coding":[{"system":"urn:ietf:bcp:47","code":"de-CH","display":"German (Switzerland)"}]}}]},{"productName":"Cyramza conc perf 100 mg/10 ml","usage":[{"country":{"coding":[{"system":"urn:iso:std:iso:3166","code":"CH","display":"Switzerland"}]},"language":{"coding":[{"system":"urn:ietf:bcp:47","code":"fr-CH","display":"French (Switzerland)"}]}}]},{"productName":"Cyramza Inf Konz 100 mg/10 ml","usage":[{"country":{"coding":[{"system":"urn:iso:std:iso:3166","code":"CH","display":"Switzerland"}]},"language":{"coding":[{"system":"urn:ietf:bcp:47","code":"it-CH","display":"Italian (Switzerland)"}]}}]}]}},{"fullUrl":"http://fhir.epl.bag.admin.ch/RegulatedAuthorization/65206","resource":{"resourceType":"RegulatedAuthorization","id":"65206","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"]},"text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">Marketing Authorisation 65206 for MedicinalProductDefinition de872be1-02ff-4b8e-8691-658099182eb7</div>"},"contained":[{"resourceType":"Organization","id":"7601001261853","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"]},"identifier":[{"system":"urn:oid:2.51.1.3","value":"7601001261853"}],"name":"Eli Lilly (Suisse) SA"}],"identifier":[{"system":"http://fhir.ch/ig/ch-epl/sid/authno","value":"65206"}],"subject":[{"reference":"CHIDMPMedicinalProductDefinition/de872be1-02ff-4b8e-8691-658099182eb7"}],"type":{"coding":[{"system":"http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type","code":"756000002001","display":"Marketing Authorisation"}]},"region":[{"coding":[{"system":"urn:iso:std:iso:3166","code":"CH","display":"Switzerland"}]}],"holder":{"reference":"#7601001261853"}}},{"fullUrl":"http://fhir.epl.bag.admin.ch/PackagedProductDefinition/c3a247c9-d686-49ab-9344-892d8b93f148","resource":{"resourceType":"PackagedProductDefinition","id":"c3a247c9-d686-49ab-9344-892d8b93f148","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition"]},"text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">Cyramza Inf Konz 100 mg/10 ml Durchstf 1 Stk</div>"},"packageFor":[{"reference":"CHIDMPMedicinalProductDefinition/de872be1-02ff-4b8e-8691-658099182eb7"}],"containedItemQuantity":[{"unit":"Durchstf 1 Stk"}],"description":"Cyramza Inf Konz 100 mg/10 ml Durchstf 1 Stk","legalStatusOfSupply":[{"code":{"coding":[{"system":"http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply","code":"756005022001","display":"Medicinal product subject to medical or veterinary prescription single dispensation (A)"}]}}],"packaging":{"identifier":[{"system":"urn:oid:2.51.1.1","value":"7680652060015"}]}}},{"fullUrl":"http://fhir.epl.bag.admin.ch/RegulatedAuthorization/65206001-c3a247c9-d686-49ab-9344-892d8b93f148","resource":{"resourceType":"RegulatedAuthorization","id":"65206001-c3a247c9-d686-49ab-9344-892d8b93f148","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"]},"text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">Marketing Authorisation 65206001-c3a247c9-d686-49ab-9344-892d8b93f148 for PackagedProductDefinition c3a247c9-d686-49ab-9344-892d8b93f148</div>"},"contained":[{"resourceType":"Organization","id":"7601001261853","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"]},"identifier":[{"system":"urn:oid:2.51.1.3","value":"7601001261853"}],"name":"Eli Lilly (Suisse) SA"}],"identifier":[{"system":"http://fhir.ch/ig/ch-epl/sid/authno","value":"65206001"}],"subject":[{"reference":"CHIDMPPackagedProductDefinition/c3a247c9-d686-49ab-9344-892d8b93f148"}],"type":{"coding":[{"system":"http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type","code":"756000002001","display":"Marketing