HEOR, Value & Evidence

Global HTA expertise with over 20 years of experience translating complex, country-specific requirements into high-impact submissions across major markets. By combining strategic insight, advanced analytics, ITCs and economic modelling, we deliver strategically aligned, evidence driven outcomes to support successful reimbursement decisions, market access, and payer negotiations.

• Country-specific submissions and support:
  • Pre-submission strategy and health technology assessment (HTA) early engagement
  • Dossier development and supportive activities such as systematic literature reviews (SLRs)
  • De novo or adapted indirect-treatment comparison (ITC) and statistical support
  • De novo economic model development or adaptation (cost-effectiveness model [CEM] and budget impact model [BIM])
  • Post-submission responses to HTA comments
  • Meeting preparation and attendance
• End-to-end, full-service support for National Institute for Health and Care Excellence (NICE) and Canadian HTA submissions
• Experience in virtually all therapeutic areas for both pharmaceuticals and medical devices.
• Diverse perspectives from former HTA staff, biostatistics experts, and global thought leaders in ITCs, including authors on international and Canadian guidelines, globally-experienced modelers, and certified medical writers who are requested to provide insights for policies for HTA agencies.

Comprehensive JCA advice and execution spanning end-to-end services including strategy, evidence generation, full dossier development, and submission. Our team has direct practical experience delivering compliant and successful submissions.

• PICOS planning and structured validation of approach through iterative consultations with clinical experts and affiliates.
• AI tools for agile support in exploring multiple PICO scenarios.
• Pre-JCA clinical trial design support and joint scientific consultation (JSC) support.
• Analogue identification.
• Rapid, iterative clinical systematic literature review (SLR) and indirect-treatment comparison (ITC) approach aligned with JCA standard requirements.
• JCA dossier development and writing.
• JCA objection handler.
• Post-submission support (e.g., country-specific health technology assessment [HTA] dossiers).
• EVERSANA is one of only a few consultancies supporting multiple JCA dossier submissions.

We support approximately one-third of all Canadian HTA submissions reflecting our depth of expertise, high-quality strategy, robust technical expertise, and comprehensive understanding of Canada’s market access ecosystem.

• End-to-end, full-service support for Canadian HTA submissions:
  • Market access and pricing strategy
  • HTA and private payer dossier development
  • Clinical dossier including Sponsor Summary of Evidence template for CDA-AMC and clinical summary (for INESSS and private payers)
  • Cost-utility analysis (CUA) – de-novo or adaptation from global CUAs
  • Pan-Canadian budget impact analysis (BIA) – de-novo or adaptation
  • Clinical key opinion leader (KOL) consultation
  • Advisory boards
  • Clinician and patient advocacy support
  • Pan-Canadian Pharmaceutical Alliance (pCPA) negotiation support
• CDA-AMC, INESSS, private payers, public drug programs, biosimilar submissions, line extension submissions, new format submissions.
• Experience in a broad array of therapeutic areas, pharmaceuticals, and medical devices.
• Former CDA-AMC staff, biostatistics experts, world-class modelling, and top medical writers, including authors on international and Canadian guidelines.

Our US HEOR services translate clinical evidence into compelling payer value by demonstrating real-world effectiveness, quantifying economic impact, and aligning evidence to the needs of payers, ICER, and health systems. We support informed coverage, reimbursement, and access decisions across a broad range of therapies including CAR-T, cell and gene therapy, 505(b)(2), radiopharmaceutical, medical device or diagnostic test.

• Unapproved and approved AMCP dossiers.
• Pre-approval information exchange (PIE) decks.
• Epidemiology population calculators.
• Budget impact models (BIMs), cost-offset models, and Salesforce models.
• Outcomes-based contracting tools.
• Integrated evidence generation plans.
• Delphi panels and publications; patient and physician surveys.
• Prospective studies and registries.
• Workflow efficiency studies (ie, time and motion).
• US real-world evidence (RWE) analytics.
• Institute for Clinical and Economic Review (ICER) preparedness and response.
• CMS dossiers for Inflation Reduction Act (IRA) negotiations.
• Hospital formulary kits.
• Manuscripts and conference presentations.

We deliver rigorous and transparent economic models that demonstrate value and support evidence-based decision-making across clinical development, market access, and reimbursement with robust technical report documentation.

• Global model development and local adaptations for HTA submissions.
• Transparent, validated models with stakeholder-ready interfaces and documentation.
• Cost-effectiveness models (CEMs) and cost-utility analyses (CUAs):
  • Markov and state transition models
  • Partitioned survival models (PSM)
  • Patient simulation/microsimulation models and discrete event simulation (DES) models
  • Advanced survival modeling including mixture cure approaches
• Budget impact models (BIMs), including interactive field tools and dashboards
• Cost-minimization, cost-consequence, cost-offset, and cost of illness models
• Economic, societal, and health system impact models: burden of illness, capacity, social return on investment (SROI), environmental impact

EVERSANA’s medical writers develop persuasive and compelling communications that demonstrate value to key decision-makers. Collaborating across multidisciplinary teams, they integrate evidence synthesis, biostatistics, and economic modelling, leveraging advanced scientific training and certification such as American Medical Writers Association (AMWA).

