The Reality of Market Access Today
Market access requires translating clinical evidence into payer-relevant value narratives across diverse HTA frameworks. Traditional siloed approaches force HEOR teams to re-analyze data already processed for regulatory submissions, creating duplicated effort and potential inconsistencies.
Regulatory-Payer Evidence Gap
Clinical trial data alone doesn't satisfy HTA body requirements for comparative effectiveness and real-world outcomes. Payers want to see evidence of value in their populations, with their treatment pathways, under their budget constraints—none of which is directly addressed by pivotal trial results.
Duplicated Analysis
HEOR teams re-analyze data already processed for regulatory submissions, creating redundant work and potential inconsistencies. The same efficacy and safety data gets extracted, cleaned, and analyzed multiple times by different teams using different tools and methods.
Multi-Market Complexity
Different HTA bodies (NICE, G-BA, HAS, CADTH, PBAC) have different evidence requirements and decision frameworks. Tailoring your value story to each market's expectations while maintaining consistency requires manual customization that's time-consuming and error-prone.
Your Workflow, Transformed
One Data Foundation for Regulatory and HEOR Evidence
Build regulatory submissions and HTA dossiers from the same comprehensive data foundation. Real-world evidence integration, indirect treatment comparisons, and network meta-analyses extend clinical trial data into the comparative effectiveness frameworks HTA bodies require.
- Unified data foundation serving both regulatory and HEOR needs, eliminating duplicated analysis and ensuring consistency
- Real-world evidence integration for comparative effectiveness in target populations with relevant treatment patterns
- Indirect treatment comparisons and network meta-analyses when head-to-head trials aren't available
- Market-specific epidemiology and treatment pathway analysis for NICE, G-BA, HAS, CADTH, and PBAC requirements
Safety-Contextualized Value Narratives
Transform benefit-risk assessments into payer-relevant value narratives. Our Decision Intelligence module contextualizes safety within comparative effectiveness frameworks, supports subpopulation evidence for tiered access decisions, and builds the quantitative foundation for cost-effectiveness models.
- Safety-contextualized value narratives positioning benefit-risk within payer decision frameworks
- Subpopulation evidence generation for tiered access and managed entry agreements
- Comparative effectiveness analysis aligned with HTA body methodological guidelines
- Quantitative inputs for cost-effectiveness models including utility weights and adverse event rates
Multi-Market HTA Submission Packages
Generate value dossiers, HTA submission evidence packages, and budget impact frameworks tailored to each market's requirements. From a single analytical foundation, produce NICE Evidence Submission Group reports, G-BA dossiers, HAS transparency committee files, and CADTH pCODR submissions.
- Value dossiers structured to market-specific HTA frameworks (NICE, G-BA, HAS, CADTH, PBAC)
- HTA submission evidence packages with comparative effectiveness summaries and economic evaluation inputs
- Budget impact frameworks and forecasting models for payer negotiations and managed entry agreements
- Comparative effectiveness summaries supporting payer formulary decisions and coverage policies
Impact for Market Access Teams
"ArcaScience eliminated the regulatory-HEOR evidence gap that was creating duplicated work and inconsistent narratives across our global submissions. We now generate NICE ESG reports, G-BA dossiers, and CADTH submissions from the same data foundation that supports our regulatory CTD. Our time from approval to market access has dropped by 50%, and payers consistently comment on the thoroughness and consistency of our evidence packages."
GSK Respiratory: Multi-Market HTA Success from Unified Evidence Foundation
GSK's respiratory market access team used ArcaScience to prepare simultaneous HTA submissions for a novel biologic across five major markets. By generating market-specific value dossiers from a single evidence foundation, they achieved positive coverage recommendations from NICE, G-BA, HAS, CADTH, and PBAC within 12 months of regulatory approval.
Deepen Your Understanding
Bridging the Regulatory-Payer Evidence Gap: One Platform for CTD and HTA
How leading pharma companies generate regulatory and HEOR evidence from a single analytical foundation.
Download →Multi-Market HTA Strategy: NICE, G-BA, HAS, CADTH, PBAC from One Evidence Base
A practical guide to simultaneous HTA submissions with consistent evidence narratives across markets.
Read →Value Dossier Excellence: Evidence Packages That Win Payer Coverage
Best practices for translating clinical evidence into payer-relevant value narratives.
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