Global Value Dossier (GVD) Services
Comprehensive Evidence Package for Market Access & Reimbursement Success
A Global Value Dossier (GVD) is a strategic evidence-based document that consolidates clinical, economic, and humanistic value data to support payers, health technology assessment (HTA) agencies, and reimbursement decision-makers worldwide. It serves as a cornerstone of market access strategy, ensuring that healthcare stakeholders understand the value proposition of a pharmaceutical product, medical device, or healthcare intervention.
At Clievi, we specialize in developing high-quality, globally aligned GVDs that comply with HTA and payer expectations across diverse regulatory landscapes. Our methodologically robust, scientifically sound, and regulatory-compliant GVDs facilitate smooth submissions and enhance the probability of favorable reimbursement decisions.
Key Components of Our Global Value Dossier (GVD) Services
1. Strategic Literature Review & Evidence Synthesis
A well-structured GVD requires a comprehensive evidence base derived from systematic literature reviews (SLRs), meta-analyses, real-world evidence (RWE), and health economic modeling. Our approach includes:
- Systematic Literature Review (SLR) for Clinical and Economic Outcomes – Identifying pivotal studies from PubMed, Embase, Cochrane, HTA reports, and clinical trial registries.
- Comparative Effectiveness Research (CER) and Meta-analysis – Conducting quantitative evidence synthesis to compare treatment options.
- Real-World Evidence (RWE) Integration – Leveraging electronic health records (EHRs), insurance claims, and patient registries to complement clinical trial data.
- Burden of Disease and Unmet Need Analysis – Highlighting epidemiological data, quality-of-life measures (QoL), and treatment gaps.
2. Clinical Value Proposition & Comparative Effectiveness Data
A robust GVD demonstrates superiority or non-inferiority of a product compared to existing standards of care. Our services include:
- Clinical Outcomes Summary – Structured presentation of efficacy, safety, and tolerability data from pivotal Phase II, III, and IV trials.
- Network Meta-analysis (NMA) for Indirect Comparisons – Conducting Bayesian and Frequentist NMAs to compare multiple treatment options.
- Quality-of-Life (QoL) and Patient-Reported Outcomes (PROs) – Incorporating validated HRQoL instruments (EQ-5D, SF-36, SF-12, EORTC QLQ-C30).
- Subgroup and Sensitivity Analyses – Identifying patient populations with optimal treatment response.
3. Economic Modeling & Cost-Effectiveness Analysis
Health technology assessment (HTA) agencies require robust economic evaluations to determine reimbursement and pricing strategies. Our expertise includes:
- Cost-Effectiveness Analysis (CEA) & Cost-Utility Analysis (CUA) – Demonstrating incremental cost-effectiveness ratios (ICERs) and QALY gains.
- Budget Impact Modeling (BIM) – Estimating financial implications of adopting a new intervention within different healthcare systems.
- Price Sensitivity & Threshold Analysis – Identifying willingness-to-pay (WTP) thresholds in global markets.
- Health Economics & Outcomes Research (HEOR) Integration – Aligning economic evidence with payer expectations in key markets.
4. Value Story Development & Stakeholder Engagement
An effective Global Value Dossier (GVD) tells a compelling value story that resonates with payers, policymakers, and HTA reviewers. We provide:
- Global Value Narrative Development – Crafting differentiated, evidence-based messaging tailored to market needs.
- HTA Submission-Ready Documents – Aligning dossier content with NICE, CADTH, ICER, PBAC, HAS, and G-BA requirements.
- Customization for Local Adaptations – Preparing AMCP dossiers, country-specific payer submissions, and reimbursement dossiers.
- Stakeholder Communication Strategy – Supporting value communication, payer engagement, and advisory board discussions.
Applications of Global Value Dossier (GVD) in Market Access
Our GVD services are essential for:
- Pharmaceutical and Biotech Companies – Facilitating drug pricing, reimbursement, and formulary inclusion.
- Medical Device and Digital Health Companies – Supporting regulatory submissions and market access.
- Health Technology Assessment (HTA) Agencies – Assisting in evidence evaluation and healthcare decision-making.
- Payers and Insurers – Providing cost-effectiveness and budget impact analyses to support reimbursement decisions.
- Regulatory and Market Access Teams – Strengthening HTA submissions, negotiation strategies, and commercialization plans.
Why Choose Clievi for Global Value Dossier (GVD) Services?
- Expert-Led Evidence Synthesis – Our team includes health economists, epidemiologists, biostatisticians, and regulatory professionals.
- HTA-Compliant Dossiers – Aligning with global and regional payer requirements (NICE, CADTH, ICER, PBAC, EMA, FDA, G-BA, HAS).
- Advanced Statistical and Economic Modeling – Incorporating network meta-analysis (NMA), cost-effectiveness modeling, and real-world evidence (RWE) analytics.
- Customizable Market-Specific Adaptations – Ensuring seamless global-to-local dossier transitions.
- Regulatory-Ready, Submission-Optimized Content – Delivering publication-grade GVDs for HTA and payer submissions.
Key Databases and Sources We Utilize
To develop high-impact, evidence-driven GVDs, we extract and analyze data from:
- Clinical and Biomedical Literature – PubMed, Embase, Cochrane, Scopus, Web of Science
- Clinical Trial Databases – ClinicalTrials.gov, EU Clinical Trials Register, WHO ICTRP
- Health Technology Assessment (HTA) Reports – NICE, CADTH, ICER, PBAC, HAS, G-BA
- Regulatory Agencies – EMA, FDA, MHRA, TGA, Health Canada
- Real-World Data (RWD) and Epidemiological Sources – EHRs, claims data, patient registries
- Health Economics & Outcomes Research (HEOR) Repositories – ISPOR, Tufts CEA Registry, AMCP dossiers
Get in Touch
Ensure your Global Value Dossier (GVD) meets payers’ evidence expectations and HTA standards with Clievi’s comprehensive, data-driven, and globally adaptable solutions.
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Website: www.clievi.com