• Global value dossiers (GVDs), core value dossiers (CVDs), and summary value dossiers.
• Unapproved and approved AMCP dossiers; pre-approval information exchange (PIE) decks.
• Strategic support for Joint Clinical Assessment (JCA) dossiers and national health technology assessment (HTA) submission dossiers (eg, NICE, CDA-AMC, etc.).
• Value message platform development and testing.
• Value briefs and infographics.
• Objection handlers and frequently asked questions (FAQ) documents.
• Peer-reviewed publications including conference abstracts, posters, scientific publications.
• Support for formal medical, legal, and regulatory (MLR) review.

Our seasoned staff are authors on PRISMA indirect treatment comparison (ITC) guidelines, deliver workshops and panels at major conferences, conduct ITC training for the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and lead global ITC programs and real-world evidence (RWE) studies.

• Feasibility assessments for real-world evidence programs, global ITC programs, ITCs for Joint Clinical Assessments (JCA), and ITCs for post-launch publications:
  • ITCs, including network meta-analysis (NMA), matching adjusted indirect comparison (MAIC), simulated treatment comparison (STC), multi-level network meta-regression (ML-NMR).
• Meta-analysis and surrogate analysis/validation studies.
• Causal inference and advanced analytic modeling, including propensity score methods (PSM), g computation, regression analyses, and interrupted time series designs.
• Statistical support for economic models, including utility mapping, estimating health state utility values, psychometric analyses of patient-reported outcomes (PROs).
• Real-world evidence (RWE) services: feasibility assessments, data management, protocol development, and execution for external control arms (ECA), burden of illness (BOI) studies, cost of care, analyses of claims/transactional data, and retrospective cohort studies (e.g., using claims and electronic medical records).
• Technical writing including protocols, statistical analysis plans (SAPs), technical reports, publications.
• Strategic support including HTA and regulatory readiness planning, ITC critical appraisals, and objection handling for ITCs and RWE.

Our expert team provides end-to-end solutions, from protocol development through publication-ready outputs. Our literature reviews are tailored to the specific evidentiary standards of downstream needs including regulatory, reimbursement, and EU Joint Clinical Assessment (JCA) submissions, indirect treatment comparisons (ITCs), and payer evidence dossiers.

• Comprehensive systematic literature reviews (SLRs) including:
  • Multi-database searches performed by experienced information specialists and peer-reviewed using the PRESS checklist
  • Full internal protocol development (in accordance with PRISMA-P guidance), with option for PROSPERO registration
  • Quality assessment/risk of bias conducted with industry-standard tools
  • Comprehensive reporting in accordance with PRISMA statement
• Targeted literature reviews (TLR):
  • Tailored reviews to rapidly address key market access questions
  • Flexibility to increase or reduce rigour of the review according to product needs
• Umbrella reviews (SLR of SLRs) and scoping reviews to assess evidence gaps.
• In-depth feasibility assessments to support recommendations for meta-analyses and ITCs:
  • ITCs include but are not limited to: network meta-analyses (NMAs), matching-adjusted indirect comparisons (MAICs), simulated treatment comparisons (STCs).
• Strategic investments to offer AI-enabled evidence synthesis solutions.
• • In-house large-language model (LLM) tool development and partnerships with external SLR platforms.

Integrated evidence gap analysis and generation planning to strengthen clinical and value narratives across the product lifecycle. Leveraging extensive experience in HTA and reimbursement environments, our team identifies, demonstrates, and communicates insights to maximize decision making and market access.

• Targeted literature reviews (TLRs) and systematic literature reviews (SLRs).
• Evidence gap assessments (EGAs) and integrated evidence generation plans (EGPs/iEGPs) to inform commercial launch strategy, medical affairs strategy, and payer strategy.
• Internal cross-functional stakeholder workshops (eg, Market Access, Medical Affairs, Commercial, etc.) for alignment and evidence generation prioritization.
• External clinician and payer key opinion leader (KOL) surveys, interviews, advisory boards for perspectives on evidence gaps and evidence synthesis needs.
• External control arm and indirect-treatment comparison (ITC) feasibility assessments.
• Review of clinical trial design landscape to inform clinical program development, comparator and outcome/endpoint selection, patient-reported outcome (PRO) evidence planning.
• Health technology assessment (HTA) and payer evidence requirements mapping.
• Product lifecycle and real-world evidence (RWE) strategy development.

Our specialized team supports the demonstration of medical device value and differentiation across complex US reimbursement device categories. We develop stakeholder-specific value propositions and deliver evidence-based insights to optimize product adoption, utilization, and reimbursement throughout the lifecycle.

• Health economic sales aids (2-pagers)
• Value Analysis Committee Packages (VAC Packs)
• Support with HTA submissions
• Health economic models, cost-calculators, and salesforce models
• Systematic reviews, meta-analyses and indirect treatment comparisons (ITCs)
• Global value dossiers and abbreviated value dossiers (NAMCP)
• Pre-approval information exchange (PIE) decks and unapproved product dossiers
• Delphi panels and publications
• Patient and physician surveys
• Prospective studies and registries
• Workflow efficiency studies (ie, time and motion), including video-analysis
• Hospital formulary kits
• Manuscripts and conference presentations