Authorisation"}]},"region":[{"coding":[{"system":"urn:iso:std:iso:3166","code":"CH","display":"Switzerland"}]}],"holder":{"reference":"#7601001261853"}}},{"fullUrl":"http://fhir.epl.bag.admin.ch/RegulatedAuthorization/9c50920a-2d9d-476f-89d8-9477c8840de9","resource":{"resourceType":"RegulatedAuthorization","id":"9c50920a-2d9d-476f-89d8-9477c8840de9","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"]},"text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">Reimbursement SL 9c50920a-2d9d-476f-89d8-9477c8840de9 for PackagedProductDefinition c3a247c9-d686-49ab-9344-892d8b93f148</div>"},"contained":[{"resourceType":"Organization","id":"7601001261853","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"]},"identifier":[{"system":"urn:oid:2.51.1.3","value":"7601001261853"}],"name":"Eli Lilly (Suisse) SA"}],"extension":[{"url":"http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL","extension":[{"url":"FOPHDossierNumber","valueIdentifier":{"system":"urn:oid:2.16.756.1","value":"20403"}},{"url":"status","valueCodeableConcept":{"coding":[{"system":"http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status","code":"756001021001","display":"Reimbursed"}]}},{"url":"statusDate","valueDate":"2019-06-01"},{"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":"2019-06-01"}},{"url":"firstListingDate","valueDate":"2016-03-01"},{"url":"costShare","valueInteger":10},{"url":"priceModel","valueBoolean":true},{"url":"http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice","extension":[{"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":"756002006009","display":"Normal price mutation"}]}},{"url":"value","valueMoney":{"value":421.65,"currency":"CHF"}},{"url":"changeDate","valueDate":"2024-10-01"}]},{"url":"http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice","extension":[{"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":"756002006009","display":"Normal price mutation"}]}},{"url":"value","valueMoney":{"value":372.61,"currency":"CHF"}},{"url":"changeDate","valueDate":"2024-10-01"}]}]}],"subject":[{"reference":"CHIDMPPackagedProductDefinition/c3a247c9-d686-49ab-9344-892d8b93f148"}],"type":{"coding":[{"system":"http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type","code":"756000002003","display":"Reimbursement SL"}]},"indication":[{"extension":[{"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":"2024-10-01"},{"url":"period","valuePeriod":{"start":"2024-10-01"}},{"url":"firstLimitationDate","valueDate":"2016-03-01"},{"url":"indicationCode","valueString":"20403.01"},{"url":"limitationIndication","valueReference":{"reference":"ClinicalUseDefinition/CYRAMZA.01"}}]}]},{"extension":[{"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":"2024-10-01"},{"url":"period","valuePeriod":{"start":"2024-10-01","end":"2027-09-30"}},{"url":"reimbursementEndDate","valueDate":"2027-12-31"},{"url":"firstLimitationDate","valueDate":"2016-03-01"},{"url":"indicationCode","valueString":"20403.02"},{"url":"limitationIndication","valueReference":{"reference":"ClinicalUseDefinition/CYRAMZA.02"}}]}]}],"holder":{"reference":"#7601001261853"}}},{"fullUrl":"http://fhir.epl.bag.admin.ch/Ingredient/a5edbabc-f9d6-4019-ac6f-2a80fe033339","resource":{"resourceType":"Ingredient","id":"a5edbabc-f9d6-4019-ac6f-2a80fe033339","meta":{"profile":["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient"]},"text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">Ramucirumabum 100 mg</div>"},"status":"draft","for":[{"reference":"CHIDMPMedicinalProductDefinition/de872be1-02ff-4b8e-8691-658099182eb7"}],"role":{"coding":[{"system":"http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role","code":"756005051001","display":"Active"}]},"substance":{"code":{"concept":{"text":"Ramucirumabum"}},"strength":[{"presentationQuantity":{"value":100,"unit":"mg"}}]}}},{"fullUrl":"http://fhir.epl.bag.admin.ch/ClinicalUseDefinition/CYRAMZA.01","resource":{"resourceType":"ClinicalUseDefinition","id":"CYRAMZA.01","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">In Kombination mit Paclitaxel für die Behandlung von erwachsenen Patienten mit ECOG-Status 0 oder 1 mit fortgeschrittenem Adenokarzinom des Magens oder gastroösophagealen Übergangs mit einem Progress nach vorausgegangener Platin- und Fluoropyrimidin-haltiger Chemotherapie.