MII IG Kerndatensatz-Modul Onkologie
2027.0.0-ballot.1 -
Germany
MII IG Kerndatensatz-Modul Onkologie
2027.0.0-ballot.1 -
Germany
This page is part of the MII IG Kerndatensatz-Modul Onkologie (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions
The MII provides curated terminologies relevant to oncology for systemic therapies:
Important: the ValueSets contain only substances relevant to oncology, not the complete ATC classification.
Name, status, version and the number of codes are shown on the artifact page
mii-cs-onko-systemische-therapie-protokolle.
Examples of common protocols: FOLFOX, R-CHOP, AC, BEACOPP, ICE
Please submit new protocols via GitHub Issues.
The ATC classification is published annually at international level by the WHO
Collaborating Centre for Drug Statistics Methodology (Oslo). For Germany, the
BfArM publishes the official German version annually (ATC-DE, with
defined daily doses/DDD) — it may deviate from the WHO version in individual
codes and DDD definitions. This module uses exclusively the German version
with the system URL http://fhir.de/CodeSystem/bfarm/atc; the WHO version
(http://www.whocc.no/atc) is not used.
On the MII terminology server, ATC-DE — like ICD-10-GM, OPS and ICD-O — is held
as a separate CodeSystem resource per year under the common system URL (for
example L01XC18 pembrolizumab exists in the resource |2021, but no longer in
|2026). The same rules follow from this as for ICD-O
(see ICD-O Terminology):
…atc|2018#…) —
historical codes therefore validate against the CodeSystem resource in which
they exist.coding.version (the ATC year) so that validation
and analysis know the year.Unlike ICD-O (where the entire classification is relevant to oncology and the ValueSets cover the complete axis), the annual ATC ValueSets are curated oncological subsets (approximately 320–440 substances per year) based on the oBDS substance list. A different maintenance contract follows from this: besides the version pin, each year requires content curation (new oncology drug approvals, reclassifications). Curation gaps are the typical source of errors — for instance the L01XC antibodies were temporarily missing from the years 2018–2021 (GitHub #308). Please report missing substances as a GitHub issue; the systematic tracking of new approvals is planned as a monitoring process (GitHub #282–#284).
Name, status, version and expansion of the main ValueSet are shown on the artifact page
mii-vs-onko-systemische-therapie-substanzen.
Year-specific ValueSets are available for validating historical data:
The German ATC classification is updated annually; code moves between the years are documented by the transition ConceptMaps — the tool for ETL pipelines and the migration of historical medication data:
| Transition | ConceptMap | Focus |
|---|---|---|
| 2020 → 2021 | mii-cm-onko-atc-transitions-2021 |
kinase inhibitors L01XE → L01E (e.g. quizartinib L01XE52 → L01EX11, abemaciclib L01XE50 → L01EF03) |
| 2021 → 2022 | mii-cm-onko-atc-transitions-2022 |
largest reclassification in oncology: 20 monoclonal antibodies L01XC → L01F* (trastuzumab, rituximab, pembrolizumab, nivolumab, …) |
| 2022 → 2023 | mii-cm-onko-atc-transitions-2023 |
subsequent adjustments |
| 2023 → 2024 | mii-cm-onko-atc-transitions-2024 |
subsequent adjustments |
| 2024 → 2025 | mii-cm-onko-atc-transitions-2025 |
subsequent adjustments |
| 2025 → 2026 | mii-cm-onko-atc-transitions-2026 |
subsequent adjustments |
Coding recommendation: use the ATC code that was valid at the time of
therapy and state coding.version. In case of doubt, the UNII code can be used
as an alternative.
Example — imatinib across an ATC version change: mii-exa-onko-medikation-imatinib-atc-version-transition
DIC may map historical free-text medication data to ATC codes retrospectively if:
medicationCodeableConcept.text.Name, status, version and expansion of the UNII ValueSet are shown on the artifact page
mii-vs-onko-systemische-therapie-substanzen-unii.
Example — substance with a UNII code only (iberdomide): mii-exa-onko-medikation-iberdomide-unii
The following oBDS entries have neither ATC nor UNII codes:
→ Use Coding.text with free text.
Newly available: disodium folinate is now available as LEUCOVORIN SODIUM (UNII: 4MXU9LJS4Q) in the UNII ValueSet and as sodium folinate (ATC: V03AF06) in the ATC ValueSets.
Procedure (protocol):
* usedCode from MII_VS_Onko_Systemische_Therapie_Protokolle (extensible)
MedicationStatement (substance):
* medicationCodeableConcept from MII_VS_Onko_Systemische_Therapie_Substanzen (extensible)