The cost–benefit assessment under Section 35b SGB V is a German procedure in which IQWiG analyses the costs of medical interventions in relation to their patient-relevant benefit. It can be commissioned following a benefit assessment and supplements the information used for reimbursement decisions. It does not re-examine whether an additional benefit exists under the procedure set out in Section 35a SGB V.
Mandate and independent objective
The G-BA commissions IQWiG to conduct a cost–benefit assessment in accordance with the statutory requirements. The analysis compares medicinal products or other forms of treatment on the basis of clinical trials or real-world care studies and considers benefit aspects such as health status, disease duration, survival, adverse events and quality of life in relation to costs. IQWiG’s methods classify it as a health-economic analysis with its own research question.
Such an assessment may become relevant, for example, in connection with an arbitration award on the reimbursement amount or at the request of a party involved. The procedure works with a clearly defined population, intervention, comparators, perspective, time horizon and a health-economic target outcome. Depending on the available data, decision-analytic models can depict long-term consequences that were not observed directly in a clinical trial.
Outcome and classification
The cost–benefit assessment does not result in a universal willingness-to-pay threshold. For multiple therapies, the efficiency frontier can be used: it graphically contrasts the benefits and costs of the efficient alternatives. Dominated or extendedly dominated options do not shape this frontier. Uncertainty is made visible, among other methods, through sensitivity analyses.
Because modelling uses extrapolations, assumptions and various data sources, its evidentiary strength does not reach the level of proof, indication, or suggestion intended for an evidence-based statement on additional benefit. This does not make it arbitrary. Rather, parameters, structural choices and scenarios must be presented transparently so that it is clear which economic consequences follow from different assumptions.
Distinction: additional benefit and general health economics
The early benefit assessment under Section 35a SGB V primarily answers whether, and to what extent, a medicinal product has a patient-relevant additional benefit compared with the appropriate comparator therapy. A cost–benefit assessment does not overturn this result. It uses the clinical evidence to address a different question, namely the relationship between resource use and benefit.
The entry “health economics” describes the broader field of health-economic analyses. By contrast, the cost–benefit assessment under Section 35b SGB V is a specific German statutory procedure, commissioned by the G-BA and conducted using IQWiG’s methods. Not every cost-effectiveness analysis prepared by a manufacturer is therefore a cost–benefit assessment under Section 35b.
The choice of perspective determines which costs are included in the calculation. Explicitly to be specified are, for example, medicinal products, outpatient and inpatient services, and other resources insofar as they are relevant to the research question. The time horizon likewise shapes the results: a short study window can reliably capture treatment costs, but may underestimate long-term disease consequences. These decisions are defined in the decision problem and must be consistent with the model and the data sources.
The health-economic evaluation must also be distinguished from a pure budget impact analysis. The latter asks about the financial consequences of an introduction for a budget over a defined period. A cost–benefit assessment contrasts resource use with patient-relevant effects. Both analyses can be informative for negotiations, but they answer different questions and should not be replaced by the same metric.
Precisely because the procedure is rare, a commission should not be treated like a standard dossier. The modelling question, comparators and required data arise from the specific, legally embedded assessment mandate.
A robust assessment therefore requires a clearly defined decision question before modelling begins. Without this definition, it is not possible to determine which comparators are relevant or which costs and utility values belong in the analysis.
When presenting results, absolute and incremental values must be distinguished for each therapy. Only the combination of costs, patient-relevant effect and uncertainty shows whether an observed difference is driven by robust data or by individual model assumptions.
Relevance for clinical trials
Clinical trials provide key parameters for economic modelling, including efficacy, adverse events, quality of life and resource use. Their later usability depends on whether definitions, assessment time points and analysis populations match the model states. Long-term projections often require additional data, but a lack of transparency regarding transition probabilities or cost assumptions makes them difficult to assess.
Full-service CROs such as Mediconomics support clients with health-economic analysis plans, the collection of resource-use data, and the preparation of clinical inputs for decision models. Biostatistics can document parameter estimates and uncertainty analyses, while Medical Writing provides a transparent account of the model assumptions, the evidence used and the results of the cost–benefit analysis.
Frequently Asked Questions (FAQ)
Does the cost–benefit assessment set a drug price?
No. It provides economic information; the reimbursement amount is not determined by a blanket threshold from this assessment.
Can the cost–benefit assessment refute the established additional benefit?
No. Its methods build on the benefit assessment and pursue a separate health-economic objective.
Why are models used in the cost–benefit assessment?
Models can represent consequences beyond the observation period of individual studies, but must disclose their assumptions and uncertainties.
Regulatory references
- Section 35b SGB V – governs the cost–benefit assessment of medicinal products.
- Section 130b SGB V – concerns the agreement of reimbursement amounts.
- IQWiG, General Methods Version 8.0 – describes methods for cost–benefit assessment.
- Rules of Procedure of the G-BA, Chapter 5 – contains procedural rules for the assessment of medicinal products.