\nAls Monotherapie für die Behandlung von erwachsenen Patienten mit ECOG-Status 0 oder 1 mit fortgeschrittenem Adenokarzinom des Magens oder des gastroösophagealen Übergangs mit einem Progress nach vorausgegangener Platin- oder Fluoropyrimidin-haltiger Chemotherapie, wenn diese Patienten für eine Kombinationstherapie mit Paclitaxel nicht geeignet sind.\nDie Behandlung bedarf der Kostengutsprache durch den Krankenversicherer nach vorgängiger Konsultation des Vertrauensarztes.\nFolgender Indikationscode ist an den Krankenversicherer zu übermitteln: 20403.01</div>"},"type":"indication","indication":{"diseaseSymptomProcedure":{"concept":{"text":"In Kombination mit Paclitaxel für die Behandlung von erwachsenen Patienten mit ECOG-Status 0 oder 1 mit fortgeschrittenem Adenokarzinom des Magens oder gastroösophagealen Übergangs mit einem Progress nach vorausgegangener Platin- und Fluoropyrimidin-haltiger Chemotherapie.\nAls Monotherapie für die Behandlung von erwachsenen Patienten mit ECOG-Status 0 oder 1 mit fortgeschrittenem Adenokarzinom des Magens oder des gastroösophagealen Übergangs mit einem Progress nach vorausgegangener Platin- oder Fluoropyrimidin-haltiger Chemotherapie, wenn diese Patienten für eine Kombinationstherapie mit Paclitaxel nicht geeignet sind.\nDie Behandlung bedarf der Kostengutsprache durch den Krankenversicherer nach vorgängiger Konsultation des Vertrauensarztes.\nFolgender Indikationscode ist an den Krankenversicherer zu übermitteln: 20403.01"}}}}},{"fullUrl":"http://fhir.epl.bag.admin.ch/ClinicalUseDefinition/CYRAMZA.02","resource":{"resourceType":"ClinicalUseDefinition","id":"CYRAMZA.02","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">In Kombination mit FOLFIRI (Irinotecan, Folsäure und 5-Fluorouracil) zur Behandlung von erwachsenen Patienten mit metastasiertem kolorektalem Karzinom (mKRK) mit Progress während oder nach vorausgegangener Therapie mit Bevacizumab, Oxaliplatin und einem Fluoropyrimidin. Die Behandlung bedarf der Kostengutsprache durch den Krankenversicherer nach vorgängiger Konsultation des Vertrauensarztes.\nDie Eli Lilly (Suisse) SA vergütet dem Krankenversicherer, bei dem die versicherte Person zum Zeitpunkt des Bezugs versichert war, auf dessen erste Aufforderung hin für auf jede bezogene Packung CYRAMZA einen festgelegten Anteil des Fabrikabgabepreises zurück. Sie gibt dem Krankenversicherer die Höhe der Rückvergütung bekannt. Die Mehrwertsteuer kann nicht zusätzlich zu diesem Anteil des Fabrikabgabepreises zurückgefordert werden. Die Aufforderung zur Rückvergütung soll ab dem Zeitpunkt der Verabreichung erfolgen.\nFolgender Indikationscode ist an den Krankenversicherer zu übermitteln: 20403.02</div>"},"type":"indication","indication":{"diseaseSymptomProcedure":{"concept":{"text":"In Kombination mit FOLFIRI (Irinotecan, Folsäure und 5-Fluorouracil) zur Behandlung von erwachsenen Patienten mit metastasiertem kolorektalem Karzinom (mKRK) mit Progress während oder nach vorausgegangener Therapie mit Bevacizumab, Oxaliplatin und einem Fluoropyrimidin. Die Behandlung bedarf der Kostengutsprache durch den Krankenversicherer nach vorgängiger Konsultation des Vertrauensarztes.\nDie Eli Lilly (Suisse) SA vergütet dem Krankenversicherer, bei dem die versicherte Person zum Zeitpunkt des Bezugs versichert war, auf dessen erste Aufforderung hin für auf jede bezogene Packung CYRAMZA einen festgelegten Anteil des Fabrikabgabepreises zurück. Sie gibt dem Krankenversicherer die Höhe der Rückvergütung bekannt. Die Mehrwertsteuer kann nicht zusätzlich zu diesem Anteil des Fabrikabgabepreises zurückgefordert werden. Die Aufforderung zur Rückvergütung soll ab dem Zeitpunkt der Verabreichung erfolgen.\nFolgender Indikationscode ist an den Krankenversicherer zu übermitteln: 20403.02"}}}}}]}

