Market Access · HEOR & HTA
Evidence Payers
Will Accept.
Health economics and outcomes research submitted to NICE, HAS, IQWiG, PBAC, and beyond — built on evidence payers will accept.
NICE·HASIQWiG·PBAC
Overview
Built on Agency-Specific Intelligence
HEOR services that generate evidence no payer will challenge require more than methodological competence they require an understanding of what each HTA body specifically looks for, and why the same evidence package that succeeds at NICE can fail at IQWiG. Our HTA consulting services are built around this agency-specific intelligence. We do not produce generic dossiers. We produce submissions that reflect the methodological expectations of each reviewing body, because the difference determines whether your therapy reaches patients. Health economics and outcomes research is most valuable when it begins before pivotal data exist — shaping evidence generation to address the questions payers will ask at HTA.
- Full HEOR evidence cycle and modelling
- Agency-specific dossiers: NICE, HAS, IQWiG, PBAC
- Transparent, auditable economic models
- Coordinated multi-market positioning
What We Deliver
Capabilities Across Every Stage
Three integrated disciplines, delivered by senior specialists as one accountable programme.
Health Economics & Outcomes Research
Health economics pharma work at Vigilare Biopharma covers the full HEOR evidence cycle: study design, evidence synthesis, economic modelling, and dossier preparation. Outcomes research services are designed to generate evidence that is relevant to payer decisions — not just statistically significant in a clinical sense. Payer evidence generation requires understanding what constitutes meaningful benefit from the perspective of each HTA agency, and designing studies that produce that evidence in a form those agencies will accept. Economic modeling pharma work covers Markov models, partitioned survival models, decision trees, and individual patient simulations — each selected for methodological appropriateness, not computational convenience.
HTA Submissions (NICE, HAS, IQWiG, PBAC)
HTA submission NICE HAS IQWiG PBAC experience is not interchangeable across agencies. NICE requires cost-utility analysis anchored in a QALY framework. HAS assesses actual clinical benefit against a defined comparator set with particular sensitivity to PRO instrument quality. IQWiG applies its own benefit assessment methodology based on direct head-to-head evidence. PBAC places significant weight on cost-minimisation arguments and Australian-specific cost data. Our HTA dossier preparation teams are organised by agency — each dossier is produced by a team with direct submission experience at the relevant body, not adapted from a generic global template.
Value Demonstration & Reimbursement
Cost effectiveness analysis pharma submissions are built on transparent, auditable assumptions — because payer technical reviewers will stress-test every parameter. Reimbursement strategy pharma planning begins at the evidence generation stage. Pharma value demonstration through HTA dossiers, budget impact models, and payer advisory board engagements positions your therapy's benefits in the economic language each payer uses. Global market access strategy coordination ensures evidence generated for one market is deployed effectively in others without creating reference pricing risks. For sponsors requiring global HEOR services USA UK EU Australia with coordinated multi-market positioning — HTA consulting NICE HAS IQWiG PBAC, all under one operational team.
4Core HTA Agencies
4Global Regions
QALYCost-Utility Models
ISO 90012015 Quality System
Key Deliverables
What You Receive
Tangible, submission-ready outputs — not status updates.
HTA Dossier
Agency-specific submission package for NICE, HAS, IQWiG, PBAC, or other bodies with all appendices.
Economic Model
Transparent cost-effectiveness model with full technical documentation and payer-facing summary materials.
Budget Impact Analysis
Payer-facing model quantifying the financial impact of reimbursement for the target health system.
QALY Analysis
Quality-adjusted life-year calculations supporting cost-utility analysis with evidence synthesis documentation.
Submission Package
All supporting documents, systematic literature reviews, and technical appendices for a complete submission.
Why Vigilare
Why Sponsors Choose Vigilare
What sets this engagement apart from a generic vendor.
Agency-Specific Teams
Agency-specific dossier teams with direct submission experience at NICE, HAS, IQWiG, PBAC, and other major HTA bodies — not a central team applying a single methodology to all markets.
Auditable Economic Models
Economic models built for auditability and payer interrogation transparent structure, pre-specified sensitivity analyses, and clear assumption documentation that holds up under technical review.
Early Evidence Planning
HEOR evidence planning integrated with clinical program design — evidence gap identification begins before the pivotal study protocol is finalized, not at the dossier writing stage.
Payer Advisory Boards
Payer advisory board facilitation to test evidence narratives and economic assumptions before formal HTA submission improving submission quality and reducing the risk of negative recommendations.
Who We Work With
Configured to Your Model
We engage differently depending on the function you already have in place.
EU / UK Launch Teams
Challenge
Preparing for simultaneous HTA submissions across multiple European markets
How We Help
Coordinated multi-market dossier strategy meeting each agency's requirements without duplicating effort.
Post-Approval Brands
Challenge
Facing re-assessment, pricing renegotiation, or label extension HTA requirements
How We Help
Rapid evidence reviews, model updates, and dossier refreshes calibrated to the re-assessment scope.
Biotech at First Reimbursement
Challenge
Seeking first commercial reimbursement without an established HEOR function
How We Help
We build the HEOR infrastructure, evidence strategy, and submission capability from the ground up.
FAQs
HEOR & HTA Strategy, Answered.
01
What is HEOR in pharma?
HEOR (Health Economics and Outcomes Research) covers the evidence generation and economic modelling activities that support market access and reimbursement decisions. It includes cost-effectiveness analysis, budget impact modelling, quality of life measurement, systematic evidence reviews, and real-world evidence studies — all designed to demonstrate the clinical and economic value of a therapy to HTA bodies, payers, and formulary committees.
02
How does HTA impact drug approval?
HTA bodies review clinical and economic evidence to determine whether a new therapy provides sufficient added benefit over existing treatments to justify reimbursement at its proposed price. A positive HTA decision is required for national reimbursement in countries including the UK (NICE), France (HAS), Germany (IQWiG/G-BA), and Australia (PBAC). Without reimbursement, patient access is severely limited even after regulatory approval.
03
What is cost effectiveness analysis?
Cost-effectiveness analysis compares the costs and health outcomes of a new therapy against an existing treatment. The result is expressed as an incremental cost-effectiveness ratio — typically cost per quality-adjusted life year (QALY) gained. HTA bodies compare this ratio against their willingness-to-pay threshold to determine whether the therapy represents value for money for the health system.
Related Services
Complete the Access Strategy
Bundle this with the wider evidence and access programme — coordinated from one team.
Ready to build your HTA case?
Speak to our team about your programme requirements. We respond within one business day.