FAIR Package Registry ontology

• has ATC code ^dp
• has care activity code ^dp
• has care product code ^dp
• has claim code ^dp
• has EMA reference ^dp
• has international nonproperietary name ^dp
• has marketing authorization holder ^dp

• has cost estimation ^op
• has trend assumption ^op

• has cost type ^op
• has market penetration ^dp
• has number of patients ^dp
• has timepoint ^dp
• has total costs ^dp

• Literature Search ^c
• Systematic Literature Review ^c

A mechanism or agreement, often a managed entry or risk-sharing scheme, that links a new technology's funding or reimbursement to its actual use in a specific patient population or clinical setting, typically to manage clinical or financial uncertainty or to ensure cost-effective utilization

Type of assessment of a intervention-indication combination evaluation, such as initial assessment or reassessment

Economic evaluation that maps the expected change in (total) expenditures resulting from the implementation of new care (intervention, process) or the de-implementation of existing care, and focuses on whether the implementation is actually financeable

• has cost estimation ^op
• has trend assumption ^op

A type of economic evaluation that compares the relative costs and health outcomes of two or more alternative interventions to determine which one provides the greatest health benefit for a given cost, often expressed as the Incremental Cost-Effectiveness Ratio (ICER)

Indicator of a cost type in the context of a BIA, such as the cost in the current situation, or the additional care costs when a substitute is reimbursed

Section of a Package Statement that evaluates whether the Intervention conforms to Established Medical Science and Medical Practice in relation to the Indication.

• has outcome measurement ^op
• has PICO ^op
• has relative effectiveness ^op
• has systematic literature review ^op
• adheres to EMSMP ^dp

Editorial status of a package type, such as definitive

Relative outcome of a comparison or evaluation, such as positive or negative

• has conclusion ^op
• has relative effectiveness ^op

Grouping of all evaluations related to one Intervention-Indication Combination in the context of a Package Statement

• has BIA ^op
• has conclusion ^op
• has cost-effectiveness ^op
• has EMSMP ^op
• has indication ^op
• has intervention ^op
• has managed entry agreement ^op
• has conclusion text ^dp

Filtered (literature) results that resulted from literature searches and cleaning/evaluation of each result

• schema:ItemList ^c
• Collection ^c

Execution of a search for relevant literature/evidence in a data source using a particular search query, executed at a particular time.

• schema:SearchAction ^c
• Activity ^c

• has date limit ^op
• has evidence type ^op

Formal, negotiated contract between a health technology provider and a payer (like a national health system) that provides conditional access and reimbursement for a health technology, specifically addressing and mitigating uncertainty about its real-world performance or budget impact

The official determination by the Dutch Health Care Institute regarding the content of the standard health insurance package (basisverzekering) that defines the boundaries of what should be collectively insured and what should not.

• has assessment type ^op
• has IIC assessment ^op
• has package type ^op
• has package type medical subtype ^op
• has status ^op
• has case number ^dp
• has guarantee document ^dp
• has serial number ^dp

Type of the package statement, i.e. point-of-view or advice

In case of medication, the subtype of the package statement, which can be lock procedure drug

Possible financial situation that is evaluated in the context of a BIA

Search for evidence (literature) in the context of a Package Statement, and listing of filtered results

Indicates the assessment type of a Package Statement

The Budget Impact Analysis for an IIC

The conclusion about a ICC assessment, expressed as positive or negative

The discussion of cost-effectiveness for an IIC

The cost estimation dataset of a BIA

The cost type dimension of a particular cost estimation value

The date limit for a search for evidence

The discussion of EMSMP for an IIC

The type of evidence (RTC, Systematic review etc) that was searched for

An IIC assessment that a Package Statement covers

The indication that an IIC assessment is about

The intervention that a IIC assessment is about

A managed entry agreement for a IIC

The actual value of a outcome measure that is part of the EMSMP evaluation

The PICO that is defined for an EMSMP investigation

Indicates the package type of a Package Statement

Indicates the package subtype in case the intervention is medication

The relative effectiveness of a Intervention for an Indication, expressed as positive, negative, or equal

The scenario for a BIA dataset

Indicates the editorial status of the Package Statement

The search for evidence and results for the EMSMP evaluation

The trend assumption dataset of a BIA

Whether the Intervention adheres to Established Medical Science and Medical Practice for the relevant indication

ATC code for the Intervention

Care activity code (ZA-code) of the Intervention

Care product code of the Intervention

Case number of the Package Statement

Claim code of the Intervention

Conclusion text for an IIC assessment

EMA reference for the Intervention

Guarantee document of the Package Statement

Nonproperietary name of the Intervention

Expected Intervention market penetration

Authorization holder of the Intervention

Number of patients for a BIA estimate

Serial number of the Package Statement

Time point of a particular BIA estimate

Total costs for a particular BIA estimate

Whether an Intervention is cost-effective for the Indication

Whether an outcome is a surrogate outcome