data/spec/fhir_spec.rb

@@ -0,0 +1,85 @@
+require "spec_helper"
+require "oddb2xml/downloader"
+require "oddb2xml/extractor"
+require "oddb2xml/fhir_support"
+require "oddb2xml/builder"
+
+describe "FHIR Indikationscode support" do
+  let(:cyramza_fixture) { File.join(Oddb2xml::SpecData, "fhir", "cyramza.ndjson") }
+
+  describe Oddb2xml::FHIR::ClinicalUseDefinition do
+    it "extracts the .NN suffix from id" do
+      cud = described_class.new("id" => "CYRAMZA.02", "type" => "indication")
+      expect(cud.nn_suffix).to eq("02")
+      expect(cud.indication?).to be true
+    end
+
+    it "returns nil suffix for non-conforming ids" do
+      cud = described_class.new("id" => "CYRAMZA")
+      expect(cud.nn_suffix).to be_nil
+    end
+  end
+
+  describe Oddb2xml::FHIR::Bundle do
+    it "collects ClinicalUseDefinition entries" do
+      line = File.read(cyramza_fixture).lines.first
+      bundle = described_class.new(line)
+      expect(bundle.clinical_use_definitions).not_to be_empty
+      expect(bundle.clinical_use_definitions.map(&:id)).to include("CYRAMZA.01", "CYRAMZA.02")
+    end
+  end
+
+  describe Oddb2xml::FHIR::PreparationsParser do
+    it "constructs XXXXX.NN indication codes from FOPHDossierNumber + CUD suffix" do
+      parser = described_class.new(cyramza_fixture)
+      prep = parser.preparations.first
+      codes = prep.IndicationCodes.map(&:code)
+      expect(codes).to include("20403.01", "20403.02")
+    end
+  end
+
+  describe Oddb2xml::FhirExtractor do
+    it "exposes indication_codes on each item and package" do
+      data = described_class.new(cyramza_fixture).to_hash
+      expect(data).not_to be_empty
+
+      item = data.values.first
+      codes = item[:indication_codes].map { |ic| ic[:code] }
+      expect(codes).to include("20403.01", "20403.02")
+
+      pkg = item[:packages].values.first
+      expect(pkg[:indication_codes]).to eq(item[:indication_codes])
+    end
+  end
+
+  describe Oddb2xml::Builder, "PRD INDICATION_CODE emission" do
+    it "emits one <INDICATION_CODE> child per indication on the PRD" do
+      items = Oddb2xml::FhirExtractor.new(cyramza_fixture).to_hash
+      builder = described_class.new
+      builder.instance_variable_set(:@items, items)
+      builder.instance_variable_set(:@refdata, {})
+      builder.instance_variable_set(:@packs, {})
+      builder.instance_variable_set(:@migel, {})
+      builder.instance_variable_set(:@interactions, [])
+      builder.instance_variable_set(:@flags, {})
+      builder.instance_variable_set(:@orphan, [])
+      builder.instance_variable_set(:@firstbase, {})
+      builder.instance_variable_set(:@substances, [])
+      builder.instance_variable_set(:@codes, {})
+      builder.instance_variable_set(:@missing, [])
+      builder.instance_variable_set(:@tag_suffix, nil)
+
+      xml = builder.send(:build_product)
+      expect(xml).to include("<INDICATION_CODE")
+      expect(xml).to include('code="20403.01"')
+      expect(xml).to include('code="20403.02"')
+      expect(xml).to include('cud_id="CYRAMZA.01"')
+      expect(xml).to include('cud_id="CYRAMZA.02"')
+      # The CUD's indication text travels into the element body so
+      # downstream consumers can show the human-readable indication
+      # next to the code.
