
Empowering pharmaceutical and biotech companies from early evidence planning to global HTA submissions with integrated, decision-focused HEOR.
We help pharmaceutical companies showcase the clinical and economic impact of innovative therapies through robust, evidence-driven health economics and outcomes research. Our team leverages advanced analytics, real-world data, and strategic expertise to strengthen market access and reimbursement strategies.
Qualified Consultants
Client Satisfaction Rate
Disease Areas Covered
Markets Served
End-to-end health economics and outcomes research solutions designed to support every stage of your product's lifecycle, from Phase II through global HTA submissions and beyond.
Rigorous CEA and cost-utility models (CUAs) that quantify the incremental value of your treatment versus comparators, built for HTA submissions and payer negotiations..
Key Capabilities:
Payer-facing BIA models that project the financial consequences of adopting your therapy into a health system's formulary, supporting formulary listing and pricing negotiations.
Key Capabilities:
Comprehensive, PRISMA-compliant SLRs and meta-analyses to synthesize the existing evidence base and identify data gaps, forming the foundation for all HEOR deliverables.
Key Capabilities:
Retrospective and prospective real-world evidence (RWE) studies leverage claims databases, EHRs, and patient registries to complement clinical trial findings with real-world outcomes.
Key Capabilities:
Robust PRO strategy, instrument selection, and analysis to capture the patient perspective — supporting label claims, clinically meaningfulness arguments, and value dossiers.
Key Capabilities:
Country-specific HTA planning and value dossier development aligned with agency requirements, from early scientific advice through full submission and post-launch optimization.
Key Capabilities:
Every HEOR deliverable is grounded in a systematic, transparent, and reproducible evidence framework, meeting the standards of global regulatory and HTA agencies.
All outputs meet NICE DSU, ISPOR, and ICER transparency standards with full audit trails and documentation packages.
PhD economists, biostatisticians, epidemiologists, and HTA strategists, all in-house and working as one cohesive team on your project.
Deep expertise across NICE, G-BA, HAS, TLV, AIFA, PBAC, and other major HTA bodies with local market access insight.
Beyond the model, we align your HEOR evidence package with payer value stories, pricing strategies, and access timelines from day one.
Advanced analytics and real-world evidence generation provide actionable insights beyond traditional health economics.
From protocol development to evidence communication, we support you throughout the product lifecycle with integrated HEOR solutions.
Deep disease-area knowledge allows us to build more credible models, ask the right clinical questions, and construct value arguments that resonate with payers and HTA agencies.
HEOR evidence that drives market access and commercial success
Oncology - Advanced NSCLC
Challenge
A pharmaceutical client needed to demonstrate the cost-effectiveness of their innovative targeted therapy for advanced non-small cell lung cancer (NSCLC) acrossmultiple HTA jurisdictions with varying methodological requirements and willingness-to-pay thresholds.
Solution
We developed a comprehensive partitioned survival model incorporating biomarker testing strategies, treatment sequencing, and long-term survival extrapolation. The model was adapted for UK (NICE), Canada (CADTH), Australia (PBAC), Germany (IQWiG), and France (HAS) with jurisdiction-specific inputs, comparators, and sensitivity analyses. We conducted targeted literature reviews, clinical expert elicitations, and utility studies to populate the model with robust evidence.
Outcome
Achieved positive reimbursement recommendations in all 5 target markets within 18 months of launch. The economic model demonstrated ICERs within acceptable thresholds, and our comprehensive value dossiers addressed payer concerns regarding long-term efficacy and treatment sequencing. The client reported that our HEOR evidence was instrumental in securing formulary access and premium pricing.
Key Matrix
100% HTA success rate across 5 jurisdictions
$450M incremental revenue in year 2
18-month timeline from launch to full reimbursement
Published in high-impact health economics journal
Immunology - Rheumatoid Arthritis
Challenge
Despite strong clinical trial data, payers questioned whether a new biologic for rheumatoid arthritis would deliver similar effectiveness in real-world settings with less selected patient populations. The client needed real-world evidence to support value claims and differentiate from established competitors.
Solution
We designed and executed a large-scale retrospective cohort study using claims data from 3 major US payers, analyzing over 8,000 patients initiating biologic therapy. We employed propensity score matching to control for baseline differences and conducted comparative effectiveness analyses examining treatment persistence, healthcare utilization, and economic outcomes. Additionally, we linked claims data with patient-reported outcomes to assess quality of life improvements.
Outcome
The study demonstrated significantly higher treatment persistence (HR 0.72, p<0.001) and reduced all-cause healthcare costs (-$3,200 per patient per year) compared to standard biologic therapies. Findings were presented at ACR and published in a leading rheumatology journal. The real-world evidence strengthened payer negotiations, resulting in improved formulary positioning and removal of step-therapy requirements in 3 major health plans representing 15M covered lives.
