HEOR Evidence Synthesis & Dossier Builder
Synthesize health economic evidence into payer-ready regulatory dossiers
What You Can Do
You can rapidly compile, organize, and format disparate health economic evidence—from clinical trials to cost-effectiveness analyses—into structured, regulatory-compliant dossiers. This skill maps your evidence to specific payer and HTA requirements, automatically generates evidence hierarchies, and produces submission-ready dossier outlines with formatting that meets regulatory standards for NICE, EUnetHTA, and other major bodies.
Features
Automatically organize and structure clinical, economic, and safety evidence from multiple sources into a coherent hierarchy.
Align evidence to specific payer requirements (NICE, EUnetHTA, PBAC, etc.) and flag gaps before submission.
Structure cost-effectiveness analysis (CEA), cost-utility analysis (CUA), and budget impact analysis (BIA) documentation.
Generate pre-formatted dossier outlines and section hierarchies matching regulatory submission standards.
Evaluate the quality and robustness of included evidence using validated hierarchies (GRADE, Cochrane, etc.).
Organize and format citations in regulatory-preferred styles; detect missing bibliographic data.
Identify missing evidence, highlight weak links in your economic model, and suggest data collection priorities.
Maintain dossier versions and auto-generate change summaries for iterative submissions.
Example Output
Example 1: Evidence Organization Table
| Evidence Type | Source | Quality (GRADE) | Key Finding | Regulatory Use |
|---|---|---|---|---|
| Pivotal RCT | Smith et al. 2023 | High | 35% mortality reduction vs. placebo | Primary efficacy |
| Economic Model | Internal CEA | Moderate | €42,500/QALY vs. standard care | Cost-effectiveness claim |
| Real-world data | Claims database | Moderate | 18% hospitalization reduction | Effectiveness support |
Example 2: NICE-Compliant Dossier Structure
A. Executive Summary | B. Clinical Effectiveness | B.1 Disease background and epidemiology | B.2 Clinical evidence summary | C. Health Economic Model | C.1 Model structure and justification | C.2 Cost-effectiveness results | D. Budget Impact Analysis | E. Discussion
Example 3: Gap Analysis Report
- ✅ Robust pivotal efficacy data (Phase III RCT, n=450)
- ⚠️ Limited long-term safety data (max 12-month follow-up)
- ❌ Missing real-world effectiveness in elderly subgroup
- 💡 Recommendation: Post-approval registry to address age-specific outcomes
What's Included
- Evidence synthesis templates: Pre-built frameworks for organizing clinical trials, observational studies, economic analyses, and safety data.
- Regulatory dossier blueprints: Section-by-section outlines and formatting guides for NICE, EUnetHTA, PBAC, ICER, and other major payer/HTA bodies.
- Health economic model organizer: Structure for documenting CEA/CUA inputs, assumptions, model architecture, and sensitivity analyses.
- Compliance checker: Automated review to ensure evidence meets payer-specific requirements (e.g., trial minimum size, clinical thresholds).
- Evidence quality rubric: GRADE, Cochrane risk-of-bias, and custom scales to rate and categorize evidence strength.
- Regulatory requirement matrix: Cross-reference table mapping your evidence to NICE, EUnetHTA, and other payer submission criteria.
Who It's For
- Health economics and outcomes research (HEOR) analysts
- Regulatory affairs and submissions specialists
- Medical affairs and reimbursement teams
- Payer strategy and health technology assessment managers
- Pharmaceutical and medical device R&D teams preparing submissions
Best For
- Preparing regulatory dossiers for EMA, NICE, and EUnetHTA submissions
- Synthesizing clinical and economic evidence into coherent arguments
- Structuring health economic models (CEA, CUA, BIA) for payer review
- Organizing evidence hierarchies and gap analysis for reimbursement applications
- Building rapid health technology assessment (HTA) dossiers
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