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    Health Economics and Outcomes Research

    Research discipline that generates economic, clinical, and patient-reported evidence to support payer access, HTA submissions, and value demonstration.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 9, 2026

    Definition

    Health Economics and Outcomes Research (HEOR) is the multidisciplinary field that generates economic models (cost-effectiveness, cost-utility, budget impact), real-world evidence, and patient-reported outcomes data used by payers, HTA bodies, and health systems to assess a technology's value. HEOR deliverables include the Global Value Dossier, AMCP Format submissions to US health plans, and country-specific HTA submissions (NICE, CADTH, IQWiG, HAS).
    What the regulation says
    Methodology references: ISPOR Good Practices, AMCP Format for Formulary Submissions v4.1, NICE Reference Case, ICER Value Assessment Framework. CMS's TCET program explicitly requires evidence aligned with HEOR principles.

    What this means in practice

    Strong HEOR is the difference between coverage and non-coverage in single-payer systems and is rising in importance for US commercial payers. Increasingly, HEOR planning starts at preclinical/early clinical to ensure trial endpoints support the value story.
    Common pitfalls
    • Designing pivotal trials around regulatory endpoints only and finding the dataset can't support the HEOR case.
    • Treating HEOR as a post-launch activity instead of an evidence-generation strategy from Phase 1.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    ISPOR·1AMCP·1CMS·1
    1. 1
      ISPOR — Good Practices
      Verified
      ISPORispor.org
    2. 2
      AMCP Format for Formulary Submissions
      Verified
      AMCPamcp.org
    3. 3
      CMS - Coverage
      Needs review
      CMScms.gov

    Inline markers like [1] jump to the matching reference above.