+      expect(xml).to include("In Kombination mit Paclitaxel")
+      expect(xml).to include("In Kombination mit FOLFIRI")
+    end
+  end
+end

metadata

@@ -1,7 +1,7 @@
 --- !ruby/object:Gem::Specification
 name: oddb2xml
 version: !ruby/object:Gem::Version
-  version: 3.0.5
+  version: 3.0.7
 platform: ruby
 authors:
 - Yasuhiro Asaka, Zeno R.R. Davatz, Niklaus Giger
@@ -261,6 +261,20 @@ dependencies:
     - - ">="
       - !ruby/object:Gem::Version
         version: 3.3.9
+- !ruby/object:Gem::Dependency
+  name: csv
+  requirement: !ruby/object:Gem::Requirement
+    requirements:
+    - - ">="
+      - !ruby/object:Gem::Version
+        version: '0'
+  type: :runtime
+  prerelease: false
+  version_requirements: !ruby/object:Gem::Requirement
+    requirements:
+    - - ">="
+      - !ruby/object:Gem::Version
+        version: '0'
 - !ruby/object:Gem::Dependency
   name: standardrb
   requirement: !ruby/object:Gem::Requirement
@@ -512,6 +526,7 @@ files:
 - spec/data/compressor/oddb2xml_files_lppv.txt
 - spec/data/compressor/oddb2xml_files_nonpharma.xls
 - spec/data/epha_interactions.csv
+- spec/data/fhir/cyramza.ndjson
 - spec/data/listen_neu.html
 - spec/data/medregbm_betrieb.txt
 - spec/data/medregbm_person.txt
@@ -539,6 +554,7 @@ files:
 - spec/data_helper.rb
 - spec/downloader_spec.rb
 - spec/extractor_spec.rb
+- spec/fhir_spec.rb
 - spec/fixtures/vcr_cassettes/artikelstamm.json
 - spec/fixtures/vcr_cassettes/oddb2xml.json
 - spec/galenic_spec.rb
@@ -607,6 +623,7 @@ test_files:
 - spec/data/compressor/oddb2xml_files_lppv.txt
 - spec/data/compressor/oddb2xml_files_nonpharma.xls
 - spec/data/epha_interactions.csv
+- spec/data/fhir/cyramza.ndjson
 - spec/data/listen_neu.html
 - spec/data/medregbm_betrieb.txt
 - spec/data/medregbm_person.txt
@@ -634,6 +651,7 @@ test_files:
 - spec/data_helper.rb
 - spec/downloader_spec.rb
 - spec/extractor_spec.rb
+- spec/fhir_spec.rb
 - spec/fixtures/vcr_cassettes/artikelstamm.json
 - spec/fixtures/vcr_cassettes/oddb2xml.json
 - spec/galenic_spec.rb