Post-Market Evidence Generation: Bridging PV and HTA for Long-Term Access

Post-market evidence generation is becoming a strategic priority for life sciences companies. After a drug or medical device gains regulatory approval, the focus quickly shifts to long-term access, pricing, and continued patient benefit. This shift requires new, real-world evidence to validate both product safety and health system value.

At the intersection of pharmacovigilance (PV) and health technology assessment (HTA) lies a growing opportunity: to align post-market safety monitoring with value demonstration. This integration helps life sciences companies meet both regulatory expectations and payer demands, ultimately ensuring sustainable access for patients.

The Convergence of Pharmacovigilance and HTA: Why Now?

Traditionally, pharmacovigilance and HTA served distinct purposes:

Pharmacovigilance monitors a product’s safety post-approval, identifying and managing adverse events.

HTA bodies evaluate clinical, economic, and societal value to support pricing and reimbursement decisions.

But the emergence of real-world outcomes, performance-based reimbursement, and adaptive licensing has created a new paradigm. Now, post-market evidence is central to demonstrating value, making the integration of PV and HTA data not just beneficial, but essential.

Regulatory agencies increasingly request:

Post-Authorisation Safety Studies (PASS)
Post-Authorisation Efficacy Studies (PAES)

These studies provide real-world insight that complements clinical trial data and supports HTA reassessments.

Real-World Evidence: Bridging Safety and Value

Real-world evidence (RWE) is the common thread that ties pharmacovigilance and HTA together. It is derived from:

Electronic health records (EHRs)

Claims databases

Patient registries

Patient-reported outcomes (PROs)

RWE plays a dual role:

Supports pharmacovigilance by identifying long-term or rare adverse events.

Strengthens HTA submissions by demonstrating comparative effectiveness and cost-effectiveness.

For conditions like cancer, rare diseases, or advanced therapy medicinal products (ATMPs), where trial data may be limited, RWE fills crucial evidence gaps.

Global Regulatory and HTA Expectations Are Evolving

Regulatory and HTA bodies worldwide are embedding post-market evidence requirements into product lifecycle management:

EMA: Encourages Adaptive Pathways and Parallel Scientific Advice for early alignment between regulators and HTA bodies.

FDA: Promotes RWE use through its Real-World Evidence Program.

NICE (UK) and HAS (France): Require post-launch evidence to inform ongoing reimbursement and pricing evaluations.

Germany’s AMNOG: Mandates periodic reassessment of a drug’s added benefit based on new evidence.

These trends highlight the growing need for evidence convergence, where RWE generated for PV also supports HTA and vice versa.

Common Challenges in Bridging PV and HTA

Despite shared goals, integrating PV and HTA streams involves several challenges:

Data Silos: PV and HTA teams often use separate databases, tools, and metrics, limiting collaboration.

Methodological Differences: RWE studies vary in design, making it difficult to satisfy both safety and value endpoints.

Misaligned Objectives: PV prioritizes risk minimization, while HTA focuses on cost-effectiveness leading to diverging KPIs.

Regulatory Fragmentation: Post-market evidence requirements differ across regions, complicating global strategies.

Future-Focused Strategies for Evidence Integration

Forward-thinking companies are adopting integrated post-market evidence approaches that benefit both pharmacovigilance and HTA. Key strategies include:

Cross-Functional Evidence Planning: Involving PV, market access, medical affairs, and RWE teams from early development stages ensures shared objectives.

Unified Registries and Data Platforms: Creating cross-purpose registries enables dual analysis for both safety and effectiveness outcomes.

Modular Post-Marketing Study Designs: Designing studies that answer both PASS and HTA requirements optimizes resource use and data output.

AI-Driven Pharmacovigilance: AI-enabled signal detection in pharmacovigilance enhances early identification of patterns relevant to both PV and value-based contracting.

Why Post-Market Evidence Generation Is a Strategic Advantage

For life sciences companies, investing in post-market evidence generation delivers long-term benefits:

Sustained reimbursement and access in evolving healthcare systems

Greater leverage in risk-sharing agreements

Enhanced product positioning in new and existing markets

Stronger benefit-risk documentation in PSURs and HTA reassessments

Especially for high-cost, fast-tracked, or orphan therapies, post-market evidence can directly influence market longevity.

Conclusion

With the shift of life sciences consulting from approval-based to evidence-based access models, bridging pharmacovigilance and HTA through post-market evidence generation is essential. Companies that embrace integrated, real-world data strategies will be best positioned to secure long-term access, payer trust, and patient impact.

How can DDReg help?

At DDReg, we help companies bridge regulatory compliance, safety surveillance, and market access through end-to-end post-market support. Whether you’re preparing for a benefit reassessment or negotiating a value-based pricing agreement, DDReg ensures your post-market strategy is proactive, compliant, and market-aligned.