ICER = (Cost_new − Cost_comparator) / (Effect_new − Effect_comparator). A foundational HTA metric. The U.S. organization ICER (Institute for Clinical and Economic Review) produces influential value assessments. A result is compared with a willingness-to-pay threshold, such as cost per QALY gained. If the new technology costs less and works better, it dominates and no ratio is needed. Uncertainty is shown through sensitivity analyses and cost-effectiveness acceptability curves. In device models, learning curves and changing prices can affect the result.

Why it matters

Often confused with the U.S. organization of the same name. Manufacturers must distinguish between the math and the organization in commercial conversations.

Common pitfalls

•Confusing the mathematical concept of ICER with the Institute for Clinical and Economic Review, an organization that performs HTA using ICER.
•Failing to consider the specific thresholds for cost-effectiveness that vary by country and payer.
•Not adequately accounting for all relevant costs and effects in the ICER calculation, leading to an inaccurate representation of value.
•Presenting ICER without appropriate context or sensitivity analyses, which can misrepresent the robustness of the findings.

Sources

ICER (US) · ICER
NICE health technology evaluation manual: economic evaluation · NICE

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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