Key Matrix
8,000+ patient retrospective cohort
$3,200 annual cost savings per patient
28% improvement in treatment persistence
Formulary wins covering 15M lives
Cardiovascular - Heart Failure
Challenge
A client preparing to launch a novel therapy for heart failure with reduced ejection fraction needed to understand the budget impact across diverse payer types and develop a pricing strategy that balanced value capture with payer affordability concerns in a competitive market.
Solution
We developed a sophisticated budget impact model incorporating epidemiological inputs, market share projections, treatment patterns, and cost offsets from reduced hospitalizations. The model included scenario planning capabilities allowing exploration of different pricing points, uptake curves, and patient selection strategies. We conducted payer interviews to validate assumptions and understand decision-making priorities. The model was designed with an interactive interface for use by commercial and market access teams.
Outcome
The budget impact analysis informed a launch price 12% higher than initially planned, demonstrating that cost offsets from reduced heart failure hospitalizations would result in net budget neutrality for most payers within 3 years. The interactive model became a key sales tool during payer negotiations. Within the first year, the therapy achieved formulary access with 85% of targeted commercial and Medicare Part D plans, exceeding internal forecasts by 20%.
Key Matrix
12% higher launch price achieved
Budget neutrality demonstrated by year 3
85% formulary access in year 1
20% above forecast market access success
Rare Disease - Lysosomal Storage Disorder
Challenge
For an ultra-rare disease therapy, the client faced the complex challenge of preparing HTA submissions across 12 countries simultaneously, each with unique evidentiary requirements, while working with limited clinical data typical of rare disease development programs.
Solution
We created a comprehensive global value dossier serving as the evidence foundation for all country-specific submissions. This included systematic literature reviews, a de novo cost-utility model, utility elicitation studies with patients and caregivers, budget impact analyses, and value frameworks addressing ethical considerations for rare diseases. We established an evidence generation plan addressing identified gaps and coordinated with local HEOR partners for country adaptations. The dossier incorporated innovative methodologies appropriate for small populations including Bayesian approaches and managed entry agreements.
Outcome
Successfully supported HTA submissions in 12 countries across Europe, North America, and Asia-Pacific. Achieved positive reimbursement recommendations in 10 of 12 countries (83% success rate), with 2 countries entering managed entry agreements pending additional data collection. The global value dossier approach reduced preparation time by 40% compared to developing independent submissions and ensured consistency in value messaging. The therapy achieved orphan drug designation and premium pricing reflecting its transformative value.
Key Matrix
83% HTA success rate (10 of 12 countries)
40% reduction in submission preparation time
Consistent premium pricing across markets
2 innovative managed entry agreements
We embed ourselves as an extension of your internal HEOR team, not a vendor, but a strategic partner invested in your evidence success from pre-commercialisation through post-launch life-cycle management.
01
We start with a deep dive into your compound's clinical programme, payer landscape, and HTA timelines to define a tailored HEOR evidence plan aligned to your commercial strategy.
02
Transparent, pre-registered study protocols and model specifications are co-developed with your team, ensuring methodological alignment before work begins.
03
From SLR through RWE analysis and economic modelling, we execute with rigour, providing regular progress updates and shared working document access throughout.
04
All economic models undergo internal validation and optional independent external review, with full technical reports and model documentation packages for HTA submission.
05
Deliverables are produced in submission-ready formats with plain-language summaries, payer-facing slide decks, and scientific publication packages as needed.
06
We provide post-submission query response support, model updates for new clinical data, and life-cycle management of your HEOR evidence package through re-assessment cycles.
Their team's deep understanding of NICE methodology and willingness to engage in pre-submission scientific advice preparation was invaluable. We secured a positive recommendation on the first cycle.
Dr. Sara Mitchell
Head of Market Access
Global Pharma Company
The modular GVD approach saved us 6 months of timeline and significantly reduced the cost of adapting our core model for 7 European markets. Best-in-class HEOR delivery.
James Richardson
VP HEOR
Regional Biotechnology Company
From our Phase II evidence gap analysis through to our NICE and G-BA submissions, they were a true strategic partner at every critical stage of development. The quality of scientific thinking is exceptional.
Dr. Elena Rodriguez
Chief Medical Officer
Specialty Biopharma
Whether you're planning your first HTA submission or expanding into new markets, our team is ready to help you develop a winning, evidence-based value story.
Get in Touch
Address
63, M3M 113 Market, Sector 113, Gurugram, Haryana-122017, India
Phone
USA: +14699457679
India: 124-4147595, +91-9650213330
info@delveinsight.com
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