How do you build a health economic model that withstands HTA review?
We develop health economic models, that is, cost-effectiveness and cost-utility analyses (CEA/CUA) as well as budget impact models, that meet the methodological requirements of NICE, IQWiG and ICER and feed into the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282. The sticking point is rarely the calculation, it is traceability: a reviewer accepts only a model whose structure, data sources and assumptions can be checked cell by cell, not a black box with the right ICER at the end.
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Overview
What does HTA review require of a health economic model?
Models built to the reference cases of NICE, IQWiG and ICER · aligned with the EU HTA Regulation (EU) 2021/2282
Last updated: 2026-06-13
A health economic model is judged not on whether the result is plausible, but on whether every assumption behind it is substantiated and verifiable. HTA bodies differ markedly in methodology and endpoints, which is why a model can rarely be transferred unchanged from one market to the next:
- The NICE reference case (Health Technology Evaluations: the manual) requires a cost-utility analysis with QALYs, a lifetime time-horizon logic, the perspective of the healthcare system and defined discount rates for costs and effects.
- The German AMNOG benefit assessment under SGB V § 35a and the AM-NutzenV places the added benefit relative to the appropriate comparator therapy at the center; IQWiG primarily assesses patient-relevant endpoints and does not accept QALY-based CUA as the sole basis for decision-making.
- The ICER Value Assessment Framework works with cost-effectiveness thresholds and a budget impact framework for the US market and sets its own requirements for transparency and scenarios.
- The EU HTA Regulation (EU) 2021/2282 introduces the Joint Clinical Assessment; the economic assessment remains national but builds on the same clinical evidence base. Model structure and data provenance must therefore be consistent with it.
- Reporting transparency to CHEERS 2022 is effectively an entry requirement: model structure, inputs, data sources and sensitivity analyses must be documented so that a reviewer can independently reproduce them.
Services
How we support you
Cost-Effectiveness & Cost-Utility Analysis (CEA/CUA)
Building Markov or partitioned survival models to the NICE reference case, including QALY calculation, time-horizon and discounting logic. Deliverable: a verifiable model with documented structure and a traceable ICER derivation.
Budget Impact Modeling
Modeling the budget impact over a defined time horizon from the payer perspective, with market-share and population scenarios. Deliverable: a budget impact model with auditable assumptions for payers and HTA bodies.
Sensitivity & Scenario Analyses
Deterministic (DSA, tornado diagram) and probabilistic sensitivity analyses (PSA), including the cost-effectiveness acceptability curve. Deliverable: a documented uncertainty analysis that demonstrates the robustness of the base case for review.
MedTech & IVD Pathway Modeling
Modeling the care pathway and the economic impact of medical devices and diagnostics, including the downstream costs of altered diagnostic or treatment pathways. Deliverable: a pathway model with substantiated resource and cost data.
HTA Compliance Check & Reporting
Aligning an existing model against the target-market reference case (NICE, IQWiG, ICER) and reporting to CHEERS 2022. Deliverable: a gap list with concrete corrections before submission.
Learn more →Model Validation & Reviewer Preparation
Technical and methodological validation of the model, plausibility checks of the inputs and preparation for reviewer queries. Deliverable: a validation report and documented responses to anticipated objections.
How we work together
What it comes down to
A health economic model is not created during the calculation but in the definition of the decision problem: which comparator, which perspective, which time horizon, which endpoints. This sequence is the real lever. Anyone who chooses the model structure first and only then checks what the appropriate comparator therapy under SGB V § 35a or the NICE reference case requires builds on assumptions that do not hold up in review. The NICE pathway runs through a QALY-based cost-utility analysis, the AMNOG pathway through the added benefit relative to the comparator therapy. A model that is meant to serve both must reflect this distinction from the outset rather than translating it after the fact.
The second bottleneck is transparency. A reviewer accepts no result that they cannot reproduce themselves. That is why we document structure, inputs and data provenance to CHEERS 2022, disclose every assumption and demonstrate robustness through deterministic and probabilistic sensitivity analyses. With the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282, the critical point shifts even further forward: the economic model structure must build on the same clinical evidence base that holds up in the joint assessment. Anyone who begins economic modeling only after clinical evidence planning is complete risks building the model on endpoints that later do not count.
Our approach
Our approach
Step
Result
Research question & target market
A defined decision problem, comparator and target-market reference case (NICE, IQWiG or ICER) before a single model cell is built.
Model structure & data strategy
A justified model choice (Markov, partitioned survival), defined endpoints and documented provenance for every data source.
Model build
A transparent, verifiable model with traceable formulas and no hidden assumptions.
Sensitivity analyses
DSA and PSA with tornado diagram and acceptability curve that demonstrate the robustness of the base case.
Validation & reporting
A validated model, a report to CHEERS 2022 and prepared reviewer responses.
Submission support
The model anchored in the dossier, with HTA-body queries answered in a structured way.
Common pitfalls
Where projects commonly fail
A model is built for one market and transferred unchanged to the next.
The NICE reference case with QALY-based CUA and the AMNOG logic under SGB V § 35a, with its focus on the added benefit relative to the appropriate comparator therapy, have different endpoints; a directly ported model is not accepted by IQWiG in the same form.
The assumptions are hidden in formulas and nested cells rather than documented in the open.
A reviewer who cannot follow the derivation of the ICER step by step objects to the model as unverifiable, regardless of whether the result is correct.
The comparator is not secured before modeling begins.
If the chosen comparator therapy deviates from the appropriate comparator therapy that IQWiG expects, the entire economic argument is open to challenge because the clinical evidence base does not fit.
Sensitivity analyses are added as a formal box-ticking exercise at the end.
A PSA that merely confirms the base case without exposing the driving uncertainties weakens credibility; reviewers expect the tornado diagram to name the critical parameters.
Economic modeling runs separately from clinical evidence planning.
With the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282, the economic model structure must build on the same clinical data base; anyone who brings the two together late builds on endpoints that do not hold up in the joint assessment.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2021/2282 on health technology assessment (EU HTA Regulation), primary text
- Fifth Book of the German Social Code (SGB V) § 35a and the Pharmaceutical Benefit Assessment Ordinance (AM-NutzenV), primary text
- NICE Health Technology Evaluations: the manual (Reference Case)
- ICER Value Assessment Framework
- CHEERS 2022, Consolidated Health Economic Evaluation Reporting Standards
- https://theentourage.de/expertise/heor-modeling/ (existing page content, revised)
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Case Studies
What this looks like in practice
Regulations & standards considered
- EU HTA Regulation (EU) 2021/2282 (Joint Clinical Assessment, Joint Scientific Consultation)
- SGB V § 35a (AMNOG benefit assessment in Germany)
- AM-NutzenV (Pharmaceutical Benefit Assessment Ordinance)
- NICE Health Technology Evaluations: the manual (Reference Case)
- ICER Value Assessment Framework
- CHEERS 2022 (Consolidated Health Economic Evaluation Reporting Standards)
Related topics
HTA Dossier →
The health economic model as part of the HTA submission dossier
Real-World Evidence →
RWE as a data source for model inputs beyond RCT data
Market Access Strategy →
The modeling embedded in the overarching market access strategy
Value Dossier →
The economic argument for value communication to payers
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